9. Report on Select Agents or Toxins and/or Highly Pathogenic Agents
   
   For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be included in each [annual, semi-annual, quarterly, or monthly] Progress Report:
   1. Any changes in the use of the select agent or toxin including initiation of "restricted experiments" and/or a highly pathogenic agent that have resulted in a change in the required biocontainment level and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.
   2. If work with a new or additional select agent or toxin and/or a highly pathogenic agent will be conducted in the upcoming reporting period, provide:
      • A list of each new or additional select agent or toxin and/or a highly pathogenic agent that will be studied;
      • A brief description of the work that will be done with each new or additional select agent or toxin and/or a highly pathogenic agent and whether or not the work is a select agent or toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b or listed on the U.S. National Select Agents Registry Restricted Experiments website,
      • The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.
      • For work with select agents performed in the U.S. provide documentation of registration status of all domestic organizations where select agents will be used. For work with select agents performed in a non-U.S. country, prior NIAID approval is required.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each annual, semi-annual, quarterly, or monthly progress report.

If no work involving a select agent or toxin and/or a highly pathogenic agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each [annual, semi-annual, quarterly, or monthly] progress report.

ARTICLE H.__. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

The work being conducted under this contract may involve the possession, use, or transfer of a select agent or toxin. The contractor shall not conduct work involving a select agent or toxin under this contract until it and any associated subcontractor(s) comply with the following:

Domestic institutions. For prime or subcontract awards to domestic institutions that possess, use, and/or transfer a select agent or toxin under this contract, the institution must comply with the provisions of National Select Agent Registry 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 as required, before using NIH funds for work involving a select agent or toxin. No NIH funds can be used for research involving a select agent or toxin at a domestic institution without a valid registration certificate.

Foreign institutions. For prime or subcontract awards to foreign institutions that possess, use, and/or transfer a select agent or toxin, before using NIH funds for any work directly involving a select agent or toxin, the foreign institution must provide information satisfactory to NIAID that safety, security, and training standards equivalent to those described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 are in place and will be administered on behalf of all select agent or toxin work supported by these funds.

The process for making this determination includes a site visit to the foreign laboratory facility by an NIAID representative. During this visit, the foreign institution must provide the following information:

• Concise summaries of safety, security, and training plans.
• Names of individuals at the foreign institution who will have access to the select agent or toxin and procedures for ensuring that only approved and appropriate individuals, in accordance with institution procedures, will have access to the select agent or toxin under the contract.
• Copies of or links to any applicable laws, regulations, policies, and procedures applicable to that institution for the safe and secure possession, use, and/or transfer of select agents.
• Site visits to foreign laboratories are conducted every three years after the initial review. 
• No NIH funds can be used for work involving a select agent or toxin at a foreign institution without written approval from the contracting officer.

Prior to conducting a restricted experiment with a select agent or toxin under this contract or any associated subcontract, the contractor must discuss the experiment with the contracting officer's representative (COR) and request and obtain written approval from the contracting officer. 

Domestic institutions must submit to the contracting officer written approval from the CDC to perform the proposed restricted experiment. 

Foreign institutions require review by a NIAID representative.  The prime contractor must contact the COR and the NIAID Office of Research Training and Special Programs at niaidforeignawards@niaid.nih.gov for guidance on the process used by NIAID to review proposed restricted experiments.  The NIAID Web site provides an overview of the review process at Review and Approval for Contracts That Include Foreign Institutions. The contracting officer will notify the prime contractor when the process is complete.  No NIH funds can be used for a restricted experiment with a select agent or toxin at either a domestic or foreign institution without written approval from the contracting officer.

Listings of HHS and USDA select agents and toxins, and overlap select agents or toxins as well as information about the registration process for domestic institutions, are available on the Select Agent Program Web site and Select Agents and Toxins List.

For foreign institutions, see the NIAID Biodefense and Select Agents portal.

ARTICLE H.__. HIGHLY PATHOGENIC AGENTS

The work being conducted under this contract may involve a highly pathogenic agent (HPA). The NIAID defines an HPA as a pathogen that, under any circumstances, warrants a biocontainment safety level of BSL3 or higher according to either:

• The current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL);
• The Contractor's Institutional Biosafety Committee (IBC) or equivalent body; or
• The Contractor's appropriate designated institutional biosafety official.

If there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an IBC or equivalent body, or institutional biosafety official, the highest recommended containment level must be used.

7. Possession, Use and Transfer of Select Biological Agents or Toxins

 Notice to Offerors of Requirements of National Select Agent Registry—October 16, 2008: 42 CFR Part 73, Possession , Use, and Transfer of Select Agents and Toxins (relating to public health and safety): 7 CFR Part 331, Possession, Use, and Transfer of Select Agents and Toxins (relating to plant health or plant products) (and, 9 CFR Part 121, Possession, Use, and Transfer of Select Agents and Toxins (relating to human and animal health, animal health or animal products)

These regulations implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and the Agricultural Bioterrorism Protection Act of 2002. They are designed to improve the ability of the United States government to prevent, prepare for, and respond to bioterrorism and other public health emergencies. These regulations establish requirements regarding registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications.

Listings of HHS and USDA select agents and toxins, and overlap select agents or toxins as well as information about the registration process for domestic institutions, are available on the Select Agent Program Web site.

For foreign institutions, see the NIAID Biodefense and Select Agents portal.

If the proposed contract will not involve the possession, use or transfer select agent or toxin, the offeror must include a statement in its technical proposal that the work does not now nor will it in the future (i.e. throughout the life of the award) involve the possession, use or transfer select agents or toxins.

Domestic Institutions

For prime or subcontract awards to domestic institutions that possess, use, and/or transfer select agents under this contract, the domestic institution must:

• Include details about the select agent in their technical proposal, including the quantity proposed to be used during contract performance.
• Describe the proposed use of the select agent or toxin, including any restricted experiments.
• Comply with 42 CFR part 73, 7 CFR part 331 and/or 9 CFR part 121 at National Select Agent Registry, as required, before using NIH funds for research involving select agents.  No NIH funds can be used for research involving select agents if the final registration certificate is denied. 

Foreign Institutions

For prime or subcontract awards to foreign institutions that possess, use, and/or transfer select agents under this contract, the foreign institution must:

• Include details about the select agent in their technical proposal, including the quantity proposed to be used during contract performance.
• Describe the proposed use of the select agent or toxin, including any restricted experiments.
• When requested during negotiations, provide information satisfactory to the NIAID/NIH that safety, security, and training standards equivalent to those described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 at National Select Agent Registry for U.S. institutions are in place and will be administered on behalf of all select agent work under the resulting contract.
• The process for making this determination includes a site visit to the foreign laboratory facility by an NIAID representative. During this visit, the foreign institution must provide the following information:
  • Concise summaries of safety, security, and training plans.
  • Names of individuals at the foreign institution who will have access to the select agents and procedures for ensuring that only approved and appropriate individuals, in accordance with institution procedures, will have access to the select agents under the contract.
  • Copies of or links to any applicable laws, regulations, policies, and procedures applicable to that institution for the safe and secure possession, use, and/or transfer of select agents.
  • Laboratory site visits are conducted every three years for the life of the contract.

An NIAID chaired committee of U.S. federal employees (including representatives of NIH grants/contracts and scientific program management, CDC, Department of Justice and other federal intelligence agencies, and Department of State) will ultimately assess the results of the site visit, the regulations, policies, and procedures of the foreign institution for equivalence to the U.S. requirements described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 at National Select Agent Registry.

The committee will provide recommendations to the DEA Director, NIAID. The DEA Director will make the approval decision and notify the contracting officer, who will inform the prime contractor of the approval status of the foreign institution.

No NIH funds can be used for research involving a select agent or toxin at a foreign institution until NIAID grants this approval.