[Federal Register Volume 65, Number 120 (Wednesday, June 21, 2000)]
[Notices]
[Pages 38563-38564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15633]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1306]


Draft Guidance for Industry on the Content and Format of the 
Adverse Reactions Section of Labeling for Human Prescription Drugs and 
Biologics; 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availability of a draft guidance for industry entitled ``Content and 
Format of the Adverse Reactions Section of Labeling for Human 
Prescription Drugs and Biologics.'' The agency has initiated a 
comprehensive effort to improve the content and format of prescription 
drug labeling. This draft guidance is the first in a series of guidance 
documents on the content and format of individual labeling sections. 
FDA intends to carefully coordinate development and implementation of 
these various labeling initiatives to minimize the potential burden for 
manufacturers and other affected parties.

DATES: Submit written comments on the draft guidance by September 19, 
2000. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm or at http://www.fda.gov/cber/guidelines.htm. Submit written requests for single 
copies of the draft guidance to the Drug Information Branch (HFD-210), 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, or to the Office of 
Communication, Training, and Manufacturers Assistance (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-3844, FAX 888-
CBERFAX, or Voice Information System at 800-835-4709. 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 Submit written comments on the draft guidance to the Dockets 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.

FOR FURTHER INFORMATION CONTACT:
    Janet M. Jones, Center for Drug Evaluation and Research (HFD-40), 
Food and Drug Administration,

[[Page 38564]]

5600 Fishers Lane, Rockville, MD 20857, 301-594-6758, or
    Toni M. Stifano, Center for Biologics Evaluation and Research (HFM-
602), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-6190, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 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. FDA is developing and intends to 
publish a proposed rule to revise the overall format of prescription 
drug labeling. It will propose 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 and creating a 
``highlights'' section and an index.
    FDA also is working on a proposed rule to revise the current 
requirements for the pregnancy subsection of labeling (see 62 FR 41061, 
July 31, 1997, announcing 21 CFR part 15 hearing to discuss the 
category requirements, and 64 FR 23340, April 30, 1999, announcing a 
public advisory committee meeting to discuss possible changes to 
pregnancy labeling).
    In addition, FDA is developing guidance documents that focus on the 
content of certain labeling sections. The draft guidance on ``Content 
and Format of the Adverse Reactions Section of Labeling for Human 
Prescription Drugs and Biologics'' provides guidance on, among other 
things, criteria for including adverse reactions in labeling, 
presentation of adverse reactions in a table, and organization of the 
section. This section exists in the current labeling and is expected to 
continue to exist when the new format for prescription drug labeling is 
proposed.
    At this time, FDA also is developing guidances for the Clinical 
Pharmacology, Clinical Studies, and Warnings/Precautions sections. The 
agency expects to publish these draft guidances for comment in the 
coming months. To date, the agency has focused its efforts on these 
sections because they typically contain large amounts of important and 
complex information and there have been significant variations in their 
format and content across different medical products. Guidances for 
other labeling sections may be developed later.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The draft guidance 
represents the agency's current thinking on the content and format of 
the adverse reactions 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 may be used if such approach satisfies the requirements of the 
applicable statute, regulations, or both.
    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 
the 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.

    Dated: June 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15633 Filed 6-20-00; 8:45 am]
BILLING CODE 4160-01-F