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