Division of Other Transactions Management

Public Policy Requirements for Other Transaction (OT) Agreements managed by the OD Division of Other Transactions Management

NIH intends to uphold high ethical, health, and safety standards in both the conduct of the research it funds and the expenditure of public funds by its awardees. The public policy requirements specified in this section set many of those standards. The signature of the AOR on the application certifies that the organization complies, or intends to comply, with all applicable policies, certifications and assurances referenced (and, in some cases, included) in the application instructions. The policies, certifications and assurances listed may or may not be applicable to the project, program, or type of applicant organization. This list is not intended to be comprehensive and other laws may be determined to apply generally to all NIH OT awards, or specifically to a particular award depending on the terms of an individual OT award. Details of these public policy requirements may be found on the Common Fund OT NIH Policy & Compliance website at https://grants.nih.gov/policy/index.htm.

• Animal Welfare Requirements (P.L. 99-158, Sec. 495; PHS Policy on Humane Care and Use of Laboratory Animals and International Guiding Principles for Biomedical Research Involving Animals)

  The Awardee agrees to comply with the PHS Policy on Humane Care and Use of Laboratory Animals (https://www.nal.usda.gov/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3).

  The PHS Policy requires that the Awardee obtain an approved Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (OLAW) (https://olaw.nih.gov/home.htm) at the time of award for research or related activities using live vertebrate animals. The PHS Policy defines "animal" as any live, vertebrate animal used or intended for use in research, research training, experimentation, biological testing or related purposes. The Awardee must establish appropriate policies and procedures to ensure the humane care and use of animals, and bears ultimate responsibility for compliance with the PHS Policy in all PHS supported activities.

  The PHS Policy incorporates the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training, and requires the recipient to maintain an animal care and use program based on the Guide for the Care and Use of Laboratory Animals. An Institutional Animal Care and Use Committee (IACUC) (https://olaw.nih.gov/resources/tutorial/iacuc.htm) appointed by the Chief Executive Officer or designee, is federally mandated to oversee the institution's animal program, facilities, and procedures (Public Law 99-158, Sec. 495) (https://www.congress.gov/public-laws/).

  Applications from organizations proposing the use of animals are incomplete if they do not thoroughly address the use of vertebrate animals required in the Research Plan of the application. If the involvement of animals is indefinite at the time of application, the applicant should provide an explanation and indicate when it is anticipated that animals will be used. If an award is made, prior to conducting any animal activities the recipient must submit to the NIH awarding IC for prior approval the detailed information about the use of animals as required in the Research Plan of the application, and meet the Assurance and IACUC approval requirements of the PHS Policy.

  The NIH funds may not be used to procure or support the use of cats from USDA Class B dealers. The procurement of cats may only be from USDA Class A dealers or other approved legal sources.

  The NIH funds may not be used to procure or support the use of dogs from Class B dealers. Dogs used in NIH-supported research may only be from USDA Class A dealers or other approved legal sources.

  The NIH funds may not be used for activities with live vertebrate animals unless there is a valid Animal Welfare Assurance and IACUC approval of the activity.
  The PHS Policy does not supersede applicable State or local laws or regulations that impose more stringent standards for the care and use of animals in research. The Awardee agrees to comply, as applicable, with the regulations (9 CFR, Part 2, Subparts A and C) issued by the U.S. Department of Agriculture under the Animal Welfare Act, as amended, 7 U.S.C. 2131 et seq., and other Federal statutes and regulations relating to animals.

  1. Animal Welfare Assurance Requirements
     An Animal Welfare Assurance is the document submitted by an institution assuring institutional compliance with the PHS Policy. OLAW is responsible for requesting, negotiating, approving or disapproving, and, as necessary, restricting or withdrawing approval of Assurances.
     
     If the Awardee does not have an Animal Welfare Assurance, the Authorized Organization Representative's signature on the application constitutes declaration that the institution will submit an Assurance when requested by OLAW. Upon such request, the Awardee shall prepare the Assurance as instructed by OLAW and in accordance with the PHS Policy, and the authorized IACUC shall review those components of the application related to the care and use of animals. The OD/NIH funds may not be used for activities with live vertebrate animals in the absence of a valid Assurance on file with OLAW (https://olaw.nih.gov/home.htm).
     
     If the Awardee does not have an Assurance and the animal activities will be conducted at an Assured institution named as a performance site, the Awardee must obtain an Inter-institutional Assurance from OLAW. Under the Inter-institutional Assurance, the recipient and performance site agree that the research will be conducted under the auspices and program of animal care and use of the performance site's Assurance.
  2. Verification of IACUC Approval
     The OD/NIH funds may not be used for activities involving live vertebrate animals until the Awardee and all performance sites are operating in accordance with approved Animal Welfare Assurances and the Awardee has provided the AO with verification of IACUC approval of those sections of the application that involve use of vertebrate animals. IACUC approval must have been granted within three (3) years of the budget period start date to be valid; however, IACUCs may determine that continuing review on a more frequent basis is appropriate. The Awardee is responsible for ensuring that the research conducted is congruent with any corresponding protocols approved by the IACUC (https://olaw.nih.gov/resources/tutorial/iacuc.htm).
  3. Consortiums
     The Awardee is responsible for including the PHS Policy requirements in its agreements with collaborating organizations, and for ensuring that all sites engaged in research involving the use of live vertebrate animals have an approved Animal Welfare Assurance and that the activity has valid IACUC approval. The approval of more than one IACUC is not required if the Awardee and performance site(s) have Assurances; the institutions may exercise discretion in determining which IACUC reviews research protocols and under which institutional program the research will be conducted.
  4. Foreign Recipients and Foreign Performance Sites
     Foreign Awardees must provide OLAW with an Animal Welfare Assurance for Foreign Institutions. This constitutes institutional assurance and certification of compliance with the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and a commitment to follow the International Guiding Principles for Biomedical Research Involving Animals. IACUC approval is not required of foreign Awardees; however, OLAW encourages foreign Awardees to use the standards in the Guide for the Care and Use of Laboratory Animals (https://olaw.nih.gov/resources/documents/foreign.htm).
     
     When the Awardee is a domestic institution and performance sites are foreign (i.e., domestic Awardee with a foreign component), PHS Policy requirements are applicable. Accordingly, the Awardee remains responsible for animal activities conducted at the foreign site and must provide verification of IACUC approval (i.e., certification that the activities as conducted at the foreign performance site are acceptable to the Awardee). The Awardee IACUC may accept, as its own, the approval of a foreign organization's IACUC; however, the Awardee IACUC remains responsible for the review. Additionally, the foreign site must obtain an Animal Welfare Assurance for Foreign Institutions as described in the preceding paragraph.
  5. Reporting to OLAW
     Reporting requirements under the PHS Policy include an annual report to OLAW describing any change in the institution's program for animal care and use as described in the Assurance, changes in IACUC membership, and the dates the IACUC conducted its semiannual evaluations of the institution's program and facilities. The IACUC, through the institutional official signing the Assurance, must promptly report any serious or continuing noncompliance with the PHS Policy, serious deviations from the Guide for the Care and Use of Laboratory Animals, and any IACUC suspensions.
     
     Instances of serious noncompliance with section IV.F.3. of the PHS Policy, such as those mentioned above, are to be reported to OLAW and the AO and PO. In cases where charges have been made for unauthorized animal activities, appropriate adjustments must be made to remove those charges.
     
     The Awardee agrees to continue to maintain and care for animals during periods when animal activities are conducted in the absence of a valid Animal Welfare Assurance and/or IACUC approval. The OD/NIH funds may be used for maintenance and care of animals on a case-by-case basis. Consultation with the AO and PO is encouraged regarding questions concerning this issue.

• Civil Rights Act of 1964

  This Agreement is subject to the compliance requirements of Title VI of the Civil Rights Act of 1964 as amended (42 U.S.C. § 2000d) relating to nondiscrimination in Federally assisted programs. The Awardee will timely provide an Assurance of Compliance with the nondiscriminatory provisions of the Act (https://www.hhs.gov/civil-rights/index.html).

• ClinicalTrials.gov Requirement (42 U.S.C. 282j; 42 CFR Part 11, Section 801 also known as FDAAA 801; NIH Policy on Dissemination of NIH-Funded Clinical Trial Information)

  The Awardee shall ensure that any clinical trial funded under this Agreement is registered at, and that summary results information is submitted to, ClinicalTrials.gov for public posting (https://clinicaltrials.gov/). The Awardee should familiarize itself with the requirements regarding ClinicalTrials.gov, including the authorizing statute, as amended (42 U.S.C. 282(j), also known as Sec. 801 of Public Law 110-85 (the FDA Amendments Act of 2007 or FDAAA)), the implementing regulations (42 CFR Part 11), and the NIH Policy on the Dissemination of the NIH-Funded Clinical Trial Information. In particular, the Awardee should be aware that if an applicable clinical trial is funded in whole or in part pursuant to this Agreement, any progress report shall include a certification that the Responsible Party has made all required submissions to ClinicalTrials.gov. Additionally, in general, results of applicable clinical trials are due not later than 12 months after the primary completion date. If this date occurs after the completion or termination of this Agreement, results reporting is still required in accordance with FDAAA and 42 CFR Part 11 (https://www.ecfr.gov/cgi-bin/text-idx?SID=e617ec4da22678f934787ed565bbaa5a&mc=true&node=pt42.1.11&rgn=div5).

• Debarment and Suspension (2 CFR 376 and 2 CFR 180)

  The awardee certifies that no individuals or entities on this Award are debarred or suspended from receiving Federal funds (https://www.gsa.gov/about-us/organization/office-of-governmentwide-policy/office-of-acquisition-policy/gsa-acq-policy-integrity-workforce/suspension-debarment-division/suspension-debarment/frequently-asked-questions-suspension-debarment and https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.6_debarment_and_suspension.htm).

  HHS regulations published in 2 CFR 376 implement the government-wide debarment and suspension system guidance (2 CFR 180) for HHS’ non-procurement programs and activities. “Non-procurement transactions” include, among other things, grants, cooperative agreements, scholarships, fellowships and loans. NIH implements the HHS Debarment and Suspension regulations as a term and condition of award. Accordingly, recipients of NIH other transaction awards are required to determine whether it or any of its principals (as defined in 2 CFR 180.995 and 2 CFR 376.995) is excluded or disqualified from participating in a covered transaction prior to entering into the covered transaction, i.e., prior to the drawdown of funds which signal acceptance of the other transaction award. Recipients may decide the method and frequency by which this determination is made and may check excluded parties in SAM.

• Dissemination of False or Deliberately Misleading Information (pursuant to P.L. 115-245, Section 515(b))

  None of the funds made available in the governing appropriations Act may be used to disseminate information that is deliberately false or misleading.

• Federal Information Security Management Act (44 U.S.C. 3541)

  The Awardee’s information systems, electronic or hard copy, which contain Federal data need to be protected from unauthorized access consistent with the Federal Information Security Management Act (FISMA) (https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.9_federal_information_security_management_act.htm).

• Financial Conflict of Interest (42 CFR 50, Subpart F)

  NIH requires recipients of Common Fund other transaction awards and their investigators to comply with requirements consistent with 42 CFR 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.” A Final Rule amending the 1995 PHS regulation (and the companion regulation at 45 CFR 94, “Responsible Prospective Contractors,” imposing similar requirements for research contracts) was published on August 25, 2011 in the Federal Register (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf).

  When submitting an other transaction application, the signature of the AOR certifies the applicant Institution’s compliance with requirements consistent with 42 CFR 50, Subpart F, including that:

  1. There is in effect at the Institution an up-to-date, written and enforced administrative process to identify and manage Financial Conflicts of Interest (FCOI) with respect to all research projects for which NIH funding is sought or received;
  2. The Institution shall promote and enforce Investigator compliance with the regulation’s requirements including those pertaining to disclosure of Significant Financial Interests;
  3. The Institution shall identify and manage FCOIs and provide initial and ongoing FCOI reports to the NIH consistent with this subpart;
  4. When requested, the Institution will promptly make information available to the NIH/HHS relating to any Investigator disclosure of financial interests and the Institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of an FCOI;
  5. The Institution shall fully comply with the requirements of the regulation.

  When the Institution determines that an FCOI exists (see #3 above), the Institution must report to the NIH awarding IC through the submission of an initial and annual FCOI report using the eRA Commons FCOI Module. The initial FCOI report will include the following information:

  • Other transaction award number and PD/PI;
  • Name of Investigator (if different from the PD/PI) with the FCOI;
  • Name of the entity with which the Investigator has an FCOI;
  • Nature of the FCOI (e.g., consulting fees, honoraria, paid authorship, equity interest, intellectual property rights and interests);
  • Value of the financial interest $0-4,999; $5,000-9,999; $10,000-19,999; amounts between $20,000-100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000 or a statement that a value cannot be readily determined;
  • A description how the financial interest relates to the NIH-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research; and
  • Key elements of the Institution’s management plan, including:
    1. Role and principal duties of the conflicted Investigator in the research project;
    2. Conditions of the management plan;
    3. How the management plan is designed to safeguard objectivity in the research project;
    4. Confirmation of the Investigator’s agreement to the management plan;
    5. How the management plan will be monitored to ensure Investigator compliance; and
    6. Other information as needed.

• Fly American Act (49 U.S.C. 40118 and http://www.gsa.gov/portal/content/103191);

  The Fly America Act (49 U.S.C. 40118) generally provides that foreign air travel funded by Federal government money may only be conducted on U.S. flag air carriers. A “U.S. flag air carrier” is an air carrier that holds a certificate under 49 U.S.C. 41102 but does not include a foreign air carrier operating under a permit. There are limited circumstances under which use of a foreign-flag air carrier is permissible. These circumstances are outlined below:

  1. Airline "Open Skies" Agreement. A foreign flag air carrier may be used if the transportation is provided under an air transportation agreement between the United States and a foreign government, which the Department of Transportation has determined meets the requirements of the Fly America Act. For example, in 2008, the U.S. entered into an "Open Skies" Agreement with the European Union (EU). This Agreement gives European Community airlines (airlines of Member States) the right to transport passengers and cargo on flights funded by the U.S. government, when the transportation is between a point in the United States and any point in a Member State or between any two points outside the United States.
     
     The U.S.-EU Open Skies Agreement was amended effective June 24, 2010. GSA issued Guidance October 6, 2010. Pursuant to the amendment, federal contractors and recipients (not U.S. Government employees) need not be concerned about city-pair contract fares. However, contractors and recipients must check with the airline to ensure that the airline is covered by the U.S.-EU Open Skies agreement which may change periodically.
     
     Additionally, pursuant to the amendment, EU airlines are no longer limited to flying passengers between points in the United States and points in the EU. Instead, EU airlines are authorized to transport passengers between points in the United States and points outside the EU if the EU airline is authorized to serve the route under the U.S.-EU Open Skies Agreement. This includes flights that originate, arrive, or stop in the European Union. For additional information, please see the text of the Amendment and GSA Bulletin FTR 11-02. For information on other "open skies" agreements in which the United States has entered, refer to GSA's Web site: http://www.gsa.gov/portal/content/103191.
  2. Involuntary Rerouting. Travel on a foreign-flag carrier is permitted if a U.S.-flag air carrier involuntarily reroutes the traveler via a foreign-flag air carrier, notwithstanding the availability of alternative U.S.-flag air carrier service.
  3. Travel To and From the U.S. Use of a foreign-flag air carrier is permissible if the airport abroad is: (a) the traveler's origin or destination airport, and use of U.S.-flag air carrier service would extend the time in a travel status by at least 24 hours more than travel by a foreign-flag air carrier; or (b) an interchange point, and use of U.S.-flag air carrier service would increase the number of aircraft changes the traveler must make outside of the U.S. by two or more, would require the traveler to wait four hours or more to make connections at that point, or would extend the time in a travel status by at least six hours more than travel by a foreign-flag air carrier.
  4. Travel Between Points Outside the U.S. Use of a foreign-flag air carrier is permissible if: (a) travel by a foreign-flag air carrier would eliminate two or more aircraft changes en route; (b) travel by a U.S.-flag air carrier would require a connecting time of four hours or more at an overseas interchange point; or (c) the travel is not part of the trip to or from the U.S., and use of a U.S.- flag air carrier would extend the time in a travel status by at least six hours more than travel by a foreign-flag air carrier.
  5. Short Distance Travel. For all short distance travel, regardless of origin and destination, use of a foreign-flag air carrier is permissible if the elapsed travel time on a scheduled flight from origin to destination airport by a foreign-flag air carrier is three hours or less and service by a U.S.-flag air carrier would double the travel time.

• Gun Control (pursuant to P.L. 115-245, Section 210);

  The Consolidated and Further Continuing Appropriations Act, 2020, provides that NIH funds may not be used, in whole or in part, to advocate or promote gun control (see https://www.congress.gov/bill/116th-congress/house-bill/1865/text).

• Harassment and Discrimination Protections

  The awardee certifies the commitment to:

  • (i) Ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices;
  • (ii) Responding appropriately to allegations of discriminatory practices; and
  • (iii) Adopting and following institutional procedure for requesting NIH prior approval of a change in the status of the Program Director/Principal Investigator (PD/PI) or other senior/key personnel if administrative or disciplinary action is taken that impacts the ability of the PD/PI or other key personnel to continue his/her role on the NIH award (https://www.nih.gov/anti-sexual-harassment/nih-awardee-organizations-those-who-work-there).

• Human Embryo Research and Cloning Ban (pursuant to P.L. 115-245, Section 508)

  NIH funds may not be used to support human embryo research. NIH funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or (2) for 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 subsection 498(b) of the PHS Act (42 U.S.C. 289g(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 enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

  In addition to the statutory restrictions on human fetal research under subsection 498(b) of the PHS Act, by Presidential memorandum of March 4, 1997, NIH is prohibited from using Federal funds for cloning of human beings.

• Human Fetal Tissue Research (Sections 498A and 498B of the PHS Act, 42 U.S.C. 298g-1 and 298g-2);

  Human fetal tissue is defined as tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion or stillbirth. This definition does not include established human fetal cell lines. Research involving the transplantation of human fetal tissue must be conducted in accordance with applicable Federal, State and local laws as well as the following NIH guidance. Guidance for recipients conducting research on human fetal tissue and other information on the governing Federal statute is found in Sections 498A and 498B of the PHS Act, 42 U.S.C. 298g-2. The scientific and ethical challenges associated with research utilizing human fetal tissue make it imperative that researchers and their organizations be fully aware of and in compliance with the Federal requirements, particularly Section 498B. When an application involving human fetal tissue research is submitted to NIH, the AOR’s signature certifies that researchers using these tissues are in compliance with Section 498B of the PHS Act. The statute specifically prohibits any person from knowingly acquiring, receiving, or transferring any human fetal tissue for valuable consideration. The term “valuable consideration” is a concept similar to profit and does not include reasonable payment for costs associated with the collection, processing, preservation, storage, quality control, or transportation of these tissues. Violation of this statute carries criminal penalties that apply to both those that supply and those that acquire human fetal tissue.

• Human Subjects Protection (45 CFR 46)

  The Awardee must obtain Federal Wide Assurance (FWA) from the DHHS Office for Human Research Protections (OHRP) (https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html), and comply with 45 CFR 46 (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html), and, as applicable, any relevant FDA regulations (e.g., 21 CFR 11, 50, 54, 56, 312, and 812) (https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs) governing the protection of human subjects and the conduct, management, and oversight of clinical trials. The Awardee shall provide to the AO evidence of an active FWA prior to the commencement of any human subject research activities contemplated under this Agreement. Further, Awardee must comply with all applicable laws and regulations relating to the privacy and confidentiality of human subjects.

• Human Stem Cell Research (pursuant to Executive Order 13505 and NIH Guidelines on Human Stem Cell Research)

  Under Executive Order 13505 NIH may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law. NIH Guidelines on Human Stem Cell Research, effective July 7, 2009, implement the Executive Order. The Guidelines apply to the expenditure of NIH funds for research using hESCs and certain uses of induced pluripotent stem cells.

  For the purpose of the NIH Guidelines, "human embryonic stem cells (hESCs)" are cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Although hESCs are derived from embryos, such stem cells are not themselves human embryos. Induced pluripotent stem cells are human cells that are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.

  NIH recipients may use hESCs that have been approved by NIH in accord with the NIH Guidelines and are posted on the NIH Human Embryonic Stem Cell Registry, or may establish eligibility of specific cell lines for NIH funding by submitting a Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research (NIH Form 2890). Prior to the use of NIH funds, applicants and recipients must provide assurances, when endorsing applications and progress reports submitted to NIH for projects using hESCs, that the hESCs to be used are listed on the NIH Registry and will be used in accordance with any restrictions associated with the line as cited on the Registry. If a specific line from the NIH Registry cannot be identified at the time of submission, the applicant/recipient must provide a strong justification why one cannot be identified at that time and a certification that one from the NIH Registry will be used.

• Indirect Costs for Other Transaction Agreements and Cloud Computing

  Indirect costs for cloud computing expenses in any Office of Strategic Coordination (OSC) application funded under an Other Transaction (OT) mechanism will be capped at a rate of ten (10) percent or may be subject to change based on the Terms and Conditions of the award.

• Lobbying Prohibition (pursuant to P.L. 115-245, Section 503 and https://grants.nih.gov/policy/lobbying_guidance.htm);

  • (a) No part of any appropriation contained in the Consolidated and Further Continuing Appropriations Act, 2015, or transferred pursuant to Section 4002 of Public Law 111–148 shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any State or local legislature itself, or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any State or local government, except in presentation to the executive branch of any State or local government itself.
  • (b) No part of any appropriation contained in this Act or transferred pursuant to Section 4002 of Public Law 111–148 shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any State government, State legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a State, local or tribal government in policymaking and administrative processes within the executive branch of that government.
  • (c) The prohibitions in subsections (a) and (b) shall include any activity to advocate or promote any proposed, pending or future Federal, State or local tax increase, or any proposed, pending, or future requirement or restriction on any legal consumer product, including its sale or marketing, including but not limited to the advocacy or promotion of gun control.

• Metric System (EO 12770, July 25, 1991);

  Consistent with EO 12770 (July 25, 1991), Metric Usage in Federal Government Programs, measurement values in applications and recipient-prepared reports, publications, and other transaction award-related documents should be in metric.

• National Environmental Policy Act (1969);

  All NIH other transaction awards, whether or not they include construction or major A&R activities, are subject to the requirements of the National Environmental Policy Act (NEPA) of 1969, as amended. This Act requires Federal agencies to consider the reasonably foreseeable environmental consequences of all other transaction-supported activities. As part of NIH’s implementation of this Act, recipients are required to promptly notify NIH of any reasonably foreseeable impacts on the environment from other transaction-supported activities, or certify that no such impacts will arise upon receipt of an other transaction award. In addition, NIH has determined that most NIH other transaction awards are not expected to individually or cumulatively have a significant effect on the environment unless any part of the proposed research and/or project includes one or more of the following categorical exclusions listed below:

  1. The potential environmental impacts of the proposed research may be of greater scope or size than other actions included within a category.
  2. The proposed research threatens to violate a Federal, State, or local law established for the protection of the environment or for public health and safety.
  3. Potential effects of the proposed research are unique or highly uncertain.
  4. Use of especially hazardous substances or processes is proposed for which adequate and accepted controls and safeguards are unknown or not available.
  5. The proposed research may overload existing waste treatment plants due to new loads (volume, chemicals, toxicity, additional hazardous wasted, etc.)
  6. The proposed research may have a possible impact on endangered or threatened species.
  7. The proposed research may introduce new sources of hazardous/toxic wastes or require storage of wastes pending new technology for safe disposal.
  8. The proposed research may introduce new sources of radiation or radioactive materials.
  9. Substantial and reasonable controversy exists about the environmental effects of the pro-posed research.

• Pro Children Act of 1994 (P.L. 103-227, Title X, Part C);

  Public Law 103-227, Title X, Part C, Environmental Tobacco Smoke, also known as the Pro-Children Act of 1994, imposes restrictions on smoking in facilities where federally funded children’s services are provided. NIH other transaction awards are subject to these requirements only if they meet the Act’s specified coverage. The Act specifies that smoking is prohibited in any indoor facility (owned, leased, or contracted for) used for the routine or regular provision of kindergarten, elementary, or secondary education or library services to children under the age of 18. In addition, smoking is prohibited in any indoor facility or portion of a facility (owned, leased, or contracted for) used for the routine or regular provision of federally funded health care, day care, or early childhood development (Head Start) services to children under the age of 18. The statutory prohibition also applies if such facilities are constructed, operated, or maintained with Federal funds. The statute does not apply to children’s services provided in private residences, facilities funded solely by Medicare or Medicaid funds, portions of facilities used for inpatient drug or alcohol treatment, or facilities where Women, Infants and Children (WIC) coupons are redeemed. Failure to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up to $1,000 per violation and/or the imposition of an administrative compliance order on the responsible entity. Because of the nature of NIH programs and funding, individual transactions, rather than entire programs, may be subject to these requirements. The signature of the AOR will indicate the intent to comply. Any questions concerning the applicability of these provisions to an NIH other transaction award should be directed to the AO.

• Prohibition on Promotion or Legalization of Controlled Substances (pursuant to P.L. 115-245,19 Section 509)

  Awardees are prohibited from knowingly using appropriated 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 by Section 2020 of the Controlled Substances Act, 21 U.S.C. 812 except for normal and recognized executive-congressional communications. This limitation does not apply if the awardee notifies the AO 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.

• Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines. November 2013 or latest revision and 42 CFR 73),

  The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) (November 2013 or latest revision) apply to all research projects (NIH-funded and non-NIHfunded) that involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by an organization that receives NIH support for recombinant or synthetic nucleic acid molecule research. A copy of the NIH Guidelines is available at http://osp.od.nih.gov/office-biotechnologyactivities/biosafety/nih-guidelines.

  According to the NIH Guidelines, recombinant and synthetic nucleic acid molecules are defined as (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 studies. Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines.

  Failure to comply with these requirements may result in suspension or termination of an award for recombinant or synthetic nucleic acid molecule research at the organization, or a requirement for NIH prior approval of any or all recombinant or synthetic nucleic acid molecule projects at the organization. Two specific requirements of the NIH Guidelines are discussed below, but the recipient should carefully review the NIH Guidelines in their entirety to ensure compliance with all of the requirements for projects involving recombinant or synthetic nucleic acid molecules.

  Recombinant or synthetic nucleic acid research involving select agents also is subject to pertinent CDC and USDA regulations, 42 CFR 73, Select Agents and Toxins; and 7 CFR 331 and 9 CFR 121, Possession, Use, and Transfer of Biological Agents and Toxins.

• Research Misconduct (Title 42 CFR 93, Subpart C);

  Title 42 CFR 93, PHS Policies on Research Misconduct, Subpart C, “Responsibilities of Institutions” specifies recipient responsibilities to have written policies and procedures for addressing allegations of research misconduct, to file an Assurance of Compliance with the HHS Office of Research Integrity, and take all reasonable and practical steps to foster research integrity. Research misconduct is defined as the fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. The HHS Office of Research Integrity (ORI) has responsibility for addressing research integrity and misconduct, monitors institutional investigations of research misconduct and facilities the responsible conduct of research through education, preventive and regulatory activities (http://www.ori.dhhs.gov)

• Restriction of Abortion Funding (pursuant to P.L. 115-245, Section 506);

  NIH appropriated funds and funds in any trust fund to which funds are appropriated in the governing appropriation Act may not be spent for any abortion. None of the funds appropriated in the governing appropriation Act, and none of the funds in any trust fund to which funds are appropriated in this Act, shall be expended for health benefits coverage that includes coverage of abortion. The term ‘‘health benefits coverage’’ means the package of services covered by a managed care provider or organization pursuant to a contract or other arrangement.

• Exceptions to Restrictions on Abortions (pursuant to P.L. 115-245, Section 507)

  • (a) The limitations established in the preceding section shall not apply to an abortion— (1) if the pregnancy is the result of an act of rape or incest; or (2) in the case where a woman suffers from a physical disorder, physical injury, or physical illness, including a life endangering physical condition caused by or arising from the pregnancy itself, that would, as certified by a physician, place the woman in danger of death unless an abortion is performed.
  • (b) Nothing in the preceding section shall be construed as prohibiting the expenditure by a State, locality, entity, or private person of State, local, or private funds (other than a State’s or locality’s contribution of Medicaid matching funds).
  • (c) Nothing in the preceding section shall be construed as restricting the ability of any managed care provider from offering abortion coverage or the ability of a State or locality to contract separately with such a provider for such coverage with State funds (other than a State’s or locality’s contribution of Medicaid matching funds).
  • (d) (1) None of the funds appropriated to NIH may be made available to a Federal agency or program, or to a State or local government, if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions. (2) In this subsection, the term ‘‘health care entity’’ includes an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.

• Restriction on Distribution of Sterile Needles (pursuant to P.L. 115-245, Section 529)

  NIH appropriated funds may not be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drugs (see https://www.congress.gov/bill/116th-congress/house-bill/1865/text).

• Restriction of Pornography on Computer Networks (pursuant to P.L. 115-245, Section 520)

  The Further Consolidated Appropriations Act, 2020 (PL 116-94) includes the following restrictions (see https://www.congress.gov/bill/116th-congress/house-bill/1865/text):

  • (a) None of the funds made available in this Act may be used to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.
  • (b) Nothing in subsection (a) shall limit the use of funds necessary for any Federal, State, tribal, or local law enforcement agency or any other entity carrying out criminal investigations, prosecution, or adjudication activities

• Salary Cap/Salary Limitation (pursuant to P.L. 115-245, Section 202);

  The awardee certifies that each individual on the award may not exceed the NIH Salary Cap (https://grants.nih.gov/grants/policy/salcap_summary.htm).

• Select Agents and Toxins (42 CFR 73, Sections 3 and 4; 9 CFR 121; 7 CFR 331, Section 3);

  Domestic recipients who conduct research involving select agents or toxins (see Section 3 and 4 of 42 CFR 73 and 9 CFR 121 and Section 3 of 7 CFR 331) must maintain a registration with CDC (or USDA, depending on the agent) before using NIH funds. No funds can be used for research involving select agents or toxins if the registration certificate maintained by CDC or USDA is suspended or revoked.

• USA Patriot Act (P.L. 107-56);

  The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act) (P.L. 107-56) amends 18 U.S.C. Chapter 10 and provides criminal penalties for possession of any biological agent, toxin, or delivery system of a type or in a quantity that is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. The Act also establishes restrictions on access to specified materials. “Restricted persons,” as defined by the Act, may not possess, ship, transport, or receive any biological agent or toxin that is listed as a select agent.