[Federal Register: March 29, 2005 (Volume 70, Number 59)]
[Notices]               
[Page 15863-15864]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr05-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0554]

 
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.

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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: 202-395-6974.

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


[[Page 15864]]

    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.
[FR Doc. 05-6086 Filed 3-28-05; 8:45 am]

BILLING CODE 4160-01-S