4306 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–01152 Filed 1–22–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Generic Clearance for 

Financial Reports Used for ACF 

Mandatory Grant Programs (Office of 

Management and Budget #: 0970–0510) 

AGENCY: Administration for Children 

and Families, U.S. Department of Health 

and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families (ACF) proposes 

to extend approval of the existing 

overarching generic clearance for 

Financial Reports used for ACF 

Mandatory Grant Programs (OMB 

#0970–0510) as well as all information 

collections currently approved under 

the overarching generic. There are no 

changes to the proposed types of 

information collection or uses of data as 

described in the overarching generic, 

and there are no changes proposed to 

currently approved information 

collections for which we are requesting 

an extension. Burden estimates for the 

next 3 years have been adjusted based 

on use to date. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: ACF programs require 

detailed financial information from their 

grantees that allows ACF to monitor 

various specialized cost categories 

within each program, to closely manage 

program activities, and to have 

sufficient financial information to 

enable periodic thorough and detailed 

audits. 

The information included on the 

standard Federal Financial Report Form 

(SF–425; OMB #4040–0014) provides 

only minimal, bare-bones, non-program 

specific financial information 

insufficient for these purposes. This 

generic clearance allows ACF programs 

to efficiently develop and receive 

approval for financial reports that are 

tailored to specific funding recipients 

and the associated needs of the program. 

This umbrella generic is a mechanism 

that is available to all ACF mandatory 

grant programs to use to obtain OMB 

approval of financial forms. Currently 

only a small number of ACF’s 

mandatory grant program financial 

forms are covered under this umbrella; 

it does not cover all ACF mandatory 

grant program financial forms. Program 

offices use the information collected 

under this generic information 

collection to: 

• Monitor program operations and 

prepare technical assistance and 

guidance as needed 

• Assess the effect of program changes 

and make informed decision 

• Assist in the computation of the grant 

awards issued to each program’s 

grantees 

• Assist in the computation of the Child 

Support Services program’s annual 

incentive payments 

• Determine that child support 

collections are being properly 

distributed (Child Support Services 

Program only) 

• Ensure funding recipients are meeting 

funding requirements established by 

Congress 

• Produce annual financial and 

statistical reports as may be required 

by Congress and respond to periodic 

detailed inquiries from Congress 

ACF may require an information 

collection approved under this generic 

from funding recipients to obtain or 

retain benefits. 

Prior to a new form being submitted 

for review under this umbrella generic, 

ACF will publish a notice in the Federal 

Register announcing the agency’s 

intention to request an OMB review of 

the form and providing a 14-day period 

for public comment on that specific 

request. ACF will review any comments 

received and address them as 

appropriate. ACF will provide a copy of 

any comments received and will 

provide a description of how comments 

were considered in the submission form 

along with the request package for the 

individual collection. ACF will then 

follow standard OMB requirements for a 

generic information collection and 

submit a generic information collection 

request for each individual data 

collection activity under this generic 

clearance. Each request will include the 

individual form(s) and instructions, a 

summary of any comments received, 

and a short overview of the proposed 

purpose and use of the data collected. 

OMB should review requests within 10 

days of submission. 

Respondents: ACF-funded mandatory 

grant programs. 

Annual Burden Estimates 

Find currently approved information 

collections here: https://

www.reginfo.gov/public/do/PRAICList?

ref_nbr=202308-0970-008. The request 

to OMB will include an extension 

request for approved information 

collections that are planned to continue 

beyond spring 2024. The current list of 

ongoing collections follows, but more 

collections may be approved prior to 

submission of the extension request to 

OMB. We will update the list in the 

subsequent Federal Register notice, if 

needed. 

Burden Estimates—Ongoing Requests 

Study Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Burden hours 

ACF–196P, TANF Pandemic Emergency Assistance Fund (PEAF) Financial 

Report for States, Territories and Tribes ..................................................... 137 1 6 822 

Child Care and Development Fund (CCDF) ACF–696 Financial Report for 

States and Territories ................................................................................... 56 4 5 1,120 

Child Care and Development Fund (CCDF) ACF–696T Financial Report for 

Tribal Grantees ............................................................................................ 221 1 7 1,547 

Child Support Services Program Financial Reporting Forms (OCSE–34 and 

OCSE–396) .................................................................................................. 168 4 14 9,408 

Form CB–496: Title IV–E Programs Quarterly Financial Report .................... 67 4 25 6,700 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 4307 

Study Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Burden hours 

Refugee Cash and Medical Assistance Federal Financial Report (ORR–2) 

Supplemental Data Collection ...................................................................... 66 1 1.67 110 

Refugee Support Services Federal Financial Report (SF–425) Supplemental 

Data Collection ............................................................................................. 53 4 4 848 

Totals ........................................................................................................ 768 Avg: 2.7 Avg: 8.9 20,555 

Burden Estimates—New Requests 

Based on use of this generic, we have 

revised burden estimates for the next 3 

years. 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Burden hours 

Mandatory Grant Financial Reports ................................................................. 1,200 3 9 32,400 

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. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–01206 Filed 1–22–24; 8:45 am] 

BILLING CODE 4184–88–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) authorizes FDA to 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA is required to 

publish notice of the issuance of priority 

review vouchers as well as the approval 

of products redeeming a priority review 

voucher. FDA has determined that the 

supplemental application (Supplement35) for COSENTYX (secukinumab), 

approved June 16, 2020, meets the 

criteria for redeeming a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of a product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that the 

supplemental application (Supplement35) for COSENTYX (secukinumab) 

meets the redemption criteria. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about COSENTYX 

(secukinumab), go to the ‘‘Drugs@FDA’’ 

website at https://www.accessdata.fda.

gov/scripts/cder/daf/. 

Dated: January 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01164 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–5430] 

Characterization of Metallic Coatings 

and/or Calcium Phosphate Coatings on 

Orthopedic Devices; Draft 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 the draft 

guidance entitled ‘‘Characterization of 

Metallic Coatings and/or Calcium 

Phosphate Coatings on Orthopedic 

Devices.’’ This draft guidance document 

provides recommendations for 

premarket submissions for orthopedic 

devices that contain metallic coatings 

and/or calcium phosphate coatings on 

the surface. This draft guidance is not 

final nor is it for implementation at this 

time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 25, 2024 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: 


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