[Federal Register Volume 75, Number 54 (Monday, March 22, 2010)]
[Notices]
[Pages 13547-13548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6173]
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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,
[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 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