
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76359-76360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0117]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Hypertension Indication: Drug Labeling for Cardiovascular Outcome 
Claims

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by 
December 2, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0670. 
Also include the FDA docket number found in brackets in the heading of 
this document.

Guidance for Industry on Hypertension Indication: Drug Labeling for 
Cardiovascular Outcome Claims; OMB Control Number 0910-0670--Extension

    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. FDA 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. The intent of the guidance is to 
provide common labeling for antihypertensive drugs except where 
differences are clearly supported by clinical data. The guidance 
encourages applicants to submit labeling supplements containing the new 
language.
    The guidance contains two provisions that are subject to OMB review 
and approval under the PRA and one provision that would be exempt from 
OMB review:
    1. Section IV.C of the guidance requests that the CLINICAL STUDIES 
section of the Full Prescribing Information of the labeling should 
include a summary of placebo or active-controlled trials showing 
evidence of the specific drug's effectiveness in lowering blood 
pressure. If trials demonstrating cardiovascular outcome benefits 
exist, those trials also should be summarized in this section. Table 1 
in Section V of the guidance contains the specific drugs for which FDA 
has concluded that such trials exist. If there are no cardiovascular 
outcome data to cite, one of the following two paragraphs should 
appear:
    ``There are no trials of [DRUGNAME] or members of the [name of 
pharmacologic class] pharmacologic class demonstrating reductions in 
cardiovascular risk in patients with hypertension,'' or ``There are no 
trials of [DRUGNAME] demonstrating reductions in cardiovascular risk in 
patients with hypertension, but at least one pharmacologically similar 
drug has demonstrated such benefits.''
    In the latter case, the applicant's submission generally should 
refer to table 1 in section V of the guidance. If the applicant 
believes that table 1 is incomplete, it should submit the clinical 
evidence for the additional information to Docket No. FDA-2008-D-0150. 
The labeling submission should reference the submission to the docket. 
FDA estimates that no more than one submission to the docket will be 
made annually from one company, and that each submission will take 
approximately 10 hours to prepare and submit. Concerning the 
recommendations for the CLINICAL STUDIES section of the Full 
Prescribing Information of the labeling, FDA regulations at Sec. Sec.  
201.56 and 201.57 (21 CFR 201.56 and 201.57) require such labeling, and 
the information collection associated with these regulations is 
approved by OMB under OMB control number 0910-0572.
    2. Section VI.B of the guidance requests that the format of 
cardiovascular outcome claim prior approval supplements submitted to 
FDA under the guidance should include the following information:
     A statement that the submission is a cardiovascular 
outcome claim supplement, with reference to the guidance and related 
Docket No. FDA-2008-D-0150.
     Applicable FDA forms (e.g., 356h, 3397).
     Detailed table of contents.
     Revised labeling to:
    [cir] Include draft revised labeling conforming to the requirements 
in Sec. Sec.  201.56 and 201.57 and
    [cir] include marked-up copy of the latest approved labeling, 
showing all additions and deletions, with annotations of where 
supporting data (if applicable) are located in the submission.
    FDA estimates that approximately 1 cardiovascular outcome claim 
supplement will be submitted annually from approximately 1 different 
companies, and that each supplement will take approximately 20 hours to

[[Page 76360]]

prepare and submit. The guidance also recommends that other labeling 
changes (e.g., the addition of adverse event data) should be minimized 
and provided in separate supplements, and that the revision of labeling 
to conform to Sec. Sec.  201.56 and 201.57 may require substantial 
revision to the ADVERSE REACTIONS or other labeling sections.
    3. Section VI.C of the guidance states that applicants are 
encouraged to include the following statement in promotional materials 
for the drug.
    ``[DRUGNAME] reduces blood pressure, which reduces the risk of 
fatal and nonfatal cardiovascular events, primarily strokes and 
myocardial infarctions. Control of high blood pressure should be part 
of comprehensive cardiovascular risk management, including, as 
appropriate, lipid control, diabetes management, antithrombotic 
therapy, smoking cessation, exercise, and limited sodium intake. Many 
patients will require more than one drug to achieve blood pressure 
goals.''
    The inclusion of this statement in the promotional materials for 
the drug would be exempt from OMB review based on 5 CFR 1320.3(c)(2), 
which states that the public disclosure of information originally 
supplied by the Federal government to the recipient for the purpose of 
disclosure to the public is not included within the definition of 
collection of information.
    In the Federal Register of February 22, 2016 (81 FR 8726), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of    responses  per   Total  annual    Hours  per     Total  hours
                                    respondents      respondent      responses       response
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Submission to Docket No. FDA-                  1               1               1              10              10
 2008-D-0150....................
Cardiovascular Outcome Claim                   1               1               1              20              20
 Supplement Submission..........
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    Total.......................  ..............  ..............  ..............  ..............              30
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26399 Filed 11-1-16; 8:45 am]
 BILLING CODE 4164-01-P


