[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29216-29217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13220]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0021]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

[[Page 29217]]


ADDRESSES: 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 [email protected]. 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.

FOR FURTHER INFORMATION CONTACT: 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, 
[email protected].

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.

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\
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                                                     Number of
    Activity; 21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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GRAS notification procedure for              100               1             100             170          17,000
 human food; 170.210-170.280
 (part 170, subpart E)..........
GRAS notification procedure for               25               1              25             170           4,250
 animal food and animal feed;
 570.210-570.280 (part 570,
 subpart E).....................
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    Total.......................  ..............  ..............              75  ..............          21,250
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\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.

    Dated: June 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13220 Filed 6-20-19; 8:45 am]
 BILLING CODE 4164-01-P