Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Notices 82905 

10See https://www.whitehouse.gov/wp-content/ 

uploads/2022/04/eo13985-vision-for-equitabledata.pdf. 

and earnings, and education data? For 

example, what is the earliest turnaround 

time for reliably reporting that a TANF 

case has closed? What are the timelines 

involved in matching and working with 

employment and earnings data and 

education data? 

4.6 What factors (e.g., demographic, 

economic, policy, programmatic) should 

be considered for presenting the work 

outcomes measures in context? Are 

there variables such as state economic 

conditions that may impact state 

outcomes and are outside a state TANF 

program’s control? 

4.7 In what ways should equity be 

considered when implementing work 

outcome measures? What are the 

advantages of and/or possible 

difficulties associated with reporting 

data disaggregated by race, ethnicity, 

gender, age, disability, other 

demographic characteristics, or 

geography to enable equity analyses 

around work outcomes? 10

4.8 What technical assistance or 

supports would be helpful for collecting 

data for work outcomes? What obstacles 

do you foresee and how can ACF and 

its partners provide assistance to 

overcome or manage those barriers? 

4.9 Please describe the 

characteristics of successful 

partnerships between the public 

workforce system and the TANF system 

that support the collection of data for 

the work outcomes measures required 

by the FRA? 

4.10 Please describe the specific 

steps for a state to begin collecting and 

reporting data and their estimated 

duration. For example, please estimate 

the timeframe for system changes to 

generate a list of SSNs of work-eligible 

individuals who left TANF in a given 

quarter. 

4.11 Are there any other questions 

or issues related to the work outcomes 

measures for which you wish to provide 

comments? 

4.12 HHS has determined that tribes 

are NOT required to report work 

outcomes measures as laid out in the 

Fiscal Responsibility Act. However, 

OFA is committed to supporting Tribal 

TANF programs that wish to voluntarily 

measure work outcomes for their 

caseloads. As we explore this 

possibility, what factors do we need to 

better understand? What training or 

technical assistance could support 

Tribal TANF programs interested in 

measuring work outcomes? 

Authority: Fiscal Responsibility Act of 

2023. 

Ann Flagg, 

Director, Office of Family Assistance. 

[FR Doc. 2023–26100 Filed 11–22–23; 11:15 am] 

BILLING CODE 4184–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–1554] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Qualitative 

Feedback on Agency Service Delivery 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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: Submit written comments 

(including recommendations) on the 

collection of information by December 

27, 2023. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0697. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Qualitative Feedback on Agency 

Service Delivery 

OMB Control Number 0910–0697— 

Extension 

FDA will garner qualitative customer 

and stakeholder feedback using a variety 

of methods in order to gain useful 

insights into customer or stakeholder 

perceptions, experiences, and 

expectations; provide an early warning 

of issues with service; or focus attention 

on areas where communication, 

training, or changes in operations might 

improve delivery of products or 

services. These collections will allow 

for ongoing, collaborative, and 

actionable communications between the 

Agency and its customers and 

stakeholders. It will also allow feedback 

to contribute directly to the 

improvement of program management. 

Feedback collected under this generic 

clearance will provide useful 

information, but it will not yield data 

that can be generalized to the overall 

population. This type of generic 

clearance for qualitative information 

will not be used for quantitative 

information collections that are 

designed to yield reliably actionable 

results, such as monitoring trends over 

time or documenting program 

performance. 

Respondents to this collection of 

information cover a broad range of 

customers and stakeholders who have 

specific characteristics related to certain 

products or services regulated by FDA. 

These stakeholders include members of 

the general public, healthcare 

professionals, industry, and others who 

have experience with a product under 

FDA’s jurisdiction. 

In the Federal Register of May 25, 

2023 (88 FR 33889), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

but it was outside the scope of the PRA. 

FDA estimates the burden of this 

collection of information as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES
82906 Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Focus groups ........................................................... 3,000 1 3,000 1.75 ........................... 5,250 

Customer comment cards/forms .............................. 1,500 1 1,500 0.25 (15 minutes) ...... 375 

Small discussion groups .......................................... 800 1 800 1.75 ........................... 1,400 

Customer satisfaction surveys ................................. 20,000 1 20,000 0.33 (20 minutes) ...... 6,600 

Usability studies ....................................................... 1,100 1 1,100 1 ................................ 1,100 

Total .................................................................. ........................ ........................ ........................ .................................... 14,725 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we increased the 

number of respondents for focus groups, 

customer comment cards/forms, 

customer satisfaction surveys, and 

usability studies. This adjustment 

results in an overall burden increase of 

6,234 hours. 

Dated: November 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26043 Filed 11–24–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2894] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Good Laboratory 

Practice Requirements for Nonclinical 

Laboratory Studies 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

Agency) 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: Submit written comments 

(including recommendations) on the 

collection of information by December 

27, 2023. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0119. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Good Laboratory Practice 

Requirements for Nonclinical 

Laboratory Studies—21 CFR Part 58 

OMB Control Number 0910–0119— 

Extension 

Sections 409, 505, 512, and 515 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 348, 355, 360b, and 360e) and 

related statutes require manufacturers of 

food additives, human drugs and 

biological products, animal drugs, and 

medical devices to demonstrate the 

safety and utility of their product by 

submitting applications to FDA for 

research or marketing permits. Such 

applications contain, among other 

important items, full reports of all 

studies done to demonstrate product 

safety in man and/or other animals. In 

order to ensure adequate quality control 

for these studies and to provide an 

adequate degree of consumer protection, 

the Agency issued good laboratory 

practice (GLP) regulations for 

nonclinical laboratory studies in part 58 

(21 CFR part 58). The regulations 

specify minimum standards for the 

proper conduct of safety testing and 

contain sections on facilities, personnel, 

equipment, standard operating 

procedures (SOPs), test and control 

articles, quality assurance, protocol and 

conduct of a safety study, records and 

reports, and laboratory disqualification, 

and include information collection 

provisions. 

Part 58 requires testing facilities 

engaged in conducting toxicological 

studies to retain, and make available to 

regulatory officials, records regarding 

compliance with GLPs. Records are 

maintained on file at each testing 

facility and examined there periodically 

by FDA inspectors. The GLP regulations 

require that, for each nonclinical 

laboratory study, a final report be 

prepared that documents the results of 

quality assurance unit inspections, test 

and control article characterization, 

testing of mixtures of test and control 

articles with carriers, and an overall 

interpretation of nonclinical laboratory 

studies. The GLP regulations also 

require written records pertaining to: (1) 

personnel job descriptions and 

summaries of training and experience; 

(2) master schedules, protocols and 

amendments thereto, inspection reports, 

and SOPs; (3) equipment inspection, 

maintenance, calibration, and testing 

records; (4) documentation of feed and 

water analyses and animal treatments; 

(5) test article accountability records; 

and (6) study documentation and raw 

data. 

Description of Respondents: 

Respondents to the collection of 

information are sponsors of nonclinical 

laboratory studies that support or are 

intended to support applications for 

research or marketing permits for 

products regulated by FDA. 

In the Federal Register of August 8, 

2023 (88 FR 53492), we published a 60- 

day notice soliciting comment on the 

proposed collection of information. One 

comment was received underscoring the 

critical nature of language translations 

in information exchange between 

international communities but did not 

suggest any modifications to our burden 

estimates. 

We estimate the burden of this 

collection of information as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES