21988 Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices

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 Request:

Extension of a currently approved

collection; Title of Information

Collection: Medicare+Choice (M+C)

Provider Sponsored Organization (PSO)

Waiver Request Form and Supporting

Regulations in 42 CFR 422.370–422.378;

Form Number: HCFA–R–231 (0938–

0722); Use: The PSO waiver request

form is for use by PSO’s that do not

have a State risk-bearing entity licence

and that wish to enter into a M+C

contract with HCFA to provide prepaid

health care services to eligible Medicare

beneficiaries. HCFA will use the

information requested on this form to

determine whether the applicant is

eligible for a waiver of the state

licensure requirement for M+C

organizations as allowed under section

1855(a)(2) of the Social Security Act.;

Frequency: One-time.; Affected Public:

Business or other for-profit, Not-forprofit institutions, and Federal

Government.; Annual Number of

Respondents: 10.; Total Annual

Responses: 10.; Total Annual Hours

Requested: 100.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, 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: Dawn Willinghan, HCFA–R–

231, Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: April 23, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–10882 Filed 5–1–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute: Proposed Collection;

Comment Request; The Framingham

Study

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Heart, Lung, and Blood

Institute (NHLBI), the National

Institutes of Health (NIH) will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (MB) for

review and approval.

Proposed Collection: Title: The

Framingham Study. Type of Information

Collection Request: Revision of a

currently approved collection (OMB No.

0925–0216). Need and Use of

Information Collection: The

Framingham Study will conduct

examinations and morbidity and

mortality follow-up in original,

offspring, and third generation

participants for the purpose of studying

the determinants of cardiovascular

disease. Frequency of Response: The

participants will be contacted annually.

Affected Public: Individuals or

households; Businesses or other for

profit; Small businesses or

organizations. Type of Respondents:

Adult men and women; doctors and

staff of hospitals and nursing homes.

The annual reporting burden is as

follows; Estimated Number of

Respondents: 2,833: Estimated Number

of Responses per Respondent: 3.78;

Average Burden Hours Per Response:

0.806; and Estimated Total Annual

Burden Hours Requested: 8,639. The

annualized cost to respondents is

estimated at $44,080, assuming

respondents time at the rate of $10 per

hour for participant and $55 per hour

for physicians and other professional

health care respondents.

There are no Capital Costs to report.

There are no Operating or Maintenance

Costs to report.

ESTIMATE OF ANNUAL HOUR BURDEN

Type of respondents Number of

respondents

Estimated

number of

responses

per

respondent

Average

burden

hours per

response

Estimated

total

annual

burden

hours

requested

Participant examination ................................................................................................... 2,133 4.69 0.836 8,376.5 1Physician, hospital, nursing home staff ......................................................................... 350 1.0 0.6700 234.5 1Participant’s next-of-kin .................................................................................................. 350 1.0 0.0800 28

Total .......................................................................................................................... 2,833 3,78 0.806 8639

1Annual burden is placed on doctors, hospitals, nursing homes, and respondent relatives/informants through requests for information which will

help in the compilation of the number and nature of new fatal and nonfatal events.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used: (3)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) Ways to minimize the

burden of the collection of information

on those who are to respond, including

the use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

FOR FURTHER INFORMATION: To request

more information on the proposed

project or to obtain a copy of the data

collection plans and instruments,

contact Dr. Paul Sorlie, Project Officer,

NIH, NHLBI, 6701 Rockledge Drive,

Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices 21989

MSC 7934, Bethesda, MD 20892, or call

non-toll-free number (301) 435–0707 or

E-mail your request, including your

address to : Sorlie@nih.gov.

Comments Due Date: Comments

regarding this information collection are

best assured of having their full effect if

received on or before July 2, 2001.

Dated: April 19, 2001.

Peter J. Savage,

Acting Director, Division of Epidemiology and

Clinical Applications, National Heart, Lung,

and Blood Institute.

[FR Doc. 01–10932 Filed 5–1–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES (DHHS)

National Institutes of Health (NIH)

National Institutes of Health Clinical

Center (NIHCC); Opportunity for

Cooperative Research and

Development Agreement (CRADA)

SUMMARY: The National Institutes of

Health Clinical Center (NIHCC) is

seeking to enter at least one Cooperative

Research and Development Agreement

(CRADA). The goal is to develop and

implement an application specific

artificial neural network based

intelligent computing system for on-line

and off-line quality control of a process,

particularly a medical process, and

especially test result production in

clinical laboratory automated analyzers.

The development of this technology is

part of the ongoing activities of the

NIHCC. The term of any CRADA will be

up to five (5) years.

DATES: Interested parties should notify

this office in writing of their intent to

file a formal proposal no later than June

1, 2001. Formal proposals should be

submitted to this office no later than

July 2, 2001. Proposals received after

this date will still be considered, but

only after all proposals received before

this date have been considered.

ADDRESSES: Questions concerning this

announcement, and all research

proposals, should be submitted to Bruce

D. Goldstein, Esq., Technology Transfer

Branch, National Cancer Institute,

National Institutes of Health, Suite 450,

6120 Executive Blvd., Rockville, MD

20852, Phone: 301–496–0477, Fax: 301–

402–2117. Scientific questions should

be addressed to James M. DeLeo, 6100

Executive Blvd., Suite 5C01, Rockville,

MD 20852; Phone (direct): 301–496–

3848; Fax: 301–496–3848; e-mail:

jdeleo@nih.gov. Inquiries directed to

obtaining patent license(s) related to

participation in the CRADA opportunity

should be addressed to Dale Berkley,

PhD., J.D., Senior Technology Licensing

Specialist, Office of Technology

Transfer, National Institutes of Health,

6011 Executive Blvd., Suite 325,

Rockville, MD 20852–3804, Phone: 301–

496–7735, Fax: 301–402–0220, e-mail:

Berkld@od.nih.gov.

SUPPLEMENTARY INFORMATION: A CRADA

is the anticipated joint agreement to be

entered into by NIHCC and a

collaborator pursuant to the Federal

Technology Transfer Act of 1986 (15

U.S.C. 3710 a), as amended. A CRADA

is an agreement designed to enable

certain collaborations between

Government laboratories and nonGovernment laboratories. It is not a

grant, and is not a contract for the

procurement of goods/services. THE

NIHCC IS PROHIBITED FROM

TRANSFERRING FUNDS TO A CRADA

COLLABORATOR. Under a CRADA, the

NIHCC can offer the selected

collaborator access to facilities, staff,

materials, and expertise. The

collaborator may contribute facilities,

staff, materials, expertise, and funding

to the collaboration. A CRADA

collaborator may elect an option to an

exclusive or non-exclusive license to

Government intellectual patent rights

arising under the CRADA, and may

qualify as an inventor or co-inventor of

new technology developed under the

CRADA. As between two or more

sufficient, overlapping research

proposals (where the overlap cannot be

cured), the NIHCC, as specified in 15

U.S.C. § 3710a(c)(4), will give special

consideration to small businesses, and

will give preference to business units

located in the U.S. that agree to

manufacture CRADA products in the

U.S.

The CRADA will employ a

generalized computational system and

method developed earlier at the

National Institutes of Health. This

technology was developed for the

purpose of detecting errors in processes

including, but not limited to, data

collection in laboratory automated

analyzers. The technology is capable of

early on-line detection of various types

of errors such as bias, precision, and

random errors. It may also be developed

as an off-line computational component.

Theoretical studies have demonstrated

significant advantages of this technology

over current state-of-the art quality

control practice in laboratory

instrument quality control monitoring.

The primary goal of the CRADA is to

use the developed system and method

to build practical and useful software

and/or hardware components for

application in real-world production or

assembly process environments such as

commercially available laboratory

automated analyzers and other

appropriate medical or non-medical

applications.

The described methods and system

are the subject of a U.S. patent

application filed November 26, 1998 by

the Public Health Service on behalf of

the Federal Government.

Commercialization of new CRADA

technology may require obtaining an

appropriate PHS license.

The collaborator in this endeavor is

expected to commit technical personnel

commensurate with the level of research

activities defined by the CRADA

Research Plan. It is anticipated that PHS

facilities and/or those of the collaborator

will be utilized, as appropriate, for the

research activities as defined by the

Research Plan. NIHCC anticipates, in

addition, that the Collaborator, as

appropriate, will provide funding for

the project.

Party Contributions

The NIHCC anticipates that its role

may include, but not be limited to, the

following:

(1) Plan research studies, interpret

research results, and, as appropriate,

jointly publish the conclusions with the

collaborator;

(2) Provide collaborator with access to

existing NIHCC research data, both

already collected and yet to be collected

(except for medical or other personal

data regarding identifiable patients);

(3) Provide staff, expertise, and

materials for the development and

testing of promising application

products;

(4) Provide work space and

equipment for testing of any prototype

products developed.

The NIHCC anticipates that the role of

the successful collaborator will include

at least the following:

(1) Provide significant intellectual,

scientific, and technical expertise in the

development of relevant products;

(2) Plan research studies, interpret

research results, and, as appropriate,

jointly publish the conclusions; and

(3) Provide NIHCC a supply of

necessary materials, access to necessary

proprietary technology and/or data, and

as necessary for the project, staff and

funding in support of the research goals.

Other contributions may be necessary

for particular proposals.

Selection Criteria

Proposals submitted for consideration

should address, as best as possible and

to the extent relevant to the proposal,

each of the following:

(1) Expertise:

A. Expertise in the research and

development of diagnostic, prognostic,