Document ID: FDA-2012-D-0529-0011
Agency: fda
Document Type: Notice
Title: Recommended Statement for Over-the-Counter Aspirin-Containing Drug
Products Labeled With Cardiovascular-Related Imagery; Guidance for
Industry; Availability
Posted Date: 2017-11-07T05:00Z

[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]

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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.

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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