25216 Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices

HCFA–R–235; Use: The agreement

addresses the conditions under which

HCFA will disclose and the User will

maintain HCFA data that are protected

by the Privacy Act of 1974, 552a.

Frequency: On occasion; Affected

Public: Business of other for-profit, Notfor-profit institutions; Number of

Respondents: 1,500; Total Annual

Responses: 1,500; Total Annual Hours:

750.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or any

related forms, 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 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: April 30, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 98–12160 Filed 5–6–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Announcement of Office of

Management and Budget (OMB)

Control Numbers for Agency

Information Collections Approved

Under the Paperwork Reduction Act of

1995

AGENCY: Health Care Financing

Administration, HHS.

This notice announces and displays

OMB control numbers for Health Care

Financing Administration (HCFA)

information collections that have been

approved by OMB.

Under OMB’s regulations

implementing the Paperwork Reduction

Act (PRA), 44 U.S.C. 3501, each agency

that proposes to collect information

must submit its proposal for OMB

review and approval in accordance with

5 CFR Part 1320. Once OMB has

approved an agency’s proposed

collection of information and issues a

control number, the agency must

display the control number.

OMB regulations provide for

alternative methods of displaying OMB

control numbers. In the case of

collections of information published in

regulations, display is to be ‘‘provided

in a manner that is reasonably

calculated to inform the public.’’ To

meet this requirement an agency may

display such information in the Federal

Register by publishing such information

in the preamble or the regulatory text,

or in a technical amendment to the

regulation, or in a separate notice

announcing OMB approval of the

collection of information.

To comply with this requirement

HCFA has chosen to publish this notice

announcing OMB approval of the

collections of information published in

regulations. As stated above, this notice

announces and displays the assigned

OMB control numbers for HCFA’s

information collections that have been

approved by OMB.

OMB control Nos.

42 CFR :

403.210 .................................................................................................................................................................... 0938–0640.

405.262 .................................................................................................................................................................... 0938–0267.

405.374 .................................................................................................................................................................... 0938–0270.

405.427 .................................................................................................................................................................... 0938–0155.

405.711 .................................................................................................................................................................... 0938–0045.

405.807 .................................................................................................................................................................... 0938–0033.

405.821 .................................................................................................................................................................... 0938–0034.

405.1632 .................................................................................................................................................................. 0938–0454.

405.1701–.1726 ....................................................................................................................................................... 0938–0273.

405.2100–.2171 ....................................................................................................................................................... 0938–0386.

405.2110, 405.2112 ................................................................................................................................................. 0938–0657 and 0658.

405.2133 .................................................................................................................................................................. 0938–0046 and 0447 and

0448.

405.2135–.2171 ....................................................................................................................................................... 0938–0360.

405.2401 .................................................................................................................................................................. 0938–0685.

406.13 ...................................................................................................................................................................... 0938–0080.

406.15 ...................................................................................................................................................................... 0938–0501.

406.28, 407.27 ......................................................................................................................................................... 0938–0025.

407.10, 407.11 ......................................................................................................................................................... 0938–0245.

407.18 ...................................................................................................................................................................... 0938–0679.

407.40 ...................................................................................................................................................................... 0938–0035.

408.6 ........................................................................................................................................................................ 0938–0041.

409.40–.50 ............................................................................................................................................................... 0938–0357.

410.1 ........................................................................................................................................................................ 0938–0679.

410.36 ...................................................................................................................................................................... 0938–0357.

410.38 ...................................................................................................................................................................... 0938–0534.

410.40 ...................................................................................................................................................................... 0938–0042 and 0685.

410.69 ...................................................................................................................................................................... 0938–0685.

410.170 .................................................................................................................................................................... 0938–0357.

411.4–.15 ................................................................................................................................................................. 0938–0357.

411.15 ...................................................................................................................................................................... 0938–0224 and 0357.

411.20–411.206 ....................................................................................................................................................... 0938–0565.

411.372, 411.373, 411.378 ...................................................................................................................................... 0938–0714.

411.404, 411.406 ..................................................................................................................................................... 0938–0465.

411.408 .................................................................................................................................................................... 0938–0566.

412.20–.32 ............................................................................................................................................................... 0938–0358.

412.40–.62 ............................................................................................................................................................... 0938–0359.
Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices 25217

OMB control Nos.

412.44, 412.46 ......................................................................................................................................................... 0938–0445.

412.92 ...................................................................................................................................................................... 0938–0477.

412.105 .................................................................................................................................................................... 0938–0456.

412.106 .................................................................................................................................................................... 0938–0691.

412.116 .................................................................................................................................................................... 0938–0269.

412.256 .................................................................................................................................................................... 0938–0573.

413.13 ...................................................................................................................................................................... 0938–0463.

413.16 ...................................................................................................................................................................... 0938–0583.

413.17, 413.20 ......................................................................................................................................................... 0938–0202.

413.20, 413.24 ......................................................................................................................................................... 0938–0022 and 0037 and

0050 and 0102 and 0107

and 0301 and 0463 and

0511.

413.56 ...................................................................................................................................................................... 0938–0463.

413.64 ...................................................................................................................................................................... 0938–0269.

413.157 .................................................................................................................................................................... 0938–0463.

413.170 .................................................................................................................................................................... 0938–0296.

413.198, 413.200 ..................................................................................................................................................... 0938–0236.

414.40 ...................................................................................................................................................................... 0938–0008.

414.330 .................................................................................................................................................................... 0938–0372.

414.451, 414.452, 414.456, 414.460 ...................................................................................................................... 0938–0685.

416.43 ...................................................................................................................................................................... 0938–0506.

416.47 ...................................................................................................................................................................... 0938–0266 and 0506.

417.1–.106 ............................................................................................................................................................... 0938–0469.

417.124 .................................................................................................................................................................... 0938–0472.

417.126 .................................................................................................................................................................... 0938–0701.

417.143 .................................................................................................................................................................... 0938–0470.

417.162 .................................................................................................................................................................... 0938–0469.

417.408 .................................................................................................................................................................... 0938–0470.

417.436. ................................................................................................................................................................... 0938–0610.

417.470 .................................................................................................................................................................... 0938–0701.

417.479, 417.500 ..................................................................................................................................................... 0938–0700.

417.801 .................................................................................................................................................................... 0938–0610.

418.22, 418.24, 418.28, 418.30, 418.56, 418.58, 418.70, 418.74, 418.80, 418.83, 418.96, 418.100 ................... 0938–0302.

420.200–.206 ........................................................................................................................................................... 0938–0086.

421.100 .................................................................................................................................................................... 0938–0357.

422.430 .................................................................................................................................................................... 0938–0390.

424.5 ........................................................................................................................................................................ 0938–0534.

424.20. ..................................................................................................................................................................... 0938–0454.

424.22 ...................................................................................................................................................................... 0938–0357 and 0489.

424.32 ...................................................................................................................................................................... 0938–0008.

424.57 ...................................................................................................................................................................... 0938–0685.

424.73 ...................................................................................................................................................................... 0938–0685.

424.123 .................................................................................................................................................................... 0938–0484.

424.124 .................................................................................................................................................................... 0938–0042.

430.10–.20 ............................................................................................................................................................... 0938–0193.

430.12 ...................................................................................................................................................................... 0938–0610 and 0673.

431.20 ...................................................................................................................................................................... 0938–0610.

431.1–431.865 ......................................................................................................................................................... 0938–0062.

431.17 ...................................................................................................................................................................... 0938–0467.

431.110 .................................................................................................................................................................... 0938–0390.

431.107 .................................................................................................................................................................... 0938–0610.

431.306 .................................................................................................................................................................... 0938–0502.

431.630 .................................................................................................................................................................... 0938–0445.

431.800 .................................................................................................................................................................... 0938–0094 and 0300.

431.802–.822 ........................................................................................................................................................... 0938–0246.

431.814 .................................................................................................................................................................... 0938–0146 and 0147.

431.820 .................................................................................................................................................................... 0938–0144.

431.865 .................................................................................................................................................................... 0938–0094 and 0246.

431.940–431.965 ..................................................................................................................................................... 0938–0467.

433.68, 433.74 ......................................................................................................................................................... 0938–0618.

433.110–.131 ........................................................................................................................................................... 0938–0487.

433.110, 433.112–433.114, 433.116, 433.117, 433.119, 433.121, 433.122, 433.127, 433.130, 433.131 ............ 0938–0247.

433.138 .................................................................................................................................................................... 0938–0502.

433.139 .................................................................................................................................................................... 0938–0502.

434.27 ...................................................................................................................................................................... 0938–0572.

434.28 ...................................................................................................................................................................... 0938–0610.

434.44, 434.67, 434.70 ............................................................................................................................................ 0938–0700.

435.1–435.1011 ....................................................................................................................................................... 0938–0062.

435.217, 435.726, 435.735 ...................................................................................................................................... 0938–0449.

435.940–.965 ........................................................................................................................................................... 0938–0467.

440.1–.270 ............................................................................................................................................................... 0938–0062.

440.10 ...................................................................................................................................................................... 0938–0449.

440.30 ...................................................................................................................................................................... 0938–0685.
25218 Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices

OMB control Nos.

440.167 .................................................................................................................................................................... 0938–0193.

440.180 .................................................................................................................................................................... 0938–0272.

441.16 ...................................................................................................................................................................... 0938–0713.

441.250–.300 ........................................................................................................................................................... 0938–0481.

441.300–.305 ........................................................................................................................................................... 0938–0272.

441.302 .................................................................................................................................................................... 0938–0449.

442.1–.119 ............................................................................................................................................................... 0938–0062 and 0379.

442.10–.119 ............................................................................................................................................................. 0938–0355.

442.30 ...................................................................................................................................................................... 0938–0678.

447.31 ...................................................................................................................................................................... 0938–0287.

447.53 ...................................................................................................................................................................... 0938–0429.

447.253 .................................................................................................................................................................... 0938–0523.

447.272 .................................................................................................................................................................... 0938–0618.

447.280 .................................................................................................................................................................... 0938–0624.

447.299 .................................................................................................................................................................... 0938–0618.

447.500–.542 ........................................................................................................................................................... 0938–0676.

447.550 .................................................................................................................................................................... 0938–0676.

455.100–.106 ........................................................................................................................................................... 0938–0086.

456.650–.657 ........................................................................................................................................................... 0938–0061.

456.654 .................................................................................................................................................................... 0938–0445.

456.700, 456.705, 456.709, 456.711, 456.712 ....................................................................................................... 0938–0659.

466.71, 466.73, 466.74, 466.78, 466.80, 466.94 .................................................................................................... 0938–0445.

473.18, 473.34, 473.36, 473.42 .............................................................................................................................. 0938–0443.

476.104, 476.105, 476.116, 476.134 ...................................................................................................................... 0938–0426.

482.1–.66. ................................................................................................................................................................ 0938–0380.

482.2–.57 ................................................................................................................................................................. 0938–0382.

482.12, 482.22 ......................................................................................................................................................... 0938–0328.

482.27 ...................................................................................................................................................................... 0938–0328 and 0698.

482.41 ...................................................................................................................................................................... 0938–0242.

482.30, 482.41, 482.43, 482.53, 482.56, 482.57, 482.60–.62 ................................................................................ 0938–0328 and 0378.

482.66 ...................................................................................................................................................................... 0938–0328 and 0624.

483.10 ...................................................................................................................................................................... 0938–0610.

483.70 ...................................................................................................................................................................... 0938–0242.

483.400–.480 ........................................................................................................................................................... 0938–0062 and 0678.

483.470 .................................................................................................................................................................... 0938–0242.

484.1–.52 ................................................................................................................................................................. 0938–0365.

484.10 ...................................................................................................................................................................... 0938–0610.

484.18 ...................................................................................................................................................................... 0938–0357.

484.48 ...................................................................................................................................................................... 0938–0519.

484.52 ...................................................................................................................................................................... 0938–0687.

485.56, 485.58, 485.60, 485.64, 485.66 ................................................................................................................. 0938–0267.

485.701–.729 ........................................................................................................................................................... 0938–0273 and 0065.

485.709, 485.711, 485.717, 485.719, 485.721, 487.723, 485.725, 485.727, 485.729 .......................................... 0938–0336.

486.100–.110 ........................................................................................................................................................... 0938–0338.

486.150–.163 ........................................................................................................................................................... 0938–0258 and 0071.

486.155, 486.161, 486.163 ...................................................................................................................................... 0938–0336.

486.301–.325. .......................................................................................................................................................... 0938–0391, 0512 and

0688.

488.1–.28 ................................................................................................................................................................. 0938–0355.

488.4 ........................................................................................................................................................................ 0938–0690.

488.18 ...................................................................................................................................................................... 0938–0667.

488.26 ...................................................................................................................................................................... 0938–0379.

488.60 ...................................................................................................................................................................... 0938–0360.

489.20 ...................................................................................................................................................................... 0938–0667.

489.21 ...................................................................................................................................................................... 0938–0357.

489.24 ...................................................................................................................................................................... 0938–0667.

489.27 ...................................................................................................................................................................... 0938–0692.

489.28 ...................................................................................................................................................................... 0938–0713.

489.40–.41 ............................................................................................................................................................... 0938–0383.

489.66, 489.67 ......................................................................................................................................................... 0938–0713.

489.102 .................................................................................................................................................................... 0938–0610.

491.1–.11 ................................................................................................................................................................. 0938–0074.

491.2 ........................................................................................................................................................................ 0938–0685.

491.9 ........................................................................................................................................................................ 0938–0334.

493.1–.2001 ............................................................................................................................................................. 0938–0151, 0170, 0544,

0581, 0612 and 0653.

493.501, 493.506, 493.513, 493.515 ...................................................................................................................... 0938–0686.

493.1840 .................................................................................................................................................................. 0938–0655.

498.40–.95 ............................................................................................................................................................... 0938–0486 and 0567.

1003.100, 1003.101, 1003.103 ................................................................................................................................ 0938–0700.

1004.40, 1004.50, 1004.60, 1004.70 ...................................................................................................................... 0938–0444.

45 CFR:

96.70–.74 ................................................................................................................................................................. 0938–0481.

146.111, .115, .117, .150, .152, .160, .180 ............................................................................................................. 0938–0702.
Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 / Notices 25219

OMB control Nos.

148.120, .122, .124, .128 ........................................................................................................................................ 0938–0703.

Dated: April 28, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–12095 Filed 5–6–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute: VHL and

MET Mutation Detection Technology:

Opportunities for Cooperative

Research and Development

Agreements (CRADAs) for the Joint

Evaluation and Development of

Methods to Detect Mutation in Both

Gene Sequences Using Nucleic Acid

Array Technology

The methods may include but are not

limited to spectroscopic partitioning

techniques and DNA chip technology.

The NCI is looking for multiple CRADA

Collaborators to develop independently

different aspects of this VHL and MET

mutation detection technology.

AGENCY: National Cancer Institute,

National Institutes of Health, PHS,

DHHS.

ACTION: Notice for CRADA

Opportunities.

SUMMARY: Pursuant to Federal

Technology Transfer Act of 1986 (FTTA,

15 U.S.C. 3710; and Executive Order

12591 of April 10, 1987, as amended by

the National Technology Transfer and

Advancement Act of 1995), the National

Cancer Institute (NCI) of the National

Institutes of Health (NIH) of the Public

Health Service (PHS) of the Department

of Health and Human Services (DHHS)

seeks Cooperative Research and

Development Agreements (CRADAs)

with pharmaceutical or biotechnology

companies to evaluate and develop

methods to detect mutations in both the

MET and VHL gene sequences using

nucleic acid array technology. Any

CRADA for the biomedical use of this

technology will be considered. The

CRADAs would have an expected

duration of one (1) to five (5) years. The

goals of the CRADAs include the rapid

publications of research results and

timely commercialization of products,

diagnostics and treatments that result

from the research. The CRADA

Collaborators will have an option to

elect a non-exclusive or exclusive

commercialization license to subject

inventions arising under the CRADAs

that are related to the DNA array

technology of the collaborators, which

are the subject of the CRADA Research

Plan, for diagnostics and research

supply and can apply for background

licenses to the existing patents listed

below, subject to any pre-existing

licenses already issued for other fields

of use. Licensing by NIH is subject to 35

U.S.C. 207 and 37 CFR Part 404.

ADDRESSES: Proposals and questions

about this CRADA opportunity may be

addressed to Dr. Thomas M. Stackhouse,

Technology Development &

Commercialization Branch, National

Cancer Institute-Frederick Cancer

Research & Development Center,

Fairview Center, Room 502, Frederick,

MD 21701 (phone: 301–846–5465, fax:

301–846–6820).

Scientitific inquiries—Dr. Berton

Zbar, Chief, Laboratory of

Immunobiology, National Cancer

Institute-Frederick Cancer Research &

Development Center, P.O. Box B,

Building 560, Room 12–68, Frederick

MD, 21702–1201 (phone: 301–846–1288

FAX: 301–846–6145).

EFFECTIVE DATE: Inquiries regarding

licensing and scientific matters may be

forwarded at any time. Confidential

CRADA proposals, preferably one page

or less, must be submitted to NCI on or

before July 6, 1998. Guidelines for

preparing full CRADA proposals will be

communicated shortly thereafter to all

respondents who have been selected.

SUPPLEMENTARY INFORMATION:

Technology Available

DHHS scientists have identified

mutations in the proto-oncogene c-MET,

and the von Hippel-Lindau disease

(VHL) tumor suppressor gene in human

cancers. c-MET is the receptor for

hepatocyte growth factor/scatter factor.

Germline mutations in the MET gene

have been detected in affected members

of families with an inherited

predisposition to develop papillry renal

carcinomas; somatic mutations in the

MET gene have been detected in a

subset of papillary renal carcinomas. All

mutations detected in the MET gene to

date were located in the tyrosine kinase

domain; all mutations were missense.

The VHL gene is mutated in patients

with von Hippel-Lindau disease, and in

sporadic clear cell carcinomas of the

kidney. Disease-causing mutations

include gender deletions (partial or

complete), missense and nonsense and

frame shift mutations.

About 30,000 individuals develop

kidney cancer each year. We anticipate

that the novel mutation detection

techniques for the MET and VHL genes

will be used in patients with sporadic

and inherited predispositions to renal

cancer. Possible uses would include

diagnosis and prognosis of kidney

cancer. In addition, these new methods

might be applied to the study of other

types of human neoplasia.

DHHS now seeks collaborative

arrangements for the joint evaluation

and development of methods to detect

mutations in both gene sequences using

nucleic acid array technology. The

methods may include but are not

limited to spectroscopic partitioning

techniques and DNA chip technology.

For collaborations with the commercial

sector, a Cooperative Research and

Development Agreement (CRADA) will

be established to provide equitable

distribution of intellectual property

rights developed under the CRADA. The

successful CRADA partner will

collaboratively develop and test known

mutations within the genes from

samples provided by the government.

CRADA aims will include rapid

publication of research results as well as

full and timely exploitation of any

commercial opportunities.

NCI’s VHL/MET Patents and Patent

Applications

1. Von Hippel-Lindau(VHL) Disease

Gene and Corresponding cDNA and

Methods for Detecting Carriers of the

VHL Disease Gene; United States Patent

5,654,138, issued August 5, 1997.

The role of the National Cancer

Institute in this CRADA will include,

but not be limited to:

1. Providing intellectual, scientific,

and technical expertise and experience

to the research project.

2. Providing the Collaborator with

samples of the subject gene sequences

for evaluation.

3. Planning research studies and

interpreting research results.

4. Publishing research results.

The role of the CRADA Collaborator

may include, but not be limited to:

1. Providing significant intellectual,

scientific, and technical expertise or

experience to the research project.

2. Planning research studies and

interpreting research results.