Responsible development and deployment of biotechnology within the Department of Defense
Division A — Department of Defense Authorizations › Title II — Research, Development, Test, and Evaluation › Subtitle B — Program Requirements, Restrictions, and Limitations
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(a) Requirement (1) Policies and guidelines The Secretary of Defense shall issue policies and guidelines on the responsible development and deployment of biotechnology within the Department of Defense. (2) Executive agent The Secretary shall designate a senior civilian official within the Office of the Secretary of Defense to serve as the executive agent to develop the policies and guidelines under paragraph (1). (3) Coordination The Secretary shall ensure that the policies and guidelines under paragraph (1) are developed in consultation with— (A) the Under Secretary of Defense for Research and Engineering; (B) the Under Secretary of Defense for Policy; and (C) individuals representing industry, academia, and civil society. (4) Public availability The Secretary shall make the policies and guidelines under paragraph (1) publicly available. (b) Matters included The policies and guidelines under subsection (a)(1) shall include the following: (1) Definitions related to the responsible development and use of biotechnology. (2) An assessment of whether, and to what extent, existing statutes, regulations, directives, manuals, or instructions limit the ability of the Department of Defense to provide guidelines for the responsible development of emerging biotechnology. (3) Guidelines encouraging the safe use of biotechnology products under appropriate regulatory and other oversight processes. (4) Policies relating to informed consent of members of the Armed Forces participating in the development of biotechnology products that have not received regulatory approval. (5) Policies relating to whether, and under which conditions, irreversible or heritable treatments of potential biotechnology applications are acceptable. (6) Policies relating to the potential effects of biotechnologies on the environment. (7) Policies relating to the compliance by and obligations of the Department of Defense with respect to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological and Toxin Weapons and on their Destruction (commonly referred to as the Biological Weapons Convention). (8) Such other matters as the Secretary of Defense determines relevant. (c) Report (1) In general Not later than one year after the date of the enactment of this Act, the Secretary of Defense shall submit to the congressional defense committees a report on the policies and guidelines under subsection (a)(1), including the methodologies used to develop the policies and guidelines. (2) Form The report required under paragraph (1) shall be submitted in unclassified form but may include a classified annex. (3) Public availability The Secretary of Defense shall make report required under paragraph (1) publicly available, except such publicly available version of the report may not include any classified annex provided under paragraph (2). (d) Briefing During the two-year period beginning on the date that is one year after the date of the enactment of this Act, the Secretary of Defense shall provide to the congressional defense committees an annual briefing on the implementation of the policies and guidelines under subsection (a)(1), including a description of any needed resources for such implementation.
(a) Requirement (1) Policies and guidelines The Secretary of Defense shall issue policies and guidelines on the responsible development and deployment of biotechnology within the Department of Defense. (2) Executive agent The Secretary shall designate a senior civilian official within the Office of the Secretary of Defense to serve as the executive agent to develop the policies and guidelines under paragraph (1). (3) Coordination The Secretary shall ensure that the policies and guidelines under paragraph (1) are developed in consultation with— (A) the Under Secretary of Defense for Research and Engineering; (B) the Under Secretary of Defense for Policy; and (C) individuals representing industry, academia, and civil society. (4) Public availability The Secretary shall make the policies and guidelines under paragraph (1) publicly available. (b) Matters included The policies and guidelines under subsection (a)(1) shall include the following: (1) Definitions related to the responsible development and use of biotechnology. (2) An assessment of whether, and to what extent, existing statutes, regulations, directives, manuals, or instructions limit the ability of the Department of Defense to provide guidelines for the responsible development of emerging biotechnology. (3) Guidelines encouraging the safe use of biotechnology products under appropriate regulatory and other oversight processes. (4) Policies relating to informed consent of members of the Armed Forces participating in the development of biotechnology products that have not received regulatory approval. (5) Policies relating to whether, and under which conditions, irreversible or heritable treatments of potential biotechnology applications are acceptable. (6) Policies relating to the potential effects of biotechnologies on the environment. (7) Policies relating to the compliance by and obligations of the Department of Defense with respect to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological and Toxin Weapons and on their Destruction (commonly referred to as the Biological Weapons Convention). (8) Such other matters as the Secretary of Defense determines relevant. (c) Report (1) In general Not later than one year after the date of the enactment of this Act, the Secretary of Defense shall submit to the congressional defense committees a report on the policies and guidelines under subsection (a)(1), including the methodologies used to develop the policies and guidelines. (2) Form The report required under paragraph (1) shall be submitted in unclassified form but may include a classified annex. (3) Public availability The Secretary of Defense shall make report required under paragraph (1) publicly available, except such publicly available version of the report may not include any classified annex provided under paragraph (2). (d) Briefing During the two-year period beginning on the date that is one year after the date of the enactment of this Act, the Secretary of Defense shall provide to the congressional defense committees an annual briefing on the implementation of the policies and guidelines under subsection (a)(1), including a description of any needed resources for such implementation.
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