Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices 4305

Medicare Beneficiaries, due to provider

non-payment.

HCFA is requesting that OMB provide

a seven working day review and a 180-

day approval. During this 180-day

period HCFA will pursue OMB

clearance of this collection as stipulated

by 5 CFR 1320.5.

1. Type of Information Collection

Request: Reinstatement without change,

of a previously approved collection;

Title of Information Collection:

Medicare/Medicaid Health Insurance

Common Claim Form and Instructions,

and Supporting Regulations 42 CFR

424.32 (Basic Requirements for all

Claims) and 42 CFR 414.40 (Coding and

Ancillary Policies); Form No.: HCFA–

1500; Use: This form and instructions

are standardized for use in the

Medicare/Medicaid programs to apply

for reimbursement for covered services.

HCFA does not require exclusive use of

this form for Medicaid. 42 CFR 424.32

and 42 CFR 414.40 are regulations

underlying the use of the form HCFA–

1500 and the information captured on

the form HCFA–1500, including the use

of diagnostic and procedural coding

systems; Frequency: On occasion;

Affected Public: Business or other for

profit, not for profit institutions, State,

local or tribal government; Number of

Respondents: 976,239; Total Annual

Responses: 614,967,982; Total Annual

Hours: 52,139,385.

To request copies of the proposed

paperwork collections referenced above,

call the Reports Clearance Office on

(410) 786–1325. Written comments and

recommendations for the proposed

information collections should be sent

within five working 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: January 23, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–2088 Filed 1–28–97; 8:45 am]

BILLING CODE 4120–03–P

[ORD–089–N]

Medicare and Medicaid Programs;

Small Business Innovation Research

Grants for Fiscal Year 1997

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

availability of HCFA funding, through

grants, for small businesses under the

Small Business Innovation Research

(SBIR) Program. This notice contains

information about the subject areas for

grants that will be given priority,

application requirements, review

procedures, and other relevant

information.

DATES: Grant applications must be

submitted by April 29, 1997, in order to

be considered under the fiscal year (FY)

1997 annual funding cycle.

ADDRESSES: Standard application forms

and related instructions are available

from and must be formally submitted to:

HCFA Grants Officer, Office of

Acquisition and Grants, Health Care

Financing Administration, 7500

Security Boulevard, C2–21–15,

Baltimore, MD 21244–1856, (410) 786–

5701.

FOR FURTHER INFORMATION CONTACT: Carl

Hackerman, (410) 786–6644. Internet:

Chackerman@hcfa.gov.

SUPPLEMENTARY INFORMATION:

I. Small Business Innovation Research

Program

The Small Business Innovation

Development Act of 1982 (Public Law

97–219, enacted on July 22, 1982), as

amended by the Small Business

Innovation Research Program Extension

(Public Law 99–443, enacted on October

6, 1986), the Small Business

Administration Reauthorization and

Amendment Act of 1988 (Public Law

100–590, enacted on November 3, 1988),

the Small Business Research and

Development Enhancement Act of 1992

(Public Law 102–564, enacted on

October 28, 1992), and the Small

Business Administration

Reauthorization Act of 1994 (Public Law

104–403, enacted on October 2, 1994),

(15 U.S.C. 638(e) through (m)), requires

Federal agencies to reserve a specific

amount of their extramural research and

budgets for a Small Business Innovation

Research (SBIR) Program. This SBIR

Program is intended to—

• Stimulate technological

innovation;

• Use small business to meet Federal

research and demonstrations (‘‘R & D’’)

needs;

• Increase private sector

commercialization of innovations

derived from Federal R & D; and

• Foster and encourage participation

by minority and disadvantaged persons

in technological innovation.

The principal purpose of HCFA’s

SBIR Program is to provide assistance to

creative applicants so that innovation

can be encouraged that will result in

better health care.

A. SBIR Program Phases, Award

Amounts, and Period of Support

The SBIR Program consists of the

following three phases:

Phase I

The objective of this phase is to

establish the technical merit and

feasibility of proposed research or

Research and Demonstrations efforts

and to determine the quality of

performance of the small business

awardee organization before furnishing

further Federal support in Phase II.

Phase I awards will be approximately

$50,000 (for both direct and indirect

costs) for a period not to exceed 12

months.

Phase II

The objective of this phase is to

continue the research or R & D efforts

initiated in Phase I and to actually

create the proposed product and test it

before marketing. Funding is based on

the results of Phase I and technical

merit of the Phase II application,

including its potential for

commercialization. (Only Phase I

awardees are eligible to apply for Phase

II funding.) Phase I awardees are eligible

to apply for Phase II funding only from

the Federal agency that supported their

Phase I project. Phase II awards will be

approximately $100,000 to 150,000 (for

both direct and indirect costs) for a

period normally not to exceed 12

months.

Phase III

The objective of this phase, if

appropriate, is for the small business

concern to pursue with non-Federal

funds the commercialization of the

results of the research or R & D in

Phases I and II.

The purpose of this notice is to invite

Phase I and II grant applications from

for-profit domestic small business

concerns that have the expertise to

develop or further develop innovative

technology. This technology should be

compatible with the general mission of

HCFA and contribute to the health care

field. HCFA is responsible for the

Medicare program, Federal participation

in the Medicaid program, and related

health care quality assurance programs.

HCFA’s mission is to promote the

timely delivery of appropriate quality

health care to its Medicare beneficiaries

and Medicaid recipients—over 70

million of the nation’s aged, disabled,

and poor. HCFA must also ensure that

Medicare beneficiaries and Medicaid

recipients are aware of the services for
4306 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices

which they are eligible. In addition,

HCFA must ensure that those services

are accessible and of high quality.

In carrying out its mission, HCFA

conducts studies and projects that

examine and demonstrate payment,

coverage, eligibility, and management

alternatives to the present programs.

HCFA also studies the impact of HCFA

programs on health care costs, program

expenditures, beneficiary and recipient

access to services, health care providers,

and the health care segment of the

American economy.

In addition, HCFA monitors national

health care expenditures and prices and

provides analyses of the costs of current

programs, as well as the impact of

possible legislative or administrative

changes in the programs. HCFA’s Office

of Research and Demonstrations (ORD)

is responsible for the technical aspects

of the SBIR Program described in this

section.

This notice outlines the eligibility

requirements for organizations wishing

to participate in the HCFA SBIR

Program and the research grant

application and review processes. It also

provides both general program

information as well as specific research

topics and subtopics that may be of

interest to small business concerns.

Although areas of special

programmatic interest or priority are

described in section VII. of this notice,

we will consider grant applications in

any area within the field of health care

research and demonstrations unless

otherwise specifically excluded.

However, we are not generally

interested in funding the biomedical or

clinical projects that more appropriately

fit the mission of the National Institutes

of Health.

B. Eligibility

Each organization submitting a grant

application under our SBIR Program

must qualify as a small business

concern. ‘‘Small business concern’’ is

defined in section II.F. of this notice. In

determining whether an applicant is a

small business concern, an assessment

will be made of several factors,

including whether it is organized for

profit, whether it is independently

owned and operated, and whether it

meets the size requirement of 500 or

fewer employees. Whether the size

requirement is met may depend on

whether the applicant organization is

affiliated with another organization

whose employees, when added to those

of the applicant organization, exceed

500. In conducting this assessment, all

appropriate factors will be considered,

including common ownership, common

management, and contractual

relationships.

Affiliation exists when one concern

controls or has the power to control the

other, or there is third party control, or

an identity of interest between or among

parties exists so that affiliation may be

found. Control may be affirmative or

negative, and it is immaterial whether it

is exercised so long as the power to

control exists. Indeed, control can arise

from a variety of circumstances. One

example of a circumstance that could

lead to a finding that an organization is

controlling, or has the power to control,

another organization is the sharing of

common office space, employees, or

other facilities (for example, laboratory

space). Although access to special

facilities or equipment in another

organization is permitted (as in cases in

which the SBIR applicant has entered

into a subcontractual agreement with

another institution for a specific, limited

portion of the research project), research

space occupied by an SBIR applicant

must be space that is not generally

shared with another organization and

over which the applicant has exclusive

control. When there is an indication of

sharing of common employees, a

determination will be made on a caseby-case basis of whether the sharing

constitutes control or the power to

control.

Additionally, control or the power to

control is generally considered to exist

when ‘‘key employees of one concern

organize a new concern and serve as its

officers, directors, principal

stockholders, and/or key employees,

and the one concern is furnishing or

will furnish the other concern with

subcontracting financial or technical

assistance, bid or performance bond

indemnification, and/or other facilities,

whether for a fee or otherwise.’’

Affiliation can also arise between or

among two or more persons when an

identity of interest exists, such as

members of the same family or persons

with common investments in more than

one concern.

All SBIR grant applications will be

reviewed with the above considerations

in mind. Organizations considering

submitting an application are referred to

the SBA’s SBIR Program Policy

Directive published in the Federal

Register on January 26, 1993 (58 FR

6144) and to the regulations set forth at

13 CFR part 121 for further guidance

regarding eligibility. In particular, to

determine whether affiliation exists, the

applicant should also refer to 13 CFR

121.401 for the definition of affiliation,

which will be used as HCFA’s guide on

this matter. If it appears that an

applicant organization does not meet

eligibility requirements with respect to

size, HCFA will request a size

determination of the organization from

the applicable Small Business

Administration (SBA) regional office.

The review of the application may be

deferred until a definitive response is

furnished by SBA.

Of particular concern in considering

grant awards is the position of principal

investigator. We wish to ensure that

support is furnished to a carefully

directed working group led by an

individual personally committed to the

development of the innovation.

Accordingly, we are adopting the

‘‘principal investigator’’ concept from

42 CFR part 52. These regulations define

the term ‘‘principal investigator’’ to

mean ‘‘a single individual designated by

the grantee in the grant application

* * * who is responsible for the

scientific and technical direction of the

project’’ (42 CFR 52.2). In order to meet

this standard, the principal

investigator’s primary employment must

be with the grantee at the time of the

award and remain so for the duration of

the project. Primary employment means

that more than one-half of the principal

investigator’s time is spent in the

employment of the small business

concern. Primary employment with a

small business concern precludes fulltime employment at another

organization.

In accordance with SBA’s SBIR

Program Policy Directive published in

the Federal Register on January 26,

1993 (58 FR 6144), we have further

restricted the definition of primary

employment of the principal

investigator to accurately reflect HCFA’s

needs. The applicant must declare the

principal investigator’s employment,

whether paid or unpaid, at the time of

application, and must declare all

employment relationships, whether

paid or unpaid, that the principal

investigator is expected to have at the

time the SBIR grant awards are expected

to be made and for the duration of the

proposed project. In the event that, at

the time of application, the principal

investigator (1) is, or expects to be, a

less-than-full-time employee of the

small business concern; (2) is, or

expects to be, concurrently employed by

another organization; or (3) gives, or

expects that he or she may give, the

appearance of being concurrently

employed by another organization,

whether for a paid or unpaid position,

it is essential that documentation be

submitted with the application to verify

the applicant’s eligibility at the time of

the award. Thus, if the principal

investigator is also employed or appears

to be employed by an institution other
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices 4307

than the applicant organization (for

example, a university, nonprofit

research institute, or a company other

than the applicant organization), a letter

must be furnished by the nonapplicant

organization confirming that the

principal investigator, if awarded an

SBIR grant, is, or will become, a lessthan-half-time employee of the

organization and will remain so for the

duration of the SBIR project. If the

principal investigator is employed by a

university, the letter must be furnished

by the dean of the school or the

departmental chairperson. If the

principal investigator is employed by

another for-profit organization, the letter

must be signed by a corporate official.

This documentation of the primary

employment of the principal

investigator is required for every

application that is submitted, even one

that is a revision of a previously

submitted application. In the event that

solicitation of this documentation

would place the principal investigator’s

current employment in jeopardy should

the grant award not be made, the

applicant may delay submission of the

documentation, provided the

documentation is submitted no later

than 30 days after receiving notice of a

grant award, and provided that the

applicant includes a statement with the

grant application to the effect that

solicitation of the documentation at this

time would place the principal

investigator’s current employment in

jeopardy, that the applicant will forward

the documentation within 30 days of

receiving notice of a grant award, and

that the applicant understands that

should it fail to provide the

documentation, we may, at our

discretion, immediately suspend or

terminate the grant. If the principal

investigator fails to furnish adequate

documentation, the application may be

returned without review. In the event a

grantee is required to submit

documentation of the principal

investigator’s employment, but fails to

do so within 30 days of the date of the

notice of grant award, we may

immediately suspend or terminate the

grant.

For both Phase I and Phase II, the

research or R & D must be performed in

its entirety in the United States (U.S.),

that is, the States, territories, and

possessions of the U.S.; the

Commonwealths of Puerto Rico and the

Northern Mariana Islands; and the

District of Columbia.

II. Definitions

The words and phrases that appear on

the SBIR application form, or are

needed in the application narrative, are

not readily defined. Therefore, for

convenience and clarity, we have

furnished the following definitions,

which, except as noted, are taken from

SBA’s SBIR Program Policy Directive

that implements this program and was

published on January 26, 1993, in the

Federal Register (58 FR 6144). This

policy directive requires an agency to

define in a separate section whatever

terms it uses that are unique to either

the SBIR Program, a specific SBIR

solicitation, or a portion of the

solicitation. The section must also

include, at a minimum, specific terms as

defined in the policy directive.

Accordingly, in addition to the terms

required by the policy directive, we are

also defining the terms ‘‘Contract’’ and

‘‘Grant’’ and including the policy

directive’s definition of the term

‘‘Research and Development.’’

A. Contract

A ‘‘contract’’ is an award instrument

establishing a binding legal

procurement relationship between a

funding agency and the recipient,

obligating the latter to furnish an end

product or service and binding the

agency to furnish payment for the

product or service.

B. Grant

A ‘‘grant’’ is a financial assistance

mechanism whereby either money or

direct assistance, or both, is furnished to

carry out approved activities.

C. Socially and Economically

Disadvantaged Individual

In accordance with the Small

Business Administrations definitions

(13 CFR Part 124), a ‘‘socially and

economically disadvantaged

individual’’ is defined as a member of

any of the following groups:

• Asian-Pacific Americans

• Black Americans

• Hispanic Americans

• Native Americans

• Subcontinent Asian Americans

D. Socially and Economically

Disadvantaged Small Business Concern

A ‘‘socially and economically

disadvantaged’’ small business concern

is one—

• In which at least 51 percent is

owned by one or more socially and

economically disadvantaged individuals

or, in the case of any publicly owned

business, at least 51 percent of the

voting stock is owned by one or more

socially and economically

disadvantaged individuals; and

• Whose management and daily

business operations are controlled by

one or more of the individuals.

E. Research and Development

• Research and Development’’ or

Research and Demonstrations is defined

as any activity that is—

• A systematic, intensive study

directed toward greater knowledge or

understanding of the subject studies;

• A systematic study directed

specifically toward applying new

knowledge to meet a recognized need;

or

• A systematic application of

knowledge toward the production of

useful materials, devices, and systems

or methods, including design,

development, and improvement of

prototypes and new processes to meet

specific requirements.

F. Small Business Concern

At the time of award of Phase I and

of Phase II, a ‘‘small business concern’’

is one that—

• Is organized for profit,

independently owned and operated, not

dominant in the field of operation in

which it is proposing, and has its

principal place of business located in

the U.S.;

• Is at least 51 percent owned or, in

the case of a publicly owned business,

at least 51 percent of its voting stock is

owned by U.S. citizens or lawfully

admitted permanent resident aliens; and

• Has, including its affiliates

(‘‘affiliation’’ is defined in 13 CFR

121.401), a number of employees (as

defined in 13 CFR 121.407) not

exceeding 500, and meets the other

small business concern size regulation

requirements found in 13 CFR 121.

Business concerns, other than

investment companies licensed, or State

development companies qualifying,

under the Small Business Investment

Act of 1958 (15 U.S.C. 661 et seq.), are

affiliates of one another when either

directly or indirectly (1) one concern

controls or has the power to control the

other, (2) a third party or parties

controls or has the power to control

both, or (3) an identity of interest

between or among parties exists so that

affiliation may be found. Control can be

exercised through common ownership,

common management, and contractual

relationships. Business concerns

include, but are not limited to, any

individual, partnership, corporation,

joint venture, association, or

cooperative.

G. Subcontract

A ‘‘subcontract’’ is any agreement,

other than one involving an employeremployee relationship, entered into by a

Federal government funding agreement

awardee calling for supplies or services
4308 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices

required solely for the performance of

the original funding agreement.

H. Women-Owned Small Business

Concern

A ‘‘women-owned small business

concern’’ is a business that is at least 51

percent owned, controlled, and operated

by a woman or women. ‘‘Control’’ is

defined as exercising the power to make

policy decisions; ‘‘operate’’ is defined as

being actively involved in the day-today management.

III. Preparation of Grant Applications

The forms and instructions will be

supplied to the applicant by the HCFA

Grants Officer (see the ADDRESSES

section of this notice) and are designed

for use in applying for SBIR Phase I or

Phase II research grants. The

instructions contain the SBA policy

directive’s guidelines on proposal

content and limitations.

Potential applicants are encouraged to

contact the SBIR Coordinator (see the

FOR FURTHER INFORMATION CONTACT

section of this notice) for preapplication

technical assistance and for more

specific information on the research

topics described in section VII. of this

notice.

Health science research literature is

available at academic and health science

libraries and Regional Medical Libraries

through a network supported by the

National Library of Medicine. A list of

Regional Medical Libraries and

information about network services may

be requested from the Public

Information Office, National Library of

Medicine, Bethesda, MD 20894,

telephone (301) 496–6308.

Other sources that provide technology

search and document services include

the organizations listed below. They

should be contacted directly for service

and cost information.

National Technical Information Service

5285 Port Royal Road

Springfield, VA 22161

(703) 487–4600

NASA Industrial Applications Center

University of Pittsburgh

701 LIS Building

Pittsburgh, PA 15280

(412) 624–5211

North Carolina Science and Technology

Research Center

Post Office Box 12235

Research Triangle Park, NC 27709

(919) 549–0671

NASA/Florida State Technology

Applications Center

State University

System of Florida, 500 Well Hall

Gainesville, FL 32611

(904) 392–6626

NASA/UK Technology

University of Kentucky

109 Kinkead Hall

Lexington, KY 40506

(606) 257–6322

Aerospace Research Applications

Center

611 N. Capitol Avenue

Indianapolis, IN 46204

(317) 262–5003

Kerr Industrial Applications Center

Southeastern Oklahoma State

University Durant, OK 74701

(405) 924–6822

IV. Submission of Grant Applications

Grant applications must be submitted

to the HCFA Grants Officer (see the

ADDRESSES section of this notice).

Applications must be postmarked by

April 29, 1997. Applications mailed

through the U.S. Postal Service or a

commercial delivery service will be ‘‘on

time’’ if they are received or postmarked

on or before April 29, 1997.

Submissions by facsimile (fax)

transmission will not be accepted.

Applications that do not meet the above

criteria will be considered late

applications. Respondents are cautioned

that if their application is late, it will be

returned without review.

V. Method of Selection and Evaluation

Criteria

All Phase I and Phase II grant

applications will be evaluated and

judged on a competitive basis.

Applications will be screened, and

those found to be inadequate for review

or programmatically unrelated to

HCFA’s mission will be returned to the

applicant. Those passing the screening

will be reviewed for technical merit.

Each application will be judged

individually, as described in this

section. HCFA is under no obligation to

fund any application or make any

specific number of awards in a given

topic area. It may also elect to fund no

projects within a given topic area.

A. Review Process

Grant applications are subject to a

review process involving two sequential

steps. The first step is performed by a

technical review panel composed

primarily of Federal and non-Federal

professionals selected for their

competence in particular fields. The

task of the panel is to evaluate

applications for technical merit. The

reviewers furnish a number rating, make

an overall recommendation, and, on

occasion, make highly specific

recommendations related to the scope,

direction, and conduct of the proposed

research. The second level of review is

made by the senior management of

HCFA’s ORD. ORD management

decisions are based on judgments about

not only the technical merit of the

proposed research, but also its relevance

to our mission. Generally, HCFA may

award a grant only if the corresponding

application has been recommended for

approval by the panel. However,

applications recommended for approval

are not automatically funded.

B. Review Criteria

• In considering the technical merit

of each application, the following

criteria and weights will be used:

• The soundness and technical merit

of the proposed approach—35 percent.

• The potential of the research for

technological innovation including the

potential for commercial application—

30 percent.

• The qualifications of the proposed

principal investigator, support staff, and

consultant—20 percent.

• The appropriateness of the budget—

10 percent.

• The adequacy and suitability of the

facilities and research environment—5

percent.

C. Funding Decisions

When making funding decisions, ORD

takes into consideration the following:

(1) Ratings resulting from the technical

evaluation process, (2) program

relevance, and (3) applications.

D. Release of Grant Application Review

Information

Following decisions on grant

applications, their summary statements

are mailed with a disapproval letter to

principal investigators whose proposals

have not been accepted.

E. Submission of Similar Grant

Applications by the Applicant

Organization

HCFA discourages the submission of

more than one grant application

submitted by the same applicant

organization with essentially the same

research focus: That is, a product or

technology that, with nonsubstantive

modifications, can be applied to a

variety of purposes. In evaluating

groupings of applications with a

common focus or objective, technical

review groups are in a position to easily

identify multiple grant applications

from the same organization for

essentially the same project. In these

cases, HCFA will give funding

consideration to only one application.

VI. Considerations

SBA’s SBIR Program Policy Directive

(58 FR 6144) specifies that we furnish

the following information:
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices 4309

A. Awards

• There will be approximately 10 to

15 Phase I and/or Phase II awards in FY

’97.

• The SBA Program Policy Directive

permits the payment of a reasonable fee

or profit under the SBIR program.

B. Reports

The grantee organization will be

required to submit semi-annual progress

reports, a complete draft final report,

and a final report. Additionally, a

financial status report (SF–269A) must

be submitted to the HCFA Grants Officer

annually. The award will specify the

schedule for these reports and place of

delivery.

C. Payment Schedule

Once an SBIR grant is awarded, the

grantee organization will receive

information and forms regarding

requests for cash, manner of payment,

and associated reporting requirements.

Payment may be made on a costreimbursement or advance basis. Cost

reimbursements may be requested

monthly, quarterly, or at other periodic

intervals. Advance payments may be

requested on a monthly basis only.

D. Limited Rights Information and Data

1. Proprietary Information

Information contained in an unfunded

grant application will remain the

property of the applicant. HCFA may,

however, retain copies of all

applications.

If proprietary information is provided

by a proposer in a proposal that

constitutes a trade secret, proprietary,

commercial or financial information,

confidential personal information or

data affecting the national security, it

will be treated in confidence, to the

extent permitted by law, provided this

information is clearly marked by the

proposer with the term ‘‘confidential

proprietary information’’ and provided

the following legend appears on the title

page of the proposal:

For any purpose other than to evaluate the

proposal, this data shall not be disclosed

outside the government and shall not be

duplicated, used, or disclosed in whole or in

part, provided that if a funding agreement is

awarded to this proposer as a result of or in

connection with the submission of this data,

the government shall have the right to

duplicate, use, or disclose the data to the

extent provided in the funding agreement.

This restriction does not limit the

government’s right to use information

contained in the data if it is obtained from

another source without restriction. The data

subject to this restriction are contained in

pages llll of this proposal.

Any other legend may be

unacceptable to the Federal government

and may constitute grounds for

removing the proposal from further

consideration and without assuming

any liability for inadvertent disclosure.

The government will limit

dissemination of the information to

official channels only.

2. Title to Property

Title to real property, equipment, and

supplies acquired by a for-profit

recipient under a financial assistance

award or subaward will vest, upon

acquisition, in the Federal government.

However, the title may be transferred to

the awardee upon termination of the

project if the transfer would be more

cost-effective than our recovery of the

property. It is recommended that

applicants consider leasing

arrangements whenever possible. HCFA

will generally not fund projects that

require the acquisition of real property,

equipment, or supplies.

3. Rights in Data Developed Under the

SBIR Grant

Rights in data, including software

developed under the terms of any grant

resulting from an application submitted

in response to this notice, will remain

with the grantee, except that the Federal

government will have the limited right

to use the data for internal Federal

government purposes. These data will

not be released outside the Federal

government without permission of the

grantee for a period of 4 years from

completion of the project from which

the data were generated. However, at the

end of this 4-year period a royalty-free

license will exist for HCFA to use, and

to authorize others to use on its behalf,

these data for Federal government

purposes. At this time, HCFA is also

relieved of all disclosure prohibitions

and assumes no liability for

unauthorized use of these data by third

parties. This notice will be affixed to

any reproductions of these data, in

whole or in part.

4. Copyrights

With prior written permission of the

Grants Officer, the awardee may

normally copyright and publish

(consistent with appropriate national

security considerations, if any) material

developed with HCFA’s support. HCFA

receives a royalty-free license for the

Federal government and requires that

each publication contain an appropriate

acknowledgment of agency support and

a disclaimer statement.

5. Patents

Small business concerns may

normally retain the principal worldwide

patent rights to any invention developed

with HCFA support. The Federal

government receives a royalty-free

license for Federal government use,

reserves the right to require the

patentholder to license others in certain

circumstances, and requires that anyone

exclusively licensed to sell the

invention in the U.S. must normally

manufacture it substantially in the U.S.

To the extent authorized by 35 U.S.C.

205, the government will not make

public any information disclosing a

government-supported invention for a 4-

year period to allow the awardee a

reasonable time to pursue a patent.

E. Profit or Fee

Absent a statutory prohibition,

payment of a reasonable fee or profit

will be made under the SBA’s SBIR

Program Policy Directive (58 FR 6144).

Because the regulations set forth at 45

CFR 74.705, which provide that no

profit or fee will be furnished to forprofit organizations through grants, do

not invoke a statutory prohibition on

paying a fee or profit, the SBA’s policy

directive applies to these SBIR grants.

F. Joint Ventures and Limited

Partnerships

Joint ventures and limited

partnerships are eligible provided the

entity created qualifies as a small

business concern in accordance with the

definition included in this notice.

G. Performance of Research and

Analytical Work by the Applicant

Organization

In Phase I, a minimum of two-thirds

or 67 percent of the research or

analytical effort must be carried out by

the small business concern; that is,

consultant fees and contracts to a third

party for portions of the technical effort

may not exceed 33 percent of the total

proposed budget.

In Phase II, a minimum of one-half or

50 percent of the research or analytical

effort must be carried out by the small

business concern; that is, consultant

fees and contracts to a third party for

portions of the technical effort may not

exceed 50 percent of the total proposed

budget.

H. Terms and Conditions of Awards

Upon acceptance of a grant, the

awardee must comply with the terms

and conditions contained or referenced

in the Notice of Grant Award document.

These terms and conditions,

constituting legal requirements imposed

on a grantee by statute, regulations,
4310 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices

administrative policy, or the award

document itself, comprise the following

‘‘standard’’ and ‘‘special’’ provisions:

• Standard Provisions—Terms and

conditions required as part of each

Notice of Grant Award.

1. SBIR Grant program legislation:

The Small Business Innovation

Development Act of 1982 (Public Law

97–219); SBIR Program Extension

(Public Law 99–443); the SBA

Reauthorization and Amendment Act of

1988 (Public Law 100–590); and the

Small Business Research and

Development Enhancement Act of 1992

(Public Law 102–564).

2. The SBA’s SBIR Program Policy

Directive published in the Federal

Register on January 26, 1993 (58 FR

6144).

3. Regulations set forth at 13 CFR part

121.

4. The inclusion of special terms and

conditions, if any (see below).

5. Regulations set forth at 45 CFR part

74 (Administration of Grants).

• Special Provisions—Additional

terms and conditions judged necessary

to attain the objectives for which the

grant is being made, to facilitate postaward administration of the grant, to

conserve grant funds, or to otherwise

protect the interests of the Federal

government.

1. Requirement for written progress

reports and due dates.

2. Requirement for a draft final report

and due date.

3. Grantees’ responsibilities with

respect to information contained in

technical documents.

4. HCFA’s rights to suspend or

terminate the grant.

5. Protection of individually

identifiable data.

6. Grantees’ responsibilities with

respect to presentation of information.

7. Key personnel.

8. Submission of data to the Federal

government.

9. Submission of items developed to

the Federal government.

10. Other special terms and

conditions that are appropriate to the

circumstances of the individual award.

The grant must be administered in

accordance with the following

regulations:

13 CFR Part 121—Small Business Size

Regulations

42 CFR Part 52—Grants for Research

Projects

45 CFR Part 46—Protection of Human

Subjects

45 CFR Part 74—Administration of

Grants

45 CFR Part 80—Nondiscrimination

Under Programs Receiving Federal

Assistance Through the DHHS

Effectuation of Title VI of the Civil

Rights Act of 1964

45 CFR Part 84—Nondiscrimination on

the Basis of Handicap in Programs

and Activities Receiving Federal

Financial Assistance

45 CFR Part 91—Nondiscrimination on

the Basis of Age in HHS Programs or

Activities Receiving Federal Financial

Assistance.

I. Cost Sharing

Cost sharing is not required nor will

it be an evaluation factor in

consideration of the proposal. However,

due to the special nature of the SBIR

Program, the applicant may choose to

share the costs of a project. This may be

done through cash or in-kind

contributions. Most frequently, we

expect that the applicant will contribute

more labor or use unreimbursed

equipment as the applicant’s share.

J. Additional Information

This Federal Register notice is

intended for informational purposes and

reflects current planning. If there is any

inconsistency between the information

contained in this notice and the terms

of any resulting SBIR grant, the terms of

the grant are controlling.

Before award of an SBIR grant, HCFA

may request the applicant to submit

certain organization, management,

personnel, and financial information in

order to ensure responsibility of the

applicant.

The Federal government is not

responsible for any monies expended by

the applicant before the award of any

grant.

This notice is not an offer by HCFA

and does not obligate HCFA to make

any specific number of awards.

The SBIR Program is not a substitute

for HCFA’s existing unsolicited

proposal mechanisms, and unsolicited

proposals will not be accepted under

either Phase I or Phase II of the SBIR

Program.

The applicant may be required to

certify that he or she has not previously

been paid, nor is currently being paid,

for essentially equivalent work by an

agency of the Federal government. If a

grant is made under this notice for a

project, some of whose elements are

being supported, or will be supported,

by another Federal agency, HCFA and

the applicant will negotiate a budget

that reflects the elimination of any

overlapping support.

This program is not covered by

Executive Order 12372,

‘‘Intergovernment Review of Federal

Programs.’’ Executive Order 12372

provides for a State clearinghouse in

each State to review Federal programs.

Research grants are exempt from this

review.

VII. Research Topic Areas

This notice invites SBIR Phase I

applications in the following areas. The

topics are defined in general terms.

They are intended to indicate where we

believe we can properly offer assistance

in the development of innovative

technology. ORD will consider any idea

that is within the general subject of a

topic. In addition, ORD will review any

idea that is within the general purview

of HCFA, as described in section I of

this notice. Applicants are reminded

that the overall intent of the HCFA SBIR

Program is to provide assistance to the

development of products and processes

that have commercial potential and not

to the acquisition of products for

HCFA’s own use.

A. High Quality and Effective Care

HCFA invites ideas that would

develop products to assist all

participants in health care in assessing

and monitoring the quality of care and

level of care being furnished to patients.

Projects should aim to develop tools for

health care professionals, providers, and

managers that permit them to examine

patterns of services being delivered, and

the health and social outcome of those

services. Projects that would assist

private organizations in developing

patient guidelines and in conducting

technology assessments are of interest.

These tools should provide a way to

monitor and measure the delivery of

health care services and the outcomes of

those services. They should also make

possible a judgment about the quality of

the care, the effectiveness of the care, or

both. The technical efficiency with

which care is delivered and the

appropriateness of the overall outcome

for the patient should be addressed.

B. Management of Ambulatory Services

HCFA invites ideas that would

develop tools to monitor, assess, and

control overutilization and

underutilization of ambulatory services

and products at all levels of the health

care system. Apart from the inflation in

the cost of each service, a significant

cause of the rising cost of health care

services is excessive utilization.

Traditionally, utilization review

techniques have been applied to high

cost, acute services, such as surgery and

hospitalizations. We wish to focus on

physician services and other ambulatory

services and products, for example,

drugs, medical equipment, and testing.

HCFA invites applications related to

services or products commonly
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices 4311

associated with Medicare beneficiaries

and Medicaid recipients, who are

primarily the aged, the poor, the

disabled, and persons with end-stage

renal disease. Techniques to be explored

involve systems both for retrospective

utilization pattern review and for

managing prospective interventions in

individual physician or beneficiary and

recipient service or product use. This

area also includes broader management

tools, based on information derived

from utilization review, that promote or

ensure more efficient and effective

service delivery.

C. Beneficiary Information and

Assistance

HCFA invites ideas that may make the

Medicare and Medicaid programs

understandable to beneficiaries and

recipients and that provide assistance to

these individuals in their attempts to

deal with the programs. Potential

program users (Medicare and Medicaid

beneficiaries) need to understand when

they are eligible, what services or

products are covered, and what their

rights and responsibilities are within

each program. (It is important to

understand that detailed information on

Medicaid must be assembled on a stateby-state basis). An example would be an

information project that would assist

health care consumers, including

Medicare and Medicaid beneficiaries, by

providing aggregate data on provider

performance and utilization trends,

discrete price information, and

information on related copayments, etc.;

in a sense, a ‘‘Blue Book for

Consumers.’’ Another example is

obtaining payment for claims, one of the

most frequent problems encountered by

Medicare beneficiaries. The process of

dealing with Medicare’s fiscal

intermediaries and carriers is difficult

for many beneficiaries. Tools that would

ease this process would be welcome.

Beneficiaries also need to be able to

decide whether they should join, or exit

from, a health maintenance

organization, and the advantages and

disadvantages of the decision.

Beneficiaries need to understand what

considerations to take into account

when long term care is a possibility.

Similarly, beneficiaries need to be

assisted in the decision about the

purchase of health insurance in addition

to Medicare. HCFA invites ideas in

beneficiary communication and

assistance approaches that are tailored

to special populations (such as

significant demographic, sociocultural,

or disease-related groups of

beneficiaries), as well as approaches

that could be used by supplemental

health benefit program sponsors (for

example, employers and unions) in

assisting Medicare-eligible retirees.

Applicants who are considering this

topic should understand that the SBIR

Program generally seeks to support the

development of commercially viable

products and that there is already a fair

amount of existing commercial activity

in this area.

D. Program Efficiencies and

Improvement

The existing systems for health care

delivery and financing have undergone,

and are continuing to undergo, changes

due to new technology, legislation,

regulation, and market forces. Major

payers for health care are continually

studying the feasibility of new

approaches to improving the

management of care, the delivery of

care, and financing. Therefore, HCFA

invites applications that focus on tools

to assist in the goal of improved

management of the Medicare and

Medicaid programs. The term

management is used in a broad sense.

These could be tools that are directed

toward providers who furnish services

or products to Medicare beneficiaries or

Medicaid recipients, organizations that

handle the financing of care,

organizations that oversee the quality of

services and products, or the

beneficiaries and recipients themselves,

and State and local organizations that

deal primarily with Medicare and

Medicaid populations.

HCFA will consider any innovative

idea that appears to have the potential

for improving the programs for any of

the several parties involved, and that

has a potential for sale in the normal or

commercial market. An example of an

innovative idea is the development of

improved computer-based case

management systems for community

care services. Case management

programs are commonly being used to

coordinate community-based care for

frail elderly and other populations

under Medicaid and other programs.

Automated systems use client eligibility

and assessment information to assist

case management agencies in preparing

appropriate plans of care based on the

client’s condition and select service

providers. These systems would also

interface with service approval or

financial or billing systems to improve

the cost-efficiency of case management

programs. Proposed systems should

complement or integrate existing

mandated HCFA instruments

(particularly functional assessment

tools, minimum data sets, discharge

planning, etc.). Redundant instruments

will not be considered for funding.

E. Other Health Care Research and

Demonstrations

We encourage small business

concerns to submit applications for

proposed research in any area within

the field of health care R & D.

VIII. Other Required Information

In accordance with the provisions of

Executive Order 12866, this notice was

not reviewed by the Office of

Management.

Authority: Public Law 97–219, 96 Stat.

217–221; Public Law 99–443, 100 Stat. 1120;

Sec. 108, Public Law 100–590, 102 Stat.

2989, 2994; Public Law 102–564, 106 Stat.

4249 (15 U.S.C. 638 (e) through (m)).

(Catalog of Federal Domestic Assistance

Program No. 93.779, Health Care Financing

Research, Demonstration and Experiments)

Dated: December 17, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 97–2087 Filed 1–28–97; 8:45 am]

BILLING CODE 4120–01–P

[ORD–081–CN; ORD–082–CN; ORD–083–

CN; ORD–091–CN; ORD–094–CN]

Medicaid Program; New and Pending

Demonstration Project Proposals

Submitted Pursuant to Section 1115(a)

of the Social Security Act: August and

September 1995; October 1995;

November 1995; July 1996; and

October 1996; Correction

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Correction.

SUMMARY: In the following Federal

Register documents delete the entry and

description for the Montana Mental

Health Access Plan as a ‘‘pending’’

section 1115 demonstration proposal.

• Federal Register document 95–

30066, in the issue of December 11,

1995, page 63535, second column.

• Federal Register document 95–

30559, in the issue of December 15,

1995, page 64443, first column.

• Federal Register document 96–824,

in the issue of January 23, 1996, page

1772, first column.

• Federal Register document 96–

23116, in the issue of September 11,

1996, page 47949 third column.

• Federal Register document 96–

31237, in the issue of December 9, 1996,

page 64916, third column.

In Federal Register document No. 95–

30066, in the issue of December 11,

1995, on page 63536, first column, the

narrative information under the heading

‘‘5. Disapproval Proposals’’ should read

as follows:

‘‘5. Disapproval Proposals