(iii) Preparing reports of the ACUC evaluations conducted as required by § 1232.105 (e)(7)(i) and (ii), and submitting the reports to the Field Installation Director. (Note: the reports shall be updated at least once every 6 months upon completion of the required semiannual evaluations and shall be maintained by the field installation and made available to the Authorized NASA Official upon request. The reports must contain a description of the nature and extent of the field installation's adherence to the Guide and this rule and must identify specifically any departures from the provisions of the Guide and this rule, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, consistent with PHS Policy, and, in the judgment of the ACUC and the Field Installation Director, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency.)

(iv) Reviewing concerns involving the care and use of animals at the field installation;

(v) Making recommendations to the Field Installation Director regarding any aspect of the field installation's animal program, facilities, or personnel training.

(f) NASA Assurances. Each NASA field installation involved in activities using animal subjects must assure that its programs and facilities have been evaluated and accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC). Written assurance of compliance with the provisions of the PHS Policy and this rule is also required from NASA field installations involved in animal activities before approval of any such activity. This Assurance should follow the sample PHS Assurance format shown on pages 19-26 of the PHS Policy and must be submitted by the Field Installation Director to the Authorized NASA Official. The Assurance is subject to renewal every 5 years.

(g) Recordkeeping Requirements. (1) Each NASA field installation involved

in activities using animal subjects shall maintain:

(i) An Assurance of compliance with PHS Policy and this rule (§ 1232.105 (f)); (ii) Minutes of ACUC meetings, including records of attendance, activities of the committee, and committee deliberations;

(iii) Records of applications, proposals, and proposed significant changes in the care and use of animals and whether ACUC approval was given or withheld;

(iv) Records of semiannual ACUC reports and recommendations (including minority views) as forwarded to the Field Installation Director;

(v) Records of AAALAC accreditation; and

(vi) The Field Installation's Animal Users Guide and Animal Care Facility Management Manual. The Field Installation Animal Users Guide and Animal Care Facility Management Manual should be revised at appropriate intervals.

(2) All records shall be maintained for at least 3 years; records that relate directly to applications, proposals, and proposed significant changes in ongoing activities reviewed and approved by the ACUC shall be maintained for the duration of the activity and for an additional 3 years after completion of the activity. All records shall be furnished upon request to the Authorized NASA Official.

(h) Reporting Requirements. For each NASA field installation involved in activities using animal subjects:

(1) Statements of ACUC approval of research proposals, ACUC evaluation reports of flight experiment proposals and of experiment proposals utilizing field installation facilities, and the field installation's Assurance of compliance shall be submitted in the manprescribed in §§ 1232.104(c) and 1232.105 (b), (c), (d), and (f).

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(2) At least once every 12 months, the ACUC, through the Field Installation Director, shall report in writing to the Authorized NASA Official:

(i) Any change in the field installation's program or facilities that would affect the AAALAC accreditation status;

(ii) Any change in the description of the field installation's program for animal care and use;

(iii) Any changes in the ACUC membership;

(iv) Notice of the dates that the ACUC conducted its semiannual evaluations of the field installation's program and facilities and submitted the evaluations to the Field Installation Director;

(v) A statement that the field installation has no changes to report as specified in § 1232.105(h)(2) (i), (ii), or (iii) of this rule, if there are no changes.

(3) The ACUC, through the Field Installation Director, shall promptly provide the Authorized NASA Official with a full explanation of the circumstances and actions taken with respect to:

(i) Any serious or continuing noncompliance with this rule and PHS Policy;

(ii) Any serious deviation from the provisions of the Guide; or

(iii) Any suspension of an activity by the ACUC.

(4) Reports filed under § 1232.105 (h) of this rule shall include any minority views filed by members of the ACUC.

(5) A copy of the U.S. Department of Agriculture (USDA) Annual Report will be furnished to the Authorized NASA Official.

(a) Authorized NASA Official. The Authorized NASA Official is the NASA Administrator's representative and is responsible for all NASA activities involving animal subjects. This individual is responsible for implementation of the provisions of this rule and for ensuring that agency programs involving animal subjects comply fully with all applicable laws, regulations, and guidelines.

(b) Field Installation Director. The Field Installation Director is responsible for and has the authority to:

(1) Sign the field installation's Assurance, making a commitment on behalf of the field installation that the requirements of the PHS Policy and this rule will be met in all field installation activities involving animal subjects;

(2) Create and oversee the functioning of the field installation ACUC;

(3) Decide and administer sanctions in cases of noncompliance with this rule;

(4) Fulfill the reporting requirements assigned to this individual in

§ 1232.105(h); and

(5) Sign the annual USDA report. (c) NASA Field Installation(s) ACUC Responsibility. Each NASA Field Installation ACUC is responsible to its Field Installation Director for the activities described in §§ 1232.104(c) and 1232.105 (b), (c), (d), (e) and (h).

(d) Research or Flight Program Manager Responsibility. The Research or Flight Program Manager is responsible for ascertaining the presence of the required PHS Assurance file number for proposals involving animal subjects received from non-NASA institutions, and a statement of ACUC review and approval of all NASA and non-NASA proposals involving animal subjects. No awards for activities involving animal subjects can be made without this documentation [see §§ 1232.104 (b) and (d) and 1232.105(b)].

(e) NASA Veterinarian(s) Responsibility. NASA veterinarian(s) have direct or delegated authority and responsibility for activities involving animal subjects at their field installation. Such authority and responsibilities shall include recommending approval or disapproval of procedures involving animal subjects as a member of the ACUC, continual monitoring of these activities, surveillance of the health and condition of animal subjects, and reporting any observed deviations from approved procedures involving animal subjects to the Field Installation Director and the ACUC. In the case of deviation from ACUC-approved practices or procedures, the veterinarian shall have the authority to immediately halt such procedures until they are reviewed and resolved by the ACUC. In cases of a conflict concerning animal usage by an investigator that cannot be resolved between him/her and the veterinarian, the matter may be brought to the attention of the Field Installation ACUC for review and recommendation for action as set forth in this rule. Whereas the performance of the veterinarian's duties can be delegated to other qualified individuals, the ultimate responsibility rests with

the veterinarian. This responsibility extends not only to the Animal Care Facility (ACF), but also to other locations where animal subjects are used.

Other specific areas of responsibility and authority vested in the veterinarian are:

(1) Entry of personnel into the ACF. The veterinarian has the responsibility to develop access procedures to the ACF and submit them to the ACUC for approval.

(2) Personnel Training. The veterinarian will participate in the training of personnel in the handling of animal subjects and in specimen sampling procedures.

(3) Animal Training. The veterinarian will monitor all schedules and procedures involving the training and acclimation of animal subjects.

(4) Surgery and Surgical Procedures. The veterinarian will monitor all surgical procedures and verify that the principles of the Guide with regard to aseptic surgery are employed. Post-surgical recovery procedures are included. If necessary, training will be provided by the veterinarian to bring procedures conducted by investigators to the level of these standards.

(5) Veterinary Medical and Engineering Procedures. The veterinarian will monitor all veterinary medical and engineering procedures performed on animal subjects and verify their appropriateness. The veterinarian will actively participate in identifying and/or establishing the design requirements and adequacy of animal facilities for ground and spaceflight-related activities.

(f) NASA Representative to the Interagency Research Animal Committee (IRAC). The NASA representative to the IRAC will obtain information of all cases in which an institution's Assurance has been revoked by the PHS. The NASA IRAC representative will notify NASA ACUC's, Field Installation Directors, the Authorized NASA Official, and all Headquarters Research and Flight Program Managers so that they can determine which NASA awards involving the use of animal subjects are affected and can take appropriate sanctions.

§ 1232.107 Sanctions.

(a) Non-NASA Institutions. Principal investigators not employed by NASA whose activities are supported by NASA but whose activities using animal subjects are restricted to nonNASA facilities shall be subject to the control of their institution's ACUC and responsible institutional official. Notification of noncompliance with this rule shall be made either as described in §1232.106(f) or by the non-NASA institution to the Director of the NASA Field Installation through which the activity has been supported and to the Authorized NASA Official. Any continued noncompliance may be caused for termination of funding or support.

(b) NASA Field Installations. (1) Inappropriate procedures on animal subjects by NASA principal investigators shall be halted by the NASA Field Installation Veterinarian or line management and brought to the attention of the ACUC if the issue cannot be immediately resolved. The ACUC will review the activity and report any noncompliance with this rule to the Field Installation Director. Principal investigators not employed by NASA, whose activities using animal subjects are performed in NASA facilities, aircraft, or spacecraft, are subject to similar action. Such noncompliance will be cause for sanctions. The principal investigator can contest, in writing, these decisions to the ACUC.

(2) The ACUC as the agent of the Field Installation Director may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, PHS Policy requirements, or this rule.

(3) Any suspension or termination of approval will include a statement of the reasons for the action and will be promptly reported to the principal investigator and the appropriate Field Installation Director. In the case of investigators from non-NASA institutions, notification should be sent to the investigator, the appropriate institution, and the Director of the Field Installation through which the activity has been supported. If the ACUC suspends an activity involving animal subjects, the Field Installation Director in

consultation with the ACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to the Authorized NASA Official, NASA Headquarters. If an ACUC recommends disapproval suspension, termination, or conditional approval of an activity, the principal investigator will be given the opportunity to ask for reconsideration of the decision in person and/or in writing to the appropriate NASA ACUC.

(4) If, after notification of the Field Installation Director and an opportunity for correction, such deficiencies or deviations remain uncorrected, the ACUC will notify (in writing) the Authorized NASA Official, NASA Headquarters, who is then responsible for all corrective action to be taken.

NASA for scientific and technical contributions which have significant value in the conduct of aeronautical and space activities pursuant to 42 U.S.C. 2458, and establishes the awards program consistent with the Federal Technology Transfer Act of 1986, Section 12, 15 U.S.C. 3710b(1).

§ 1240.101 Scope.

This subpart applies to any scientific or technical contribution, whether or not patentable, which is determined by the Administrator after referral to the Inventions and Contributions Board to have significant value in the conduct of aeronautical and space activities for which an application for award has been submitted to NASA under 42 U.S.C. 2458.

§ 1240.102 Criteria.

(a) Only those contributions to NASA which have been (1) used in a NASA program or adopted or sponsored or supported by NASA, and (2) found to have significant value in the conduct of aeronautical and space activities will be recommended for award under this subpart.

(b) In determining the amount, terms, and conditions of any award, the following criteria will be considered:

(1) The value of the contribution to the United States;

(2) The aggregate amount of any sums which have been expended by the applicant for the development of such contribution;

(3) The amount of any compensation (other than salary received for services rendered as an officer or employee of the Government) previously received by the applicant for or on account of the use of such contributions by the United States; and

(4) Such other factors as the Administrator shall determine to be material.

§ 1240.103 Applications for awards.

(a) Eligibility. Applications for award may be submitted by any person including any individual, partnership, corporation, association, institution, or other entity.

(b) Information required. Applications for award should be addressed to the Inventions and Contributions Board

(herein referred to as the Board), National Aeronautics and Space Administration, Washington, DC 20546, and will contain:

(1) The name and address of the applicant, the person's relationship to the contributor if the contribution is made by one other than the applicant, and the names and addresses of any others having information as to the value or usage of the contribution;

(2) A complete written description of the contribution, in the English language, accompanied by drawings, sketches, diagrams, or photographs illustrating the nature of the contribution and the technical and scientific principles upon which it is based, any available test or performance data or observations of pertinent scientific phenomena, and the aeronautics or space application of the contribution;

(3) The date and manner of any previous submittal of the contribution to any other United States Government agency, and the name of such agency;

(4) The aggregate amount of any sums which have been expended by the applicant for the development of the contribution;

(5) The nature and extent of any known use of the contribution by the United States and by any agency of the United States Government;

(6) The amount of any compensation (other than salary received for services rendered as an officer or employee of the Government) previously received by the applicant for or on account of the use of such contribution by the United States;

(7) Identification of any United States and foreign patents applied for or issued relating to the contribution; and

(8) An agreement to surrender all claims which such applicant may have for the use of such contribution by the Government.

(c) General. (1) Each contribution will be made the subject of a separate application in order that each contribution may be evaluated individually.

(2) Material constituting a possible hazard to safety or requiring unusual storage facilities should not be submitted, and will not be accepted. Models or intricate exhibits demonstrating the contribution will not be accepted un

the

less specifically requested by Board. In those few cases where such models or exhibits have been submitted pursuant to a request made by the Board, the same will be returned to the applicant upon written request from the applicant.

(3) It is the policy of the Board to use or disclose information contained in applications for awards for evaluation purposes only. Applications for awards submitted with restrictive legends or statements differing from this policy will be treated in accordance with the Board's policy.

§ 1240.104 Special procedures—-NASA and NASA contractor employees.

(a) A NASA Headquarters office, a NASA field installation, or a NASA contractor may submit to the Board an application for an award identifying the originator(s) of any scientific or technical contribution conceived or developed during the performance of a NASA program or contract, and which is considered to be of value in advancing the state of knowledge in space or aeronautical activities, whether or not the contribution is the subject of a NASA Tech Brief or of a U.S. patent application.

(b) When the Board receives written notice (NASA Form 1548) that the Associate General Counsel for Intellectual Property at NASA Headquarters or the cognizant Patent Counsel at a NASA field installation has authorized the filing of a U.S. patent application for an invention made and reported by an employee of NASA or an employee of a NASA contractor, the Board will recommend to the Administrator or a designee that an initial award of at least $500 be granted to a sole inventor, and an award in the amount of at least $250 will normally be granted to each of joint inventors. The Board is authorized to recommend a supplemental monetary award in an amount that will be based on the evaluation of the technical and commercial merits of the invention.

(c) When the Board receives written notice (NASA Form 1546) that the Technology Utilization Officer at a NASA field installation has approved for publication a selected NASA Tech Brief based on an innovation made and