Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications, 18029 [05-7021]
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18029
Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices
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at https://www.cms.hhs.gov/faca.
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(42 U.S.C. 13951(t)(9)(A). The Panel is
governed by the provisions of Pub. L. 92–463,
as amended (5 U.S.C. Appendix 2).
(Catalog of Federal Domestic Assistance
Program No. 93.774, MedicareSupplementary Medical Insurance Program)
Dated: March 31, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–6862 Filed 4–7–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0564]
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 May 9,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (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 ‘‘[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 January 13,
2005 (70 FR 2411), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of the
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Number of Respondents
21 CFR section
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total hours
130.17(c)
3
2
6
25
150
130.17(i)
4
2
8
2
16
Total
1There
166
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, 2001,
through September 30, 2004, and
information from firms that have
submitted recent requests for temporary
marketing permits.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7021 Filed 4–7–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0565]
Food and Drug Administration,
HHS.
ACTION:
BILLING CODE 4160–01–S
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
VerDate jul<14>2003
19:00 Apr 07, 2005
Jkt 205001
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Frm 00074
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Fax written comments on the
collection of information by May 9,
2005.
DATES:
Agency Information Collection
Activities; Submission for Office of
Managment and Budget Review;
Comment Request; State Petitions for
Exemption From Preemption
AGENCY:
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.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
ADDRESSES:
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Page 18029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7021]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0564]
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 May 9,
2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (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 ``[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 January 13, 2005 (70 FR 2411), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of the collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of Annual Frequency per Total Annual Hours per
21 CFR section Respondents Response Responses Response Total hours
----------------------------------------------------------------------------------------------------------------
130.17(c) 3 2 6 25 150
----------------------------------------------------------------------------------------------------------------
130.17(i) 4 2 8 2 16
----------------------------------------------------------------------------------------------------------------
Total .................... .................... ............ ............ 166
----------------------------------------------------------------------------------------------------------------
\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, 2001, through September 30, 2004, and
information from firms that have submitted recent requests for
temporary marketing permits.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7021 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S
