[Federal Register Volume 67, Number 202 (Friday, October 18, 2002)]
[Notices]
[Pages 64397-64398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0259]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 18, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Telephone Questionnaire Administration to Control Subjects Recruited 
Into FDA Lyme Vaccine Safety Study entitled ``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 
post-market 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 they 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 before 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

[[Page 64398]]

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.
    In the Federal Register of June 27, 2002 (67 FR 43323) FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency per       Total Annual          Hours per
      Survey          Respondents        [chyph]Response        [chyph]Responses        Response     Total Hours
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``A Case-Control   225                1                      225                     0.5             112.5
 Study of HLA
 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: October 11, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26621 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S