Draft Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Availability, 3998-3999 [06-543]

Download as PDF 3998 Federal Register / Vol. 71, No. 15 / Tuesday, January 24, 2006 / Notices 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. 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. rwilkins on PROD1PC63 with NOTICES_2 DATES: VerDate Aug<31>2005 16:11 Jan 23, 2006 Jkt 208001 1061, Rockville, MD 20852. Submit electronic comments to https:// 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. PO 00000 Frm 00001 Fmt 4701 Sfmt 4703 • 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 E:\FR\FM\24JAN2.SGM 24JAN2 Federal Register / Vol. 71, No. 15 / Tuesday, January 24, 2006 / Notices 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 https:// www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/ guidelines.htm, or https://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] FOR FURTHER INFORMATION CONTACT: BILLING CODE 4160–01–S 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. rwilkins on PROD1PC63 with NOTICES_2 ACTION: Notice. 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. Submit written requests for single copies of these guidances to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and ADDRESSES: VerDate Aug<31>2005 16:11 Jan 23, 2006 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 https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to guidance documents. Jkt 208001 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 3999 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 E:\FR\FM\24JAN2.SGM 24JAN2

Agencies

[Federal Register Volume 71, Number 15 (Tuesday, January 24, 2006)]
[Notices]
[Pages 3998-3999]
From the Federal Register Online via the Government Printing 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 https://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 
https://www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/
guidelines.htm, or https://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

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