Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Appendix 1; Extension of Comment Period, 47108-47109 [2024-11987]

Download as PDF 47108 Proposed Rules Federal Register Vol. 89, No. 106 Friday, May 31, 2024 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA–2016–D–2343] Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Appendix 1; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notification of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Human Food’’ which were announced in the Federal Register of February 2, 2024. 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 DATES: FDA is extending the comment period on our draft guidance published February 2, 2024 (89 FR 7315). Submit either electronic or written comments by August 2, 2024, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final guidance.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. SUMMARY: khammond on DSKJM1Z7X2PROD with PROPOSALS 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 VerDate Sep<11>2014 16:22 May 30, 2024 Jkt 262001 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; Appendix 1.’’ 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 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 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 February 2, 2024 (89 FR 7315), we published a notice announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance entitled ‘‘Hazard Analysis and Risk-Based Preventive Controls for Human Food.’’ The notice of availability opened a docket with a 120-day comment period, to close on June 3, 2024. We have received a request to extend the comment period for the revised draft Introduction, and revised draft Appendix 1. The request conveys that additional time would be helpful for stakeholders to fully evaluate and develop meaningful comments to the Introduction and Appendix which are E:\FR\FM\31MYP1.SGM 31MYP1 Federal Register / Vol. 89, No. 106 / Friday, May 31, 2024 / Proposed Rules highly complex and detailed. We have considered the request and have concluded that an extension of the comment period by 60 days, until August 2, 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: May 28, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–11987 Filed 5–30–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 45 CFR Parts 302, 303, and 304 RIN: 0970–AD00 Employment and Training Services for Noncustodial Parents in the Child Support Program Office of Child Support Services (OCSS), Administration for Children and Families (ACF), Department of Health and Human Services (HHS or the Department). ACTION: Notice of proposed rulemaking. AGENCY: In an effort to make the child support program more effective, this Notice of Proposed Rulemaking (NPRM) proposes to allow Federal financial participation (FFP) for certain optional and nonduplicative employment and training services for eligible noncustodial parents in the child support program. The proposed rule will permit states, at their discretion, to use FFP to provide any or all of the following services: job search assistance; job readiness training; job development and job placement services; skills assessments; job retention services; work supports; and occupational training and other skills training directly related to employment. DATES: Consideration will be given to written comments on this NPRM received on or before July 30, 2024. ADDRESSES: You may submit comments, identified by [docket number and/or Regulatory Information Number (RIN) number], by one of the following methods: • Federal e-Rulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Mail: Written comments may be submitted to: Office of Child Support Services, Attention: Director of Policy khammond on DSKJM1Z7X2PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 16:22 May 30, 2024 Jkt 262001 and Training, 330 C Street SW, Washington, DC 20201. Instructions: All submissions received must include the agency name and docket number or RIN for this rulemaking. All comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. Docket: Go to the Federal Rulemaking Portal at https://www.regulations.gov for access to the rulemaking docket, including any background documents and the plain-language summary of the proposed rule of not more than 100 words in length required by the Providing Accountability Through Transparency Act of 2023. FOR FURTHER INFORMATION CONTACT: Chad Edinger, Program Specialist, OCSS Division of Regional Operations, at mail to: ocss.dpt@acf.hhs.gov or (303) 844– 1213. Telecommunications Relay users may dial 711 first. SUPPLEMENTARY INFORMATION: Submission of Comments Comments should be specific, address issues raised by the proposed rule, and explain reasons for any objections or recommended changes. Additionally, we will be interested in comments that indicate agreement with the proposal. We will not acknowledge receipt of the comments we receive. However, we will review and consider all comments that are relevant and received during the comment period. We will respond to these comments in the preamble to the final rule. Statutory Authority This NPRM is published under the authority granted to the Secretary of Health and Human Services by section 1102 of the Social Security Act (the Act) (42 U.S.C. 1302). Section 1102 of the Act authorizes the Secretary to publish regulations, not inconsistent with the Act, as may be necessary to the efficient administration of the functions with which the Secretary is responsible under the Act. This NPRM is also authorized by section 452(a)(1) of the Act, which states that the Secretary’s designee ‘‘shall establish such standards for State programs for locating noncustodial parents, establishing paternity, and obtaining child support . . . as he determines to be necessary to assure that such programs will be effective.’’ Section 454 of the Act establishes requirements that states must include in their title IV–D State plans, the costs of which are eligible for FFP under section 455 of the Act. Section 454(13) of the Act requires the State plan to ‘‘provide PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 47109 that the State will comply with such other requirements and standards as the Secretary determines to be necessary to the establishment of an effective program for locating noncustodial parents, establishing paternity, obtaining support orders, and collecting support payments . . . .’’ The rulemaking is also consistent with section 451, which authorizes federal funding to states for enforcing support obligations, obtaining child support payments, and assuring that assistance in obtaining support is available to all children. Background In 1975, Congress established the child support program under title IV–D of the Social Security Act (Pub. L. 93– 647). The child support program is administered at the federal level by the Office of Child Support Services (OCSS) and functions in 54 states and territories and over 60 tribes. When the child support program began, its primary focus was collecting child support to recover welfare costs, but that has changed significantly over time. Today, the program is focused on delivering family-centered child support services that improve the long-term financial and emotional support of children, by collecting and facilitating consistent child support payments based on the noncustodial parents’ ability to pay. This evolution has been guided by the changing needs of families, by federal legislation, and by research and data that contribute to OCSS’s understanding of the standards and requirements necessary to establish an effective child support program. Families and work have fundamentally changed since 1975. The percent of children who need child support services has increased and the ability of noncustodial parents to pay child support has declined. Families are more likely to divorce or never marry, increasing the likelihood that children will spend time apart from one of their parents. In 2021, 40 percent of births were to unmarried women, up from 14 percent in 1975.1 In FY 2022, the child support program served one in five children in the United States, or 12.8 1 U.S. Department of Health and Human Services, National Center for Health Statistics, ‘‘Nonmarital Childbearing in the United States, 1940–99,’’ National Vital Statistics Reports, 48: 16 (October 18, 2000), available at https://www.cdc.gov/nchs/data/ nvsr/nvsr48/nvs48_16.pdf. Osterman, Michelle J.K., Brady E. Hamilton, Joyce A. Martin, Anne K. Driscoll, and Claudia P. Valenzuela, ‘‘Births: Final Data for 2021,’’ National Vital Statistics Reports, 72: 1 (January 31, 2023), available at https:// www.cdc.gov/nchs/data/nvsr/nvsr72/nvsr72-01.pdf. E:\FR\FM\31MYP1.SGM 31MYP1

Agencies

[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Proposed Rules]
[Pages 47108-47109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11987]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 89, No. 106 / Friday, May 31, 2024 / Proposed 
Rules

[[Page 47108]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

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


Hazard Analysis and Risk-Based Preventive Controls for Human 
Food; Draft Guidance for Industry; Appendix 1; 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 a revised draft Introduction, and a 
revised draft Appendix 1, within a multichapter guidance for industry 
entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human 
Food'' which were announced in the Federal Register of February 2, 
2024. 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 February 2, 2024 (89 FR 7315). Submit either electronic or 
written comments by August 2, 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; Appendix 1.'' 
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 February 2, 2024 
(89 FR 7315), we published a notice announcing the availability of a 
revised draft Introduction, and a revised draft Appendix 1, within a 
multichapter guidance entitled ``Hazard Analysis and Risk-Based 
Preventive Controls for Human Food.'' The notice of availability opened 
a docket with a 120-day comment period, to close on June 3, 2024.
    We have received a request to extend the comment period for the 
revised draft Introduction, and revised draft Appendix 1. The request 
conveys that additional time would be helpful for stakeholders to fully 
evaluate and develop meaningful comments to the Introduction and 
Appendix which are

[[Page 47109]]

highly complex and detailed. We have considered the request and have 
concluded that an extension of the comment period by 60 days, until 
August 2, 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: May 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11987 Filed 5-30-24; 8:45 am]
BILLING CODE 4164-01-P

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