Document ID: FDA-2010-N-0117-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Posted Date: 2019-11-15T05:00Z

[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62537-62539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24780]

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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; 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 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.

DATES: Fax written comments on the collection of information by 
December 16, 2019.

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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601

[[Page 62538]]

Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims, 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 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).
    In the Federal Register of July 16, 2019 (84 FR 33952), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We therefore 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..........
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[[Page 62539]]

 
    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: November 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24780 Filed 11-14-19; 8:45 am]
 BILLING CODE 4164-01-P