110 Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the revocation of the 

temporary permit issued to M.G. 

Waldbaum Co., a subsidiary of Michael 

Foods Egg Co., to market test 

‘‘ultrapasteurized liquid whole eggs’’ 

and ‘‘ultrapasteurized liquid whole eggs 

with citric acid’’ because the need for 

the temporary permit no longer exists. 

DATES: This permit is revoked as of 

January 2, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Marjan Morravej, Nutrition Center of 

Excellence, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–2371; or Jessica Ritsick, Office 

of Policy, Regulations, and Information, 

Human Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 21, 1989 (54 FR 

30612), we issued a notice announcing 

that we had issued a temporary permit 

to Crystal Foods, Inc., 6465 Wayzata 

Blvd., Minneapolis, MN 55426, a 

subsidiary of Michael Foods, Inc., to 

market test experimental packs of 

‘‘ultrapasteurized liquid whole eggs’’ 

and ‘‘ultrapasteurized liquid whole eggs 

with citric acid,’’ which we stated 

deviate from the standard of identity for 

liquid eggs at § 160.115 (21 CFR 

160.115) because they were processed 

with increased heat treatment and 

aseptic processing and packaging. We 

refer to the temporary permit holder as 

‘‘the company’’ throughout this notice. 

The temporary permit allowed the 

company to measure consumer 

acceptance of the product, identify mass 

production problems, and assess 

commercial feasibility (Id.). In February 

1991, FDA combined the original docket 

for the temporary permit (FDA–1989–P– 

0168) with other related dockets for the 

company into what is now docket 

number FDA–1991–P–0355. 

After issuance of the temporary 

permit, the company requested, and 

FDA granted, several revisions: 

• July 11, 1990 (55 FR 28456)—FDA 

amended the temporary permit to 

provide for package sizes larger than the 

designated 2.27 kilograms (5 pounds) to 

provide a broader base for data 

collection on consumer acceptance of 

the test products. 

• September 20, 1990 (55 FR 

38753)—FDA extended the temporary 

permit so the company could continue 

experimental market testing of the 

products and continue gathering data in 

support of its petition to amend the 

standard of identity for liquid eggs at 

§ 160.115. As part of the extension, FDA 

invited interested persons to participate 

in the market test under the conditions 

in the temporary permit, except for the 

designated area of distribution. We have 

no records that show that any interested 

persons notified us of their intent to 

participate in the market test, as 

required under § 130.17(i) (21 CFR 

130.17(i)). 

• March 22, 1991 (56 FR 12206)— 

FDA amended the temporary permit to 

allow the test products to be packaged 

in aseptic packages ranging in size from 

42.5 grams (1.5 ounces) to 1 kilogram 

(2.2 pounds). Additionally, as requested 

by the company, we changed the name 

and address of the permit holder from 

Crystal Foods, Inc., Minneapolis, MN 

55426, to M.G. Waldbaum Co., 

Wakefield, NE 68784. 

In the time since the temporary 

permit was originally issued, FDA has 

concluded that the temporary permit is 

not necessary, because the standard of 

identity in § 160.115 provides for the 

treatment process used by the company 

under the temporary permit. Our 

regulation, at § 160.115(a), states that 

liquid eggs must be pasteurized or 

otherwise treated to destroy all viable 

Salmonella microorganisms. The 

specific process used by the company 

under the temporary permit—increased 

heat treatment and aseptic processing 

and packaging—is consistent with 

§ 160.115(a). Specifically, the standard 

of identity for liquid eggs permits other 

treatments that destroy all viable 

Salmonella microorganisms. As such, 

we have concluded that the temporary 

permit is not necessary to market liquid 

eggs using the company’s process, 

consistent with the standard of identity. 

In addition, in April 2024, FDA 

contacted the company via email 

regarding the current use of its 

temporary permit. The company did not 

object to FDA revoking the temporary 

permit under § 130.17(g)(3). 

Therefore, under § 130.17(g)(3), we 

are revoking the company’s temporary 

permit because the need for it no longer 

exists. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31470 Filed 12–31–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4974] 

Advanced Manufacturing Technologies 

Designation Program; 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 

‘‘Advanced Manufacturing Technologies 

Designation Program.’’ FDA encourages 

the early adoption of advanced 

manufacturing technologies (AMTs) by 

the pharmaceutical industry, which can 

improve the reliability and robustness of 

the manufacturing process and can 

benefit patients by enhancing product 

quality and reducing drug development 

time or increasing or maintaining the 

supply of drugs that are life-supporting, 

life-sustaining, of critical importance to 

providing health care, or in shortage. 

This guidance provides 

recommendations to persons and 

organizations interested in participating 

in FDA’s Advanced Manufacturing 

Technologies Designation Program, 

which facilitates the development of 

drugs manufactured using an AMT that 

has been designated as such under the 

program. The guidance finalizes the 

draft guidance of the same title issued 

on December 13, 2023. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 2, 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Notices 111 

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– 

2023–D–4974 for ‘‘Advanced 

Manufacturing Technologies 

Designation Program.’’ 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 (CDER), 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 

(CBER), 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: 

Ranjani Prabhakara, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 6648, 

Silver Spring, MD 20993, 240–402– 

4652; 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 

‘‘Advanced Manufacturing Technologies 

Designation Program.’’ FDA’s Advanced 

Manufacturing Technologies 

Designation Program, which is required 

under section 506L of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act, 21 

U.S.C. 356l), offers a framework for 

persons or organizations (e.g., 

applicants, contract manufacturers, 

technology developers) to request 

designation of a method or combination 

of methods of manufacturing a drug as 

an AMT. The program facilitates the 

development of drugs as described in 

section 506L(b) of the FD&C Act that are 

manufactured using a designated AMT, 

submitted in an application under 

section 505 of the FD&C Act (21 U.S.C. 

355) or section 351 of the Public Health 

Service Act (42 U.S.C. 262), and 

regulated by CDER or CBER. An 

application or supplemental application 

referencing a designated AMT can 

receive certain benefits under the 

program, such as FDA’s early 

interaction with applicants regarding 

the development and manufacture of 

drugs using a designated AMT, as 

described in section 506L(c)(1) of the 

FD&C Act. 

The guidance outlines the eligibility 

criteria for AMT designation, the 

submission and assessment process for 

requests, including data and 

information to be submitted, and the 

benefits of receiving an AMT 

designation, among other information, 

and includes a questions and answers 

section to cover additional details about 

key concepts important for program 

utilization. The guidance finalizes the 

draft guidance of the same title issued 

on December 13, 2023 (88 FR 86333). 

FDA considered comments received on 

the draft guidance in finalizing the 

guidance. FDA made changes from the 

draft guidance to improve clarity about 

the AMT designation process, the 

content of AMT designation requests, 

the roles and responsibilities of different 

entities involved in the development 

and use of designated AMTs, and the 

relationship between the Advanced 

Manufacturing Technologies 

Designation Program and other FDA 

programs addressing emerging or 

advanced technologies. 

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 ‘‘Advanced 

Manufacturing Technologies 

Designation Program.’’ 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 

Under the Paperwork Reduction Act 

of 1995 (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. 

FDA is issuing this guidance, as final, in 

accordance with section 506L of the 

FD&C Act, which directs FDA to initiate 

a program and establish a process for 


ddrumheller on DSK120RN23PROD with NOTICES1
112 Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Notices 

AMT designation, including 

information collection provisions 

subject to review and approval by OMB 

under the PRA. Section 506L(e)(2) of the 

FD&C Act further directs FDA to issue 

program guidance. Before implementing 

the information collection provisions of 

the guidance, FDA will publish a notice 

in the Federal Register continuing to 

invite public comment on the proposed 

collections of information (see 88 FR 

86333) and announce OMB’s decision to 

approve, modify, or disapprove the 

collections of information, including the 

OMB control number(s). 

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/ 

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

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://

www.regulations.gov. 

Dated: December 27, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31493 Filed 12–31–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Initial Review Group; Career 

Development for Established Investigators 

and Conference Grants Study Section. 

Date: February 13–14, 2025. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute on Aging, 5601 

Fishers Lane, Suite 8B, Rockville, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Rajasri Roy, Ph.D., 

Scientific Review Officer, National Institute 

on Aging, National Institutes of Health, 5601 

Fishers Lane, Suite 8B, Rockville, MD 20892, 

301–496–6477, rajasri.roy@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 26, 2024. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–31444 Filed 12–31–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Initial Review Group; Career 

Development for Clinicians/Health 

Professionals Study Section. 

Date: February 10–11, 2025. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute on Aging, 5601 

Fishers Lane, Suite 8B, Rockville, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Mariel Jais, Ph.D., M.D., 

Scientific Review Officer, National Institute 

on Aging, National Institutes of Health, 5601 

Fishers Lane, Suite 8B, Rockville, MD 20892, 

(301) 594–2614, mariel.jais@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 26, 2024. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–31441 Filed 12–31–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Nutrition Obesity 

Research Centers (P30–P2C). 

Date: March 12–13, 2025. 

Time: 9:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Embassy Suites at the Chevy 

Chase Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Meeting Format: In Person and Virtual 

Meeting. 

Contact Person: Thomas A. Tatham, Ph.D., 

Scientific Review Officer, National Institute 

of Diabetes and Digestive and Kidney, 

National Institutes of Health, 6707 

Democracy Boulevard, Rm. 7021, Bethesda, 

MD 20892–5452, (301) 594–3993, tathamt@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: December 26, 2024. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–31445 Filed 12–31–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 


ddrumheller on DSK120RN23PROD with NOTICES1