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HR 2227 112th Congress House 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

Medical Gas Safety Act

Introduced: June 16, 2011 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 22, 2011
Referred to the Subcommittee on Health.
Jun 16, 2011
Referred to the House Committee on Energy and Commerce.
Jun 16, 2011
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now June 22, 2011

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2