[Federal Register Volume 66, Number 65 (Wednesday, April 4, 2001)]
[Notices]
[Pages 17912-17914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8199]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-1852]
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;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Reports on the Status of Postmarketing Studies--Implementation of
Section 130 of the Food and Drug Administration Modernization Act of
1997.'' This draft guidance provides recommendations on procedures,
content, and format for submitting a postmarketing study status report
for an approved human drug or licensed biological product; timeframes
for FDA's review of postmarketing studies; and 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 The draft
guidance is intended to assist applicants in meeting the requirements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.
DATES: Submit written comments on the draft guidance to ensure their
adequate consideration in preparation of the final document by July 3,
2001. Submit written comments on the information collection provisions
by June 4, 2001. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: Reports on the Status of
Postmarketing Studies--Implementation of Section 130 of the Food and
Drug Administration Modernization Act of 1997'' to the Drug Information
Branch (HFD-210), Center for Drug Evaluation and Research (CDER), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The document may also be obtained by mail by
calling CDER at 301-827-4573 or the CBER Voice Information System at 1-
800-835-4709 or 301-827-1800, or by fax by calling the FAX Information
System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY
INFORMATION: section for electronic access to the draft guidance
document.
Submit written comments on the document to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Requests and comments should be identified
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Sharon T. Risso, Center for Biologics Evaluation and Research (HFM-
500), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-5098; or
James L. Cobbs, Center for Drug Evaluation and Research (HFD-102),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-594-5610.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Reports on the Status of Postmarketing
Studies--Implementation 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 makes several changes to the existing regulations for approved
human drugs and licensed biological products.
This draft guidance, when finalized, is intended to provide
information on the following: (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. This draft guidance would
be applicable to postmarketing studies for approved human drug products
and licensed biological products that meet the definition of ``drug''
under the act. It would 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.
The draft guidance is being issued consistent with FDA's good
guidance
[[Page 17913]]
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000).
This draft guidance document represents the agency's current thinking
on the submission of postmarketing study reports for approved human
drug or licensed biological products. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations. As with
other guidance documents, FDA does not intend this document to be all-
inclusive and cautions that not all information may be applicable to
all situations.
II. Comments
This draft document is being distributed for comment purposes only,
and is not intended for implementation at this time. Interested persons
may submit to the Dockets Management Branch (address above) written
comments regarding this draft guidance document. Submit written
comments to ensure adequate consideration in preparation of the final
document by July 3, 2001. Two copies of any comments are to be
submitted, except individuals may submit one copy. Comments should be
identified with the docket number found in the brackets in the heading
of this document. A copy of the document and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
III. The Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (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, 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, when appropriate, and other forms of information
technology.
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
This draft guidance document is intended to complement the final
rule that implemented section 506B of the act by describing in greater
detail the content, format, and timing requirements for the
postmarketing study reports required to be submitted to FDA by section
506B. In compliance with section 3507(d) of the PRA (44 U.S.C.
3507(d)), the agency has submitted the information collection
provisions of the final rule to OMB for review.
In addition to the information collection provisions of the final
rule submitted to OMB, this draft guidance would recommend an
additional information collection. 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. Applicants would redact
complete reports to the extent necessary to protect trade secrets or to
conceal individual patient identifiers. FDA would use this redacted
report for release to the public on its website and in the report on
the status of postmarketing studies required under section 506B(c) of
the act. FDA would 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.
Respondents to this information collection are applicants holding
approved applications for human drugs and biological products that are
required or have committed to conduct postmarketing studies.
Based on agency records, there are approximately 183 drug
applicants who are required or who have committed to conduct
approximately 462 postmarketing studies and approximately 33 applicants
holding approved biologics license applications who are required or who
have committed to conduct approximately 86 postmarketing studies. The
agency assumes that all of the estimated 216 respondents would submit
voluntarily approximately 548 redacted versions of 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 status report that already has been formatted and
completed for submission.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
No. of Frequency Total Hours Total
Respondents per Annual per Hours
Response Response Response
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Redacted Version for 216 2.5 548 0.5 274
Public Release
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
In compliance with section 3507(d) of the PRA, the agency is
submitting the information collection provisions of this draft guidance
to OMB for review.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance
document at http://www.fda.gov/cder/guidance/index.htm, or at http://www.fda.gov/cber/guidelines.htm.
[[Page 17914]]
Dated: March 21, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-8199 Filed 4-3-01; 8:45 am]
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