E9-10964. 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: [phone], or e-mailed to [e-mail]. 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. 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 §§ 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 Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per 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 Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Record	Total Hours
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.