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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” The draft guidance, when finalized, will advise the dietary supplement industry of our intent to exercise enforcement discretion, for a limited time and in limited circumstances, regarding the requirement to submit a new dietary ingredient (NDI) notification prior to marketing. The purpose of the policy is to encourage manufacturers and distributors of certain NDI-containing dietary supplements to correct any past failures to submit a required NDI notification.
Submit either electronic or written comments on the draft guidance by July 19, 2022 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by July 19, 2022.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2022-D-0281 for “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” 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.
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.
Submit comments on the information collection under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) at https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The title of this proposed collection is “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification; Draft Guidance for Industry.”
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 Office of Dietary Supplement Programs, 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.
With regard to the draft guidance: Laura Rich, 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, 240-402-8152; or Alexandra Jurewitz, 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.
With regard to the proposed collection of information: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
We are announcing the availability of a draft guidance for industry entitled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA 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.
The draft guidance, when finalized, will advise manufacturers and distributors of certain NDI-containing dietary supplements (namely, those that are subject to the premarket notification requirement and are being marketed without such a notification) of FDA's intent to exercise enforcement discretion for such firms to submit a late NDI notification for a limited time and in limited circumstances.
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.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the ( printed page 30845) information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This draft guidance, when finalized, is intended to advise the dietary supplement industry of our intent to exercise enforcement discretion, for a limited time and in limited circumstances, regarding the requirement to submit an NDI notification prior to marketing. The purpose of the policy is to encourage manufacturers and distributors of certain NDI-containing dietary supplements to correct any past failures to submit an NDI notification as required by § 190.6 (21 CFR 190.6). The proposed information collection requests that manufacturers and distributors who submit a late NDI notification under the enforcement discretion policy in the draft guidance supplement the notification with the following additional information: (1) A copy of the current label for the dietary supplement containing the NDI and (2) documentation to demonstrate the date that the dietary supplement was first introduced or delivered for introduction into interstate commerce.
We are developing a new submission type in the CFSAN Online Submission Module that will be used for late notifications submitted under the temporary enforcement discretion policy if the draft guidance is finalized. A draft screenshot of the questions specific to late notifications is available for comment at https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient.
Description of Respondents: The respondents to this collection of information are manufacturers and distributors in the dietary supplement industry; specifically, firms that failed to comply with the NDI notification requirements in § 190.6 and that wish to take advantage of FDA's temporary enforcement discretion policy to submit a late NDI notification.
FDA estimates the burden of this collection of information as follows:
| Activity | Number of respondents | Number of responses per respondent | Total responses | Average burden per response (in hours) | Total hours |
|---|---|---|---|---|---|
| Submit product label and documentation of date of introduction into interstate commerce to FDA | 3,500 | 1 | 3,500 | 0.30 (18 minutes) | 1,050 |
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
The estimates in table 1 are based on our experience with our current NDI program. We estimate that 3,500 respondents will submit their product labels and documentation of dates of introduction into interstate commerce and that each respondent will submit 1 product label and corresponding documentation of date of introduction into interstate commerce. We further estimate that preparing and submitting each response will take approximately 0.30 hour (18 minutes), resulting in a total reporting burden of 1,050 hours (3,500 responses × 0.30 hour). This will be a temporary collection of information, as we expect to conduct this program for 6 months.
This draft guidance also refers to previously approved FDA collections of information. The collections of information in § 190.6 have been approved under OMB control number 0910-0330.
Dated: May 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10942 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P
11 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.