1130 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–65 and CMS– 

10142] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Correction 

In notice document 2024–30444 

beginning in the third column on page 

104182 in the issue of Friday, December 

20, 2024, make the following correction: 

On page 104182, in the third column, 

under the DATES section, replace the text 

[INSERT DATE 30 DAYS AFTER DATE 

OF PUBLICATION IN THE FEDERAL 

REGISTER] with ‘‘January 21, 2025’’. 

[FR Doc. C1–2024–30444 Filed 1–6–25; 8:45 am] 

BILLING CODE 0099–10–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Refugee Resettlement 

Statement of Organization, Functions, 

and Delegations of Authority; 

Delegation From Office of Refugee 

Resettlement Director to 

Unaccompanied Children Bureau Chief 

Notice is hereby given that I delegate 

to the Chief of the Unaccompanied 

Children Bureau the following authority 

delegated to the Deputy Assistant 

Secretary for Humanitarian Services and 

Director of the Office of Refugee 

Resettlement by the Assistant Secretary 

for Children and Families and the 

Secretary under the William Wilberforce 

Trafficking Victims Protection 

Reauthorization Act of 2008 (Pub. L. 

110–457 sec. 235, amended). 

(a) Authority Delegated 

Authority under the William 

Wilberforce Trafficking Victims 

Protection Reauthorization Act of 2008 

section 235(d)(1) to specifically consent 

to juvenile court jurisdiction for an 

unaccompanied alien child who is 

applying for special immigrant status 

pursuant to the Immigration and 

Nationality Act (8 U.S.C. 1101 (a)(27)(J)) 

and who is in the custody of the 

Secretary. 

(b) Limitations 

1. This delegation shall be exercised 

under the Department’s existing 

delegation of authority and policy on 

regulations. 

2. This delegation shall be exercised 

under financial and administrative 

requirements applicable to all 

Administration for Children and 

Families authorities. 

(c) Effective Date 

This delegation of authority is 

effective on date of signature. In 

addition, I hereby affirm and ratify any 

actions taken by the Chief of the 

Unaccompanied Children Bureau, 

which, in effect, involved the exercise of 

these authorities prior to the effective 

date of this delegation. 

Robin Dunn Marcos, 

Deputy Assistant Secretary for Humanitarian 

Services and Director, Office of Refugee 

Resettlement. 

[FR Doc. 2025–00004 Filed 1–6–25; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–3539] 

Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act; 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 ‘‘Interim 

Policy on Compounding Using Bulk 

Drug Substances Under Section 503B of 

the Federal Food, Drug, and Cosmetic 

Act.’’ This guidance describes FDA’s 

interim regulatory policy concerning 

compounding by outsourcing facilities 

using bulk drug substances while FDA 

develops the list of bulk drug substances 

that outsourcing facilities can use in 

compounding under the applicable 

section of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). This guidance 

finalizes the draft guidance of the same 

title issued in December 2023 and 

replaces the final guidance of the same 

title issued in January 2017. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 7, 2025. 

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– 

2015–D–3539 for ‘‘Interim Policy on 

Compounding Using Bulk Drug 

Substances Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1131 

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. 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: 

Rechelle Buford, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave, Bldg., 51, Silver Spring, 

MD 20993–0002, 240–402–0447, 

compounding@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act’’ (2024 503B Interim 

Policy Guidance). This guidance 

finalizes the draft guidance entitled 

‘‘Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act’’ issued on December 7, 

2023 (88 FR 85293), and replaces the 

guidance of the same title issued in 

January 2017 (2017 503B Interim Policy 

Guidance). 

Section 503B of the FD&C Act (21 

U.S.C. 353b) sets forth the conditions 

that must be satisfied for human drug 

products compounded by an 

outsourcing facility to be exempt from 

the following three sections of the FD&C 

Act: (1) section 505 (21 U.S.C. 355) 

(concerning the approval of drugs under 

new drug applications or abbreviated 

new drug applications); (2) section 

502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use); and (3) 

section 582 (21 U.S.C. 360eee–1) 

(concerning drug supply chain security 

requirements). One of the conditions 

that must be met for a drug product 

compounded by an outsourcing facility 

to qualify for these exemptions is that 

the outsourcing facility does not 

compound a drug using a bulk drug 

substance unless: (1) the bulk drug 

substance appears on a list established 

by the Secretary of the Department of 

Health and Human Services identifying 

bulk drug substances for which there is 

a clinical need (the 503B bulks list) (see 

section 503B(a)(2)(A)(i)) or (2) the drug 

product compounded from such bulk 

drug substances appears on the drug 

shortage list in effect under section 506E 

of the FD&C Act (21 U.S.C. 356e) at the 

time of compounding, distribution, and 

dispensing (see section 503B(a)(2)(A)(ii) 

of the FD&C Act). 

FDA is developing the 503B bulks list, 

and this guidance describes FDA’s 

interim policy regarding outsourcing 

facilities that compound human drug 

products using bulk drug substances 

while the list is being developed. This 

guidance revises the policy described in 

FDA’s 2017 503B Interim Policy 

Guidance with respect to categorization 

of certain substances nominated for 

inclusion on the 503B bulks list. This 

guidance ends the categorization of bulk 

drug substances into Categories 1, 2, or 

3 for those bulk drug substances 

nominated on or after the date of 

publication of this guidance. 

The 2024 503B Interim Policy 

Guidance describes the conditions 

under which FDA does not intend to 

take action against an outsourcing 

facility for compounding a drug product 

using certain bulk drug substances that 

are not eligible for use in compounding 

under section 503B of the FD&C Act 

because they do not appear on the 503B 

bulks list and are not used to compound 

a drug product that appears on FDA’s 

drug shortage list at the time of 

compounding, distribution, and 

dispensing. One of these conditions is 

that the bulk drug substance appears in 

Category 1. As described in this 

guidance, FDA does not intend to 

categorize bulk drug substances 

nominated for inclusion on the 503B 

bulks list on or after the publication 

date of this guidance. However, FDA 

intends to consider such substances for 

inclusion on the 503B bulks list in 

accordance with the process and 

clinical need standard established in the 

FD&C Act (see section 503B(a)(2)(A)(i) 

of the FD&C Act). FDA is evaluating 

bulk drug substances nominated for the 

503B bulks list on a rolling basis. 

Substances that appear in Category 1 

(including substances nominated with 

adequate supporting information prior 

to the date of publication of this 

guidance) may continue to be within the 

scope of the policy for Category 1 

substances, as described in the 

guidance, until FDA makes a final 

determination whether these substances 

will be placed on the 503B bulks list in 

accordance with section 503B(a)(2)(A)(i) 

of the FD&C Act or unless the Agency 

removes the substances from Category 1 

based on, for example, information 

about safety risks. 

Prior to preparing this guidance, FDA 

considered comments received on the 

draft guidance. Editorial changes were 

made to improve clarity, such as 

updating references to the publication 

date of this final guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the ‘‘Interim Policy 

on Compounding Using Bulk Drug 

Substances Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

It does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 


ddrumheller on DSK120RN23PROD with NOTICES1
1132 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

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

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

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

www.regulations.gov. 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31545 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–4245] 

Study of Sex Differences in the Clinical 

Evaluation of Medical Products; Draft 

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 draft 

guidance for industry entitled ‘‘Study of 

Sex Differences in the Clinical 

Evaluation of Medical Products.’’ 

Clinical trials and non-interventional 

studies of medical products should be 

designed to enroll sufficient numbers of 

females and males to reflect the 

prevalence of the disease or condition 

for which the medical product is being 

investigated to help ensure the 

generalizability of results and facilitate 

exploration of potential differences in 

effects by sex. This guidance provides 

recommendations for increasing 

enrollment of females in clinical trials, 

analyzing and interpreting sex-specific 

data, and including sex-specific 

information in regulatory submissions 

of medical products. When finalized, 

this guidance will replace the guidance 

entitled ‘‘Guideline for the Study and 

Evaluation of Gender Differences in the 

Clinical Evaluation of Drugs’’ issued in 

July 1993. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 7, 2025 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: 

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–D–4245 for ‘‘Study of Sex 

Differences in the Clinical Evaluation of 

Medical Products.’’ 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 the draft 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; 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; 

the Office of Policy, Center for Devices 

and Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002; or the 

Office of Women’s Health, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 2333, 

Silver Spring, 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 draft 

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; James Myers, 

Center for Biologics Evaluation and 


ddrumheller on DSK120RN23PROD with NOTICES1