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   &lt;pre&gt;[Congressional Record Volume 167, Number 2 (Monday, January 4, 2021)][House]From the Congressional Record Online through the Government Publishing Office [&lt;a href="https://www.gpo.gov"&gt;www.gpo.gov&lt;/a&gt;]By Mr. BUCHANAN:H.R. 70.Congress has the power to enact this legislation pursuantto the following:Article I Section 8 of the United States Constitution[Page H52]&lt;/pre&gt;
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     &lt;p&gt;&lt;b&gt;Securing America's Medicine Cabinet Act of 2021&lt;/b&gt;&lt;/p&gt; &lt;p&gt;This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies.&lt;/p&gt; &lt;p&gt;The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it is likely to (1) prevent or resolve a drug shortage, (2) maintain an adequate supply of critical medications for national emergencies, or (3) promote the adoption of innovative approaches to drug design and manufacturing. &lt;/p&gt; &lt;p&gt;The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation.&lt;/p&gt; &lt;p&gt;The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.&lt;/p&gt;
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   Securing America’s Medicine Cabinet Act of 2021
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     Securing America’s Medicine Cabinet Act of 2021
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     To support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes.
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2021-02-02
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-01-04
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
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2021-01-04
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Introduced in House
IntroReferral
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2021-01-04
9
Library of Congress
Introduced in House
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2021-01-04T15:12:35Z
Referred to
House
Energy and Commerce Committee
2021-02-03T00:19:41Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
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.
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.
2021-01-04
2021-02-02
Referred to the Subcommittee on Health.
House
Health
B001260
16
Vern
Rep. Buchanan, Vern [R-FL-16]
N
Buchanan
R
FL
Advanced technology and technological innovations Congressional oversight Drug safety, medical device, and laboratory regulation Educational facilities and institutions Emergency medical services and trauma care Government information and archives Health technology, devices, supplies Higher education Manufacturing Medical research Prescription drugs Research and development Technology assessment
2021-01-04
Introduced in House
 <p><b>Securing America's Medicine Cabinet Act of 2021</b></p> <p>This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies.</p> <p>The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it is likely to (1) prevent or resolve a drug shortage, (2) maintain an adequate supply of critical medications for national emergencies, or (3) promote the adoption of innovative approaches to drug design and manufacturing. </p> <p>The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation.</p> <p>The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.</p>
2021-01-27T16:06:56Z
00
2021-01-04T05:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr70ih/xml/BILLS-117hr70ih.xml
Securing America’s Medicine Cabinet Act of 2021
Securing America’s Medicine Cabinet Act of 2021
Display Title
IH
Introduced in House
To support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Securing America’s Medicine Cabinet Act of 2021
Short Title(s) as Introduced
HR
2023-01-11T13:43:22Z
2023-01-11T13:43:22Z
3.0.0
2021-02-02
Health Subcommittee
hsif14
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House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-01-04
Energy and Commerce Committee
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Referred to the House Committee on Energy and Commerce.
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2021-01-04
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Library of Congress
Introduced in House
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Vern
Rep. Buchanan, Vern [R-FL-16]
N
Buchanan
R
FL
Advanced technology and technological innovations Congressional oversight Drug safety, medical device, and laboratory regulation Educational facilities and institutions Emergency medical services and trauma care Government information and archives Health technology, devices, supplies Higher education Manufacturing Medical research Prescription drugs Research and development Technology assessment
2021-01-04
Introduced in House
 <p><b>Securing America's Medicine Cabinet Act of 2021</b></p> <p>This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies.</p> <p>The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it is likely to (1) prevent or resolve a drug shortage, (2) maintain an adequate supply of critical medications for national emergencies, or (3) promote the adoption of innovative approaches to drug design and manufacturing. </p> <p>The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation.</p> <p>The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.</p>
2021-01-27T16:06:56Z
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Securing America’s Medicine Cabinet Act of 2021
Securing America’s Medicine Cabinet Act of 2021
Display Title
IH
Introduced in House
To support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Securing America’s Medicine Cabinet Act of 2021
Short Title(s) as Introduced
2021-02-02
Referred to the Subcommittee on Health.