[Federal Register: June 27, 2002 (Volume 67, Number 124)]
[Notices]               
[Page 43323-43324]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn02-90]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0259]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Telephone Questionnaire Administration to Control 
Subjects Recruited into FDA Lyme Vaccine Safety Study, ``A Case-Control 
Study of HLA Type and T-Cell Reactivity to Recombinant Outer Surface 
Protein A and Human Leukocyte Function-Associated Antigen-1''

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the use of a survey questionnaire to be 
administered by telephone interview to control subjects recruited into 
and participating in a vaccine safety study conducted by FDA to 
investigate reports of arthritis following administration of the Lyme 
disease vaccine. Informed consent for administration of this 
questionnaire will have been received prior to the interview, and the 
interview is to be conducted at a time specified by the control subject 
at the time of initial recruitment into this study. This questionnaire 
is an abridged version of one used in followup survey interviews with 
persons reported to the national Vaccine Adverse Event Reporting System 
(VAERS) as having developed joint problems or arthropathy following 
Lyme disease vaccine administration.

DATES: Submit written or electronic comments on the collection of 
information by August 26, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques,

[[Page 43324]]

when appropriate, and other forms of information technology.

Telephone Questionnaire Administration to Control Subjects Recruited 
into FDA Lyme Vaccine Safety Study, ``A Case-Control Study of HLA Type 
and T-Cell Reactivity to Recombinant Outer Surface Protein A and Human 
Leukocyte Function-Associated Antigen-1''

    Section 505 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355), requires that important safety information relating to 
all human prescription drug products be made available to FDA so that 
it can take appropriate action to protect the public health when 
necessary. Section 702 of the act (21 U.S.C. 372) authorizes 
investigational powers to FDA for enforcement of the act.
    Under section 519 of the act (U.S.C. 360i), FDA is authorized to 
require manufacturers to report medical device-related deaths, serious 
injuries, and malfunctions to FDA and to require user facilities to 
report device-related deaths directly to FDA and to manufacturers, and 
to report serious injuries to the manufacturer. Section 522 of the act 
(21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct 
postmarket surveillance of medical devices. Section 705(b) of the act 
(21 U.S.C. 375(b)) authorizes FDA to collect and disseminate 
information regarding medical products or cosmetics in situations 
involving imminent danger to health or gross deception of the consumer. 
Section 903(d)(2) of the act (21 U.S.C. 393(d)(2)) authorizes the 
Commissioner of Food and Drugs (the Commissioner) to implement general 
powers (including conducting research) to carry out effectively the 
mission of FDA. These sections of the act enable FDA to enhance 
consumer protection from risks associated with medical products usage 
that are not foreseen or apparent during the premarket notification and 
review process.
    FDA's regulations governing application for agency approval to 
market a new drug (21 CFR part 314) and regulations governing 
biological products (21 CFR part 600) implement these statutory 
provisions.
    Currently FDA monitors medical product related postmarket adverse 
events via both the mandatory and voluntary MedWatch reporting systems 
using FDA forms 3500 and 3500A (OMB control number 0910-0291) and the 
vaccine adverse event reporting system (VAERS) using form VAERS-1. 
Health care providers and manufacturers are required by law (42 U.S.C. 
300aa-25) to report adverse events following vaccination listed in the 
vaccine injury table. Reports for reactions to other vaccines are 
voluntary, and are received from vaccine recipients, their health care 
providers, and other reporters.
    FDA is seeking OMB clearance to collect vital information through 
the use of the proposed survey questionnaire for control subjects 
participating in this vaccine safety study. The intended respondents 
are control subjects previously recruited to participate in this study, 
and are matched with case subjects reported to VAERS who developed 
arthritis following Lyme vaccine administration. Informed consent for 
administration of this questionnaire will have been received prior to 
the interview, and the interview is to be conducted at a time specified 
by the control subject at the time of initial recruitment into this 
study. Case and control subjects should have similar age, gender, and 
ethnic backgrounds. Specific genetic and immune factors will be 
compared between case and control subjects. This is a common, accepted 
type of epidemiological study called a case-control study. Information 
collected includes medical and vaccination history, family history, and 
possible exposures such as in the workplace that may play a part in the 
development of arthritis in some patients. FDA will use the information 
gathered from the use of this survey questionnaire to ensure 
appropriate matching of cases and controls in the study and to assess 
possible factors which may factor in the development of this adverse 
event. This study was approved by the FDA Research Involving Human 
Subjects Committee on February 15, 2002 (RIHSC 01-028B). This 
survey questionnaire is an abbreviated version of one used during 
enhanced surveillance followup of adverse events following Lyme vaccine 
administration reported to VAERS. The use of the vital information 
gathered using this survey questionnaire will aid FDA in assessing 
risks that may be associated with vaccine product usage that are not 
foreseen or apparent during the premarket notification and review 
process, so the agency may take appropriate public health or regulatory 
action including dissemination of this information as necessary and 
appropriate.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                        Annual
            Survey                    No. of        Frequency per     Total Annual      Hours per    Total Hours
                                   Respondents         Response        Responses        Response
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``A Case-Control Study of HLA   225                1                225              0.5             112.5
 Type and T-Cell Reactivity to
 Recombinant Outer Surface
 Protein A and Human Leukocyte
 Function-Associated Antigen-
 1''
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA projects that there will be up to 75 case subjects recruited 
into this study with 3 control subjects recruited for each case 
subject, with a total maximum of 225 survey questionnaire respondents. 
FDA also projects a response time no greater than 0.5 hours per 
response. This estimate is based on previous results experienced with 
the instrument during enhanced surveillance followup of adverse events 
reported to VAERS. Respondents will only be contacted once during 
conduct of this study for the purposes of collection of vital 
information using this survey questionnaire.

    Dated: June 21, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16294 Filed 6-26-02; 8:45 am]
BILLING CODE 4160-01-S