18560 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 

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’ 


Emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 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 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: 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. 

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 


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