[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://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