[Federal Register Volume 62, Number 19 (Wednesday, January 29, 1997)]
[Notices]
[Pages 4305-4311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2087]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[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.
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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
[[Page 4306]]
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 case-by-
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 full-time 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
[[Page 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 less-than-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
employer-employee relationship, entered into by a Federal government
funding agreement awardee calling for supplies or services
[[Page 4308]]
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-to-day 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:
[[Page 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 cost-reimbursement 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 ________ 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 for-profit
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,
[[Page 4310]]
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 post-award 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
[[Page 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 state-by-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
