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 


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