[Federal Register: January 4, 2005 (Volume 70, Number 2)]
[Notices]               
[Page 366-367]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja05-48]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0554]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
from manufacturers of monoenergetic neutron sources in order to comply 
with an amendment to FDA's food additive regulations.

DATES: Submit written or electronic comments on the collection of 
information by March 7, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

    In the Federal Register of December 21, 2004 (69 FR 76401), FDA 
announced OMB's approval of this collection of information (OMB control 
number 0910-0549). Since this was an emergency approval that expires on 
January 31, 2005, FDA is following the normal PRA clearance procedures 
by issuing this document.
    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

[[Page 367]]

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

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                                                       Total Operating
               21 CFR Section                      No. of       Annual Frequency    Total Annual        Hours per       & Maintenance      Total Hours
                                                 Respondents      per Response        Responses         Response            Costs
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179.21(a)(5), (b)(1)(iv), 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.

    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: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-29 Filed 1-3-05; 8:45 am]

BILLING CODE 4160-01-S