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2010-09-24
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Human Drugs and Biologics; Determination That Informed Consent Is NOT Feasible or Is Contrary to the Best Interests of Recipients; Revocation of 1990 Interim Final Rule; Establishment of New Interim Final Rule
Part V
Rules and Regulations
D09002ee1be354059
D09002ee1be3542ed
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.
64 FR 54180
https://www.govinfo.gov/app/details/FR-1999-10-05/99-25376
99-25376
fr05oc99-33
RIN 0910-AA89
4160-01-F
Docket No. 90N-0302
https://www.govinfo.gov/app/details/FR-1999-10-05/99-25376
https://www.govinfo.gov/content/pkg/FR-1999-10-05/html/99-25376.htm
https://www.govinfo.gov/content/pkg/FR-1999-10-05/pdf/99-25376.pdf
10 p.
54180
54189
64 FR 54180
Code of Federal Regulations
Title 21 Part 312
21 CFR Part 312
Code of Federal Regulations
Title 21 Part 50
21 CFR Part 50
Regulation Identification Number 0910-AA89
RIN 0910-AA89
Human Drugs and Biologics; Determination That Informed Consent Is NOT Feasible or Is Contrary to the Best Interests of Recipients; Revocation of 1990 Interim Final Rule; Establishment of New Interim Final Rule; Federal Register Vol. 64, Issue
RULE
99-25376
V
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1999-10-05
1999-12-20
Docket No. 90N-0302
4160-01-F
99-25376
Interim final rule; opportunity for public comment.
The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.
Effective October 5, 1999. Submit written comments by December 20, 1999.
Bonnie M. Lee, Division of Compliance Policy, Office of Enforcement, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0415.
Federal Register
Vol. 64, no. 192
Office of the Federal Register, National Archives and Records Administration
1999-10-05
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-1999-10-05
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https://www.govinfo.gov/app/details/FR-1999-10-05
https://www.govinfo.gov/content/pkg/FR-1999-10-05/pdf/FR-1999-10-05.pdf
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