Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-Contact; Availability, 31507-31508 [2023-10523]

Download as PDF 31507 Federal Register / Vol. 88, No. 95 / Wednesday, May 17, 2023 / Notices The SORN is now obsolete and is being rescinded. SUPPLEMENTARY INFORMATION: SYSTEM NAME AND NUMBER: eLease. GSA/PBS–5. Families (ACF), Department of Health and Human Services (HHS). ACTION: Request for public comments. The Office of Refugee Resettlement (ORR) is requesting a 3year extension with revisions of the Unaccompanied Refugee Minors (URM) Program Application and Withdrawal of Application or Declination of Placement Form (OMB #0970–0550, expiration 08/ 31/2023). Proposed revisions include additional instructions, a small number of new questions, dropping a few questions, and rephrasing existing questions. DATES: Comments due within 30 days of publication. OMB must make a decision about the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ SUMMARY: HISTORY: 73 FR 22414, April 25, 2008. Richard Speidel, Chief Privacy Officer, Office of the Deputy Chief Information Officer, General Services Administration. [FR Doc. 2023–10500 Filed 5–16–23; 8:45 am] BILLING CODE 6820–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Office of Refugee Resettlement Unaccompanied Refugee Minors Program Application and Withdrawal of Application or Declination of Placement Form (OMB #0970–0550) Office of Refugee Resettlement, Administration for Children and AGENCY: PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. You can also obtain copies of the proposed collection of information by emailing infocollection@ acf.hhs.gov. Identify all emailed requests by the title of the information collection. SUPPLEMENTARY INFORMATION: Description: The URM Program Application is completed on behalf of unaccompanied children in the United States who are applying for entry into the URM Program. The application includes biographical data and information on the child’s needs to support placement efforts. The Withdrawal of Application or Declination of Placement Form is completed when a child is no longer interested in entering the URM Program or is not interested in entering the placement they were offered. Respondents: Case managers, attorneys, or other representatives working with unaccompanied children who are eligible for the URM Program. ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Total number of responses per respondent 450 3 1.5 2,025 675 50 3 0.2 30 10 Unaccompanied Refugee Minors Program Application ..... Withdrawal of Application or Declination of Placement Form ............................................................................... 555.250 Major Food Allergen Labeling and Cross-contact.’’ The draft guidance, when finalized, will replace existing guidance for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and cross-contact. DATES: Submit either electronic or written comments on the draft guidance by July 17, 2023 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Estimated Total Annual Burden Hours: 685. Authority: 8 U.S.C. 1522(d). Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2023–10539 Filed 5–16–23; 8:45 am] BILLING CODE 4184–89–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ddrumheller on DSK120RN23PROD with NOTICES1 [Docket No. FDA–2023–D–1103] Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-Contact; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a draft Compliance Policy Guide entitled ‘‘Sec. SUMMARY: VerDate Sep<11>2014 18:34 May 16, 2023 Jkt 259001 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Average burden hours per response Total burden hours Annual burden hours 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 E:\FR\FM\17MYN1.SGM 17MYN1 ddrumheller on DSK120RN23PROD with NOTICES1 31508 Federal Register / Vol. 88, No. 95 / Wednesday, May 17, 2023 / Notices 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–1103 for ‘‘Sec. 555.250 Major Food Allergen Labeling and Crosscontact.’’ 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.’’ We will review this copy, including the claimed confidential information, in our 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-201509-18/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. VerDate Sep<11>2014 18:34 May 16, 2023 Jkt 259001 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 Office of Compliance (HFS–605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two selfaddressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Yinqing Ma, Office of Compliance (HFS–605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2479, email: Yinqing.ma@fda.hhs.gov; or Denise See, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2378. SUPPLEMENTARY INFORMATION: 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 draft guidance at either https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: May 12, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–10523 Filed 5–16–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration I. Background [Docket No. FDA–2020–N–2226] We are announcing the availability of a draft Compliance Policy Guide (CPG) entitled ‘‘Sec. 555.250 Major Food Allergen Labeling and Cross-contact.’’ This draft CPG would update and replace existing guidance for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and crosscontact. The content of current CPG Sec. 555.250 was written before the enactment of three major laws that are the foundation of FDA’s regulatory framework for major food allergens: Food Allergen Labeling and Consumer Protection Act (2004), FDA Food Safety Modernization Act (2011), and the Food Allergy Safety, Treatment, Education and Research Act (2021). The current CPG Sec. 555.250 also does not reflect requirements in our regulation entitled ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food’’ (now codified at 21 CFR part 117). We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. Cheese Products Deviating From Identity Standard; Temporary Permit for Market Testing II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the extension of a temporary permit issued to Bongards Creameries (the applicant) to market test several pasteurized standardized cheeses that deviate from the U.S. standards of identity for cheese products. The extension allows the applicant to continue to evaluate commercial viability of the products and to collect data on consumer acceptance of the products, in support of a petition to amend the standard of identity for cheese products. We also invite other interested parties to participate in the market test. DATES: The new expiration date of the permit will be either the effective date of a final rule amending the standard of identity of cheese products that may result from the petition or 30 days after denial of the petition. FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2371. SUPPLEMENTARY INFORMATION: In accordance with § 130.17 (21 CFR SUMMARY: E:\FR\FM\17MYN1.SGM 17MYN1

Agencies

[Federal Register Volume 88, Number 95 (Wednesday, May 17, 2023)]
[Notices]
[Pages 31507-31508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1103]


Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling 
and Cross-Contact; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft Compliance Policy Guide entitled ``Sec. 555.250 
Major Food Allergen Labeling and Cross-contact.'' The draft guidance, 
when finalized, will replace existing guidance for FDA staff on FDA's 
enforcement policy regarding major food allergen labeling and cross-
contact.

DATES: Submit either electronic or written comments on the draft 
guidance by July 17, 2023 to ensure that we consider your comment on 
the draft guidance before we begin 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

[[Page 31508]]

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-1103 for ``Sec. 555.250 Major Food Allergen Labeling and 
Cross-contact.'' 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.'' We will review 
this copy, including the claimed confidential information, in our 
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 
Office of Compliance (HFS-605), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740. Send two self-addressed adhesive labels to assist that office 
in processing your request. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Yinqing Ma, Office of Compliance (HFS-
605), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2479, 
email: [email protected]; or Denise See, Center for Food Safety 
and Applied Nutrition, Office of Regulations and Policy (HFS-024), Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft Compliance Policy 
Guide (CPG) entitled ``Sec. 555.250 Major Food Allergen Labeling and 
Cross-contact.'' This draft CPG would update and replace existing 
guidance for FDA staff on FDA's enforcement policy regarding major food 
allergen labeling and cross-contact. The content of current CPG Sec. 
555.250 was written before the enactment of three major laws that are 
the foundation of FDA's regulatory framework for major food allergens: 
Food Allergen Labeling and Consumer Protection Act (2004), FDA Food 
Safety Modernization Act (2011), and the Food Allergy Safety, 
Treatment, Education and Research Act (2021). The current CPG Sec. 
555.250 also does not reflect requirements in our regulation entitled 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food'' (now codified at 21 CFR part 117).
    We are issuing the draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking on this topic. It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft 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 draft guidance 
at either https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: May 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10523 Filed 5-16-23; 8:45 am]
BILLING CODE 4164-01-P

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