07-801. Substances Approved for Use in the Preparation of Meat and Poultry Products; Announcement of Effective Date

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; announcement of effective date.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the effective date for the information collection requirements contained in a final rule published in the Federal Register of August 25, 2000 (65 FR 51758). The rule amended FDA's regulations on food additive and color additive petitions to permit an efficient joint review by both FDA and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), of petitions for approval to use a food ingredient or source of radiation in or on meat or poultry products. An information collection requirement cannot be instituted unless it is reviewed by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA), approved by OMB, and assigned an OMB control number. OMB's approval of the information collection requirements of the August 25, 2000, final rule was announced in the Federal Register of March 1, 2001 (66 FR 12938), and these requirements are currently approved under OMB control number 0910-0016. Accordingly, FDA is announcing that the information collection requirements of the August 25, 2000, final rule will go into effect on March 26, 2007.

DATES:

Effective Date: The amendments to §§ 71.1 and 171.1 (21 CFR 71.1 and 171.1), published in the Federal Register of August 25, 2000, are effective as of March 26, 2007.

FOR FURTHER INFORMATION CONTACT:

Ellen M. Waldron, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1256.

SUPPLEMENTARY INFORMATION:

On August 25, 2000, FDA published a final rule entitled, “Substances Approved for Use in the Preparation of Meat and Poultry Products,” which, in part, amended its regulations to permit an efficient joint review by both FDA and FSIS of USDA, of petitions for approval to use a food ingredient or source of radiation in or on meat or poultry products. The final rule requires applicants petitioning for approval for the use of substances in meat and poultry products to provide four copies of the petition to FDA, rather than the three copies previously specified in §§ 71.1 and 171.1. FDA will then forward a copy of the petition or relevant portions of the petition to FSIS so that both agencies can perform the necessary reviews simultaneously, thus reducing the time it takes to authorize a food additive or color additive for use in meat and poultry products. The rule does not require petitioners to submit any new information to either FDA or FSIS. This final rule resulted from a coordinated effort by the two agencies to ease the paperwork burden on regulated industries through streamlining the Government's approval process for substances used as food additives or color additives in meat and poultry products (§§ 71.1 and 171.1).

At the time of publication of the final rule, the information collection requirements contained in §§ 71.1 and 171.1 had been submitted to, but not yet approved by, OMB under the PRA (44 U.S.C. 3501-3520). Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless and until the collection displays a valid OMB control number.

FDA announced OMB approval of the information collection requirements in §§ 71.1 and 171.1, as amended by FDA's August 25, 2000, final rule, in the Federal Register of March 1, 2001. The agency is now announcing that these requirements will become effective on March 26, 2007. The information collection requirements at §§ 71.1 and 171.1 were originally assigned OMB control number 0910-0461. In December 2003, OMB control number 0910-0016 replaced OMB control number 0910-0461 as the valid control number that authorizes the information collection requirements. OMB control number 0910-0016 remains the currently approved control number for §§ 71.1 and 171.1.

Dated: February 14, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.