[Federal Register: December 16, 2003 (Volume 68, Number 241)]
[Notices]               
[Page 70016-70017]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de03-50]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

 
Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: 

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otice.

SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) allow the proposed information collection 
project: ``National Children's Study Pilot: Primary Care Practice-Based 
Research Networks (PBRNs).'' In accordance with the Paperwork Reduction 
Act of 1995, Public Law 1004-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites 
the public to comment on this proposed information collection.

DATES: Comments on this notice must be received by February 17, 2004.

ADDRESSES: Written comments should be submitted to: Cynthia D. 
McMichael, Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 
5022, Rockville, MD 20850.
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ, Reports 
Clearance Officer, (301) 427-1651.

SUPPLEMENTARY INFORMATION: 

Proposed Project

    National Children's Study pilot project to determine feasibility of 
NCS data collection in Primary Care Practices.''
    The project is being conducted in response to a modification of an 
AHRQ RFP entitled ``Recourse Center for Primary Care Practice-Based 
Research Networks (PBRNs)'' (issued under Contract 290-02-0008). In 
January 2003 AHRQ requested that the PBRN Resource Center assess the 
potential for PBRNs to participate in the National Children's Study 
(NCS).
    In 2000, Congress passed the Children's Health Act, authorizing an 
unprecedented study of the impact of the environment on children's 
health.
    The goal of the NCS is to identify sufficient numbers of women of 
childbearing age to enroll 100,000 pregnant women into the NCS early in 
gestation, and then to enroll and follow their children through 21 
years of age.
    A key design issue for the NCS is the manner in which participants 
will be recruited and enrolled into the study. Previous research states 
that a well-established relationship between the researcher and the 
subject, convenient study location and active community ties bolster 
recruitment success and the likelihood of a parent to enroll their 
child in longitudinal studies. PBRNs

[[Page 70017]]

consist mainly of non-academic, community-based primary care practices 
with well-established relationships with their subject population. 
PBRNs therefore offer a potentially valuable resource for identifying, 
enrolling, and following women and children for the NCS.
    Recognizing this, AHRQ requested that the Resource Center 
participate in the design of a pilot study of PBRNs' ability to 
participate in the NCS. The proposed NCS pilot study will test the 
ability of PBRNs to collect, process, and manage data similar to that 
which is expected to be collected and processed in the NCS. This pilot 
study will allow the Resource Center to determine the factors that 
enable or hinder the collection of such data at primary care practices, 
as well as make an overall determination of the feasibility of PBRN 
practices' participation in the NCS.
    The pilot study will involve use of in-person interviews, 
developmental assessments of children, self-administered parent/
guardian questionnaires, and physical exams including the collection of 
urine. The pilot study will evaluate the feasibility of having PBRNs 
participate in the NCS using several indicators:
    The ability of practices to use self-administered questionnaires to 
collect and manage the medical and dietary history data of pregnant 
women and of children ages 1 and 5;
    The ability of practices to effectively collect and manage data 
from a physical examination of study subjects (including health status 
and urine collection);
    The ability of practices to facilitate a developmental assessment 
of children conducted at age one and age five;
    The amount of burden data collection places on practices;
    The characteristics of successful and unsuccessful practices in the 
study;
    The ease of data collection across different patient populations 
and data collection modes and;
    To make the necessary determinations, assessments and surveys will 
be conducted with PBRN practice patients as well as with a small number 
of patients who ordinarily receive care elsewhere, and PBRN staff will 
also be surveyed.

Methods of Collection

    The data will be collected from 36 practices per respondent 
category, meaning 36 practices will collect data on pregnant women, 36 
practices will collect data on children aged 1 and 5. It is expected 
that some practices will collect data on more than one respondent 
group. Each practice will recruit 14 patients per respondent group 
using convenience sampling procedures. A total of 504 pregnant women 
and 504 children and their parents (half will be 1 year old and half 
will be 5 years old) will be involved in the data collection. Because a 
small proportion (20%) of patients will be asked to visit another 
practice participating in the pilot study in order to test the ability 
of practices to collect and manage data on non-member patients, the NCS 
will require some providers to collect data on some patients they do 
not normally care for.
    The method of data collection for the patient assessment includes 
self-administered questionnaires, physical examination, and collection 
of a urine sample. The practice will contact potential participants 
through a mailing and a phone call. Non-respondents will not be 
contacted again.

Estimated Annual Respondent Burden

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                                                  Estimated time     Estimated
         Data collection             Number of    per respondent   total burden   Average hourly    Labor rates
                                    respondents      in hours          hours         wage rate
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Pregnant woman: Data collected               403             2.5          1007.5          17.18*      $17,308.85
 at their current practice......
Pregnant woman: Data collected               101               3             303          17.18*        5,205.54
 at a practice other than usual
 source of care.................
Parent of a 1 year old or 5 year             403               4           1,612          17.18*       27,694.16
 old: Data collected at their
 current practice...............
Parent of a 1 year old or 5 year             101             4.5           454.5          17.18*        7,808.31
 old: Data collected at a
 practice other than usual
 source of care.................
1 year old or 5 year old: Data               403               4           1,612               0            0.00
 collected at their usual
 practice.......................
1 year old or 5 year old: Data               101             4.5           454.5               0            0.00
 collected at their usual
 practice.......................
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    Total.......................            1512             3.6         5443.50  ..............     $58,016.86
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* Based on the average hourly wage across private and public sector jobs in the United States, National
  Compensation Survey, July 2002. U.S. Bureau of Labor Statistics.

Estimated Costs to the Federal Government

    The total cost to the government for activities directly related to 
this data collection is estimated to be $780,411.

Request for Comments

    In accordance with the above cited legislation, comments on the 
AHRQ information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of functions of AHRQ, including 
whether the information will have practical utility; (b) the accuracy 
of the AHRQ's estimate of burden (including hours and cost) of the 
proposed collection of information; (c) ways to enhance the quality, 
utility and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the request for OMB approval of the proposed 
information collection. All comments will become a matter of public 
record.

    Dated: December 10, 2003.
Carolyn M. Clancy,
Director.
[FR Doc. 03-31023 Filed 12-12-03; 10:46 am]

BILLING CODE 4160-90-M