3.0.0 2227 2019-11-15T21:21:13Z 2019-11-15T21:21:13Z House H HR 2011-06-16 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LANCE:H.R. 2227.Congress has the power to enact this legislation pursuantto the following:Article I of the Constitution of the United States.[Page H4329]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-06-22T19:22:45Z Referred to 2011-06-16T13:04:30Z 2011-06-22 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-06-16 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-06-16 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-06-16 Introduced in House IntroReferral 1000 9 Library of Congress L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 N M001169 Rep. Murphy, Christopher [D-CT-5] Christopher Murphy D CT S. 5 2011-06-16 True R000573 Rep. Ross, Mike [D-AR-4] MIKE ROSS D AR 4 2011-07-14 False B001252 Rep. Barrow, John [D-GA-12] John Barrow D GA 12 2011-11-02 False E000179 Rep. Engel, Eliot L. [D-NY-17] ELIOT ENGEL D NY L. 17 2011-11-02 False M001142 Rep. Matheson, Jim [D-UT-2] JIM MATHESON D UT 2 2011-11-02 False S001155 Rep. Sullivan, John [R-OK-1] John Sullivan R OK 1 2012-02-01 False G000550 Rep. Gingrey, Phil [R-GA-11] Phil Gingrey R GA 11 2012-03-13 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2012-03-13 False C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2012-03-28 False C001058 Rep. Chandler, Ben [D-KY-6] Ben Chandler D KY 6 2012-04-17 False Health Administrative law and regulatory procedures Advisory bodies Cardiovascular and respiratory health Department of Health and Human Services Drug safety, medical device, and laboratory regulation Licensing and registrations Surgery and anesthesia User charges and fees Health 00 2011-06-16 Introduced in House 2011-09-28T20:19:02Z Medical Gas Safety Act - Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions regarding the regulation of medical gases, including to establish a certification and approval process for medical gases. Lists designated medical gases, including oxygen, nitrous oxide, and medical air. Requires the Secretary to: (1) approve a certification for designated medical gases; and (2) establish by rule appropriate procedures for the approval of medical gases that are not designated medical gases.

Requires the Secretary to establish regulations for medical gases, including: (1) appropriate current good manufacturing practice requirements, (2) separate labeling requirements, (3) separate wholesale distribution requirements, (4) a streamlined electronic process for registration and listing of medical gases, and (5) separate and proportionate product tracking and anti-counterfeiting rules for medical gases.

Requires the Secretary to establish: (1) a separate risk-based inspection regime specific to medical gas manufacturers that ensures coordination with state and local inspection activities, and (2) the Medical Gas Advisory Committee to provide the Secretary with regular guidance and specific advice on medical gas regulatory activities.

Directs the Secretary to assess and collect fees with respect to drugs that are non-designated medical gases, and establish the amount of fees to generate the total amount of costs of the Food and Drug Administration's (FDA's) regulation of non-designated medical gases. Exempts medical gases from new drug fees and new animal drug fees.

]]> Medical Gas Safety Act Short Titles as Introduced Medical Gas Safety Act Display Title Medical Gas Safety Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of medical gases, taking into account the special characteristics of medical gases, the special techniques and processes required to produce medical gases, and the established history of safe and effective use of medical gases. Introduced in House 2011-06-16T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr2227ih/xml/BILLS-112hr2227ih.xml 2011-06-22 Referred to the Subcommittee on Health. 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.