Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Notices 38839

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New Collection;

Title of Information Collection:

Children’s Health Insurance Program

(CHIP) Budget and Expenditure System

State Reporting Forms.

Form Nos.: HCFA–21, 21B, 21P,

21.11A, 21E;

Use: These forms will be used by

State CHIP agencies to report CHIP

program budget projections and actual

CHIP program benefits and

administrative expenditures, and the

numbers of children being served in the

CHIP program, to the Health Care

Financing Administration (HCFA). The

information provided by these new

forms will be used by HCFA to prepare

the grant awards to States for the CHIP,

to ensure that the appropriate level of

Federal payments for State expenditures

under the CHIP are made in accordance

with the CHIP-related BBA legislative

provisions of 1997, and to track,

monitor, and evaluate the numbers of

children being served by the CHIP.

Note: at this time Form HCFA–21E of

this package is for States to report the

numbers of children, by service delivery

system, that are served in the States’

CHIPs based on age categories.

However, we are continuing to work

with the States to develop an

appropriate format for States to report

the numbers of children, by service

delivery system, that are served in the

CHIP based on Federal poverty income

level categories and under the age

categories previously requested. When

this format is finalized it will be

incorporated into Form HCFA–21E.

For a short description of the CHIP

reporting forms, see below:

• Form HCFA–21 Summary Sheet.

Quarterly Children’s Health Insurance

Program Statement of Expenditures for

Title XXI Summary Sheet. This form

summarizes the total expenditures in

the State’s CHIP reported by the State

for the reporting quarter.

• Form HCFA–21. Children’s Health

Expenditures by Type of Service for the

Title XXI Program, Expenditures in this

Quarter. States use this form to report

CHIP current quarter expenditures in

accordance with services categories

authorized under title XXI.

• Form HCFA–21B. Children’s Health

Insurance Program Budget Report for

the Title XXI Program State Expenditure

Plan. States use this form to report their

budget projections each quarter for their

Title XXI CHIPs for the current and

budget Federal fiscal years and broken

out by quarter.

• Form HCFA–21P. Children’s Health

Expenditures by Type of Service for the

Title XXI Program, Prior Period

Adjustments. States use this form to

report CHIP prior period adjustment

expenditures claimed in the submission

quarter in accordance with services

categories authorized under title XXI.

• Form HCFA–21.11A. ProviderRelated Donations and Health Care

Related Taxes, Fees, and Assessments

Received Under Section 1903(w) for

Title XXI. States use this form to report

CHIP-related State receipts of provider

related donations, and health care

related taxes, fees, and assessments.

• Form HCFA–21E. Children’s Health

Insurance Program, Number of Children

Served. States use this form to report the

numbers of children, by service delivery

system, that are served in the States’

CHIPs based on age categories.

Note: HCFA is working with States to

develop an appropriate format for States to

report numbers of children, by service

delivery system, that are served in the CHIP

based on Federal poverty income level

categories and under the age categories

previously requested. When the format is

finalized it will be incorporated into this

form.

Frequency: Quarterly;

Affected Public: State and Federal

government;

Number of Respondents: 56;

Total Annual Responses: 224;

Total Annual Hours: 7,840.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: John Rudolph, Room C2–26–

17, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: July 9, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Security and

Standards Group, Health Care Financing

Administration.

[FR Doc. 98–19256 Filed 7–17–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–P–11]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Medicare Home

Health Quality Assurance

Demonstration and Supporting

Regulations 42 CFR 484.48; Form No.:

HCFA—P–11, OMB # 0938–0519; Use:

Do to the accelerated growth in the

home health Care industry, the Health

Care Financing Administration (HCFA)

has identified a need to measure the

effectiveness of home health services by

analyzing patient outcomes. The

Medicare Home Health Quality

Assurance Demonstration will test the

feasibility of collecting patient outcome

data in Medicare-certified Home Health

Agencies (HHAs) nationally. Frequency:

On occasion; Affected Public: Not-forprofit institutions, business or other forprofit, and individuals or households;

Number of Respondents: 35,905; Total

Annual Responses: 99,825; Total

Annual Hours: 7,697.
38840 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Notices

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: July 9, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 98–19257 Filed 7–17–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institute of Health

Government-Owned Inventions;

Availability for Licensing: Compound,

Composition and Method for Treating

Cancer

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health is seeking licensees for the

further development, evaluation and

commercialization of materials and

methods for a novel cancer treatment

strategy. The invention claimed in

DHHS reference No. E–013–96/0,

‘‘Compound, Composition and Method

for Treating Cancer,’’ (Hartman, N., et

al.) filed on 3 June 1996 as USSN 60/

019,086, and in corresponding

international filings, is available for

licensing (in accordance with 35 U.S.C.

207 and 37 CFR Part 404).

ADDRESSES: Questions about the

licensing opportunity should be

addressed to Girish C. Barua, Ph.D.,

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; Telephone: 301/

496–7056 ext. 263; Fax: 301/402–0220.

SUPPLEMENTARY INFORMATION: The

invention is a novel compound for

treating cancer, Demethylpenclomedine,

which is a derivative of the drug

Penclomedine. Penclomedine is already

under investigation for its remarkable

preclinical activity against breast

cancer, but it suffers from several doselimiting side effects. The invention,

Demethylpenclomedine, appears to

have reduced toxicity while still having

a similar therapeutic efficacy to that of

Penclomedine in animal models.

Demethylpenclomedine may thus

prove to be a useful chemotherapeutic

against breast cancer and other cancers.

The lower toxicity may allow use at

higher levels than have been tried with

Penclomedine, and other possible

cancers, such as brain tumors, could be

targeted.

Information about the patent

application and pertinent information

not yet publicly described can be

obtained under a Confidential

Disclosure Agreement. Respondees

interested in licensing the invention

will be required to submit an

Application for License to Public Health

Service Inventions.

Dated: July 6, 1998.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 98–19145 Filed 7–17–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies 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.

Murine Intracisternal a Particle

Constitutive Transport Elements and

Uses Thereof

BK Felber, C Tabernero, AS Zolotukhin

(NCI)

Serial No. 60/070,204 filed 31 Dec 97

Licensing Contact: Robert Benson, 301/

496–7056 ext. 267

This invention concerns recombinant

attenuated HIV strains useful as

vaccines. HIV regulates its expression

by controlling the nuclear transport of

unspliced mRNA encoding structural

proteins. HIV utilizes the Rev/RRE

system. RRE (Rev. Responsive Element)

is an HIV encoded nucleo-cytoplasmic

transport element (NCTE), which is part

of every HIV RNA encoding the

structural genes (gas/pol and env). Rev

is an HIV encoded protein which binds

to the RRE. This interaction is essential

for the nucleo-cytoplasmic transport of

the RRE-containing viral mRNAs and

the expression of Gap/Pol and Env

proteins. The inventors have produced

an attenuated HIV by disabling rev/RRE,

by point mutations, and inserting in its

place a novel murine NCTE, isolated

form an intracisternal A-type particle

(IAP). The resultant HIV is attenuated

between 50 and 200 fold compared to

wild-type HIV. Claimed are the novel

murine NCTE, recombinant retroviruses

comprising the NCTE, and vaccines.

The use of another NCTE is described in

Zolotukhin et al., (1994) J. Virology

68:7944–7952.

Design and Construction of NonInfectious Human Retroviral Mutants

Deficient in Genomic RNA

RJ Gorelick, LO Arthur, A Rein, LE

Henderson, S Oroszlan (NCI)

U.S. Patent No. 5,674,720 issued 07 Oct

97

Licensing Contract: Robert Benson, 301/

496–7056 ext. 267

This invention describes methods for

generating non-replicating (i.e. noninfectious) virus-like particles that

mimic HIV–1, SIV and other

retroviruses, which are capable of

generating a protective immune

response. In addition to being

replication defective, these virus like

particles are deficient in packaged

genomic RNA but have the added

benefit of a normal compliment of viral

and cellular proteins that remain in

their native conformations. Also

claimed are methods of making the

mutant retroviruses which may

potentially be used as immunogens for

vaccines, particularly against HIV–1.

The basis of the method and the mutant

viruses of the claims is the finding that

a conserved amino acid sequence motif,

found in the nucleocapsid domain of