[Federal Register Volume 75, Number 125 (Wednesday, June 30, 2010)]
[Notices]
[Pages 37816-37818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15859]


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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 
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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under

[[Page 37817]]

the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by July 
30, 2010.

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 e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-new and 
title Guidance for Industry entitled ``Hypertension Indication: Drug 
Labeling for Cardiovascular Outcome Claims.'' Also include the FDA 
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, 
[email protected].

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.

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 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:
    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.''

[[Page 37818]]

    In the Federal Register of March 22, 2010, (75 FR 13547), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                           No. of         No. of Responses  per      Total Annual        Hours per
                                                         Respondents           Respondent             Responses          Response         Total Hours
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Submission to Docket No. 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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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15859 Filed 6-29-10; 8:45 am]
BILLING CODE 4160-01-S