Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling: Notification Procedures for Statements on Dietary Supplements

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments (including recommendations) on the collection of information by July 13, 2022.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to 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 OMB control number for this information collection is 0910-0331. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Food Labeling: Notification Procedures for Statements on Dietary Supplements—21 CFR 101.93

OMB Control Number 0910-0331—Extension

Section 403(r)(6) (21 U.S.C. 343(r)(6)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and § 101.93 (21 CFR 101.93) require that, no later than 30 days after the first marketing, we be notified by the manufacturer, packer, or distributor of a dietary supplement that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in section 403(r)(6) of the FD&C Act. In accordance with these requirements, submissions must include: (1) the name and address of the manufacturer, packer, or distributor of the dietary supplement product; (2) the text of the statement that is being made; (3) the name of the dietary ingredient or supplement that is the subject of the statement; (4) the name of the dietary supplement (including the brand name); and (5) the signature of a responsible individual or the person who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

Our electronic form (Form FDA 3955) allows respondents to the information collection to electronically submit notifications to FDA via the Food Applications Regulatory Management (FARM) system. Firms that prefer to submit a paper notification in a format of their own choosing will still have the option to do so; however, Form FDA 3955 prompts respondents to include certain elements in their structure/function claim notification (SFCN) described in § 101.93 in a standard electronic format and helps respondents organize their SFCN to include only the information needed for our review of the claim. Note that the SFCN, whether electronic or paper, is used for all claims made pursuant to section 403(r)(6) of the FD&C Act, including nutrient deficiency claims and general well-being claims in addition to structure/function claims. The electronic form, and any optional elements prepared as attachments to the form ( e.g., label), can be submitted in electronic format via FARM. Submissions of SFCNs will continue to be allowed in paper format. We use this information to evaluate whether statements made for dietary ingredients or dietary supplements are permissible under section 403(r)(6) of the FD&C Act.

Description of Respondents: Respondents to this collection of information include manufacturers, packers, or distributors of dietary supplements that bear section 403(r)(6) of the FD&C Act statements on their labels or labeling.

In the Federal Register of December 2, 2021 (86 FR 68504), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

We estimate the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. This estimate is based on our experience with this information collection and the number of notifications received in the past 3 years, which has remained constant.