Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications, 35402 [E8-14151]
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35402
Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Notices
ISO (International Organization for
Standardization). IOS 8243: Cigarettes—
Sampling. (1991). Second Edition. Prepared
by Technical Committee ISO/TC 126,
Tobacco and tobacco products. International
Organization for Standardization, Case
Postale 56, CH–1211 Genve 20, Switzerland.
Westgard, J.O., Barry P., Hunt M., and
Groth T. (1981). A multi-rule Shewhart chart
for quality control in clinical chemistry.
Clinical Chemistry 27:493.
[FR Doc. E8–14112 Filed 6–20–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0184]
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.
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.
SUMMARY:
Fax written comments on the
collection of information by July 23,
2008.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0133. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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.
DATES:
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 April 2,
2008 (73 FR 17986), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
130.17(c)
13
2
26
25
650
130.17 (i)
1
2
2
2
4
Total
1There
654
are no capital costs or operating and maintenance costs associated with this collection of information.
mmaher on PROD1PC70 with NOTICES
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, 2004,
through September 30, 2007, and
information from firms that have
submitted recent requests for temporary
marketing permits.
Dated: June 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14151 Filed 6–20–08; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
01:51 Jun 21, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–E–0440] (formerly
Docket No. 2006E–0483)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ERAXIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for ERAXIS
and is publishing this notice of that
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Notices]
[Page 35402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14151]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0184]
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.
-----------------------------------------------------------------------
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 July
23, 2008.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0133. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 April 2, 2008 (73 FR 17986), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
130.17(c) 13 2 26 25 650
--------------------------------------------------------------------------------------------------------------------------------------------------------
130.17 (i) 1 2 2 2 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 654
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, 2004, through September 30, 2007, and
information from firms that have submitted recent requests for
temporary marketing permits.
Dated: June 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14151 Filed 6-20-08; 8:45 am]
BILLING CODE 4160-01-S
