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 whether it has reasonable access thereto for that purpose.

(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]

(a) Animal Welfare Act. The Act of August 24, 1966 (Pub. L. 89-544), commonly known as the Laboratory Animal Welfare Act, as amended by the Act of December 24, 1970 (Pub. L. 91-579), the Animal Welfare Act of 1970.

(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.

area

(c) Animal facility. “Animal facility" means any room, building, or 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, John

ston 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 DHEW 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 DHEW.

§ 3-4.5802 Policy.

It is the policy of the Department of Health, Education, and Welfare that institutions using animals in projects or other activities supported with funds from DHEW grants, awards, or contracts shall assure the DHEW 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 DHEW "Principles for Use of Experimental Animals" (Exhibit X3-4.58-1), and DHEW publication, "Guide for Care and Use of Laboratory Animals," Fourth Edition. No DHEW grant or contract involving the use of animals will be awarded to an institution unless such assurance has been filed with the DHEW. 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 DHEW.

§ 3-4.5803 Applicability.

(a) This policy is applicable to the grants and contracts of any DHEW agency which involve the use of animals in direct research, training, testing, or other activities to be performed by the grantee or contractor institu

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

tion. While the bulk of such support is offered by a few DHEW 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 DHEW intramural activities shall be determined by the DHEW officials responsible for administering programs which award such contracts.

on a consultant basis is the permissible alternative.

(3) Both of the foregoing (accreditation and committee), if the accreditation is limited to only a portion of the institution's facilities for the care and use of live animals.

(b) Institutional review of applications and proposals. Grantee and contractor institutions are encouraged to review their applications and proposals in the light of the pertinent provisions of the Animal Welfare Act, the standards set by the Institute of Labo

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 call institutional animal facilities by a nationally recognized professional laboratory animal accrediting body."

(2) Establishment of an institutional committee to evaluate on a continuing basis the care of all animals held or used by or for the grantee or contractor institution for use in research, teaching, or other activities supported by DHEW grants or contracts.

(i) Where the institution uses significant numbers of animals in DHEW supported activities, the committee will consist of at least three members, at least one of whom must be a Doctor of Veterinary Medicine.

(ii) Where the institution does not use significant numbers of animals in DHEW supported activities, the committee will consist of at least three members. At least one of the members must be a scientist with demonstrated expertise in the care and use of laboratory animals. If such expertise is not available, a Doctor of Veterinary Medicine available to the committee

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.

Academy of Sciences, National Research Council (NAS, NRC), and the DHEW Principles for the Use of Laboratory Animals (Exhibit X3-4.58-1), and to familiarize their staff with these provisions, standards, and principles. However, there is no requirement under this policy that institutional committees perform review of individual proposals or regularly provide to the DHEW summaries or certifications of such committee actions.

(c) Reporting to DHEW. No routine reports are required. Assurance requirements are limited to the description, on a one-time basis, of administrative mechanisms for the continuing evaluation of institutional facilities and activities concerned with the care and use of animals. However, significant changes in assurance status or significant problems encountered in implementing this policy shall be promptly reported to the Institutional Relations Branch, DRG, NIH, DHEW. Review of these changes or problems, or of institutional and other records of performance under the terms and conditions of this policy, may require renegotiation of the assurance, or such other action as may be appropriate. (See § 3-4.5805(d).)

(d) Maintenance of institutional records. As a part of the continuing evaluation process, DHEW awardee institutions shall keep records of committee activities, including recommendations and determinations, and/or records of accrediting body determinations. Institutions shall also keep animal inventory records to establish whether significant numbers of animals are being used. These records shall be available for inspection by the

Secretary, DHEW, or his authorized representatives. They shall be retained for a period of three years after termination of the budget period to which they apply.

§ 3-4.5805 Departmental implementation.

(a) The Division of Research Grants, NIH, DHEW, will be responsible for general administration and coordination of the implementation of this policy. The Institutional Relations Branch, DRG, will publish and distribute to all DHEW components a cumulative list of all institutions which have filed assurances of compliance as specified by § 3-4.5804.

(b) Staff, advisory groups, and consultants, in their review of applications for DHEW grants and contracts, shall consider the requirements of this policy with special attention to the principles described in Exhibit X34.58-1. If a project is disapproved or not awarded as requested, entirely or in part on grounds of incompatibility with this policy or its related principles, DHEW program staff shall bring the circumstances to the attention of the Institutional Relations Branch, which will call the matter to the attention of the applicant institution on behalf of the DHEW.

procedures.

(c) Implementation DHEW agencies shall publish their implementation requirements within 60 days of publication of this policy. Assurances previously accepted by the DRG, NIH, for the NIH and listed in its current "protection of Animal Subject *. Cumulative List of Institutions in Compliance with NIH Policy" will be considered acceptable for the purposes of this policy provided that the DHEW supported activities are limited to the use of the six species (dogs, cats, monkeys, guinea pigs, rabbits, and hamsters) covered by the NIH policy memorandum of August 2, 1971. Application of this policy will be made to all contracts, and to all grants resulting from competing applications awarded after July 1, 1973.

(1) No DHEW grant or contract involving the use of animals shall be awarded when the application or proposal for such grant or contract raises questions in the minds of DHEW operating agency staff as to the applicant's

or proposer's compliance with the terms of this policy or its related principles. The principal investigator or project director will be contacted by DHEW operating agency staff and given an opportunity to resolve the questions, in a time period specified by the DHEW operating agency.

(2) Final adverse action shall be taken by DHEW only if the principal investigator or project director fails or refuses to satisfactorily resolve the questions within the time period specified by the DHEW operating agency. Alternatively, if, in the judgment of DHEW operating agency staff, the project or activity can properly be restricted so as to eliminate those parts of the design which are incompatible with this policy or its related principles, such a restricted award may be offered.

(d) Follow-up. If, in the judgment of the Secretary or his authorized representative, an institution has failed in a material manner3 to comply with the terms of this policy, he may:

(1) With respect to an institution, determine that its eligibility to receive further DHEW grants or contracts involving the use of animals be withdrawn, such disqualification to continue until terminated in the public interest by the Secretary or his authorized representative. The institution shall be promptly notified of such action.

(2) With respect to a particular DHEW grant or contract involving the use of animals, require that it be terminated in the manner provided for in applicable grant or procurement regulations. The grantee or contractor shall be promptly notified of such action.

(3) With respect to an individual employed by the grantee or contractor institution, determine that he is no longer qualified to serve as principal investigator, program director, or other person responsible for the direction of activities funded by DHEW as grants or contracts involving the use of animals, such disqualification to continue until terminated in the

'Any violation under section 19 or 20 of the Animal Welfare Act (Exhibit X3-4.58-3) shall be considered to constitute a material failure to comply with the terms of this policy.

public interest by the Secretary or his authorized representative. The individual shall be promptly notified of such action.

EXHIBIT X3-4.58-1

PRINCIPLES FOR USE OF LABORATORY ANIMALS

The personnel. 1. Projects or activities involving live, warm-blooded animals and the procurement of living animal tissues for biomedical activities must be performed by, or under the immediate supervision of, a scientist qualified in the scientific area under study.

2. The housing, care, and feeding of all laboratory animals must be supervised by a properly qualified veterinarian or other scientist competent in such matters.

The project or activity. 3. The intent of the project or activity should be such as to yield fruitful results for the good of society, and not random and unnecessary in nature.

4. The project or activity should be so designed and based on knowledge of the disease or problem under study that the significance of anticipated results will justify its performance.

5. The project or activity should be so conducted as to avoid all unnecessary suffering and injury to the subject animals.

6. The scientist in charge of the project or activity must be prepared to terminate it whenever he believes that its continuation may result in unnecessary injury to the subject animals.

7. If any aspect of the project or activity is likely to cause greater discomfort than that attending anesthetization, the subject animals must be rendered incapable of perceiving the pain prior to its possible onset and be maintained in that condition until the threat of pain is ended. The only exception to this guideline should be in those cases where anesthetization would defeat the purpose of the project; such exceptions must be specifically approved and supervised by the principal investigator.

8. If it is necessary to sacrifice a laboratory animal, the subject animal must be killed in a humane manner in such a way as to insure immediate death in accordance with procedures approved by the institutional committee. No animal shall be discarded until death is certain.

9. Post-experiment care of subject animals must be such as to minimize discomfort, in accordance with acceptable practice in veterinary medicine.

The facilities. 10. Standards for the construction and use of housing, service, and surgical facilities should be consistent with the recommendations in DHEW publication, "Guide for Care and Use of Laboratory Animals," Fourth Edition, or as otherwise required by the U.S. Department of Agricul

ture regulations established under the terms of the Animal Welfare Act.

EXHIBIT X3-4.58-2

EXAMPLES OF ACCEPTABLE ASSURANCE FORMS Assurances may take any one of several forms depending on circumstances, but should include the information provided by one or more of the examples below, be dated, and be signed by an authorized representative of the institution:

1. "This institution uses or intends to use significant numbers of warm-blooded animals in activities supported by DHEW grants, contracts, or awards. We are accredited by the American Association for Accreditation of Laboratory Animal (AAALAC). Our director(s) of laboratory animal care, as listed with AAALAC, are as follows: (insert name(s), degree(s), title(s)). Our accreditation applies to the following facilities and components of this institution:

Records of accrediting body determinations will be available for inspection by the Secretary, DHEW, or his authorized representatives."

2. "This institution uses or intends to use significant numbers of warm-blooded animals in activities supported by DHEW grants, contracts, or awards. We have established a committee of at least three members, at least one of whom is a Doctor of Veterinary Medicine (insert name), to evaluate the care of all warm-blooded animals held or used for research, teaching or other activities supported by DHEW grants, contracts, or awards. The committee will be responsible for animals housed at the following facilities and components of this institution:

The evaluation committee will periodically inspect the animal facilities of this institution and report its findings and recommendations to the institution's responsible officials on a schedule the committee determines necessary; but in no case will these reports be issued less than annually. Records will be kept of committee activities and recommendations. These records will be availa