[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Notices]
[Pages 21808-21809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10964]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0031]


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.

-----------------------------------------------------------------------

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 June 
10, 2009.

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: 202-395-6974, or e-mailed 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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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: Notification Procedure--(OMB 
Control Number 0910-0342)--Extension

    Section 409 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C.

[[Page 21809]]

348) establishes a premarket approval requirement for ``food 
additives;'' section 201(s) of the act (21 U.S.C. 321) provides an 
exemption from the definition off ``food additive'' and thus from the 
premarket approval requirement, for uses of substances that are 
Generally Recognized as Safe (GRAS) by qualified experts. In April 
1997, FDA proposed a voluntary procedure whereby manufacturers would 
notify FDA about a view that a particular use (or uses) of a substance 
is not subject to the statutory premarket approval requirements based 
on a determination that such use is GRAS (62 FR 18938, April 17, 1997). 
Proposed Sec. Sec.  170.36 and 570.36 provide a standard format for the 
voluntary submission of a notice. The notice would include a detailed 
summary of the data and information that support the GRAS 
determination, and the notifier would maintain a record of such data 
and information. FDA would make the information describing the subject 
of the GRAS notice, and the agency's response to the notice, available 
in a publicly accessible file; the entire GRAS notice would be publicly 
available consistent with the Freedom of Information Act and other 
Federal disclosure statutes.
    Description of Respondents: Manufacturers of Substances Used in 
Food and Feed.
    In the Federal Register of February 11, 2009 (74 FR 6894), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
170.36                            25                  1                 25                150              3,750
----------------------------------------------------------------------------------------------------------------
570.36                             5                  1                  5                150                750
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      4,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
----------------------------------------------------------------------------------------------------------------
170.36(c)(v)                      25                  1                 25                 15                375
----------------------------------------------------------------------------------------------------------------
570.36(c)(v)                       5                  1                  5                 15                 75
----------------------------------------------------------------------------------------------------------------
Total                                                                                                        450
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    In the proposed rule, FDA estimated that the Center for Food Safety 
and Applied Nutrition (CFSAN) would receive approximately 50 GRAS 
notices per year and that the Center for Veterinary Medicine (CVM) 
would receive approximately 10 GRAS notices per year. Although FDA 
requested comment on this estimate, the comments did not provide useful 
information regarding this issue. Therefore, FDA evaluated the number 
of notices received by CFSAN to date. CFSAN received 274 GRAS notices 
during the 11-year period from 1998 through 2008, for an average of 
approximately 25 GRAS notices per year. Based on this experience, FDA 
is revising its estimate of the annual number of GRAS notices submitted 
to CFSAN to be 25 or less. FDA also is revising its estimate of the 
annual number of GRAS notices submitted to CVM to be 5 or less.

    Dated: May 4, 2009.
Jeffrey Shuren
Associate Commissioner for Policy.
[FR Doc. E9-10964 Filed 5-8-09; 8:45 am]
BILLING CODE 4160-01-S