[Federal Register: November 5, 2003 (Volume 68, Number 214)]
[Notices]
[Page 62610-62611]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05no03-90]
-----------------------------------------------------------------------
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of Management and Budget Review; Comment Request; ``Draft Guidance for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.
-----------------------------------------------------------------------
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Draft Guidance for Industry: Reports on the Status of Postmarketing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the reporting requirements contained in the draft guidance for industry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 The draft guidance provides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
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses
Title Respondents per Respondent Total Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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