APPENDIX F - CONTRACT REQUIREMENTS.pdf

APPENDIX F – CONTRACT REQUIREMENTS

7 CONTRACT REQUIREMENTS

Upon award of a contract, the contractor will be required to make certain legal commitments through acceptance of Government contract clauses. This Section discusses which clauses will be included in a contract resulting from this solicitation, if applicable to the project being proposed. For the purposes of this solicitation, ARPA-H will follow the polices noted within this Appendix.

7.2 CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015)

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c)above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with Animal Welfare Assurances.

Note : The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (Email ace@aphis.usda.gov; Web site: ( http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare ). (End of clause)

7.3 Animal Welfare

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy).

The PHS Policy can be accessed at:

http://grants1.nih.gov/grants/olaw/references/phspol.htm .

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor's technical proposal, which is incorporated by reference.

7.4 PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

c. Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP Website at:

http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf ).

d. If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs

(a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the

Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part. (End of clause)

7.5 Required Education in the Protection of Human Research Participants

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html .

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

7.6 Inclusion of Women and Minorities in Research Involving Human Subjects

NIH-conducted and supported clinical research must conform to the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research in accord with Public Health Service Act sec. 4928 U.S.C. sec 289a-2. The policy requires that women and members of minority groups and their subpopulations must be included in all NIH-conducted or supported clinical research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of ARPA-H Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The Director, NIH, may determine that exclusion under other circumstances is acceptable, upon the recommendation of an IC Director, based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources.

Women of childbearing potential should not be routinely excluded from participation in clinical research.

All investigators proposing research involving human subjects should read the UPDATED "NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended November 2017," published in the NIH Guide for Grants and Contracts on October 9, 2001 at the following web site:

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001 .htm .

The Contractor must submit the results of valid analyses by sex/gender and race/ethnicity to Clinicaltrials.gov for all NIH-conducted or supported applicable NIH-defined Phase III clinical trials. This requirement does not apply to NIH-defined Phase III trials not considered to applicable clinical trials under 42 CFR Part 11. The Contractor must report applicable NIH-defined Phase III clinical trials involving research subjects of all ages, including foreign awards and domestic awards with a foreign component. The Contractor must specify outcomes on sex/gender and race/ethnicity, as required based on prior evidence, and as explained in the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.

Note: Applicable clinical trials are required to be registered in ClinicalTrials.gov not later than 21 calendar days after the enrollment of the first participant. Results information, including the results of the valid analyses by sex/gender and race/ethnicity, from those trials must be submitted not later than one year after the trial's primary completion date.

Submission of results information can be delayed in certain circumstances for up to two additional years for trials of products regulated by the FDA that are unapproved, unlicensed, or uncleared or for trials of products for which approval, licensure, or clearance of new use is being sought.

7.7 Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects

Section 2038 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions requiring NIH to address the consideration of age as an inclusion variable in research involving human subjects, to identify criteria for justification for any age-related exclusions in NIH research, and to provide data on the age of participants in clinical research studies. The NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects applies to all NIH conducted or supported research involving human subjects, including research that is otherwise "exempt" in accordance with Sections 101(b) and 401(b) of 45 CFR 46 - Federal Policy for the Protection of Human Subjects.

Effective on all solicitations issued on or after January 25, 2019, individuals of all ages, including children (i.e. individuals under the age of 18) and older adults, must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. The inclusion of individuals across the lifespan as subjects in research must be in compliance with all applicable subparts of 45 CFR 46 as well as with other pertinent federal laws and regulations.

The Contractor must address the age-appropriate inclusion or exclusion of individuals in the proposed research project. The Contractor must provide a description of plans for including individuals across the lifespan, including a rationale for selecting the specific age range justified in the context of the scientific question proposed. If individuals will be excluded from the research based on age, the contractor must provide acceptable justification for the exclusion.

The Contractor must submit cumulative data as prescribed in the Age Enrollment Report template on participant age at enrollment in monthly progress reports. Investigators planning to conduct research involving human subjects should design their studies in such a way that de-identified individual level participant data on sex/gender, race, ethnicity, and age at enrollment may be provided in progress reports.

7.8 Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials

All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization.

GCP training should be refreshed at least every three years to remain current with regulations, standards and guidelines. The Contractor shall provide completion of training documentation to the Contracting Officer's Representative (COR).

Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Clinical Trial Staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub- investigator.

7.9 Clinical Trial Registration and Results Information Submission

The Contractor conducting clinical trials, funded wholly or partially through the NIH extramural and intramural programs, shall ensure that its NIH-funded clinical trials are registered at, and summary results information is submitted to, www.clinicaltrials.gov for public posting. See NIH Guide Notice NOT-OD-16-149 dated September 16, 2016.

All NIH-funded clinical trials shall be registered and results information submitted to www.clinicaltrials.gov regardless of study phase, type of intervention, or whether they are subject to the regulation 42 CFR Part 11. Clinical trials subject to the regulation are called "applicable clinical trials."

The Contractor must submit a plan with its proposal to meet the regulatory requirements of the dissemination of information of NIH- funded Clinical Trials. This plan should be uploaded to Section 4.7, Dissemination Plan, of Appendix A.2. – Study Record, which can be found in Section 13 – Appendices. The Contractor and investigators are required to comply with all terms and conditions of award, including following their acceptable plan for the dissemination of NIH-funded clinical trial information.

The Contractor must register all NIH-funded clinical trials in www.clinicaltrials.gov not later than 21 calendar days after the enrollment of the first participant. Results information from those trials must be submitted not later than one year after the trial's primary completion date. Submission of results information can be delayed in certain circumstances for up to two additional years for trials of products regulated by the FDA that are unapproved, unlicensed, or uncleared or for trials of products for which approval, licensure, or clearance of a new use is being sought. The Contractor shall include the trial registration number (NCT number) in the Technical Progress Report covering the period in which registration occurred, and as a standalone notification to the Contracting Officer within ten (10) calendar days of the registration. Each NIH-funded clinical trial must have only one entry in ClinicalTrials.gov that contains its registration and results information.

The Contractor shall include a specific statement in all informed consent documents relating to posting of clinical trials information to www.clinicaltrials.gov . The responsibilities of the Contractor will fall within one of the following three categories:

1. If the NIH-funded clinical trial is an applicable clinical trial under the regulation and the Contractor is the responsible party, the Contractor will ensure that all regulatory requirements are met.

2. If the NIH-funded clinical trial is an applicable clinical trial under the regulation but the Contractor is not the responsible party, the Contractor will coordinate with the responsible party to ensure that all regulatory requirements are met.

3. If the NIH-funded clinical trial is not an applicable clinical trial under the regulation, the Contractor will be responsible for carrying out the tasks and meeting the timelines described in regulation. Such tasks include registering the clinical trial in ClinicalTrials.gov and submitting results information to ClinicalTrials.gov.

Failure to comply with the terms and conditions of the award may provide a basis for enforcement actions. Identifying clinical trial record as non-compliant in ClinicalTrials.gov may lead to termination, consistent with 45 CFR 75.371 and/or other authorities, as appropriate. If the NIH-funded clinical trial is also an applicable clinical trial, non-compliance with the requirements specified in 42 USC 282(j) and 42 CFR Part 11 may also lead to the actions described in 42 CFR 11.66.

The Contracting Officer may take one or more of the following enforcement actions, if the Contractor fails to provide evidence of compliance within 30 days.

• Temporary withhold payments pending correction of the deficiency;

• Disallow all or part of the cost of the activity or action not in compliance;

• Wholly or partly suspend or terminate the contract award;

• Initiate suspension or debarment proceedings as authorized under 2 CFR part 180 and HHS awarding regulations at 2 CFR part 376;

• Withhold further awards for the project and program;

• Take other remedies that may be legally available.

7.10 Posting Clinical Trial Informed Consent Forms to Clinicaltrials.Gov

The Revised Common Rule sections 46.102(b) and 46.116(h) requires Contractors to post one IRB-approved version of an Informed Consent Form that has been used to enroll participants on a public federal website designated for posting such Consent Forms.

Contractors shall post the Informed Consent Form to the National Institutes of Health's (NIH's) clinical trials registry and results database ClinicalTrials.gov . Note: ClinicalTrials.gov only accepts Informed Consent Forms written in English; non-English language forms must be submitted to Regulations.gov . The Informed Consent Form must be posted after recruitment closes, and no later than 60 days after the final study visit. The Contracting Officer (CO) and/or Contracting Officer Representative (COR) may permit or require redactions as appropriate.

7.11 Certificate of Confidentiality

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

NIH considers research in which identifiable, sensitive information is collected or used, to include:

• Human subjects research as defined in the Federal Policy for the Protection of Human

Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

• Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

The Contractor shall not:

• Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

• Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

The Contractor is permitted to disclose only in below circumstances. The Contractor shall notify the CO minimum ten (10) calendar days prior to disclosure.

• Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and

Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;

• Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

• Made with the consent of the individual to whom the information, document, or biospecimen pertains; or

• Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

In accordance with 45 CFR Part 75.303(a), the Contractor shall maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal Statutes and regulations.

The recipient of CoCs shall ensure that any company/institution/individual not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate is subject to the requirements of subsection 301(d) of the Public Health Service Act. The Contractor shall ensure that Subcontractors who receive funds to carry out part of the Federal award are subject to subsection 301(d) of the Public Health Service Act and the NIH Policy for Issuing CoC.

7.13 Human Materials (Assurance of OHRP Compliance)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990- 0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required.

The human subject certification can be met by submission of a self-designated form, provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No.

09900263(formerly Optional Form 310).

7.14 Research Involving Recombinant or Synthetic Nucleic Acid (Including Human Gene Transfer Research)

All research projects (both NIH-funded and non-NIH-funded) involving recombinant or synthetic nucleic acid molecules that are conducted at or sponsored by an entity in the U.S. that receives any support for recombinant or synthetic nucleic acid research from NIH shall be conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules ( NIH Guidelines ) available at:

http://osp.od.nih.gov/biotechnology/nih-guidelines ). All NIH-funded projects abroad that include recombinant or synthetic nucleic acid molecules must also comply with the NIH Guidelines .

The NIH Guidelines stipulate biosafety and containment measures for recombinant or synthetic nucleic acid research, which is defined in the NIH Guidelines as research with

(1) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell, i.e. recombinant nucleic acids, or (2) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids, or (3) molecules that result from the replication of those described in (1) or (2). The NIH Guidelines apply to both basic and clinical research. Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines .

Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of the contract for any work related to recombinant or synthetic nucleic acid research or a requirement for the Contracting Officer to approve any or all recombinant or synthetic nucleic acid molecule projects under this contract. This includes the requirement for the institution to have an Institutional Biosafety Committee (IBC) registered with the NIH Office of Science Policy that complies with the requirements of the NIH Guidelines . Further information about compliance with the NIH Guidelines can be found on the NIH Office of Science Policy website available at: http://osp.od.nih.gov /.

7.15 Copyrights

With prior written permission of the Contracting Officer, the awardee may copyright material developed with HHS support. HHS receives a royalty-free license for the Federal Government and requires that each publication contain an appropriate acknowledgment and disclaimer statement.

7.17 Technical Data Rights

Rights in Data Developed Under SBIR Funding Agreement. The Act provides for “retention by an SBC of the rights to data generated by the concern in the performance of an SBIR award.”

(1) Each agency must refrain from disclosing SBIR technical data to outside the Government (except reviewers) and especially to competitors of the SBC, or from using the information to produce future technical procurement specifications that could harm the SBC that discovered and developed the innovation.

(2) SBIR agencies must protect from disclosure and non-governmental use all SBIR technical data developed from work performed under an SBIR funding agreement for a period of not less than four years from delivery of the last deliverable under that agreement (either Phase I, Phase II, or follow-on non-SBIR Federal funding agreement) unless, subject to paragraph (b) (3) of this section, the agency obtains permission to disclose such SBIR technical data from the awardee or SBIR applicant. Agencies are released from obligation to protect SBIR data upon expiration of the protection period except that any such data that is also protected and referenced under a subsequent SBIR award must remain protected through the protection period of that subsequent SBIR award. For example, if a follow-on non-SBIR Federal funding award is issued within or after the Phase II data rights protection period and the follow-on non-SBIR Federal funding award refers to and protects data developed and protected under the Phase II award, then that data must continue to be protected through the award protection period. Agencies have discretion to adopt a protection period longer than four years. The Government retains a royalty-free license for Government use of any technical data delivered under an SBIR award, whether patented or not. This section does not apply to program evaluation.

(3) SBIR technical data rights apply to all SBIR awards, including subcontracts to such awards, that fall within the statutory definition of Phase I or II of the SBIR Program, or follow-on non-SBIR Federal funding award, as described in section 4 of the SBIR Policy Directive. The scope and extent of the SBIR technical data rights applicable to follow-on non-SBIR Federal funding awards is identical to the SBIR data rights applicable to Phases I and II SBIR awards. The data rights protection period lapses only:

(i) Upon expiration of the protection period applicable to the SBIR award; or

(ii) By agreement between the awardee and the agency.

7.18 Patents and Invention Reporting

Small business firms normally may retain the principal worldwide patent rights to any invention developed with Government support. The Government receives a royalty-free license for its use, reserves the right to require the patent holder to license others in certain limited circumstances, and requires that anyone exclusively licensed to sell the invention in the United States must normally manufacture it domestically. To the extent authorized by 35 USC 205, the Government will not make public any information disclosing a Government-supported invention to allow the awardee to pursue a patent.

The reporting of inventions is accomplished by submitting information through the Edison Invention Reporting System for those Awarding Components participating in “Interagency Edison”, or iEdison. NIH and CDC require contractors to use iEdison, which streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected.

Inventions must be reported promptly—within two months of the inventor’s initial report to the contractor organization.

This should be done prior to any publication or presentation of the invention at an open meeting, since failure to report at the appropriate time is a violation of 35 U.S.C. 202 and may result in loss of the rights of the small business concern, inventor, and Federal Government in the invention. All foreign patent rights are immediately lost upon publication or other public disclosure unless a United States patent application is already on file. In addition, statutes preclude obtaining valid United States patent protection after one year from the date of a publication that discloses the invention.

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer.

Inquiries or information about invention reporting or requirements imposed by 37 CFR 401 may also be directed to:

Office of Policy for Extramural Research Administration, Division of Extramural Inventions and Technology Resources, National Institutes of Health (NIH) 6705 Rockledge Drive, MSC 7980 Bethesda, MD 20892-7980 Phone: (301) 451-4235 Fax: (301) 480-0272 E-mail: hammerslaa@mail.nih.gov

7.19 Salary Rate Limitation

None of the funds appropriated shall be used to pay the direct annual salary of an individual at a rate in excess of Executive Schedule, Level II of the Federal Executive Pay Scale. Effective January 2022, Executive Schedule, Level II of the Federal Executive Pay Scale is $203,700.

7.20 Other Contract Requirements

The outline that follows is illustrative of the types of generally-applicable clauses required by the Federal Acquisition Regulations that will be included in contracts resulting from this solicitation. This is not a complete list of clauses to be included, nor does it contain specific wording of these clauses. An award document reflecting all contract requirements applicable to your proposal will be made available prior to award.

a. Technical Progress Reporting. Contractors will be required to submit periodic technical progress reports throughout the period of performance, to be specified by the Awarding Component. On fixed-price contracts, payments may be tied to delivery and acceptance of these technical progress reports. For all contracts, final payment will not be made until all reports and deliverables included in the contract have been delivered and accepted by the Government.

If reports are required to be submitted in electronic format, they must be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

For NCI, the Contractor shall include the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

b. Inspection. Work performed under the contract is subject to Government inspection and evaluation at all reasonable times.

c. Audit and Examination of Records. The Contracting Officer and the Comptroller General, or a fully authorized representative of either, shall have the right to examine and audit all records and other evidence sufficient to reflect properly all costs claimed to have been incurred or anticipated to be incurred directly or indirectly in performance of this contract.

d. Basic Information Systems Security. The Contractor shall utilize defined security controls to provide at least a minimum level of protection for covered contractor information systems. See FAR clause 52.204-21 Basic Safeguarding of Covered Contractor Information Systems for applicability and specific requirements.

e. Default. The Government may terminate the contract if the contractor fails to perform the work contracted.

f. Termination for Convenience. The contract may be terminated at any time by the

Government if it deems termination to be in its best interest, in which case the contractor will be compensated for work performed and for reasonable termination costs.

g. Disputes. Any dispute concerning the contract which cannot be resolved by agreement shall be decided by the Contracting Officer with right of appeal.

h. Acknowledgement of Federal Funding. The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

i. Items Unallowable Unless Otherwise Provided. Unless authorized in writing by the

Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs: purchase or lease of any interest in real property;

special rearrangement or alteration of facilities; purchase or lease of any item of general purpose office furniture or equipment regardless of dollar value; travel to attend general scientific meetings; foreign travel; non-expendable personal property with an acquisition cost of $1,000 or more.

j. Continued Ban on Funding Abortion and Continued Ban on Funding of Human

Embryo Research. The Contractor shall not use contract funds for (1) any abortion;

(2) the creation of a human embryo or embryos for research purposes; or (3) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, Federal funds shall not be used for the cloning of human beings.

k. Use of Funds for Conferences, Meetings and Food. The Contractor shall not use contract funds (direct or indirect) to conduct meetings or conferences in performance of this contract without prior written Contracting Officer approval. In addition, the use of contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited.

l. Use of Funds for Promotional Items. The Contractor shall not use contract funds to purchase promotional items. Promotional items include, but are not limited to:

clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees, or conference attendees. This includes items or tokens given to individuals as these are considered personal gifts for which contract funds may not be expended.

m. Equal Opportunity. The contractor will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, or national origin.

n. Equal Opportunity for Veterans. The contractor will not discriminate against any employee or applicant for employment because he or she is a disabled veteran.

o. Equal Opportunity for Workers with Disabilities. The contractor will not discriminate against any employee or applicant for employment because he or she is physically or mentally handicapped.

p. Anti-Kickback Procedures. The contractor is prohibited from offering or accepting any money, gifts, things of value, etc. for the purpose of improperly obtaining or rewarding favorable treatment in connection with a federal contract or subcontract and shall have procedures in place to prevent and detect violations.

q. Covenant Against Contingent Fees. No person or agency has been employed to solicit or secure the contract upon an understanding for compensation except bona fide employees or commercial agencies maintained by the contractor for the purpose of securing business.

r. Gratuities. The contract may be terminated by the Government if any gratuities have been offered to any representative of the Government to secure the contract.

s. Patent Infringement. The contractor shall report each notice or claim of patent infringement based on the performance of the contract.

t. Employment Eligibility Verification. The contractor shall be enrolled as a Federal

Contractor in E-Verify and verify all employees assigned to the contract as well as all new employees hired by the contractor.

u. Needle Exchange. The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

v. Limitation on Use of Funds for Promotion of Legalization of Controlled

Substances. The Contractor shall not use contract funds to support activities that promote the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established under section 202 of the Controlled Substances Act, except for normal and recognized executive-congressional communications. This limitation shall not apply when the Government determines that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.

w. Dissemination of False or Deliberately Misleading Information. The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

x. Anti-Lobbying. Pursuant to the current appropriations act, except for normal and recognized executive legislative relationships, the contractor shall not use any contract funds for (i) publicity or propaganda purposes; (ii) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or (iii) payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

y. Gun Control. The contractor shall not use contract funds in whole or in part to advocate or promote gun control.

z. Restriction on Pornography on Computer Networks. The contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

aa. Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment. Contracts resulting from this solicitation will include FAR clause 52.204-25, attached and incorporated as Solicitation APPENDIX I.2.

ab. Subcontracts for Commercial Products and Commercial Services. Contracts resulting from this solicitation will include FAR clause 52.244-6 (Jan 2022), which can be referenced here.

ac. Service Contract Reporting Requirements. Contracts with an estimated total value of $500,000 or greater resulting from this solicitation will include FAR clause 52.204- 14, which can be referenced here.

7.21 Research Involving Vertebrate Animals

If it is intended that live vertebrate animals will be used during performance of this contract the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (authority derived from the Health Research Extension Act of 1985) specifies that certain information is required from offerors in contract proposals submitted to the NIH.

The following criteria must be addressed in a separate section titled "Vertebrate Animals Section” within the Detailed Approach and Methodology section of the technical proposal:

Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Request for Proposal (RFP) Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

A concise (no more than 1-2 pages), complete description addressing these criteria must be provided. The description must be cohesive and include sufficient information to allow evaluation by reviewers and NIH staff. For more discussion regarding the VAS, see http://grants.nih.gov/grants/olaw/vertebrate_animal_section.htm. For additional guidance see the Worksheet for Review of the Vertebrate Animal Section under Contract Proposals, http://grants.nih.gov/grants/olaw/VAScontracts.pdf.

The PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) requires that offeror organizations proposing to use vertebrate animals file a written Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW), establishing appropriate policies and procedures to ensure the humane care and use of live vertebrate animals involved in research activities supported by the PHS. The PHS Policy defines “animal” as “any live vertebrate animal used or intended for use in research, research training, experimentation or biological testing or for related purposes.”

In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution’s animal program, facilities, and procedures. No PHS award for research involving vertebrate animals will be made to an offeror organization unless that organization is operating in accordance with an approved Animal Welfare Assurance and provides verification that the IACUC has reviewed and approved the proposed activity in accordance with the PHS Policy. This information should be addressed in the Technical Proposal section on Vertebrate Animals.

Proposals may be referred by the PHS back to the IACUC for further review in the case of apparent or potential violations of the PHS Policy. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the PHS Policy. Foreign offeror organizations applying for PHS awards for activities involving vertebrate animals are required to comply with PHS Policy or provide evidence that acceptable standards for the humane care and use of animals will be met.

The PHS Policy stipulates that an offeror organization, whether domestic or foreign, bears responsibility for the humane care and use of animals in PHS-supported research activities. This policy implements and supplements the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training and requires that institutions use the Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing an institutional animal care and use program, see: http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of- Laboratory-Animals.pdf. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, unless a deviation is justified for scientific reasons in writing by the investigator, see:

https://www.avma.org/KB/Policies/Documents/euthanasia.pdf . This policy does not affect applicable state or local laws or regulations that impose more stringent standards for the care and use of laboratory animals. All institutions are required to comply, as applicable, with the Animal Welfare Act as amended (7 U.S.C. 2131 et sec.)

and other Federal statutes and regulations relating to animals. These documents are available from the Office of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892, (301) 496-7163, e-mail: olaw@mail.nih.gov.

For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892- 7982 (E-mail: olaw@od.nih.gov; Phone: 301–496–7163).

The PHS Policy is available on the OLAW website at: