Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2); Draft Guidance for Industry; Extension of Comment Period, 87589-87590 [2024-25567]

Download as PDF 87589 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices 2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and 5. Assess information collection costs. Proposed Project The National Violence Death Reporting System (NVDRS) (OMB Control No. 0920–0607, Exp. 9/30/ 2025)—Revision—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description Violence against others or oneself is a major public health problem in the United States and is a particular problem for the young: suicide and homicide were among the top four leading causes of death for Americans 10–44 and 1–34 years of age in 2022. A key to preventing these violent deaths is to understand and target their circumstances. Given the magnitude of helping inform efforts to prevent fatal school violence. To address duplication, the SAVD was phased out and the SAVD module in NVDRS will capture in depth information about such incidents. The Public Safety Officer Suicide Reporting module was also added to the system to capture more detailed information on suicides among public safety officers. This module includes information specific to first responders and builds upon elements collected as part of current NVDRS. Like the SAVD module, it is a tab in the NVDRS webbased system that only applies to a subset of incidents. NVDRS is an ongoing surveillance system that captures annual violent death counts, CDC aggregates deidentified data from each state into one national database that is analyzed and released in annual reports and other publications. A restricted access database is available for researchers to request access to NVDRS data for analysis and a web-based query system is open for public use that allows for electronic querying of data. NVDRS generates public health surveillance information at the national, state, and local levels that is more detailed, useful, and timely. The information helps identify where prevention efforts need to be focused. CDC requests OMB approval for an estimated 41,827 annual burden hours. There are no costs to respondents other than their time to participate. the problem, it is noteworthy that no national surveillance system for violent deaths existed in the U.S. until the National Violent Death Reporting System (NVDRS) was developed. NVDRS is a state-based surveillance system developed to monitor the occurrence of violent deaths (e.g., homicide, suicide, deaths due to legal intervention, deaths of undetermined intent, and unintentional firearm deaths) in the U.S. by collecting comprehensive data from multiple sources (e.g., death certificates, coroner/ medical examiner reports, law enforcement reports) into a useable, anonymous database. CDC received initial OMB approval for NVDRS in November 2004 and renewals through July 2020. This Revision request includes several minor updates: (1) implement updates to the web-based system to improve performance, functionality, and accessibility; (2) add new data elements to the system; and (3) make minimal revisions to the NVDRS Coding Manual. The School Associated Violent Death (SAVD) module was added in the previous Revision request on July 2020, due to the discontinuation of the SAVD Surveillance System (OMB Control No. 0920–0604). SAVD currently monitors school-associated violent deaths across the U.S. by abstracting data from media reports. These data play an important role in assessing national trends in school-associated violent deaths and lotter on DSK11XQN23PROD with NOTICES1 ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average burden per response (in hours) Number responses per respondent Total burden hours Type of respondent Form name Public Agencies ............. Web-based Data Entry ........................................ School Associated Violent Death Module ........... Public Safety Officer Suicide Reporting Module 56 45 56 1,350 1 429 30/60 30/60 10/60 37,800 23 4,004 Total ........................ .............................................................................. ........................ ........................ ........................ 41,827 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Food and Drug Administration SUMMARY: [FR Doc. 2024–25555 Filed 11–1–24; 8:45 am] [Docket No. FDA–2014–D–0055] BILLING CODE 4163–18–P Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2); Draft Guidance for Industry; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:28 Nov 01, 2024 Jkt 265001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Notice of availability; extension of comment period. The Food and Drug Administration (FDA or we) is extending the comment period for a draft guidance for industry entitled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2).’’ The draft guidance, when finalized, will describe our views on the next voluntary goals (Phase II (3-year)) for sodium reduction in a variety of identified categories of E:\FR\FM\04NON1.SGM 04NON1 87590 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices foods that are commercially processed, packaged, or prepared. These goals are intended to address the excessive intake of sodium in the current population to help reduce the burden of diet-related chronic disease, promote improvements in public health, and advance health equity by supporting a healthier food supply. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit either electronic or written comments on the draft guidance by January 13, 2025, 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’’). lotter on DSK11XQN23PROD 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.’’ VerDate Sep<11>2014 17:28 Nov 01, 2024 Jkt 265001 Instructions: All submissions received must include the Docket No. FDA– 2014–D–0055 for ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2).’’ 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)). Submit written requests for single copies of the draft guidance to the Nutrition Center of Excellence, Human Foods Program, Food and Drug PO 00000 Frm 00054 Fmt 4703 Sfmt 9990 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: Kasey Heintz, Nutrition Center of Excellence, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1376. SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2024 (89 FR 66727), we published a notice announcing the availability of a draft guidance entitled, ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry (Edition 2).’’ The draft guidance, when finalized, will describe our views on the next voluntary goals (Phase II (3-year)) for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. We provided a 90-day comment period for the draft guidance. We have received requests for a 90day extension of the comment period. In general, the requests explained that industry needed more time to thoroughly review the draft guidance against numerous product lines and that industry also anticipates a need to manage multiple critical initiatives from FDA, including a final rule on ‘‘healthy’’ labeling and a proposed rule on frontof-package nutrition labeling. We have considered the requests and are extending the comment period for an additional 60 days until January 13, 2025. We believe that this extension will allow adequate time for interested persons to submit comments without significantly delaying finalizing the guidance. Dated: October 29, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–25567 Filed 11–1–24; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Notices]
[Pages 87589-87590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25567]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0055]


Voluntary Sodium Reduction Goals: Target Mean and Upper Bound 
Concentrations for Sodium in Commercially Processed, Packaged, and 
Prepared Foods (Edition 2); Draft Guidance for Industry; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for a draft guidance for industry entitled ``Voluntary 
Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for 
Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 
2).'' The draft guidance, when finalized, will describe our views on 
the next voluntary goals (Phase II (3-year)) for sodium reduction in a 
variety of identified categories of

[[Page 87590]]

foods that are commercially processed, packaged, or prepared. These 
goals are intended to address the excessive intake of sodium in the 
current population to help reduce the burden of diet-related chronic 
disease, promote improvements in public health, and advance health 
equity by supporting a healthier food supply. The Agency is taking this 
action in response to requests for an extension to allow interested 
persons additional time to submit comments.

DATES: Submit either electronic or written comments on the draft 
guidance by January 13, 2025, 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 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-2014-D-0055 for ``Voluntary Sodium Reduction Goals: Target Mean and 
Upper Bound Concentrations for Sodium in Commercially Processed, 
Packaged, and Prepared Foods (Edition 2).'' 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 
the Nutrition Center of Excellence, Human Foods Program, 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: Kasey Heintz, Nutrition Center of 
Excellence, Human Foods Program, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1376.

SUPPLEMENTARY INFORMATION: 
    In the Federal Register of August 16, 2024 (89 FR 66727), we 
published a notice announcing the availability of a draft guidance 
entitled, ``Voluntary Sodium Reduction Goals: Target Mean and Upper 
Bound Concentrations for Sodium in Commercially Processed, Packaged, 
and Prepared Foods; Draft Guidance for Industry (Edition 2).'' The 
draft guidance, when finalized, will describe our views on the next 
voluntary goals (Phase II (3-year)) for sodium reduction in a variety 
of identified categories of foods that are commercially processed, 
packaged, or prepared. We provided a 90-day comment period for the 
draft guidance.
    We have received requests for a 90-day extension of the comment 
period. In general, the requests explained that industry needed more 
time to thoroughly review the draft guidance against numerous product 
lines and that industry also anticipates a need to manage multiple 
critical initiatives from FDA, including a final rule on ``healthy'' 
labeling and a proposed rule on front-of-package nutrition labeling.
    We have considered the requests and are extending the comment 
period for an additional 60 days until January 13, 2025. We believe 
that this extension will allow adequate time for interested persons to 
submit comments without significantly delaying finalizing the guidance.

    Dated: October 29, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-25567 Filed 11-1-24; 8:45 am]
BILLING CODE 4164-01-P
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