[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8726-8728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
associated with the guidance ``Hypertension Indication: Drug Labeling 
for Cardiovascular Outcome Claims,'' which is intended to assist 
applicants in developing labeling for outcome claims for drugs that are 
indicated to treat hypertension.

DATES: Submit either electronic or written comments on the collection 
of information by April 22, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0117 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry on 
Hypertension Indication: Drug Labeling for Cardiovascular Outcome 
Claims.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be

[[Page 8727]]

made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 
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

[[Page 8728]]

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.
    FDA requests public comments on the information collection 
provisions described set forth in the following table:

                                 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..........
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............              30
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03543 Filed 2-19-16; 8:45 am]
 BILLING CODE 4164-01-P