Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Enforcement Notifications, 73009 [05-23744]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 235 / Thursday, December 8, 2005 / Notices
Dated: December 1, 2005.
Joan Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E5–7040 Filed 12–7–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0457]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notice of a Claim
for Generally Recognized as Safe
Exemption Based on a Generally
Recognized as Safe Determination
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
[Docket No. 2005N–0186]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
State Enforcement Notifications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘State Enforcement Notifications’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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.
In the
Federal Register of September 14, 2005
(70 FR 54393), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0275. The
approval expires on November 30, 2008.
A copy of the supporting statement for
this information collection is available
on the Internet at ‘‘https://www.fda.gov/
ohrms/dockets’’.
SUPPLEMENTARY INFORMATION:
Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23744 Filed 12–7–05; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
16:29 Dec 07, 2005
Food and Drug Administration,
HHS.
Jkt 208001
ACTION:
Notice.
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
the procedures used for submitting a
Generally Recognized as Safe (GRAS)
notice stating that a particular use of a
substance is not subject to the premarket
approval requirements of the Federal
Food, Drug, and Cosmetic Act (the act).
DATES: Submit written or electronic
comments on the collection of
information by February 6, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (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 Robbins, Office of Management
Programs (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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
73009
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 in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (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.
Notice of a Claim for GRAS Exemption
Based on a GRAS Determination—21
CFR 170.36 and 570.36 (OMB Control
Number 0910–0342)—Extension
Section 409 of the act (21 U.S.C. 348)
establishes a premarket approval
requirement for ‘‘food additives;’’
section 201(s) of the act (21 U.S.C.
321(s)) provides an exemption from the
definition of ‘‘food additive’’ and thus
from the premarket approval
requirement, for uses of substances that
are GRAS by qualified experts. FDA is
proposing a voluntary procedure
whereby members of the food industry
who determine that use of a substance
satisfies the statutory exemption may
notify FDA of that determination. The
notice would include a detailed
summary of the data and information
that support the GRAS determination,
and the notifier would maintain a
record of such data and information.
FDA would make the information
describing the GRAS claim, and the
agency’s response to the notice,
available in a publicly accessible file;
the entire GRAS notice would be
publicly available consistent with the
Freedom of Information Act and other
Federal disclosure statutes.
Description of Respondents:
Manufacturers of Substances Used in
Food and Feed.
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 70, Number 235 (Thursday, December 8, 2005)]
[Notices]
[Page 73009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23744]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0186]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; State Enforcement Notifications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``State Enforcement Notifications''
has been approved by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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 the Federal Register of September 14,
2005 (70 FR 54393), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0275.
The approval expires on November 30, 2008. A copy of the supporting
statement for this information collection is available on the Internet
at ``https://www.fda.gov/ohrms/dockets''.
Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23744 Filed 12-7-05; 8:45 am]
BILLING CODE 4160-01-S
