Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51631 

with the Agency’s intention for further 

integration to maximize the strengths of 

the QIO program and PfP HENs to 

sustain and expand current national 

reductions in in-patient harm and 30- 

day readmissions. The alignment of the 

two programs permits the systematic 

use of innovative patient safety 

practices at a national scale. 

Under this initiative, CMS has 

awarded multiple contracts to Hospital 

Improvement Innovation Networks 

(HIINs), formerly known as HENs, to 

engage the hospital, provider, and 

broader caregiver communities to 

implement well-tested and measured 

best practices. The end result of the 

overall initiative is the anticipated 

reduction in preventable hospital-based 

harm and readmissions for patients. 

The PfP initiative is a public-private 

partnership dedicated to the 

improvement of health care quality, 

safety, and affordability. CMS, working 

with hospitals, providers, and the 

broader caregiver community, aims to 

implement and disseminate best 

practices on a national scale to reduce 

hospital acquired conditions (HACs) 

and all-cause readmissions. Through the 

PfP model, which was initiated in April 

2011, CMS fostered rapid learning 

among a nationwide community of 

practice, resulting in major strides in 

patient safety and engagement by 

patients and families. 

A mixed methods approach to 

answering the PfP HIIN evaluation 

questions includes three primary data 

collection activities, as follows: Hospital 

Survey on Prevention of Adverse Events 

and Reduction of Readmissions, HIIN 

Data Quality Assurance (QA) Survey 

and Qualitative Discussions with HIIN 

leaders and Other Support Contractors. 

The data collected will provide us 

feedback to focus efforts to improve the 

effectiveness and efficiency of the HIIN 

initiative. As we draft future HIIN and 

QIO contracts, information from 

hospitals about HIIN influence on their 

care processes will be used together 

with follow-up input from stakeholders 

about the survey results. Form Number: 

CMS–10656 (OMB Control Number: 

0938–NEW); Frequency: Annually; 

Affected Public: Private Sector: Business 

or other for-profits and Not-for-profit 

institutions; Number of Respondents: 

835; Total Annual Responses: 854; Total 

Annual Hours: 392. (For policy 

questions regarding this collection 

contact Israel Cross at 410–786–0619.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Report of a 

Hospital Death Associated with 

Restraint or Seclusion; Use: The 

regulation that was published on May, 

16, 2012 (77 FR 29074) included a 

reduction in the reporting requirement 

related to hospital deaths associated 

with the use of restraint or seclusion, 

§ 482.13(g). Hospitals must use Form 

CMS–10455 to report those deaths 

associated with restraint and/or 

seclusion directly to the Centers for 

Medicare & Medicaid Services (CMS) 

Regional Office (RO). This requirement 

also applies to rehabilitation or 

psychiatric distinct part units (DPUs) in 

Critical Access Hospitals (CAHs). The 

RO must provide hospitals with 

instructions for submitting the form fax 

and/or email, based on RO preference. 

Hospitals are no longer required to 

report to CMS those deaths where there 

was no use of seclusion and the only 

restraint was 2-point soft wrist restraints 

beginning in May 9, 2014. This 

reporting requirement change resulted 

in no necessary edits to the form CMS– 

10455 as soft wrist restraints may be 

used in combination with other types of 

restraints. It was estimated that this 

would reduce the volume of reports that 

must be submitted by 90 percent for 

hospitals. In addition, the final rule 

replaced the previous requirement for 

reporting via telephone to CMS, which 

proved to be cumbersome for both CMS 

and hospitals, with a requirement that 

allows submission of reports via 

telephone, facsimile or electronically, as 

determined by CMS. 

Form CMS–10455 is being revised in 

order to obtain the necessary 

information for the ROs to make a 

determination whether or not to 

authorize an on-site investigation 

related to the details surrounding the 

death of individuals associated with 

restraint and/or seclusion. Form 

Number: CMS–10455 (OMB control 

number: 0938–1210); Frequency: 

Occasionally; Affected Public: Private 

Sector; Number of Respondents: 6,389; 

Number of Responses: 6,389; Total 

Annual Hours: 2,619. (For policy 

questions regarding this collection 

contact Karina Meushaw at 410–786– 

1000.) 

Dated: November 1, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–24134 Filed 11–6–17; 8:45 am] 

BILLING CODE 4120–01–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 CardiovascularRelated 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-theCounter Aspirin-Containing Drug 

Products Labeled With CardiovascularRelated 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 


ethrower on DSK3G9T082PROD with NOTICES
51632 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 

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 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 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-theCounter Aspirin-Containing Drug 

Products Labeled With CardiovascularRelated 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 

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 AspirinContaining 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 AspirinContaining 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 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 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/Guidance

ComplianceRegulatoryInformation/ 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–1129] 

Medical Devices; Exemptions From 

Premarket Notification: Class II 

Devices; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing its intent to exempt a list of 

class II devices from premarket 

notification requirements, subject to 

certain limitations. The Agency has 

determined that, based on established 

factors, these devices no longer require 

premarket notification to provide 

reasonable assurance of safety and 

effectiveness. FDA is publishing this 

notice to obtain comments regarding the 

proposed exemptions, in accordance 

with the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act). 

DATES: Submit either electronic or 

written comments on the notice by 

January 8, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 8, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 8, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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): 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– 

2017–N–1129 for ‘‘Medical Devices; 

Exemptions from Premarket 

Notification: Class II Devices; Request 

for Comments.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Bryce Bennett, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5244, Silver Spring, 

MD 20993, 301–348–1446, 

Gregory.Bennett@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION : 

I. Statutory Background 

Section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and the implementing 

regulations, 21 CFR part 807 subpart E, 

require persons who intend to market a 

new device to submit and obtain 

clearance of a premarket notification 

(510(k)) containing information that 

allows FDA to determine whether the 

new device is ‘‘substantially equivalent’’ 

within the meaning of section 513(i) of 

the FD&C Act to a legally marketed 

device that does not require premarket 

approval. 

The 21st Century Cures Act (Cures 

Act) (Pub. L. 114–255) was signed into 

law on December 13, 2016. Section 3054 

of the Cures Act amended section 

510(m) of the FD&C Act. As amended, 


ethrower on DSK3G9T082PROD with NOTICES