3.0.0 4374 2023-09-05T16:12:23Z 2023-09-05T16:12:23Z House HR 2017-11-13 115 [Congressional Record Volume 163, Number 185 (Monday, November 13, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. WALDEN:H.R. 4374.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3 of the United StatesConstitution.[[Page H9179]][Page H9178]]]> hsas00 Armed Services Committee House Standing hsas02 Military Personnel Subcommittee Referred to 2017-11-14T20:19:00Z Referred to 2017-11-13T17:00:48Z hsif00 Energy and Commerce Committee House Standing Referred to 2017-11-13T17:00:43Z 2017-12-12 Signed by President. President E30000 2 House floor actions 2017-12-12 Signed by President. BecameLaw 36000 9 Library of Congress 2017-11-30 Presented to President. Floor E20000 2 House floor actions 2017-11-30 Presented to President. President 28000 9 Library of Congress 2017-11-16 Senate Message on Senate action sent to the House. Floor 2017-11-16 Senate Passed Senate without amendment by Unanimous Consent. (consideration: CR S7270) Floor 2017-11-16 Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7270) Floor 17000 9 Library of Congress 2017-11-15 Senate Received in the Senate, read twice. IntroReferral 2017-11-15 16:16:14 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2017-11-15 16:16:12 On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9297-9298) Floor H37300 2 House floor actions 2017-11-15 16:16:12 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H9297-9298) Floor 8000 9 Library of Congress 2017-11-15 15:56:29 DEBATE - The House proceeded with forty minutes of debate on H.R. 4374. Floor H8D000 2 House floor actions 2017-11-15 15:56:28 Considered under suspension of the rules. (consideration: CR H9297-9300) Floor H30000 2 House floor actions 2017-11-15 15:56:20 Mr. Walden moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2017-11-14 hsas02 Military Personnel Subcommittee 1 House committee actions Referred to the Subcommittee on Military Personnel. Committee 2017-11-13 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. IntroReferral H11100 2 House floor actions hsas00 Armed Services Committee 2017-11-13 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. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2017-11-13 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-11-13 Introduced in House IntroReferral 1000 9 Library of Congress W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 N Public Law 115-92 Health Blood and blood diseases Chemical and biological weapons Conflicts and wars Drug safety, medical device, and laboratory regulation Drug therapy Emergency medical services and trauma care Government studies and investigations Health promotion and preventive care Immunology and vaccination Licensing and registrations Military medicine Nuclear weapons Health 00 2017-11-13 Introduced in House 2018-02-06T16:13:55Z 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.

]]> 81 2017-11-15 Passed House without amendment 2018-02-09T17:19:01Z (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

(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.

]]> 82 2017-11-16 Passed Senate without amendment 2018-02-09T17:21:00Z (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.

]]> 49 2017-12-12 Public Law 2018-02-09T17:23:21Z (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.

]]> 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. Display Title 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. Official Title as Introduced 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. Enrolled Bill https://www.govinfo.gov/content/pkg/BILLS-115hr4374enr/xml/BILLS-115hr4374enr.xml Engrossed in House 2017-11-15T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr4374eh/xml/BILLS-115hr4374eh.xml Received in Senate 2017-11-15T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr4374rds/xml/BILLS-115hr4374rds.xml Introduced in House 2017-11-13T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr4374ih/xml/BILLS-115hr4374ih.xml 2017-12-13T04:59:59Z https://www.govinfo.gov/content/pkg/PLAW-115publ92/uslm/PLAW-115publ92.xml Public Law 2017-12-12 Signed by President. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.