94740 Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// 

www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: November 19, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28033 Filed 11–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4687] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medicated Feed 

Mill License Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish 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 the information 

collection provisions of medicated feed 

mill license reporting. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

January 28, 2025. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 28, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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– 

2024–N–4687 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Medicated Feed Mill License 

Application.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 


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Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 94741 

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, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (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. 

Medicated Feed Mill License 

Application—21 CFR Part 515 

OMB Control Number 0910–0337— 

Extension 

This information collection helps 

support implementation of statutory and 

regulatory provisions related to 

medicated animal feed mill licensing. 

Feed manufacturers that seek to 

manufacture a Type B or Type C 

medicated feed using Category II, Type 

A medicated articles or manufacture 

certain liquid and free-choice feed using 

Category I, Type A medicated articles 

that must follow proprietary formulas or 

specifications, are required to obtain a 

facility license under section 512 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360b). Our 

regulations in 21 CFR part 515 establish 

the procedures associated with applying 

for a facility license. We require that a 

manufacturer seeking a facility license 

submit a completed medicated feed mill 

license application using Form FDA 

3448 (21 CFR 515.10(b)). This form may 

be submitted via U.S. mail or 

electronically to a dedicated email 

address, MedicatedFeedsTeamMail@

fda.hhs.gov. We use the information 

submitted to establish that the applicant 

has made the certifications required by 

section 512 of the FD&C Act, to register 

the mill, and to schedule a preapproval 

inspection. Form FDA 3448 may be 

accessed on our website at: https://

www.fda.gov/about-fda/reportsmanuals-forms/forms. 

We require the submission of a 

supplemental medicated feed mill 

license application for a change in 

facility ownership or a change in facility 

address (§ 515.11(b) (21 CFR 515.11(b))). 

If a licensed facility is no longer 

manufacturing medicated animal feed 

under § 515.23 (21 CFR 515.23), a 

manufacturer may request voluntary 

revocation of a medicated feed mill 

license. An applicant also has the right 

to file a request for hearing under 

§ 515.30(c) (21 CFR 515.30(c)) to give 

reasons why a medicated feed mill 

license should not be refused or 

revoked. 

Under § 510.305 (21 CFR 510.305), we 

require each applicant to maintain in a 

single accessible location: (a) A copy of 

the approved medicated feed mill 

license (Form FDA 3448) on the 

premises of the manufacturing 

establishment; and (b) approved or 

index listed labeling for each Type B 

and/or Type C feed being manufactured 

on the premises of the manufacturing 

establishment or the facility where the 

feed labels are generated. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

Total 

hours 

515.10(b), 515.11(b); Medicated Feed Mill License 

Application and Supplemental Applications using 

Form FDA 3448 .................................................... 34 1 34 0.25 (15 minutes) 8.5 

515.23; Voluntary Revocation of Medicated Feed 

Mill License ........................................................... 14 1 14 0.25 (15 minutes) 3.5 

515.30; Filing a Request for a Hearing on Medicated Feed Mill License ....................................... 1 1 1 4 4 

Total .................................................................. ........................ ........................ 49 ........................................ 16 

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

We estimate that respondents will 

spend 15 minutes to assemble the 

necessary information, prepare, and 

submit an application for a feed mill 

license or revocation of a feed mill 

license. We estimate that respondents 

will spend 4 hours to prepare their 

request for a hearing. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Part; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping 

Total 

hours 

510.305; Maintenance of Records for Approved Labeling for Each ‘‘Type B’’ and ‘‘Type C’’ Feed.779 1 779 0.03 (2 minutes) ....... 23 

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

We base our estimates on our recent 

experience with the existing medicated 

feed mill license application process. 

Our estimated burden for the 

information collection reflects an 

overall increase of 2.5 hours. We 


khammond on DSK9W7S144PROD with NOTICES
94742 Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 

attribute this adjustment to a slight 

increase in the overall number of 

submissions we received over the last 

few years. 

Dated: November 19, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28036 Filed 11–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Availability of Final Health 

Center Program Policy Guidance 

Regarding Services To Support 

Transitions in Care for JusticeInvolved Individuals Reentering the 

Community 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Final notice. 

SUMMARY: The final Health Center 

Program Policy Guidance Regarding 

Services to Support Transitions in Care 

for Justice-Involved Individuals 

Reentering the Community Policy 

Information Notice (JI–R PIN) has been 

developed to assist health centers who 

choose to provide certain primary 

health care services to support the 

transition of JI–R individuals from the 

carceral setting back into the 

community setting. 

DATES: This Final JI–R PIN is effective 

on the date of publication of this notice. 

FOR FURTHER INFORMATION CONTACT: For 

questions regarding this notice, use the 

HRSA Bureau of Primary Health Care 

Contact Form: https://hrsa.force.com/ 

support/s/ or call Jennifer Joseph, 

Director, Office of Policy and Program 

Development, Bureau of Primary Health 

Care, HRSA, at 301–594–4300. 

SUPPLEMENTARY INFORMATION: HRSA 

provides grants to eligible applicants 

under section 330 of the Public Health 

Service Act, as amended (42 U.S.C. 

254b), to support the delivery of 

preventive and primary care services to 

the nation’s underserved individuals 

and families. HRSA also certifies 

eligible applicants under the Health 

Center Look-Alike Program (see sections 

1861(aa)(4)(B) and 1905(l)(2)(B) of the 

Social Security Act). Look-alikes do not 

receive Health Center Program funding 

but must meet the Health Center 

Program statutory and regulatory 

requirements. Health centers are local 

organizations that provide 

comprehensive, high-quality primary 

health care services tailored to their 

communities regardless of their 

patients’ ability to pay. Nearly 1,400 

Health Center Program-funded health 

centers and more than 100 Health 

Center Program look-alike organizations 

operate more than 16,100 service 

delivery sites that provide care to more 

than 32 million patients in every U.S. 

state, the District of Columbia, Puerto 

Rico, the U.S. Virgin Islands, and the 

Pacific Basin. Note that for the purposes 

of this document, the term ‘‘health 

center’’ refers to entities that receive a 

federal award under section 330 of the 

Public Health Service Act, as well as 

subrecipients and organizations 

designated as look-alikes, unless 

otherwise stated. 

This final JI–R PIN establishes policy 

for all health centers that apply for and 

receive a federal award under the Health 

Center Program, as authorized by 

section 330 of the Public Health Service 

(PHS) Act (including sections 330(e), 

(g), (h), and (i)), as well as section 330 

subrecipient organizations and Health 

Center Program look-alikes. This final 

JI–R PIN is intended to support health 

centers in providing certain health 

services—delivered under the exclusive 

control and authority of the health 

center—to support the transition of JI– 

R individuals from the carceral setting 

back into the community setting. The 

services the health center provides are 

limited to services that support reentry. 

A health center may not take on or 

replace the provision of any other health 

care services the carceral authority 

provides to those who are incarcerated 

or detained. 

HRSA released a draft of the JI–R PIN 

for a 60-day public comment period. 

HRSA revised the JI–R PIN in response 

to comments and posted a summary of 

comments and HRSA’s responses at 

https://bphc.hrsa.gov/sites/default/files/ 

bphc/compliance/pin-2024-05- 

comments-summary.pdf. 

Organizations receiving Health Center 

Program federal awards, including 

subrecipients, and organizations 

designated as Health Center Program 

look-alikes, continue to be subject to all 

requirements stated in Notices of 

Funding Opportunity, Notices of 

Award, Look-Alike Initial Designation 

and Redesignation Instructions, Notices 

of Look-Alike Designation, as well as 

other applicable laws, regulations, and 

policies. Organizations are also subject 

to the distinct statutory, regulatory, and 

policy requirements of other federal 

programs in which they participate. 

Carole Johnson, 

Administrator. 

[FR Doc. 2024–27903 Filed 11–27–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Federal Financial Participation in State 

Assistance Expenditures; Federal 

Matching Shares for Medicaid, the 

Children’s Health Insurance Program, 

and Aid to Needy Aged, Blind, or 

Disabled Persons for October 1, 2025, 

Through September 30, 2026 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: The Federal Medical 

Assistance Percentages (FMAP), 

Enhanced Federal Medical Assistance 

Percentages (eFMAP), and disasterrecovery FMAP adjustments for fiscal 

year 2026 have been calculated 

pursuant to the Social Security Act (the 

Act). These percentages will be effective 

from October 1, 2025, through 

September 30, 2026. This notice 

announces the calculated FMAP rates, 

in accordance with the Act, that the U.S. 

Department of Health and Human 

Services (HHS) will use in determining 

the amount of Federal matching for state 

medical assistance (Medicaid), 

Temporary Assistance for Needy 

Families (TANF) Contingency Funds, 

Child Support collections, Child Care 

Mandatory and Matching Funds of the 

Child Care and Development Fund, 

Title IV–E Foster Care Maintenance 

payments, Adoption Assistance 

payments and Kinship Guardianship 

Assistance payments, and the eFMAP 

rates for the Children’s Health Insurance 

Program (CHIP) expenditures. Table 1 

gives figures for each of the 50 states, 

the District of Columbia, Puerto Rico, 

the Virgin Islands, Guam, American 

Samoa, and the Commonwealth of the 

Northern Mariana Islands. This notice 

reminds states of adjustments available 

for states meeting requirements for 

disproportionate employer pension or 

insurance fund contributions and 

adjustments for disaster recovery. Based 

on the criteria for a qualifying state, one 

state meets the requirements for an 

adjustment for disaster recovery. 

DATES: The percentages listed in Table 

1 will be effective for each of the four 

quarter-year periods beginning October 

1, 2025, and ending September 30, 2026. 


khammond on DSK9W7S144PROD with NOTICES