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4. 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/Monthly] Progress Report:
   • Any changes in the use of the Select Agent or Toxin 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.
   • 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 description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent ;
     • The title 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.

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/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/Monthly] Progress Report.

ARTICLE H.48. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS
The contractor shall not conduct work involving select agents or toxins under this contract until it and any associated subcontractor(s) comply with the following:

For prime or subcontract awards to domestic institutions that possess, use, and/or transfer Select Agents under this contract, the institution must comply with the provisions of 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 ( http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf ) 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.

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 the 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 inspection of the foreign laboratory facility by an NIAID representative. During this inspection, 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; and 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. 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.

Listings of HHS 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 at http://www.cdc.gov/od/sap/ and http://www.cdc.gov/od/sap/docs/salist.pdf .
Listings of USDA select agents and toxins as well as information about the registration process for domestic institutions are available on the APHIS/USDA website at: http://www.aphis.usda.gov/programs/ag_selectagent/index.html and:
http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html

For foreign institutions, see the NIAID Select Agent Award information:
( http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm ).

ARTICLE H.51. POSSESSION, USE OR TRANSFER OF A HIGHLY PATHOGENIC AGENT
The work being conducted under this contract may involve the possession, use, or transfer of a Highly Pathogenic Infectious 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:

1. The current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)

( http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm );

2. The Contractor's Institutional Biosafety Committee (IBC) or equivalent body; or
3. 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.

17. Possession, Use and Transfer of Select Biological Agents or Toxins
    
    Notice to Offerors of Requirements of : 42 CFR Part 73, Possession , Use, and Transfer of Select Agents and Toxins (relating to public health and safety): ( http://www.cdc.gov/od/sap/42_cfr_73_final_rule.pdf );
    7 CFR Part 331, Possession, Use, and Transfer of Select Agents and Toxins (relating to plant health or plant products) ( http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf ); 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)
    ( http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf ) - March 18, 2005.
    
    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 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 at http://www.cdc.gov/od/sap/ and http://www.cdc.gov/od/sap/docs/salist.pdf . Listings of USDA select agents and toxins as well as information about the registration process for domestic institutions are available on the APHIS/USDA website at http://www.aphis.usda.gov/programs/ag_selectagent/index.html and http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html . For foreign institutions, see the NIAID Select Agent Award information ( http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm ).
    
    If the proposed contract will not involve Select Agents, 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 Select Agents.

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.
• comply with 42 CFR part 73, 7 CFR part 331 and/or 9 CFR part 121 at:
  http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf , 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.
• 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:
  
  http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf 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 inspection of the foreign laboratory facility by an NIAID representative. During this inspection, the foreign institution must provide the following information: concise summaries of safety, security, and training plans; names of all 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; and 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.

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 facility inspection, 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:
http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf .
The committee will provide recommendations to the DEA Director, NIAID. The DEA Director will make the approval decision and notify the Contracting Officer. The Contracting Officer will inform the prime contractor of the approval status of the foreign institution. No NIH funds can be used for research involving Select Agents at a foreign institution until NIAID grants this approval.