82 FR 51631 - Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 214 (November 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 214 (November 7, 2017)
| Page Range | 51631-51633 | |
| FR Document | 2017-24192 |
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)] [Notices] [Pages 51631-51633] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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
![Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51631
with the Agency’s intention for further regulation that was published on May, DEPARTMENT OF HEALTH AND
integration to maximize the strengths of 16, 2012 (77 FR 29074) included a HUMAN SERVICES
the QIO program and PfP HENs to reduction in the reporting requirement
sustain and expand current national related to hospital deaths associated Food and Drug Administration
reductions in in-patient harm and 30- with the use of restraint or seclusion, [Docket No. FDA–2012–D–0529]
day readmissions. The alignment of the § 482.13(g). Hospitals must use Form
two programs permits the systematic CMS–10455 to report those deaths Recommended Statement for Over-the-
use of innovative patient safety associated with restraint and/or Counter Aspirin-Containing Drug
practices at a national scale. seclusion directly to the Centers for Products Labeled With Cardiovascular-
Under this initiative, CMS has Related Imagery; Guidance for
Medicare & Medicaid Services (CMS)
awarded multiple contracts to Hospital Industry; Availability
Improvement Innovation Networks Regional Office (RO). This requirement
(HIINs), formerly known as HENs, to also applies to rehabilitation or AGENCY: Food and Drug Administration,
engage the hospital, provider, and psychiatric distinct part units (DPUs) in HHS.
broader caregiver communities to Critical Access Hospitals (CAHs). The ACTION: Notice of availability.
implement well-tested and measured RO must provide hospitals with
instructions for submitting the form fax SUMMARY: The Food and Drug
best practices. The end result of the
and/or email, based on RO preference. Administration (FDA or Agency) is
overall initiative is the anticipated
Hospitals are no longer required to announcing the availability of a
reduction in preventable hospital-based
report to CMS those deaths where there guidance for industry entitled
harm and readmissions for patients.
The PfP initiative is a public-private ‘‘Recommended Statement for Over-the-
was no use of seclusion and the only
partnership dedicated to the Counter Aspirin-Containing Drug
restraint was 2-point soft wrist restraints Products Labeled With Cardiovascular-
improvement of health care quality, beginning in May 9, 2014. This
safety, and affordability. CMS, working Related Imagery.’’ The guidance is
reporting requirement change resulted intended to promote the safe use of
with hospitals, providers, and the in no necessary edits to the form CMS–
broader caregiver community, aims to nonprescription (also referred to as
10455 as soft wrist restraints may be over-the-counter or OTC) aspirin drug
implement and disseminate best used in combination with other types of
practices on a national scale to reduce products by encouraging drug
restraints. It was estimated that this manufacturers, packagers, and labelers
hospital acquired conditions (HACs)
would reduce the volume of reports that marketing aspirin drug products with
and all-cause readmissions. Through the
PfP model, which was initiated in April must be submitted by 90 percent for cardiovascular-related imagery to
2011, CMS fostered rapid learning hospitals. In addition, the final rule include a statement that reminds
among a nationwide community of replaced the previous requirement for consumers to talk to their health care
practice, resulting in major strides in reporting via telephone to CMS, which provider before using aspirin for their
patient safety and engagement by proved to be cumbersome for both CMS heart.
patients and families. and hospitals, with a requirement that DATES: The announcement of the
A mixed methods approach to allows submission of reports via guidance is published in the Federal
answering the PfP HIIN evaluation telephone, facsimile or electronically, as Register on November 7, 2017.
questions includes three primary data determined by CMS. ADDRESSES: You may submit either
collection activities, as follows: Hospital Form CMS–10455 is being revised in electronic or written comments on
Survey on Prevention of Adverse Events order to obtain the necessary Agency guidances at any time as
and Reduction of Readmissions, HIIN follows:
information for the ROs to make a
Data Quality Assurance (QA) Survey
determination whether or not to Electronic Submissions
and Qualitative Discussions with HIIN
leaders and Other Support Contractors. authorize an on-site investigation Submit electronic comments in the
The data collected will provide us related to the details surrounding the following way:
feedback to focus efforts to improve the death of individuals associated with • Federal eRulemaking Portal:
effectiveness and efficiency of the HIIN restraint and/or seclusion. Form https://www.regulations.gov. Follow the
initiative. As we draft future HIIN and Number: CMS–10455 (OMB control instructions for submitting comments.
QIO contracts, information from number: 0938–1210); Frequency: Comments submitted electronically,
hospitals about HIIN influence on their Occasionally; Affected Public: Private including attachments, to https://
care processes will be used together Sector; Number of Respondents: 6,389; www.regulations.gov will be posted to
with follow-up input from stakeholders Number of Responses: 6,389; Total the docket unchanged. Because your
about the survey results. Form Number: Annual Hours: 2,619. (For policy comment will be made public, you are
CMS–10656 (OMB Control Number: questions regarding this collection solely responsible for ensuring that your
0938–NEW); Frequency: Annually; contact Karina Meushaw at 410–786– comment does not include any
Affected Public: Private Sector: Business 1000.) confidential information that you or a
or other for-profits and Not-for-profit third party may not wish to be posted,
Dated: November 1, 2017.
institutions; Number of Respondents: such as medical information, your or
835; Total Annual Responses: 854; Total William N. Parham, III, anyone else’s Social Security number, or
Annual Hours: 392. (For policy Director, Paperwork Reduction Staff, Office confidential business information, such
questions regarding this collection of Strategic Operations and Regulatory as a manufacturing process. Please note
ethrower on DSK3G9T082PROD with NOTICES
contact Israel Cross at 410–786–0619.) Affairs. that if you include your name, contact
2. Type of Information Collection [FR Doc. 2017–24134 Filed 11–6–17; 8:45 am] information, or other information that
Request: Revision of a currently BILLING CODE 4120–01–P identifies you in the body of your
approved collection; Title of comments, that information will be
Information Collection: Report of a posted on https://www.regulations.gov.
Hospital Death Associated with • If you want to submit a comment
Restraint or Seclusion; Use: The with confidential information that you
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![Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51633
information originally supplied by the Electronic Submissions information you claim to be confidential
Federal government to the recipient for Submit electronic comments in the with a heading or cover note that states
the purpose of disclosure to the public’’ following way: ‘‘THIS DOCUMENT CONTAINS
(5 CFR 1320.3(c)(2)). • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
III. Electronic Access
instructions for submitting comments. the claimed confidential information, in
Persons with access to the internet Comments submitted electronically, its consideration of comments. The
may obtain the document at either including attachments, to https:// second copy, which will have the
https://www.fda.gov/Drugs/Guidance www.regulations.gov will be posted to claimed confidential information
ComplianceRegulatoryInformation/ the docket unchanged. Because your redacted/blacked out, will be available
Guidances/default.htm or https:// comment will be made public, you are for public viewing and posted on
www.regulations.gov. solely responsible for ensuring that your https://www.regulations.gov. Submit
Dated: November 2, 2017. comment does not include any both copies to the Dockets Management
Anna K. Abram, confidential information that you or a Staff. If you do not wish your name and
Deputy Commissioner for Policy, Planning, third party may not wish to be posted, contact information to be made publicly
Legislation, and Analysis. such as medical information, your or available, you can provide this
[FR Doc. 2017–24192 Filed 11–6–17; 8:45 am] anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
BILLING CODE 4164–01–P
as a manufacturing process. Please note must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
DEPARTMENT OF HEALTH AND information, or other information that as ‘‘confidential’’ will not be disclosed
HUMAN SERVICES identifies you in the body of your except in accordance with 21 CFR 10.20
comments, that information will be and other applicable disclosure law. For
Food and Drug Administration posted on https://www.regulations.gov. more information about FDA’s posting
• If you want to submit a comment of comments to public dockets, see 80
[Docket No. FDA–2017–N–1129] with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
Medical Devices; Exemptions From public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
Premarket Notification: Class II written/paper submission and in the 23389.pdf.
Devices; Request for Comments manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
AGENCY: Food and Drug Administration, electronic and written/paper comments
HHS. Written/Paper Submissions received, go to https://
ACTION: Notice; request for comments. Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for heading of this document, into the
Administration (FDA or the Agency) is written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
announcing its intent to exempt a list of Management Staff (HFA–305), Food and and/or go to the Dockets Management
class II devices from premarket Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
notification requirements, subject to Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
certain limitations. The Agency has • For written/paper comments FOR FURTHER INFORMATION CONTACT:
determined that, based on established submitted to the Dockets Management Bryce Bennett, Center for Devices and
factors, these devices no longer require Staff, FDA will post your comment, as Radiological Health, Food and Drug
premarket notification to provide well as any attachments, except for Administration, 10903 New Hampshire
reasonable assurance of safety and information submitted, marked and Ave., Bldg. 66, Rm. 5244, Silver Spring,
effectiveness. FDA is publishing this identified, as confidential, if submitted MD 20993, 301–348–1446,
notice to obtain comments regarding the as detailed in ‘‘Instructions.’’ Gregory.Bennett@fda.hhs.gov.
proposed exemptions, in accordance Instructions: All submissions received SUPPLEMENTARY INFORMATION :
with the Federal Food, Drug, and must include the Docket No. FDA–
Cosmetic Act (the FD&C Act). 2017–N–1129 for ‘‘Medical Devices; I. Statutory Background
DATES: Submit either electronic or Exemptions from Premarket Section 510(k) of the FD&C Act (21
written comments on the notice by Notification: Class II Devices; Request U.S.C. 360(k)) and the implementing
January 8, 2018. for Comments.’’ Received comments, regulations, 21 CFR part 807 subpart E,
ADDRESSES: You may submit comments those filed in a timely manner (see require persons who intend to market a
as follows. Please note that late, ADDRESSES), will be placed in the docket new device to submit and obtain
untimely filed comments will not be and, except for those submitted as clearance of a premarket notification
considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly (510(k)) containing information that
be submitted on or before January 8, viewable at https://www.regulations.gov allows FDA to determine whether the
2018. The https://www.regulations.gov or at the Dockets Management Staff new device is ‘‘substantially equivalent’’
electronic filing system will accept between 9 a.m. and 4 p.m., Monday within the meaning of section 513(i) of
comments until midnight Eastern Time through Friday. the FD&C Act to a legally marketed
ethrower on DSK3G9T082PROD with NOTICES
at the end of January 8, 2018. Comments • Confidential Submissions—To device that does not require premarket
received by mail/hand delivery/courier submit a comment with confidential approval.
(for written/paper submissions) will be information that you do not wish to be The 21st Century Cures Act (Cures
considered timely if they are made publicly available, submit your Act) (Pub. L. 114–255) was signed into
postmarked or the delivery service comments only as a written/paper law on December 13, 2016. Section 3054
acceptance receipt is on or before that submission. You should submit two of the Cures Act amended section
date. copies total. One copy will include the 510(m) of the FD&C Act. As amended,
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Document Created: 2018-10-25 10:27:34
Document Modified: 2018-10-25 10:27:34
| 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 | The announcement of the guidance is published in the Federal Register on November 7, 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. | |
| FR Citation | 82 FR 51631 |
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