[Federal Register: August 31, 1999 (Volume 64, Number 168)]
[Notices]               
[Page 47508-47509]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au99-96]                         


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