24496 Federal Register / Vol. 77, No. 79 / Tuesday, April 24, 2012 / Notices 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of organs to transplant centers 

throughout the country. Qualified OPOs 

are designated by the Centers for 

Medicare & Medicaid Services (CMS) to 

recover or procure organs in CMSdefined exclusive geographic service 

areas, pursuant to section 371(b)(1) of 

the Public Health Service Act (42 U.S.C. 

273(b)(1)) and our regulations at 42 CFR 

486.306. Once an OPO has been 

designated for an area, hospitals in that 

area that participate in Medicare and 

Medicaid are required to work with that 

OPO in providing organs for transplant, 

pursuant to section 1138(a)(1)(C) of the 

Social Security Act (the Act) and our 

regulations at 42 CFR 482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must notify the 

designated OPO (for the service area in 

which it is located) of potential organ 

donors. Under section 1138(a)(1)(C) of 

the Act, every participating hospital 

must have an agreement only with its 

designated OPO to identify potential 

donors. 

However, section 1138(a)(2)(A) of the 

Act provides that a hospital may obtain 

a waiver of the above requirements from 

the Secretary under certain specified 

conditions. A waiver allows the hospital 

to have an agreement with an OPO other 

than the one initially designated by 

CMS, if the hospital meets certain 

conditions specified in section 

1138(a)(2)(A) of the Act. In addition, the 

Secretary may review additional criteria 

described in section 1138(a)(2)(B) of the 

Act to evaluate the hospital’s request for 

a waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver—(1) is 

expected to increase organ donations; 

and (2) will ensure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 

changes made in definitions for 

metropolitan statistical areas; and (4) 

the length and continuity of a hospital’s 

relationship with an OPO other than the 

hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the 

Secretary is required to publish a notice 

of any waiver application received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to submit 

comments during the 60-day comment 

period beginning on the publication 

date in the Federal Register. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

sections 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at § 486.308(e) and (f). 

II. Waiver Request Procedures 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95– 

11) detailing the waiver process and 

discussing the information hospitals 

must provide in requesting a waiver. We 

indicated that upon receipt of a waiver 

request, we would publish a Federal 

Register notice to solicit public 

comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the comments received. 

During the review process, we may 

consult on an as-needed basis with the 

Health Resources and Services 

Administration’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Request 

As permitted by 42 CFR 486.308(e), 

the following hospital has requested a 

waiver in order to enter into an 

agreement with a designated OPO other 

than the OPO designated for the service 

area in which the hospital is located: 

Transplant Institute at Methodist Le 

Bonheur Healthcare of Memphis, 

Tennessee, is requesting a waiver to 

work with: Tennessee Donor Services, 

1600 Hayes Street, Suite 300, Nashville, 

TN 37203. 

The Hospital’s Designated OPO is: 

Mid-South Transplant Foundation, Inc., 

8001 Centerview Parkway, Suite 302, 

Memphis, TN 38018. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; Program No. 93.774, Medicare— 

Supplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 

Dated: April 18, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–9977 Filed 4–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: TANF Quarterly Financial 

Report, ACF–196. 

OMB No.: 0970–0247. 

Description: This information 

collection is authorized under Section 

411(a)(3) of the Social Security Act. This 

request is for renewal of approval to use 

the Administration for Children and 

Families’ (ACF) 196 form for periodic 

financial reporting under the Temporary 

Assistance for Needy Families (TANF) 

program. States participating in the 

TANF program are required by statute to 

report financial data on a quarterly 

basis. This form meets the legal 

standard and provides essential data on 

the use of Federal funds. Failure to 

collect the data would seriously 

compromise ACF’s ability to monitor 

program expenditures, estimate funding 

needs, and to prepare budget 

submissions required by Congress. 

Financial reporting under the TANF 

program is governed by 45 CFR part 

265. This renewal removes columns for 

reporting Emergency Contingency Fund 

and Supplemental Grant expenditures, 

as those funding streams are no longer 

available, and includes a requirement to 

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Federal Register / Vol. 77, No. 79 / Tuesday, April 24, 2012 / Notices 24497 

provide an addendum to the fourth 

quarter report to describe estimates used 

in deriving any expenditures reported in 

any category. 

Respondents: TANF Agencies. 

ANNUAL BURDEN ESTIMATES 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ACF–196 .......................................................................................................... 51 4 8 1,632 

Estimated Total Annual Burden 

Hours: 1,632. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–9759 Filed 4–23–12; 8:45 am] 

BILLING CODE 4184–01–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. 

FOR FURTHER INFORMATION CONTACT: 

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. 

Small-Molecule Modulators of Lipid 

Storage for Treatment of Obesity, 

Atherosclerosis, Metabolic Syndrome 

and Lipid Storage Diseases 

Description of Technology: Lipid 

droplets are key organelles involved in 

lipid homeostasis. In normal 

physiology, these droplets are formed in 

response to elevated fatty acid levels, 

and are broken down when needed for 

energy production. Imbalances in lipid 

homeostasis trigger compensatory 

alterations in metabolism that can lead 

to diseases such as obesity, 

atherosclerosis, and metabolic 

syndrome. There are also a number of 

inherited lipid storage diseases that 

result in harmful buildup of various 

lipids, such as Gaucher disease, Fabry 

disease, and others. Reducing the 

accumulation of lipid droplets is a 

promising potential strategy for 

treatment of such disorders. 

This technology describes three novel 

structural classes of small-molecule 

compounds that significantly reduce the 

accumulation of lipid droplets. These 

compounds hold promise for the 

treatment of diseases associated with 

aberrant lipid deposition. 

Potential Commercial Applications: 

• Treatment of inherited metabolic 

diseases such as Gaucher disease, Fabry 

disease, and Tay Sachs disease. 

• Treatment of obesity and metabolic 

disease. 

• Treatment of atherosclerosis. 

Competitive Advantages: Modulation 

of lipid droplet accumulation is a novel 

mechanism for treatment of lipid storage 

diseases. 

Development Stage: 

• Early-stage 

• In vitro data available 

Inventors: Matthew Boxer et al. 

(NCATS). 

Intellectual Property: HHS Reference 

No. E–277–2011/0—U.S. Provisional 

Patent Application No. 61/562,894 filed 

22 Nov 2011. 

Licensing Contact: Tara L. Kirby, 

Ph.D.; 301–435–4426; 

tarak@mail.nih.gov. 

A Broadly Neutralizing Human AntiHIV Monoclonal Antibody (10E8) 

Capable of Neutralizing Most HIV–1 

Strains 

Description of Technology: This 

Human Anti-HIV Monoclonal Antibody 

(10E8) has great potential to provide 

passive protection from infection, as a 

therapeutic vaccine, or as a tool for the 

development of vaccine immunogens. 

10E8 is one of the most potent HIVneutralizing antibodies isolated thus far 

and it can potently neutralize up to 98% 

of genetically diverse HIV–1 strains. 

10E8 is specific to the membraneproximal external region (MPER) of the 

HIV envelope protein, GP41. It is 

anticipated that 10E8 could be used in 

combination with another human antiHIV–1 monoclonal antibody to provide 

an antibody response that neutralizes 

nearly all strains of HIV–1. 

Additionally, 10E8 is a useful tool for 

the design of vaccine immunogens that 

can elicit an adaptive immune response 

to produces 10E8 like antibodies. This 

technology also includes monoclonal 

antibodies from the same germ line as 

10E8. 

Potential Commercial Applications: 

• Passive protection to prevent HIV 

infection 

• Passive protection to prevent motherto-infant HIV transmission 

• Topical microbicide to prevent HIV 

infection 

• Gene-based vectors for anti-gp41 

antibody expression 

• Therapeutic for the elimination of 

HIV infected cells that are actively 

producing virus 

Competitive Advantages: 

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