[Federal Register: November 20, 2001 (Volume 66, Number 224)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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Draft Guidance for Industry on the Clinical Studies Section of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.
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November 26, 2001, the comment period for the draft guidance for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 This draft guidance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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 Submit written comments on the draft guidance to the Dockets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
electronic comments to http://www.fda.gov/dockets/ecomments. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
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: firstname.lastname@example.org.
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.
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
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