Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient, 62507 [E8-25091]
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Federal Register / Vol. 73, No. 204 / Tuesday, October 21, 2008 / Notices
Ethics Office, Financial Management
Office (FMO), Office of Commissioned
Corps Personnel, Coordinating Office for
Global Health (COGH), Office of
Personnel Management, Office of
Workforce and Career Development, and
Procurement and Grants Office (PGO);
(3) provides direct and daily
management and execution of the
coordination of laboratory and office
facilities, and supplies technical
guidance and expertise regarding
occupancy and facilities management to
emergency situations, CDC; (4) provides
direct and daily management and
execution of the distribution,
accountability, and maintenance of CDC
property and equipment; (5) provides
direct and daily management and
execution of micro purchases and
procurement requisitions, and performs
administrative tasks related to initiating,
processing and maintaining interagency
agreements; and provides training and
administration of policies and
procedures developed by PGO and FMO
regarding acquisitions; 6) provides
direct and daily management and
execution of the creation, organization,
access, maintenance, and disposition of
CCID records, and of the establishment
of policies and procedures coordinating
a CCID response to Freedom of
Information Act (FOIA) requests; and (7)
provides direct and daily management
and execution of the coordination of
logistics for CCID’s federal government
committee meetings and conferences.
Delete in their entirety the titles and
functional statements for the following:
Travel (CVA22), Personnel/Training
(CVA23), Procurement/Property/
Facilities (CVA24), and Records
Management/FOIA/Committee
Management/Conference Logistics
(CVA25).
Dated: October 8, 2008.
William H. Gimson,
Chief Operating Officer, Centers for Disease
Control and Prevention (CDC).
[FR Doc. E8–24812 Filed 10–20–08; 8:45 am]
BILLING CODE 4160–18–M
mstockstill on PROD1PC66 with NOTICES
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Premarket Notification for a New
Dietary Ingredient
Food and Drug Administration,
17:06 Oct 20, 2008
Jkt 217001
Dated: October 14, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–25091 Filed 10–20–08; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0548]
Authorization of Emergency Use of
Doxycycline Hyclate Tablet Emergency
Kits for Eligible United States Postal
Service Participants in the Cities
Readiness Initiative and Their
Household Members; Availability
ACTION:
[Docket No. FDA–2008–N–0170]
VerDate Aug<31>2005
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Premarket Notification for a New
Dietary Ingredient’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 19, 2008 (73 FR
34940), 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 0910–0330. The
approval expires on August 31, 2011. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Food and Drug Administration,
HHS.
Food and Drug Administration
HHS.
Notice.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for doxycycline hyclate tablet
emergency kits for eligible United States
Postal Service (USPS) participants in
the Cities Readiness Initiative (CRI) and
their household members. FDA is
issuing this Authorization under the
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
62507
Federal Food, Drug, and Cosmetic Act
(the act), as requested by the Biomedical
Advanced Research and Development
Authority (BARDA), Office of the
Assistant Secretary for Preparedness
and Response, HHS. The Authorization
contains, among other things,
conditions on the emergency use of
doxycycline hyclate tablet emergency
kits. The Authorization follows the
determination by the Secretary of the
Department of Homeland Security that
there is a significant potential for a
domestic emergency, involving a
heightened risk of attack with a
specified biological, chemical,
radiological, or nuclear agent or
agents—in this case, Bacillus anthracis.
On the basis of such determination,
Secretary of Health and Human Services
Michael O. Leavitt (the Secretary)
declared an emergency justifying the
authorization of the emergency use of
doxycycline hyclate tablets
accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a). The Authorization, which
includes an explanation of the reasons
for its issuance, is reprinted in this
Notice.
DATES: The Authorization is effective as
of October 3, 2008.
ADDRESSES: Submit written requests for
single copies of the Emergency Use
Authorization to the Office of
Counterterrorism and Emerging Threats
(HF–29), Food and Drug
Administration, 5600 Fishers Lane (HF–
29), rm. 14C–26, Rockville, MD 20857.
Send one self-addressed adhesive label
to assist that office in processing your
request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT:
Boris Lushniak, Office of
Counterterrorism and Emerging Threats
(HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4067.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the act (21 U.S.C.
360bbb–3), as amended by the Project
BioShield Act of 2004 (Public Law 108–
276), allows FDA to strengthen the
public health protections against
biological, chemical, nuclear, and
radiological agents. Among other things,
section 564 of the act allows FDA to
authorize the use of an unapproved
medical product or an unapproved use
of an approved medical product during
a domestic emergency, or a significant
E:\FR\FM\21OCN1.SGM
21OCN1
]]>Agencies
[Federal Register Volume 73, Number 204 (Tuesday, October 21, 2008)]
[Notices]
[Page 62507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25091]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0170]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Premarket Notification for a New
Dietary Ingredient
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Premarket Notification for a New
Dietary Ingredient'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 19, 2008 (73
FR 34940), 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 0910-0330.
The approval expires on August 31, 2011. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: October 14, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25091 Filed 10-20-08; 8:45 am]
BILLING CODE 4160-01-P
