Document ID: FDA-2010-N-0117-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry Entitled Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims
Posted Date: 2010-03-22T04:00Z

[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Notices]               
[Page 13547-13548]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr10-62]                         

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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 Entitled 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, 
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 written or electronic comments on the collection of 
information by May 21, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@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 that 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, 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 entitled ``Hypertension Indication: Drug Labeling 
for Cardiovascular Outcome Claims'' 21 CFR 201.56 and 201.57--(OMB 
Control Number 0910--New)

    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.
    In the Federal Register of March 13, 2008 (73 FR 13546), FDA 
published the draft guidance entitled ``Hypertension Indication: Drug 
Labeling for Cardiovascular Outcome Claims.'' The draft guidance 
contained no information collection subject to OMB review under the 
PRA. The final guidance, however, contains two new provisions that are 
subject to OMB review and approval under the PRA, and one new provision 
that would be exempt from OMB review. Under the PRA, FDA must first 
obtain OMB approval for this information collection before we may issue 
the final guidance.
    (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 the 
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 1 submission to the docket will be made annually from 
1 company, and that each submission will take approximately 10 hours to 
prepare and submit. Concerning the

[[Page 13548]]

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:
    1. A statement that the submission is a cardiovascular outcome 
claim supplement, with reference to the guidance and related Docket No. 
FDA-2008-D-0150
    2. Applicable FDA forms (e.g., 356h, 3397)
    3. Detailed Table of Contents
    4. Revised labeling:
    a. Include draft revised labeling conforming to the requirements in 
Sec. Sec.  201.56 and 201.57
    b. 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 70 cardiovascular outcome claim 
supplements will be submitted annually from approximately 30 different 
companies, and that each supplement will take approximately 4 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 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 previously and set forth in the following table:
    FDA estimates the burden of this collection of information as 
follows:

                                                            Estimated Annual Reporting Burden
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                                                            Number of       Number of Responses     Total Annual        Hours Per
                                                           Respondents        per Respondent         Responses           Response         Total Hours
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Submission to Docket Number FDA-2008-D-0150                             1                     1                  1                 10                 10
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Cardiovascular Outcome Claim Supplement Submission                     30                  2.33                 70                  4                280
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Total                                                                                                                                                290
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    Dated: March 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6173 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S