Statement of Organization, Functions and Delegations of Authority, 18560-18561 [2011-7781]

Download as PDF 18560 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices Section RR–20, Functions DEPARTMENT OF HEALTH AND HUMAN SERVICES Delete the functional statement for the Healthcare Systems Bureau (RR) and replace in its entirety. Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 75 FR 68806–68808 dated November 9, 2010). This notice reflects organizational changes to the Health Resources and Services Administration. Specifically, this notice updates the Healthcare Systems Bureau (RR) mission and better aligns functional responsibility, improve management and administrative efficiencies, and optimize use of available staff resources. Chapter RR—Healthcare Systems Bureau Section RR–00, Mission The Healthcare Systems Bureau leads the Agency in providing health care programs to eligible organizations around the country. This includes providing overall leadership and direction for the procurement allocation and transplantation of human organs, blood stem cell and cord blood; providing architectural/engineering support for construction/renovation of health care facility projects; managing and promoting the 340B Drug Pricing Program; directing and administering the Poison Center Support, Enhancement, and Awareness Act, the National Vaccine Injury Compensation and the Countermeasures Injury Compensation Programs. Emcdonald on DSK2BSOYB1PROD with NOTICES Section RR–10, Organization Delete in its entirety and replace with the following: The Healthcare Systems Bureau (RR) is headed by the Associate Administrator, who reports directly to the Administrator, Health Resources and Services Administration. The Healthcare Systems Bureau includes the following components: (1) Office of the Associate Administrator (RR); (2) Division of Transplantation (RR1); (3) Division of Health Facilities (RR9); (4) Division of Vaccine Injury Compensation (RR4); and (5) Office of Pharmacy Affairs (RR7). VerDate Mar<15>2010 18:47 Apr 01, 2011 Jkt 223001 Office of the Associate Administrator (RR) The Healthcare Systems Bureau leads the Agency in providing health care programs to eligible organizations around the country. Specifically, (1) administers the Organ Transplantation Program (OTP) to include the Organ Procurement and Transplantation Network (OPTN) to facilitate the allocation of donor organs to patients waiting for an organ transplant and the Scientific Registry of Transplant Recipients that provides analytic support to the OPTN in the development and assessment of organ allocation and other OPTN policies; (2) administers the C.W. Bill Young Cell Transplantation Program to increase the number of unrelated blood stem cell transplants and improve the outcomes of blood stem cell transplants; (3) administers the National Cord Blood Inventory (NCBI) to increase the number of high quality cord blood units available for transplantation; (4) develops and maintains a national program of grants and contracts to organ procurement organizations and other entities to increase the number of organs made available for transplantation; (5) manages the national program for compliance with the Hill-Burton uncompensated care requirement and other assurances; (6) directs and administers a congressionally-directed grant program for the construction/ renovation/equipping of health care and other facilities; (7) directs and administers the National Vaccine Injury Compensation Program; (8) manages and promotes the 340B Drug Pricing Program; (9) directs and administers the Poison Center Support, Enhancement, and Awareness Act; (10) directs and administers the State Health Access Program that awards grants to States to expand access to affordable healthcare coverage for people who are uninsured; and (11) implements and administers the Countermeasures Injury Compensation Program (CICP) under PREP Act authorities. The Poison Control Program (PCP) administers the activities authorized by the Poison Center Support, Enhancement and Awareness Act of 2008, which includes: (1) Maintaining the national toll-free Poison Help hotline (800–222–1222), connecting callers to their local poison control center; (2) implementing and expanding a national media campaign to educate PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 the public and health care providers about poison prevention and the availability of local poison control centers; and (3) awarding grants to certified poison control centers for the purposes of preventing and providing treatment recommendations for poisonings. The Countermeasures Injury Compensation Program (CICP) administers the Federal compensation program established by the Public Readiness and Emergency Preparedness Act (‘‘PREP Act’’) enacted as Division C of the Defense Appropriations Act for fiscal year 2006, Public Law 109–148, which added new authorities under the Public Health Service (PHS) Act to alleviate concerns about liability related to the manufacture, testing, development, distribution, administration, and use of countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. The Office discharges all PREP Act authorities regarding compensation including: (1) Developing and disseminating requests for benefits information to inform individuals that the CICP exists so that people requesting benefits do not miss the 1-year filing deadline; (2) accepting letters of intent to file requests for benefits so that individuals preserve their rights to file by the 1-year deadline; (3) evaluation of requests for benefits for compensation filed under the CICP through medical review and assessment of compensability for all complete claims; (4) processing of requests for benefits made under the CICP; (5) promulgation of regulations to create and revise the CICP Vaccine Injury Tables; (6) development and maintenance of all automated information systems necessary for Program implementation; and (7) collection, analysis and dissemination of Program information. Division of Transplantation (RR1) The Division of Transplantation (DoT), on behalf of the Secretary of Health and Human Services (HHS), administers national systems to facilitate solid organ and blood stem cell transplantation including: the Organ Transplantation Program (OTP), the C.W. Bill Young Cell Transplantation Program (CWBYCTP), the National Cord Blood Inventory (NCBI), cross-cutting medical activities and the breakthrough collaborative to increase the number of deceased donor organs made available for transplantation. Division of Health Facilities (RR9) The Division of Health Facilities (DOHF) substantiates health facilities’ E:\FR\FM\04APN1.SGM 04APN1 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices Emcdonald on DSK2BSOYB1PROD with NOTICES compliance with the Hill-Burton uncompensated services assurance and administers construction grant programs under section 1610(b) of the Public Health Service Act, under the Health Care and Other Facilities (HCOF) program, and under the Patient Protection and Affordable Care Act, Public Law 111–148. Specifically, the Division: (1) Administers the process for awarding new construction and equipment grants, under section 1610(b), the HCOF, and the PPACA programs, including ensuring the delivery of comprehensive architectural and engineering services and ensuring compliance with historic preservation and other laws and regulations related to construction projects, maintains a computerized database of key project information, and provides technical assistance in application preparation to potential grantees under Division grant programs; (2) monitors grant projects during construction to assure compliance with the terms of the award, reviews requests for changes in scope to grant projects, and obtains information needed to close out completed grant projects; (3) establishes, develops, monitors, and enforces the implementation of Hill-Burton regulations, policies, procedures, and guidelines for use by staff and health care facilities; (4) maintains a system for receipt, analysis and disposition of audit appeals by Hill-Burton obligated facilities and for receiving and responding to patient complaints; (5) manages the recovery or waiver of recovery of Federal grant funds process for Titles VI and XVI; (6) manages the national Hill-Burton Hotline to ensure that consumers receive timely and accurate information on the program; and (7) provides architectural and engineering services to other Agencies such as the Administration for Children and Families and the Food and Drug Administration. Division of Vaccine Injury Compensation (RR4) This Division of Vaccine Injury Compensation (DVIC) administers all statutory authorities related to the operation of the National Vaccine Injury Compensation Program (VICP) by the: (1) Evaluation of petitions for compensation filed under the VICP through medical review and assessment of compensability for all complete claims; (2) processing of awards for compensation made under the VICP; (3) promulgation of regulations to revise the Vaccine Injury Table; (4) provision of professional and administrative support to the Advisory Commission on Childhood Vaccines (ACCV); (5) VerDate Mar<15>2010 18:47 Apr 01, 2011 Jkt 223001 development and maintenance of all automated information systems necessary for program implementation; (6) provision and dissemination of program information; and (7) contributes to the understanding of vaccine-related adverse events through the analysis of VICP claims. The VICP maintains a working relationship with other relevant Federal and private sector partners in its administration and operation. Office of Pharmacy Affairs (RR7) The Office of Pharmacy Affairs (OPA) promotes access to clinical and cost effective pharmacy services to enable participating entities to stretch scarce Federal resources in order to serve more patients, expand their services or offer additional services. Specifically the office: (1) Manages the 340B involvement of pharmaceutical manufacturers that participate in the Medicaid program, through Pharmaceutical Pricing Agreements; (2) maintains a publicly accessible database of participating covered entities, sites, and contract pharmacies; (3) publishes guidelines/regulations to assist in the understanding and participation in the 340B Program; (4) maintains a Prime Vendor Program to increase the value of the 340B Program; (5) maintains the Pharmacy Services Support Center to assist OPA and the diverse Program stakeholders to understand and make best use of the 340B Program; (6) fosters mutually productive relationships with Federal and private sector partners; (7) provides a national platform for the coordination and development of leading practices for pharmacy services; (8) promotes comprehensive and efficient pharmacy management application and systems use to ensure safe and effective medication use; and (9) manages quality improvement activities such as the Patient Safety and Clinical Pharmacy Services Collaborative. Section RR–30, Delegations of Authority All delegations of authority and redelegations of authority made to HRSA officials that were in effect immediately prior to this reorganization, and that are consistent with this reorganization, shall continue in effect pending further re-delegation. This reorganization is upon date of signature. Dated: March 28, 2011. Mary K. Wakefield, Administrator. [FR Doc. 2011–7781 Filed 4–1–11; 8:45 am] BILLING CODE 4165–15–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 18561 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. SUMMARY: New Molecules for HIV Therapeutics: Fab, scFv, and Related Binding Molecules Specific for HIV–1 Rev Description of Invention: The invention offered for licensing and commercial development is in the field of HIV therapeutics. More specifically, the invention relates to methods and compositions for treating and/or inhibiting HIV infection or any other lentivirus. The invention describes the identification, though phage display, of a chimeric rabbit/human anti-Rev Fab (SJS–R1) that can inhibit polymerization of the HIV Rev protein and thus inhibit its normal function in virus replication. The Fab binds with very high affinity to a conformational epitope in the Nterminal half of HIV–1 Rev. The corresponding single chain antibody (scFv) was also prepared and characterized. Methods of making and using SJS–R1 Fab and SJS–R1 scFv, and antibodies and antibody fragments that share at least one CDR with SJS–R1 Fab, are provided. Specific described methods include methods of preventing or reversing polymerization of HIV Rev, methods of reducing infectivity of replication of a lentivirus, inhibiting Rev function in a cell infected with a lentivirus, and methods of treating a E:\FR\FM\04APN1.SGM 04APN1

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[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18560-18561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7781]



[[Page 18560]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Statement of Organization, Functions and Delegations of Authority

    This notice amends Part R of the Statement of Organization, 
Functions and Delegations of Authority of the Department of Health and 
Human Services (HHS), Health Resources and Services Administration 
(HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 75 
FR 68806-68808 dated November 9, 2010).
    This notice reflects organizational changes to the Health Resources 
and Services Administration. Specifically, this notice updates the 
Healthcare Systems Bureau (RR) mission and better aligns functional 
responsibility, improve management and administrative efficiencies, and 
optimize use of available staff resources.

Chapter RR--Healthcare Systems Bureau

Section RR-00, Mission

    The Healthcare Systems Bureau leads the Agency in providing health 
care programs to eligible organizations around the country. This 
includes providing overall leadership and direction for the procurement 
allocation and transplantation of human organs, blood stem cell and 
cord blood; providing architectural/engineering support for 
construction/renovation of health care facility projects; managing and 
promoting the 340B Drug Pricing Program; directing and administering 
the Poison Center Support, Enhancement, and Awareness Act, the National 
Vaccine Injury Compensation and the Countermeasures Injury Compensation 
Programs.

Section RR-10, Organization

    Delete in its entirety and replace with the following:
    The Healthcare Systems Bureau (RR) is headed by the Associate 
Administrator, who reports directly to the Administrator, Health 
Resources and Services Administration. The Healthcare Systems Bureau 
includes the following components:

(1) Office of the Associate Administrator (RR);
(2) Division of Transplantation (RR1);
(3) Division of Health Facilities (RR9);
(4) Division of Vaccine Injury Compensation (RR4); and
(5) Office of Pharmacy Affairs (RR7).

Section RR-20, Functions

    Delete the functional statement for the Healthcare Systems Bureau 
(RR) and replace in its entirety.
Office of the Associate Administrator (RR)
    The Healthcare Systems Bureau leads the Agency in providing health 
care programs to eligible organizations around the country. 
Specifically, (1) administers the Organ Transplantation Program (OTP) 
to include the Organ Procurement and Transplantation Network (OPTN) to 
facilitate the allocation of donor organs to patients waiting for an 
organ transplant and the Scientific Registry of Transplant Recipients 
that provides analytic support to the OPTN in the development and 
assessment of organ allocation and other OPTN policies; (2) administers 
the C.W. Bill Young Cell Transplantation Program to increase the number 
of unrelated blood stem cell transplants and improve the outcomes of 
blood stem cell transplants; (3) administers the National Cord Blood 
Inventory (NCBI) to increase the number of high quality cord blood 
units available for transplantation; (4) develops and maintains a 
national program of grants and contracts to organ procurement 
organizations and other entities to increase the number of organs made 
available for transplantation; (5) manages the national program for 
compliance with the Hill-Burton uncompensated care requirement and 
other assurances; (6) directs and administers a congressionally-
directed grant program for the construction/renovation/equipping of 
health care and other facilities; (7) directs and administers the 
National Vaccine Injury Compensation Program; (8) manages and promotes 
the 340B Drug Pricing Program; (9) directs and administers the Poison 
Center Support, Enhancement, and Awareness Act; (10) directs and 
administers the State Health Access Program that awards grants to 
States to expand access to affordable healthcare coverage for people 
who are uninsured; and (11) implements and administers the 
Countermeasures Injury Compensation Program (CICP) under PREP Act 
authorities.
    The Poison Control Program (PCP) administers the activities 
authorized by the Poison Center Support, Enhancement and Awareness Act 
of 2008, which includes: (1) Maintaining the national toll-free Poison 
Help hotline (800-222-1222), connecting callers to their local poison 
control center; (2) implementing and expanding a national media 
campaign to educate the public and health care providers about poison 
prevention and the availability of local poison control centers; and 
(3) awarding grants to certified poison control centers for the 
purposes of preventing and providing treatment recommendations for 
poisonings.
    The Countermeasures Injury Compensation Program (CICP) administers 
the Federal compensation program established by the Public Readiness 
and Emergency Preparedness Act (``PREP Act'') enacted as Division C of 
the Defense Appropriations Act for fiscal year 2006, Public Law 109-
148, which added new authorities under the Public Health Service (PHS) 
Act to alleviate concerns about liability related to the manufacture, 
testing, development, distribution, administration, and use of 
countermeasures against chemical, biological, radiological and nuclear 
agents of terrorism, epidemics, and pandemics. The Office discharges 
all PREP Act authorities regarding compensation including: (1) 
Developing and disseminating requests for benefits information to 
inform individuals that the CICP exists so that people requesting 
benefits do not miss the 1-year filing deadline; (2) accepting letters 
of intent to file requests for benefits so that individuals preserve 
their rights to file by the 1-year deadline; (3) evaluation of requests 
for benefits for compensation filed under the CICP through medical 
review and assessment of compensability for all complete claims; (4) 
processing of requests for benefits made under the CICP; (5) 
promulgation of regulations to create and revise the CICP Vaccine 
Injury Tables; (6) development and maintenance of all automated 
information systems necessary for Program implementation; and (7) 
collection, analysis and dissemination of Program information.
Division of Transplantation (RR1)
    The Division of Transplantation (DoT), on behalf of the Secretary 
of Health and Human Services (HHS), administers national systems to 
facilitate solid organ and blood stem cell transplantation including: 
the Organ Transplantation Program (OTP), the C.W. Bill Young Cell 
Transplantation Program (CWBYCTP), the National Cord Blood Inventory 
(NCBI), cross-cutting medical activities and the breakthrough 
collaborative to increase the number of deceased donor organs made 
available for transplantation.
Division of Health Facilities (RR9)
    The Division of Health Facilities (DOHF) substantiates health 
facilities'

[[Page 18561]]

compliance with the Hill-Burton uncompensated services assurance and 
administers construction grant programs under section 1610(b) of the 
Public Health Service Act, under the Health Care and Other Facilities 
(HCOF) program, and under the Patient Protection and Affordable Care 
Act, Public Law 111-148. Specifically, the Division: (1) Administers 
the process for awarding new construction and equipment grants, under 
section 1610(b), the HCOF, and the PPACA programs, including ensuring 
the delivery of comprehensive architectural and engineering services 
and ensuring compliance with historic preservation and other laws and 
regulations related to construction projects, maintains a computerized 
database of key project information, and provides technical assistance 
in application preparation to potential grantees under Division grant 
programs; (2) monitors grant projects during construction to assure 
compliance with the terms of the award, reviews requests for changes in 
scope to grant projects, and obtains information needed to close out 
completed grant projects; (3) establishes, develops, monitors, and 
enforces the implementation of Hill-Burton regulations, policies, 
procedures, and guidelines for use by staff and health care facilities; 
(4) maintains a system for receipt, analysis and disposition of audit 
appeals by Hill-Burton obligated facilities and for receiving and 
responding to patient complaints; (5) manages the recovery or waiver of 
recovery of Federal grant funds process for Titles VI and XVI; (6) 
manages the national Hill-Burton Hotline to ensure that consumers 
receive timely and accurate information on the program; and (7) 
provides architectural and engineering services to other Agencies such 
as the Administration for Children and Families and the Food and Drug 
Administration.
Division of Vaccine Injury Compensation (RR4)
    This Division of Vaccine Injury Compensation (DVIC) administers all 
statutory authorities related to the operation of the National Vaccine 
Injury Compensation Program (VICP) by the: (1) Evaluation of petitions 
for compensation filed under the VICP through medical review and 
assessment of compensability for all complete claims; (2) processing of 
awards for compensation made under the VICP; (3) promulgation of 
regulations to revise the Vaccine Injury Table; (4) provision of 
professional and administrative support to the Advisory Commission on 
Childhood Vaccines (ACCV); (5) development and maintenance of all 
automated information systems necessary for program implementation; (6) 
provision and dissemination of program information; and (7) contributes 
to the understanding of vaccine-related adverse events through the 
analysis of VICP claims. The VICP maintains a working relationship with 
other relevant Federal and private sector partners in its 
administration and operation.
Office of Pharmacy Affairs (RR7)
    The Office of Pharmacy Affairs (OPA) promotes access to clinical 
and cost effective pharmacy services to enable participating entities 
to stretch scarce Federal resources in order to serve more patients, 
expand their services or offer additional services. Specifically the 
office: (1) Manages the 340B involvement of pharmaceutical 
manufacturers that participate in the Medicaid program, through 
Pharmaceutical Pricing Agreements; (2) maintains a publicly accessible 
database of participating covered entities, sites, and contract 
pharmacies; (3) publishes guidelines/regulations to assist in the 
understanding and participation in the 340B Program; (4) maintains a 
Prime Vendor Program to increase the value of the 340B Program; (5) 
maintains the Pharmacy Services Support Center to assist OPA and the 
diverse Program stakeholders to understand and make best use of the 
340B Program; (6) fosters mutually productive relationships with 
Federal and private sector partners; (7) provides a national platform 
for the coordination and development of leading practices for pharmacy 
services; (8) promotes comprehensive and efficient pharmacy management 
application and systems use to ensure safe and effective medication 
use; and (9) manages quality improvement activities such as the Patient 
Safety and Clinical Pharmacy Services Collaborative.

Section RR-30, Delegations of Authority

    All delegations of authority and re-delegations of authority made 
to HRSA officials that were in effect immediately prior to this 
reorganization, and that are consistent with this reorganization, shall 
continue in effect pending further re-delegation.
    This reorganization is upon date of signature.

    Dated: March 28, 2011.
Mary K. Wakefield,
Administrator.
[FR Doc. 2011-7781 Filed 4-1-11; 8:45 am]
BILLING CODE 4165-15-P