[Federal Register: January 24, 2006 (Volume 71, Number 15)]
[Notices]
[Page 3998-3999]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja06-150]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0011]
Draft 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 draft guidances for industry entitled ``Labeling
for Human Prescription Drug and Biological Products--Implementing the
New Content and Format Requirements'' and ``Warnings and Precautions,
Contraindications, and Boxed Warning Sections of Labeling for Human
Prescription Drug and Biological Products--Content and Format.'' These
draft 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 prescription drug and
biological products published elsewhere in this issue of the Federal
Register. Elsewhere in this issue of the Federal Register, the agency
is announcing the availability of two guidances on the content and
format of the ``Clinical Studies'' and ``Adverse Reactions'' sections
of labeling.
DATES: Submit written or electronic comments on the draft guidances by
April 24, 2006. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
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 (HFD-040), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448. The draft 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 draft 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
documents.
FOR FURTHER INFORMATION CONTACT:
Janet Norden, Center for Drug Evaluation and Research (HFD-40),
Food and Drug Administration, 10903 New Hampshire Ave., bldg. W022, 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 Register of 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. The
final rule requires that labeling of new and recently approved products
include highlights of prescribing information and a table of contents.
It reorders certain sections of labeling, based on the importance of
the information to practitioners and the frequency with which
practitioners refer to a section, and makes minor content changes.
II. The Draft Guidances
FDA is developing guidance on how to implement the new requirements
as well as a series of guidances on selected sections of prescription
drug labeling. This document announces the availability of two draft
guidances entitled ``Labeling for Human Prescription Drug and
Biological Products--Implementing the New Content and Format
Requirements'' and ``Warnings and Precautions, Contraindications, and
Boxed Warning Sections of Labeling for Human Prescription Drug and
Biological Products--Content and Format.'' FDA developed these draft
guidances to accompany the publication of the final rule, published
elsewhere in this issue of the Federal Register, on the content and
format of prescription drug labeling.
The draft guidance entitled ``Labeling for Human
Prescription Drug and Biological Products--Implementing the New Content
and Format Requirements'' provides recommendations on issues to
consider when revising labeling for approved products to meet the new
requirements, issues to consider when developing highlights of
prescribing information, how to format labeling, and other procedural
information.
The draft guidance entitled ``Warnings and Precautions,
Contraindications, and Boxed Warning Sections of Labeling for Human
Prescription Drug and Biological Products--Content and Format''
provides recommendations on how to select, characterize, and organize
information for inclusion in the ``Warnings and Precautions'' and
``Contraindications'' sections, as well as what information to include
in a boxed warning.
Elsewhere in this issue of the Federal Register, the agency is
announcing the availability of guidances on the content and format of
the ``Clinical Studies'' and ``Adverse Reactions'' sections of
labeling. These final guidances were previously published in draft for
comment.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidances,
when finalized, will represent the agency's current thinking on these
topics. They do not create or 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 draft guidances.
Submit a single copy of electronic commments 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 draft 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 draft guidances contain information collection provisions
that
[[Page 3999]]
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection(s) of information in the draft 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
ets/default.htm.
Dated: September 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-543 Filed 1-18-06; 10:28 am]
BILLING CODE 4160-01-S