310 Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices 

ANNUAL BURDEN FOR RECORD KEEPERS—Continued 

Information collection title 

Annual 

number of 

record 

keepers 

Annual 

number of 

responses 

per record 

keeper 

Average 

burden 

hours per 

response 

Annual 

total burden 

hours 

Sponsor Verification Application (Form SVP–3/3s)—Cases requiring a Financial Care Plan ......................................................................................... 216 87 1.00 

Sponsor Verification Application (Form SVP–3/3s)—Applicants choosing to 

submit to an ORR-paid DNA test ................................................................. 216 78 1.00 

Sponsor Care Agreement (SVP–4/4s) All UAC check-in ................................ 216 265 0.75 42,930 

Sponsor Care Agreement (SVP–4/4s) All UAC check-in ................................ 11 5,200 3.00 171,600 

Fingerprinting Instructions (SVP–7/7s) ............................................................ 216 177 1.00 38,232 

Letter of Designation for Care of a Minor (Form SVP–9/9s) .......................... 216 79 0.50 8,532 

Estimated Annual Burden Hours Total ..................................................... ........................ ........................ ........................ 714,246 

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: 6 U.S.C. 279; 8 U.S.C. 1232; 

Flores v. Reno Settlement Agreement, No. 

CV85–4544–RJK (C.D. Cal. 1996). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–29117 Filed 1–4–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Submission for OMB 

Review; Public Comment Request; 

Information Collection Request for the 

State Grants for Assistive Technology 

Program Annual Progress Report; 

OMB #0985–0042 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living is announcing that 

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 

reinstatement with change for the 

information collection requirements 

related to State Grants for Assistive 

Technology Program Annual Progress 

Report [OMB #0985–0042]. 

DATES: Submit written comments on the 

collection of information by February 4, 

2021. 

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: 

Robert Groenendaal, Assistive 

Technology Program Manager, Center 

for Innovation and Partnership in the 

Office of Interagency Innovation 

Administration for Community Living; 

Email: Robert.Groenendaal@acl.hhs.gov; 

Phone: 202–795–7356. 

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 for 

a reinstatement with change for the 

information collection associated with 

the State Grants for Assistive 

Technology Program Annual Progress 

Report (AT APR) 0985–0042. 

The information collected through 

this data collection instrument is 

necessary for ACL and states to comply 

with Sections 4 and 7 of the Assistive 

Technology Act of 1998, as amended 

(AT Act). ACL is requesting a 

reinstatement with change of a 

previously approved information 

collection under OMB No. 0985–0042. 

Section 4 of the AT Act authorizes 

grants to public agencies in the 50 states 

and the District of Columbia, Puerto 

Rico, the Virgin Islands, Guam, 

American Samoa, and the 

Commonwealth of the Northern 

Marianas (states and outlying areas). 

With these funds, the 56 states and 

outlying areas operate ‘‘Statewide AT 

Programs’’ that conduct activities to 

increase access to and acquisition of 

assistive technology (AT) for 

individuals with disabilities and older 

Americans. Divided into two 

comprehensive activity categories: 

‘‘State-level Activities’’ and ‘‘State 

Leadership Activities.’’ According to 

Section 4 of the AT Act, as a condition 

of receiving a grant to support their 

Statewide AT Programs, the 56 states 

and outlying areas must provide to ACL: 

(1) Applications and (2) annual progress 

reports on their activities. 

Applications: The application 

required of states and outlying areas is 

a three-year State Plan for Assistive 

Technology (State Plan for AT or State 

Plan) (OMB No. 0985–0048). The 

content of the State Plan for AT is based 

on the requirements in Section 4(d) of 

the AT Act. As a part of this State Plan, 

Section 4(d)(3) of the AT Act requires 

that states and outlying areas set 

measurable goals for addressing the 

assistive technology needs of 

individuals with disabilities in 

education, employment, community 

living and information technology/ 

telecommunications. 

Every state and outlying area is 

required to include a minimum of seven 

prescribed measurable goals in its State 

Plan. These seven goals apply to all 


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Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices 311 

states and outlying areas in order to 

aggregate information on performance of 

the program at the national level. 

National aggregation of data related to 

these goals is necessary for the 

Government Performance and Results 

Modernization Act of 2010 (GPRAMA) 

(Pub. L. 111–352), as well as an Annual 

Report to Congress (see ‘‘Section 7 

Requirements Necessitating Collection’’ 

below). 

Therefore, this data collection 

instrument provides a way for all 56 

grantees—50 U.S. states, DC, Puerto 

Rico, the U.S. Virgin Islands, Guam, 

American Samoa, and the 

Commonwealth of the Northern Mariana 

Islands to collect and report data on 

their performance in a consistent 

manner, including a uniform survey to 

be given to consumers. This uniform 

survey is included as part of the data 

collection package. 

Annual Reports: In addition to 

submitting a State Plan every three 

years, states and outlying areas are 

required to submit annual progress 

reports on their activities. The data 

required in that progress report is 

specified in Section 4(f) of the AT Act. 

Section 7(d) of the AT Act requires 

that ACL submit to Congress an annual 

report on the activities conducted under 

the Act and an analysis of the progress 

of the states and outlying areas in 

meeting their measurable goals. 

This report must include a 

compilation and summary of the data 

collected under Section 4(f). In order to 

make this possible, states and outlying 

areas must provide their data uniformly. 

This data collection instrument was 

developed to ensure that all 56 states 

and outlying areas report data in a 

consistent manner in alignment with the 

requirements of Section 4(f). 

As stated above, ACL will use the 

information collected via this 

instrument to: 

(1) Complete the annual report to 

Congress required by the AT Act; 

(2) Comply with reporting 

requirements under the Government 

Performance and Results Modernization 

Act of 2010 (GPRAMA) (Pub. L. 111– 

352); and 

(3) Assess the progress of states and 

outlying areas regarding measurable 

goals in their State Plans for AT. 

Data collected from the grantees will 

provide a national description of 

activities funded under the AT Act to 

increase the access to and acquisition of 

AT devices and services through 

statewide AT programs for individuals 

with disabilities. Data collected from 

grantees will also provide information 

for usage by Congress, the Department, 

and the public. In addition, ACL will 

use this data to inform program 

management, monitoring, and technical 

assistance efforts. While States will be 

able to use the data for internal 

management and program improvement. 

Comments in Response to the 60-Day 

Federal Register Notice 

A notice published in the Federal 

Register on September 28, 2020 in 85 

FR 60803. There were 32 public 

comments received during the 60-day 

FRN comment period. 

Proposed change in State Financing 

Activities: Financial Loan—partnership 

loans reported with no guarantee or 

interest buy-down have narrative 

description added to document subsidy/ 

investment. 

Comment Summary: Two State AT 

Act Program grantees commented in 

support. One organization representing 

the State AT Act Programs requested 

clarification. 

ACL Response: Sentence identified as 

confusing has been deleted in the AT 

APR—IC document. 

Proposed change in Reuse: 

Exchange—option for automatic 

exclusion of exchange recipients from 

performance measure data collection 

eliminated. 

Comment Summary: Two AT grantees 

commented in support. One AT 

organization requested clarification. 

ACL Response: Clarification text has 

been added into the AT APR—IC 

document. 

Proposed change in Device Loan— 

separate type of borrower and type of 

device data reporting tables by purposed 

of loan. 

Comment Summary: Three AT 

grantees commented in support. One 

requested clarification of timeline for 

implementation. 

ACL Response: No changes made. 

ACL will clarify the timeline for 

implementation to begin with federal 

fiscal year 2022, with first data 

collection October 1, 2021 to provide 

time for data system revision. 

Proposed change in Device 

Demonstration—separate decisionmaking participant from other 

participants reported in participant type 

table. 

Comment Summary: Three AT 

grantees commented in support. One 

grantee and one organization 

commented in opposition with one 

saying this is duplicative data reporting 

and one saying it is understood that an 

individual with a disability is the 

decision-maker unless unable to be and 

then it is the caregiver/provider role. 

One grantee requested clarification of 

the timeline for implementation. 

ACL Response: The proposed change 

is designed to support data fidelity by 

ensuring the decision-maker is 

identified by type within what can be a 

larger number of participants reported 

for each demonstration event. Currently 

all participants are reported by type. As 

a result, this change does not duplicate 

or increase data reporting burden. It 

only separates the decision-maker 

participant type reported from the type 

or types reported for all other 

participants. No change is made. ACL 

will clarify the timeline for 

implementation to begin with federal 

fiscal year 2022, with first data 

collection October 1, 2021 to provide 

time for data system revision. 

Updated Outcome Measures—Overall 

acquisition and access performance 

measure tables and consumer 

satisfaction tables updated to align with 

outcome/output data and targets used 

by ACL for program evaluation and 

budget justification since FY18. 

Comment Summary: One AT 

organization requested clarification. 

ACL Response: Clarification has been 

added to the AT APR—IC document. 

Proposed new data elements in Public 

Awareness and Information & 

Assistance—New question added for 

description of partnerships as part of 

public awareness, new data table added 

to report how individuals learned about 

the AT Program, new information 

request in Notes for description of 

partnerships that increase referrals. 

Comment Summary: Five AT grantees 

and one AT organization commented in 

opposition to these changes and the new 

data element. All commenters expressed 

concern about lack of clarity and 

significant new data burden (both for 

AT Programs and consumers) associated 

with the proposed new data collection 

requirements. 

Commenters suggested these new data 

elements be removed and requested 

ACL work with AT Act grantees to 

determine the most efficient and 

effective way to report referral source 

data in a future information collection. 

ACL Response: ACL is appreciative of 

the participation of AT stakeholders in 

the Federal Register Notice comment 

process and values the submission of 

comments on the proposed updates to 

the Public Awareness and Information 

and Assistance sections of the AT APR 

data collection instrument. Once 

approved, ACL intends to address and 

work through these changes with AT 

stakeholders to identify the most 

efficient and effective way to collect 

referral source data in the Information 

Collection. 

State Improvement Outcomes—new 

optional section added to collect data on 


jbell on DSKJLSW7X2PROD with NOTICES
312 Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices 

coordination and collaboration with two 

new required narratives and associated 

drop-down menu data. 

Comment Summary: Two AT grantees 

commented in support. 

ACL Response: No changes made. 

Leveraged Funding—eliminated 

Section B and folded data into Section 

A to simplify. 

Comment Summary: Two AT grantees 

commented in support. 

ACL Response: No changes made. 

Instruction Manual—deleted 

redundant text and updated AT 

Taxonomy. 

Comment Summary: Two AT grantees 

commented in support. 

ACL Response: No changes made. 

Estimated Program Burden 

ACL estimates the burden associated 

with this collection of information as 

follows: 

(A) A web-based system that collects 

data from states. 

(B) A performance measurement 

survey that states collect from 

individuals 

(C) A customer satisfaction survey 

that states collect from individuals. 

(A) Fifty-six grantees report to ACL 

using the web-based data collection 

system. A workgroup of grantees 

estimated that the average amount of 

time required to complete all responses 

to the data collection instrument is 80 

hours annually. The estimated response 

burden includes time to review the 

instructions, gather existing data, and 

complete and review the data entries. 

These estimates are based on the 

experience of staff who implement these 

programs at the state level. In addition, 

we project that clean-up and 

clarification of data elements will 

require no change in data burden 

estimates. 

(B) The fifty-six grantees ask 

consumers to complete surveys that 

provide information on their 

performance related to the state’s 

measurable goals. Historical data from 

states indicates that the average state 

will ask for this information from 3,242 

consumers at 1 minute per consumer to 

complete the question survey, for a total 

of 54 hours annually. 

(C) The fifty-six grantees also ask 

consumers to complete customer 

satisfaction surveys. Historical data 

from states indicated that the average 

state asks for this information from 

3,242 consumers at 1 minute per 

consumer, for a total of 54 hours 

annually. 

Number of 

responses 

Hours per 

response 

Annual 

burden per 

grantee 

Total annual 

burden hours 

Work-Based System ........................................................................................ 56 1.428 80 4,480 

Performance Measurement ............................................................................. 3,242 0.01666 54 3.024 

Customer Satisfaction ...................................................................................... 3,242 0.01666 54 3,024 

Subtotal ..................................................................................................... ........................ ........................ 188 10,528 

Program Support ............................................................................................. 56 4 208 11,648 

Record Keeping Burden .................................................................................. 56 0.14286 8 448 

Subtotal ..................................................................................................... ........................ ........................ 216 12,096 

Total ................................................................................................... ........................ ........................ 404 22,624 

Dated: December 29, 2020. 

Lance Robertson, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2020–29150 Filed 1–4–21; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–2105] 

Mouse Embryo Assay for Assisted 

Reproduction Technology Devices; 

Guidance for Industry and Food and 

Drug Administration Staff; 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 final 

guidance entitled ‘‘Mouse Embryo 

Assay for Assisted Reproduction 

Technology Devices.’’ This guidance 

document provides recommendations 

on conducting the mouse embryo assay 

to support premarket submissions and 

lot release of assisted reproduction 

technology devices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 5, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 


jbell on DSKJLSW7X2PROD with NOTICES