Food and Drug Administration, HHS.
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.
Submit written or electronic comments on the collection of information by March 7, 2005.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 Start Printed Page 367their 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:
|21 CFR Section||No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Operating & Maintenance Costs||Total Hours|
|179.21(a)(5), (b)(1)(iv), 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.Start Signature
Dated: December 28, 2004.
Assistant Commissioner for Policy.
[FR Doc. 05-29 Filed 1-3-05; 8:45 am]
BILLING CODE 4160-01-S