[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