Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance: Emergency Use Authorization of Medical Products, 25456 [2013-10247]
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25456
Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Notices
Resettlement, 901 D Street SW.,
Washington, DC 20447, Telephone (202)
401–4997. Email:
jallyn.sualog@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: Since the
beginning of FY 2013, the
Unaccompanied Alien Children (UAC)
program has seen a dramatic increase in
the number of DHS referrals. The influx
of border crossers referred by DHS has
grown beyond anticipated rates
resulting in the need for a significant
increase in the number of shelter beds
and supportive services for the children.
The UAC program has specific
requirements for the provision of
services to unaccompanied alien
children. The named organizations were
chosen for the noncompetitive awards
because they already have the
infrastructure, licensing, and
appropriate levels of trained staff to
meet service requirements and the
urgent need for expanded services in
order to respond to the increased
numbers of unaccompanied children.
The immediate provision of services
will alleviate the buildup of children
held in border patrol stations while
awaiting placement in shelter care.
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 31, 2013, the Agency submitted
a proposed collection of information
entitled ‘‘Medical Devices; Inspection
by Accredited Persons Program’’ 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 0910–0510. The
approval expires on April 30, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Statutory Authority: Section 462 of the
Homeland Security Act, (6 U.S.C. 279) and
sections 235(c) and 235(d) of the William
Wilberforce Trafficking Victims Protection
Reauthorization Act of 2008, (8 U.S.C.
1232(c) and 1232(d)).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Eskinder Negash,
Director, Office of Refugee Resettlement.
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance: Emergency Use
Authorization of Medical Products
[FR Doc. 2013–10311 Filed 4–30–13; 8:45 am]
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Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Devices; Inspection by
Accredited Persons Program
AGENCY:
Food and Drug Administration,
HHS.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Devices; Inspection by
Accredited Persons Program’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
VerDate Mar<15>2010
14:21 Apr 30, 2013
Jkt 229001
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0867]
[FR Doc. 2013–10248 Filed 4–30–13; 8:45 am]
HHS.
BILLING CODE 4160–01–P
ACTION:
Food and Drug Administration
[Docket No. FDA–2012–N–0976]
ACTION:
[Docket No. FDA–2012–N–0427]
[FR Doc. 2013–10247 Filed 4–30–13; 8:45 am]
Ashley Brandon Foyle: Debarment
Order
Food and Drug Administration,
HHS.
Food and Drug Administration
Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 0910–0595. The
approval expires on March 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Emergency Use Authorization of
Medical Products’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 8, 2013, the Agency submitted
a proposed collection of information
entitled ‘‘Emergency Use Authorization
of Medical Products’’ 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
AGENCY:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Ashley Brandon Foyle for 5 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on a finding that Mr. Foyle
was convicted of introducing and
delivering for introduction into
interstate commerce a misbranded drug,
which relates to the development or
approval, including the process for
development or approval, of drug
products and to the regulation of drug
products under the FD&C Act. In
addition, FDA determined that the type
of conduct that served as the basis for
Mr. Foyle’s conviction undermines the
process for the regulation of drugs. Mr.
Foyle was given notice of the proposed
debarment and an opportunity to
request a hearing within the prescribed
timeframe by regulation but failed to
respond. Mr. Foyle’s failure to respond
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective May 1,
2013.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
E:\FR\FM\01MYN1.SGM
01MYN1
Agencies
[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Page 25456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10247]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0976]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance: Emergency Use
Authorization of Medical Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Emergency Use Authorization of
Medical Products'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On January 8, 2013, the Agency submitted a
proposed collection of information entitled ``Emergency Use
Authorization of Medical Products'' 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
0910-0595. The approval expires on March 31, 2016. A copy of the
supporting statement for this information collection is available on
the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10247 Filed 4-30-13; 8:45 am]
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