[Federal Register Volume 67, Number 104 (Thursday, May 30, 2002)]
[Notices]
[Pages 37835-37836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13589]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0052]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Temporary Marketing Permit Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by July 
1, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i) (OMB 
Control Number 0910-0133)--Extension

    Section 401 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 341) directs FDA to issue regulations establishing 
definitions and standards of identity for food ``[w]henever * * * such 
action will promote honesty and fair dealing in the interest of 
consumers * * *.'' Under section 403(g) of the act (21 U.S.C. 343(g)), 
a food that is subject to a definition and standard of identity 
prescribed by regulation is misbranded if it does not conform to such 
definition and standard of identity. Section 130.17 (21 CFR 130.17) 
provides for the issuance by FDA of temporary marketing permits that 
enable the food industry to test consumer acceptance and measure the 
technological and commercial feasibility in interstate

[[Page 37836]]

commerce of experimental packs of food that deviate from applicable 
definitions and standards of identity. Section 130.17(c) specifies the 
information that a firm must submit to FDA to obtain a temporary 
marketing permit. The information required in a temporary marketing 
permit application under [sect]130.17(c) enables the agency to monitor 
the manufacture, labeling, and distribution of experimental packs of 
food that deviate from applicable definitions of standards of identity. 
The information so obtained can be used in support of a petition to 
establish or amend the applicable definition or standard of identity to 
provide for the variations. Section 130.17(i) specifies the information 
that a firm must submit to FDA to obtain an extension of a temporary 
marketing permit.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                               Annual Frequency    Total Annual     Hours per
   21 CFR Section       No. of Respondents       per Response        Responses      Response       Total Hours
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130.17(c)            7                                1                 7             25             175
130.17(i)            4                                2                 8              2              16
  Total              .......................  ..................  ..............  ............       191
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated number of temporary marketing permit applications and 
hours per response is an average based on the agency's experience with 
applications received October 1, 1998, through September 30, 2001, and 
information from firms that have submitted recent requests for 
temporary marketing permits.

    Dated: May 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-13589 Filed 5-29-02; 8:45 am]
BILLING CODE 4160-01-S