Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance: Emergency Use Authorization of Medical Products, 25456 [2013-10247]

Download as PDF 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] BILLING CODE 4184–45–P 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 BILLING CODE 4160–01–P 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.

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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]
BILLING CODE 4160-01-P