Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery; Draft Guidance for Industry; Availability, 3335-3336 [2017-00374]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On March 13, 2017, from 9:15 a.m. to 5 p.m., and on March 14, 2017, from 8 a.m. to 5 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before February 27, 2017, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 10:30 a.m. on March 14, 2017. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 16, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 17, 2017. Closed Committee Deliberations: On March 13, 2017, from 8 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the premarketing drug development program of an extendedrelease opioid product. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2017–N–0067. The docket will close on March 10, 2017. Comments received on or before February 27, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. FDA welcomes the attendance of the public at its advisory committee VerDate Sep<11>2014 19:05 Jan 10, 2017 Jkt 241001 meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Stephanie L. Begansky at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 6, 2017. Janice M. Soreth, Associate Commissioner for Special Medical Programs. [FR Doc. 2017–00463 Filed 1–10–17; 8:45 am] BILLING CODE 4164–01–P 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 Cardiovascular Related Imagery; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Recommended Statement for Over-the-Counter AspirinContaining 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. SUMMARY: 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 DATES: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 3335 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: 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: • 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 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential E:\FR\FM\11JAN1.SGM 11JAN1 3336 Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES 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 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: https://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 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 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, Emily.Baker@fda.hhs.gov. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:05 Jan 10, 2017 Jkt 241001 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Recommended Statement for Over-theCounter 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 § 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 § 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). PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–0198] Current Good Manufacturing Practice Requirements for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled ‘‘Current Good Manufacturing Practice Requirements for Combination Products.’’ The guidance describes and explains the document on current good manufacturing practice (CGMP) requirements for combination products, which published in the Federal Register of January 22, 2013, and includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios. SUMMARY: E:\FR\FM\11JAN1.SGM 11JAN1

Agencies

[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: 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:
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 https://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 https://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: https://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 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 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, Emily.Baker@fda.hhs.gov.

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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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

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