[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)]
[Notices]
[Pages 3335-3336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00374]


-----------------------------------------------------------------------

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Drug Products Labeled With Cardiovascular Related Imagery; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Recommended 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115(a)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 13, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-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 http://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

[[Page 3336]]

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 http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. 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: http://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 http://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.
    Submit written requests for single copies of the draft 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 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft 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, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft 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 draft 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 draft 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.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on this topic. 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.

II. Paperwork Reduction Act of 1995

    The recommendations in this draft 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 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 draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00374 Filed 1-10-17; 8:45 am]
 BILLING CODE 4164-01-P