[Federal Register Volume 71, Number 15 (Tuesday, January 24, 2006)]
[Notices]
[Pages 3999-4000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2000D-1306 (formerly 00D-1306) and 2001D-0269 (formerly 
01D-0269)]


Two Guidances for Industry on the Content and Format of Labeling 
for Human Prescription Drug and Biological Products; 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 two guidances for industry entitled ``Clinical Studies 
Section of Labeling for Human Prescription Drug and Biological 
Products--Content and Format'' and ``Adverse Reactions Section of 
Labeling for Human Prescription Drug and Biological Products--Content 
and Format.'' These guidances are two of a series of guidance documents 
intended to assist applicants in complying with the new requirements in 
the final rule on the content and format of labeling for human 
prescription drug and biological products published elsewhere in this 
issue of the Federal Register.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of these guidances 
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 to 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. The guidances may also be obtained by calling 
CBER at 1-800-835-4709 or 301 827-1800. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the guidances to the Division of Dockets 
Management (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 guidance documents.

FOR FURTHER INFORMATION CONTACT:
    Janet Norden, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., bldg. WO22, rm. 4202, 
Silver Spring, MD 20993, 301-796-2270, or
    Toni Stifano, Center for Biologics Evaluation and Research (HFM-
600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-6190.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Registerof December 22, 2000 (65 FR 81082), FDA 
published a proposed rule to revise the content and format of 
prescription drug labeling. The agency's final rule amending the 
requirements for the content and format of labeling for human 
prescription drug and biological products is published elsewhere in 
this issue of the Federal Register. The new regulations are designed to 
make information in prescription drug labeling easier for health care 
practitioners to access, read, and use, thereby increasing the extent 
to which practitioners rely on labeling for prescribing decisions. 
Among other changes, the final rule makes minor content changes and 
reorders certain sections of labeling, based on the importance of the 
information to practitioners and the frequency with which practitioners 
refer to a section.

II. The Guidances

    FDA is developing a series of guidances on selected sections of 
prescription drug labeling, as well as guidance on how to implement the 
new requirements. This notice announces the availability of two 
guidance documents, entitled ``Clinical Studies Section of Labeling for 
Human Prescription Drug and Biological Products--Content and Format'' 
and ``Adverse Reactions Section of Labeling for Human Prescription Drug 
and Biological Products--Content and Format.'' As described later in 
this document, these two guidances were previously published for 
comment.
    The guidances are intended to help applicants and reviewers do the 
following: (1) Select information for inclusion in the ``Adverse 
Reactions'' and ``Clinical Studies'' sections of prescription drug 
labeling; (2) characterize information selected for inclusion in these 
sections; and (3) organize and present the information, including use 
of graphs and tables, within these sections.
     The guidance entitled ``Adverse Reactions Section of 
Labeling for Human Prescription Drug and Biological Products--Content 
and Format'' provides recommendations on the ``Adverse Reactions'' 
section of labeling. In the Federal Register of June 21, 2000 (65 FR 
38563), FDA published a document announcing the availability of a draft 
guidance for industry entitled ``Content and Format of the Adverse 
Reactions Section of Labeling for Human Drugs and Biologics.'' The 
agency received 14 comments from nine pharmaceutical firms, a trade 
organization, a pharmacy professional society, a health insurance 
company, a medical publishing company, and a consumer. In response to 
these comments, the agency made a number of revisions to the draft 
guidance. Most significantly, the final guidance makes recommendations 
on how to make the most clinically important information accessible to 
health care practitioners. It provides recommendations on how to 
characterize and organize information and it clarifies the recommended 
criteria for determining when to include low frequency adverse events 
in the ``Adverse Reactions'' section.
     The guidance entitled ``Clinical Studies Section of 
Labeling for Human Prescription Drug and Biological Products--Content 
and Format'' provides recommendations on the ``Clinical Studies'' 
section of labeling. In the Federal Register of July 9, 2001 (66 FR 
35797), FDA published a document announcing the availability of a draft 
guidance for industry entitled ``Content and Format of the Clinical 
Studies Section of Labeling for Human Drugs and Biologics.'' The agency 
received seven comments from six pharmaceutical firms and one trade

[[Page 4000]]

organization. In response to these comments, the agency has made 
revisions to the draft guidance. The final guidance provides several 
examples of the types of studies that can be included in the ``Clinical 
Studies'' section. The final guidance also provides clarification on 
when it is appropriate to include comparative data.
    Elsewhere in this issue of the Federal Register, the agency is 
making available for comment draft guidances on implementing the 
content and format requirements and on the ``Warnings and 
Precautions,'' ``Contraindications,'' and ``Boxed Warning'' sections of 
labeling.
    These guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). They represent the 
agency's current thinking on this topic. They do not confer any rights 
for or on any person and do 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.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidances. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
should identify clearly which guidance they are commenting on and 
should be identified with the docket number found in brackets in the 
heading of this document. The guidances and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

IV. Paperwork Reduction Act of 1995

    These guidances contain information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The 
collection(s) of information in the guidances are estimated in section 
``VIII. Paperwork Reduction Act of 1995'' of the final rule entitled 
``Requirements on Content and Format of Labeling for Human Prescription 
Drug and Biological Products,'' published elsewhere in this issue of 
the Federal Register.

V. Electronic Access

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

    Dated: September 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-544 Filed 1-18-06; 10:29 am]
BILLING CODE 4160-01-S