tract should clearly specify such additional or different requirements as

necessary.

§ 3-4.5602 Change or absence of the principal investigator or project leader.

(a) The decision as to whether the Department is interested in a proposed research contract is based, to a considerable extent, upon its evaluation of the proposed contractor's principal investigator or project leader's knowledge of the field and his capabilities to manage the contract in an efficient and productive manner. Therefore, the Department desires that the named principal investigator or project leader be continuously responsible for the conduct of the contract and be closely involved with the research efforts.

(b) Written prior approval of the contracting officer is required by the contractor to change the contractor's principal investigator or project leader or to continue work under the contract without participation of the principal investigator or project leader for a period in excess of 3 continuous months. Any substantial reduction in the effort devoted to the contract work by the contractor's principal investigator or project leader also requires the prior written approval of the contracting officer. If the contracting officer determines that the reduction of effort would be so substantial as to impair the successful prosecution of the contract, he may request a change of principal investigator or project leader suitable to the Department, or terminate or appropriately modify the contract.

(c) The provisions of paragraph (b) of this section also apply when the contract identifies coprincipal investigators or project leaders or otherwise includes and identifies additional contractor personnel considered essential to the conduct of the proposed research contract.

§ 3-4.5603 Subcontracting or transferring the research effort.

The Department's decision to enter into a research contract with an educational institution is based in part upon its evaluation of the principal investigator(s) or project leader(s) as

well as the support available to the contract from the institution, such as facilities and administrative assistance. During the negotiation of the contract, the contracting officer (contract negotiator) shall to the extent possible, obtain complete information concerning the contractor's plans for subcontracting any portion of the research effort. None of the research effort shall be subcontracted or transferred to another organization without having been specifically set forth in the contract, or without the prior approval of the contracting officer. This does not preclude the purchase of supplies, materials, equipment or general support services. None of the foregoing shall be construed to authorize transfer of a research contract or any interest therein, where prohibited by law.

The Indian Health Service, U.S. Public Health Service, will utilize the negotiating authority of the Buy Indian Act to give preference to Indians whenever the use of that authority is authorized and is practicable. The Buy Indian Act was enacted as a proviso to section 23 of the Act of June 25, 1910, Chapter 431, Pub. L. 313, 61st Congress, 36 Stat. 861, prescribing the application of the advertising requirements of section 3709 of the Revised Statutes to the purchase of Indian supplies. As set out in 25

U.S.C. 47, the Buy Indian Act provides as follows:

So far as may be practicable Indian labor shall be employed, and purchases of the products of Indian industry may be made in open market in the discretion of the Secretary of the Interior.

au

The functions, responsibilities, thorities, and duties of the Secretary of the Interior for maintenance and operation of hospital and health facilities for Indians and for the conservation of the health of Indians were transferred to the Secretary of Health and Human Services on July 1, 1955, by Pub. L. 568, 83d Congress, 42 U.S.C. 2001 et seq. Accordingly, the Secretary is authorized to use the Buy Indian Act in the purchase of the products of Indian industry in connection with the maintenance and operation of hospital and health facilities for Indians and the conservation of the health of Indians. This authority has been delegated exclusively to the Indian Health Service and is not available for use by any other HHS component. Section 303 of the Indian Health Care Improvement Act (Pub. L. 94-437) calls for the use of the Buy Indian Act in the construction and renovation of facilities pursuant to section 301 of that Act and in the construction of safe water and sanitary waste disposal facilities pursuant to section 302 of that Act.

(Sec. 303 of Pub. L. 94-437 (25 U.S.C. 1633); 25 U.S.C. 47; sec. 702 of Pub. L. 94-437 (25 U.S.C. 1672))

[40 FR 4913, Feb. 3, 1975, as amended at 42 FR 59642, Nov. 18, 1977]

§ 3-4.5702-2 Indian Firm.

or

An Indian firm means a sole enterprise, partnership, corporation, other type of business organization owned and controlled by one or more Indians (including, for the purpose of sections 301 and 302 of Pub. L. 94-437, former or currently federally recognized Indian tribes in the State of New York) or by an Indian firm; or a nonprofit firm organized for the benefit of Indians and controlled by Indians.

(Sec. 303 of Pub. L. 94-437 (25 U.S.C. 1633); 25 U.S.C. 47; sec. 702 of Pub. L. 94-437 (25 U.S.C. 1672))

[42 FR 59642, Nov. 18, 1977]

§ 3-4.5702-3 Product of Indian Industry.

The product of Indian industry means anything produced by Indians through physical labor or by intellectual effort involving the use and application by them of skills.

§ 3-4.5702-4 Buy Indian Contract.

Buy Indian contract means any contract involving activities covered by the Buy Indian Act that is negotiated under the provisions of 41 U.S.C. 252(c)(15) and 25 U.S.C. 47 between an Indian firm and a contracting officer representing the Indian Health Service, U.S. Public Health Service.

§ 3-4.5703 Requirements.

(a) Indian ownership. The degree of ownership that is called for by § 34.5702-2 shall be 100 percent during the period covered by a Buy Indian contract unless a deviation from that 100 percent requirement is approved on an individual basis by the Area or Program Office Director of the Indian Health Service responsible for the area or program with respect to which the Buy Indian contract is to be entered into. Such a deviation, which may be to not less than 51 percent, must be accompanied by an appropriate justification for such a deviation.

(b) Joint ventures. Indian firms may enter into joint ventures with other entities for specific projects as long as an Indian firm is the managing partner. The joint venture must, however, be approved by the contracting officer prior to its negotiating a contract under the Buy Indian Act.

(c) Indian employment. Contracts negotiated under the Buy Indian Act shall contain the following clause:

INDIAN PREFERENCE IN TRAINING AND
EMPLOYMENT

(a) The Contractor shall give preference in employment for all work performed under the contract, including subcontracts, thereunder, to qualified Indians regardless of age, religion, or sex and, to the extent feasible consistent with the efficient performance of the contract, provide employment and training opportunites to Indians, regardless of age, religion, or sex that are not fully qualified to perform under the contract. The Contractor shall comply with any Indian preference requirements established by the tribe receiving services under the contract to the extent that such requirements are consistent with the purpose and intent of this paragraph.

(b) If the Contractor or any of its subcontractors is unable to fill its employment openings after giving full consideration to Indians as required in paragraph (a) of this clause, these employment openings may then be filled by other than Indians under the conditions set forth in the Equal Opportunity clause of this contract.

(c) The Contractor agrees to include this clause or one similar thereto in all subcontracts issued under the contract.

(d) Bonds. In the case of contracts for the construction, alteration, or repair of public buildings or public works, performance and payment bonds are required by the Miller Act (40 U.S.C. 270a) and §§ 1-10.104 and 110.105 of this title. In the case of contracts with Indian tribes or public nonprofit corporations serving as governmental instrumentalities of an Indian tribe, such bonds are not required except in relation to private business entities even if they are owned by an Indian tribe or members of an Indian tribe, and may be required of private business entities who are joint venturers with, or subcontractors of, an Indian tribe or a public nonprofit corporation serving as a governmental instrumentality of an Indian tribe. A bid guarantee or bid bond is required only when a performance or payment bond is required.

(e) Subcontracting. Not more than 50 percent of the work to be performed under a prime contract negotiated pursuant to the Buy Indian Act shall be subcontracted to one other than an Indian firm. For this purpose,

work to be performed does not include the provision of materials, supplies, or equipment. Each prime contract shall incorporate the following clause.

USE OF INDIAN BUSINESS CONCERNS

(a) As used in this clause, the term "Indian business concern" means an Indian organization of an Indian-owned economic enterprise as defined in 42 CFR 36.204(i).

(b) The Contractor agrees to give preference to qualified Indian business concerns in the awarding of any subcontracts entered into under the contract consistent with the efficient performance of the contract. The Contractor shall comply with any preference requirements regarding Indian business concerns established by the tribe(s) receiving services under the contract to the extent that such requirements are consistent with the purpose and intent of this paragraph.

(c) If no Indian business concerns are available under the conditions in paragraph (b) of this clause, the Contractor agrees to accomplish the maximum amount of subcontracting, as the Contractor determines is consistent with its efficient performance of the contract, with small business concerns, labor surplus area concerns, or minority business enterprises, the definitions for which are contained in Subparts 1-1.7, 1-1.8, and 1-1.13 of the Federal Procurement Regulations. The Contractor is not, however, required to establish a small business, labor surplus, or minority business subcontracting program as described in §§ 1-1.710-3(b), 11.805-3(b), and 1-1.1310-2(b), respectively, of the Federal Procurement Regulations (41 CFR Chapter 1).

(Sec. 303 of Pub. L. 94-437 (25 U.S.C. 1633); 25 U.S.C. 47; sec. 702 of Pub. L. 94-437 (25 U.S.C. 1672))

[40 FR 4913, Feb. 3, 1975, as amended at 42 FR 52400, Sept. 30, 1977; 42 FR 54552, Oct. 7, 1977; 42 FR 59643, Nov. 18, 1977]

§ 3-4.5704 Competition.

(a) Contracts negotiated under the Buy Indian Act shall be subject to competition among Indians to the maximum extent that competition is determined by the contracting officer to be practicable, pursuant to §§ 11.301-1 and 1-3.101(d) of this title. When competition is determined not to be practicable, a Justification for Noncompetitive Procurement shall be prepared in accordance with § 3-3.80250 of this chapter and retained in the contract file.

(b) Notwithstanding the provisions of § 3-3.802-50 of this chapter, requests for approval of procurements to be negotiated under the Buy Indian Act in activities covered by that Act may, if $25,000 or less, be approved by the Chief of the procurement office, or, if over $25,000, by the official in charge of the office one level above the procurement office.

(c) Contracts proposed to be entered into by the Indian Health Service should be synopsized and publicized in the Commerce Business Daily (see 41 CFR 1-1.1003-1) and copies thereof sent to the tribal office of the Indian tribal government directly concerned with the proposed procurement as well as to Indian firms and others having a legitimate interest therein. Such synopses should state that to the extent provided for pursuant to the Buy Indian Act qualified Indian firms will be given preference in the award of such contracts.

(Sec. 303 of Pub. L. 94-437 (25 U.S.C. 1633); 25 U.S.C. 47; sec. 702 of Pub. L. 94-437 (25 U.S.C. 1672))

[40 FR 4913, Feb. 3, 1975, as amended at 42 FR 59643, Nov. 18, 1977]

§ 3-4.5705 Evaluation criteria.

(a) A contract may be negotiated with, and preference given to, Indians under the Buy Indian Act only if it is first determined that the project or function to be contracted for is likely to be satisfactorily performed under such a contract and that the project or function is likely to be properly completed or maintained under such a contract.

(b) The determination called for by paragraph (a) of this section, to be made prior to the award of a negotiated contract under the Buy Indian Act will be made by the official specified in § 3-4.5704(b). Such determinations are to be in writing and are to reflect a consideration of the following criteria:

(1) Whether there is ownership of a business organization, and control of such a business organization or of a nonprofit firm, as is called for by § 34.5702-2.

(2) Whether the Indian firm has the equipment, buildings and facilities necessary to assure the efficient and orderly performance of the contract or

(3) Whether the Indian firm has established bookkeeping and accounting procedures, adequate to assure the efficient and orderly performance of the contract, including a compliance with labor requirements and a timely compliance with reporting requirements.

(4) Whether the Indian firm has substantive knowledge of the project or function to be contracted for, based either upon satisfactory performance of a similar project under a prior contract or upon demonstrated experience in managing, or being otherwise intimately involved in, a similar project.

(5) Whether the Indian firm has an adequate number of employees, or has reasonably available to it sufficient personnel, who are or will be under a reasonable on-the-job training program adequately trained to satisfactorily perform the contract.

(6) Whether the Indian firm has the experience and financial ability to adequately perform a contract of the proposed scope and magnitude, considering its present and potential commitments to other projects.

(Sec. 303 of Pub. L. 94-437 (25 U.S.C. 1633); 25 U.S.C. 47; sec. 702 of Pub. L. 94-437 (25 U.S.C. 1672))

[42 FR 59643, Nov. 18, 1977]

(b) Animal. "Animal" means any live, warm-blooded animal (homiotherm) which is being used, or is intended for use, for research, testing, training, education, experimentation, or demonstration purposes.

(c) Animal facility. “Animal facility" means any room, building, or area used to contain a primary enclosure designed to immediately restrict an animal or animals to a limited amount or space, such as a room, pen, run, cage, compartment, or hutch.

(d) Institution. Any corporation, institution, organization, agency, or other legally accountable person, other than an individual, located in a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, Wake Island, Johnston Island, the Virgin Islands, the Canal Zone, or the Trust Territory of the Pacific Islands.

(e) Significant numbers of animals. No fixed quantitative definition of this term is offered. Institutions believing that they do not use significant numbers of animals in DHHS supported activities and wishing to modify their institutional committee make-up on the basis of their animal inventory as provided for by § 3-4.5804(a)(2)(ii) should give inventory information as suggested by the assurance examples in Exhibit X3-4.58-2. Final determination as to the acceptability of such modifications will be made by the DHHS.

§ 3-4.5802 Policy.

It is the policy of the Department of Health and Human Services that institutions using animals in projects or other activities supported with funds from DHHS grants, awards, or contracts shall assure the DHHS in writing that they will evaluate on a continuing basis their animal facilities in regard to the care, use, and treatment of such animals, consistent with the standards established by the Animal Welfare Act, the DHHS "Principles for Use of Experimental Animals” (Exhibit X3-4.58-1), and DHHS publication, "Guide for Care and Use of Labo

ratory Animals," Fourth Edition.1 No DHHS grant or contract involving the use of animals will be awarded to an institution unless such assurance has been filed with the DHHS. No such grant or contract will be awarded to an individual without affiliation with an institution which has accepted responsibility for administration of the funds awarded and has filed an assurance with DHHS.

§ 3-4.5803 Applicability.

(a) This policy is applicable to the grants and contracts of any DHHS agency which involve the use of animals in direct research, training, testing, or other activities to be performed by the grantee or contractor institution. While the bulk of such support is offered by a few DHHS agencies (NIH, FDA), staff of all agencies shall be alert to the inclusion of procedures involving animals into proposals received.

(b) Applicability of this policy to contracts for the procurement of animals or animal materials for use in DHHS intramural activities shall be determined by the DHHS officials responsible for administering programs which award such contracts.

§ 3-4.5804 Grantee and contractor imple

mentation.

(a) See Exhibit X3-4.58-2 for examples of acceptable assurance forms. An assurance will identify the evaluation mechanism or mechanisms to be used by the institution, based on one of the following three actions, as appropriate.

(1) Accreditation of all institutional animal facilities by a nationally recognized professional laboratory animal accrediting body. 2

'Revision of PHS publication number 1024, "Guide for Laboratory Animal Facilities and Care," Third Edition, 1968.

"Registration, licensing, or inspection by the Animal and Plant Health Inspection Service of the Department of Agriculture, or by any State, county, or municipal government agency, does not serve to satisfy the terms of this policy. Accreditation by the American Association for Accreditation of Laboratory Animal Care does serve to satisfy the terms of this policy.