[Federal Register Volume 68, Number 214 (Wednesday, November 5, 2003)]
[Notices]
[Pages 62610-62611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27717]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999N-1852]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; ``Draft Guidance for 
Industry: Reports on the Status of Postmarketing Studies--
Implementation of Section 130 of the Food and Drug Administration 
Modernization Act of 1997''

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
December 5, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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.

Draft Guidance for Industry: Reports on the Status of Postmarketing 
Studies--Implementation of Section 130 of the Food and Drug 
Administration Modernization Act of 1997

    FDA is requesting OMB approval under the PRA (44 U.S.C. 3507) for 
the reporting requirements contained in the draft guidance for industry 
entitled ``Reports on the Status of Postmarketing Studies--
Implementation of Section 130 of the Food and Drug Administration 
Modernization Act of 1997.'' The draft guidance provides 
recommendations on these topics:
    [sbull] Procedures, content, and format for submitting a 
postmarketing study status report for an approved human drug or 
licensed biological product;
    [sbull] Timeframes for FDA's review of postmarketing studies; and
    [sbull] Information about postmarketing studies that will be 
available to the public.
    The draft guidance is intended to assist applicants in meeting the 
requirements of section 130 of the Food and Drug Administration 
Modernization Act of 1997. Section 506B ``Reports of Postmarketing 
Studies'' of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 356b) provides FDA with additional authority for monitoring the 
progress of postmarketing studies that drug and biologics applicants 
have made a commitment to conduct. Postmarketing studies are those 
studies conducted after approval to gather information about approved 
drug or biologics products. Such studies are used to gather additional 
information about product safety, efficacy, or optimal use.
    Under 506B(a) of the act, an applicant who has entered into an 
agreement with FDA to conduct a postmarketing study is required to 
provide the agency with an annual report on the status of the study 
until the study is completed or terminated. The annual report must 
address the progress of the study or the reasons for the failure of the 
applicant to conduct the study. Section 506B(c) of the act directs FDA 
to develop and publish annually in the Federal Register a report on the 
status of postmarketing studies that applicants have made a commitment 
to conduct and for which status reports have been submitted. In the 
Federal Register of October 30, 2000 (65 FR 64607), the agency 
published a final rule to implement section 506B of the act. The final 
rule made several changes to the regulations for approved human drugs 
and licensed biological products.
    The draft guidance is intended to provide information on the 
following topics: (1) Procedures concerning the submission of 
postmarketing study status reports; (2) the content and format of a 
postmarketing study status report; (3) timeframes for FDA's review of 
postmarketing study reports; and (4) information about postmarketing 
studies that will be available to the public. The draft guidance 
applies to postmarketing studies for approved human drug products and 
licensed biological products that meet the definition of ``drug'' under 
the act. It does not apply to biological products that meet the 
definition of medical ``device'' under the act, or to veterinary drug 
products, which will be addressed separately.
    In addition to the information collection provisions covered by the 
October 30, 2000, final rule, the guidance recommends an additional 
reporting requirement. The draft guidance proposes that applicants with 
postmarketing study commitments submit with their annual report a 
redacted version of each status report that already has been formatted 
and completed for submission. The draft guidance requests that 
applicants redact complete reports to the extent necessary to protect 
trade secrets or to conceal individual patient identifiers. FDA will 
use this redacted report for release to the public on its Web site and 
in the report on the status of postmarketing studies required under 
section 506B(c) of the act. FDA will accept the redacted version of the 
applicant's status report either in an electronic format compatible 
with FDA's electronic database or in hard copy.

[[Page 62611]]

    Respondents to this information collection are applicants holding 
approved applications for human drugs and licensed biological products 
that are required or have committed to conduct postmarketing studies.
    Based on agency data, there are approximately 152 drug applicants 
who are required or who have committed to conduct approximately 935 
postmarketing studies, and approximately 44 applicants holding approved 
biologics license applications who are required or who have committed 
to conduct approximately 223 postmarketing studies. The agency assumes 
that all of the estimated 196 respondents would voluntarily submit 
approximately 1,158 redacted versions of each study in their annual 
status reports. Based on FDA experience, the agency estimates that an 
applicant would expend a total of 0.5 hours preparing a redacted 
version of each study in the status report that already has been 
formatted and completed for submission.
    In the Federal Register of April 4, 2001 (66 FR 17912), FDA 
announced the availability of the draft guidance and requested comments 
for 60 days on the information collection. No comments were received 
that pertained to information collection estimates.
    FDA estimates the burden of this collection of information as shown 
in table 1 of this document. The estimates have been updated from the 
April 4, 2001, notice to reflect current data.

                                                       Table 1.--Estimated Annual Reporting Burden
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                                                       No. of        No. of Responses
                     Title                          Respondents       per Respondent    Total Responses     Hours per Response          Total Hours
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Center for Drug Evaluation and Research                        152          approx. 6                935            0.5                   467.50
Center for Biologics Evaluation and Research                    44          approx. 5                223            0.5                   111.50
Total                                            .................  .................  .................  ......................          579
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    Dated: October 29, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27717 Filed 11-4-03; 8:45 am]
BILLING CODE 4160-01-S