82 FR 3335 - Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 7 (January 11, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 7 (January 11, 2017)
| Page Range | 3335-3336 | |
| FR Document | 2017-00374 |
[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)] [Notices] [Pages 3335-3336] From the Federal Register Online [www.thefederalregister.org] [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Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.''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on any guidance at any time (see 21 CFR 10.115(a)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 13, 2017.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
![Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices 3335
location of the advisory committee meetings and will make every effort to on the draft guidance by March 13,
meeting, and the background material accommodate persons with disabilities. 2017.
will be posted on FDA’s Web site after If you require accommodations due to a ADDRESSES: You may submit comments
the meeting. Background material is disability, please contact Stephanie L. as follows:
available at http://www.fda.gov/ Begansky at least 7 days in advance of
AdvisoryCommittees/Calendar/ the meeting. Electronic Submissions
default.htm. Scroll down to the FDA is committed to the orderly Submit electronic comments in the
appropriate advisory committee meeting conduct of its advisory committee following way:
link. meetings. Please visit our Web site at • Federal eRulemaking Portal: http://
Procedure: On March 13, 2017, from http://www.fda.gov/ www.regulations.gov. Follow the
9:15 a.m. to 5 p.m., and on March 14, AdvisoryCommittees/ instructions for submitting comments.
2017, from 8 a.m. to 5 p.m., the meeting AboutAdvisoryCommittees/ Comments submitted electronically,
is open to the public. Interested persons ucm111462.htm for procedures on including attachments, to http://
may present data, information, or views, public conduct during advisory www.regulations.gov will be posted to
orally or in writing, on issues pending committee meetings. the docket unchanged. Because your
before the committees. All electronic Notice of this meeting is given under comment will be made public, you are
and written submissions submitted to the Federal Advisory Committee Act (5 solely responsible for ensuring that your
the Docket (see the ADDRESSES section) U.S.C. app. 2). comment does not include any
on or before February 27, 2017, will be confidential information that you or a
Dated: January 6, 2017.
provided to the committees. Oral third party may not wish to be posted,
presentations from the public will be Janice M. Soreth,
such as medical information, your or
scheduled between approximately 8:30 Associate Commissioner for Special Medical anyone else’s Social Security number, or
a.m. and 10:30 a.m. on March 14, 2017. Programs.
confidential business information, such
Those individuals interested in making [FR Doc. 2017–00463 Filed 1–10–17; 8:45 am]
as a manufacturing process. Please note
formal oral presentations should notify BILLING CODE 4164–01–P that if you include your name, contact
the contact person and submit a brief information, or other information that
statement of the general nature of the identifies you in the body of your
evidence or arguments they wish to DEPARTMENT OF HEALTH AND comments, that information will be
present, the names and addresses of HUMAN SERVICES posted on http://www.regulations.gov.
proposed participants, and an • If you want to submit a comment
indication of the approximate time Food and Drug Administration
with confidential information that you
requested to make their presentation on do not wish to be made available to the
or before February 16, 2017. Time [Docket No. FDA–2012–D–0529] public submit the comment as a written/
allotted for each presentation may be paper submission and in the manner
limited. If the number of registrants Recommended Statement for Over-the- detailed (see ‘‘Written/Paper
requesting to speak is greater than can Counter Aspirin-Containing Drug Submissions’’ and ‘‘Instructions’’).
be reasonably accommodated during the Products Labeled With Cardiovascular
scheduled open public hearing session, Related Imagery; Draft Guidance for Written/Paper Submissions
FDA may conduct a lottery to determine Industry; Availability Submit written/paper submissions as
the speakers for the scheduled open AGENCY: Food and Drug Administration, follows:
public hearing session. The contact HHS. • Mail/Hand delivery/Courier (for
person will notify interested persons written/paper submissions): Division of
regarding their request to speak by ACTION: Notice of availability. Dockets Management (HFA–305), Food
February 17, 2017. SUMMARY: The Food and Drug and Drug Administration, 5630 Fishers
Closed Committee Deliberations: On Administration (FDA) is announcing the Lane, Rm. 1061, Rockville, MD 20852.
March 13, 2017, from 8 a.m. to 9:15 availability of a draft guidance for • For written/paper comments
a.m., the meeting will be closed to industry entitled ‘‘Recommended submitted to the Division of Dockets
permit discussion and review of trade Statement for Over-the-Counter Aspirin- Management, FDA will post your
secret and/or confidential commercial Containing Drug Products Labeled With comment, as well as any attachments,
information (5 U.S.C. 552b(c)(4)). Cardiovascular Related Imagery.’’ The except for information submitted,
During this session, the committees will guidance is intended to promote the safe marked and identified, as confidential,
discuss the premarketing drug use of nonprescription (also referred to if submitted as detailed in
development program of an extended- as over-the-counter or OTC) aspirin drug ‘‘Instructions.’’
release opioid product. Instructions: All submissions received
products by encouraging drug
Persons attending FDA’s advisory must include the Docket No. FDA–
manufacturers, packagers, and labelers
committee meetings are advised that the 2012–D–0529 for ‘‘Recommended
marketing aspirin drug products with
Agency is not responsible for providing Statement for Over-the-Counter Aspirin-
cardiovascular related imagery to
access to electrical outlets. Containing Drug Products Labeled With
include a statement that reminds
FDA is establishing a docket for Cardiovascular Related Imagery;
consumers to talk to their health care
public comment on this meeting. The Guidance for Industry.’’ Received
provider before using aspirin for their
docket number is FDA–2017–N–0067. comments will be placed in the docket
heart.
sradovich on DSK3GMQ082PROD with NOTICES
The docket will close on March 10, and, except for those submitted as
2017. Comments received on or before DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly
February 27, 2017, will be provided to any guidance at any time (see 21 CFR viewable at http://www.regulations.gov
the committee. Comments received after 10.115(a)(5)), to ensure that the Agency or at the Division of Dockets
that date will be taken into considers your comments on this draft Management between 9 a.m. and 4 p.m.,
consideration by the Agency. guidance before it begins work on the Monday through Friday.
FDA welcomes the attendance of the final version of the guidance, submit • Confidential Submissions—To
public at its advisory committee either electronic or written comments submit a comment with confidential
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![3336 Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
information that you do not wish to be I. Background The draft guidance, when finalized, will
made publicly available submit your FDA is announcing the availability of represent the current thinking of FDA
comments only as a written/paper a draft guidance for industry entitled on this topic. It does not establish any
submission. You should submit two ‘‘Recommended Statement for Over-the- rights for any person and is not binding
copies total. One copy will include the Counter Aspirin-Containing Drug on FDA or the public. You can use an
information you claim to be confidential Products Labeled With Cardiovascular alternative approach if it satisfies the
with a heading or cover note that states Related Imagery.’’ Aspirin is a common requirements of the applicable statutes
‘‘THIS DOCUMENT CONTAINS active ingredient in many prescription and regulations.
CONFIDENTIAL INFORMATION.’’ The and OTC drug products. Most OTC II. Paperwork Reduction Act of 1995
Agency will review this copy, including aspirin drug products are currently
the claimed confidential information, in The recommendations in this draft
marketed pursuant to the Tentative
its consideration of comments. The guidance are not subject to review by
Final Monograph (TFM) for Internal
second copy, which will have the the Office of Management and Budget
Analgesic, Antipyretic, and
claimed confidential information because they do not constitute a
Antirheumatic (IAAA) Drug Products
redacted/blacked out, will be available ‘‘collection of information’’ under the
(53 FR 46204, November 16, 1988) for
for public viewing and posted on http:// Paperwork Reduction Act of 1995 (44
the temporary relief of minor aches and
www.regulations.gov. Submit both U.S.C. 3501–3520). Rather, the labeling
pains associated with a cold, headache,
copies to the Division of Dockets statements are a ‘‘public disclosure of
backache, toothache, premenstrual and
Management. If you do not wish your information originally supplied by the
menstrual cramps; minor pain of
name and contact information to be Federal government to the recipient for
arthritis; and reduction in fever.
made publicly available, you can In addition to the OTC conditions of the purpose of disclosure to the public’’
provide this information on the cover use in the IAAA TFM, FDA regulations (5 CFR 1320.3(c)(2)).
sheet and not in the body of your at § 343.80 (21 CFR 343.80) also contain III. Electronic Access
comments and you must identify this professional labeling about
information as ‘‘confidential.’’ Any Persons with access to the Internet
cardiovascular uses of aspirin directed
may obtain the draft guidance at either
information marked as ‘‘confidential’’ at health care practitioners (63 FR
http://www.fda.gov/Drugs/Guidance
will not be disclosed except in 56802, October 23, 1998). After
ComplianceRegulatoryInformation/
accordance with 21 CFR 10.20 and other publication of the professional labeling
Guidances/default.htm or http://
applicable disclosure law. For more regulation for aspirin, some OTC aspirin
www.regulations.gov.
information about FDA’s posting of labels were modified to include
comments to public dockets, see 80 FR cardiovascular related imagery (e.g., Dated: January 5, 2017.
56469, September 18, 2015, or access heart image, electrocardiography Leslie Kux,
the information at: http://www.fda.gov/ graphic, stethoscope around a heart Associate Commissioner for Policy.
regulatoryinformation/dockets/ image). However, the final rule for [FR Doc. 2017–00374 Filed 1–10–17; 8:45 am]
default.htm. IAAA products at § 343.80 authorizes BILLING CODE 4164–01–P
Docket: For access to the docket to labeling for cardiovascular events only
read background documents or the in professional labeling directed to
electronic and written/paper comments health care professionals. DEPARTMENT OF HEALTH AND
received, go to http:// Because of the potential side effects HUMAN SERVICES
www.regulations.gov and insert the associated with long-term aspirin
therapy, FDA recommends that any Food and Drug Administration
docket number, found in brackets in the
cardiovascular related imagery on OTC
heading of this document, into the [Docket No. FDA–2015–D–0198]
aspirin labels be accompanied by a
‘‘Search’’ box and follow the prompts
statement that reminds consumers to Current Good Manufacturing Practice
and/or go to the Division of Dockets
talk to their health care provider before Requirements for Combination
Management, 5630 Fishers Lane, Rm.
using aspirin for the professional Products; Guidance for Industry and
1061, Rockville, MD 20852.
indication of secondary prevention of Food and Drug Administration Staff;
Submit written requests for single cardiovascular events. Therefore, this
copies of the draft guidance to the Availability
draft guidance provides that FDA does
Division of Drug Information, Center for not intend to take action against AGENCY: Food and Drug Administration,
Drug Evaluation and Research, Food manufacturers of single-ingredient HHS.
and Drug Administration, 10001 New aspirin, buffered aspirin, and aspirin in ACTION: Notice of availability.
Hampshire Ave., Hillandale Building, combination with an antacid, marketed
4th Floor, Silver Spring, MD 20993– pursuant to the TFM for IAAA Drug SUMMARY: The Food and Drug
0002. Send one self-addressed adhesive Products because the product label Administration (FDA) is announcing the
label to assist that office in processing includes cardiovascular related imagery availability of a final guidance for
your request. See the SUPPLEMENTARY (e.g., heart image, electrocardiography industry and FDA staff entitled ‘‘Current
INFORMATION section for electronic graphic, stethoscope around a heart Good Manufacturing Practice
access to the draft guidance document. image) if the label also includes Requirements for Combination
language as described in the draft Products.’’ The guidance describes and
FOR FURTHER INFORMATION CONTACT:
explains the document on current good
sradovich on DSK3GMQ082PROD with NOTICES
Emily Baker, Center for Drug Evaluation guidance recommending that patients
talk to a health care professional before manufacturing practice (CGMP)
and Research, Food and Drug
taking aspirin for cardiovascular uses requirements for combination products,
Administration, 10903 New Hampshire
and the product is otherwise marketed which published in the Federal Register
Ave., Bldg. 51, Rm. 5203, Silver Spring,
in accordance with the TFM. of January 22, 2013, and includes
MD 20993–0002, 301–796–7524,
This draft guidance is being issued general considerations for CGMP
Emily.Baker@fda.hhs.gov.
consistent with FDA’s good guidance compliance as well as analysis of
SUPPLEMENTARY INFORMATION: practices regulation (21 CFR 10.115). hypothetical scenarios.
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Document Created: 2018-02-01 14:59:05
Document Modified: 2018-02-01 14:59:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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] | |
| FR Citation | 82 FR 3335 |
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