Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75289 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Annual 

burden hours 

RFP and Contract ................................................................ 50 4.5 4 900 300 

Emergency Funding Request .............................................. 21 1 2 42 14 

Biennial Reports ................................................................... 54 1.5 1.5 121.5 40.5 

Advance Planning Document .............................................. 44 3.6 120 19,008 6,336 

Operational Advance Planning Document ........................... 10 3 30 900 300 

Independent Verification and Validation (ongoing) .............. 3 12 10 360 120 

Independent Verification and Validation (semiannually) ..... 4 6 16 384 128 

Independent Verification and Validation (quarterly) ............ 10 12 30 3,600 1,200 

System Certification ............................................................. 3 3 240 2,160 720 

Estimated Total Annual Burden 

Hours: 9,158.50. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 45 CFR part 95, subpart F. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–24211 Filed 11–1–23; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; State Plan for Grants to States 

for Refugee Resettlement (Office of 

Management and Budget #0970–0351) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families (ACF), Office of 

Refugee Resettlement (ORR) is 

requesting a 3-year extension of the 

State Plan for Grants to States for 

Refugee Resettlement (Office of 

Management and Budget #0970–0351, 

expiration 6/30/2024). ORR is proposing 

changes to the form. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: A State Plan is a required 

comprehensive narrative description of 

the nature and scope of a state’s or 

Replacement Designee’s (RD) Refugee 

Resettlement Program and provides 

assurances that the program will be 

administered in conformity with the 

specific requirements stipulated in 45 

CFR 400.4–400.9. The State Plan must 

include all applicable state or RD 

procedures, designations, and 

certifications for each requirement as 

well as supporting documentation. The 

plan assures ORR that the state or RD is 

capable of administering refugee 

assistance and coordinating 

employment and other social services 

for eligible caseloads in conformity with 

specific requirements. 

ORR proposes the following changes 

to the previously approved State Plan 

for Grants to States for Refugee 

Resettlement: 

• streamlining/formatting multiple 

sections of the form, including 

technical corrections 

• enhancing requirements for 

collaboration and engagement and 

expanding the non-discrimination 

aspects 

• standardizing sections of the template 

related to health to reduce burden by 

clarifying text and removing 

duplicative parts 

• streamlining sections related to the 

unaccompanied children to reduce 

burden by providing better options for 

responses and selections and by 

removing unnecessary and confusing 

text to ensure consistency regarding 

assurances 

Respondents: State agencies and RDs 

under 45 CFR 400.301(c) administering 

or supervising the administration of 

programs. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

State Plan for Grants to States for Refugee Resettlement ............................. 59 1 18 1,062 


khammond on DSKJM1Z7X2PROD with NOTICES
75290 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 8 U.S.C. 1522 of the 

Immigration and Nationality Act (the 

Act) [Title IV, Sec. 412 of the Act] for 

each state agency requesting federal 

funding for refugee resettlement under 8 

U.S.C. 524 [Title IV, Sec. 414 of the 

Act]. 

Mary Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–24185 Filed 11–1–23; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–2809] 

Advisory Committee; Patient 

Engagement Advisory Committee; 

Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the renewal of the Patient 

Engagement Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Patient 

Engagement Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until the October 6, 2025, 

expiration date. 

DATES: Authority for the Patient 

Engagement Advisory Committee would 

have expired on October 6, 2025, unless 

the Commissioner had formally 

determined that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Letise Williams, Office of the Center 

Director, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5407, Silver Spring, 

MD 20993–0002, 301–796–8398, 

Letise.Williams@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Patient Engagement 

Advisory Committee (the Committee). 

The Committee is a discretionary 

Federal advisory committee established 

to provide advice to the Commissioner. 

The Patient Engagement Advisory 

Committee advises the Commissioner or 

designee in discharging responsibilities 

as they relate to helping to ensure safe 

and effective devices for human use 

and, as required, any other product for 

which FDA has regulatory 

responsibility. 

The Committee provides advice to the 

Commissioner of Food and Drugs or 

designee on complex scientific, issues 

relating to medical devices, the 

regulation of devices, and their use by 

patients. Agency guidance and policies, 

clinical trial or registry design, patient 

preference study design, benefit-risk 

determinations, device labeling, unmet 

clinical needs, available alternatives, 

patient reported outcomes, and devicerelated quality of life measures or health 

status issues are among the topics that 

may be considered by the Committee. 

The Committee provides relevant skills 

and perspectives to improve 

communication of benefits, risks, and 

clinical outcomes, and increase 

integration of patient perspectives into 

the regulatory process for medical 

devices. It performs its duties by 

identifying new approaches, promoting 

innovation, recognizing unforeseen risks 

or barriers, and identifying unintended 

consequences that could result from 

FDA policy. 

Pursuant to its Charter, 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 who are knowledgeable in 

areas such as clinical research, patient 

experience, and healthcare needs of 

patient groups in the United States, or 

who are experienced in the work of 

patient and health professional 

organizations, methodologies for patient 

reported outcomes and eliciting patient 

preferences, and strategies for 

communicating benefits, risks, and 

clinical outcomes to patients and 

research subjects, as well as other 

relevant areas. Members will be invited 

to serve for overlapping terms of up to 

4 years. Non-Federal members of this 

committee will serve as either as Special 

Government Employees or non-voting 

representatives. Federal members will 

serve as Regular Government 

Employees. The core of voting members 

may include one technically qualified 

member, selected by the Commissioner 

or designee, who serves as an 

individual, but 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 also have the authority 

to select from a group of individuals 

nominated by industry to serve 

temporarily as nonvoting members who 

are identified with industry interests. 

The number of temporary members 

selected for a particular meeting will 

depend on the meeting topic. 

The Commissioner or designee shall 

also 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. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

committees-and-meeting-materials/ 

patient-engagement-advisory-committee 

or by contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 


khammond on DSKJM1Z7X2PROD with NOTICES