Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry; Availability, 16003-16004 [2024-04718]

Download as PDF Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices Written/Paper Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–5280] Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry; 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 final guidance for industry entitled ‘‘Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.’’ The guidance focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to FDA. DATES: The announcement of the guidance is published in the Federal Register on March 6, 2024 ADDRESSES: You may submit either electronic or written comments on FDA guidances at any time as follows: ddrumheller on DSK120RN23PROD with NOTICES1 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 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’’). VerDate Sep<11>2014 16:57 Mar 05, 2024 Jkt 262001 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– 2023–D–5280 for ‘‘Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: 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:// PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 16003 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 guidance to the Office of Dietary Supplement Programs, HFS– 810, 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 guidance. FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740; or Deirdre Jurand, Office of Regulations and Policy (HFS–024), Center for Food Safety and Applied Nutrition, 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 guidance for industry entitled ‘‘Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.’’ We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents 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 alternative approach if it satisfies the requirements of the applicable statutes and regulations. In the Federal Register of July 5, 2011 (76 FR 39111), we announced the availability of a draft guidance for industry entitled ‘‘Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues’’ and gave interested parties an opportunity to submit comments by October 3, 2011. Among other topics, the July 2011 draft guidance discussed FDA’s views and recommendations on when an ingredient intended for use in a dietary supplement is a new dietary ingredient (NDI), when the requirement to submit a new dietary ingredient notification (NDIN) to FDA applies, the types of data and information that manufacturers and distributors should consider when they E:\FR\FM\06MRN1.SGM 06MRN1 16004 Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 evaluate the safety of a dietary supplement containing an NDI, what to include in an NDIN (including recommendations about identity and safety information), and the procedures for submitting an NDIN. We received significant comments and decided to issue a revised draft guidance. In the Federal Register of August 12, 2016 (81 FR 53486), we announced the availability of a revised draft guidance for industry entitled ‘‘Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry’’ to replace the July 2011 draft guidance. In the notice of availability, we gave interested parties an opportunity to submit comments on the 2016 revised draft guidance by October 11, 2016. On October 4, 2016, we extended the comment period for the revised draft guidance to December 12, 2016 (81 FR 68434). We received numerous comments on the 2016 revised draft guidance, including requests for FDA to separate the 2016 revised draft guidance into discrete sections for ease of use. The final guidance whose availability we are announcing through this document reflects that approach. The guidance finalizes Section V of the 2016 revised draft guidance, ‘‘NDI Notification Procedures and Timeframes,’’ as well as several related questions from other sections. Changes since the revised draft guidance include providing the following: additional clarity on the procedures for preparing and submitting an NDIN; technical updates related to recent changes to our online submission portal for NDINs; and more information about communications with FDA during the NDIN review process. In addition, we made editorial changes to improve clarity. We understand the importance of finalizing other parts of the 2016 revised draft guidance, and we plan to finalize other individual sections as we complete our review and analysis of those sections. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). The collections of information in 21 CFR 190.6 and found in the guidance have been approved under OMB control number 0910–0330. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/FoodGuidances, https:// www.fda.gov/regulatory-information/ VerDate Sep<11>2014 16:57 Mar 05, 2024 Jkt 262001 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: February 29, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–04718 Filed 3–5–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP). FOR FURTHER INFORMATION CONTACT: CDR George Reed Grimes, Director, Division of Injury Compensation Programs, Health Systems Bureau, HRSA, by mail at 5600 Fishers Lane, 8W25A, Rockville, Maryland 20857; or call (301) 443–9350. SUPPLEMENTARY INFORMATION: Section 100.2 of the VICP’s implementing regulation (42 CFR part 100) states that the revised amount of an average cost of a health insurance policy, as determined by the Secretary of Health and Human Services (the Secretary), is effective upon its delivery by the Secretary to the United States Court of Federal Claims (the Court) and will be published periodically in a notice in the Federal Register. This responsibility has been delegated to the Director, Division of Injury Compensation Programs. This figure is calculated using the most recent Medical Expenditure Panel Survey—Insurance Component data available as the baseline for the average monthly cost of a health insurance policy. This baseline is adjusted by the annual percentage increase/decrease obtained from the most recent annual Kaiser Family Foundation Employer Health Benefits Survey. In 2023, the Medical Expenditure Panel Survey—Insurance Component, available at www.meps.ahrq.gov, published the annual 2022 average total single premium per enrolled employee at private-sector establishments that SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 provide health insurance. The figure published was $7,590. This figure is divided by 12 to determine the cost per month of $632.50. The $632.50 figure is increased or decreased by the percentage change reported by the most recent Kaiser Family Foundation Employer Health Benefits Survey, available at www.kff.org. The increase from 2022 to 2023 was 7 percent. By adding this percentage increase, the calculated average monthly cost of a health insurance policy for a 12-month period is $676.78. Therefore, the Secretary announces that the revised average cost of a health insurance policy under the VICP is $676.78 per month. In accordance with section 100.2, the revised amount was effective upon its delivery by the Secretary to the Court. Such notice was delivered to the Court on February 23, 2024. Suma Nair, Associate Administrator, Health System Bureau. [FR Doc. 2024–04734 Filed 3–5–24; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Neurological Disorders and Stroke Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend as well as those who need special assistance, such as sign language interpretation or other reasonable accommodations, must notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https:// videocast.nih.gov/). The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5, U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16003-16004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04718]



[[Page 16003]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5280]


Dietary Supplements: New Dietary Ingredient Notification 
Procedures and Timeframes: Guidance for Industry; 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 final guidance for industry entitled ``Dietary 
Supplements: New Dietary Ingredient Notification Procedures and 
Timeframes: Guidance for Industry.'' The guidance focuses on frequently 
asked questions about the new dietary ingredient notification 
submission and review process. The guidance is intended to help 
manufacturers and distributors of new dietary ingredients and dietary 
supplements prepare and submit new dietary ingredient notifications to 
FDA.

DATES: The announcement of the guidance is published in the Federal 
Register on March 6, 2024

ADDRESSES: You may submit either electronic or written comments on FDA 
guidances 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-2023-D-5280 for ``Dietary Supplements: New Dietary Ingredient 
Notification Procedures and Timeframes: 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)).
    Submit written requests for single copies of the guidance to the 
Office of Dietary Supplement Programs, HFS-810, 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 guidance.

FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740; or Deirdre Jurand, Office of Regulations and 
Policy (HFS-024), Center for Food Safety and Applied Nutrition, 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 guidance for industry 
entitled ``Dietary Supplements: New Dietary Ingredient Notification 
Procedures and Timeframes: Guidance for Industry.'' We are issuing this 
guidance consistent with our good guidance practices regulation (21 CFR 
10.115). The guidance represents 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 alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    In the Federal Register of July 5, 2011 (76 FR 39111), we announced 
the availability of a draft guidance for industry entitled ``Draft 
Guidance for Industry; Dietary Supplements: New Dietary Ingredient 
Notifications and Related Issues'' and gave interested parties an 
opportunity to submit comments by October 3, 2011. Among other topics, 
the July 2011 draft guidance discussed FDA's views and recommendations 
on when an ingredient intended for use in a dietary supplement is a new 
dietary ingredient (NDI), when the requirement to submit a new dietary 
ingredient notification (NDIN) to FDA applies, the types of data and 
information that manufacturers and distributors should consider when 
they

[[Page 16004]]

evaluate the safety of a dietary supplement containing an NDI, what to 
include in an NDIN (including recommendations about identity and safety 
information), and the procedures for submitting an NDIN. We received 
significant comments and decided to issue a revised draft guidance.
    In the Federal Register of August 12, 2016 (81 FR 53486), we 
announced the availability of a revised draft guidance for industry 
entitled ``Dietary Supplements: New Dietary Ingredient Notifications 
and Related Issues; Revised Draft Guidance for Industry'' to replace 
the July 2011 draft guidance. In the notice of availability, we gave 
interested parties an opportunity to submit comments on the 2016 
revised draft guidance by October 11, 2016. On October 4, 2016, we 
extended the comment period for the revised draft guidance to December 
12, 2016 (81 FR 68434). We received numerous comments on the 2016 
revised draft guidance, including requests for FDA to separate the 2016 
revised draft guidance into discrete sections for ease of use. The 
final guidance whose availability we are announcing through this 
document reflects that approach. The guidance finalizes Section V of 
the 2016 revised draft guidance, ``NDI Notification Procedures and 
Timeframes,'' as well as several related questions from other sections. 
Changes since the revised draft guidance include providing the 
following: additional clarity on the procedures for preparing and 
submitting an NDIN; technical updates related to recent changes to our 
online submission portal for NDINs; and more information about 
communications with FDA during the NDIN review process. In addition, we 
made editorial changes to improve clarity. We understand the importance 
of finalizing other parts of the 2016 revised draft guidance, and we 
plan to finalize other individual sections as we complete our review 
and analysis of those sections.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR 190.6 and found in the guidance 
have been approved under OMB control number 0910-0330.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
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: February 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04718 Filed 3-5-24; 8:45 am]
BILLING CODE 4164-01-P
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