Browse by Year
/ 2003
/ October
/ Monday, October 27, 2003
[Federal Register: October 27, 2003 (Volume 68, Number 207)]
[Notices]
[Page 61281-61300]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc03-119]
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Part III
Department of Health and Human Services
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Center for Disease Control and Prevention
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HIV/AIDS Surveillance; Notice
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
HIV/AIDS Surveillance
Announcement Type: New.
Funding Opportunity Number: Program Announcement 04017
Catalog of Federal Domestic Assistance Number: 93.944
Key Dates: Letter of Intent Deadline: None. Application Deadline:
January 16, 2004.
I. Funding Opportunity Description
Authority: This program is authorized under the Public Health
Service Act sections 301 (42 U.S.C. 241); 318b (42 U.S.C. 247c-2),
as amended.
Purpose: The purpose of the program is to monitor the HIV epidemic
through core surveillance of HIV/AIDS cases; HIV incidence; HIV
behavioral surveillance; capacity building for epidemiologic and
program evaluation activities; enhanced surveillance for perinatal
prevention; for special evaluations of these HIV Surveillance programs;
and supplemental projects to assess surveillance of transmission of
atypical strains of HIV, including antiretroviral drug resistant virus;
unusual modes of transmission of HIV; and assessments of HIV
prevalence. FY 2004 is the first year of a three-year project period.
Recipients may implement certain required or supplemental activities in
years one, two or three, depending on eligibility criteria and when HIV
case surveillance activities have been, or will be implemented.
Recipients will need to submit a competitive application for each
supplemental project described in Parts IV and V of this announcement
in the year in which funds are requested. See further discussion on
this subject in Parts IV and V. This program addresses the ``Healthy
People 2010'' focus area for HIV.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for HIV/STD/TB
Prevention (NCHSTP): Strengthen the capacity nationwide to monitor the
epidemic, develop and implement effective HIV prevention interventions
and evaluate prevention programs.
Part I. Core Surveillance
AIDS case surveillance is conducted in all States and U.S.
Territories, and the cities of Chicago, Houston, Los Angeles, New York,
Philadelphia, and San Francisco. HIV infection case surveillance is not
yet conducted in all States or territories, but CDC recommends that all
areas should conduct HIV infection case surveillance as an integrated
component of their HIV/AIDS surveillance activities. The National HIV/
AIDS Surveillance System is the primary source of population-based
information on persons with HIV/AIDS in the United States.
The primary purpose of providing cooperative agreement funds for
the core HIV/AIDS Surveillance program is to assist all State and
territorial health departments to conduct the following activities:
1. Monitor the number of annual cases of HIV diagnosed, the
prevalence of persons living with HIV infection, and HIV-related
morbidity (including AIDS) and mortality in adults, adolescents and
children.
2. Monitor perinatal exposure to HIV and HIV infection in infants.
3. Monitor behaviors related to HIV testing, risks/exposure to HIV
infection, and access to care in HIV-infected populations.
4. Identify changes in trends of HIV transmission.
5. Assist State and local health departments to use these data as a
guide for allocation of many federal resources for HIV treatment, care,
and other services provided to HIV-infected persons and affected
communities, and for prevention and treatment services planning and
evaluation.
6. Evaluate the performance of HIV/AIDS surveillance systems.
7. Implement projects to supplement the information available
through HIV and AIDS case reporting to enhance and extend the ability
of States and local areas to plan for public health programs.
Part II. HIV Incidence Surveillance
The purpose of HIV Incidence Surveillance is to provide reliable
and scientifically valid estimates of the number of newly acquired
infections at the local, State, territorial, and national level. The
purpose of CDC funding for this activity is to provide support to
State, territorial and local health departments for development of the
infrastructure in newly funded areas, and expansion of activities in
areas previously funded for this activity, to incorporate HIV incidence
estimation into HIV Surveillance. The ultimate goal is for States,
territories, and the separately funded cities to be able to:
1. Collect and test the diagnostic blood specimens from all newly
diagnosed HIV infections reported from public and private laboratories
and providers to HIV Surveillance.
2. Collect the HIV testing information needed for the statistical
estimates of incidence.
3. Calculate population-based estimates of HIV incidence.
4. Use these to identify emerging epidemics, monitor trends in
transmission, target prevention resources and interventions to areas
and populations most heavily affected, and evaluate programs designed
to prevent the transmission of HIV.
Part III. Capacity Building for Epidemiologic and Program Evaluation
Activities
There are multiple sources of data available to health departments
that can be analyzed to guide program planning and assess the impact of
HIV prevention programs in a health department's jurisdiction. These
include surveillance, program evaluation and data from special
projects. There are systems and guidances in place for various data
sets. Opportunities to use these data are often not exploited to better
assess HIV status and prevention efforts in a jurisdiction because of
the limited availability of trained and dedicated personnel with the
capacity to collectively or comprehensively analyze and synthesize
these types of information.
The purpose of providing funds for this activity is to improve the
epidemiologic, evaluative, analytic, and dissemination capabilities of
health departments that currently have limited resources. The specific
purpose of this support is to allow health departments to hire
dedicated, professional staff. Staff employed through this funding will
assist health departments to develop and implement a more integrated
use of these independent, but related data sets by:
1. Analyzing and interpreting HIV/AIDS surveillance and other
health-related data to describe the HIV/AIDS epidemic within their
jurisdiction in terms of person, place and time for various
populations.
2. Producing consolidated epidemiologic profiles that meet the
needs of both CDC-supported HIV prevention planning programs and HRSA-
supported HIV care planning programs.
3. Collecting, analyzing, interpreting, and disseminating
surveillance, program, and other health-related data to assess the
effectiveness of HIV prevention efforts.
4. Providing technical assistance to community planning groups on
the use of HIV and other public health data for program planning and
evaluation.
5. Collaborating with CDC to develop the systematic collection and
analysis of
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community-related and program data which can be used with HIV/AIDS
surveillance data to track progress towards goals identified in CDC's
HIV Prevention Strategic Plan (http://www.cdc.gov/nchstp/od/hiv_plan/default.htm
).
Part IV. Enhanced Surveillance for Perinatal Prevention
The purpose of providing funds for this activity is to target and
follow the progress toward maximal reduction of perinatal HIV
transmission. Specifically, this support is to allow State and local
health departments to evaluate (1) the impact of implementation of
efforts to maximally reduce perinatal HIV transmission; (2) prevention
failures for perinatal HIV transmission; (3) the efficacy of zidovudine
(ZDV) and other antiretroviral medications in preventing perinatal HIV
transmission; (4) potential adverse outcomes of perinatal and postnatal
antiretroviral therapy; and (5) the Public Health Service
recommendations for opportunistic infection prophylaxis by:
1. Conducting medical record reviews of mother/infant pairs and
longitudinal follow-up of all HIV exposed children to ascertain
knowledge of maternal HIV infection status before birth, HIV incidence,
AIDS incidence, and death, the use of maternal and neonatal ZDV and its
efficacy in preventing HIV transmission, and the use of other
antiretroviral medications.
2. Conducting medical record reviews to evaluate recommendations
for opportunistic infection prophylaxis and initiation of HIV
evaluation and treatment in children.
3. Assessing potential adverse outcomes of exposure to
antiretroviral medications among infected and uninfected children in
the short term (e.g., birth defects, ascertained through record reviews
and registry matches) and in the long term (e.g., by matching to tumor
registries).
4. Matching HIV/AIDS registries to birth registries to ensure
complete ascertainment of mother/infant pairs.
5. Collaborating with CDC to track progress towards the maximal
reduction of perinatal HIV transmission.
Part V. Laboratory Testing for Recent HIV Infection
The Serologic Testing Algorithm for Recent HIV Seroconversion
(STARHS) is the currently accepted method used for estimation of HIV
incidence. With STARHS, confirmed HIV-positive samples are analyzed
with a Less Sensitive HIV Enzyme-Linked Immunosorbent Assay (LS-EIA)
which identifies antibodies at a point later in the course of infection
than the routine test. In performance of STARHS, the standard testing
methodology for a commercially available HIV Enzyme-Linked
Immunosorbent Assay (EIA) is altered by reducing the incubation time
and increasing the dilution of the sample according to extremely
precise criteria. Quantitative values from these tests are evaluated
against control values and cut-off points to estimate the likelihood
that that sample was collected from an individual who was infected with
HIV within a finite period of time before the sample was collected.
Because the testing procedures must be conducted with extreme
precision, multiple control samples are run in tandem with each sample
run. Other tests to identify recent HIV infection are currently being
developed. In order to adopt those for more widespread use, new tests
will need to be run on samples tested with the existing method to
validate the new methodology.
STARHS has not been approved by the Food and Drug Administration
(FDA) for routine use. STARHS is conducted under an Investigational New
Drug/Device (IND) authorization from the FDA which allows for testing
in controlled settings in which performance is closely monitored and
data with regard to unforeseen adverse events and aggregate results are
reported through CDC. All IND laboratories are required to participate
in a quarterly proficiency testing program administered by CDC. A
limited number of laboratories participate in the CDC-sponsored IND.
Since 1999, CDC has supported six health department laboratories to
conduct the STARHS on stored, un-linked HIV-positive samples from HIV
testing programs and research projects. This testing was for research
purposes, therefore, it was not necessary to complete testing and
return test results quickly. Laboratories were allowed to hold
specimens, run them in batches, and schedule testing to accommodate the
time requirements for their other work. For HIV Incidence Surveillance,
laboratories will be required to return results to submitting health
departments quickly. The current laboratory protocol allows for either
manual or automated dilution and processing. For this activity, only
laboratories that agree to use automated methods will be supported in
order to maximize the number of tests they will be able to process and
to optimize the accuracy and consistency of STARHS results.
Laboratories will be selected to maximize efficiency, ensure timely
availability of test results for all geographic areas and to
standardize methodology.
Part VI. Behavioral Surveillance
CDC's HIV/AIDS Strategic Plan has identified that monitoring
behaviors that place people at risk for HIV infection is a key element
of an integrated surveillance system. Measures of behavior are
necessary to quantify progress in the plan's objectives. In addition,
the plan identifies that studies of HIV incidence in special
populations, including populations at high risk for infection, are an
important strategy to provide locally relevant data for prevention
resource allocation. The objectives of this program are to develop an
ongoing surveillance system to ascertain the prevalence of HIV risk
behaviors among groups at high risk for HIV infection for use in
developing and directing national prevention services and programs; and
to evaluate the impact of a variety of prevention efforts.
This announcement provides an opportunity to capitalize on
experience recruiting at-risk individuals from non-healthcare community
settings using a scientifically sound methodology to develop an ongoing
system for surveillance of behaviors related to HIV acquisition. This
system will assess risk behaviors and trends in behaviors over time
among adults 18 years old and older at high risk for HIV infection
through sexual behavior between men and injection drug use. These
studies may be expanded to include high risk heterosexuals. In
addition, access to and utilization of HIV prevention programs,
including HIV testing, will be assessed. Each funded site will be
expected to enroll at least 500 Men Who Have Sex with Men (MSM) and 500
Injection Drug Users (IDUs). Funded sites will also be expected to
collaborate with CDC directly funded community-based organizations
(CBOs) and CBOs funded by States/cites through the community planning
process for allocating Federal HIV prevention funds, schools of public
health, universities, ethnographers and behavioral scientists.
Part VII. Core Surveillance in the Pacific Island Jurisdictions
AIDS case surveillance is conducted in all U.S. dependencies,
possessions, and independent nations that make up the six Pacific
Island jurisdictions referred to as the Pacific Island Jurisdiction
AIDS Advisory Group (PIJAAG). These islands and island groups are
American Samoa, Guam, Marshall Islands, Palau, the Commonwealth of the
Northern Mariana Islands and the Federated States of
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Micronesia. HIV infection case surveillance is not yet conducted in all
these areas, but CDC recommends that all areas should conduct HIV case
surveillance as an integrated component of their HIV/AIDS surveillance
activities. However, there are substantial public health, logistical
and medical infrastructure challenges to conducting core surveillance
in these island jurisdictions.
The objective of this proposal is to support the infrastructure and
activities necessary to enable newly identified HIV/AIDS cases to be
reported to the Centers for Disease Control and Prevention's Statistics
and Data Management Branch. Preparatory to this end, each island
jurisdiction must be authorized by local public health law, rule or
regulation to collect and report the necessary medical and socio-
demographic information to the CDC. A letter, signed by the
jurisdiction's senior public health official, must be sent to Dr.
Matthew McKenna, Chief for Informatics, HIV Incidence and Case
Surveillance Branch (HICSB) declaring the jurisdiction's intent to
report previously unidentified HIV/AIDS cases to the CDC. Also a copy
of the jurisdiction's legal authority to report HIV/AIDS cases to the
CDC will be needed.
The primary purpose of providing cooperative agreement funds for
the core HIV/AIDS Surveillance program is to assist all State and
territorial health departments to conduct the following activities:
1. Monitor the number of annual cases of HIV diagnosed, the
prevalence of persons living with HIV infection, and HIV-related
morbidity (including AIDS) and mortality in adults, adolescents and
children.
2. Monitor perinatal exposure to HIV and HIV infection in infants.
3. Monitor behaviors related to HIV testing, risks/exposure to HIV
infection, and access to care in HIV-infected populations.
4. Identify changes in trends of HIV transmission.
5. Assist territorial and local health departments to use these
data as a guide for allocation of many federal resources for HIV
treatment, care, and other services provided to HIV-infected persons
and affected communities, and for prevention and treatment services
planning and evaluation.
6. Conduct basic evaluation and quality control assessment of the
surveillance data collected.
Activities
Awardee activities for this program are as follows:
Part I. Core Surveillance
Recipient Activities
1. Plan and conduct HIV/AIDS surveillance activities in
collaboration and coordination with CDC, and, where appropriate, with
State and local professional associations; health care providers and
institutions serving, diagnosing, or providing treatment and care for
persons with HIV/AIDS, including laboratories providing HIV, CD4+
lymphocyte and HIV-1 Ribonucleic Acid Determination (i.e. viral load)
testing; organizations that serve persons at increased risk of HIV/AIDS
(e.g., drug treatment facilities, STD clinics, family planning
agencies, maternal and infant care programs, comprehensive hemophilia
treatment centers, correctional facilities); community groups and
organizations, especially those with a racial and ethnic minority
membership and focus; and HIV/AIDS service organizations.
a. Active case finding.
At a minimum, all recipients shall conduct active case finding
(i.e. soliciting case reports in a timely manner directly from
potential reporting sources) in large in- and out-patient facilities
serving HIV-infected persons and in laboratories, where feasible and
permitted by law, and shall conduct a systematic review of death
certificates. Other required components of active surveillance programs
include educating providers on their reporting responsibilities,
establishing on-going communication with all reporting sites and
providing them feedback, conducting routine visits to reporting
sources, and establishing awareness of and support for surveillance
activities. In particular, in areas where a large volume of reports or
limited resources preclude timely investigation of new case reports,
special efforts shall be made to inform providers of their importance
in promptly notifying the health department of any cases with unusual
transmission, laboratory or clinical circumstances/characteristics. The
minimum information required to report a case of HIV infection or AIDS
to CDC's HIV/AIDS Reporting System (HARS) is the alpha-numeric
(soundex) code of the patient's name (patient and physician names
should not be submitted to CDC); state-assigned patient identifier
number; HIV/AIDS diagnosis information, including date(s) of diagnosis;
and the patient's date of birth, race/ethnicity, and sex.
Two additional variables that are critical to ascertain are initial
CD4 count and mode of HIV exposure. In an effort to better characterize
the extent of disease at diagnosis, and the impact of targeted testing
efforts on identifying persons early in the course of their infections,
information on CD4 count at initial diagnosis shall be collected. This
information should be submitted to CDC as part of the case record.
Information on the mode of HIV exposure is also essential in order to
monitor epidemic trends and target prevention interventions. Therefore,
timely follow-up to complete risk history shall be conducted. Funding
limitations may preclude complete investigations of all cases, but at a
minimum, States are expected to follow-up a representative sample of
reported cases to ascertain risk according to a protocol developed by
CDC and the recipient.
Where pediatric HIV exposure and infection surveillance is
conducted, recipients shall also collect data on maternal HIV test
history, prenatal and neonatal antiretroviral therapy, and other
variables relevant to the evaluation of recommended actions to prevent
perinatal HIV transmission. For areas with the highest burden of
perinatal HIV transmission, additional funds are available to conduct
enhanced surveillance activities for HIV-infected mothers and their
children (See section D, Funding, above; and Part IV, Enhanced
Surveillance for Perinatal Prevention, below in this section)
b. Follow-up investigations of cases/populations of special
epidemiologic significance.
Recipients shall develop procedures for promptly notifying CDC of
unusual occurrences of HIV transmission and for using CDC-developed
protocols and criteria to conduct epidemiologic and laboratory
investigations of cases that may have rare or previously unidentified
modes of HIV transmission, unusual clinical manifestations, or unusual
laboratory test results. These include transfusion and transplant-
related cases, cases of HIV transmitted in health care or other
occupational settings, cases of HIV-2 infection, cases transmitted
through female-to-female sexual contact, cases with potentially unusual
HIV strain variants, and cases with clinical evidence of HIV infection
but negative HIV test results.
Recipients may also propose activities to better describe the
epidemic in specific populations of epidemiologic significance or
interest (e.g. for example, persons diagnosed concurrently with HIV and
TB or HIV and STDs), or in collaboration with prevention and care
partners to augment the collection of risk behaviors in cases reported
initially with no reported risk (NRR) or projects to collect risk
behaviors of cases using
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novel methods of risk assessment such as computer-assisted interviews.
c. Evaluation of the performance of the surveillance system.
Recipients shall continue to evaluate the attributes of their HIV/
AIDS surveillance system according to protocols provided by CDC that
have been developed as part of focused pilot projects. Ongoing
evaluation will continue regardless of the status of, or procedures
used, to conduct HIV/AIDS surveillance (e.g. AIDS or HIV reporting, or
name or code-based reporting).
All evaluation projects should include critical reviews of
surveillance methods and redirection of resources to those case-finding
methods that are the most accurate and productive. Using the
recommendations published in ``CDC Guidelines for National Human
Immunodeficiency Virus Case Surveillance, Including Monitoring for
Human Immunodeficiency Virus Infection and Acquired Immunodeficiency
Syndrome'' (see Attachment A for summary) these evaluations should
include routine analysis of surveillance data to discover possible
sources of under reporting and delays in reporting, monitoring data
quality, and assessing completeness of reporting by statistical methods
developed by CDC (e.g. multiple source capture-recapture) or comparing
surveillance registries with alternate databases that are not routinely
used for case finding (e.g., Medicaid databases).
At least once a year, all recipients shall routinely re-abstract
demographic, risk, laboratory, and clinical data from a representative
sample of records to assess the quality and validity of information
collected.
d. Interstate reciprocal notification of newly identified HIV/AIDS
cases.
Recipients should routinely interact with other reporting areas
using a list of potential inter-State duplicates supplied by CDC to
ensure that reciprocal notification of newly identified HIV/AIDS cases,
perinatal exposure cases, and deaths from HIV infection is executed.
Routine engagement in this activity will minimize the number of
duplicate case reports in the national data system. This communication
is supported by the Council of State and Territorial Epidemiologists
(Position statement 01-ID-04). It should be carried out by
appropriately trained and authorized surveillance staff, in a
confidential manner consistent with local security, confidentiality and
reporting policies and procedures. Recipients will use the same system
for reciprocal notification of HIV, AIDS, perinatal HIV exposure and
deaths among persons with HIV infection, including provision of
appropriate identifying information (e.g., name or other identifier).
Currently, because of the diversity and limitations of the coded
identifiers used by reporting areas in States engaged in alternatives
to confidential, name-based reporting for HIV cases, there is no
scientifically validated, systematic way for CDC to identify potential
duplicates for HIV cases in those areas. These areas are encouraged to
communicate with nearby reporting areas to identify the most accurate
and efficient methods for minimizing duplication across State reporting
jurisdictions.
e. Analysis and dissemination of HIV/AIDS surveillance data and
promoting their uses of prevention and health services planning and
evaluation.
All recipients should routinely disseminate reports of aggregate
surveillance data for epidemic monitoring and education of the public
and reporting sources and should promote uses of HIV/AIDS surveillance
data for prevention and health services planning and evaluation. These
activities should include: Providing HIV/AIDS surveillance data and
ongoing epidemiologic assistance to community planning groups;
disseminating surveillance data through publications and presentations;
participating in planning and implementation meetings; conducting
analyses to monitor trends, assess need for health-care resources, and
project the future impact of the disease; and providing feedback to
reporting sources on ways in which the surveillance data have been used
to promote public health.
f. Conduct activities to improve the quality, efficiency, and
productivity of the core surveillance program.
As part of core surveillance (given availability of either
increased core funding or a redirection of existing core surveillance
funding) all recipients shall also conduct one or more surveillance
activities to develop and test new approaches to conducting
surveillance whose aim is to improve the quality of the data, develop
more efficient methods of case ascertainment, ensure accurate and valid
case report information, and maximize the performance of the system. In
particular, areas should develop technical information systems that
facilitate electronic reporting of HIV and AIDS surveillance data from
health care providers and public and private laboratories to health
departments. Examples of focused analyses and evaluations of
surveillance data that applicants may conduct include:
(1) Assessing how priority populations access or receive referrals
to prevention and treatment services in public and private settings
(e.g., treatment for HIV infection and prevention of opportunistic
infections).
(2) Assessing the association of stage of disease (i.e., HIV or
AIDS) with interstate migration.
(3) Better defining trends (through analysis of HARS reports or
chart reviews or interviews):
(a) In various populations (e.g., Native Americans, health-care
workers, substance-abusing pregnant women).
(b) For various AIDS-defining conditions or opportunistic
infections (e.g., Tuberculosis, Mycobacterium Avium Complex (MAC).
(c) In conjunction with other Federal, State, local prevention and
care programs (e.g., HRSA Ryan White CARE locations).
g. Reporting of data using CDC standards and software.
Recipients should ensure that data collection forms and electronic
data formats used to submit case reports from laboratories, clinical
records, and patient interviews contain CDC's recommended standard data
elements/questions on HIV testing behaviors, risk/exposure behaviors,
and treatment access/adherence behaviors. In addition, during this
project period, recipients should report HIV/AIDS case surveillance
data to CDC on at least a monthly basis using either standardized
software or according to data submission standards established by CDC.
Data from reporting areas using coded identifiers for HIV
surveillance will be eligible for inclusion in national surveillance
reports after these systems are evaluated using published performance
standards (see Attachment A) through the implementation of protocols
established by CDC. Areas using coded identifier systems will need to
use customized data transfer and storage systems (either electronic or
hardcopy) in order to accommodate the diversity of codes,
inconsistencies in codes between areas (e.g. inability to generate
soundex in some areas), and inability of areas using coded reporting to
reciprocally notify and de-duplicate cases with other areas using
standardized lists generated by CDC. Specific data management systems
will be developed by CDC in consultation with the local areas. These
areas should continue to report AIDS cases and deaths to CDC using HARS
or its identified equivalent, as is current practice.
h. Security.
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Consistent with ``Appendix C'' of CDC's ``Guidelines for HIV/AIDS
Surveillance,'' applicants must ensure that the program requirements
detailed in the Security Standards are attained as indicated by the
signature of the Overall Responsible Party (ORP) on the attached form
(Attachment B). HIV/AIDS surveillance funds will be restricted unless
the signed ORP form has been submitted to CDC.
i. All applicants are required to attend CDC-sponsored conferences
and workshops consistent with recipient activities in accordance with
the budget allocated.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
a. Provide training in surveillance methods, study methods, and
surveillance program planning and management.
b. Provide laboratory training that includes current scientific and
technical information about the practical and the theoretical
sensitivity and specificity of the different serological tests.
c. Coordinate and convene conferences, develop routine
communications, provide guidelines and standards for the conduct of
surveillance program activities, and communicate with recipients to
develop, refine, and disseminate HIV/AIDS surveillance program
information that describes effective methods to carry out program
activities and monitor progress.
d. Provide: (1) Criteria for the surveillance definition of
nationally reported HIV infection/disease (including AIDS); (2)
prototype (model) case report forms; and (3) assistance in establishing
and maintaining software for collecting, transferring and evaluating
HIV/AIDS surveillance data.
e. Participate in the analysis and dissemination of information and
data gathered from program activities and facilitate the transfer and
utilization of information and technology among all States and
communities.
f. Provide standardized protocols, data collection forms, data
entry capability for core surveillance and time-limited studies, and on
a routine basis generate lists of records of potential inter-State
duplicate cases to facilitate reciprocal notification and de-
duplication of HIV, AIDS, perinatal exposure cases as well as deaths
from HIV infection.
g. Assist in the evaluation of the overall effectiveness of program
operations, including the impact of surveillance data on the
development of public policy and on targeting and evaluating HIV
Prevention Community Planning activities.
h. Assist States to better use the national HIV/AIDS surveillance
data provided to CDC by States for public health policy formulation; to
obtain and allocate federal resources for HIV/AIDS surveillance,
prevention, and care; and to evaluate national public health
recommendations. Promote and facilitate coordination of CDC
surveillance data and activities with other CDC programs and other
agencies of the federal government.
i. Provide technical assistance in the area of information
technology to assure that reporting areas using electronic transfer of
HIV/AIDS surveillance data: (1) Adhere to appropriate confidentiality
and security procedures; (2) execute the necessary data management and
analytic procedures to assure data integrity and accuracy; and (3)
provide guidance to grantees in obtaining equipment that possesses the
necessary technologic capabilities to process and transfer data using
either CDC provided software or according to standards developed by CDC
for reporting to the national system. Supplemental funds may be
provided by CDC contingent on the availability of funds and the
magnitude of the identified requirements for information technology
improvements in areas that do not currently have adequate
infrastructure to manage data according to current or emerging CDC
specifications.
j. Disseminate national surveillance data for public health
research purposes through routine reports, articles in books and peer-
reviewed journals, and presentations.
k. Maintain a secure and confidential national HIV/AIDS
surveillance database.
Part II. HIV Incidence Surveillance
Recipient Activities
a. Collaborate with CDC, laboratories, providers and affected
communities to develop the capacity to conduct population-based HIV
incidence surveillance.
b. Collaborate with CDC (and other funded project sites) in project
design, implementation, and evaluation.
c. Collaborate with CDC in the development of area specific
protocols that demonstrate the ability to link HIV case data to
laboratory specimens, and to HIV testing history information to meet
the statistical data requirements for HIV incidence estimates.
d. Collaborate with public and commercial HIV testing laboratories
(within and outside the state) to secure an aliquot of serum from
original diagnostic HIV tests and have it shipped to the state public
health laboratory or an appropriately designated lab that is authorized
to store specimens for the area health department.
e. Identify, in a timely fashion, which diagnostic specimens
represent HIV infection cases new to the State HIV Surveillance system.
f. Prepare and transport aliquots of serum from the original
diagnostic HIV test of new HIV infection cases from the state public
health laboratory to a CDC designated STARHS testing laboratory.
g. Obtain adequate information on HIV testing history from a
sufficient number of persons with newly identified, recent HIV
infections, reported from private and public providers to allow for HIV
incidence estimation. The sources and methods for acquiring this
testing history information, and the procedures for linking, or
unlinking, these data from surveillance records with personal
identifiers when computing incidence estimates will be developed
collaboratively with CDC.
h. In some areas results from investigational tests such as STARHS
may be linked to identifying information on individual patients. These
protocols must be approved by a local IRB, and undergo review by CDC
and the Food and Drug Administration (FDA) before they can be
implemented.
i. On at least a monthly basis, report to CDC the data necessary to
conduct incidence surveillance using either standardized software or
according to data submission standards provided by CDC.
j. Areas conducting HIV incidence surveillance have the unique
capacity to identify active transmission of atypical strains of HIV,
including antiretroviral drug resistant virus. As part of incidence
surveillance, areas may collaborate with CDC to develop procedures for
obtaining the appropriate specimens to monitor transmission of such
atypical strains.
k. Maintain a secure environment to protect the security and
confidentiality of data obtained during this surveillance activity.
l. All applicants are required to attend CDC-sponsored conferences
and workshops consistent with recipient activities in accordance with
the budget allocated.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
[[Page 61287]]
a. Provide training in HIV incidence surveillance and estimation
methodology.
b. Provide laboratory training that includes current scientific and
technical information required to obtain, ship, and process specimens
according to existing standards of safety in order to obtain reliable
results for incidence estimation.
c. Coordinate and convene conferences, provide guidelines, provide
technical assistance for development as well as review and approval of
protocols, develop materials such as model consent forms and procedural
standards for the conduct of incidence surveillance program activities.
CDC will communicate regularly with recipients to develop, refine, and
disseminate HIV information that describes effective methods to carry
out program activities and monitor progress.
d. Provide support in the form of technical assistance, and where
necessary and available, supplemental funding to establish and maintain
information systems adequate for collecting, transferring and
evaluating HIV incidence surveillance data.
e. Provide technical assistance for activities designed to assess
and monitor the active transmission of atypical strains of HIV,
including antiretroviral resistant virus.
f. Participate in the analysis and dissemination of information and
data from these program activities.
g. Assist in the evaluation of the overall effectiveness of program
operations, including the impact of incidence data on the development
of public policy and on targeting and evaluating HIV Prevention
Community Planning activities.
h. Maintain a secure and confidential national data system for HIV
Incidence Surveillance and estimation.
i. Coordinate the identification and interaction between areas
supported to conduct HIV incidence surveillance and designated CDC
STARHS laboratories.
j. Conduct at least one site visit during a program announcement
funding period to each grantee to assess progress toward meeting
program objectives and provide such technical assistance as is
necessary as determined by the grantee and CDC.
k. Provide technical assistance in the area of information
technology to assure that reporting areas using electronic transfer of
HIV/AIDS surveillance data: (1) Adhere to appropriate confidentiality
and security procedures; (2) execute the necessary data management and
analytic procedures to assure data integrity and accuracy; and (3)
provide guidance to grantees in obtaining equipment that has the
necessary technologic capabilities to process and transfer data using
either CDC provided software or according to standards developed by CDC
for reporting to the national system. Supplemental funds may be
provided by CDC contingent on the availability of funds and the
magnitude of the identified requirements for information technology
improvements in areas that do not currently have adequate
infrastructure to manage data according to current or emerging CDC
specifications.
1. Coordinate with recipients and private and public health
laboratories to promote the efficient transport and processing of
diagnostic specimens for identification of newly diagnosed persons and
execution of STARHS, or other CDC approved testing for recent HIV
infections.
Part III. Capacity Building for Epidemiologic and Program Evaluation
Activities
Recipient Activities
a. Employ and sufficiently support trained staff who will develop
or enhance the recipient's capacity to plan and conduct epidemiologic
and program evaluation activities in collaboration and coordination
with CDC, and state and local HIV prevention and care community
planning groups; and
b. Promote uses of the HIV/AIDS surveillance, program, and other
health-related data for the planning and evaluation of HIV prevention
and care services. These uses should address two components:
(1) Epidemiologic activities. These activities should include
providing or recommending the use of HIV/AIDS and other public health
surveillance data. Activities should also include the analysis,
interpretation, and presentation of these data in describing the HIV/
AIDS epidemic in the recipient's jurisdiction in terms of socio-
demographic, geographic, behavioral, and clinical characteristics for
use in the epidemiologic profile for HIV prevention and care community
planning.
(2) Program evaluation activities. These activities should include
collecting, analyzing, and reporting process and outcome data that can
be used:
(a) To assess the effectiveness of various types of interventions.
(b) To monitor achievement of the health department's goals and
objectives.
(c) To provide program data to CDC in appropriate and useful
formats so that data may be aggregated by CDC to monitor progress in
achieving the goals and objectives of its strategic plan.
(d) To assess the impact of HIV prevention efforts in health
department jurisdictions.
c. All applicants are required to attend CDC-sponsored conferences
and workshops consistent with recipient activities in accordance with
the budget allocated.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
a. Develop and promote the use of standard guidelines for
development of epidemiologic profiles and program evaluation for HIV
prevention and care community planning.
b. Assist recipients to better use HIV/AIDS surveillance, program,
and other health-related data for HIV prevention and care community
planning and to evaluate HIV prevention program effectiveness.
c. Collaborate with recipients to facilitate the use of
surveillance, program, and other health-related data to monitor
achievement of CDC and HRSA prevention and care planning goals and
objectives.
d. Assist recipients to use surveillance, evaluation, and other
health-related data to assess the impacts of HIV prevention efforts
(e.g., to inform policy and service delivery issues).
e. Collaborate with grantees to ensure appropriate transfer of
data.
Part IV. Enhanced Surveillance for Perinatal Prevention
Recipient Activities
Implement and continue surveillance for perinatal HIV exposure and
pediatric HIV infection by performing the following activities:
a. Conduct medical record review of mother/infant pairs and
longitudinal follow-up of all HIV exposed children to ascertain
knowledge of maternal HIV infection status before birth, HIV incidence,
AIDS incidence, and death, the use of maternal and neonatal ZDV and its
efficacy in preventing HIV transmission, and the use of other
antiretroviral medications.
b. Conduct medical record review to evaluate recommendations for
opportunistic infection prophylaxis and initiation of HIV evaluation
and treatment in children.
c. Assess potential adverse outcomes of antiretroviral exposure
among infected and uninfected children in the short term (e.g., birth
defects,
[[Page 61288]]
ascertained through record reviews and registry matches) and in the
long term (e.g., by matching to tumor registries).
d. Match HIV/AIDS registries to birth registries to ensure complete
ascertainment of mother/infant pairs.
e. Regularly report data to CDC in a secure manner using CDC-
provided forms and software.
f. All applicants are required to attend CDC-sponsored conferences
and workshops consistent with recipient activities in accordance with
the budget allocated.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
a. Provide training in surveillance methodology, study methodology,
and in program planning and management.
b. Provide laboratory training that includes current scientific and
technical information about the practical and the theoretical
sensitivity and specificity of the different serological tests.
c. Develop, refine, and disseminate HIV/AIDS surveillance program
information that describes effective methods to carry out program
activities and monitor progress.
d. Provide: (1) Criteria for the surveillance definition of
nationally reported HIV infection/ disease; (2) case report forms; and
(3) assistance in establishing and maintaining the computerized HARS.
e. Participate in the analysis and dissemination of information and
data gathered from program activities and facilitate the transfer and
utilization of information and technology among all States and
communities.
f. Provide standardized protocols, data collection forms, and
computer software.
g. Assist in the evaluation of the overall effectiveness of program
operations, including the impact of enhanced perinatal surveillance
data on the development of public policy and on targeting and
evaluating HIV Prevention Community Planning activities.
h. Provide standard data collection forms, questionnaires, and
computer software for the supplemental surveillance projects.
i. Disseminate national perinatal surveillance data for public
health research purposes through routine reports, articles, and
presentations.
j. Maintain a secure and confidential national HIV/AIDS
surveillance database.
Part V. Laboratory Testing for Recent HIV Infection
Recipient Activities
a. Conduct testing according to the protocols and requirements
stipulated in the existing CDC IND agreement.
b. Establish local procedures for specimen testing and processing.
c. Conduct quality control for each run, and on an ongoing basis,
participate in CDC's quality assurance program. Establish quality
criteria for inclusion or exclusion of testing runs.
d. Establish protocols for collaborating health departments for the
preparation and shipping of specimens. Laboratories may specify the
type of vial and conditions for acceptable specimens, designate the
days of the week that specimens will be received, specify how specimens
will be labeled (label type, numbering system, barcoding), shipped, and
the format for packing lists.
e. Return test results to submitting health department within seven
days of receipt of specimen.
f. Develop data management systems for tracking specimens, raw data
including control values and specimen results consistent with the IND
protocol.
g. Ensure the confidentiality of data and specimens.
h. Obtain, from collaborating health departments, protocols and
documentation of institutional review board approval (or non-research
determination) that allowed for the initial specimen collection and for
incidence testing. Track testing results by protocol for required
reports.
i. Conduct testing for other CDC supported research projects.
j. Establish mechanism for tracking all costs (staff time, project
resources and reagents) associated with testing for specimens not
associated with national HIV incidence.
k. All applicants are required to attend CDC-sponsored conferences
and workshops consistent with recipient activities in accordance with
the budget allocated.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
a. Provide protocols for conducting tests for recent HIV infection.
b. Facilitate the distribution or designation of assigned
collaborating health departments to ensure optimal work loads for
funded laboratories and optimal ability to return results in a timely
manner.
c. Provide proficiency testing program.
d. Provide resources to collaborating health departments for the
collection, processing and shipping of specimens to funded
laboratories.
e. Provide technical assistance to laboratories on testing methods.
f. Provide computer software for interpretation of testing results,
quality control and for tracking results for required reports.
VI. Behavioral Surveillance
Recipient Activities
a. Collaborate with CDC and other funded project sites in the
design, implementation and evaluation of proposed activities.
Participate in required planning meetings with other funded sites and
CDC at an out of state location to be determined by CDC and grantees.
b. Collaborate with CDC and other funded sites to develop a multi-
site protocol and questionnaire.
c. Collaborate with CDC in the development of site specific
operational plans.
d. Engage Community Based Organizations (CBOs) funded directly by
CDC or by States/cities through the Community Planning process,
behavioral scientists, ethnographers, schools of public health, or
universities in the formative research and questionnaire development.
e. Collaborate with local HIV/AIDS prevention program to assess
exposure to and use of HIV prevention programs.
f. Maintain a secure environment to protect the security and
confidentiality of data obtained in this activity.
g. Report project data to CDC in a timely manner according to
established protocols for data collection, storage and transfer.
h. Disseminate study data for use in state/local prevention, and in
treatment services planning and evaluation.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
a. Lead the development of a standardized multi-site protocol and
questionnaire.
b. Facilitate the development of site-specific operational plans.
c. Provide training in the methodology (including formative
research), program planning and management.
d. Provide technical assistance to support implementation of agreed
upon methods to accomplish project objectives.
e. Provide assistance in establishing and maintaining the
computerized
[[Page 61289]]
database to record information collected in this activity.
f. Participate in the analysis and dissemination of data. Conduct
and/or coordinate analyses of the multi-site data and distribute
information to support national HIV prevention efforts.
g. Lead the development of computer programs to evaluate
performance indicators and data quality.
h. Assist in the evaluation of the overall effectiveness of program
operations. Provide timely feedback on reported data for quality
assurance purposes.
i. Maintain a secure and confidential national database.
Part VII. Core Surveillance in the Pacific Island Jurisdictions
Recipient Activities
Plan and conduct HIV/AIDS surveillance activities in collaboration
and coordination with CDC, and, where appropriate, with professional
associations; health care providers and institutions serving,
diagnosing, or providing treatment and care for persons with HIV/AIDS,
including facilities or organizations providing HIV, CD4+ lymphocyte
and HIV-1 Ribonucleic Acid Determination (i.e. viral load) testing;
organizations that serve persons at increased risk of HIV/AIDS (e.g.,
drug treatment facilities, STD clinics, family planning agencies,
maternal and infant care programs, correctional facilities); community
groups and organizations. Specific areas with laboratories capable of
providing confirmatory testing services (i.e. Western Blot or IFA)
should indicate a willingness and describe their capacity to serve as
central data coordination areas by working with other island
jurisdictions that submit specimens for such confirmatory testing.
These descriptions should include a process for assuring compliance
with security and confidentiality requirements.
Collaboration with CDC includes attendance at meetings and
workshops that address recipient HIV/AIDS surveillance activities
described in this announcement. In accordance with available funds, all
applicants should plan to attend CDC-sponsored conferences and
workshops consistent with recipient activities.
a. Active case finding
At a minimum, all recipients shall conduct active case finding
(i.e. soliciting case reports in a timely manner directly from
potential reporting sources) in appropriate in-patient and out-patient
facilities serving HIV-infected persons and in laboratories, where
feasible and permitted by law, and shall conduct a systematic review of
death certificates. Other required components of active surveillance
programs include educating providers on their reporting
responsibilities, establishing on-going communication with all
reporting sites and providing them feedback, conducting routine visits
to reporting sources, and establishing awareness of and support for
surveillance activities. The minimum information required to report a
case of HIV infection or AIDS to CDC's HARS is the alpha-numeric
(soundex) code of the patient's name (patient and physician names
should not be submitted to CDC); state-assigned patient identifier
number; HIV/AIDS diagnosis information, including date(s) of diagnosis;
and the patient's date of birth, race/ethnicity, and sex.
An additional variable that is critical to ascertain is the initial
CD4 count. In an effort to better characterize the extent of disease at
diagnosis, and the impact of targeted testing efforts on identifying
persons early in the course of their infections, information on CD4
count at initial diagnosis shall be collected. This information should
be submitted to CDC as part of the case record. Information on the mode
of HIV exposure is also essential in order to monitor epidemic trends
and target prevention interventions. Therefore, timely follow-up to
complete risk history shall be conducted.
b. Follow-up investigations of cases/populations of special
epidemiologic significance. Recipients shall develop procedures for
promptly notifying CDC of unusual occurrences of HIV transmission and
for using CDC-developed protocols and criteria to conduct epidemiologic
and laboratory investigations of cases that may have rare or previously
unidentified modes of HIV transmission, unusual clinical
manifestations, or unusual laboratory test results. These include
transfusion and transplant-related cases, cases of HIV transmitted in
health care or other occupational settings, cases of HIV-2 infection,
cases transmitted through female-to-female sexual contact, cases with
potentially unusual HIV strain variants, and cases with clinical
evidence of HIV infection but negative HIV test results.
c. Evaluation of the performance of the surveillance system.
Recipients shall continue to assess the quality of their HIV/AIDS
surveillance system and the data generated from this set of activities.
Assessment will continue regardless of the status of, or procedures
used, to conduct HIV/AIDS surveillance (e.g. AIDS or HIV reporting, or
name or code-based reporting).
Evaluation activities should include critical reviews of
surveillance methods and redirection of resources to those case-finding
methods that are the most accurate and productive. Using the
recommendations published in ``CDC Guidelines for National Human
Immunodeficiency Virus Case Surveillance, Including Monitoring for
Human Immunodeficiency Virus Infection and Acquired Immunodeficiency
Syndrome'', assessments should include routine analysis of surveillance
data to discover possible sources of under reporting and delays in
reporting, monitoring data quality. At least once a year, recipients
shall routinely re-abstract demographic, risk, laboratory, and clinical
data from a sample of records to assess the quality and validity of
information collected.
d. Inter-island and inter-state reciprocal notification of newly
identified HIV/AIDS cases.
Recipients should routinely interact with other reporting areas to
assure coordinate reporting between the island jurisdictions and ensure
that reciprocal notification of newly identified HIV/AIDS cases,
perinatal exposure cases, and deaths from HIV infection is executed.
Routine engagement in this activity will improve the efficiency in
reporting to CDC and minimize the number of duplicate case reports in
the national data system. This communication is supported by the
Council of State and Territorial Epidemiologists (Position Statement
01-ID-04). It should be carried out by appropriately trained and
authorized surveillance staff, in a confidential manner consistent with
local security, confidentiality and reporting policies and procedures.
Recipients will use the same system for reciprocal notification of HIV,
AIDS, perinatal HIV exposure and deaths among persons with HIV
infection, including provision of appropriate identifying information
(e.g., name or other identifier).
e. Analysis and dissemination of HIV/AIDS surveillance data and
promoting their uses of prevention and health services planning and
evaluation.
All recipients should routinely disseminate reports of aggregate
surveillance data for epidemic monitoring and education of the public
and reporting sources and should promote uses of HIV/AIDS surveillance
data for prevention and health services planning and evaluation. These
activities should include: providing HIV/AIDS surveillance data and
ongoing epidemiologic assistance to community planning groups;
disseminating surveillance data through publications and presentations;
[[Page 61290]]
participating in planning and implementation meetings; conducting
analyses to monitor trends, assess need for health-care resources, and
project the future impact of the disease; and providing feedback to
reporting sources on ways in which the surveillance data have been used
to promote public health.
f. Reporting of data using CDC standards and software.
Recipients should ensure that data collection forms used to submit
case reports from laboratories, clinical records, and patient
interviews contain CDC's recommended standard data elements/questions
on HIV testing behaviors, risk/exposure behaviors, and treatment
access/adherence behaviors.
g. Security
Consistent with ``Appendix C'' of CDC's ``Guidelines for HIV/AIDS
Surveillance,'' recipients must ensure that the program requirements
detailed in the Security Standards are attained as indicated by the
signature of the Overall Responsible Party (ORP) on the attached form.
HIV/AIDS surveillance funds will be restricted unless the signed ORP
form has been submitted to CDC.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
a. Provide training in surveillance methods, study methods, and
surveillance program planning and management.
b. Provide laboratory training that includes current scientific and
technical information about the practical and the theoretical
sensitivity and specificity of the different serological tests.
c. Coordinate and convene conferences, develop routine
communications, provide guidelines and standards for the conduct of
surveillance program activities, and communicate with recipients to
develop, refine, and disseminate HIV/AIDS surveillance program
information that describes effective methods to carry out program
activities and monitor progress.
d. Provide: (1) Criteria for the surveillance definition of
nationally reported HIV infection/disease (including AIDS), (2)
prototype (model) case report forms, and (3) assistance in establishing
and maintaining software for collecting, transferring and evaluating
HIV/AIDS surveillance data.
e. Participate in the analysis and dissemination of information and
data gathered from program activities and facilitate the transfer and
utilization of information and technology among all States and
communities.
f. Assist in the evaluation of the overall effectiveness of program
operations, including the impact of surveillance data on the
development of public policy and on targeting and evaluating HIV
Prevention Community Planning activities.
g. Assist areas to better use the national HIV/AIDS surveillance
data provided to CDC by areas for public health policy formulation;
obtaining and allocating federal resources for HIV/AIDS surveillance,
prevention, and care; and evaluation of national public health
recommendations. Promote and facilitate coordination of CDC
surveillance data and activities with other CDC programs and other
agencies of the federal government.
h. Provide technical assistance in the area of data storage and
management to assure that reporting areas: (1) Adhere to appropriate
confidentiality and security procedures; and (2) execute the necessary
data management and analytic procedures to assure data integrity and
accuracy.
i. Disseminate national surveillance data for public health
research purposes through routine reports, articles in books and peer-
reviewed journals, and presentations.
j. Maintain a secure and confidential national HIV/AIDS
surveillance database.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Part I. Core Surveillance
Fiscal Year Funds: 2004.
Approximate Total Funding: $34,000,000.
Approximate Number of Awards: 65.
Approximate Average Award: $500,000.
Floor of Award Range: $9,000 to $4,000,000.
Ceiling of Award Range: $4,000,000.
Anticipated Award Date: April 1, 2004.
Budget Period Length: 9 months.
Project Period Length: 2 years and 9 months.
Considerations for Funding Levels: All technically acceptable
applications will be funded. The following items are general
considerations that will affect decisions on funding levels.
1. Greatest consideration will be given to areas with an HIV case
reporting system as of the due date of this application.
2. Areas that do not meet criterion one, but have a written plan
with established regulations or laws that will enable HIV case
reporting to be in place as of April 1, 2004 will receive greater
consideration than areas with no immediate plans for implementation of
such a reporting system.
3. The presence of at least one Ryan White Title I Eligible
Metropolitan Area (EMA) within the jurisdiction of the applicant.
4. The applicant's description of:
(a) Surveillance evaluation activities that are in place.
(b) Information from surveillance evaluation activities
demonstrating that the HIV case reporting system meets the minimum
performance standards for HIV case reporting published in ``CDC
Guidelines for National Human Immunodeficiency Virus Case Surveillance,
Including Monitoring for Human Immunodeficiency Virus Infection and
Acquired Immunodeficiency Syndrome''. These standards are summarized in
Attachment A (as posted with this announcement on the CDC Web site.)
5. Additional programmatic consideration will be based on increases
or decreases in the volume of reported cases of HIV or AIDS and their
implications for HIV/AIDS surveillance program activities.
Part II. HIV Incidence Surveillance
Fiscal Year Funds: 2004.
Approximate Total Funding: $15,000,000.
Approximate Number of Awards: 35.
Approximate Average Award: $250,000.
Floor of Award Range: $130,000 to $790,000.
Ceiling of Award Range: $790,000.
Anticipated Award Date: April 1, 2004.
Budget Period Length: 9 months.
Project Period Length: 2 years and 9 months.
Consideration for Funding Levels: All technically acceptable
applications will be funded. Funding levels will be determined by a
formula using the highest new annual AIDS case count estimated for
either of the two most recent calendar years available. Additional
programmatic consideration will be based on trends in reported cases of
HIV and the implications for HIV Incidence surveillance program
activities.
Part III. Capacity Building for Epidemiologic and Program Evaluation
Activities
Fiscal Year Funds: 2004.
Approximate Total Funding: $2,100,000.
Approximate Number of Awards: 21.
[[Page 61291]]
Approximate Average Award: $100,000.
Floor of Award Range: None.
Ceiling of Award Range: $100,000.
Anticipated Award Date: April 1, 2004.
Budget Period Length: 9 months.
Project Period Length: 2 years and 9 months.
Consideration for Funding Levels: All technically acceptable
applications will be funded.
Part IV. Enhanced Surveillance for Perinatal Prevention
Fiscal Year Funds: 2004.
Approximate Total Funding: $1,800,000.
Approximate Number of Awards: 20.
Approximate Average Award: $82,000.
Floor of Award Range: $30,000 to $200,000.
Ceiling of Award Range: $200,000.
Anticipated Award Date: April 1, 2004.
Budget Period Length: 9 months.
Project Period Length: 2 years and 9 months.
Funding Preferences
Because Part IV is competitive, applications for activity under
this Part will be evaluated by an Objective Review Panel. Some
applicants may not be funded.
The following items are general considerations that will affect
decisions on funding levels:
1. Greatest preference will be given to areas that receive
categorical funding from CDC for perinatal prevention program
activities.
2. Secondary preference will be given to areas that possess an
authorized reporting system for pediatric HIV exposure as well as
adult, adolescent, and pediatric HIV infection.
3. Additional programmatic funding considerations will be based on
the estimated number of HIV infected women giving birth (Source: 1994
Survey of Childbearing Women) and its implications for HIV/AIDS
surveillance program activities.
Part V. Laboratory Testing for Recent HIV Infection
Fiscal Year Funds: 2004.
Approximate Total Funding: $800,000.
Approximate Number of Awards: 2 to 3.
Approximate Average Award: $320,000.
Floor of Award Range: $270,000 to $400,000.
Ceiling of Award Range: $400,000.
Anticipated Award Date: April 1, 2004.
Budget Period Length: 9 months.
Project Period Length: 2 years and 9 months.
Funding Preferences
Because Part V is competitive, applications for activity under this
Part will be evaluated by an independent review panel (formerly
Objective Review Panel). Some applicants may not be funded.
Preference will be given to sites that achieve the best
distribution and representation of geographic regions (e.g., Northeast,
South, and West).
Preference will be given to areas that demonstrate the greatest
degree of automation in sample processing and testing.
Part VI. Behavioral Surveillance
Fiscal Year Funds: 2004.
Approximate Total Funding: $10,000,000.
Approximate Number of Awards: 25.
Approximate Average Award: $400,000.
Floor of Award Range: $350,000 to $450,000.
Ceiling of Award Range: $450,000.
Anticipated Award Date: April 1, 2004.
Budget Period Length: 9 months.
Project Period Length: 2 years and 9 months.
Consideration for Funding
All technically acceptable applications will be funded.
Part VII. Core Surveillance in the Pacific Island Jurisdictions
Fiscal Year Funds: 2004.
Approximate Total Funding: $100,000.
Approximate Number of Awards: 6.
Approximate Average Award: $17,500.
Floor of Award Range: $10,000 to $25,000.
Ceiling of Award Range: $25,000.
Anticipated Award Date: April 1, 2004.
Budget Period Length: 9 months.
Project Period Length: 2 years and 9 months.
Considerations for Funding Levels
All technically acceptable applications will be funded. The
following items are general considerations that will affect decisions
on funding levels.
1. Greatest consideration will be given to areas that have a
functional laboratory physically located on an island within the funded
island jurisdiction that is either currently able, or could, with a
reasonable investment in the appropriate equipment, accept, process,
and distribute results for confirmatory HIV diagnostic tests. This
laboratory should be able to execute Western Blot or immunofluoresence
assay (IFA) tests. The health department on an island jurisdiction with
such a facility should be able to serve as a central data collection
center that coordinates available clinical information on cases
confirmed through processing of specimens from other island
jurisdictions.
2. The next greatest consideration will be given to areas with an
HIV case reporting system as of the due date of this application.
3. Areas that do not meet criterion one, but have a written plan
with established regulations or laws that will enable HIV case
reporting to be in place as of April 1, 2004 will receive greater
consideration than areas with no immediate plans for implementation of
such a reporting system.
4. Additional programmatic consideration will be based on increases
or decreases in the volume of reported cases of HIV or AIDS and their
implications for HIV/AIDS surveillance program activities.
Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal Government.
III. Eligibility Information
Eligible Applicants
Part I. Core Surveillance
Applications may be submitted by health departments of States, U.S.
territories or their bona fide agents, including the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, and the
six independently-funded city health departments of Chicago, Houston,
Los Angeles, New York City, Philadelphia, and San Francisco. All
eligible applicants for core HIV/AIDS surveillance activities will be
funded. Funding will include activities that expand the uses and
improve the quality of HIV/AIDS surveillance data to more effectively
guide public health policy and provide relevant information necessary
to direct and evaluate prevention and care activities.
Part II. HIV Incidence Surveillance
In order to ensure execution of this complex project, and provide
estimates for incidence that possess adequate
[[Page 61292]]
statistical precision, eligible sites must possess HIV reporting
systems, and they must have a sufficient number of reports on new,
annual HIV diagnoses.
Therefore, eligibility is limited to applicants previously funded
for this activity as part of the supplemental awards provided through
Program Announcement 00005. States will be eligible regardless of the
AIDS case count if there is an independently funded city health
department within the State that has either been previously funded, or
will be funded under the criteria described below.
New applicants eligible for these funds will include those areas
which will have HIV case reporting as of April 1, 2004, and have,
according to the National AIDS Reporting System maintained by CDC, at
least 300 new AIDS cases in either of the calendar years during the
budget period.
The known eligible sites are: Alabama, Arizona, California,
Chicago, Colorado, Connecticut, District of Columbia, Florida, Georgia,
Houston, Illinois, Indiana, Kentucky, Los Angeles, Louisiana, Maryland,
Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York
State, New York City, North Carolina, Ohio, Oklahoma, Pennsylvania,
Philadelphia, Puerto Rico, San Francisco, South Carolina, Tennessee,
Texas, Virginia, and Washington.
Part III. Capacity Building for Epidemiologic and Program Evaluation
Activities
Recipient health departments must have sufficient disease burden
for analytic activities to provide information with sufficient
statistical and epidemiologic precision.
Therefore, assistance will be provided to moderate morbidity States
reporting from 240 to 1500 AIDS cases from July 2000 through June 2001,
(Centers for Disease Control, HIV/AIDS Surveillance Report,
2000;13(no.1):6) and States or territories previously funded for fewer
than five of the following supplemental surveillance projects.
Projects include the following and correspond to the appropriate
sections of Part II of FY2000's Program Announcement 00005 and
Activities One through Four of FY2001's Program Announcement 00005B:
(1) Adult/Adolescent Spectrum of Disease (ASD); (2) Survey of HIV
Disease and Care (SHDC); (3) Survey of HIV Disease and Care plus
Interview Supplement (SHDC+); (4) Supplement to HIV/AIDS Surveillance
(SHAS); (5) New Supplemental Interview Projects; (6) Enhanced
Surveillance for Perinatal Prevention; (7) Alternate Approaches; (8)
Regional Technical Assistance Centers; (9) HIV Testing Survey; and (10)
Estimation of HIV incidence.
Known eligible applicants are: Alabama, Arizona, Connecticut,
Delaware, District of Columbia, Georgia, Illinois, Indiana, Kentucky,
Louisiana, Massachusetts, Mississippi, Missouri, Nevada, North
Carolina, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, and
Virginia.
Part IV. Enhanced Surveillance for Perinatal Prevention
This is a complex activity that requires substantial resources,
commitment on the part of the affected surveillance program, and a
sufficient number of events to provide reasonably precise assessments
of the effectiveness of perinatal prevention efforts.
Therefore, eligible applicants are limited to the high-morbidity
areas (estimated 60 or more HIV-positive women giving birth--Source:
1994 Survey of Childbearing Women) previously funded by CDC for
Enhanced Perinatal Surveillance, or to areas that have received
categorical funding from CDC for perinatal HIV prevention program
activities.
Eligible applicants should have implemented, or plan to implement,
HIV surveillance for adults and children (including reporting HIV-
exposed infants) as an extension of their AIDS surveillance activities,
by April 1, 2004. If this has not occurred, the applicant may propose
to continue to conduct these activities in selected facilities serving
large numbers of HIV-infected women and their infants using established
research (i.e., IRB) procedures for case ascertainment.
Known eligible applicants are: Alabama, California, Chicago,
Connecticut, Delaware, District of Columbia, Florida, Georgia, Houston,
Illinois, Los Angeles, Louisiana, Maryland, Massachusetts, Michigan,
Mississippi, New Jersey, New York, New York City, North Carolina,
Pennsylvania, Philadelphia, Puerto Rico, Ohio, Tennessee, Texas,
Virginia, and South Carolina.
Part V. Laboratory Testing for Recent HIV Infection
Because this is a technically sophisticated technique, only
laboratories that are already participating in the IND with prior
experience conducting large numbers of STARHS tests and documented
proficiency will be considered.
Part VI. Behavioral Surveillance
Eligibility will be limited to the State or local health
departments which include the top 26 Metropolitan Statistical Areas
(MSA's) by number of people living with AIDS at the end of 2000 as
reported in ``HIV/AIDS Surveillance Supplemental Report,''
(2002;8(No.2:18-19)).
These are the directly funded city health departments of Los
Angeles, CA; San Francisco, CA; Chicago, IL; New York City, NY;
Philadelphia, PA; Houston, TX; and, the State health departments
containing the following MSAs: Phoenix, AZ; San Diego, CA; Denver, CO;
New Haven, CT; Washington, DC; Miami, and Ft. Lauderdale, FL; Atlanta,
GA; New Orleans, LA; Boston, MA; Baltimore, MD; Detroit, MI; St. Louis,
MO; Las Vegas, NV; Newark, NJ; Nassau-Suffolk, NY; San Juan, PR;
Dallas, TX; Norfolk, VA; and, Seattle, WA.
Projects will be supported only within the MSA listed and only
within the geographic bounds of the funded entity (where MSAs extend
beyond the jurisdiction of the eligible state or city health
department). Recruitment venues may be limited to the geographic
subdivision (e.g., city, county, health district) within the MSA with
the highest AIDS morbidity where it would be impractical to conduct
surveillance in the entire area.
Part VII. Core Surveillance in the Pacific Island Jurisdictions
Applications may be submitted by health departments of American
Samoa, Guam, Marshall Islands, Palau, the Commonwealth of the Northern
Mariana Islands and the Federated States of Micronesia.
All technically acceptable applicants for core HIV/AIDS
surveillance activities will be funded. Funding will include activities
that facilitate the development and improvement in the quality of HIV/
AIDS surveillance data to more effectively guide public health policy
and provide relevant information necessary to direct and evaluate
prevention and care activities.
Other Eligibility Requirements: None.
Cost Sharing or Matching: Matching funds are not required for this
program.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant, or loan.
IV. Application and Submission Information
How to Obtain Application Forms: To apply for this funding
opportunity use application form PHS 5161-1. Forms are available on the
CDC Web site, at the
[[Page 61293]]
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
This program announcement is the definitive guide on application
format, content, and deadlines. It supersedes information provided in
the application instructions. If there are discrepancies between the
application form instructions and the program announcement, adhere to
the guidance in the program announcement.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the CDC Web site at: http://
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
If your application form does not have a DUNS number field, please
write your DUNS number at the top of the first page of your
application, and/or include your DUNS number in your application cover
letter.
Content and Form of Submission
Application: Applications for activities under Section I, II, III,
VI, and VII will receive a Technical Acceptability Review. Part IV and
Part V will be evaluated separately by an independent and separate
objective review panel. To facilitate this review, submit separate and
complete applications for each activity under Parts I, II, III, IV, V,
VI, and VII for which you are applying, including separate budgets and
narrative justifications, that can stand alone as an application for
review purposes.
You must submit a signed original and two copies of your
application forms. You must include a project narrative with your
application forms. Your narrative must be submitted in the following
format:
Part I. Core Surveillance
[sbull] Maximum number of pages: 30 pages double spaced, including
up to five pages of program plans and budgets for years 2005 and 2006,
excluding reports and appendices. Applications with narratives in
excess of 30 pages will be returned to the applicant and not considered
for funding.
[sbull] Font size: 12 point unreduced.
[sbull] Paper size: 8.5 by 11 inches.
[sbull] Page margin size: 1 inch.
[sbull] Printed only on one side of page.
[sbull] Held together only by rubber bands or metal clips; not
bound in any other way.
Format:
In developing this Part of the application, your narrative must
follow the format below:
1. Program Need and Resources.
2. Collaboration and Use of Data.
3. Objectives.
4. Program Plan and Methods for Implementation.
5. Program Evaluation Plan.
6. Project Management and Staffing Plan.
7. Budget.
8. Attachments.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
1. Describe proposed active case-finding efforts, follow-up of
priority cases, and activities that promote uses of HIV and AIDS
surveillance data for prevention planning.
2. Describe procedures for critically reviewing surveillance
methodologies to promote efficient and effective use of resources,
disseminating data for public health purposes, ensuring that the
surveillance program contributes to the goals and public health mission
of the health department, using surveillance data to evaluate the
effectiveness of State/local prevention efforts, policies, and
programs, and using surveillance data to target and evaluate proposed
community-based interventions.
Also, describe proposed activities that will facilitate the
efficiency, reliability, completeness of variables and accuracy of HIV/
AIDS surveillance data. Examples of such activities include procedures
that facilitate the identification and investigations of cases of
public health importance (e.g. atypical or variant HIV sub-types or
strains), with specific outcomes and co-morbidities (e.g., persons
diagnosed concurrently with HIV and TB or HIV and STDs), or
collaborations with prevention and care partners (e.g., projects to
assess the availability of data on risk behaviors in Prevention
Counseling and Referral Systems [PCRS], or assessment of the validity
of CD4 or viral load reporting as a marker of receiving regular care
and treatment of HIV).
3. If HIV case surveillance is, or will soon be implemented, and
case reports are used to facilitate voluntary prevention referral
services [e.g. PCRS], or conduct registry matching with other public
health programs in the health department (e.g., tuberculosis, STD),
document steps to ensure that such practices are consistent with the
Security and Confidentiality Standards (as published in ``Appendix C''
of the Guidelines for HIV/AIDS Surveillance) and consistent with CDC
and State or local IRB requirements for secondary uses of surveillance
data.
4. PCRS can be conducted without linkage to surveillance
information. Some areas may elect to link surveillance information to
PCRS. In areas that link surveillance reporting and PCRS activities,
CDC recommends that these activities should be evaluated to assure that
the programmatic objectives of PCRS are attained without unnecessarily
compromising community and provider support for surveillance program
activities. These evaluations should be executed in partnership with
HIV prevention programs. Applicants should document that such
evaluations are jointly funded and conducted by the surveillance and
HIV/AIDS prevention program staff.
5. Describe existing evaluation activities to assess the
performance attributes of the HIV/AIDS surveillance system according to
published CDC recommendations (Attachment A). This description should
include the methods and results associated with efforts to limit the
number of inter-state duplication of HIV, AIDS, perinatal exposure and
HIV infection deaths across States, and intra-state reporting areas
through reciprocal notification of cases. Provide documentation that
the applicant will collaborate with CDC to conduct evaluations during
the period of this cooperative agreement according to established and
validated protocols developed by CDC.
6. Describe State laws, rules, or regulations pertaining to the
protection or release of surveillance information; and physical
security of hard copies and electronic files containing confidential
surveillance information; any laws, rules, regulations, or health
department policies that require or permit the release of patient
identifying information collected under the HIV/AIDS surveillance
system to entities outside of the public health department and measures
the health department has taken to ensure that the confidentiality of
individuals reported to the surveillance system is protected from
further or unlawful disclosure. As part of the application, you must
submit a signed copy of the form (Attachment B) designating the ORP and
attesting that
[[Page 61294]]
all Program Requirements as stipulated in the Security Standards in
Appendix C of the ``Guidelines for HIV/AIDS Surveillance'' have been
attained.
7. Provide a description of the personnel, and the level of support
provided through CDC funding for each staff person involved with HIV/
AIDS core surveillance activities. A description of the experience,
training, credentials and activities of these staff members should be
included. Curriculum vitae should be included as attachments to the
application for those staff members occupying supervisory, leadership,
and advanced technical or scientific positions.
8. Budget
a. In the travel category, include a total for local travel and a
total for out-of-state travel.
b. The following information is required for all proposed
contracts: name of contractor, period of performance, method of
selection (e.g., competitive or sole source), description of
activities, justification for subcontracting, and itemized budget.
c. Submit a single budget and justification for core surveillance
Recipient Activities.
Following receipt of your FY 2004 award, CDC may request additional
activity- or project-specific budgetary information.
Part II. HIV Incidence Surveillance
[sbull] Maximum number of pages: 20 double spaced, including up to
five pages of program plans and budgets for years 2005 and 2006
excluding reports and appendices. Applications with narratives in
excess of 20 pages will be returned to the applicant and not considered
for funding.
[sbull] Font size: 12 point unreduced.
[sbull] Paper size: 8.5 by 11 inches.
[sbull] Page margin size: 1 inch.
[sbull] Printed only on one side of page.
[sbull] Held together only by rubber bands or metal clips; not
bound in any other way.
Format:
In developing this Part of the application, your narrative must
follow the format below:
1. Program Plan.
2. Objectives.
3. Methods for Implementation.
4. Program Evaluation Plan.
5. Budget.
6. Attachments.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
1. Describe the characteristics of the HIV reporting system
including regulations or statutes that authorize the collection of HIV
data, length of time it has been in place, major sources of reports,
whether laboratory reporting exists, and if so, if electronic
laboratory reporting is used. This description must also verify that
diagnosed HIV infections are reported in a timely manner.
2. Describe the potential ability of the surveillance system to
coordinate with laboratory partners, including public health
laboratories and commercial laboratories responsible for HIV testing in
the state, to obtain aliquots of blood for STARHS testing.
3. How the recipient will collaborate with CDC to assure
appropriate and efficient preparation and transport from the lab of
diagnosis to the public health lab, and then from the public health lab
to reference laboratories for STARHS testing.
4. Describe how HIV testing histories will be obtained (either
before or after STARHS testing) from persons identified as recently
infected by the STARHS assay, or its equivalent. The strategies for
acquiring these data should include a diverse sample of persons from
public and private facilities to assure representative and adequately
precise population-based estimates for incidence.
5. Describe how HIV case data will be linked to results from
laboratory specimens, and to HIV testing history information.
6. In addition to linking STARHS results to information in the HIV
reporting system, in some settings a set of specimens will be tested in
an unlinked fashion. Describe how specimens from such individuals will
be anonymized, and data for this component of the surveillance system
will be managed.
7. Describe the number, activities, level of support and
qualifications of the personnel who will be involved in the HIV
Incidence Surveillance program.
8. Budget
a. In the travel category, include a total for local travel and a
total for out-of-state travel.
b. The following information is required for all proposed
contracts: name of contractor, period of performance, method of
selection (e.g., competitive or sole source), description of
activities, justification for subcontracting, and itemized budget.
c. Submit a single budget and justification for HIV Incidence
Surveillance Recipient Activities.
Following receipt of your FY 2004 award, CDC may request additional
activity- or project-specific budgetary information.
Part III. Capacity Building for Epidemiologic and Program Evaluation
Activities
[sbull] Maximum number of pages: 15 double-spaced pages including
up to five pages of program plans for years 2005 and 2006, excluding
reports and appendices. Applications with narratives in excess of 15
pages will be returned to the applicant and not considered for funding.
[sbull] Font size: 12 point unreduced.
[sbull] Paper size: 8.5 by 11 inches.
[sbull] Page margin size: 1 inch.
[sbull] Printed only on one side of page.
[sbull] Held together only by rubber bands or metal clips; not
bound in any other way.
Format:
In developing this Part of the application, your narrative must
follow the format below:
1. Program Need and Resources.
2. Plan and Objectives.
3. Methods.
4. Staffing.
5. Budget.
6. Attachments.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
Describe how staff hired for this project will:
1. Provide on-going assistance in the development and use of the
epidemiologic profile, program, and other health-related data for HIV
prevention and care community planning.
2. Assist HIV prevention and care community planning groups with
evaluation activities.
3. Describe the number, and type of activities, the level of
support and qualifications of the personnel who will be involved in the
HIV Incidence Surveillance program.
4. Budget
a. In the travel category, include a total for local travel and a
total for out-of-state travel.
b. The following information is required for all proposed
contracts: name of contractor, period of performance, method of
selection (e.g., competitive or sole source), description of
activities, justification for subcontracting, and itemized budget.
c. Submit a single budget and justification for Capacity Building
for Epidemiologic and Program Evaluation Activities Recipient
Activities. Following receipt of your FY 2004 award, CDC may request
additional activity- or project-specific budgetary information.
[[Page 61295]]
Part IV. Enhanced Surveillance for Perinatal Prevention
[sbull] Maximum number of pages: The narrative should be no more
than 15 double-spaced pages, including up to five pages of program
plans and budgets for years 2005 and 2006, excluding reports and
appendices. Applications with narratives in excess of 15 pages will be
returned to the applicant and not considered for funding.
[sbull] Font size: 12 point unreduced.
[sbull] Paper size: 8.5 by 11 inches.
[sbull] Page margin size: 1 inch.
[sbull] Printed only on one side of page.
[sbull] Held together only by rubber bands or metal clips; not
bound in any other way.
Format:
In developing this Part of the application, your narrative must
follow the format below:
1. Program Plan.
2. Objectives.
3. Methods.
4. Evaluation.
5. Proposed Data Uses.
6. Staffing.
7. Budget.
8. Attachments.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
1. Describe the current ability of surveillance activities to
collect information on all HIV exposed infants and HIV infected
mothers. Applicants that will not implement HIV reporting to include
HIV exposure reporting by April 1, 2004 and apply for a time-limited
research project must submit evidence that the proposed activity will
be approved by an IRB as required by CDC.
2. Describe the methods that will be used in identifying and
linking data on HIV exposed infants and HIV infected mothers;
conducting systematic chart reviews to complete abstraction forms and
HIV/AIDS case report forms; conducting longitudinal follow-up of HIV
exposed infants to ascertain infection status and initiation of HIV
related treatment and care; and assessing short-and/or long-term
outcomes in HIV exposed infants.
3. Describe the methods that will be used in evaluating the
Enhanced Surveillance of Perinatal Prevention activities, to include a
description of the timeliness and completeness of data collection and
submission of data to CDC.
4. Describe how the data from Enhanced Surveillance of Perinatal
Prevention will be coordinated with and used to improve perinatal
prevention activities.
5. Describe the number, activities, level of support and
qualifications of the personnel who will be involved in the Enhanced
Surveillance of Perinatal Prevention.
6. Budget
a. In the travel category, include a total for local travel and a
total for out-of-state travel.
b. The following information is required for all proposed
contracts: name of contractor, period of performance, method of
selection (e.g., competitive or sole source), description of
activities, justification for subcontracting, and itemized budget.
c. Submit a single budget and justification for Enhanced
Surveillance of Perinatal Prevention Activities. Following receipt of
your FY 2004 award, CDC may request additional activity-or project-
specific budgetary information.
Part V. Laboratory Testing for Recent HIV Infection
[sbull] Maximum number of pages: The narrative should be no more
than 15 double-spaced pages printed on one side, including up to five
pages of program plans and budgets for years 2005 and 2006 excluding
reports and appendices. Attachments should not exceed an additional 25
pages, including budget and budget narrative. Required forms do not
count toward page limits. Applications with narratives in excess of 15
pages will be returned to the applicant and not considered for funding.
[sbull] Font size: 12 point unreduced.
[sbull] Paper size: 8.5 by 11 inches.
[sbull] Page margin size: 1 inch.
[sbull] Printed only on one side of page.
[sbull] Held together only by rubber bands or metal clips; not
bound in any other way.
Format:
In developing this Part of the application, your narrative must
follow the format below:
1. Technical Competence.
2. Capacity.
3. Evaluation.
4. Staffing.
5. Budget.
6. Attachments.
VI. Behavioral Surveillance
[sbull] Maximum number of pages: The program narrative should be no
more than 15 double-spaced pages. Attachments should not exceed an
additional 25 pages, including budget and budget narrative. Required
forms do not count toward page limits. Applications with narratives in
excess of 15 pages will be returned to the applicant and not considered
for funding.
[sbull] Font size: 12 point unreduced.
[sbull] Paper size: 8.5 by 11 inches.
[sbull] Page margin size: 1 inch.
[sbull] Printed only on one side of page.
[sbull] Held together only by rubber bands or metal clips; not
bound in any other way.
Format:
In developing this Part of the application, your narrative must
follow the format below:
1. Program Plan.
2. Objectives.
3. Methods.
4. Evaluation.
5. Proposed Data Uses.
6. Staffing.
7. Budget.
8. Attachments.
Part VII. Core Surveillance in the Pacific Island Jurisdictions
[sbull] Maximum number of pages: The narrative should be no more
than 15 double-spaced pages, including up to five pages of program
plans and budgets for years 2005 and 2006, excluding reports and
appendices. Applications with narratives in excess of 30 pages will be
returned to the applicant and not considered for funding.
[sbull] Font size: 12 point unreduced.
[sbull] Paper size: 8.5 by 11 inches.
[sbull] Page margin size: 1 inch.
[sbull] Printed only on one side of page.
[sbull] Held together only by rubber bands or metal clips; not
bound in any other way.
Format:
In developing this Part of the application, your narrative must
follow the format below:
1. Program Need and Resources.
2. Collaboration and Use of Data.
3. Objectives.
4. Program Plan and Methods for Implementation.
5. Program Evaluation Plan.
6. Project Management and Staffing Plan.
7. Budget.
8. Attachments.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
1. Describe proposed plans for developing active case-finding
efforts, follow-up of priority cases, and activities that promote uses
of HIV and AIDS surveillance data for prevention planning.
2. Describe procedures for critically reviewing surveillance
methodologies to promote efficient and effective use of resources;
disseminating data for public health purposes; ensuring that the
surveillance program contributes to the goals and public health mission
of the
[[Page 61296]]
health department; using surveillance data to evaluate the
effectiveness of prevention efforts, policies, and programs; and using
surveillance data to target and evaluate proposed community-based
interventions.
3. Describe existing or proposed assessment activities to improve
the performance attributes of the HIV/AIDS surveillance system. This
description should include the methods to improve the completeness of
reporting, limit the number of inter-island duplicates of HIV, AIDS,
and promote the accuracy of the data.
4. In specific areas where there is laboratory capacity to perform
confirmatory testing (i.e. Western Blot or IFA) describe the capacity
to serve as central data coordination area through collaboration with
other island jurisdictions that submit specimens for such confirmatory
testing. These descriptions should include a process for assuring
compliance with security and confidentiality requirements.
5. Describe State laws, rules, or regulations pertaining to the
protection or release of surveillance information; physical security of
hard copies and electronic files containing confidential surveillance
information; any laws, rules, regulations, or health department
policies that require or permit the release of patient identifying
information collected under the HIV/AIDS surveillance system to
entities outside of the public health department and measures the
health department has taken to ensure that the confidentiality of
individuals reported to the surveillance system is protected from
further or unlawful disclosure. As part of the application, you must
submit a signed copy of the form (Attachment B) designating the ORP and
attesting that all Program Requirements as stipulated in the Security
Standards in Appendix C of the ``Guidelines for HIV/AIDS Surveillance''
have been attained.
6. Provide a description of the personnel, and the level of support
provided through CDC funding for each staff person involved with HIV/
AIDS core surveillance activities. A description of the experience,
training, credentials and activities of these staff members should be
included. Curriculum vitae should be included as attachments to the
application for those staff members occupying supervisory, leadership,
and advanced technical or scientific positions.
7. Budget
a. In the travel category, include a total for local travel and a
total for out-of-state travel.
b. The following information is required for all proposed
contracts: name of contractor, period of performance, method of
selection (e.g., competitive or sole source), description of
activities, justification for subcontracting, and itemized budget.
c. Submit a single budget and justification for core surveillance
Recipient Activities. Following receipt of your CY 2004 award, CDC may
request additional activity-or project-specific budgetary information.
Funding Restrictions:
Funding restrictions, which must be taken into account while
writing your budget for parts I-VII are as follows:
[sbull] Funds are awarded for a specifically defined purpose
described in this announcement and may not be used for any other
purpose or program.
[sbull] Funds may be used to support personnel and to purchase
equipment, supplies, and services directly related to project
activities.
[sbull] Funds may not be used to supplant State or local health
department funds available for HIV Prevention and Surveillance.
[sbull] Funds may not be used to provide direct medical care or
prevention case management.
If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement must be less than 12
months of age.
Guidance for completing your budget can be found on the CDC Web
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm
.
Submission Date, Time, and Address: Application Deadline Date:
January 16, 2004.
Application Submission Address: Submit your application by mail or
express delivery service to:
Technical Information Management-PA 04017, CDC Procurement
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline
date. If you send your application by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery of the application by the closing date
and time. If CDC receives your application after closing due to: (1)
Carrier error, when the carrier accepted the package with a guarantee
for delivery by the closing date and time, or (2) significant weather
delays or natural disasters, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the application as having
been received by the deadline.
This program announcement is the definitive guide on application
format, content, and deadlines. It supersedes information provided in
the application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that you did not meet the submission
requirements.
If you have a question about the receipt of your application, first
contact your courier. If you still have a question, contact the PGO-TIM
staff at: 770-488-2700. Before calling, please wait two to three days
after the application deadline. This will allow time for applications
to be processed and logged. CDC will not be sending post cards
acknowledging receipt of applications.
Intergovernmental Review of Applications
Your application is subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (EO) 12372. This order sets up
a system for state and local governmental review of proposed federal
assistance applications. You should contact your state single point of
contact (SPOC) as early as possible to alert the SPOC to prospective
applications, and to receive instructions on your state's process.
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html
.
V. Application Review Information
Review Criteria: You are required to provide measures of
effectiveness that will demonstrate the accomplishment of the various
identified objectives of the cooperative agreement. Measures of
effectiveness must relate to the performance goals stated in the
``Purpose'' section of this announcement. Measures must be objective
and quantitative, and must measure the intended outcome. These measures
of effectiveness must be submitted with the application and will be an
element of evaluation.
Your application will be evaluated against the following criteria:
A Technical Acceptability Review will be conducted by CDC for Parts
I, II, III, VI, and VII. Parts IV and V will involve Objective Review
Panels. The individual ``Parts'' are further discussed below.
[[Page 61297]]
Part I. Core Surveillance
The following criteria will be used to evaluate applications for
their technical acceptability:
1. Program Need and Resources: The extent to which the applicant
describes the requirements for, and activities of, the HIV/AIDS
surveillance system that includes a presentation of existing strengths
and limitations. The extent to which this overview includes: the
program need in terms of HIV/AIDS morbidity (i.e., delineation of the
annual number of HIV/AIDS cases and case rates); extent and level of
funding devoted to prevention, treatment, and care programs in the area
that require HIV/AIDS surveillance data for resource allocation and
program planning; uses of surveillance data, including linkages to
public health program activities such as PCRS; ability to analyze data
that allows for the identification of trends in emerging modes of HIV
transmission (by various demographic indicators and behaviors); all
existing and potential sources of HIV/AIDS cases; a description of HIV/
AIDS reporting procedures and resources in the area including a
presentation of data items currently collected; ongoing quality
assurance procedures to promote data quality; sources of funding beyond
federal monies provided by CDC; the flow of data through the reporting
system; existing policies and procedures that are written and
implemented for security, confidentiality, data dissemination and
surveillance procedural activities; educational and training activities
undertaken to develop and enhance the skills of surveillance staff and
staff in reporting facilities; a copy of the most recent annual
surveillance report; State legislation and/or regulations pertaining to
the reporting, collection, uses and dissemination of HIV/AIDS
surveillance data.
2. Collaboration and Use of Data: The extent to which the applicant
describes past, current, and proposed collaboration with: the relevant
HIV/AIDS organizations and agencies within the reporting area; CDC, and
other States or national organizations involved in coordinating and
assuring the quality, completeness, and accuracy of HIV/AIDS
surveillance data; locally and Federally-funded prevention, treatment
and care programs such as the CDC prevention programs or the Ryan White
Care Act; and the extent HIV/AIDS surveillance data are used to assist
public and private partners (e.g., community planning groups, AIDS
Service Organizations) as a guide for allocating HIV prevention and
care resources, and as a means to evaluate the success of their
intervention programs.
3. Proposed Objectives: The extent to which program objectives are:
specific, measurable, time-phased, and realistic; related to recipient
activities, program purpose and program activities; derived from needs
identified in the resources and needs assessment; and consistent with
national HIV/AIDS surveillance program objectives.
4. Program Plan and Methods for Implementation: The extent to which
the applicant adequately describes the procedures and methods to be
used to accomplish the program objectives for their surveillance
program; and describes how program plans and procedures will facilitate
achievement of national objectives for HIV/AIDS surveillance.
5. Program Evaluation Plan: The applicant provides an evaluation
plan that is appropriate for measuring progress toward program area and
national HIV/AIDS surveillance objectives; the plan should include a
specified time-line and methods for identifying promoters and barriers
to program success.
6. Project Management and Staffing Plan: The extent to which
proposed staffing, organizational structure, staff experience and
background, identified training needs or plan, and job descriptions and
curricula vitae for both proposed and current staff indicate ability to
carry out the purposes of the program.
7. Budget: The budget is reasonable, clearly justified, consistent
with the demonstrated need and proposed activities, and likely to lead
to program success.
Part II. HIV Incidence Surveillance
1. Program Plan: The degree to which the applicant provides
evidence of their understanding of the project goals and conceptual
background through the presentation of a coherent plan that describes
all the necessary activities and personnel needed to conduct HIV
Incidence surveillance. Quality of plans for conducting data analysis
and presentation showing how data have been and will be used to improve
state and local HIV prevention programs and HIV services and care.
2. Objectives: The extent to which the objectives are specific
(with time frames), realistic, and address the required recipient
activities.
3. Methods for Implementation: The extent to which the applicant
demonstrates the technical capability to conduct the project using the
appropriate data collection and analytic methods. Specific technical
capabilities to be reviewed for each project include: The ability to
identify new HIV infections reported to the surveillance system in a
timely manner; collaboration with laboratory partners, including public
health laboratories and commercial laboratories responsible for HIV
testing in the state, to obtain aliquots of blood for STARHS testing;
preparation and transport of specimens to reference laboratories for
STARHS testing; obtainment of sufficient HIV testing history
information; linkage of HIV case data to laboratory specimens, and to
HIV testing history information; and in areas that execute unlinked
STARHS, the extent to which the methods are feasible and appropriate.
4. Program Evaluation Plan: The applicant provides an evaluation
plan that is appropriate for measuring progress toward program area and
national HIV Incidence surveillance objectives; the plan should include
a specified time-line and methods for identifying promoters and
barriers to program success.
5. Budget: The budget is reasonable, clearly justified, consistent
with the demonstrated need and proposed activities, and likely to lead
to program success.
Part III. Capacity Building for Epidemiologic and Program Evaluation
Activities
1. Program Need and Resources: The extent to which the applicant
describes the need for resources to achieve the purpose. The detail
should include how awardees will collaborate with public and private
partners (such as, HIV prevention and care community planning groups
and AIDS service organizations) to use surveillance, program, and other
health-related data to enhance community planning, evaluation, and
monitoring achievement of goals and objectives.
2. Plan and Objectives: The extent to which the applicant describes
its plan for achieving the purpose, including presentation of goals,
objectives, activities, and time frames along with narrative
discussion. The narrative discussion should include:
a. Objectives for the collection, use, analysis, interpretation of
surveillance, program, and other health-related data to enhance
epidemiologic and program evaluation activities.
b. Discussion of the ``Recipient Activities'' outlined above.
3. Methods: The extent to which the applicant describes how
surveillance and other health-related data will be used to improve
epidemiologic and program evaluation activities, including,
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but not limited to, prevention and care community planning, assessment
of prevention program effectiveness, and the monitoring of goals and
objectives. Requests should include discussion of various data sets and
specific studies that may be available to assist with assessment of the
impact of HIV prevention activities in the jurisdiction.
4. Staffing: The extent to which the qualifications, duties,
responsibilities, and time allocation of proposed staff (including
potential contractors) are discussed, and how these attributes are
justified and appropriate to accomplish the purpose and implement the
recipient activities. Discussion should include the degree to which
proposed staff will be able to provide appropriate scientific oversight
as well as programmatic and administrative support for the proposed
activities.
5. Budget: Budgets will be assessed to ensure they are reasonable,
clearly justified, consistent with the demonstrated need and proposed
activities, and likely to lead to program success.
Part IV. Enhanced Surveillance for Perinatal Prevention
Note: Applications submitted for this Part will be reviewed by
an independent objective review panel appointed by CDC that will
evaluate each application against the following criteria:
1. Methods (25 points): The extent to which the applicant
demonstrates technical capability to conduct the project using the
appropriate data collection and analytic methods. Specific methods
for accomplishing the following technical activities should be
described:
a. Identifying and linking data on related infected mothers and
HIV exposed children.
b. Conducting systematic chart reviews, abstraction forms and
HIV/AIDS case report forms.
c. Conducting longitudinal follow-up of HIV-exposed infants to
ascertain infection status and initiation of HIV related treatment
and care.
d. Past ability to conduct the project including a description
of the timeliness and completeness of data collection and submission
on mother-infant pairs.
2. Program Plan (20 points): The extent to which the applicant
provides a clear and feasible plan for enhancing surveillance
activities for children and women by expanding core perinatal
surveillance by collecting data:
a. On all children born to HIV-infected women (including
zidovudine (ZDV) and other antiretroviral therapy used during
pregnancy, at labor or delivery, and to the neonate; opportunistic
infection prophylaxis; initiation of HIV evaluation and care; HIV
infection status; and short as well as long-term outcomes in
antiretroviral exposed and unexposed children).
b. On HIV-infected women who deliver a live infant, to assess
the counseling and therapy they received during pregnancy, the date
of their HIV diagnosis, dates of initiation of prenatal care, dates
of initiation of ZDV and other antiretroviral therapy, pregnancy
outcomes, stage of HIV disease, and HIV risk behaviors.
c. Applicants that will not implement HIV reporting by April 1,
2004 and apply for a time-limited research project must submit
evidence that the proposed activity will be approved by an IRB as
required by CDC.
3. Objectives (15 points): The extent to which the objectives
are specific (with time frames), realistic, and address the required
recipient activities.
4. Evaluation (15 points): The extent to which realistic plans
for evaluation of project activities have been developed, and the
quality of such plans. Includes a description of the timeliness of
the system and the completeness of ascertainment of mother-infant
pairs.
5. Proposed Data Uses (15 points): The extent to which data
have, or will, assist in HIV prevention and care activities, so that
these data are used for formulating public health strategies and
targeting resources. In areas that received categorical CDC funding
for perinatal prevention activities, the extent to which the
applicant describes how the data from this system will be
coordinated with and be used to improve these activities.
6. Staffing (10 points): The extent to which proposed staffing,
organizational structure, staff experience and background,
identified training needs or plan, and job descriptions and
curricula vitae for both proposed and current staff indicate ability
to carry out the purposes of the program.
7. Budget (not scored): The extent to which the budget is
reasonable, clearly justified, and consistent with the intended use
of funds. All budget categories should be itemized.
Part V. Laboratory Testing for Recent HIV Infection
Note: Applications submitted for this Part will be reviewed by
an independent objective review panel appointed by CDC that will
evaluate each application against the following criteria:
1. Technical Competence (40 points): Ability to perform the
assay for incident HIV infection with an extremely high degree of
reliability, as evidenced by previous successful proficiency
conducting this test and demonstrated satisfactory participation in
the CDC quality assurance program for this test. Applicants should
include quality control charts from actual testing conducted over
the most recent three months.
2. Capacity (40 points): Ability to process and test at least
6,000 specimens per month, using acceptable automated testing
equipment and protocols. Ability to track receipt of specimens and
report results within seven days of receipt of specimen using
appropriate data and specimen management systems. Availability of
adequate, dedicated laboratory space and equipment for receipt,
testing and short-term storage of a large volume of specimens.
3. Staff capabilities and Project Oversight (20 points):
Demonstrates inclusion of scientific oversight as appropriate for
the complexity of the proposed activities, as evidenced by: (a)
Project administration plans; (b) ability to recruit, hire, and
train appropriate number and type of personnel to conduct a large
number of highly complex tests; and (c) qualifications, research and
laboratory experience of the staff who will participate in this
project documented in attached CVs of key staff. This includes
evidence of ability to collaborate and conduct testing for external,
collaborating organization (e.g., documentation from state health
departments for which they have conducted testing in the past)
including attached letters of support from current collaborators and
a letter from the State or City health department human resources
office director confirming their ability to recruit and hire
appropriate staff within three months of the start of the funding.
4. Budget (Not scored): The extent to which the budget is
reasonable, clearly justified, and consistent with the intended use
of funds.
Part VI. Behavioral Surveillance
The technical acceptability of the application will be evaluated
based on the following criteria:
1. The degree to which the applicant provides evidence of their
understanding of the project protocol and objectives. The extent to
which plans for evaluation of project activities have been developed
and are realistic. Quality of plans for data analysis and presentation
showing how data have been and will be used to improve state and local
HIV prevention programs and HIV services and care.
2. The extent to which the applicant provides evidence of their
ability to implement study methodology. The extent to which the
applicant provides evidence of their ability to recruit/sample 500 MSM
and 500 IDUs within the budget period.
3. The quality of the applicant's plan to develop, implement and
administer the project operations and the degree to which the
objectives and time schedules are reasonable, time-phased and
appropriate for accomplishing project activities. The quality of the
applicants plan to address Recipient Activities outlined in Section E
(1). The degree to which the applicant has met the CDC policy
requirements regarding the inclusion of ethnic, racial groups in the
proposed research. This includes:
a. The proposed plan for the inclusion of both sexes' racial and
ethnic minority populations for appropriate representation.
b. The proposed justification when representation is limited or
absent.
c. A statement as to whether the design of the study is adequate to
measure differences when warranted.
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4. A statement as to whether the plans for recruitment and outreach
for study participants include the process of establishing partnerships
with community(ies) and recognition of mutual benefits.
5. The degree to which the qualifications, duties,
responsibilities, and time allocation of proposed staff (including
potential contractors), are justified and appropriate to accomplish
study objectives. The degree to which the proposed staff will be able
to provide appropriate scientific oversight, as well as programmatic
and administrative support for the proposed activities. The extent to
which collaborating entities (e.g., HIV prevention programs, community
groups, community gatekeepers, CBOs, behavioral scientists) are
appropriate (i.e., meet specific needs), sufficient, promote project
objectives, and document their ability in letters of support.
6. The extent to which the budget is reasonable, clearly justified,
and consistent with the intended use of funds.
Part VII. Core Surveillance in the Pacific Island Jurisdictions
The following criteria will be used to evaluate applications for
their technical acceptability:
1. Program Need and Resources: The extent to which the applicant
describes the requirements for, and activities of, the HIV/AIDS
surveillance system that includes a presentation of existing strengths
and limitations. The extent to which this overview includes: The
program need in terms of HIV/AIDS morbidity; extent and level of
funding devoted to prevention, treatment, and care programs in the area
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