[Federal Register Volume 64, Number 109 (Tuesday, June 8, 1999)]
[Notices]
[Pages 30524-30525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1522]


Agency Information Collection Activities: Proposed Collection; 
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 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 reporting requirements 
contained in existing FDA regulations governing temporary marketing 
permit applications.

DATES: Submit written comments on the collection of information by 
August 9, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (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 Schlosburg, Office of 
Information Resources Management (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 below.
    With respect to the following collection of information, 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.

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 ``whenever * * * 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) 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 
Sec. 130.17(c) enables the agency to monitor the manufacture, labeling, 
and distribution of experimental packs of food that deviate from 
applicable definitions or 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

[[Page 30525]]

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 Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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130.17(c)                               3               1               3              25              75
130.17(i)                               4               2               8               2              16
Total                                   7                              11                              91
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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 from October 1, 1995, through September 30, 1998, 
and information from firms that have submitted recent requests for 
temporary marketing permits.

    Dated: May 28, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-14401 Filed 6-7-99; 8:45 am]
BILLING CODE 4160-01-F