[Federal Register Volume 66, Number 224 (Tuesday, November 20, 2001)]
[Notices]
[Pages 58150-58151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28961]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0269]


Draft Guidance for Industry on the Clinical Studies Section of 
Labeling for Prescription Drugs and Biologics--Content and Format; 
Availability; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
November 26, 2001, the comment period for the draft guidance for 
industry entitled ``Clinical Studies Section of Labeling for 
Prescription Drugs and Biologics--Content and Format'' that appeared in 
the Federal Register of July 9, 2001 (66 FR 35797). This draft guidance 
is part of a comprehensive effort to improve the format and content of 
prescription drug labeling. The agency is taking this action in 
response to a request for an extension and to allow interested parties 
additional time to submit comments.

DATES: Submit written or electronic comments on the draft guidance by 
November 26, 2001. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, 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, 
Rockville, MD 20852-1448, 301-827-3844, FAX 1-888-CBERFAX, or Voice 
Information System at 800-835-4709 or 301-827-1800. Send one self-
addressed, adhesive label to assist that office in processing your 
requests. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit

[[Page 58151]]

electronic comments to http://www.fda.gov/dockets/ecomments. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Janet M. Jones, Center for Drug 
Evaluation and Research (HFD-40), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6758, or Toni Stifano, 
Center for Biologics Evaluation and Research (HFM-602), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 2001 (66 FR 35797), FDA 
announced the availability of a draft guidance for industry entitled 
``Clinical Studies Section of Labeling for Prescription Drugs and 
Biologics--Content and Format.'' As part of a comprehensive effort to 
make prescription drugs safer to use, FDA is engaged in several 
initiatives to make prescription drug labeling a better information 
source for health care practitioners--clearer, more informative, more 
accessible, and more consistent from drug to drug. Recently the agency 
published a proposed rule to revise the overall format of prescription 
drug labeling (65 FR 81082, December 22, 2000). The agency also is 
developing a number of guidance documents that focus on the content of 
certain labeling sections. The first draft guidance entitled ``Content 
and Format of the Adverse Reactions Section of Labeling for Human 
Prescription Drugs and Biologics'' was made available for public 
comment on June 21, 2000 (65 FR 38563).
    The draft guidance entitled ``Clinical Studies Section of Labeling 
for Prescription Drugs and Biologics--Content and Format'' is the 
second guidance document on the content and format of individual 
labeling sections. Among other things, the draft guidance discusses 
what studies to include in the Clinical Studies section, how to 
describe those studies, and how to present clinical study data in 
graphs and tables. The agency also is trying to raise awareness, with 
this draft guidance, of the implications for product promotion of 
information contained in the Clinical Studies section. This section 
exists in the current labeling and is expected to continue to exist 
when the proposed rule to revise the format for prescription drug 
labeling is made final.
    On October 1, 2001, FDA received a request from the Pharmaceutical 
Research and Manufacturers of America (PhRMA) to extend the comment 
period. PhRMA indicated that it needed additional time to coordinate 
comments from its member companies. In response to this request, and to 
provide all interested persons additional time to comment on this draft 
guidance, FDA is reopening the comment period until November 26, 2001.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The draft guidance 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. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or at http://www.fda.gov/cber/guidelines.htm.

    Dated: November 14, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-28961 Filed 11-19-01; 8:45 am]
BILLING CODE 4160-01-S