[Federal Register Volume 71, Number 15 (Tuesday, January 24, 2006)]
[Notices]
[Pages 3998-3999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-543]



  Federal Register / Vol. 71, No. 15 / Tuesday, January 24, 2006 / 
Notices  

[[Page 3998]]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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://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://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. 06-543 Filed 1-18-06; 10:28 am]
BILLING CODE 4160-01-S