E6-19201. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions

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 December 15, 2006.

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].

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 Additive Petitions—21 CFR Part 571 (OMB Control Number 0910-0546)—Extension

Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(a)), provides that a food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Section 409(b) of the act (21 U.S.C. 348(b)) specifies the information that must be submitted by a petition in order to establish the safety of a food additive and to secure the issuance of a regulation permitting its use.

To implement the provision of section 409 of the act (21 U.S.C. 348), procedural regulations have been issued under part 571 (21 CFR part 571). These procedural regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broader terms by the law. The regulations add no substantive requirements to those indicated in the law, but attempt to explain the requirements and provide a standard format for submission to speed the processing of the petition. Labeling requirements for food additives intended for animal consumption are also set forth in various regulations contained in 21 CFR parts 573 and 582. The labeling regulations are considered by FDA to be cross-referenced to § 571.1, which is the subject of this same OMB clearance for food additive petitions.

On September 29, 2004, OMB approved a new information collection on food additive petitions submitted by the Center for Veterinary Medicine (CVM). The terms of clearance for this information collection stated that, given the interrelatedness of this collection to the information collected under OMB control number 0910-0016 by the Center for Food Safety and Applied Nutrition (CFSAN), FDA should consider merging the two collections. In consultation with CFSAN, CVM has decided not to merge these two collections, because what was once a food additive petitions approval (OMB control number 0910-0016), is now also the approval for affirmation of generally recognized as safe (GRAS) status (formerly OMB control number 0910-0132), labeling requirements for color additives (other than hair dyes) and petitions (formerly OMB control number 0910-0185), electronic submission of food and color additive petitions (formerly OMB control number 0910-0480), and substances approved for use in the preparation of meat and poultry products (formerly OMB control number 0910-0461). Thus, adding one CVM process to a collection now containing four dissimilar CFSAN processes is not justifiable any more. Finally, the CVM food additive petition process stems from a different section of the CFR and the two processes are handled separately. CVM's food additive petition process relates to part 571; CFSAN's process relates to 21 CFR part 171. There is no efficiency in discussing these separate processes in a single collection of information.

Respondents are expected to be the veterinary feed industry.

FDA estimates the burden of this collection of information as follows:

The estimated annual burden for this information collection is 18,000 hours.

Food additive petitions submitted to CVM are estimated to fall into one of two categories of complexity that also can be used to represent estimates of the information collection burden for food additive petitions. These include only expected petitions for food additives not eligible for exemption under new section 409(h) of the act (21 U.S.C. 348(h)).

Under § 571.1(c) moderate category, for a food additive petition without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per petition is approximately 3,000 hours. An average of one petition of this type is received on an annual basis, resulting in a burden of 3,000 hours.

Under § 571.1(c) complex category, for a food additive petition with complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per petition is approximately 10,000 hours. An average of one petition of this type is received on an annual basis, resulting in a burden of 10,000 hours.

Under § 571.6, for a food additive petition amendment, the estimated time requirement per petition is approximately 1,300 hours. An average of four petitions of this type are received on an annual basis, resulting in a burden of 5,200 hours.

In the Federal Register of September 1, 2006 (71 FR 52124), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
571.1(c) moderate category	1	1	1	3,000	3,000
571.1(c) complex category	1	1	1	10,000	10,000
571.6	2	2	4	1,300	5,200
Total					18,200
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: November 6, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.