3.0.0 3780 2023-01-11T13:42:39Z 2023-01-11T13:42:39Z Senate S 2020-05-20 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2020-05-20T20:26:59Z 2020-05-20 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2020-05-20 Introduced in Senate IntroReferral 10000 9 Library of Congress P000595 Sen. Peters, Gary C. [D-MI] Gary Peters D MI N Health Chemical and biological weapons Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Executive agency funding and structure Federal officials Government lending and loan guarantees Health programs administration and funding Health technology, devices, supplies Licensing and registrations Manufacturing Military procurement, research, weapons development Public contracts and procurement Strategic materials and reserves Terrorism Health 00 2020-05-20 Introduced in Senate 2021-01-28T16:09:54Z Help Onshore Manufacturing Efficiencies for Drugs and Devices Act or the HOME Act

This bill contains provisions related to critical drugs and medical devices.

The bill establishes within the Department of Health and Human Services (HHS) the Center for Domestic Advanced Manufacturing of Critical Drugs and Devices. The center shall establish and implement a program to provide grants and forgivable loans to support investment in advanced manufacturing for the domestic production of critical drugs, medical devices, and active pharmaceutical ingredients.

Furthermore, a supplemental application for a critical drug approved by the Food and Drug Administration (FDA) may receive expedited review if, among other requirements, the applicant plans to produce the drug domestically after the approval of the supplemental application. (A supplemental application generally involves a change, such as a manufacturing change, to an existing application for FDA approval.)

The bill also authorizes HHS and the Department of Defense to enter into multiyear high-volume contracts to purchase critical drugs and medical devices.

]]> HOME Act Display Title HOME Act Short Title(s) as Introduced HOME Act Introduced in Senate IS Short Title(s) as Introduced Help Onshore Manufacturing Efficiencies for Drugs and Devices Act Introduced in Senate IS Official Title as Introduced A bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains. Introduced in Senate IS Introduced in Senate 2020-05-20T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s3780is/xml/BILLS-116s3780is.xml 2020-05-20 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.