[Federal Register Volume 74, Number 200 (Monday, October 19, 2009)]
[Notices]
[Pages 53507-53508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0302] (formerly Docket No. 2007D-0185)


Guidance for Industry and Review Staff on Labeling for Human 
Prescription Drug and Biological Products--Determining Established 
Pharmacologic Class for Use in the Highlights of Prescribing 
Information; 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 guidance for industry and review staff entitled 
``Labeling for Human Prescription Drug and Biological Products--
Determining Established Pharmacologic Class for Use in the Highlights 
of Prescribing Information.'' This guidance is intended to provide 
applicants and review staff with a definition of established 
pharmacologic class and to help them identify the most appropriate word 
(term) or phrase that describes the established pharmacologic class for 
a drug or biological product for inclusion in the Indications and Usage 
section of Highlights of Prescribing Information (Highlights) of 
approved labeling. This guidance finalizes the draft guidance published 
in the Federal Register on May 16, 2007.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm 2201, Silver Spring, MD 20993-0002, or the Office of 
Communication, Outreach, and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your 
requests. The guidance may also be obtained by mail by calling CBER at 
1-800-835-4709 or 301-827-1800. Submit electronic comments to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Laurie B. Burke, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6462, 
Silver Spring, MD 20993-0002, 301-796-0136; or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration,1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
review staff entitled ``Labeling for Human Prescription Drug and 
Biological Products--determining Established Pharmacologic Class for 
Use in the Highlights of Prescribing Information.'' This guidance is 
intended to provide applicants and review staff with a definition of 
established pharmacologic class and to help them identify the most 
appropriate word (term) or phrase that describes the established 
pharmacologic class for a drug or biological product for inclusion in 
the Indications and Usage section of Highlights of approved labeling, 
as required under 21 CFR 201.57(a)(6).
    In January 2006, FDA published a final rule that amended the 
requirements for the content and format of labeling for human 
prescription drug and biological products.\1\
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    \1\ See ``Requirements on Content and Format of Labeling for 
Human Prescription Drug and Biological Products'' (71 FR 3922, 
January 24, 2006; 21 CFR parts 201, 314, 601).
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    The new labeling format is intended to make it easier for health 
care professionals to access, read, and use the information in 
prescription drug labeling, thereby facilitating professionals' use of 
labeling to make prescribing decisions.
    The rule requires that the following statement appear under the 
Indications and Usage section of Highlights if a drug is a member of an 
established pharmacologic class:\2\
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    \2\ See Sec.  201.57(a)(6)..
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    ``(Drug) is a (name of class) indicated for (indication(s)).''
    If the drug is not a member of an established pharmacologic class, 
the name of class component of this statement should be omitted.
    Knowing the established pharmacologic class can provide health care 
professionals with important information about what to expect from a 
drug and how it relates to other therapeutic options. Such information 
can also help reduce the risk of duplicative therapy and drug 
interactions. This guidance provides recommendations for identifying 
the established pharmacologic class and its appropriate term for 
inclusion in the Indications and Usage section of Highlights.
    A draft version of this guidance was made available for public 
comment in 2007 (72 FR 27576, May 16, 2007). All of the public comments 
we received have been considered and the guidance has been revised as 
appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on this topic. 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 statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
information collection associated with the final rule entitled 
``Requirements on Content and Format of Labeling for Human Prescription 
Drug and Biological Products'' is approved by OMB under Control Number 
0910-0572. The submission of prior-approval labeling supplements, as 
described in section VI of the guidance, is approved by OMB under 
Control Numbers 0910-0001 and 0910-0338.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic

[[Page 53508]]

comments or two paper copies of any mailed comments, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: October 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24991 Filed 10-16-09; 8:45 am]
BILLING CODE 4160-01-S