05-6086. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Irradiation in the Production, Processing, and Handling of Food

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 April 28, 2005.

ADDRESSES:

OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: [phone].

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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.

Irradiation in the Production, Processing, and Handling of Food—21 CFR 179.21 (OMB Control Number 0910-0549)—Extension

Under section 409(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(a)), the use of a food additive is deemed unsafe unless it conforms to the terms of a regulation prescribing its use, or to an exemption for investigational use, or in the case of a food additive that is a food contact substance, there is in effect a regulation prescribing the conditions under which such additive may be safely used or a notification that is effective. In response to a petition that is submitted under section 409 of the act to establish that a food additive is safe, the agency may either: (1) By order establish a regulation (whether or not in accord with that proposed by the petitioner) prescribing, with respect to one or more proposed uses of the food additive involved, the conditions under which such additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity which may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and shall notify the petitioner of such order and the reasons for such action; or (2) by order deny the petition and notify the petitioner of such order and of the reasons for such action.

In response to a petition filed by Science Applications International Corp., who subsequently transferred their rights to the petition to Ancore Corp., FDA published in the Federal Register of December 21, 2004, a document that amended 21 CFR 179.21 to provide for the use of sources of monoenergetic neutrons to inspect cargo containers that may contain food. Under this regulation, monoenergetic neutron sources producing neutrons at energies not less than 1 million electron volts (MeV) but no greater than 14 MeV may be used for inspection of cargo containers that may contain food, providing that the neutron source bears a label stating the minimum and maximum energy of radiation emitted by the source. The regulation also requires that the label or accompanying labeling bear adequate directions for safe use and a statement that no food shall be exposed to this radiation source so as to receive a dose in excess of 0.01 gray. FDA has determined that this information is needed to assure safe use of the source of radiation.

In the Federal Register of January 4, 2005 (70 FR 366), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

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

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	Number of Respondents	Annual Frequency Per Response	Total Annual Responses	Hours Per Response	Total Operating and Maintenance Costs	Total Hours
179.21(a)(5) and (b)(2)(v)	1	1	1	1	$100	1
1 There are no capital costs associated with this collection of information.

FDA estimates that the burden will be insignificant because the reporting requirement reflects customary business practice. Based on discussions with an industry representative, the burden hours estimated for this collection of information is 1 hour. The operating and maintenance cost associated with this collection is $100 for preparation of labels.

Dated: March 21, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.