[Federal Register Volume 64, Number 168 (Tuesday, August 31, 1999)]
[Notices]
[Pages 47508-47509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22605]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-1522]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Temporary Marketing Permit Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 (the PRA).
DATES: Submit written comments on the collection of information by
September 30, 1999.
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:
Wendy Taylor, 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 ``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
[[Page 47509]]
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 to FDA to obtain an extension of a temporary
marketing permit.
In the Federal Register of June 8, 1999 (64 FR 30524), the agency
requested comments on the proposed collections of information. No
significant comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
130.17(c) 3 1 3 25 75
130.17(I) 4 2 8 2 16
Total 91
----------------------------------------------------------------------------------------------------------------
\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: August 25, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-22605 Filed 8-30-99; 8:45 am]
BILLING CODE 4160-01-F
