[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Notices]               
[Page 18029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap05-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0564]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 9, 
2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

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: 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 commerce of 
experimental packs of food that deviate from applicable definitions and 
standards of identity. Section 130.17(c) enables the agency to monitor 
the manufacture, labeling, and distribution of experimental packs of 
food that deviate from applicable definitions and 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.
    In the Federal Register of January 13, 2005 (70 FR 2411), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of the collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                          Number of       Annual Frequency per  Total Annual    Hours per
  21 CFR section         Respondents            Response          Responses     Response         Total hours
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130.17(c)                           3                     2             6            25                   150
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130.17(i)                           4                     2             8             2                    16
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Total               ....................  ....................  ............  ............               166
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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, 2001, through September 30, 2004, and 
information from firms that have submitted recent requests for 
temporary marketing permits.

    Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7021 Filed 4-7-05; 8:45 am]

BILLING CODE 4160-01-S