Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, 33952-33954 [2019-15101]
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Federal Register / Vol. 84, No. 136 / Tuesday, July 16, 2019 / Notices
do not have to repeat the clinical testing
otherwise necessary to gain approval of
a new drug application (NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
MIOCHOL (acetylcholine chloride
intraocular solution), 20 mg/vial, is the
subject of NDA 016211, held by
Novartis Pharmaceutical Corporation
(Novartis). MIOCHOL is indicated to
obtain complete miosis of the iris in
seconds after delivery of the lens in
cataract surgery, in penetrating
keratoplasty, iridectomy, and other
anterior segment surgery where rapid,
complete miosis may be required.
In a letter dated January 18, 2006,
Novartis requested withdrawal of NDA
016211 for MIOCHOL (acetylcholine
chloride intraocular solution). In the
Federal Register of July 12, 2018 (83 FR
32305), FDA announced that it was
withdrawing approval of NDA 016211,
effective August 13, 2018.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
January 23, 2019, under 21 CFR 10.30,
requesting that the Agency determine
whether MIOCHOL (acetylcholine
chloride intraocular solution), 20 mg/
vial, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that MIOCHOL (acetylcholine
chloride intraocular solution), 20 mg/
vial, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that MIOCHOL
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(acetylcholine chloride intraocular
solution), 20 mg/vial, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
MIOCHOL (acetylcholine chloride
intraocular solution), 20 mg/vial, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list MIOCHOL
(acetylcholine chloride intraocular
solution), 20 mg/vial, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to MIOCHOL (acetylcholine chloride
intraocular solution), 20 mg/vial, may
be approved by the Agency as long as
they meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15089 Filed 7–15–19; 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 or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
SUMMARY:
PO 00000
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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 FDA
‘‘Guidance for Industry on 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.
Submit either electronic or
written comments on the collection of
information by September 16, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 16,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 16, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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
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:
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Federal Register / Vol. 84, No. 136 / Tuesday, July 16, 2019 / Notices
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
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 Dockets Management
Staff. If you do not wish your name and
contact information to be 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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
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Jkt 247001
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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 information collection request
supports recommendations found in
Agency guidance. The document
entitled, ‘‘Guidance for Industry;
Hypertension Indication: Drug Labeling
PO 00000
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Fmt 4703
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33953
for Cardiovascular Outcome Claims,’’
available from our website at https://
www.fda.gov/media/71824/download,
encourages the submission of
supplemental labeling and is intended
to assist applicants in developing
labeling for outcome claims for drugs
that are indicated to treat hypertension,
and to provide common labeling for
antihypertensive drugs except where
differences are clearly supported by
clinical data.
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. We believe 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.
As discussed in the guidance, we
therefore recommend the following
information collection:
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
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
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Federal Register / Vol. 84, No. 136 / Tuesday, July 16, 2019 / Notices
information to Docket No. FDA–2008–
D–0150. The labeling submission
should reference the submission to the
docket. We estimate 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. Recommendations for the
CLINICAL STUDIES section of the Full
Prescribing Information of the labeling
are covered by FDA regulations at
§§ 201.56 and 201.57 (21 CFR 201.56
and 201.57) and require such labeling.
The information collection associated
with these regulations is approved
under OMB control number 0910–0572.
2. Section VI.B of the guidance
requests that the format of the
cardiovascular outcome claim submitted
to FDA in a prior approval supplement
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 include:
Æ Draft revised labeling conforming to
the requirements in §§ 201.56 and
201.57, and
Æ 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.
We estimate that on average, 4
cardiovascular outcome claim
supplements will be submitted annually
from 4 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 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 the
drug’s promotional materials:
• ‘‘[DRUGNAME] reduces blood
pressure, which reduces the risk of fatal
and nonfatal cardiovascular events,
primarily strokes and myocardial
infarctions. Controlling 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 is
exempt from OMB review under 5 CFR
1320.3(c)(2).
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Total hours
Submission to Docket No. FDA–2008–D–0150 ..................
Cardiovascular Outcome Claim Supplement Submission ...
1
4
1
1
1
4
10
20
10
80
Total .....................................................................................
........................
........................
........................
........................
90
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate for the information
collection reflects an overall increase of
burden. This increase corresponds to an
increase in submissions we have
received over the last few years.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[OMB No. 0915–0334—Extension]
[FR Doc. 2019–15101 Filed 7–15–19; 8:45 am]
BILLING CODE 4164–01–P
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request; Information
Collection Request Title:
Countermeasures Injury
Compensation Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
SUMMARY:
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Hours per
response
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public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than September 16,
2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR
title, below, for reference.
Information Collection Request Title:
Countermeasures Injury Compensation
Program, OMB No. 0915–0334—
Extension.
Abstract: This is a request for
continued OMB approval of the
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]]>Agencies
[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 33952-33954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15101]
-----------------------------------------------------------------------
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 FDA ``Guidance for Industry on 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 September 16, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 16, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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:
[[Page 33953]]
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. If you do not wish
your name and contact information to be 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected]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 information collection request supports recommendations found
in Agency guidance. The document entitled, ``Guidance for Industry;
Hypertension Indication: Drug Labeling for Cardiovascular Outcome
Claims,'' available from our website at https://www.fda.gov/media/71824/download, encourages the submission of supplemental labeling and
is intended to assist applicants in developing labeling for outcome
claims for drugs that are indicated to treat hypertension, and to
provide common labeling for antihypertensive drugs except where
differences are clearly supported by clinical data.
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. We believe 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.
As discussed in the guidance, we therefore recommend the following
information collection:
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
[[Page 33954]]
information to Docket No. FDA-2008-D-0150. The labeling submission
should reference the submission to the docket. We estimate 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. Recommendations for the CLINICAL STUDIES section of
the Full Prescribing Information of the labeling are covered by FDA
regulations at Sec. Sec. 201.56 and 201.57 (21 CFR 201.56 and 201.57)
and require such labeling. The information collection associated with
these regulations is approved under OMB control number 0910-0572.
2. Section VI.B of the guidance requests that the format of the
cardiovascular outcome claim submitted to FDA in a prior approval
supplement 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 include:
[cir] Draft revised labeling conforming to the requirements in
Sec. Sec. 201.56 and 201.57, and
[cir] 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.
We estimate that on average, 4 cardiovascular outcome claim
supplements will be submitted annually from 4 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 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 the drug's promotional
materials:
``[DRUGNAME] reduces blood pressure, which reduces the
risk of fatal and nonfatal cardiovascular events, primarily strokes and
myocardial infarctions. Controlling 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 is exempt from OMB review under 5 CFR 1320.3(c)(2).
We estimate the burden of the information collection 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 4 1 4 20 80
Supplement Submission..........
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total........................... .............. .............. .............. .............. 90
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimate for the information collection reflects an overall
increase of burden. This increase corresponds to an increase in
submissions we have received over the last few years.
Dated: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15101 Filed 7-15-19; 8:45 am]
BILLING CODE 4164-01-P
