[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14024-14025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0150]


Guidance for Industry on Hypertension Indication: Drug Labeling 
for Cardiovascular Outcome Claims; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 14025]]

availability of a guidance for industry entitled ``Hypertension 
Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This 
guidance is intended to assist applicants in developing labeling for 
outcome claims for drugs that are indicated to treat hypertension. With 
few exceptions, current labeling for antihypertensive drugs includes 
only the information that these drugs are indicated to reduce blood 
pressure; the labeling does not include information on the clinical 
benefits related to cardiovascular outcomes expected from such blood 
pressure reduction. However, blood pressure control is well established 
as beneficial in preventing serious cardiovascular events, and 
inadequate treatment of hypertension is acknowledged as a significant 
public health problem. The Agency believes that the appropriate use of 
these drugs can be encouraged by making the connection between lower 
blood pressure and improved cardiovascular outcomes more explicit in 
labeling.

DATES: Submit either 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. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to 
http:[sol][sol]www.regulations.gov. Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Devi Kozeli, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4183, Silver Spring, MD 20993-0002, 301-
796-1128.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Hypertension Indication: Drug Labeling for Cardiovascular 
Outcome Claims.'' The intent of the guidance is to provide common 
labeling for antihypertensive drugs except where differences are 
clearly supported by clinical data. With publication of this guidance, 
applicants are encouraged to submit labeling supplements containing the 
new language.
    A draft guidance of the same title was announced in the Federal 
Register on March 13, 2008 (73 FR 13546), and Docket No. FDA-2008-D-
0150 was open for comments until May 12, 2008. Comments received from 
industry, professional societies, and consumer groups on the draft 
guidance were taken into consideration by FDA in finalizing this 
guidance. Throughout the guidance, the language has been condensed and 
simplified to be more concise and clear. A section has been added to 
clarify procedures for obtaining approval of new labeling and its 
applicability to advertising. The guidance describes how applicants can 
provide clinical evidence for any drugs they perceive to be missing 
from Table 1, Approved Drugs for Chronic Treatment of Hypertension, by 
submitting the information to the docket number listed in brackets in 
the heading of this document. The division will review the information 
and revise the guidance to include any new labeling changes supported 
by clinical data submitted to the docket.
    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 labeling for cardiovascular outcome claims 
for drugs to treat hypertension. 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 contains information collection provisions that 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 of information in this guidance was approved under OMB 
control number 0910-0670.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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 
either http:[sol][sol]www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
http:[sol][sol]www.regulations.gov.

    Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5945 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P