Liquid Eggs Deviating From the Standard of Identity; Revocation of Temporary Permit for Market Testing, 109-110 [2024-31470]

Download as PDF Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Notices Request for letters of nomination and resumes. ACTION: The Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) established MACPAC to review Medicaid and CHIP access and payment policies and to advise Congress on issues affecting Medicaid and CHIP. CHIPRA gave the Comptroller General of the United States responsibility for appointing MACPAC’s members. The Government Accountability Office (GAO) is now accepting nominations for MACPAC appointments that will be effective May 2025. Nominations should be sent to the email address listed below. Acknowledgement of receipt will be provided within a week of submission. DATES: Letters of nomination and resumes should be submitted no later than January 28, 2025, to ensure adequate opportunity for review and consideration of nominees prior to appointment. SUMMARY: Submit letters of nomination and resumes to MACPACappointments@gao.gov. 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[FR Doc. 2024–31416 Filed 12–31–24; 8:45 am] BILLING CODE 4184–40–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1991–P–0355] Liquid Eggs Deviating From the Standard of Identity; Revocation of Temporary Permit for Market Testing AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\02JAN1.SGM Notice. 02JAN1 110 Federal Register / Vol. 90, No. 1 / Thursday, January 2, 2025 / Notices 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:23 Dec 31, 2024 Jkt 265001 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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. 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: SUMMARY: 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 E:\FR\FM\02JAN1.SGM 02JAN1

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[Federal Register Volume 90, Number 1 (Thursday, January 2, 2025)]
[Notices]
[Pages 109-110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1991-P-0355]


Liquid Eggs Deviating From the Standard of Identity; Revocation 
of Temporary Permit for Market Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 110]]

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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  160.115 provides for the treatment 
process used by the company under the temporary permit. Our regulation, 
at Sec.  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 Sec.  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 Sec.  130.17(g)(3).
    Therefore, under Sec.  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

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