12352 Federal Register / Vol. 89, No. 33 / Friday, February 16, 2024 / Notices 

1https://www.whitehouse.gov/briefing-room/ 

presidential-actions/2021/01/20/executive-orderadvancing-racial-equity-and-support-forunderserved-communities-through-the-federalgovernment/. 

2Assistant Secretary for Planning and Evaluation. 

(2021, December). Methods and Emerging Strategies 

to Engage People with Lived Experience. (Contract 

Number HHSP233201500071I). U.S. Department of 

Health and Human Services. https://aspe.hhs.gov/ 

sites/default/files/documents/47f62cae96710d1fa1

3b0f590f2d1b03/lived-experience-brief.pdf. 

3https://www.whitehouse.gov/briefing-room/ 

presidential-actions/2023/02/16/executive-orderon-further-advancing-racial-equity-and-support-forunderserved-communities-through-the-federalgovernment/. 

4https://www.whitehouse.gov/briefing-room/ 

presidential-actions/2021/01/27/memorandum-onrestoring-trust-in-government-through-scientificintegrity-and-evidence-based-policymaking/. 

5https://www.hhs.gov/about/strategic-plan/2022- 

2026/index.html. 

6https://www.acf.hhs.gov/about/acf-strategicplan-2022. 

7https://www.acf.hhs.gov/opre/report/acfevaluation-policy. 

Instrument Respondent 

Number of 

respondents 

(total over request period) 

Number of 

responses per 

respondent 

(total over request period) 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Annual burden 

(in hours) 

1: Applicant Characteristics ................. Program applicants ............................. 150,000 1 0.25 37,500 12,500 

Program staff ...................................... 330 455 0.10 15,015 5,005 

2: Program Operations ........................ Program staff ...................................... 110 12 0.32 422 141 

3: Service Delivery Data ...................... Program staff ...................................... 1,650 86 0.50 70,950 23,650 

4: Entrance and Exit Surveys .............. Program clients (entrance) ................. 141,498 1 0.42 59,429 19,810 

Program clients (exit) .......................... 94,734 1 0.42 39,788 13,263 

Program staff (entrance and exit on 

paper).

220 351 0.10 7,722 2,574 

5: Semi-annual Performance Progress 

Report (PPR).

Program staff ...................................... 110 6 3 1,980 660 

6: Quarterly Performance Report 

(QPR).

Program staff ...................................... 110 6 1 660 220 

7: CQI Plan .......................................... Program staff ...................................... 110 3 4 1,320 440 

Estimated Total Annual Burden 

Hours: 78,263. 

Authority: Sec. 403. [42 U.S.C. 603]. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–03282 Filed 2–15–24; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Administration for 

Children and Families Generic for 

Engagement Efforts (New Umbrella 

Generic) 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families (ACF) at the U.S. 

Department of Health and Human 

Services (HHS) intends to request 

approval from the Office of Management 

and Budget (OMB) to establish a new 

umbrella generic clearance to request 

information while engaging individuals 

and groups who could provide valuable 

information to inform ACF programs 

and work, including but not limited to 

those who are served or have been 

served by ACF, those with expertise in 

ACF program areas, and individuals 

invested in the outcomes of ACF 

research and evaluation. These 

engagement activities often need to be 

conducted quickly, to allow for 

sufficient time to inform project 

direction and decision-making. 

Additionally, planning for engagement 

activities is most often on a quick 

timeline and the standard timeline to 

comply with a full request under the 

Paperwork Reduction Act (PRA) often 

inhibits the ability to collect 

information to inform these activities. 

Therefore, an umbrella generic is 

necessary to allow for quick turnaround 

requests for similar information 

collections related to these activities. 

DATES: Comments due within 30 days of 

publication. OMB must decide about the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review-Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing 

OPREinfocollection@acf.hhs.gov. 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The Executive Order 

(E.O.), Advancing Racial Equity and 

Support for Underserved Communities 

Through the Federal Government (E.O. 

13985) 1 emphasizes consulting with 

communities that have been historically 

underserved by Federal policies and 

programs and those with lived 

experience 2 in ACF programs. The E.O. 

on Further Advancing Racial Equity and 

Support for Underserved Communities 

Through the Federal Government 3

followed in 2023 and built on E.O. 

13985, calling upon agencies to increase 

engagement with underserved 

communities and to ‘‘collaborate with 

OMB, as appropriate, to identify and 

develop tools and methods’’ to meet this 

goal. This generic mechanism is a tool 

that could directly address these E.O.s. 

Particularly many requirements 

outlined in section 3 and section 5 of 

the 2023 E.O. 

Additionally, the Presidential 

Memorandum on Restoring Trust in 

Government through Scientific Integrity 

and Evidence-Based Policy Making,4 the 

HHS Strategic Plan fiscal year (FY) 

2022–2026,5 ACF’s Strategic Plan,6 and 

the ACF Evaluation Policy 7 discuss 

community engagement and inclusion 

in research. Consistent with these 

guidance documents, and to ensure 

meaningful involvement with a variety 

of individuals with diverse experiences 

and perspectives, ACF often conducts 

active engagement activities to inform 

various efforts, including research and 

evaluation. 

Hearing the perspective of those 

affected by, experienced in, interested 

in, or potentially interested in ACF 

programs and similar programs is vital 

to ensure ACF is responsive to the needs 

of those it serves and that resources are, 

and programming is appropriate, useful, 

and relevant for audiences. Information 

collections under this generic would 

gather information from individuals 


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Federal Register / Vol. 89, No. 33 / Friday, February 16, 2024 / Notices 12353 

with diverse experiences and 

perspectives to inform ACF policies and 

programs. The information collected 

would allow for ongoing, two-way 

collaborative and actionable 

communications between ACF and its 

State, local and/or Tribal partners, 

program participants, communities 

served or affected by ACF programs, and 

or others experienced with or interested 

in ACF programs or similar programs. 

ACF envisions using information 

collected to inform a variety of efforts 

and activities such as the improvement, 

planning, and implementation of 

research studies, program changes, 

development and dissemination of 

resources and products developed 

under ACF studies, regulatory activities, 

guidance, outreach and/or training 

activities. The specific types of 

information gathering methods included 

under the umbrella of this clearance 

will vary, but will use well-established 

methodologies, including but not 

limited to: 

• Semi-structured discussions or 

conference calls 

• Focus groups 

• Telephone or in-person interviews 

• Questionnaires/Surveys 

• Roundtable and/or Breakout Sessions 

• Open-ended requests 

• Contextualizing Existing Data 

Data collection will take place 

through a variety of activities—both inperson and virtual—dependent on the 

specific project. ACF will submit 

individual requests under this 

clearance. ACF requests OMB provide a 

response on individual generic 

information collections within 10 

business days. 

Respondents: Respondents could 

include current or prospective service 

providers, training and technical 

assistance providers, grant recipients, 

contractors, current and potential 

participants in ACF programs or other 

comparable groups and other 

individuals with lived experience with 

ACF or similar programs, experts in 

fields pertaining to ACF programs, other 

key groups involved in ACF projects 

and programs, individuals engaged in 

program re-design or demonstration 

development for evaluation, State or 

local government officials, those in 

broader fields of study related to human 

services, or others involved in or 

prospectively involved in ACF 

programs. 

Burden Estimates: The burden table 

below is illustrative. Estimates for the 

number of respondents and time per 

response have been made based on 

discussion with ACF program offices, 

but as this is a new umbrella generic, it 

may be possible that we will need to 

adjust estimates throughout the threeyear approval period. If needed, ACF 

will submit a change request for these 

updates. While we will not exceed the 

total burden cap for this generic without 

requesting a change for updates, we may 

use more or less burden within each 

instrument type. 

Example types of information collections 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Semi-Structured Discussions and Focus Groups .......................................................... 10,000 1 2 20,000 

Interviews ....................................................................................................................... 4,500 1 1 4,500 

Questionnaires/Surveys ................................................................................................. 8,000 1.5 .5 6,000 

Templates and Open-ended requests ........................................................................... 1,000 1 10 10,000 

Estimated Totals ..................................................................................................... 23,500 ........................ .................... 40,500 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–03228 Filed 2–15–24; 8:45 am] 

BILLING CODE 4184–88–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–5259] 

Master Protocols for Drug and 

Biological Product Development; Draft 

Guidance for Industry; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability that published in 

the Federal Register of December 22, 

2023. In that notice, FDA requested 

comments on the draft guidance for 

industry entitled, ‘‘Master Protocols for 

Drug and Biological Product 

Development.’’ The Agency is taking 

this action in response to requests for an 

extension to allow interested persons 

additional time to submit comments. 

DATES: FDA is extending the comment 

period on the draft guidance published 

December 22, 2023 (88 FR 88623). 

Submit either electronic or written 

comments by March 21, 2024, to ensure 

that the Agency considers your 

comments 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 


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