Justification for a Single Source Cooperative Agreement Award for the World Health Organization, 46824-46825 [2014-18836]

Download as PDF 46824 13441 .......... 16196 .......... Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices CTBC Bank ............................................................................ First Financial Credit Union .................................................... Torrance ................................................. West Covina ........................................... California. California. Federal Home Loan Bank of Seattle—District 12 14722 10928 09184 03773 14711 09457 01625 01265 02841 .......... .......... .......... .......... .......... .......... .......... .......... .......... First Security Bank ................................................................. Stockman Bank of Montana ................................................... Pacific Continental Bank ........................................................ First Federal Savings & Loan Association ............................. Albina Community Bank ......................................................... Home Savings Bank ............................................................... Timberland Bank .................................................................... Raymond Federal Bank ......................................................... First Savings Bank Northwest ................................................ II. Public Comments To encourage the submission of public comments on the community support performance of Bank members, on or before August 26, 2014, each Bank will notify its Advisory Council, nonprofit housing developers, community groups and other interested parties in its district of the members of the Bank selected for this review cycle. 12 CFR 1290.2(b)(2)(ii). In reviewing a member for community support compliance, FHFA will consider any public comments it has received concerning the member. 12 CFR 1290.2(d). To ensure consideration by FHFA, comments concerning the community support performance of members selected for this review cycle must be submitted to FHFA, either by electronic mail to hmgcommunitysupportprogram@ fhfa.gov, or by fax to 202–649–4130, on or before September 25, 2014. Dated: August 6, 2014. Melvin L. Watt, Director, Federal Housing Finance Agency. [FR Doc. 2014–18977 Filed 8–8–14; 8:45 am] BILLING CODE 8070–01–P GENERAL SERVICES ADMINISTRATION [Notice: MVA–2014–01; Docket 2014–0002; Sequence 24] Discontinuance of the Looseleaf Version of the General Services Administration Acquisition Manual (GSAM) Office of Acquisition Policy, Office of Government-wide Policy, General Services Administration (GSA). ACTION: Notice. mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: As part of GSA’s effort to increase efficiency and promote environmental sustainability, the Office of Government-wide Policy (OGP) has determined that it will no longer produce the looseleaf version of the SUMMARY: VerDate Mar<15>2010 17:35 Aug 08, 2014 Jkt 232001 Bozeman ................................................ Miles City ............................................... Eugene ................................................... McMinnville ............................................ Portland .................................................. Salt Lake City ......................................... Hoquiam ................................................. Raymond ................................................ Renton .................................................... B. Procedures General Services Administration Acquisition Manual (GSAM). DATES: The GSAM and related documents can be found at gsa.gov/gsam. Effective: August 11, 2014. FOR FURTHER INFORMATION CONTACT: Montana. Montana. Oregon. Oregon. Oregon. Utah. Washington. Washington. Washington. For clarification of content, contact Mr. Nicholas West of the Office of Government-wide Policy at 703–605– 2834. SUPPLEMENTARY INFORMATION: Dated: August 6, 2014. Jeffrey Koses, Senior Procurement Executive, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2014–18918 Filed 8–8–14; 8:45 am] BILLING CODE 6820–61–P A. Background Looseleaf pages of the GSAM were originally made available at a time when it was the only means to view a change to the regulation in comparison with the existing text until the publication of the next volume of Title 48 of the Code of Regulations (48 CFR, Chapter 5) on the following October 1. Patrons who maintained the regulations in looseleaf could purchase subscriptions from the Government Printing Office (GPO) and when any change to the GSAM occurred; they would be sent the new pages. At best, it could be weeks and even months before patrons would receive the latest changes. With the coming of new technology, GSA began producing these pages and sending them to patrons electronically. Because of today’s technologies, those who follow the GSAM can view and print the latest changes on the day the changes are published in the Federal Register. Through the years, GSA continued to produce the looseleaf pages for these changes although the need for them has become almost nonexistent. GSA has come to the conclusion that the time that it takes to produce the pages for information already available is not an efficient use of government resources and has decided to discontinue the production of the looseleaf versions of the GSAM immediately. In addition, printing updated pages for those maintaining looseleaf binders of the regulations will no longer be necessary, which supports environmental sustainability. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Justification for a Single Source Cooperative Agreement Award for the World Health Organization Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: A natural re-emergence of smallpox is not deemed possible, but if it were to occur as a result of a terrorist or deliberate event, it would be a potentially devastating threat to public health worldwide and would constitute a public health emergency of international concern (PHEIC) under the International Health Regulations (IHR) (2005). A case of smallpox detected by a member state requires notification to World Health Organization (WHO) as soon as possible, and any confirmed smallpox case would generate an immediate global public health response. WHO must rely on fast and reliable laboratory diagnostic capacity worldwide to be able to identify a reemergence of smallpox, particularly in countries where systemic orthopoxvirus infections such as monkeypox, vaccinia virus infection or cowpox, and other non-pox viral rash illnesses, such as chicken pox, may cause clinical diagnostic confusion. Over the past 10 years, clinical virology laboratory diagnostics has been evolving and increasingly rely on SUMMARY: E:\FR\FM\11AUN1.SGM 11AUN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices molecular techniques. This is also true with laboratory diagnoses of poxvirus infections. Precise and consistent identification of orthopoxviruses, in particular variola viruses, is now achievable using such molecular techniques as real-time Polymerase Chain Reaction (unlike earlier techniques that may have relied on direct virus isolation and identification). Additionally, the U.S. Government supports the development of other medical products, including vaccines and drugs, for use within the U.S. upon verification of a smallpox case. The U.S. Government, through the Office of the Assistant Secretary for Preparedness and Response (ASPR), has successfully developed vaccine products, and is actively engaged in the development of several drug candidates for smallpox therapies which require access to the Variola virus to satisfy regulatory requirements for product approvals. Period of Performance: September 30, 2014 to September 29, 2015. FOR FURTHER INFORMATION CONTACT: The agency program contact is Julie Schafer, who can be contacted by phone at 202– 205–1435or via email at Julie.Schafer@ hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to Sections 42 U.S.C. 241 and 247d–7e (Sections 301 and 319L of the Public Health Service Act); ASPR’s Office of Biomedical Advanced Research and Development Authority (BARDA) is the program office for this award. Justification: WHO is the only eligible applicant; it is the only organization that is allowed by international agreements to address the issues outlined in this proposal. WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. In the 21st century, health is a shared responsibility, involving equitable access to essential care and collective defense against transnational threats. States Parties to the U.N. have agreed to international standards on reporting public health incidents of concern under IHR (2005). Additionally, a majority of States Parties have also agreed to specific work-frames for pathogens such as smallpox under the Biological Weapons Convention. Since May 1999, when the 52nd World Health Assembly (WHA) resolved to postpone the destruction of the Variola virus to allow for essential VerDate Mar<15>2010 17:35 Aug 08, 2014 Jkt 232001 research (WHA 52.10), WHO has been charged with convening a group of experts to advise on the need for continuing such research, to review proposals for research involving viable Variola virus, to review the progress of such research, and to report to the WHA each year. The need to support the activities described in this project has not changed. In fact, WHO Member States continue to exert pressure for the WHO Secretariat to carry out this work. The WHO Advisory Committee on Variola Virus Research (ACVVR) was established in 1999 to determine what essential research, if any, must be carried out with live Variola virus. The ACVVR monitored the research progress in order to reach global consensus on the timing for the destruction of existing Variola virus stocks. In 2007, the WHA requested the ACVVR undertake a thorough review of the approved research program with a report presented in 2010. The results were presented at the 64th WHA meeting in May of 2011. The ACVVR continues to serve a critically important function for global public health, and to oversee research requested specifically by the U.S. to complete its national strategic goals. This includes the development of new antiviral agents, safer vaccines, and better diagnostics, thus strengthening our national security. Estimated amount of award: up to $662,500 USD. HHS/ASPR/BARDA: $225,000 DOD: $250,000 (funds pending) HHS/NIH/NIAID: $50,000 HHS/CDC: $87,500 HHS/OGA: $50,000 Procedures for Providing Public Input: All written comments must be received no later than 15 days after the posting of this announcement. Please submit comments via asprgrants@hhs.gov. Date: August 4, 2014. Nicole Lurie, Assistant Secretary for Preparedness and Response. [FR Doc. 2014–18836 Filed 8–8–14; 8:45 am] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–14–14AQA] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC), as part of its PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 46825 continuing effort to reduce public burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404–639–7570 or send comments to Leroy Richardson, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Written comments should be received within 60 days of this notice. Proposed Project The Enhanced STD surveillance Network (eSSuN)—New—Division of STD Prevention (DSTDP), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). E:\FR\FM\11AUN1.SGM 11AUN1

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[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46824-46825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Justification for a Single Source Cooperative Agreement Award for 
the World Health Organization

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: A natural re-emergence of smallpox is not deemed possible, but 
if it were to occur as a result of a terrorist or deliberate event, it 
would be a potentially devastating threat to public health worldwide 
and would constitute a public health emergency of international concern 
(PHEIC) under the International Health Regulations (IHR) (2005). A case 
of smallpox detected by a member state requires notification to World 
Health Organization (WHO) as soon as possible, and any confirmed 
smallpox case would generate an immediate global public health 
response.
    WHO must rely on fast and reliable laboratory diagnostic capacity 
worldwide to be able to identify a re-emergence of smallpox, 
particularly in countries where systemic orthopoxvirus infections such 
as monkeypox, vaccinia virus infection or cowpox, and other non-pox 
viral rash illnesses, such as chicken pox, may cause clinical 
diagnostic confusion.
    Over the past 10 years, clinical virology laboratory diagnostics 
has been evolving and increasingly rely on

[[Page 46825]]

molecular techniques. This is also true with laboratory diagnoses of 
poxvirus infections. Precise and consistent identification of 
orthopoxviruses, in particular variola viruses, is now achievable using 
such molecular techniques as real-time Polymerase Chain Reaction 
(unlike earlier techniques that may have relied on direct virus 
isolation and identification).
    Additionally, the U.S. Government supports the development of other 
medical products, including vaccines and drugs, for use within the U.S. 
upon verification of a smallpox case. The U.S. Government, through the 
Office of the Assistant Secretary for Preparedness and Response (ASPR), 
has successfully developed vaccine products, and is actively engaged in 
the development of several drug candidates for smallpox therapies which 
require access to the Variola virus to satisfy regulatory requirements 
for product approvals.
    Period of Performance: September 30, 2014 to September 29, 2015.

FOR FURTHER INFORMATION CONTACT: The agency program contact is Julie 
Schafer, who can be contacted by phone at 202-205-1435or via email at 
Julie.Schafer@hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to Sections 42 U.S.C. 241 and 247d-
7e (Sections 301 and 319L of the Public Health Service Act); ASPR's 
Office of Biomedical Advanced Research and Development Authority 
(BARDA) is the program office for this award.
    Justification: WHO is the only eligible applicant; it is the only 
organization that is allowed by international agreements to address the 
issues outlined in this proposal. WHO is the directing and coordinating 
authority for health within the United Nations system. It is 
responsible for providing leadership on global health matters, shaping 
the health research agenda, setting norms and standards, articulating 
evidence-based policy options, providing technical support to 
countries, and monitoring and assessing health trends. In the 21st 
century, health is a shared responsibility, involving equitable access 
to essential care and collective defense against transnational threats. 
States Parties to the U.N. have agreed to international standards on 
reporting public health incidents of concern under IHR (2005). 
Additionally, a majority of States Parties have also agreed to specific 
work-frames for pathogens such as smallpox under the Biological Weapons 
Convention.
    Since May 1999, when the 52nd World Health Assembly (WHA) resolved 
to postpone the destruction of the Variola virus to allow for essential 
research (WHA 52.10), WHO has been charged with convening a group of 
experts to advise on the need for continuing such research, to review 
proposals for research involving viable Variola virus, to review the 
progress of such research, and to report to the WHA each year. The need 
to support the activities described in this project has not changed. In 
fact, WHO Member States continue to exert pressure for the WHO 
Secretariat to carry out this work.
    The WHO Advisory Committee on Variola Virus Research (ACVVR) was 
established in 1999 to determine what essential research, if any, must 
be carried out with live Variola virus. The ACVVR monitored the 
research progress in order to reach global consensus on the timing for 
the destruction of existing Variola virus stocks. In 2007, the WHA 
requested the ACVVR undertake a thorough review of the approved 
research program with a report presented in 2010. The results were 
presented at the 64th WHA meeting in May of 2011. The ACVVR continues 
to serve a critically important function for global public health, and 
to oversee research requested specifically by the U.S. to complete its 
national strategic goals. This includes the development of new 
antiviral agents, safer vaccines, and better diagnostics, thus 
strengthening our national security.
    Estimated amount of award: up to $662,500 USD.

HHS/ASPR/BARDA: $225,000
DOD: $250,000 (funds pending)
HHS/NIH/NIAID: $50,000
HHS/CDC: $87,500
HHS/OGA: $50,000

    Procedures for Providing Public Input: All written comments must be 
received no later than 15 days after the posting of this announcement. 
Please submit comments via asprgrants@hhs.gov.

    Date: August 4, 2014.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2014-18836 Filed 8-8-14; 8:45 am]
BILLING CODE 4150-37-P