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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure

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Food and Drug Administration, HHS.




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.


Fax written comments on the collection of information by July 22, 2019.

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To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to All comments should be identified with the OMB control number 0910-0342. Also include the FDA docket number found in brackets in the heading of this document.

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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,

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

Substances Generally Recognized as Safe (GRAS): Notification Procedure—21 CFR Part 170, Subpart E and 21 CFR Part 570, Subpart E

OMB Control Number 0910-0342—Extension

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that all food additives (as defined by section 201(s) (21 U.S.C. 321(s)) be approved by FDA before they are marketed. Section 409 of the FD&C Act (21 U.S.C. 349) establishes a premarket approval requirement for “food additives.” Section 201(s) of the FD&C Act provides an exclusion to the definition of food additive and thus from the premarket approval requirement, for uses of substances that are GRAS by qualified experts. The GRAS provision of section 201(s) of the FD&C Act is implemented in (part 170) 21 CFR part 170 and (part 570) 21 CFR part 570 for human food and animal food, respectively. Part 170, subpart E and part 570, subpart E provide a standard format for the submission of a notice. This collection utilizes a voluntary administrative procedure for notifying FDA about a conclusion that a substance is GRAS under the conditions of its intended use in human food or animal food. The information submitted to us in a GRAS notice is necessary to allow us to administer efficiently the FD&C Act's various provisions that apply to the use of substances added to food, specifically with regard to whether a substance is GRAS under the conditions of its intended use or is a food additive subject to premarket review. We use the information collected through the GRAS notification procedures to complete our evaluation within specific timelines.

Description of Respondents: The respondents to this collection of information are manufacturers of substances used in human food and animal food and feed.

In the Federal Register of March 12, 2019 (84 FR 8876), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of the information collection as follows:

Table 1—Estimated Annual Reporting Burden 1

Activity; 21 CFR sectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
GRAS notification procedure for human food; 170.210-170.280 (part 170, subpart E)100110017017,000
GRAS notification procedure for animal food and animal feed; 570.210-570.280 (part 570, subpart E)251251704,250
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimated burden reflects an overall increase of 8,500 hours, which corresponds to an increase in GRAS submissions for human food from 50 to 100 we have received over the last 2 years.

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Dated: June 17, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-13220 Filed 6-20-19; 8:45 am]