Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Extension of Comment Period, 20481-20482 [2024-06118]

Download as PDF 20481 Federal Register / Vol. 89, No. 57 / Friday, March 22, 2024 / Notices infusion therapy services in accordance with nationally recognized standards of practice, and in accordance with all applicable State and Federal laws and regulations. DEPARTMENT OF HEALTH AND HUMAN SERVICES B. Term of Approval Based on the review and observations described in section III. of this final notice, we have determined that URAC’s requirements for HITs meet or exceed our requirements. Therefore, we approve URAC as a national accreditation organization for HITs that request participation in the Medicare program, effective March 27, 2024 through March 27, 2030. Submission for Office of Management and Budget (OMB) Review; Interstate Administrative Subpoena and Notice of Lien (Office of Management and Budget OMB #: 0970–0152) VI. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Trenesha Fultz-Mimms, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2024–06144 Filed 3–21–24; 8:45 am] BILLING CODE 4120–01–P Administration for Children and Families Administration for Children and Families, U.S. Department of Health and Human Services. ACTION: Request for public comments. AGENCY: The Administration for Children and Families (ACF) is requesting a 3-year extension with proposed revisions to the Interstate Administrative Subpoena and Notice of Lien forms (Office of Management and Budget #0970–0152, expiration 6/30/ 2024). The forms are updated to reflect the name change of the Federal child support program office from the Office of Child Support Enforcement to the Office of Child Support Services. 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/ PRAMain. Find this particular SUMMARY: 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 Administrative Subpoena is used by State child support agencies to obtain income and other financial information regarding noncustodial parents for purposes of establishing, enforcing, and modifying child support orders. The Notice of Lien imposes liens in cases with overdue support and allows a State child support agency to file liens across State lines, when it is more efficient than involving the other State’s IV–D agency. Section 452(a)(11) of the Social Security Act requires the Secretary of the Department of Health and Human Services to promulgate forms for administrative subpoenas and imposition of liens used by State child support agencies in interstate cases. Section 454(9)(E) of the Social Security Act requires each State to cooperate with any other State in using the Federal forms for issuance of administrative subpoenas and imposition of liens in interstate child support cases. Respondents: State, local, or Tribal agencies administering a child support program under title IV–D of the Social Security Act. ANNUAL BURDEN ESTIMATES Annual number of respondents Instrument ddrumheller on DSK120RN23PROD with NOTICES1 Administrative Subpoena ................................................................................. Notice of Lien ................................................................................................... 54 54 Annual number of responses per respondent 462 29,762 Estimated Total Annual Burden Hours: 816,048. Authority: 42 U.S.C. 652; 42 U.S.C. 654. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Food and Drug Administration SUMMARY: Mary C. Jones, ACF/OPRE Certifying Officer. [Docket No. FDA–2016–D–2343] [FR Doc. 2024–06143 Filed 3–21–24; 8:45 am] Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Extension of Comment Period BILLING CODE 4184–41–P AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 19:15 Mar 21, 2024 Jkt 262001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Average burden hours per response .5 .5 Annual burden hours 12,474 803,574 Notification of availability; extension of comment period. The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for two chapters of a multichapter draft guidance entitled ‘‘Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,’’ which were announced in the Federal Register of September 27, 2023. The relevant draft chapters are entitled ‘‘Chapter 11— E:\FR\FM\22MRN1.SGM 22MRN1 20482 Federal Register / Vol. 89, No. 57 / Friday, March 22, 2024 / Notices Food Allergen Program’’ and ‘‘Chapter 16—Acidified Foods.’’ We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments before FDA begins work on the final guidance. FDA is extending the comment period on our draft guidance published September 27, 2023 (88 FR 66457). Submit either electronic or written comments by May 24, 2024, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final guidance. ADDRESSES: You may submit comments on any guidance at any time as follows. DATES: 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’’). ddrumheller on DSK120RN23PROD with NOTICES1 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– 2016–D–2343 for ‘‘Hazard Analysis and VerDate Sep<11>2014 19:15 Mar 21, 2024 Jkt 262001 Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.’’ 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). FOR FURTHER INFORMATION CONTACT: Linda Kahl, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2784. SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 2023 (88 FR 66457), we published a notice PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 announcing the availability of two chapters of a multichapter draft guidance entitled ‘‘Hazard Analysis and Risk-Based Preventive Controls for Human Food.’’ These draft chapters are entitled ‘‘Chapter 11—Food Allergen Program’’ and ‘‘Chapter 16—Acidified Foods.’’ The notice of availability opened a docket with a 180-day comment period, to close on March 25, 2024. We have received a request to extend the comment period for the two draft guidance chapters. The request conveys that additional time would be helpful for stakeholders to fully evaluate the chapters and develop meaningful comments. We have considered the request and have concluded that an extension of the comment period by 60 days, until May 24, 2024, is appropriate. We believe that the extension will allow adequate time for interested persons to submit comments without significantly delaying the final guidance. Dated: March 19, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–06118 Filed 3–21–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357–6400. For information on HRSA’s role in the Program, contact the Director, National SUMMARY: E:\FR\FM\22MRN1.SGM 22MRN1

Agencies

[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Pages 20481-20482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2343]


Hazard Analysis and Risk-Based Preventive Controls for Human 
Food; Draft Guidance for Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
extending the comment period for two chapters of a multichapter draft 
guidance entitled ``Hazard Analysis and Risk-Based Preventive Controls 
for Human Food: Draft Guidance for Industry,'' which were announced in 
the Federal Register of September 27, 2023. The relevant draft chapters 
are entitled ``Chapter 11--

[[Page 20482]]

Food Allergen Program'' and ``Chapter 16--Acidified Foods.'' We are 
taking this action in response to a request for an extension to allow 
interested persons additional time to submit comments before FDA begins 
work on the final guidance.

DATES: FDA is extending the comment period on our draft guidance 
published September 27, 2023 (88 FR 66457). Submit either electronic or 
written comments by May 24, 2024, to ensure that the Agency considers 
your comment on this draft guidance before it begins work on the final 
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-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive 
Controls for Human Food: Draft Guidance for Industry.'' 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)).

FOR FURTHER INFORMATION CONTACT: Linda Kahl, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2784.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 
2023 (88 FR 66457), we published a notice announcing the availability 
of two chapters of a multichapter draft guidance entitled ``Hazard 
Analysis and Risk-Based Preventive Controls for Human Food.'' These 
draft chapters are entitled ``Chapter 11--Food Allergen Program'' and 
``Chapter 16--Acidified Foods.'' The notice of availability opened a 
docket with a 180-day comment period, to close on March 25, 2024.
    We have received a request to extend the comment period for the two 
draft guidance chapters. The request conveys that additional time would 
be helpful for stakeholders to fully evaluate the chapters and develop 
meaningful comments. We have considered the request and have concluded 
that an extension of the comment period by 60 days, until May 24, 2024, 
is appropriate. We believe that the extension will allow adequate time 
for interested persons to submit comments without significantly 
delaying the final guidance.

    Dated: March 19, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-06118 Filed 3-21-24; 8:45 am]
BILLING CODE 4164-01-P
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