35786 Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 

regarding this collection contact Jennifer 

Tate at 410–786–0428). 

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: Provisions 

implementing this statutory reporting 

requirement for hospitals participating 

in Medicare are found at 42 CFR 

482.13(g), as revised in the final rule 

that published on May 16, 2012 (77 FR 

29034). This regulation also applies to 

Critical Access Hospitals (CAHs) with 

distinct part units (DPUs); since CAH 

DPUs are subject to the Hospital 

Conditions of Participation. The 

regulation at 42 CFR 482.13(g) requires 

that hospitals and CAHs with DPUs 

report deaths associated with the use of 

restraint and/or seclusion directly to the 

CMS locations. This regulation requires 

that information about patient deaths 

associated with the use of restraint and/ 

or seclusion must be reported to the 

CMS Locations using the online CMS– 

10455 form titled ‘‘Report Of A Hospital 

Death Associated With The Use Of 

Restraint Or Seclusion.’’ 

When a death occurs in a hospital 

(including Critical Access Hospital 

(CAH) with a rehabilitation or 

psychiatric Distinct Part Unit (DPU)) 

that is associated with the use of 

restraints and/or seclusion, the hospital 

staff must complete the online Form 

CMS–10455 (42 CFR 482.13(g)(1). The 

hospital staff must also document the 

date and time that CMS was notified of 

the death in the patient’s medical record 

(42 CFR 482.13(g)(3)(i). 

When a death occurs during the use 

of 2-point soft cloth wrist restraints with 

no seclusion, or within 24 hours after 

the patient was removed from such 

restraints, the hospital must document 

the information required by 42 CFR 

482.13(g)(4)(ii) into a hospital log or 

internal system within 7 days from the 

date of death (42 CFR 482.13(g)(4)(i). 

The hospital is not required to submit 

this log or internal records to the CMS 

Location, however, they must be made 

available in either written or electronic 

form to CMS immediately upon request 

(42 CFR 482.13(g)(4)(iii). In addition, 

the hospital staff must also document 

the date and time that the required 

information was entered into the 

hospital’s log or internal system in the 

patient’s medical record (42 CFR 

482.13(g)(3)(ii). Form Number: CMS– 

10455 (OMB control number: 0938– 

1210); Frequency: Occasionally; 

Affected Public: Private Sector; Number 

of Respondents: 3,137; Number of 

Responses: 3,137; Total Annual Hours: 

1,210. (For policy questions regarding 

this collection contact Caroline Gallaher 

at 410–786–8705.) 

Dated: June 8, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–12721 Filed 6–10–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10520] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

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 

(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 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate 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 on the collection(s) of 

information must be received by the 

OMB desk officer by July 13, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

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’ website address at: 

https://www.cms.gov/Regulationsand-Guidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Marketplace 

Quality Standards; Use: The Patient 

Protection and Affordable Care Act 

establishes requirements to support the 

delivery of quality health care coverage 

for health insurance issuers offering 

Qualified Health Plans (QHPs) in 

Exchanges. Section 1311(c)(3) of the 

Patient Protection and Affordable Care 

Act directs the Secretary to develop a 

system to rate QHPs on the basis of 

quality and price and requires 

Exchanges to display this quality rating 

information on their respective 

websites. Section 1311(c)(4) of the 

Patient Protection and Affordable Care 

Act requires the Secretary to develop an 

enrollee satisfaction survey system to 

assess enrollee experience with each 

QHP (with more than 500 enrollees in 

the previous year) offered through an 

Exchange. Section 1311(h) requires 

QHPs to contract with certain hospitals 

that meet specific patient safety and 

health care quality standards. 

This collection of information is 

necessary to provide adequate and 

timely health care quality information 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 35787 

for consumers, regulators, and 

Exchanges as well as to collect 

information to appropriately monitor 

and provide a process for a survey 

vendor to appeal HHS’ decision to not 

approve a QHP Enrollee Survey vendor 

application. Form Number: CMS–10520 

(OMB control number: 0938–1249); 

Frequency: Annually; Affected Public: 

Public sector (Individuals and 

Households); Private sector (Business or 

other for-profits and Not-for-profit 

institutions); Number of Respondents: 

314; Total Annual Responses: 314; Total 

Annual Hours: 384,014. (For policy 

questions regarding this collection 

contact Nidhi Singh Shah at 301–492– 

5110.) 

Dated: June 7, 2022 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–12651 Filed 6–10–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0362] 

Blood Pressure and Pulse Donor 

Eligibility Requirements: Compliance 

Policy; Draft Guidance for Industry; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; 

correction. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

correcting a notice that appeared in the 

Federal Register of Tuesday, May 24, 

2022. The document announced the 

availability of a draft guidance entitled 

‘‘Blood Pressure and Pulse Donor 

Eligibility Requirements: Compliance 

Policy; Draft Guidance for Industry.’’ 

The draft guidance document was 

published with incorrect information of 

a comment period due date. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 24, 2022 (87 FR 

31567), in FR Doc. 2022–11118, on page 

31567, the following correction is made: 

1. On page 3156, in the first column, 

the DATES caption is corrected to read: 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 25, 2022, to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12619 Filed 6–10–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0686] 

Advisory Committee; Science Advisory 

Board to the National Center for 

Toxicological Research; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the renewal of the Science 

Advisory Board to the National Center 

for Toxicological Research (NCTR) by 

the Commissioner of Food and Drugs 

(the Commissioner). The Commissioner 

has determined that it is in the public 

interest to renew the Science Advisory 

Board to the National Center for 

Toxicological Research for an additional 

2 years beyond the charter expiration 

date. The new charter will be in effect 

until the June 2, 2024, expiration date. 

DATES: Authority for the Science 

Advisory Board to the National Center 

for Toxicological Research will expire 

on June 2, 2024, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Donna L. Mendrick, National Center for 

Toxicological Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 2208, Silver Spring, 

MD 20993–0002, 301–796–8892, 

Donna.Mendrick@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant and by the General 

Services Administration, FDA is 

announcing the renewal of the Science 

Advisory Board to the National Center 

for Toxicological Research (the 

Committee). The Committee is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee advises the Director, 

NCTR, in establishing, implementing, 

and evaluating research programs that 

assist the Commissioner in fulfilling his 

regulatory responsibilities. The 

Committee provides an extra-agency 

review in ensuring that the research 

programs at NCTR are scientifically 

sound and pertinent. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

toxicological research. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. Federal 

members will be appointed as Regular 

Government Employees or Ex-Officios. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. 

The Commissioner or designee shall 

have the authority to select members of 

other scientific and technical FDA 

advisory committees (normally not to 

exceed 10 members) to serve 

temporarily as voting members and to 

designate consultants to serve 

temporarily as voting members when: 

(1) expertise is required that is not 

available among current voting standing 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members) or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 

a committee charter to specify quorum 

requirements. 

If functioning as a medical device 

panel, an additional non-voting 

representative member of consumer 

interests will be included in addition to 

the voting members. 


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