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(f) Foreign institutions must comply sions of this rule. The membership of with the PHS Policy (see Section II Of the ACUC shall be in accordance with PHS Policy) and this rule before being PHS Policy. supported by NASA for any activities (2) The NASA Field Installation involving animal subjects.
ACUC's will review and approve or dis
approve all proposals using animal 8 1232.105 Implementation procedures by subjects. In accordance with the PHS NASA field installations.
Policy (IV.C.), the ACUC will submit (a) Proposal Information. The infor- each report to the Field Installation mation required for proposals involv Director who will, upon request, transing the use of animal subjects is iden- mit the report with his/her recomtical to that described in § 1232.104(a). mendation to the Authorized NASA
(b) Proposal Approval by the NASA Official, NASA Headquarters. ACUC. Before a proposal for research (3) NASA ACUC's have the authorinvolving the use of animal subjects ity to approve, disapprove, or require will be considered for NASA support, changes to be made in those compothe NASA Headquarters Research or nents of proposals involving the care Flight Program Manager must receive and use of animal subjects that are a statement that the research has submitted by NASA investigators. All been reviewed in accordance with PHS decisions shall be based on the rePolicy (IV.C.) and approved by the sponse of a majority of a quorum of ACUC at the appropriate field instal the members. A minority opinion inlation.
cluding abstentions should be record(c) Proposal Approval for Flight Ex- ed; this record should include a justifiperiments. In addition to the Field In cation for the opinion. stallation ACUC review, activities in (4) The ACUC shall conduct convolving animal subjects to be flown on tinuing review of proposals at approNASA spacecraft will be subject to priate intervals as determined by the review and approval by the ARC ACUC, but not less than once every 3 ACUC. The ARC ACUC will submit years. each evalaution report to the ARC Di. (5) Proposals that have been aprector who will transmit the report proved by the ACUC may be subject to with his/her recommendation to the further appropriate review by the AuAuthorized NASA Official, NASA thorized NASA Official, NASA HeadHeadquarters. Animal activities to be quarters. However, the official may flown onboard NASA manned space not approve those sections of a proposcraft may also be subject to review by al related to the care and use of the HRPPC at JSC.
animal subjects if they have not been (d) Approval for Use of Field Instal- approved by the ACUC. lation Facilities. The NASA Field In- (6) Once experimental procedures stallation ACUC will review and ap- are approved, no substantial changes prove or disapprove those parts of pro- can be made unless a formal request posals that call for the use of their fa- with appropriate justification for such cilities to conduct any activity involv- a request is submitted to and approved ing animal subjects (e.g., Kennedy by the appropriate ACUC. If the exSpace Center or ARC Dryden facilities periment involves exposure of the used to support experiments using flight crew to the animal subjects, the animal subjects). The ACUC will HRPPC at JSC must review and apsubmit each evaluation report to the prove the proposed modifications. Field Installation Director who will copies of ACUC approval of the protransmit the report with his/her rec- posed modifications shall be submitted ommendation to the Authorized NASA to the Field Installation Director who Official, NASA Headquarters.
will, upon request, transmit the report (e) NASA Animal Care and Use Com- to the Authorized NASA Official, mittees. (1) The Director of each NASA Headquarters. NASA Field Installation that is in (7) Other functions of the field involved in animal research activities stallation ACUC include: will establish an ACUC to ensure com- (i) Reviewing at least once every 6 pliance with the policies and provi- months the field installation's pro
. gram for humane care and use of ani should follow the sample PHS Assur. mals, using the Guide as a basis for ance format shown on pages 19-26 of evaluation;
the PHS Policy and must be submitted (ii) Inspecting at least once every 6 by the Field Installation Director to months all of the field installation's the Authorized NASA Official. The animal facilities (including satellite fa- Assurance is subject to renewal every cilities), using the Guide as a basis for 5 years. evaluation;
(g) Recordkeeping Requirements. (1) (iii) Preparing reports of the ACUC Each NASA field installation involved evaluations conducted as required by in activities using animal subjects $ 1232.105 (e)(7)(i) and (ii), and sub- shall maintain: mitting the reports to the Field Instal (i) An Assurance of compliance with lation Director. (Note: the reports PHS Policy and this rule (8 1232.105 shall be updated at least once every 6 (f)); months upon completion of the re (ii) Minutes of ACUC meetings, inquired semiannual evaluations and cluding records of attendance, activishall be maintained by the field instal- ties of the committee, and committee lation and made available to the Au- deliberations; thorized NASA Official upon request. (iii) Records of applications, proposThe reports must contain a descrip- als, and proposed significant changes tion of the nature and extent of the in the care and use of animals and field installation's adherence to the whether ACUC approval was given or Guide and this rule and must identify withheld; specifically any departures from the (iv) Records of semiannual ACUC reprovisions of the Guide and this rule, ports and recommendations (including and must state the reasons for each minority views) as forwarded to the departure. The reports must distin Field Installation Director; guish significant deficiencies from (v) Records of AAALAC accreditaminor deficiencies. A significant defi- tion; and ciency is one which, consistent with (vi) The Field Installation's Animal PHS Policy, and, in the judgment of Users Guide and Animal Care Facility the ACUC and the Field Installation Management Manual. The Field InDirector, is or may be a threat to the stallation Animal Users Guide and health or safety of the animals. If pro- Animal Care Facility Management gram or facility deficiencies are noted, Manual should be revised at appropri. the reports must contain a reasonable ate intervals. and specific plan and schedule for cor (2) All records shall be maintained recting each deficiency.)
for at least 3 years; records that relate (iv) Reviewing concerns involving directly to applications, proposals, and the care and use of animals at the proposed significant changes in ongofield installation;
ing activities reviewed and approved (v) Making recommendations to the by the ACUC shall be maintained for Field Installation Director regarding the duration of the activity and for an any aspect of the field installation's additional 3 years after completion of animal program, facilities, or person the activity. All records shall be furnel training.
nished upon request to the Authorized (f) NASA Assurances. Each NASA NASA Official. field installation involved in activities (h) Reporting Requirements. For using animal subjects must assure that each NASA field installation involved its programs and facilities have been in activities using animal subjects: evaluated and accredited by the Amer (1) Statements of ACUC approval of ican Association for the Accreditation research proposals, ACUC evaluation of Laboratory Animal Care reports of flight experiment proposals (AAALAC). Written assurance of com- and of experiment proposals utilizing pliance with the provisions of the PHS field installation facilities, and the Policy and this rule is also required field installation's Assurance of comfrom NASA field installations involved pliance shall be submitted in the in animal activities before approval of manner prescribed in 8 1232.104 (c) any such activity. This Assurance and § 1232.105 (b) (c) (d) and (f).
(2) At least once every 12 months, (b) Field Installation Director. The the ACUC, through the Field Installa- Field Installation Director is responsition Director, shall report in writing to ble for and has the authority to: the Authorized NASA Official:
(1) Sign the field installation's As(i) Any change in the field installa- surance, making a commitment on tion's program or facilities that would behalf of the field installation that affect the AAALAC accreditation the requirements of the PHS Policy status;
and this rule will be met in all field in(ü) Any change in the description of stallation activities involving animal the field installation's program for subjects; animal care and use;
(2) Create and oversee the function(ii) Any changes in the ACUC mem- ing of the field installation ACUC; bership;
(3) Decide and administer sanctions (iv) Notice of the dates that the in cases of noncompliance with this ACUC conducted its semiannual eval rule; uations of the field installation's pro- (4) Fulfill the reporting requiregram and facilities and submitted the ments assigned to this individual in evaluations to the Field Installation 8 1232.105 (h); and Director;
(5) Sign the annual USDA report. (V) A statement that the field instal (c) NASA Field Installation(s) ACUC lation has no changes to report as Responsibility. Each NASA Field Inspecified in § 1232.105 (h) (2) (i) (i) or stallation ACUC is responsible to its (iii) of this rule, if there are no Field Installation Director for the acchanges.
tivities described in 8 1232.104(c) and (3) The ACUC, through the Field In 8 1232.105 (b) (c) (d) (e) and (h). stallation Director, shall promptly (d) Research or Flight Program Manprovide the Authorized NASA Official ager Responsibility. The Research or with a full explanation of the circum- Flight Program Manager is responsistances and actions taken with respect ble for ascertaining the presence of
the required PHS Assurance file (i) Any serious or continuing non- number for proposals involving animal compliance with this rule and PHS subjects received from non-NASA inPolicy;
stitutions, and a statement of ACUC (ii) Any serious deviation from the review and approval of all NASA and provisions of the Guide; or
non-NASA proposals involving animal (iii) Any suspension of an activity by subjects. No awards for activities inthe ACUC.
volving animal subjects can be made (4) Reports filed under $1232.105 without this documentation (see (h) of this rule shall include any mi. 8 1232.104 (b) and (d) and nority views filed by members of the $1232.105(b)]. ACUC.
(e) NASA Veterinarian(s) Responsi(5) A copy of the U.S. Department of bility. NASA veterinarian(s) have Agriculture (USDA) Annual Report direct or delegated authority and rewill be furnished to the Authorized sponsibility for activities involving NASA Official.
animal subjects at their field installa
tion. Such authority and responsibil8 1232.106 Management authority and re
ities shall include recommending apsponsibility.
proval or disapproval of procedures in(a) Authorized NASA Official. The volving animal subjects as a member Authorized NASA Official is the of the ACUC, continual monitoring of NASA Administrator's representative these activities, surveillance of the and is responsible for all NASA activi. health and condition of animal subties involving animal subjects. This in- jects, and reporting any observed devidividual is responsible for implementa ations from approved procedures intion of the provisions of this rule and volving animal subjects to the Field for ensuring that agency programs in Installation Director and the ACUC. volving animal subjects comply fully In the case of deviation from ACUCwith all applicable laws, regulations, approved practices or procedures, the and guidelines.
veterinarian shall have the authority
to immediately halt such procedures the IRAC will obtain information of until they are reviewed and resolved all cases in which an institution's Asby the ACUC. In cases of a conflict surance has been revoked by the PHS. concerning animal usage by an investi. The NASA IRAC representative will gator that cannot be resolved between notify NASA ACUC's, Field Installahim/her and the veterinarian, the tion Directors, the Authorized NASA matter may be brought to the atten
Official, and all Headquarters Retion of the Field Installation ACUC search and Flight Program Managers for review and recommendation for
so that they can determine which action as set forth in this rule. Where
NASA awards involving the use of as the performance of the veterinar
animal subjects are affected and can ian's duties can be delegated to other
take appropriate sanctions. qualified individuals, the ultimate responsibility rests with the veterinari
8 1232.107 Sanctions. an. This responsibility extends not only to the Animal Care Facility
(a) Non-NASA Institutions. Principal (ACF), but also to other locations
investigators not employed by NASA where animal subjects are used.
whose activities are supported by Other specific areas of responsibility NASA but whose activities using and authority vested in the veterinari.
animal subjects are restricted to nonan are:
NASA facilities shall be subject to the (1) Entry of personnel into the ACF.
control of their institution's ACUC The veterinarian has the responsibil. and responsible institutional official. ity to develop access procedures to the Notification of noncompliance with ACF and submit them to the ACUC this rule shall be made either as defor approval.
scribed in § 1232.106(f) or by the non(2) Personnel Training. The veteri NASA institution to the Director of narian will participate in the training the NASA Field Installation through of personnel in the handling of animal which the activity has been supported subjects and in specimen sampling and to the Authorized NASA Official. procedures.
Any continued noncompliance may be (3) Animal Training. The veterinari caused for termination of funding or an will monitor all schedules and pro
support. cedures involving the training and ac
(b) NASA Field Installations. (1) Inclimation of animal subjects.
appropriate procedures on animal sub(4) Surgery and Surgical Procedures.
jects by NASA principal investigators The veterinarian will monitor all sur
shall be halted by the NASA Field Ingical procedures and verify that the
stallation Veterinarian or line majageprinciples of the Guide with regard to
ment and brought to the attention of aseptic surgery are employed. Post
the ACUC if the issue cannot be imsurgical recovery procedures are included. If necessary, training will be
mediately resolved. The ACUC will provided by the veterinarian to bring
review the activity and report any
noncompliance with this rule to the procedures conducted by investigators to the level of these standards.
Field Installation Director. Principal (5) Veterinary Medical and Engi
investigators not employed by NASA, neering Procedures. The veterinarian
whose activities using animal sut jects will monitor all veterinary medical and
are performed in NASA facilities, airengineering procedures performed on
craft, or spacecraft, are subject to animal subjects and verify their appro
similar action. Such noncompl ance priateness. The veterinarian will ac
will be cause for sanctions. The princitively participate in identifying and/or
pal investigator can contest, in wr ting, establishing the design requirements these decisions to the ACUC. and adequacy of animal facilities for (2) The ACUC as the agent o the ground and spaceflight-related activi Field Installation Director may susties.
pend an activity that it previousl í ap(f) NASA Representative to the Inter proved if it determines that the a :tivi. agency Research Animal Committee ty is not being conducted in acord(IRAC). The NASA representative to ance with applicable provisions o' the
Animal Welfare Act, the Guide, PHS Sec.
1240.111 Presentation of awards. (3) Any suspension or termination of 1240.112 Financial accounting. approval will include a statement of 1240.113 Delegation of authority. the reasons for the action and will be
AUTHORITY: Sec. 306 of the National Aeropromptly reported to the principal in nautics and Space Act of 1958, as amended vestigator and the appropriate Field (42 U.S.C. 2458), and the Federal TechnoloInstallation Director. In the case of in gy Transfer Act of 1986, Sec. 12, 15 U.S.C. vestigators from non-NASA institu 3710b(1). tions, notification should be sent to
SOURCE: 55 FR 614, Jan. 8, 1990, unless the investigator, the appropriate insti. otherwise noted. tution, and the Director of the Field Installation through which the activi.
Subpart 1-Awards for Scientific and ty has been supported. If the ACUC
Technical Contributions suspends an activity involving animal subjects, the Field Installation Direc
8 1240.100 Purpose. tor in consultation with the ACUC shall review the reasons for suspen
This subpart prescribes procedures sion, take appropriate corrective for submitting applications for moneaction, and report that action with a tary awards to the Administrator of full explanation to the Authorized NASA for scientific and technical conNASA Official, NASA Headquarters. tributions which have significant If an ACUC recommends disapproval value in the conduct of aeronautical suspension, termination, or condition and space activities pursuant to 42 al approval of an activity, the princi. U.S.C. 2458, and establishes the pal investigator will be given the op awards program consistent with the portunity to ask for reconsideration of Federal Technology Transfer Act of the decision in person and/or in writ- 1986, Section 12, 15 U.S.C. 3710b(1). ing to the appropriate NASA ACUC.
(4) If, after notification of the Field 8 1240.101 Scope. Installation Director and an opportu. This subpart applies to any scientific nity for correction, such deficiencies or technical contribution, whether or or deviations remain uncorrected, the not patentable, which is determined
ACUC will notify (in writing) the Au- by the Administrator after referral to [thorized NASA Official, NASA Head
the Inventions and Contributions quarters, who is then responsible for
Board to have significant value in the all corrective action to be taken.
conduct of aeronautical and space activities for which an application for
award has been submitted to NASA PART 1240—INVENTIONS AND under 42 U.S.C. 2458. CONTRIBUTIONS
8 1240.102 Criteria. . 1 Subpart 1-Awards for Scientific and Technical (a) Only those contributions to Contributions
NASA which have been (1) used in a Sec.
NASA program or adopted or spon1240.100 Purpose.
sored or supported by NASA, and (2) 1240.101 Scope.
found to have significant value in the 1240.102 Criteria.
conduct of aeronautical and space ac1240.103 Applications for awards.
tivities will be recommended for award 1240.104 Special procedures–NASA and under this subpart. NASA contractor employees.
(b) In determining the amount, 1240.105 Review and evaluation of contri terms, and conditions of any award, bution.
the following criteria will be consid1240.106 Notification by the Board.
ered: 1240.107 Reconsideration. 1240.108 Hearing procedure.
(1) The value of the contribution to 1240.109 Recommendation to the Adminis
the United States; trator.
(2) The aggregate amount of any 1240.110 Release.
sums which have been expended by