[Federal Register Volume 66, Number 61 (Thursday, March 29, 2001)]
[Notices]
[Pages 17183-17184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7679]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0135]


Agency Emergency Processing Under OMB Review; Focus Group Study 
of Radiation Disclosure Statement Options for Foods Treated With 
Ionizing Radiation

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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information is a focus group study of radiation disclosure statement 
options for foods treated with ionizing radiation.

DATES: Submit written comments on the collection of information by 
April 9, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th Street NW., rm. 10235, Washington, DC 20503, 
Attn: Desk Officer for FDA. All comments should be identified with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:
    FDA has requested emergency processing of this proposed collection 
of information under section 3507(j) of the PRA (44 U.S.C. 3507(j)) and 
5 CFR 1320.13. The information is essential to FDA's commitment to 
Congress to finalize, by March 2002, any regulatory changes regarding 
radiation disclosure statement for foods treated with ionizing 
radiation. The use of normal PRA clearance procedures would not allow 
FDA to conduct this study within the next few months so that the 
results will be available to support in a timely way the ongoing policy 
development process.
    FDA invites comments on: (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.

Focus Group Study of Radiation Disclosure Statement Options for 
Foods Treated With Ionizing Radiation

    Under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 343), FDA is mandated to ensure that labeling 
statements be truthful and nonmisleading. In 1986, under section 409 of 
the act (21 U.S.C. 348), FDA issued regulations to require that the 
label and labeling of retail packages or displays of foods treated with 
ionizing radiation include both the radura logo (the international 
symbol that indicates radiation treatment) and a disclosure statement 
(either ``Treated with radiation'' or ``Treated by irradiation'') in 
addition to information required by other regulations (21 CFR 
179.26(c)(1) and (c)(2)). To gather information to determine if the 
existing requirements should be changed and how they should be changed, 
FDA proposes to conduct a series of six focus groups in three separate 
geographic locations, one of which will be in the Washington, DC area 
to facilitate the attendance of interested observers from FDA and 
industry and consumer stakeholders. The focus groups, eight to nine 
individuals per group, are to be held in April and May 2001. The 
objectives of the study are to collect information to: (1) Evaluate 
whether and under what conditions the current labeling requirement is 
an obstacle to consumer acceptance of irradiated foods, and (2) 
determine how other proposed versions of the disclosure statement might 
have different effects on consumer acceptance. The information will be 
used by FDA to determine if the existing requirements should be changed 
and how they should be changed and to fulfill FDA's commitment to 
Congress to finalize any regulatory changes by March 2002.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 17184]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                         Annual Frequency per        Total Annual
                  No. of Respondents                          Respondents             Respondents        Hours per Respondent         Total Hours
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54....................................................            1                      54                       1.5                    81
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 23, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-7679 Filed 3-28-01; 8:45 am]
BILLING CODE 4160-01-S