[Federal Register Volume 66, Number 131 (Monday, July 9, 2001)]
[Notices]
[Pages 35797-35798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17048]


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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Draft Guidance for Industry on the Clinical Studies Section of 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

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availability of a draft guidance for industry entitled ``Clinical 
Studies Section of Labeling for Prescription Drugs and Biologics--
Content and Format.'' The agency has initiated a comprehensive effort 
to improve the format and content of prescription drug labeling. FDA 
intends to carefully coordinate development and implementation of these 
labeling initiatives to minimize the potential burden for manufacturers 
and other affected parties.

DATES: Submit written comments on the draft guidance by October 9, 
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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 Submit written comments on the draft guidance to the Dockets 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. 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section for electronic access to the draft guidance document.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-4), 
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

    FDA is announcing 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). Among other things, the 
agency proposed reordering the sections of the labeling based on the 
importance of the information to practitioners and the frequency with 
which practitioners refer to a section. Also, the agency proposed 
creating a ``highlights'' section and an index.
    FDA is working on a proposed rule to revise the current 
requirements for the pregnancy subsection of labeling (see the notice 
(62 FR 41061, July 31, 1997) announcing a 21 CFR part 15 hearing to 
discuss the category requirements, and the notice (64 FR 23340, April 
30, 1999) announcing a meeting of a public advisory committee to 
discuss possible changes to pregnancy labeling).
    The agency also is developing guidance documents that focus on the 
content of certain labeling sections. The first draft guidance, 
``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). This draft guidance, ``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, this 
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.
    At this time, FDA is also developing guidances for the Adverse 
Reactions, Clinical Pharmacology, and Warnings/Precautions sections of 
the labeling. The draft guidance for the Adverse Reactions section was 
made available for public comment on June 21, 2000 (65 FR 38563). The 
agency expects to publish draft guidances for the Clinical Pharmacology 
and Warnings/Precautions sections for comment in the

[[Page 35798]]

coming months. The agency has focused its efforts on these sections of 
the labeling because they typically contain large amounts of important 
and complex information, and there have been significant differences in 
their format and content across product classes and individual medical 
products. Guidances for other labeling sections may be developed later.
    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115; 65 FR 56468, 
September 19, 2000). The draft guidance represents the agency's current 
thinking on the content and format of the Clinical Studies section of 
labeling for human prescription drugs and biologics. 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 can be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

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: June 27, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17048 Filed 7-6-01; 8:45 am]
BILLING CODE 4160-01-S