Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for Industry; Availability, 51631-51633 [2017-24192]
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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices
with the Agency’s intention for further
integration to maximize the strengths of
the QIO program and PfP HENs to
sustain and expand current national
reductions in in-patient harm and 30day readmissions. The alignment of the
two programs permits the systematic
use of innovative patient safety
practices at a national scale.
Under this initiative, CMS has
awarded multiple contracts to Hospital
Improvement Innovation Networks
(HIINs), formerly known as HENs, to
engage the hospital, provider, and
broader caregiver communities to
implement well-tested and measured
best practices. The end result of the
overall initiative is the anticipated
reduction in preventable hospital-based
harm and readmissions for patients.
The PfP initiative is a public-private
partnership dedicated to the
improvement of health care quality,
safety, and affordability. CMS, working
with hospitals, providers, and the
broader caregiver community, aims to
implement and disseminate best
practices on a national scale to reduce
hospital acquired conditions (HACs)
and all-cause readmissions. Through the
PfP model, which was initiated in April
2011, CMS fostered rapid learning
among a nationwide community of
practice, resulting in major strides in
patient safety and engagement by
patients and families.
A mixed methods approach to
answering the PfP HIIN evaluation
questions includes three primary data
collection activities, as follows: Hospital
Survey on Prevention of Adverse Events
and Reduction of Readmissions, HIIN
Data Quality Assurance (QA) Survey
and Qualitative Discussions with HIIN
leaders and Other Support Contractors.
The data collected will provide us
feedback to focus efforts to improve the
effectiveness and efficiency of the HIIN
initiative. As we draft future HIIN and
QIO contracts, information from
hospitals about HIIN influence on their
care processes will be used together
with follow-up input from stakeholders
about the survey results. Form Number:
CMS–10656 (OMB Control Number:
0938–NEW); Frequency: Annually;
Affected Public: Private Sector: Business
or other for-profits and Not-for-profit
institutions; Number of Respondents:
835; Total Annual Responses: 854; Total
Annual Hours: 392. (For policy
questions regarding this collection
contact Israel Cross at 410–786–0619.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Report of a
Hospital Death Associated with
Restraint or Seclusion; Use: The
VerDate Sep<11>2014
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Jkt 244001
regulation that was published on May,
16, 2012 (77 FR 29074) included a
reduction in the reporting requirement
related to hospital deaths associated
with the use of restraint or seclusion,
§ 482.13(g). Hospitals must use Form
CMS–10455 to report those deaths
associated with restraint and/or
seclusion directly to the Centers for
Medicare & Medicaid Services (CMS)
Regional Office (RO). This requirement
also applies to rehabilitation or
psychiatric distinct part units (DPUs) in
Critical Access Hospitals (CAHs). The
RO must provide hospitals with
instructions for submitting the form fax
and/or email, based on RO preference.
Hospitals are no longer required to
report to CMS those deaths where there
was no use of seclusion and the only
restraint was 2-point soft wrist restraints
beginning in May 9, 2014. This
reporting requirement change resulted
in no necessary edits to the form CMS–
10455 as soft wrist restraints may be
used in combination with other types of
restraints. It was estimated that this
would reduce the volume of reports that
must be submitted by 90 percent for
hospitals. In addition, the final rule
replaced the previous requirement for
reporting via telephone to CMS, which
proved to be cumbersome for both CMS
and hospitals, with a requirement that
allows submission of reports via
telephone, facsimile or electronically, as
determined by CMS.
Form CMS–10455 is being revised in
order to obtain the necessary
information for the ROs to make a
determination whether or not to
authorize an on-site investigation
related to the details surrounding the
death of individuals associated with
restraint and/or seclusion. Form
Number: CMS–10455 (OMB control
number: 0938–1210); Frequency:
Occasionally; Affected Public: Private
Sector; Number of Respondents: 6,389;
Number of Responses: 6,389; Total
Annual Hours: 2,619. (For policy
questions regarding this collection
contact Karina Meushaw at 410–786–
1000.)
Dated: November 1, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–24134 Filed 11–6–17; 8:45 am]
BILLING CODE 4120–01–P
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51631
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0529]
Recommended Statement for Over-theCounter Aspirin-Containing Drug
Products Labeled With CardiovascularRelated Imagery; 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
guidance for industry entitled
‘‘Recommended Statement for Over-theCounter Aspirin-Containing Drug
Products Labeled With CardiovascularRelated Imagery.’’ The guidance is
intended to promote the safe use of
nonprescription (also referred to as
over-the-counter or OTC) aspirin drug
products by encouraging drug
manufacturers, packagers, and labelers
marketing aspirin drug products with
cardiovascular-related imagery to
include a statement that reminds
consumers to talk to their health care
provider before using aspirin for their
heart.
DATES: The announcement of the
guidance is published in the Federal
Register on November 7, 2017.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
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51632
Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices
ethrower on DSK3G9T082PROD with NOTICES
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): 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–
2012–D–0529 for ‘‘Recommended
Statement for Over-the-Counter AspirinContaining Drug Products Labeled With
Cardiovascular-Related Imagery;
Guidance for Industry.’’ 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 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/
VerDate Sep<11>2014
17:29 Nov 06, 2017
Jkt 244001
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
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Emily Baker, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51 Rm. 5203, Silver Spring,
MD 20993–0002, 301–796–7524.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Recommended Statement for Over-theCounter Aspirin-Containing Drug
Products Labeled With CardiovascularRelated Imagery.’’ Aspirin is a common
active ingredient in many prescription
and OTC drug products. Most OTC
aspirin drug products are currently
marketed pursuant to the Tentative
Final Monograph (TFM) for Internal
Analgesic, Antipyretic, and
Antirheumatic (IAAA) Drug Products
(53 FR 46204, November 16, 1988) for
the temporary relief of minor aches and
pains associated with a cold, headache,
backache, toothache, premenstrual and
menstrual cramps, minor pain of
arthritis, and reduction in fever.
In addition to the OTC conditions of
use in the IAAA TFM, FDA regulations
at § 343.80 (21 CFR 343.80) also contain
professional labeling about
cardiovascular uses of aspirin directed
at health care practitioners (63 FR
56802, October 23, 1998). After
publication of the professional labeling
regulation for aspirin, some OTC aspirin
labels were modified to include
cardiovascular-related imagery (e.g.,
heart image, electrocardiography
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graphic, stethoscope around a heart
image). However, the final rule for
IAAA products at § 343.80 authorizes
labeling for cardiovascular events only
in professional labeling directed to
health care professionals.
Because of the potential side effects
associated with long-term aspirin
therapy, FDA recommends that any
cardiovascular-related imagery on OTC
aspirin labels be accompanied by a
statement that reminds consumers to
talk to their health care provider before
using aspirin for the professional
indication of secondary prevention of
cardiovascular events. Therefore, this
guidance provides that FDA does not
intend to take action against
manufacturers of single-ingredient
aspirin, buffered aspirin, and aspirin in
combination with an antacid, marketed
pursuant to the TFM for IAAA Drug
Products because the product label
includes cardiovascular-related imagery
(e.g., heart image, electrocardiography
graphic, stethoscope around a heart
image) if the label also includes
language as described in the guidance
recommending that patients talk to a
health care professional before taking
aspirin for cardiovascular uses and the
product is otherwise marketed in
accordance with the TFM.
In the Federal Register of January 11,
2017 (82 FR 3335), FDA published a
draft guidance entitled ‘‘Recommended
Statement for Over-the-Counter AspirinContaining Drug Products Labeled With
Cardiovascular-Related Imagery;
Guidance for Industry.’’ We have made
changes to the guidance in response to
comments received and revised the
recommended statement to make it
more consumer friendly.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Recommended
Statement for Over-the-Counter AspirinContaining Drug Products Labeled With
Cardiovascular-Related Imagery.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
II. Paperwork Reduction Act of 1995
The recommendations in this
guidance are not subject to review by
the Office of Management and Budget
because they do not constitute a
‘‘collection of information’’ under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520). Rather, the labeling
statements are a ‘‘public disclosure of
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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public’’
(5 CFR 1320.3(c)(2)).
III. Electronic Access
Persons with access to the internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24192 Filed 11–6–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1129]
Medical Devices; Exemptions From
Premarket Notification: Class II
Devices; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
Notice; request for comments.
The Food and Drug
Administration (FDA or the Agency) is
announcing its intent to exempt a list of
class II devices from premarket
notification requirements, subject to
certain limitations. The Agency has
determined that, based on established
factors, these devices no longer require
premarket notification to provide
reasonable assurance of safety and
effectiveness. FDA is publishing this
notice to obtain comments regarding the
proposed exemptions, in accordance
with the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).
DATES: Submit either electronic or
written comments on the notice by
January 8, 2018.
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 January 8,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 8, 2018. 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.
SUMMARY:
ethrower on DSK3G9T082PROD with NOTICES
Electronic Submissions
VerDate Sep<11>2014
17:29 Nov 06, 2017
Jkt 244001
Submit written/paper submissions as
follows:
• 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–
2017–N–1129 for ‘‘Medical Devices;
Exemptions from Premarket
Notification: Class II Devices; Request
for Comments.’’ 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
PO 00000
Frm 00037
Fmt 4703
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51633
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
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:
Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring,
MD 20993, 301–348–1446,
Gregory.Bennett@fda.hhs.gov.
SUPPLEMENTARY INFORMATION :
I. Statutory Background
Section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and the implementing
regulations, 21 CFR part 807 subpart E,
require persons who intend to market a
new device to submit and obtain
clearance of a premarket notification
(510(k)) containing information that
allows FDA to determine whether the
new device is ‘‘substantially equivalent’’
within the meaning of section 513(i) of
the FD&C Act to a legally marketed
device that does not require premarket
approval.
The 21st Century Cures Act (Cures
Act) (Pub. L. 114–255) was signed into
law on December 13, 2016. Section 3054
of the Cures Act amended section
510(m) of the FD&C Act. As amended,
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]]>Agencies
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51631-51633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24192]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0529]
Recommended Statement for Over-the-Counter Aspirin-Containing
Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Recommended
Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled
With Cardiovascular-Related Imagery.'' The guidance is intended to
promote the safe use of nonprescription (also referred to as over-the-
counter or OTC) aspirin drug products by encouraging drug
manufacturers, packagers, and labelers marketing aspirin drug products
with cardiovascular-related imagery to include a statement that reminds
consumers to talk to their health care provider before using aspirin
for their heart.
DATES: The announcement of the guidance is published in the Federal
Register on November 7, 2017.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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
[[Page 51632]]
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): 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-2012-D-0529 for ``Recommended Statement for Over-the-Counter
Aspirin-Containing Drug Products Labeled With Cardiovascular-Related
Imagery; Guidance for Industry.'' 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 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Emily Baker, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51 Rm. 5203, Silver Spring, MD 20993-0002, 301-
796-7524.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Recommended Statement for Over-the-Counter Aspirin-
Containing Drug Products Labeled With Cardiovascular-Related Imagery.''
Aspirin is a common active ingredient in many prescription and OTC drug
products. Most OTC aspirin drug products are currently marketed
pursuant to the Tentative Final Monograph (TFM) for Internal Analgesic,
Antipyretic, and Antirheumatic (IAAA) Drug Products (53 FR 46204,
November 16, 1988) for the temporary relief of minor aches and pains
associated with a cold, headache, backache, toothache, premenstrual and
menstrual cramps, minor pain of arthritis, and reduction in fever.
In addition to the OTC conditions of use in the IAAA TFM, FDA
regulations at Sec. 343.80 (21 CFR 343.80) also contain professional
labeling about cardiovascular uses of aspirin directed at health care
practitioners (63 FR 56802, October 23, 1998). After publication of the
professional labeling regulation for aspirin, some OTC aspirin labels
were modified to include cardiovascular-related imagery (e.g., heart
image, electrocardiography graphic, stethoscope around a heart image).
However, the final rule for IAAA products at Sec. 343.80 authorizes
labeling for cardiovascular events only in professional labeling
directed to health care professionals.
Because of the potential side effects associated with long-term
aspirin therapy, FDA recommends that any cardiovascular-related imagery
on OTC aspirin labels be accompanied by a statement that reminds
consumers to talk to their health care provider before using aspirin
for the professional indication of secondary prevention of
cardiovascular events. Therefore, this guidance provides that FDA does
not intend to take action against manufacturers of single-ingredient
aspirin, buffered aspirin, and aspirin in combination with an antacid,
marketed pursuant to the TFM for IAAA Drug Products because the product
label includes cardiovascular-related imagery (e.g., heart image,
electrocardiography graphic, stethoscope around a heart image) if the
label also includes language as described in the guidance recommending
that patients talk to a health care professional before taking aspirin
for cardiovascular uses and the product is otherwise marketed in
accordance with the TFM.
In the Federal Register of January 11, 2017 (82 FR 3335), FDA
published a draft guidance entitled ``Recommended Statement for Over-
the-Counter Aspirin-Containing Drug Products Labeled With
Cardiovascular-Related Imagery; Guidance for Industry.'' We have made
changes to the guidance in response to comments received and revised
the recommended statement to make it more consumer friendly.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Recommended Statement for Over-the-Counter
Aspirin-Containing Drug Products Labeled With Cardiovascular-Related
Imagery.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
The recommendations in this guidance are not subject to review by
the Office of Management and Budget because they do not constitute a
``collection of information'' under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). Rather, the labeling statements are a ``public
disclosure of
[[Page 51633]]
information originally supplied by the Federal government to the
recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
III. Electronic Access
Persons with access to the internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24192 Filed 11-6-17; 8:45 am]
BILLING CODE 4164-01-P
