Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices 11835 

Closed captioning will be provided 

during the meeting. If another 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Diversity Management 

on (301) 827–4840, no later than 

Thursday, February 29, 2024. The 

agenda, roster, and minutes will be 

available from Jenny Griffith, Committee 

Management Officer, Agency for 

Healthcare Research and Quality, 5600 

Fishers Lane, Rockville, Maryland 

20857. Jenny Griffith’s phone number is 

(240) 446–6799. 

SUPPLEMENTARY INFORMATION: 

I. Purpose 

In accordance with the Federal 

Advisory Committee Act, this notice 

announces a meeting of the National 

Advisory Council for Healthcare 

Research and Quality (the Council). 5 

U.S.C. 1009. The Council is authorized 

by section 941 of the Public Health 

Service Act, 42 U.S.C. 299c. In 

accordance with its statutory mandate, 

the Council is to advise the Secretary of 

the Department of Health and Human 

Services and the Director of AHRQ on 

matters related to AHRQ’s conduct of its 

mission including providing guidance 

on (A) priorities for health care research, 

(B) the field of health care research 

including training needs and 

information dissemination on health 

care quality and (C) the role of the 

Agency in light of private sector activity 

and opportunities for public private 

partnerships. The Council is composed 

of members of the public, appointed by 

the Secretary, and Federal ex-officio 

members specified in the authorizing 

legislation. 

II. Agenda 

On Thursday, March 14, 2024, NAC 

members will meet to conduct 

preparatory work prior to convening the 

Council meeting at 11:15 a.m., with the 

call to order by the Council Chair, an 

introduction of NAC members, and 

approval of previous Council summary 

notes. The NAC members will then 

receive an update from the AHRQ 

Director. The agenda will also include 

updates on the Subcommittee of the 

National Advisory Council (SNAC) for 

AHRQ’s Patient-Centered Outcomes 

Research Trust Fund (PCORTF) 

Investments, the 20th Anniversary of 

Digital Healthcare, an update on the 

National Action Alliance to Advance 

Patient and Workforce Safety, and a 

discussion on diagnostic safety. The 

meeting is open to the public and will 

adjourn at 4 p.m. For information 

regarding how to access the meeting as 

well as other meeting details, including 

information on how to make a public 

comment, please go to https://www.

ahrq.gov/news/events/nac/. The final 

agenda will be available on the AHRQ 

website no later than Thursday, March 

7, 2024. 

Dated: February 12, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–03155 Filed 2–14–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Community-Based 

Child Abuse Prevention Program 

(Office of Management and Budget #: 

0970–0155) 

AGENCY: Children’s Bureau, 

Administration on Children, Youth and 

Families, Administration for Children 

and Families, Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Children’s Bureau, 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS), is 

requesting a three-year extension of the 

Program Instruction (PI) for the 

Community-Based Child Abuse 

Prevention (CBCAP) program (Office of 

Management and Budget (OMB) #: 

0970–0155, expiration June 30, 2024), 

which outlines information collection 

requirements pursuant to receiving a 

grant award. There are no changes 

requested to the information collection 

process. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

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. 

SUPPLEMENTARY INFORMATION: 

Description: The PI, prepared in 

response to the enactment of the CBCAP 

program, as set forth in Title II of the 

Child Abuse Prevention and Treatment 

Reauthorization Act of 2010 (Pub. L. 

111–320) or CAPTA, provides direction 

to the states and territories to 

accomplish the purposes of (1) 

supporting community-based efforts to 

develop, operate, expand, and where 

appropriate to network, initiatives 

aimed at the prevention of child abuse 

and neglect, and to support networks of 

coordinated resources and activities to 

better strengthen and support families to 

reduce the likelihood of child abuse and 

neglect and (2) fostering an 

understanding, appreciation, and 

knowledge of diverse populations in 

order to be effective in preventing and 

treating child abuse and neglect. This PI 

contains information collection 

requirements that are found in CAPTA 

and pursuant to receiving a grant award. 

The information submitted will be used 

by the agency to ensure compliance 

with the statute, complete the 

calculation of the grant award 

entitlement, and provide training and 

technical assistance to the grantee. 

Respondents: State governments, 

quasi-public entities, and non-profit 

private agencies. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Application ....................................................................................................... 52 1 40 2,080

Annual Report .................................................................................................. 52 1 24 1,248 

Totals ........................................................................................................ ........................ ........................ ........................ 3,328 


khammond on DSKJM1Z7X2PROD with NOTICES
11836 Federal Register / Vol. 89, No. 32 / Thursday, February 15, 2024 / Notices 

Authority: The CAPTA 

Reauthorization Act of 2010; Title II of 

the CAPTA, Pub. L. 115–271 (42 U.S.C. 

5116 et seq.). 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–03107 Filed 2–14–24; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0447] 

Charging for Investigational Drugs 

Under an Investigational New Drug 

Application: Questions and Answers; 

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 final 

guidance for industry entitled ‘‘Charging 

for Investigational Drugs Under an IND: 

Questions and Answers.’’ This guidance 

addresses frequently asked questions 

related to the implementation of FDA’s 

regulation on charging for 

investigational drugs under an 

investigational new drug application 

(IND) for the purpose of either clinical 

trials or expanded access for treatment 

use. This guidance finalizes the revised 

draft guidance of the same title issued 

on August 23, 2022, and replaces the 

final guidance issued on June 3, 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on February 15, 2024. 

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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–D–0447 for ‘‘Charging for 

Investigational Drugs Under an IND: 

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 this 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 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 240–402–8926, 

Dat.Doan@fda.hhs.gov; or James Myers, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Charging for Investigational Drugs 

Under an IND: Questions and Answers.’’ 

FDA’s regulation on charging for 

investigational drugs under an IND (21 

CFR 312.8) for the purpose of either 

clinical trials or expanded access for 

treatment use allows sponsors to charge 

for investigational drugs under certain 

circumstances. 

FDA issued a final guidance on June 

3, 2016 entitled ‘‘Charging for 


khammond on DSKJM1Z7X2PROD with NOTICES