Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 20871 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Older Americans 

Act, Title VI Grant Application 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) is announcing 

an opportunity for the public to 

comment on the proposed collection of 

information listed above. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish a notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a proposed extension without change 

information collection and solicits 

comments on the information collection 

requirements related to the Application 

for Older Americans Act, Title VI Parts 

A/B and C Grants. 

DATES: Comments on the collection of 

information must be submitted 

electronically by 11:59 p.m. (EST) or 

postmarked by June 7, 2022. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: Jasmine Aplin. Submit 

written comments on the collection of 

information to the Administration for 

Community Living, Washington, DC 

20201, Attention: Jasmine Aplin. 

FOR FURTHER INFORMATION CONTACT: 

Jasmine Aplin, Administration for 

Community Living, Washington, DC 

20201, jasmine.aplin@acl.hhs.gov or 

202–795–7453. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act, Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. A 

Collection of information 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. 

ACL is responsible for administering 

the Title VI A/B (Nutrition and 

Supportive Service) and C (Caregiver) 

grants. The purpose of this data 

collection is to improve and standardize 

the format of the application. The 

instrument will collect data as 

prescribed by the Older Americans Act 

Section 612(a), 614(a) and 45 CFR 

1326.19 related to the eligibility of 

Federally-recognized Tribes and Native 

Hawaiian organizations for grant funds 

under this program and their capacity to 

deliver services to elders. 

The Application for Older Americans 

Act, Title VI A/B and C Grants collects 

information on the ability of federallyrecognized American Indian, Alaskan 

Native and Native Hawaiian 

organizations to provide nutrition, 

supportive, and caregiver services to 

elders within their service area. 

Applicants are required to provide a 

description of their organization’s 

service area, the number of eligible 

elders in their service area, and their 

ability to deliver services and sign 

assurances that the organization will 

comply with all applicable laws and 

regulations. 

This is an extension of a currently 

approved information collection. The 

proposed data collection materials have 

been updated to better align with the 

requirements of the Older Americans 

Act and Federal regulations, as well as 

to improve data quality and grantee 

accountability. Furthermore, this 

grantee application will better line up 

with the Title VI Program Performance 

Report under 0985–0059. This data 

collection will also support ACL in 

tracking performance outcomes and 

efficiency measures with respect to the 

annual and long-term performance 

targets established in compliance with 

the Government Performance Results 

Modernization Act (GPRMA). 

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 

Title VI funding is broken into three 

categories. Parts A and B are for 

nutritional and supportive 

programming, with Part A being 

restricted to American Indian and 

Alaska Native grantees, and Part B 

restricted to Native Hawaiian grantees. 

Part C is for caregiver programming. All 

Part C grantees must have Part A/B 

funding, but not all Part A/B grantees 

will have Part C programs. Therefore, 

there are likely to be 295 unique 

respondents, but only 250 will have to 

complete all three portions of the 

application. This application covers all 

three parts of Title VI. 

ACL estimates the burden associated 

with this collection of information as 

follows: 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

burden hours 

Title VI Application Part A/B ............................................................................ 295 1 2.75 270.4 

Title VI Application Part C ............................................................................... 250 1 1.5 125 

Total .......................................................................................................... ........................ ........................ 4.25 395.4 

The number of burden hours 

associated with the Title VI, Part C, data 

collection was calculated as 811.25. 

However, since this instrument is used 

only once every three years results in an 

annualized number of 270.4 hours. 


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20872 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 

Similarly, the total hours associated 

with the Title VI, Part C, application is 

375. 

Dated: April 4, 2022. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2022–07507 Filed 4–7–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1268] 

Use of Whole Slide Imaging in 

Nonclinical Toxicology Studies: 

Questions and Answers; 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 ‘‘Use of 

Whole Slide Imaging in Nonclinical 

Toxicology Studies: Questions and 

Answers.’’ When final, this guidance 

will represent FDA’s current thinking 

on the use of whole slide images during 

good laboratory practice (GLP)- 

compliant toxicology studies using nonhuman specimens. When whole slide 

images are used as part of a nonclinical 

study conducted in compliance with the 

GLP regulations, adequate 

documentation is critical. 

Documentation practices during 

generation, use, and retention of whole 

slide images have not been clearly 

defined and vary among nonclinical 

testing facilities. This question-andanswer document is intended to clarify 

FDA’s recommendations concerning the 

management, documentation, and use of 

whole slide images in histopathology 

assessment and/or pathology peer 

review for nonclinical studies 

conducted in compliance with the GLP 

regulations. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 7, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–D–1268 for ‘‘Use of Whole Slide 

Imaging in Nonclinical Toxicology 

Studies: Questions and Answers.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002 or to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Tahseen Mirza, Office of Study Integrity 

and Surveillance, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2211, 

Silver Spring, MD 20993, 301–796– 

7645; Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993, 240– 

402–7911; Judy Davis, Office of Device 

Evaluation, Center for Devices and 


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