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Title of Law:National Defense Authorization Act for Fiscal Year 2002
Law #:Public Law 107-107
Passed by Congress:107th Congress (1st Session)

The following are excerpts, highlighted in red, from the final legislation and/or conference report which contain National Academies' studies. (Pound signs [##] between passages denote the deletion of unrelated text.)

S1438 Levin (D-Mich.) 12/13/01
Enrolled (finally passed both houses)

To authorize appropriations for fiscal year 2002 for military activities of the Department of Defense, for military construction, and for defense activities of the Department of Energy, to prescribe personnel strengths for such fiscal year for the Armed Forces, and for other purposes.
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Subtitle D-Air Force Science and Technology for the 21st Century

SEC. 251. SHORT TITLE.

This subtitle may be cited as the "Air Force Science and Technology for the 21st Century Act".

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SEC. 253. STUDY AND REPORT ON EFFECTIVENESS OF AIR FORCE SCIENCE AND TECHNOLOGY PROGRAM CHANGES.

(a) REQUIREMENT.-The Secretary of the Air Force, in cooperation with the National Research Council of the National Academy of Sciences, shall carry out a study to determine how the changes to the Air Force science and

technology program implemented during the past two years affect the future capabilities of the Air Force.

(b) MATTERS STUDIED.-(1) The study shall review and assess whether such changes as a whole are sufficient to ensure the following:

(A) That the concerns about the management of the science and technology program that have been raised by Congress, the Defense Science Board, the Air Force Science Advisory Board, and the Air Force Association have been adequately addressed.

(B) That appropriate and sufficient technology is available to ensure the military superiority of the United States and counter future high-risk threats.

(C) That the science and technology investments are balanced to meet the near-, mid-, and long-term needs of the Air Force.

(D) That technologies are made available that can be used to respond flexibly and quickly to a wide range of future threats.

(E) That the Air Force organizational structure provides for a sufficiently senior level advocate of science and technology to ensure an ongoing, effective presence of the science and technology community during the budget and planning process.

(2) In addition, the study shall assess the specific changes to the Air Force science and technology program as follows:

(A) Whether the biannual science and technology summits provide sufficient visibility into, and understanding and appreciation of, the value of the science and technology program to the senior level of Air Force budget and policy decisionmakers.

(B) Whether the applied technology councils are effective in contributing the input of all levels beneath the senior leadership into the coordination, focus, and content of the science and technology program.

(C) Whether the designation of the commander of the Air Force Materiel Command as the science and technology budget advocate is effective to ensure that an adequate Air Force science and technology budget is requested.

(D) Whether the revised development planning process is effective to aid in the coordination of the needs of the Air Force warfighters with decisions on science and technology investments and the establishment of priorities among different science and technology programs.

(E) Whether the implementation of section 252 of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001 (as enacted into law by Public Law 106-398; 114 Stat. 1654A-46) is effective to identify the basis for the appropriate science and technology program funding level and investment portfolio.

(c) REPORT.-Not later than May 1, 2003, the Secretary of the Air Force shall submit to Congress the results of the study.

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Subtitle A-Financial Matters

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SEC. 1044. ACCELERATION OF RESEARCH, DEVELOPMENT, AND PRODUCTION OF MEDICAL COUNTERMEASURES FOR DEFENSE AGAINST BIOLOGICAL WARFARE AGENTS.

(a) AGGRESSIVE PROGRAM REQUIRED.-(1) The Secretary of Defense shall carry out a program to aggressively accelerate the research, development, testing, and licensure of new medical countermeasures for defense against the biological warfare agents that are the highest threat.

(2) The program shall include the following activities:

(A) As the program´s first priority, investment in multiple new technologies for medical countermeasures for defense against the biological warfare agents that are the highest threat, including for the prevention and treatment of anthrax.

(B) Leveraging of ideas and technologies from the biological technology industry.

(b) STUDY REQUIRED.-(1) The Secretary of Defense shall enter into a contract with the Institute of Medicine and the National Research Council under which the Institute and Council, in consultation with the Secretary, shall carry out a study of the review and approval process for new medical countermeasures for biological warfare agents. The purpose of the study shall be to identify-

(A) new approaches to accelerating such process; and

(B) definitive and reasonable methods for assuring the agencies responsible for regulating such countermeasures that such countermeasures will be effective in preventing disease in humans or in providing safe and effective therapy against such agents.

(2) Not later than June 1, 2002, the Institute and Council shall jointly submit to Congress a report on the results of the study.

(c) FACILITY FOR PRODUCTION OF VACCINES.-(1) Subject to paragraph (2) and to the availability of funds for such purposes appropriated pursuant to an authorization of appropriations, the Secretary of Defense may-

(A) design and construct a facility on a Department of Defense installation for the production of vaccines to meet the requirements of the Department of Defense to prevent or mitigate the physiological effects of exposure to biological warfare agents;

(B) operate that facility;

(C) qualify and validate that facility for the production of vaccines in accordance with the requirements of the Food and Drug Administration; and

(D) contract with a private-sector source for the production of vaccines in that facility.

(2) The authority under paragraph (1)(A) to construct a facility may be exercised only to the extent that a project for such construction is authorized by law in accordance with section 2802 of title 10, United States Code.

(3) The Secretary shall use competitive procedures under chapter 137 of title 10, United States Code, to enter into contracts to carry out subparagraphs (A), (B), and (D) of paragraph (1).

(d) PLAN REQUIRED.-(1) The Secretary shall develop a long-range plan to provide for the production and acquisition of vaccines to meet the requirements of the Department of Defense to prevent or mitigate the physiological effects of exposure to biological warfare agents.

(2) The plan shall include the following:

(A) An evaluation of the need for one or more vaccine production facilities that are specifically dedicated to meeting the requirements of the Department of Defense and other national interests.

(B) An evaluation of the options for the means of production of such vaccines, including-

(i) use of public facilities, private facilities, or a combination of public and private facilities; and

(ii) management and operation of the facilities by the Federal Government, one or more private persons, or a combination of the Federal Government and one or more private persons.

(C) A specification of the means that the Secretary determines is most appropriate for the production of such vaccines.

(3) The Secretary shall ensure that the plan is consistent with the requirement for safe and effective vaccines approved by the Food and Drug Administration.

(4) In preparing the plan, the Secretary shall-

(A) consider and, as the Secretary determines appropriate, include the information compiled and the analyses developed in preparing the reports required by sections 217 and 218 of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001 (as enacted into law by Public Law 106-398; 114 Stat. 1654A-36, 1654A-37); and

(B) consult with the heads of other appropriate departments and agencies of the Federal Government.

(e) REPORT.-Not later than February 1, 2002, the Secretary shall submit to the congressional defense committees a report on the plan required by subsection (d). The report shall include, at a minimum, the contents of the plan and the following matters:

(1) A description of the policies and requirements of the Department of Defense regarding acquisition and use of such vaccines.

(2) The estimated schedule for the acquisition of such vaccines in accordance with the plan.

(3) A discussion of the options considered under subsection (d)(2)(B) for the means of production of such vaccines.

(4) The Secretary´s recommendations for the most appropriate course of action to meet the requirements specified in subsection (d)(1), together with the justification for such recommendations and the long-term cost of implementing such recommendations.

(f) FUNDING.-Of the amount authorized to be appropriated under section 201(4) for research, development, test, and evaluation, Defense-wide, $5,000,000 may be available in Program Element 62384BP, and $5,000,000 may be available in Program Element 63384BP, for the program required by subsection (a).

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SEC. 3152. DEPARTMENT OF ENERGY COUNTERINTELLIGENCE POLYGRAPH PROGRAM.

(a) NEW COUNTERINTELLIGENCE POLYGRAPH PROGRAM REQUIRED.-The Secretary of Energy shall carry out, under regulations prescribed under this section, a new counterintelligence polygraph program for the Department of Energy. The purpose of the new program is to minimize the potential for release or disclosure of classified data, materials, or information.

(b) AUTHORITIES AND LIMITATIONS.-(1) The Secretary shall prescribe regulations for the new counterintelligence polygraph program required by subsection (a) in accordance with the provisions of subchapter II of

chapter 5 of title 5, United States Code (commonly referred to as the Administrative Procedures Act).

(2) In prescribing regulations for the new program, the Secretary shall take into account the results of the Polygraph Review.

(3) Not later than six months after obtaining the results of the Polygraph Review, the Secretary shall issue a notice of proposed rulemaking for the new program.

(c) REPEAL OF EXISTING POLYGRAPH PROGRAM.-Effective 30 days after the Secretary submits to the congressional defense committees the Secretary´s certification that the final rule for the new counterintelligence

polygraph program required by subsection (a) has been fully implemented, section 3154 of the Department of Energy Facilities Safeguards, Security, and Counterintelligence Enhancement Act of 1999 (subtitle D of title XXI of Public Law 106-65; 42 U.S.C. 7383h) is repealed.

(d) REPORT ON FURTHER ENHANCEMENT OF PERSONNEL SECURITY PROGRAM.-(1) Not later than January 1, 2003, the Administrator for Nuclear Security shall submit to Congress a report setting forth the recommendations of the Administrator for any legislative action that the Administrator considers appropriate in order to enhance the personnel security program of the Department of Energy.

(2) Any recommendations under paragraph (1) regarding the use of polygraphs shall take into account the results of the Polygraph Review.

(e) POLYGRAPH REVIEW DEFINED.-In this section, the term "Polygraph Review" means the review of the Committee to Review the Scientific Evidence on the Polygraph of the National Academy of Sciences.

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***********************************************************************************
HRpt 107-333 - To accompany S. 1438 NATIONAL DEFENSE AUTHORIZATION ACT FOR FISCAL YEAR 2002
Conference Committee
(12/12/01)
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######

Subtitle D-Air Force Science and Technology for the 21st Century

SEC. 251. SHORT TITLE.

This subtitle may be cited as the "Air Force Science and Technology for the 21st Century Act".

#####

SEC. 253. STUDY AND REPORT ON EFFECTIVENESS OF AIR FORCE SCIENCE AND TECHNOLOGY PROGRAM CHANGES.

(a) REQUIREMENT.-The Secretary of the Air Force, in cooperation with the National Research Council of the National Academy of Sciences, shall carry out a study to determine how the changes to the Air Force science and

technology program implemented during the past two years affect the future capabilities of the Air Force.

(b) MATTERS STUDIED.-(1) The study shall review and assess whether such changes as a whole are sufficient to ensure the following:

(A) That the concerns about the management of the science and technology program that have been raised by Congress, the Defense Science Board, the Air Force Science Advisory Board, and the Air Force Association have been adequately addressed.

(B) That appropriate and sufficient technology is available to ensure the military superiority of the United States and counter future high-risk threats.

(C) That the science and technology investments are balanced to meet the near-, mid-, and long-term needs of the Air Force.

(D) That technologies are made available that can be used to respond flexibly and quickly to a wide range of future threats.

(E) That the Air Force organizational structure provides for a sufficiently senior level advocate of science and technology to ensure an ongoing, effective presence of the science and technology community during the budget and planning process.

(2) In addition, the study shall assess the specific changes to the Air Force science and technology program as follows:

(A) Whether the biannual science and technology summits provide sufficient visibility into, and understanding and appreciation of, the value of the science and technology program to the senior level of Air Force budget and policy decisionmakers.

(B) Whether the applied technology councils are effective in contributing the input of all levels beneath the senior leadership into the coordination, focus, and content of the science and technology program.

(C) Whether the designation of the commander of the Air Force Materiel Command as the science and technology budget advocate is effective to ensure that an adequate Air Force science and technology budget is requested.

(D) Whether the revised development planning process is effective to aid in the coordination of the needs of the Air Force warfighters with decisions on science and technology investments and the establishment of priorities among different science and technology programs.

(E) Whether the implementation of section 252 of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001 (as enacted into law by Public Law 106-398; 114 Stat. 1654A-46) is effective to identify the basis for the appropriate science and technology program funding level and investment portfolio.

(c) REPORT.-Not later than May 1, 2003, the Secretary of the Air Force shall submit to Congress the results of the study.

######

Subtitle E-Other Department of Defense Provisions

#####

SEC. 1044. ACCELERATION OF RESEARCH, DEVELOPMENT, AND PRODUCTION OF MEDICAL COUNTERMEASURES FOR DEFENSE AGAINST BIOLOGICAL WARFARE AGENTS.

(a) AGGRESSIVE PROGRAM REQUIRED.-(1) The Secretary of Defense shall carry out a program to aggressively accelerate the research, development, testing, and licensure of new medical countermeasures for defense against the biological warfare agents that are the highest threat.

(2) The program shall include the following activities:

(A) As the program´s first priority, investment in multiple new technologies for medical countermeasures for defense against the biological warfare agents that are the highest threat, including for the prevention and treatment of anthrax.

(B) Leveraging of ideas and technologies from the biological technology industry.

(b) STUDY REQUIRED.-(1) The Secretary of Defense shall enter into a contract with the Institute of Medicine and the National Research Council under which the Institute and Council, in consultation with the Secretary, shall carry out a study of the review and approval process for new medical countermeasures for biological warfare agents. The purpose of the study shall be to identify-

(A) new approaches to accelerating such process; and

(B) definitive and reasonable methods for assuring the agencies responsible for regulating such countermeasures that such countermeasures will be effective in preventing disease in humans or in providing safe and effective therapy against such agents.

(2) Not later than June 1, 2002, the Institute and Council shall jointly submit to Congress a report on the results of the study.

(c) FACILITY FOR PRODUCTION OF VACCINES.-(1) Subject to paragraph (2) and to the availability of funds for such purposes appropriated pursuant to an authorization of appropriations, the Secretary of Defense may-

(A) design and construct a facility on a Department of Defense installation for the production of vaccines to meet the requirements of the Department of Defense to prevent or mitigate the physiological effects of exposure to biological warfare agents;

(B) operate that facility;

(C) qualify and validate that facility for the production of vaccines in accordance with the requirements of the Food and Drug Administration; and

(D) contract with a private-sector source for the production of vaccines in that facility.

(2) The authority under paragraph (1)(A) to construct a facility may be exercised only to the extent that a project for such construction is authorized by law in accordance with section 2802 of title 10, United States Code.

(3) The Secretary shall use competitive procedures under chapter 137 of title 10, United States Code, to enter into contracts to carry out subparagraphs (A), (B), and (D) of paragraph (1).

(d) PLAN REQUIRED.-(1) The Secretary shall develop a long-range plan to provide for the production and acquisition of vaccines to meet the requirements of the Department of Defense to prevent or mitigate the physiological effects of exposure to biological warfare agents.

(2) The plan shall include the following:

(A) An evaluation of the need for one or more vaccine production facilities that are specifically dedicated to meeting the requirements of the Department of Defense and other national interests.

(B) An evaluation of the options for the means of production of such vaccines, including-

(i) use of public facilities, private facilities, or a combination of public and private facilities; and

(ii) management and operation of the facilities by the Federal Government, one or more private persons, or a combination of the Federal Government and one or more private persons.

(C) A specification of the means that the Secretary determines is most appropriate for the production of such vaccines.

(3) The Secretary shall ensure that the plan is consistent with the requirement for safe and effective vaccines approved by the Food and Drug Administration.

(4) In preparing the plan, the Secretary shall-

(A) consider and, as the Secretary determines appropriate, include the information compiled and the analyses developed in preparing the reports required by sections 217 and 218 of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001 (as enacted into law by Public Law 106-398; 114 Stat. 1654A-36, 1654A-37); and

(B) consult with the heads of other appropriate departments and agencies of the Federal Government.

(e) REPORT.-Not later than February 1, 2002, the Secretary shall submit to the congressional defense committees a report on the plan required by subsection (d). The report shall include, at a minimum, the contents of the plan and the following matters:

(1) A description of the policies and requirements of the Department of Defense regarding acquisition and use of such vaccines.

(2) The estimated schedule for the acquisition of such vaccines in accordance with the plan.

(3) A discussion of the options considered under subsection (d)(2)(B) for the means of production ofsuch vaccines.

(4) The Secretary´s recommendations for the most appropriate course of action to meet the requirements specified in subsection (d)(1), together with the justification for such recommendations and the long-term cost of implementing such recommendations.

(f) FUNDING.-Of the amount authorized to be appropriated under section 201(4) for research, development, test, and evaluation, Defense-wide, $5,000,000 may be available in Program Element 62384BP, and $5,000,000 may be available in Program Element 63384BP, for the program required by subsection (a).

#####

Subtitle E-Other Matters

#####

SEC. 3152. DEPARTMENT OF ENERGY COUNTERINTELLIGENCE POLYGRAPH PROGRAM.

(a) NEW COUNTERINTELLIGENCE POLYGRAPH PROGRAM REQUIRED.-The Secretary of Energy shall carry out, under regulations prescribed under this section, a new counterintelligence polygraph program for the Department of Energy. The purpose of the new program is to minimize the potential for release or disclosure of classified data, materials, or information.

(b) AUTHORITIES AND LIMITATIONS.-(1) The Secretary shall prescribe regulations for the new counterintelligence polygraph program required by subsection (a) in accordance with the provisions of subchapter II of

chapter 5 of title 5, United States Code (commonly referred to as the Administrative Procedures Act).

(2) In prescribing regulations for the new program, the Secretary shall take into account the results of the Polygraph Review.

(3) Not later than six months after obtaining the results of the Polygraph Review, the Secretary shall issue a notice of proposed rulemaking for the new program.

(c) REPEAL OF EXISTING POLYGRAPH PROGRAM.-Effective 30 days after the Secretary submits to the congressional defense committees the Secretary´s certification that the final rule for the new counterintelligence

polygraph program required by subsection (a) has been fully implemented, section 3154 of the Department of Energy Facilities Safeguards, Security, and Counterintelligence Enhancement Act of 1999 (subtitle D of title XXXI of Public Law 106-65; 42 U.S.C. 7383h) is repealed.

(d) REPORT ON FURTHER ENHANCEMENT OF PERSONNEL SECURITY PROGRAM.-(1) Not later than January 1, 2003, the Administrator for Nuclear Security shall submit to Congress a report setting forth the recommendations of the Administrator for any legislative action that the Administrator considers appropriate in order to enhance the personnel security program of the Department of Energy.

(2) Any recommendations under paragraph (1) regarding the use of polygraphs shall take into account the results of the Polygraph Review.

(e) POLYGRAPH REVIEW DEFINED.-In this section, the term "Polygraph Review" means the review of the Committee to Review the Scientific Evidence on the Polygraph of the National Academy of Sciences.

#####

SUBTITLE D-AIR FORCE SCIENCE AND TECHNOLOGY FOR THE 21ST CENTURY

Air Force science and technology for the 21st Century Act (sec. 251-252)

The House amendment contained two provisions (secs. 251 and 252) that establish a sense of Congress regarding the Air Force science and technology development planning process.

The Senate bill contained no similar provisions.

The Senate recedes.

Study and report on effectiveness of Air Force science and technology program changes (sec. 253)

The House amendment contained a provision (sec. 253) that would require the Air Force and the National Research Council to study how changes to the Air Force science and technology program implemented over the past two years affect the future capabilities of the Air Force.

The Senate bill contained no similar provision.

The Senate recedes with a clarifying amendment.

The conferees direct the Air Force to ensure that the National Research Council is provided sufficient resources to adequately conduct the study called for by the provision.

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SUBTITLE E-OTHER DEPARTMENT OF DEFENSE PROVISIONS

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Acceleration of research, development, and production of medical countermeasures for defense against biological warfare agents (sec. 1044)

The Senate bill contained a provision (sec. 1025) that would authorize the Secretary of Defense, subject to the availability of authorized and appropriated funds for such purpose, to design, construct and operate on an installation of the Department of Defense a government-owned, contractor-operated (GOCO) vaccine production facility. The provision would also require the Secretary of Defense to develop a long-range plan for the production and acquisition of vaccines to defend against biological warfare agents, including an evaluation of vaccine production options, and to report to the congressional defense committees on that plan by February 1, 2002.

The House amendment contained no similar provision.

The House recedes with an amendment that would require the Secretary of Defense to carry out an accelerated program of research, development and production of medical countermeasures to defend against the highest threat biological warfare agents. In order to accomplish this objective, the conferees believe that the Department of Defense should invest in multiple new technologies for the prevention and treatment of anthrax and should take advantage of ideas and candidate technologies from the bio-tech industry. The conferees believe that the Department should consider the following approaches in this effort: understanding the germination process of anthrax spores and the means to inhibit this process; identifying the molecular behavior of the anthrax toxin and the means to intervene against it at the cellular level; investigating recombinant protein antigens and formulating new vaccines, including multivalent vaccines that may be effective against multiple strains of pathogens; investigating technologies to be used as an adjunct to antibiotic treatment that may be more effective in clearing pathogens from circulation; and determining potential means for optimizing and extending immunity in humans.

The amendment would also require a study by the National Research Council and the Institute of Medicine of the review and approval process for such medical countermeasures. Finally, the amendment would provide discretion for the Defense Department to use up to $10.0 million of available research and development funds for the accelerated program.

The conferees note the importance to the Department of Defense of producing and acquiring products needed to prevent or mitigate the physiological effects of exposure to biological warfare agents, including vaccines, decontamination capabilities and therapeutic treatments. The Department of Defense has made significant progress in this area, as indicated in the July 2001 Annual Report to Congress on the Department of Defense Chemical and Biological Defense Program.

However, the conferees believe that more needs to be done to ensure the development and acquisition of needed products, including the transition of developmental items through the review and approval process, particularly vaccines and drugs. The conferees urge the Department to expand its efforts to acquire new technologies and products to defend against biological warfare agents.

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