37858 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–224–14] 

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 25, 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/ 

PaperworkReductionActof1995/ 

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: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: 

Federally Qualified Health Center Cost 

Report Form; Use: The Form CMS–224– 

14 cost report is needed to determine a 

provider’s reasonable cost incurred in 

furnishing medical services to Medicare 

beneficiaries and to calculate the FQHC 

settlement amount. These providers, 

paid under the FQHC prospective 

payment system (PPS), may receive 

reimbursement outside of the PPS for 

Medicare reimbursable bad debts, 

pneumococcal, influenza, and COVID– 

19 vaccines, and monoclonal antibody 

products. CMS uses the Form CMS– 

224–14 for rate setting; payment 

refinement activities, including 

developing a FQHC market basket; 

Medicare Trust Fund projections; and to 

support program operations. 

Additionally, the Medicare Payment 

Advisory Commission (MedPAC) uses 

the FQHC Medicare cost report data to 

calculate Medicare margins; to 

formulate recommendations to Congress 

regarding the FQHC PPS; and to 

conduct additional analysis of the 

FQHC PPS. Form Number: CMS–224–14 

(OMB control number: 0938–1298); 

Frequency: Yearly; Affected Public: 

Private Sector, State, Local, or Tribal 

Governments, Federal Government, 

Business or other for-profits, Not-forProfit Institutions; Number of 

Respondents: 2,890; Total Annual 

Responses: 2,890; Total Annual Hours: 

167,620. (For policy questions regarding 

this collection contact LuAnn Piccione 

at 410–786–5423.) 

Dated: June 21, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–13551 Filed 6–23–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Tribal Consultation Meetings 

AGENCY: Office of Head Start (OHS), 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS). 

ACTION: Notice of meetings. 

SUMMARY: Pursuant to the Head Start 

Act, notice is hereby given of three 

tribal consultation sessions to be held 

between HHS/ACF OHS leadership and 

the leadership of tribal governments 

operating Head Start and Early Head 

Start programs. The purpose of these 

consultation sessions is to discuss ways 

to better meet the needs of American 

Indian and Alaska Native (AI/AN) 

children and their families, taking into 

consideration funding allocations, 

distribution formulas, and other issues 

affecting the delivery of Head Start 

services in their geographic locations. 

Three tribal consultations will be held 

as part of HHS/ACF or ACF Tribal 

Consultation Sessions. 

DATES: 

Tuesday, July 12, 2022 

Monday, August 15, 2022 

Wednesday, September 14, 2022 

ADDRESSES: 

• July 12, 2022—3–5 p.m. ET (Virtual) 

• August 15, 2022—1–5 p.m. PT 

(Northern Quest Resort & Casino, 100 

N Hayford Rd., Airway Heights, WA 

99001) 

• September 14, 2022—2–5 p.m. ET 

(Virtual) 

FOR FURTHER INFORMATION CONTACT: 

Todd Lertjuntharangool, Regional 

Program Manager, Region XI/AIAN, 

Office of Head Start, email 

Todd.Lertjuntharangool@acf.hhs.gov, or 

phone (866) 763–6481. Additional 

information and online meeting 

registration will be available here. 

SUPPLEMENTARY INFORMATION: In 

accordance with Section 640(l)(4) of the 

Head Start Act, 42 U.S.C. 9835(1)(4), 

ACF announces OHS Tribal 

Consultation Sessions for leaders of 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37859 

tribal governments operating Head Start 

and Early Head Start programs. 

The agenda for the scheduled OHS 

Tribal Consultations reflects the 

statutory purposes of Head Start tribal 

consultations related to meeting the 

needs of AI/AN children and families. 

OHS will also highlight the progress 

made in addressing issues and concerns 

raised in the previous OHS Tribal 

Consultations. 

The consultation sessions include 

elected or appointed leaders of tribal 

governments and their designated 

representatives. Designees must have a 

letter from the tribal government 

authorizing them to represent the tribe. 

Tribal governments must submit the 

designee letter at least 3 days before the 

consultation sessions to Todd 

Lertjuntharangool at 

Todd.Lertjuntharangool@acf.hhs.gov. 

Other representatives of tribal 

organizations and Native nonprofit 

organizations are welcome to attend as 

observers. 

Within 45 days of the consultation 

sessions, a detailed report of each 

consultation session will be available 

for all tribal governments receiving 

funds for Head Start and Early Head 

Start programs. Tribes can submit 

written testimony for the report to Todd 

Lertjuntharangool at 

Todd.Lertjuntharangool@acf.hhs.gov 

prior to each consultation session or 

within 30 days of each meeting. OHS 

will summarize oral testimony and 

comments from the consultation 

sessions in each report without 

attribution, along with topics of concern 

and recommendations. 

Roshelle M. Brooks, 

ACF Certifying Officer. 

[FR Doc. 2022–13532 Filed 6–23–22; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Notice of Federal Review of the 

American Samoa Protection and 

Advocacy System (P&A) 

AGENCY: Administration for Community 

Living, Health and Human Services 

(HHS). 

ACTION: Notice. 

SUMMARY: Representatives of the 

Administration on Disabilities (AoD), 

Administration for Community Living 

(ACL), will be conducting a federal 

review of the American Samoa 

Protection and Advocacy System (P&A) 

on September 19–23, 2022. AoD is 

soliciting comments from interested 

parties on your experiences with the 

program, and strategies employed by 

P&A in meeting the needs of individuals 

with developmental disabilities and 

their families in American Samoa. You 

are encouraged to share your 

experiences by way of any of the 

following methods: 

DATES: Comments should be received by 

September 1, 2022 in order to be 

included in the final report. 

ADDRESSES: EMAIL: Elizabeth.leef@

acl.hhs.gov, TELEPHONE: 202–475– 

2482, MAIL COMMENTS TO: Elizabeth 

Leef, Program Specialist, 

Administration on Disabilities, 

Administration for Community Living, 

330 C Street SW, 1st Floor, Washington, 

DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Leef, Administration for 

Community Living, Administration on 

Disabilities, 330 C Street SW, 1st Floor, 

Washington, DC 20201, 202–475–2482. 

Authority: 45 CFR 1326.21(h) 

Dated: June 15, 2022. 

Alison Barkoff, 

Acting Administrator & Assistant Secretary 

for Aging. 

[FR Doc. 2022–13462 Filed 6–23–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–3815] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Establishment 

Registration and Device Listing for 

Manufacturers and Importers of 

Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by July 25, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0625. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Establishment Registration and Device 

Listing for Manufacturers and 

Importers of Devices—21 CFR Part 807, 

Subparts A Through D 

OMB Control Number 0910–0625— 

Extension 

Under section 510 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360) and implementing 

regulations in 21 CFR part 807, subparts 

A through D (part 807, subparts A 

through D), medical device 

establishment owners and operators are 

required to electronically submit 

establishment registration and device 

listing information. Complete and 

accurate registration and listing 

information is necessary to accomplish 

a number of statutory and regulatory 

objectives, such as: (1) identification of 

establishments producing marketed 

medical devices; (2) identification of 

establishments producing a specific 

device when that device is in short 

supply or is needed for national 

emergency; (3) facilitation of recalls for 

devices marketed by owners and 

operators of device establishments; (4) 

identification and cataloging of 

marketed devices; (5) administering 

postmarketing surveillance programs for 

devices; (6) identification of devices 

marketed in violation of the law; (7) 

identification and control of devices 

imported into the country from foreign 

establishments; and (8) scheduling and 

planning inspections of registered 

establishments under section 704 of the 

FD&C Act (21 U.S.C. 374). 

Respondents to this information 

collection are owners or operators of 

establishments that engage in the 

manufacturing, preparation, 

propagation, compounding, or 

processing of a device or devices, who 

must register their establishments and 


jspears on DSK121TN23PROD with NOTICES1