Agency Information Collection Activities; Proposed Collection: Comment Request: Guidance for Industry Entitled Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, 13547-13548 [2010-6173]
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Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
Written comments should be received
within 60 days of this notice.
Dated: March 15, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–6192 Filed 3–19–10; 8:45 am]
BILLING CODE 4162–20–P
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.
pwalker on DSK8KYBLC1PROD with NOTICES
ACTION:
Notice.
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 https://
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
VerDate Nov<24>2008
16:41 Mar 19, 2010
Jkt 220001
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.
SUPPLEMENTARY INFORMATION:
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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
13547
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
E:\FR\FM\22MRN1.SGM
22MRN1
13548
Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
recommendations for the CLINICAL
STUDIES section of the Full Prescribing
Information of the labeling, FDA
regulations at §§ 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
§§ 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
§§ 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
Number of
Respondents
Number of Responses
per Respondent
Total Annual
Responses
Hours Per
Response
Total Hours
Submission to Docket Number
FDA–2008–D–0150
1
1
1
10
10
Cardiovascular Outcome Claim
Supplement Submission
30
2.33
70
4
280
Total
290
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0122]
pwalker on DSK8KYBLC1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups
About Drug Products, as Used by the
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
VerDate Nov<24>2008
16:41 Mar 19, 2010
Jkt 220001
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
focus groups about drug products used
by FDA to gauge informally public
opinion, on a variety of subjects related
to consumer, patient, or healthcare
professional perceptions and use of drug
products and related materials,
including but not limited to, direct-toconsumer (DTC) prescription drug
promotion, physician labeling of
prescription drugs, Medication Guides,
over-the-counter (OTC) drug labeling,
emerging risk communications, patient
labeling, online sales of medical
products, and consumer and
professional education.
DATES: Submit written or electronic
comments on the collection of
information by May 21, 2010.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22MRN1.SGM
22MRN1
]]>Agencies
[Federal Register Volume 75, Number 54 (Monday, March 22, 2010)]
[Notices]
[Pages 13547-13548]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6173]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of Responses Total Annual Hours Per
Respondents per Respondent Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission to Docket Number FDA-2008-D-0150 1 1 1 10 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cardiovascular Outcome Claim Supplement Submission 30 2.33 70 4 280
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 290
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
