2014_SBIR_Phase_II_RFP_01-10-2014.pdf

National Cancer Institute, Office of Acquisitions RFP: N44CO47004-13

SOLICITATION OF THE NATIONAL CANCER INSTITUTE

SMALL

BUSINESS INNOVATION

RESEARCH (SBIR)

PHASE II CONTRACT

PROPOSALS

PROPOSAL ISSUANCE DATE

JANUARY 10, 2014

RECEIPT DATE

FEBRUARY 24, 2014

DEADLINE FOR INQUIRIES

FEBRUARY 17, 2014 (see page 36)

TABLE OF CONTENTS

PART I INSTRUCTIONS FOR PREPARING AND SUBMITTING A PROPOSAL4

1. PROGRAM DESCRIPTION

1.1 PURPOSE OF SOLICITATION

1.2 THREE PHASE PROGRAM

1.3 SBIR PROGRAM ELIGIBILITY

1.4 REPORT FRAUD, WASTE AND ABUSE

2. DEFINITIONS

3. CERTIFICATIONS

4. PHASE II PROPOSAL PREPARATION INSTRUCTIONS AND REQUIREMENTS

4.1 LIMITATIONS ON LENGTH OF PROPOSAL

4.2 PROPOSAL COVER SHEET

4.3 TECHNICAL PROPOSAL FORMAT AND CONTENT REQUIREMENTS

4.4 BUSINESS PROPOSAL FORMAT AND CONTENT REQUIREMENTS

4.5 REQUIREMENT FOR ADEQUATE ASSURANCE OF PROTECTION OF HUMAN SUBJECTS23

4.6 REQUIREMENT FOR ADEQUATE ASSURANCE OF COMPLIANCE WITH THE PHS POLICY ON

HUMANE CARE AND USE OF LABORATORY ANIMALS

4.7 LIMITATIONS ON THE USE OF APPROPRIATED FUNDS

5. METHOD OF SELECTION AND EVALUATION CRITERIA

5.1 EVALUATION PROCESS

5.2 TECHNICAL EVALUATION CRITERIA

5.3 PROPOSAL DEBRIEFING

5.4 AWARD DECISION

6. CONSIDERATIONS

6.1 AWARDS

6.2 PROGRESS REPORTS

6.3 FINAL REPORT

6.4 PAYMENT

6.5 LIMITED RIGHTS INFORMATION AND DATA

6.6 PERFORMANCE OF RESEARCH AND ANALYTICAL WORK

6.7 ELECTRONIC AND INFORMATION TECHNOLOGY (SECTION 508)

6.8 ADDITIONAL INFORMATION

7. INSTRUCTIONS FOR PROPOSAL SUBMISSION

7.1 RECEIPT DATE

7.2 NUMBER OF COPIES

7.3 BINDING AND PACKAGING OF PROPOSAL

8. CONTRACTING OFFICERS AND ADDRESSES FOR MAILING OR DELIVERY OF PROPOSALS36

8.1 NATIONAL CANCER INSTITUTE

9. SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

PART II HUMAN SUBJECTS RESEARCH GUIDANCE AND INFORMATION SUPPLEMENT

1. INTRODUCTION

2. SCENARIOS

3. INSTRUCTIONS FOR PREPARING THE SECTION ON PROTECTION OF HUMAN SUBJECTS 39

4. INSTRUCTIONS PERTAINING TO NON-EXEMPT HUMAN SUBJECTS RESEARCH

4.1 PROTECTION OF HUMAN SUBJECTS

4.1.1 RISKS TO HUMAN SUBJECTS

4.1.2 ADEQUACY OF PROTECTION AGAINST RISKS

4.1.3 POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO HUMAN SUBJECTS AND OTHERS

4.1.4 IMPORTANCE OF THE KNOWLEDGE TO BE GAINED

4.1.5 DATA AND SAFETY MONITORING PLAN

4.1.6 CLINICALTRIALS.GOV REQUIREMENTS

4.2 INCLUSION OF WOMEN AND MINORITIES

4.2.1 ADDITIONAL INSTRUCTIONS AND REQUIREMENTS WHEN NIH-DEFINED PHASE III CLINICAL TRIALS ARE

PROPOSED

4.3 INSTRUCTIONS FOR COMPLETING THE TARGETED/PLANNED ENROLLMENT TABLES FOR REPORTING RACE AND

ETHNICITY DATA FOR SUBJECTS IN CLINICAL RESEARCH

4.4 INCLUSION OF CHILDREN

5. HUMAN SUBJECTS RESEARCH POLICY

5.1 PROTECTION OF HUMAN SUBJECTS

5.2 VULNERABLE POPULATIONS

5.3 DATA AND SAFETY MONITORING PLANS FOR CLINICAL TRIALS

5.4 IRB APPROVAL

5.5 REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

5.6 NIH POLICY ON THE INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH

5.7 NIH POLICY ON INCLUSION OF CHILDREN

5.8 NIH POLICY ON REPORTING RACE AND ETHNICITY DATA: SUBJECTS IN CLINICAL RESEARCH

5.9 RESEARCH ON TRANSPLANTATION OF HUMAN FETAL TISSUE

5.10 RESEARCH USING HUMAN EMBRYONIC STEM CELLS

5.11 CLINICALTRIALS.GOV REQUIREMENTS

6. State and Other Assistance Available.

APPENDIX A — PROPOSAL COVER SHEET

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APPENDIX B — ABSTRACT OF RESEARCH PLAN

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MS

APPENDIX C — SUMMARY OF PROPOSED COSTS

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APPENDIX D — TECHNICAL PROPOSAL COVER SHEET

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APPENDIX E — STATEMENT OF WORK SAMPLE FORMAT

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APPENDIX F — SUMMARY OF RELATED ACTIVITIES

MS Word (http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixF.doc) PDF (http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixF.pdf) http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixA.doc http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixA.pdf http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixB.doc http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixB.pdf http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixD.doc http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixD.pdf http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixE.doc http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixE.pdf http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixF.doc http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixF.pdf

APPENDIX G — PROPOSAL SUMMARY AND DATA RECORD

MS Word (http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixG.doc) PDF (http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixG.pdf)

ATTACHMENT 1 – SBA CERTIFICATIONS REQUIRED THROUGH THE EVALATUATION, AWARD AND

CONTRACT ADMINISTRATION PROCESS

ATTACHMENT 2 – SBIR PHASE II TOPICS

The Appendices noted above are in Microsoft Word and Adobe Acrobat Reader fillable format, excluding Appendix C.

NOTE: Other software packages for completing these proposals may be available from other sources; however, it is essential that the type size and format specifications are met or the proposal may be returned without review.

DISCLAIMER: Reference to these software packages neither constitutes nor should be inferred to be an endorsement or recommendation of any product, service, or enterprise by the National Institutes of Health, any other agency of the United States Government, or any employee of the United States Government. No warranties are stated or implied.

NATIONAL CANCER INSTITUTE, OFFICE OF ACQUISITIONS

SOLICITATION OF THE NATIONAL CANCER INSTITUTE FOR

SMALL BUSINESS INNOVATION RESEARCH

PHASE II CONTRACT PROPOSALS

PART I INSTRUCTIONS FOR PREPARING AND SUBMITTING A PROPOSAL

1. PROGRAM DESCRIPTION

1.1 PURPOSE OF SOLICITATION

This solicitation is for Phase II contract proposals only.

Included are instructions for offerors to prepare Phase II contract proposals, a description of the proposal review process, and some conditions of a contract award. Contract proposals will be accepted only if they respond specifically to a research topic listed on the cover letter and in Attachment #2 of this solicitation.

Otherwise, proposals will be returned to the offeror(s) without evaluation.

The objectives of the SBIR program include stimulating technological innovation in the private sector, strengthening the role of small business in meeting Federal R/R&D needs, increasing private sector commercialization of innovations developed through Federal SBIR R&D, increasing small business participation in Federal R&D, and fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned small business concerns in the SBIR program.

The basic design of the NIH/CDC SBIR program is in accordance with the Small Business Administration (SBA) SBIR Program Policy Directive, 2012 This SBIR Contract solicitation strives to encourage scientific and technical innovation in areas specifically identified by the NIH. The guidelines presented in this solicitation reflect the flexibility provided in the Policy Directive to encourage proposals based on scientific and technical approaches most likely to yield results important to the NIH and to the private sector.

1.2 THREE PHASE PROGRAM

The SBIR program consists of three separate phases.

http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixG.doc http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixG.pdf

Phase I: Feasibility

The objective of Phase I is to determine the scientific or technical feasibility and commercial merit of the proposed research or R&D efforts and the quality of performance of the small business concern, prior to providing further Federal support in Phase II. Phase I awards normally may not exceed $150,000 for direct costs, indirect costs, and profit (fixed fee) for a period normally not to exceed 6 months.

Phase II: Full R/R&D Effort

The objective of Phase II is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II proposal.

Phase II awards normally may not exceed $1,000,000 for direct costs, indirect costs, and profit (fixed fee) for a period normally not to exceed two years.

Phase III: Commercialization stage without SBIR funds

The objective of Phase III, where appropriate, is for the small business concern to pursue with non-SBIR funds the commercialization objectives resulting from the outcomes of the research or R&D funded in Phase II. Phase III may involve follow-on, non-SBIR funded R&D or production contracts for products or processes intended for use by the U.S. Government.

The competition for SBIR Phase II awards satisfies any competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the competition in Contracting Act.

Therefore, an agency that wishes to fund an SBIR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III SBIR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is a SBIR Phase III award that is derived from, extends, or logically concludes efforts performed under prior SBIR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 3303(b) . The NIH is interested in developing products and services via the SBIR program that improve the health of the American people. In its commitment to also support Executive Order 13329, encouraging innovation in manufacturing-related research and development, NIH seeks, through the SBIR program, biomedical research related to advanced processing, manufacturing processes, equipment and systems; or manufacturing workforce skills and protection. This solicitation includes some topic areas that are considered relevant to manufacturing-related R&D. Additional information will be posted on the NIH Small Business Research Funding Opportunities Web site and in the NIH Guide for Grants and Contracts as it becomes available. Small businesses may be interested in reading a U.S.

Department of Commerce 2004 report, "Manufacturing in America: A Comprehensive Strategy to Address the Challenges to U.S. Manufacturers".

1.3 SBIR PROGRAM ELIGIBILITY

Organizational Criteria: Each organization submitting a proposal under the SBIR program must qualify as a small business concern as defined in Section 2 herein. In determining whether an offeror is a small business concern, an assessment will be made of several factors, including whether or not it is independently owned and operated and whether or not it is an affiliate of a larger organization whose employees, when added to those of the offeror organization, exceed 500. In conducting this assessment, all appropriate factors will be considered, including common ownership, common management, and contractual relationships.

In accordance with 13 CFR 121.103, (a) General Principles of Affiliation. (1) Concerns and entities are affiliates of each other when one controls or has the power to control the other, or a third party or parties controls or has the power to control both. It does not matter whether control is exercised, so long as the power to control exists.

(2) SBA considers factors such as ownership, management, previous relationships with or ties to another concern, and contractual relationships, in determining whether affiliation exists.

(3) Control may be affirmative or negative. Negative control includes, but is not limited to, instances where a minority shareholder has the ability, under the concern's charter, by-laws, or shareholder's agreement, to prevent a quorum or otherwise block action by the board of directors or shareholders.

http://edocket.access.gpo.gov/2004/pdf/04-4436.pdf http://sbir.nih.gov/ http://grants.nih.gov/grants/guide/index.html http://grants.nih.gov/grants/guide/index.html http://www.ita.doc.gov/media/Publications/pdf/manuam0104final.pdf http://www.ita.doc.gov/media/Publications/pdf/manuam0104final.pdf

(4) Affiliation may be found where an individual, concern, or entity exercises control indirectly through a third party.

(5) In determining whether affiliation exists, SBA will consider the totality of the circumstances, and may find affiliation even though no single factor is sufficient to constitute affiliation.

(6) In determining the concern's size, SBA counts the receipts, employees, or other measure of size of the concern whose size is at issue and all of its domestic and foreign affiliates, regardless of whether the affiliates are organized for profit.

(b) Exceptions to affiliation coverage. (1) Business concerns owned in whole or substantial part by investment companies licensed, or development companies qualifying, under the Small Business Investment Act of 1958, as amended, are not considered affiliates of such investment companies or development companies.

(2) (i) Business concerns owned and controlled by Indian Tribes, Alaska Native Corporations (ANCs) organized pursuant to the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq. ), Native Hawaiian Organizations (NHOs), Community Development Corporations (CDCs) authorized by 42 U.S.C. 9805, or wholly-owned entities of Indian Tribes, ANCs, NHOs, or CDCs are not considered affiliates of such entities.

(ii) Business concerns owned and controlled by Indian Tribes, ANCs, NHOs, CDCs, or wholly-owned entities of Indian Tribes, ANCs, NHOs, or CDCs are not considered to be affiliated with other concerns owned by these entities because of their common ownership or common management. In addition, affiliation will not be found based upon the performance of common administrative services, such as bookkeeping and payroll, so long as adequate payment is provided for those services. Affiliation may be found for other reasons.

(3) Business concerns which are part of an SBA approved pool of concerns for a joint program of research and development or for defense production as authorized by the Small Business Act are not affiliates of one another because of the pool.

(4) Business concerns which lease employees from concerns primarily engaged in leasing employees to other businesses or which enter into a co-employer arrangement with a Professional Employer Organization (PEO) are not affiliated with the leasing company or PEO solely on the basis of a leasing agreement.

(5) For financial, management or technical assistance under the Small Business Investment Act of 1958, as amended, (an offeror is not affiliated with the investors listed in paragraphs (b)(5) (i) through (vi) of this section.

(i) Venture capital operating companies, as defined in the U.S. Department of Labor regulations found at 29 CFR

2510.3-101(d) ;

(ii) Employee benefit or pension plans established and maintained by the Federal government or any state, or their political subdivisions, or any agency or instrumentality thereof, for the benefit of employees;

(iii) Employee benefit or pension plans within the meaning of the Employee Retirement Income Security Act of 1974, as amended (29 U.S.C. 1001, et seq.);

(iv) Charitable trusts, foundations, endowments, or similar organizations exempt from Federal income taxation under section 501(c) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501(c) );

(v) Investment companies registered under the Investment Company Act of 1940, as amended (1940 Act) (15 U.S.C. 80a-1, et seq.); and

(vi) Investment companies, as defined under the 1940 Act, which are not registered under the 1940 Act because they are beneficially owned by less than 100 persons, if the company's sales literature or organizational documents indicate that its principal purpose is investment in securities rather than the operation of commercial enterprises.

(6) An 8(a) BD Participant that has an SBA-approved mentor/protégé agreement is not affiliated with a mentor firm solely because the protégé firm receives assistance from the mentor under the agreement. Similarly, a protégé firm is not affiliated with its mentor solely because the protégé firm receives assistance from the mentor http://www.law.cornell.edu/uscode/43/1601.html http://www.law.cornell.edu/uscode/42/9805.html http://www.law.cornell.edu/cfr/text/29/2510.3-101#d http://www.law.cornell.edu/uscode/29/1001.html http://www.law.cornell.edu/uscode/26/501.html#c http://www.law.cornell.edu/uscode/15/80a-1.html http://www.law.cornell.edu/uscode/15/80a-1.html under a Federal Mentor-Protégé program where an exception to affiliation is specifically authorized by statute or by SBA under the procedures set forth in § 121.903. Affiliation may be found in either case for other reasons.

(7) The member shareholders of a small agricultural cooperative, as defined in the Agricultural Marketing Act (12

U.S.C. 1141j ), are not considered affiliated with the cooperative by virtue of their membership in the cooperative.

(c) Affiliation based on stock ownership. (1) A person (including any individual, concern or other entity) that owns, or has the power to control, 50 percent or more of a concern's voting stock, or a block of voting stock which is large compared to other outstanding blocks of voting stock, controls or has the power to control the concern.

(2) If two or more persons (including any individual, concern or other entity) each owns, controls, or has the power to control less than 50 percent of a concern's voting stock, and such minority holdings are equal or approximately equal in size, and the aggregate of these minority holdings is large as compared with any other stock holding, SBA presumes that each such person controls or has the power to control the concern whose size is at issue.

This presumption may be rebutted by a showing that such control or power to control does not in fact exist.

(3) If a concern's voting stock is widely held and no single block of stock is large as compared with all other stock holdings, the concern's Board of Directors and CEO or President will be deemed to have the power to control the concern in the absence of evidence to the contrary.

(d) Affiliation arising under stock options, convertible securities, and agreements to merge. (1) In determining size, SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised.

(2) Agreements to open or continue negotiations towards the possibility of a merger or a sale of stock at some later date are not considered “agreements in principle” and are thus not given present effect.

(3) Options, convertible securities, and agreements that are subject to conditions precedent which are incapable of fulfillment, speculative, conjectural, or unenforceable under state or Federal law, or where the probability of the transaction (or exercise of the rights) occurring is shown to be extremely remote, are not given present effect.

(4) An individual, concern or other entity that controls one or more other concerns cannot use options, convertible securities, or agreements to appear to terminate such control before actually doing so. SBA will not give present effect to individuals', concerns' or other entities' ability to divest all or part of their ownership interest in order to avoid a finding of affiliation.

(e) Affiliation based on common management. Affiliation arises where one or more officers, directors, managing members, or partners who control the board of directors and/or management of one concern also control the board of directors or management of one or more other concerns.

(f) Affiliation based on identity of interest. Affiliation may arise among two or more persons with an identity of interest. Individuals or firms that have identical or substantially identical business or economic interests (such as family members, individuals or firms with common investments, or firms that are economically dependent through contractual or other relationships) may be treated as one party with such interests aggregated. Where SBA determines that such interests should be aggregated, an individual or firm may rebut that determination with evidence showing that the interests deemed to be one are in fact separate.

(g) Affiliation based on the newly organized concern rule. Affiliation may arise where former officers, directors, principal stockholders, managing members, or key employees of one concern organize a new concern in the same or related industry or field of operation, and serve as the new concern's officers, directors, principal stockholders, managing members, or key employees, and the one concern is furnishing or will furnish the new concern with contracts, financial or technical assistance, indemnification on bid or performance bonds, and/or other facilities, whether for a fee or otherwise. A concern may rebut such an affiliation determination by demonstrating a clear line of fracture between the two concerns. A “key employee” is an employee who, because of his/her position in the concern, has a critical influence in or substantive control over the operations or management of the concern.

http://www.law.cornell.edu/cfr/text/13/121.903 http://www.law.cornell.edu/uscode/12/1141j.html http://www.law.cornell.edu/uscode/12/1141j.html

(h) Affiliation based on joint ventures. A joint venture is an association of individuals and/or concerns with interests in any degree or proportion consorting to engage in and carry out no more than three specific or limited-purpose business ventures for joint profit over a two year period, for which purpose they combine their efforts, property, money, skill, or knowledge, but not on a continuing or permanent basis for conducting business generally. This means that a specific joint venture entity generally may not be awarded more than three contracts over a two year period, starting from the date of the award of the first contract, without the partners to the joint venture being deemed affiliated for all purposes. Once a joint venture receives one contract, SBA will determine compliance with the three awards in two years rule for future awards as of the date of initial offer including price.

As such, an individual joint venture may be awarded more than three contracts without SBA finding general affiliation between the joint venture partners where the joint venture had received two or fewer contracts as of the date it submitted one or more additional offers which thereafter result in one or more additional contract awards.

The same two (or more) entities may create additional joint ventures, and each new joint venture entity may be awarded up to three contracts in accordance with this section. At some point, however, such a longstanding inter-relationship or contractual dependence between the same joint venture partners will lead to a finding of general affiliation between and among them. For purposes of this provision and in order to facilitate tracking of the number of contract awards made to a joint venture, a joint venture must be in writing and must do business under its own name, and it may (but need not) be in the form of a separate legal entity, and if it is a separate legal entity it may (but need not) be populated (i.e., have its own separate employees). SBA may also determine that the relationship between a prime contractor and its subcontractor is a joint venture, and that affiliation between the two exists, pursuant to paragraph (h)(4) of this section. If it appears that an offeror does not meet eligibility requirements, the NIH/CDC will request an eligibility determination of the organization from the cognizant SBA Government Contracting Area Office. The evaluation of the proposal for scientific merit will be deferred until the SBA provides a determination.

Eligibility Requirements: To receive SBIR funds, each awardee of a SBIR Phase I or Phase II award must qualify as an SBC at the time of award and at any other time set forth in SBA's regulations at 13 CFR 121.701-

121.705. Each Phase I and Phase II awardee must submit a certification stating that it meets the size, ownership and other requirements of the SBIR Program at the time of award, and at any other time set forth in SBA's regulations at 13 CFR 121.701-705.

For Small Business Concerns (SBC) That Are Owned In Majority Part By Multiple Venture Capital Operating Companies, Hedge Funds And Private Equity Firms: Before permitting participation in the SBIR program by SBCs that are owned in majority part by multiple venture capital operating companies, hedge funds, or private equity firms:

(A) SBA's regulations at 13 CFR part 121 must set forth the eligibility criteria for SBIR offerors that are owned in majority part by multiple venture capital operating companies, hedge funds, or private equity firms.

(B) The SBIR agency must submit a written determination at least 30 calendar days before it begins making awards to SBCs that are owned in majority part by multiple venture capital operating companies, hedge funds, or private equity firms to SBA, the Senate Committee on Small Business and Entrepreneurship, the House Committee on Small Business and the House Committee on Science, Space, and Technology. The determination must be made by the head of the Federal agency or designee and explain how awards to SBCs that are owned in majority part by multiple venture capital operating companies, hedge funds, or private equity in the SBIR program will:

(I) Induce additional venture capital, hedge fund, or private equity firm funding of small business innovations;

(II) Substantially contribute to the mission of the Federal agency; 18 (III) Address a demonstrated need for public research; and (IV) Otherwise fulfill the capital needs of small business concerns for additional financing for SBIR projects.

(ii) The SBC that is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms must register with SBA in the Company Registry Database, at www.SBIR.gov, prior to the date it submits a proposal for an SBIR award.

(iii) The SBC that is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms must submit a certification with its proposal stating, among other things, that it has registered with SBA.

(iv) Any agency that makes an award under this paragraph during a fiscal year shall collect and submit to SBA data relating to the number and dollar amount of Phase I awards, Phase II awards, and any other category of awards by the Federal agency under the SBIR program during that fiscal year. See section 10 of the directive for the specific reporting requirements.

(v) If an agency awards more than the percentage of the funds authorized under paragraph (a)(2), the agency shall transfer from its non-SBIR and non-STTR R&D funds to the agency's SBIR funds any amount that is in excess of the authorized amount. The agency must transfer the funds not later than 180 days after the date on which the Federal agency made the award that exceeded the authorized amount.

Project Director/Principal Investigator Criteria. The primary employment of the Project Director/Principal Investigator (PD/PI) must be with the offeror at the time of contract award and during the conduct of the proposed project. The PD/PI is the single individual designated in the proposal with responsibility for the scientific and technical direction of the project. Primary employment means that more than one half of the PD/PI’s time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization.

In the event that the PD/PI: (1) is a less-than-full-time employee of the small business, (2) is concurrently employed by another organization, or (3) gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position, at the time of submission of the proposal, it is essential that documentation be submitted with the proposal to verify his/her eligibility. If the PD/PI also is employed or appears to be employed by an organization other than the offeror (e.g., a university, a nonprofit research institute, or another company), a letter must be provided by the non-offeror organization confirming that the PD/PI will, if awarded an SBIR contract, become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the PD/PI is employed by a university, the Dean's Office must provide such a letter. If the PD/PI is employed by another for-profit organization, the corporate official must sign the letter. This documentation is required for every proposal that is submitted, even one that is a revision of a previously submitted proposal.

Multiple Principal Investigators. Offerors may propose a multiple Project Director/Principal Investigator (PD/PI) model to direct the project or program to be supported by the contract. The multiple PD/PI model is intended to supplement, and not replace, the traditional single PI model. Ultimately, the decision to submit a proposal using the multiple PD/PI versus single PD/PI is the decision of the investigators and their organizations. The decision whether to employ multiple PDs/PIs should be consistent with and justified by the scientific goals of the project.

The offeror organization may designate multiple individuals as principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple principal investigators are named, each is responsible and accountable to the offeror organization, or as appropriate, to a collaborating organization for the proper conduct of the project or program including the submission of all required reports. The presence of more than one PD/PI on a proposal or award diminishes neither the responsibility nor the accountability of any individual PD/PI.

For Multiple PD/PI proposals: The first PI listed must be affiliated with the small business concern organization submitting the proposal and will serve as the Contact PD/PI. The primary employment of the “Contact PD/PI” must be with the small business concern at the time of award and during the conduct of the proposed project.

Performance Site Criteria. The research or R&D project activity must be performed in its entirety in the United States (see Part I, Section 2 . Definitions).

Access to special facilities or equipment in another organization is permitted (as in cases where the SBIR awardee has entered into a subcontractual agreement with another institution for a specific, limited portion of the research project). However, research space occupied by an SBIR contractor organization must be space that is available to and under the control of the SBIR contractor for the conduct of its portion of the project.

Prior, Current, or Pending Support of Similar Proposals or Awards A small business concern may not submit both a contract proposal and a grant application for essentially the same project to the same or different awarding component(s) of the NIH/CDC. The only exception would be the submission of a grant application after a contract proposal has been evaluated and is no longer being considered for award.

Whenever a proposed SBIR project is to be conducted in facilities other than those of the offeror, a letter must be submitted with the proposal stating that leasing/rental arrangements have been negotiated for appropriate research space (i.e., space that will be available to and under the control of the SBIR contractor organization).

This letter must be signed by an authorized official of the organization whose facilities are to be used for the SBIR project. It also must include a description of the facilities and, if appropriate, equipment that will be leased/rented to the offeror organization.

1.4 REPORT FRAUD, WASTE AND ABUSE

The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant.

2. DEFINITIONS

2.1 General Definitions

The following definitions from the SBA Policy Directive and the Federal Acquisition Regulation (FAR) apply for the purposes of this solicitation:

8(a) Small Business Concern. A small business concern that is owned and controlled by a socially and economically disadvantaged individual and that has been approved by the U.S. Small Business Administration as part of the 8(a) Business Development Program (see 13 CFR 124).

Act. The Small Business Act (15 U.S.C. 631, et seq.), as amended.

Applicant. The organizational entity that qualifies as an SBC at all pertinent times and that submits a contract proposal or a grant application for a funding agreement under the SBIR Program.

Affiliate. This term has the same meaning as set forth in 13 CFR part 121—Small Business Size Regulations, section 121.103. What is affiliation? (Available at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=03878acee7c064a02cac0d870e00ef43;rgn=div6;view=text;node=13%3A1.0.1.1.17.1;idno=13;cc= ecfr.) Further information about SBA's affiliation rules and a guide on affiliation is available at www.SBIR.gov and www.SBA.gov/size.

Awardee. The organizational entity receiving an SBIR Phase I, Phase II, or Phase III award.

Commercialization. The process of developing products, processes, technologies, or services and the production and delivery (whether by the originating party or others) of the products, processes, technologies, or services for sale to or use by the Federal government or commercial markets.

Consultant. An individual who provides professional advice or services for a fee, but normally not as an employee of the engaging party. In unusual situations, an individual may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. To prevent apparent or actual conflicts of interest, grantees and consultants must establish written guidelines indicating the conditions of payment of consulting fees. Consultants may also include firms that provide paid professional advice or services.

Contract. 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 provide payment therefore.

Cooperative Agreement. A financial assistance mechanism used when substantial Federal programmatic involvement with the awardee during performance is anticipated by the issuing agency. The Cooperative Agreement contains the responsibilities and respective obligations of the parties.

http://www.sba.gov/size

Covered Small Business Concern. A small business concern that:

(1) Was not majority-owned by multiple venture capital operating companies (VCOCs), hedge funds, or private equity firms on the date on which it submitted an application in response to a solicitation under the SBIR program;

and

(2) Is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms on the date of the SBIR award.

Essentially Equivalent Work. Work that is substantially the same research, which is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency or submitted to two or more different Federal agencies for review and funding consideration; or work where a specific research objective and the research design for accomplishing the objective are the same or closely related to another proposal or award, regardless of the funding source.

Extramural Budget. The sum of the total obligations for R/R&D minus amounts obligated for R/R&D activities by employees of a Federal agency in or through Government-owned, Government-operated facilities. For the Agency for 6 International Development, the “extramural budget” must not include amounts obligated solely for general institutional support of international research centers or for grants to foreign countries. For the Department of Energy, the “extramural budget” must not include amounts obligated for atomic energy defense programs solely for weapons activities or for naval reactor programs. (Also see section 7(i) of this Policy Directive for additional exemptions related to national security.)

Feasibility. The practical extent to which a project can be performed successfully.

Federal Agency. An executive agency as defined in 5 U.S.C. § 105, and a military department as defined in 5 U.S.C. 102 (Department of the Army, Department of the Navy, Department of the Air Force), except that it does not include any agency within the Intelligence Community as defined in Executive Order 12333, section 3.4(f), or its successor orders.

Federal Laboratory. As defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

Fraud, Waste, and Abuse

a. Fraud includes any false representation about a material fact or any intentional deception designed to deprive the United States unlawfully of something of value or to secure from the United States a benefit, privilege, allowance, or consideration to which an individual or business is not entitled.

b. Waste includes extravagant, careless or needless expenditure of Government funds, or the consumption of Government property, that results from deficient practices, systems, controls, or decisions.

c. Abuse includes any intentional or improper use of Government resources, such as misuse of rank, position, or authority or resources.

Funding Agreement. Any contract, grant, or cooperative agreement entered into between any Federal agency and any SBC for the performance of experimental, developmental, or research work, including products or services, funded in whole or in part by the Federal Government.

Funding Agreement Officer. A contracting officer, a grants officer, or a cooperative agreement officer.

Grant. A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the Federal agency anticipates no substantial programmatic involvement with the awardee during performance.

HubZone Small Business Concern. A small business concern that appears on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration (13 CFR 126.103). HUBZone Small

Business Concerns are located in historically underutilized business zones, in an effort to increase employment opportunities, investment, and economic development in those areas.

Innovation. Something new or improved, having marketable potential, including: (1) Development of new technologies: (2) refinement of existing technologies: or (3) development of new applications for existing technologies.

Intellectual Property. The separate and distinct types of intangible property that are referred to collectively as “intellectual property,” including but not limited to: (1) Patents; (2) trademarks; (3) copyrights; (4) trade secrets; (5) SBIR technical data (as defined in this section); (6) ideas; (7) designs; (8) know-how; (9) business; (10) technical and research methods; (11) other types of intangible business assets; and (12) all types of intangible assets either proposed or generated by an SBC as a result of its participation in the SBIR Program.

Joint Venture. See 13 CFR 121.103(h).

Key Individual. The principal investigator/project manager and any other person named as a “key” employee in a proposal , Principal Investigator/Project Manager. The one individual designated by the applicant to provide the scientific and technical direction to a project supported by the funding agreement.

Proprietary Information. Proprietary information is information that you provide which constitutes a trade secret, proprietary commercial or financial information, confidential personal information or data affecting the national security.

Prototype. A model of something to be further developed, which includes designs, protocols, questionnaires, software, and devices.

SBIR Participants. Business concerns that have received SBIR awards or that have submitted SBIR proposals/applications.

SBIR Technical Data. All data generated during the performance of an SBIR award.

SBIR Technical Data rights. The rights an SBIR awardee obtains in data generated during the performance of any SBIR Phase I, Phase II, or Phase III award that an awardee delivers to the Government during or upon completion of a Federally-funded project, and to which the Government receives a license.

Senior/Key Personnel. The PD/PI and other individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries or compensation are requested under the contract.

Small Business Concern. A concern that meets the requirements set forth in 13 CFR 121.702:

To be eligible for award of funding agreements in the SBA's Small Business Innovation Research (SBIR) program, a business concern must meet the requirements of paragraphs (a) and (b) below:

(a) Ownership and control.

(1) An SBIR awardee must

(i) Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR

(ii) Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR

(iii) Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph (a)(1)(i) or (a)(1)(ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements

(2) If an Employee Stock Ownership Plan owns all or part of the concern, SBA considers each stock trustee and plan member to be an owner.

(3) If a trust owns all or part of the concern, SBA considers each trustee and trust beneficiary to be an owner.

(b) Size. An SBIR awardee, together with its affiliates, will not have more than 500 employees.

Socially and Economically Disadvantaged SBC (SDB). See 13 CFR part 124, Subpart B. 8

Socially and Economically Disadvantaged Individual. See 13 CFR 124.103 and 124.104.

Service-Disabled Veteran-Owned Small Business Concern. A small business concern not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and the management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran. Status as a Service-Disabled Veteran-Owned Small Business Concern is determined in accordance with 13 CFR Parts 125.8 through 125.13; also see 19.307.

Subcontract. Any agreement, other than one involving an employer-employee relationship, entered into by an awardee of a funding agreement calling for supplies or services for the performance of the original funding agreement.

United States. Means the 50 states, the territories and possessions of the Federal Government, the Commonwealth of Puerto Rico, the District of Columbia, the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau.

Women-Owned SBC (WOSB). An SBC that is at least 51% owned by one or more women, or in the case of any publicly owned business, at least 51% of the stock is owned by women, and women control the management and daily business operations.

2.2 Definitions (Relating to R&D)

Autopsy Materials. The use of autopsy materials is governed by applicable Federal, state and local law and is not directly regulated by 45 CFR part 46.

Child. The NIH Policy on Inclusion of Children defines a child as an individual under the age of 21 years. The intent of the NIH policy is to provide the opportunity for children to participate in research studies when there is a sound scientific rationale for including them, and their participation benefits children and is appropriate under existing Federal guidelines. Thus, children must be included in NIH conducted or supported clinical research unless there are scientific or ethical reasons not to include them.

HHS Regulations (45 CFR part 46, Subpart D, Sec.401-409) provide additional protections for children involved as subjects in research, based on this definition: "Children are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted." Generally, state laws define what constitutes a “child.” Consequently, the age at which a child's own consent is required and sufficient to participate in research will vary according to state law.

For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.

Clinical Research. NIH defines human clinical research as research with human subjects that is:

(1) Patient-Oriented Research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes:

(a) mechanisms of human disease,

(b) therapeutic interventions,

(c) clinical studies, or

(d) development of new technologies.

(2) Epidemiologic and Behavioral Studies.

(3) Outcomes Research and Health Services Research.

Clinical Trial. The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits this definition of a clinical trial. Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision making for the subject or the test itself imposes more than minimal risk for subjects.

Biomedical clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases:

○ Phase I (if completed) clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects).

○ Phase II clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.

○ Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.

○ Phase IV studies are conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

○ NIH-Defined Phase III Clinical Trial. For the purpose of the Guidelines an NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care.