Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, 8726-8728 [2016-03543]
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Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
time were derived from the following
dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective:
December 10, 2007. The applicant
claims June 26, 2008, as the date the
investigational new drug application
(IND) became effective. However, FDA
records indicate that the IND effective
date was December 10, 2007, which was
30 days after FDA receipt of the first
IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: July 12, 2012.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
BREO ELLIPTA (NDA 204275) was
initially submitted on July 12, 2012.
3. The date the application was
approved: May 10, 2013. FDA has
verified the applicant’s claim that NDA
204275 was approved on May 10, 2013.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 981 days of patent
term extension.
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III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Petitions that have not been
made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03551 Filed 2–19–16; 8:45 am]
BILLING CODE 4164–01–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 on Hypertension Indication:
Drug Labeling for Cardiovascular
Outcome Claims
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 including each proposed
extension of an existing 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.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by April 22, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
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
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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’’).
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–
2010–N–0117 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry on Hypertension Indication:
Drug Labeling for Cardiovascular
Outcome Claims.’’ 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
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
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Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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 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,
including each proposed extension of an
existing 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
VerDate Sep<11>2014
19:03 Feb 19, 2016
Jkt 238001
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 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
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
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8727
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
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
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Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
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 set forth in the following
table:
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: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03543 Filed 2–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Production of Attenuated
Respiratory Syncytial Virus Vaccines
National Institutes of Health.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National Institute
of Allergy and Infectious Diseases
(NIAID), National Institutes of Health
(NIH), Department of Health and Human
Services (HHS), is contemplating the
grant of a an exclusive license to
practice the following invention as
embodied in the following patent
applications: (1) E–194–1999/0, Collins
et al., ‘‘Production of Attenuated
Respiratory Syncytial Virus Vaccines
Involving Modification of M2 ORF2’’,
U.S. Provisional Patent Application
Number 60/143,097, filed July 9, 1999,
PCT Patent Application Number PCT/
US2000/18534, filed July 7, 2000, U.S.
Patent Application Number 09/611,829
(now U.S. Patent Number 6,713,066),
and U.S. Patent Application Number 11/
011,502 (now U.S. Patent Number
7,485,440), (2) E–135–2010/0, Collins et
al., ‘‘Genetically Stable Live Attenuated
Vaccine for Respiratory Syncytial Virus
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SUMMARY:
VerDate Sep<11>2014
19:03 Feb 19, 2016
Jkt 238001
(RSV) with an Attenuation and
Temperature Sensitive Phenotype
Conferred by an Amino Acid Deletion’’,
U.S. Provisional Patent Application
Number 61/624,010, filed April 13,
2012, PCT Patent Application Number
PCT/US2013/030836, filed March 13,
2013, United States Patent Application
Number 14/394,226, filed October 13,
2014, European Patent Application
Number 13712641.3, filed March 13,
2013, (3) E–216–2014/0, Collins et al.,
‘‘Versions of Respiratory Syncytial Virus
(RSV) Vaccine Candidate LID Delta M2–
2 with Increased Attenuation’’, U.S.
Provisional Patent Application Number
62/266,199, filed December 11, 2015, (4)
E–241–2014/0, Collins et al., ‘‘Improved
RSV F Protein for Expression from a
Heterologous Vector’’, U.S. Provisional
Patent Application Number 62/105,667,
filed January 20, 2015, PCT Patent
Application Number PCT/US2016/
014154, filed January 20, 2016, and (5)
E–037–2016/0, Collins et al.,
‘‘Attenuated RSV Vaccine Strains in
which the NS1 and/or NS2 Genes have
been Shifted to Promoter-Distal
Positions’’, U.S. Provisional Patent
Application Number 62/266,206, filed
December 11, 2015, to Sanofi Pasteur,
Inc., having a place of business in
Swiftwater, Pennsylvania, U.S.A. The
patent rights in this invention have been
assigned to the United States of
America.
Only written comments and/or
application for a license which are
received by the National Institute of
Allergy and Infectious Diseases,
Technology Transfer and Intellectual
Property Office on or before March 8,
2016. will be considered.
DATES:
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Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Peter Soukas, Senior Technology
Licensing Specialist, Technology
Transfer and Intellectual Property
Office, National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane,
Suite 6D, Rockville, MD 20852–9804,
Tel: (301) 594–8730 or email: ps193c@
nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Respiratory syncytial virus (RSV) is the
most important cause of viral acute
lower respiratory infection (ALRI) in
infants and children worldwide and is
responsible for over 30 million new
ALRI episodes worldwide and up to
199,000 deaths in children under five
(5) years old. In the United States, the
virus infects nearly all children at least
once by the age of two (2) and is the
most common cause of bronchiolitis and
infant pneumonia, causing up to
125,000 hospitalizations of children
each year. RSV disease burden is less
understood in the developing world, but
available data indicates that the virus
causes a significant proportion of
childhood ALRI in these parts of the
world, particularly in the first months of
life. The drug palivizumab (Synagis) can
help prevent RSV disease in high risk
infants, but it cannot treat or cure
already-serious RSV infection. No
vaccine exists today to prevent RSV due
to an incomplete understanding of the
body’s immune response to the virus,
which has challenged and delayed RSV
vaccine development efforts.
The methods and compositions of this
invention provide a means for
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]]>Agencies
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8726-8728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03543]
-----------------------------------------------------------------------
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 on 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
including each proposed extension of an existing 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 either electronic or written comments on the collection
of information by April 22, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
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'').
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-2010-N-0117 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry on
Hypertension Indication: Drug Labeling for Cardiovascular Outcome
Claims.'' 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 Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be
[[Page 8727]]
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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 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, including
each proposed extension of an existing 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 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
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
[[Page 8728]]
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 set forth in the following table:
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..........
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 30
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03543 Filed 2-19-16; 8:45 am]
BILLING CODE 4164-01-P
