51630 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 

the accomplishments of the committee’s 

objectives. The Administrator is seeking 

nominations for members fulfilling the 

following categories: 

• Environmental medicine or 

Environmental health specialist; 

• Epidemiologist; 

• Occupational physician who has 

experience treating WTC rescue and 

recovery workers; 

• Occupational physician; 

• Representative of WTC responders; 

and 

• Toxicologist. 

Candidates should submit the 

following items: 

D Current curriculum vitae, including 

complete contact information 

(telephone numbers, mailing address, 

email address); 

D The category of membership 

(environmental medicine or 

environmental health specialist, 

occupational physician, pulmonary 

physician, representative of WTC 

responders, certified-eligible WTC 

survivor representative, industrial 

hygienist, toxicologist, epidemiologist, 

or mental health professional) that the 

candidate is qualified to represent); 

D A summary of the background, 

experience, and qualifications that 

demonstrates the nominee’s suitability 

for the nominated membership category; 

and 

D At least one letter of 

recommendation from person(s) not 

employed by the U.S. Department of 

Health and Human Services. 

(Candidates may submit letter(s) from 

current HHS employees if they wish, 

but at least one letter must be submitted 

by a person not employed by an HHS 

agency (e.g., CDC, NIH, FDA, etc.). 

Nominations may be submitted by the 

candidate him- or herself, or by the 

person/organization recommending the 

candidate. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Elaine L. Baker 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–24155 Filed 11–6–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10656 and CMS– 

10455] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

January 8, 2018. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number _________, Room C4– 

26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10656 Evaluation of the 

Partnership for Patients (PfP) 3.0 

CMS–10455 Report of a Hospital Death 

Associated with Restraint or 

Seclusion 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: New collection of information 

request; Title of Information Collection: 

Evaluation of the Partnership for 

Patients (PfP) 3.0; Use: In the summer of 

2015, the Centers for Medicare & 

Medicaid Services (CMS) Administrator 

approved the plans for integration of the 

Partnership for Patients (PfP) Hospital 

Engagement Network (HEN) model test 

with the Quality Improvement NetworkQuality Improvement Organization 

(QIN–QIO) program. This is consistent 


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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