[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 33952-33954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15101]


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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 FDA ``Guidance for Industry on 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 September 16, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 16, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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:

[[Page 33953]]

     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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 information collection request supports recommendations found 
in Agency guidance. The document entitled, ``Guidance for Industry; 
Hypertension Indication: Drug Labeling for Cardiovascular Outcome 
Claims,'' available from our website at https://www.fda.gov/media/71824/download, encourages the submission of supplemental labeling and 
is intended to assist applicants in developing labeling for outcome 
claims for drugs that are indicated to treat hypertension, and to 
provide common labeling for antihypertensive drugs except where 
differences are clearly supported by clinical data.
    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. We believe 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.
    As discussed in the guidance, we therefore recommend the following 
information collection:
    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

[[Page 33954]]

information to Docket No. FDA-2008-D-0150. The labeling submission 
should reference the submission to the docket. We estimate 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. Recommendations for the CLINICAL STUDIES section of 
the Full Prescribing Information of the labeling are covered by FDA 
regulations at Sec. Sec.  201.56 and 201.57 (21 CFR 201.56 and 201.57) 
and require such labeling. The information collection associated with 
these regulations is approved under OMB control number 0910-0572.
    2. Section VI.B of the guidance requests that the format of the 
cardiovascular outcome claim submitted to FDA in a prior approval 
supplement 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 include:
    [cir] Draft revised labeling conforming to the requirements in 
Sec. Sec.  201.56 and 201.57, and
    [cir] 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.
    We estimate that on average, 4 cardiovascular outcome claim 
supplements will be submitted annually from 4 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 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 the drug's promotional 
materials:
     ``[DRUGNAME] reduces blood pressure, which reduces the 
risk of fatal and nonfatal cardiovascular events, primarily strokes and 
myocardial infarctions. Controlling 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 is exempt from OMB review under 5 CFR 1320.3(c)(2).
    We estimate the burden of the information collection 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                   4               1               4              20              80
 Supplement Submission..........
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total...........................  ..............  ..............  ..............  ..............              90
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate for the information collection reflects an overall 
increase of burden. This increase corresponds to an increase in 
submissions we have received over the last few years.

    Dated: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15101 Filed 7-15-19; 8:45 am]
 BILLING CODE 4164-01-P


