Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, 76359-76360 [2016-26399]
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Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
maximize C2C’s impact. The next three
years will be dedicated to implementing
the evaluation described in this
submission. We are proposing four data
collection activities: (1) A crosssectional survey of organizations that
have ordered and used the materials
with consumers; (2) A cross-sectional
survey of consumers, drawn from the
Knowledge Networks panel, to measure
the association between C2C and
consumer knowledge and behavior; (3)
semi-structured interviews with staff
from a limited set of community
organizations as part of a case study;
and (4) focus groups of consumers as
part of a case study. The case study will
be conducted in a community where
English is not the preferred language,
and where C2C materials in another
language (e.g., Spanish, Arabic, Chinese,
Haitian Creole, Korean, Russian, and
Vietnamese) were used with consumers.
Form Number: CMS–10632 (OMB
control number: 0938-New); Frequency:
Occasionally; Affected Public:
Individuals or Households; Number of
Respondents: 3,460; Total Annual
Responses: 3,460; Total Annual Hours:
1,176. (For policy questions regarding
this collection contact Ashley
Peddicord-Austin at 410–786–0757).
Dated: October 28, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–26493 Filed 11–1–16; 8:45 am]
BILLING CODE 4120–01–P
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 on Hypertension Indication:
Drug Labeling for Cardiovascular
Outcome Claims
AGENCY:
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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
(the PRA).
SUMMARY:
VerDate Sep<11>2014
17:18 Nov 01, 2016
Jkt 241001
Fax written comments on the
collection of information by December
2, 2016.
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.
DATES:
Guidance for Industry on Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims; OMB
Control Number 0910–0670—Extension
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.
The guidance contains two provisions
that are subject to OMB review and
approval under the PRA and one
provision that would be exempt from
OMB review:
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 activecontrolled 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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
76359
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 §§ 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:
• 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:
Æ Include draft revised labeling
conforming to the requirements in
§§ 201.56 and 201.57 and
Æ 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 1
cardiovascular outcome claim
supplement will be submitted annually
from approximately 1 different
companies, and that each supplement
will take approximately 20 hours to
E:\FR\FM\02NON1.SGM
02NON1
76360
Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
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
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.
In the Federal Register of February
22, 2016 (81 FR 8726), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. No
comments were received.
We estimate the burden of this
collection of information as follows:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses
per
respondent
Number of
respondents
Activity
Total
annual
responses
Hours
per
response
Total
hours
Submission to Docket No. FDA–2008–D–0150 ..................
Cardiovascular Outcome Claim Supplement Submission ...
1
1
1
1
1
1
10
20
10
20
Total ..............................................................................
........................
........................
........................
........................
30
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
submit either electronic or written
comments on the draft revised guidance
by January 3, 2017.
[FR Doc. 2016–26399 Filed 11–1–16; 8:45 am]
ADDRESSES:
BILLING CODE 4164–01–P
as follows:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–D–0369]
Animal Drug User Fees and Fee
Waivers and Reductions; Draft Revised
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
revised guidance for industry (GFI) #170
entitled ‘‘Animal Drug User Fees and
Fee Waivers and Reductions.’’ This draft
revised guidance document describes
the types of fees the Food and Drug
Administration (FDA or the Agency) is
authorized to collect under the Animal
Drug User Fee Act of 2003 (ADUFA), as
amended, and how to request waivers
and reductions from these fees.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
revised guidance before it begins work
on the final version of the guidance,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:18 Nov 01, 2016
Jkt 241001
You may submit comments
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2004–D–0369 for ‘‘Animal Drug User
Fees and Fee Waivers and Reductions.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76359-76360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26399]
-----------------------------------------------------------------------
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
on Hypertension Indication: Drug Labeling for Cardiovascular Outcome
Claims
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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 (the PRA).
DATES: Fax written comments on the collection of information by
December 2, 2016.
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.
Guidance for Industry on Hypertension Indication: Drug Labeling for
Cardiovascular Outcome Claims; OMB Control Number 0910-0670--Extension
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.
The guidance contains two provisions that are subject to OMB review
and approval under the PRA and one provision that would be exempt from
OMB review:
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:
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:
[cir] Include draft revised labeling conforming to the requirements
in Sec. Sec. 201.56 and 201.57 and
[cir] 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 1 cardiovascular outcome claim
supplement will be submitted annually from approximately 1 different
companies, and that each supplement will take approximately 20 hours to
[[Page 76360]]
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.
In the Federal Register of February 22, 2016 (81 FR 8726), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Submission to Docket No. FDA- 1 1 1 10 10
2008-D-0150....................
Cardiovascular Outcome Claim 1 1 1 20 20
Supplement Submission..........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 30
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26399 Filed 11-1-16; 8:45 am]
BILLING CODE 4164-01-P
