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To amend the Federal Food, Drug, and Cosmetic Act to authorize additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war, and for other purposes.

USA115th CongressHR-4374| House 
| Updated: 12/12/2017
Greg Walden

Greg Walden

Republican Representative

Oregon

Military Personnel Subcommittee, Armed Services Committee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
(This measure has not been amended since it was introduced. The expanded summary of the House passed version is repeated here.) (Sec. 1) This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to authorize the emergency use of an otherwise unapproved medical product if the Department of Defense (DOD) determines that there is a military emergency involving an agent that may cause imminently life-threatening and specific risk to U.S. forces. If a military emergency is determined to exist, the bill allows DOD to request that the FDA expedite certain procedures for approving medical products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk. The FDA must take specified actions to facilitate such a request by DOD. The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA, to authorize the emergency use of an unapproved product under similar circumstances. Unless DOD determines such meetings to be unnecessary, the FDA shall meet with DOD: (1) semi-annually to conduct a full review of relevant medical products in the DOD portfolio; and (2) quarterly to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that DOD prioritizes.

Bill Text Versions

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5 versions available

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Timeline
Nov 13, 2017
Introduced in House
Nov 13, 2017
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Nov 14, 2017
Referred to the Subcommittee on Military Personnel.
Nov 15, 2017
Received in the Senate, read twice.
Nov 15, 2017
Mr. Walden moved to suspend the rules and pass the bill.
Nov 15, 2017
Considered under suspension of the rules. (consideration: CR H9297-9300)
Nov 15, 2017
DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.
Nov 15, 2017
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)
Nov 15, 2017
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)
Nov 15, 2017
Motion to reconsider laid on the table Agreed to without objection.
Nov 16, 2017
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)
Nov 16, 2017
Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)
Nov 16, 2017
Message on Senate action sent to the House.
Nov 30, 2017
Presented to President.
Dec 12, 2017
Signed by President.
Dec 12, 2017
Became Public Law No: 115-92.
  • November 13, 2017
    Introduced in House


  • November 13, 2017
    Referred to the Committee on Energy and Commerce, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.


  • November 14, 2017
    Referred to the Subcommittee on Military Personnel.


  • November 15, 2017
    Received in the Senate, read twice.


  • November 15, 2017
    Mr. Walden moved to suspend the rules and pass the bill.


  • November 15, 2017
    Considered under suspension of the rules. (consideration: CR H9297-9300)


  • November 15, 2017
    DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.


  • November 15, 2017
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)


  • November 15, 2017
    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)


  • November 15, 2017
    Motion to reconsider laid on the table Agreed to without objection.


  • November 16, 2017
    Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)


  • November 16, 2017
    Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)


  • November 16, 2017
    Message on Senate action sent to the House.


  • November 30, 2017
    Presented to President.


  • December 12, 2017
    Signed by President.


  • December 12, 2017
    Became Public Law No: 115-92.

Health

Blood and blood diseasesChemical and biological weaponsConflicts and warsDrug safety, medical device, and laboratory regulationDrug therapyEmergency medical services and trauma careGovernment studies and investigationsHealth promotion and preventive careImmunology and vaccinationLicensing and registrationsMilitary medicineNuclear weapons

To amend the Federal Food, Drug, and Cosmetic Act to authorize additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war, and for other purposes.

USA115th CongressHR-4374| House 
| Updated: 12/12/2017
(This measure has not been amended since it was introduced. The expanded summary of the House passed version is repeated here.) (Sec. 1) This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to authorize the emergency use of an otherwise unapproved medical product if the Department of Defense (DOD) determines that there is a military emergency involving an agent that may cause imminently life-threatening and specific risk to U.S. forces. If a military emergency is determined to exist, the bill allows DOD to request that the FDA expedite certain procedures for approving medical products that would be reasonably likely to diagnose, prevent, treat, or mitigate such risk. The FDA must take specified actions to facilitate such a request by DOD. The bill repeals provisions of the National Defense Authorization Act for Fiscal Year 2018 that allow DOD, rather than the FDA, to authorize the emergency use of an unapproved product under similar circumstances. Unless DOD determines such meetings to be unnecessary, the FDA shall meet with DOD: (1) semi-annually to conduct a full review of relevant medical products in the DOD portfolio; and (2) quarterly to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that DOD prioritizes.

Bill Text Versions

View Text
5 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Nov 13, 2017
Introduced in House
Nov 13, 2017
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Nov 14, 2017
Referred to the Subcommittee on Military Personnel.
Nov 15, 2017
Received in the Senate, read twice.
Nov 15, 2017
Mr. Walden moved to suspend the rules and pass the bill.
Nov 15, 2017
Considered under suspension of the rules. (consideration: CR H9297-9300)
Nov 15, 2017
DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.
Nov 15, 2017
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)
Nov 15, 2017
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)
Nov 15, 2017
Motion to reconsider laid on the table Agreed to without objection.
Nov 16, 2017
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)
Nov 16, 2017
Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)
Nov 16, 2017
Message on Senate action sent to the House.
Nov 30, 2017
Presented to President.
Dec 12, 2017
Signed by President.
Dec 12, 2017
Became Public Law No: 115-92.
  • November 13, 2017
    Introduced in House


  • November 13, 2017
    Referred to the Committee on Energy and Commerce, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.


  • November 14, 2017
    Referred to the Subcommittee on Military Personnel.


  • November 15, 2017
    Received in the Senate, read twice.


  • November 15, 2017
    Mr. Walden moved to suspend the rules and pass the bill.


  • November 15, 2017
    Considered under suspension of the rules. (consideration: CR H9297-9300)


  • November 15, 2017
    DEBATE - The House proceeded with forty minutes of debate on H.R. 4374.


  • November 15, 2017
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298)


  • November 15, 2017
    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298)


  • November 15, 2017
    Motion to reconsider laid on the table Agreed to without objection.


  • November 16, 2017
    Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270)


  • November 16, 2017
    Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270)


  • November 16, 2017
    Message on Senate action sent to the House.


  • November 30, 2017
    Presented to President.


  • December 12, 2017
    Signed by President.


  • December 12, 2017
    Became Public Law No: 115-92.
Greg Walden

Greg Walden

Republican Representative

Oregon

Military Personnel Subcommittee, Armed Services Committee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Blood and blood diseasesChemical and biological weaponsConflicts and warsDrug safety, medical device, and laboratory regulationDrug therapyEmergency medical services and trauma careGovernment studies and investigationsHealth promotion and preventive careImmunology and vaccinationLicensing and registrationsMilitary medicineNuclear weapons