Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 7183 

‘‘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. 

The PRA requires Federal agencies to 

provide a 60-day notice in the Federal 

Register concerning each proposed 

collection of information, including 

each proposed extension of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, ACL is publishing a notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, ACL invites 

comments on our burden estimates or 

any other aspect of this collection of 

information, including: 

(1) Whether the proposed collection 

of information is necessary for the 

proper performance of ACL’s functions, 

including whether the information will 

have practical utility; 

(2) the accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; 

(3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(4) ways to minimize the burden of 

the collection of information on 

respondents, including through the use 

of automated collection techniques 

when appropriate, and other forms of 

information technology. 

This is a revision to a currently 

approved information collection (IC), 

the Department replaced four existing 

Protection and Advocacy Program 

Performance Reports under one IC in 

March 2019. This is termed One-PPR. 

The four annual reports included the 

following: (1) Developmental 

Disabilities Protection and Advocacy 

Systems Program Performance Report, 

(2) Protection and Advocacy for 

Assistive Technology (PAAT) Program 

Performance Report; (3) Protection and 

Advocacy Voting Access Annual Report 

(Help America Vote Act) (HAVA); and 

(4) Protection and Advocacy for 

Traumatic Brain Injury (PATBI) Program 

Performance Report. This revision 

includes data elements based on 

funding from the Centers for Disease 

Control and Prevention to increase 

access to COVID–19 vaccines (ACCESS), 

and expand the Public Health 

Workforce (PHWF), provided under 

Section 2501 of the American Rescue 

Plan Act of 2021 (Pub. L. 117–2). Each 

P&A submits one report (One-PPR) for 

four funding sources, administered by 

ACL. As with each funding source, there 

is a reporting requirement. In an effort 

to reduce the burden of the P&As, each 

will continue to submit one report for 

all funding sources; however, as of 

FY2022, the report will incorporate the 

activities undertaken for the ACCESS 

and PHWF funding, by creating a new 

goal or priority in Part 2C, and adding 

the narrative in Part 2.C.4 (Rationale for 

Adding/Changing Goal) or 2.C.5 

(Rationale for Adding/Changing 

Priority). The guidance document 

provides a description of the data 

elements to be included in this section 

of the One-PPR template. 

State Protection and Advocacy (P&A) 

Systems in each State and Territory 

provide individual legal advocacy, 

systemic advocacy, monitoring and 

investigations to protect and advance 

the rights of people with developmental 

disabilities, using funding administered 

by the Administration on Disabilities 

(AoD), Administration for Community 

Living, HHS. To meet statutory 

reporting requirements, P&As use these 

forms for submitting annual reports. 

The PPRs are reviewed by federal staff 

for compliance and outcomes. 

Information in the reports is analyzed to 

create a national profile of 

programmatic compliance, outcomes, 

and goals and priorities for P&A 

Systems for tracking accomplishments 

against goals and to formulate areas of 

technical assistance related to 

compliance with Federal requirements. 

Information collected informs AoD of 

trends in P&A advocacy, facilitate 

collaboration with other federally 

funded entities, and identify best 

practices for the efficient use of federal 

funds. Additionally, the information is 

used to provide a national perspective 

on where the program is going 

(prospective view), and to provide a 

gage for program accomplishments 

against program objectives for purposes 

of identifying continuing challenges and 

formulating technical assistance and 

management support provided to P&A 

systems. 

The proposed data collection tools 

may be found on the ACL website for 

review at: https://www.acl.gov/aboutacl/public-input. 

Estimated Program Burden 

The following table summarizes the 

burden hour estimate for this 

information collection: 

Number of states 

Number of 

responses 

per state 

Average 

burden hours 

per state 

Total hours 

57 ................................................................................................................................................. 1 144 8208 

The estimates of annual burden to the 

States vary in accordance with the size, 

program complexity, and technological 

capacity of the States. The annual 

burden on this form is estimated to be 

144 hours, which is an increase of 16 

hours from the previous instrument. 

PPR 

Annual hours estimate 

(based on previous OMB 

burden estimates) 

PADD ............................ 90 

PAAT ............................. 16 

PATBI ............................ 16 

HAVA ............................. 20 

ACCESS ........................ 10 

PHWF ............................ 6 

ONE PPR ...................... 144 

Dated: February 3, 2022. 

Alison Barkoff, 

Principal Deputy Administrator. 

[FR Doc. 2022–02577 Filed 2–7–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Submission for OMB 

Review; Public Comment Request; 

Process Evaluation of the Aging 

Network and Its Return on Investment; 

OMB #0985–New 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living is announcing that 


khammond on DSKJM1Z7X2PROD with NOTICES
7184 Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 

the proposed collection of information 

listed above has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance as 

required under section 506(c)(2)(A) of 

the Paperwork Reduction Act of 1995. 

This 30-Day notice collects comments 

on the information collection 

requirements related to the information 

collection requirements for the Process 

Evaluation of the Aging Network and its 

Return on Investment [OMB #0985– 

New]. 

DATES: Submit written comments on the 

collection of information by March 10, 

2022. 

ADDRESSES: Submit written comments 

and recommendations for the proposed 

information collection within 30 days of 

publication of this notice to 

www.reginfo.gov/public/do/PRAMain. 

Find the information collection by 

selecting ‘‘Currently under 30-day 

Review—Open for Public Comments’’ or 

by using the search function. By mail to 

the Office of Information and Regulatory 

Affairs, OMB, New Executive Office 

Bldg., 725 17th St. NW, Rm. 10235, 

Washington, DC 20503, Attn: OMB Desk 

Officer for ACL. 

FOR FURTHER INFORMATION CONTACT: 

Caryn Bruyere, Office of Performance 

and Evaluation. Administration for 

Community Living Telephone: 202– 

795–7393 Email: caryn.bruyere@

acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. The 

Administration for Community Living 

(ACL) is requesting approval to collect 

data for the Process Evaluation of the 

Aging Network and its Return on 

Investment [OMB #0985–New]. Many 

older adults have unmet health care and 

social service needs, which require 

coordinated care across a range of 

services, including access to nutritious 

meals, transportation, preventive health 

care, home and community-based care, 

social interaction, support for family 

caregivers, and advocacy to help 

maintain older adults’ safety, dignity, 

and legal rights. This proposed data 

collection for the Process Evaluation of 

the Aging Network and its Return on 

Investment is intended to provide 

timely information on, (1) how agencies 

in the Aging Network collaborate to 

serve older adults and family caregivers, 

and (2) how agencies measure the 

effectiveness of their efforts with the 

goal of strengthening their reach and 

impact. Through this data collection 

ACL will investigate how states differ in 

their network structure, how agencies 

work together, and potential strategies 

for evaluating return on investments 

(ROI) of ACL programs. 

The Process Evaluation of the Aging 

Network and its Return on Investment 

will include: (1) A census of agencies in 

the Aging Network, and (2) key 

informant interviews with agencies that 

are evaluating ROI. The survey seeks to 

collect data from all State Units on 

Aging (SUAs), Area Agencies on Aging 

(AAAs) (including some Aging and 

Disability Resource Centers), and Older 

Americans Act Title VI Native American 

tribal organizations. Surveying these 

organizations will help ACL understand 

how and with whom agencies in the 

network collaborate to address the 

needs of older adults and family 

caregivers, partnerships that have 

formed or expanded because of COVID– 

19, and how agencies measure the 

effectiveness and ROI of their various 

programs. The study will also include 

key informant interviews with a subset 

of 10 agencies that responded to the 

survey whose responses indicate that 

their agency is evaluating ROI. The data 

collection team will ask in-depth 

questions about the costs and benefits 

included in ROI calculations, successes 

and challenges to evaluating ROI, and 

lessons learned that could benefit other 

agencies seeking to conduct their own 

assessment of ROI. 

Comments in Response to the 60-Day 

Federal Register Notice 

A notice published in the Federal 

Register on, August 30, 2021 in 86 FR 

48428. There were no substantive public 

comments received during the 60-day 

FRN. 

Estimated Program Burden: ACL 

estimates the burden associated with 

this collection of information as follows: 

The proposed data collection 

estimates the average burden per 

response to be 0.17 hours for the Aging 

Network survey. The average burden per 

response for the key informant 

interviews estimated as 1 hour. 

Data collection activity 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Total 

number of 

responses 

Average burden 

per response 

(in hours) 

Annual 

estimated 

burden hours 

Aging Network survey ...................................................... 864 1 ..................... 864 0.25 .................. 216 

Key informant interview guide .......................................... 10 1 ..................... 10 1 ....................... 10 

Total ........................................................................... 874 Varies ............. 874 0.26 (weighted 

mean).

226 

Dated: February 3, 2022. 

Alison Barkoff, 

Principal Deputy Administrator. 

[FR Doc. 2022–02578 Filed 2–7–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1051] 

Clinical Pharmacology Considerations 

for Antibody-Drug Conjugates; Draft 

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 draft 

guidance for industry entitled ‘‘Clinical 

Pharmacology Considerations for 

Antibody-Drug Conjugates,’’ which 

provides recommendations for the 

development of antibody-drug 

conjugates (ADCs). Specifically, this 

guidance addresses the FDA’s current 

thinking regarding clinical 

pharmacology considerations and 

recommendations for ADC development 

programs, including bioanalytical 

methods, dose selection and adjustment, 

dose- and exposure-response analysis, 

intrinsic factors, QTc assessments, 

immunogenicity, and drug-drug 

interactions (DDIs). Currently, there are 


khammond on DSKJM1Z7X2PROD with NOTICES