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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2227 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 2227

 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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             June 16, 2011

 Mr. Lance (for himself and Mr. Murphy of Connecticut) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL

 
 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Medical Gas Safety 
Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Regulation of medical gases.
Sec. 4. Fees relating to medical gas regulation.
Sec. 5. Miscellaneous provisions.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Medical gases have been used broadly by the medical 
        community for many decades and are critical to ensuring the 
        public health.
            (2) Most medical gases predate the new drug approval 
        provisions in the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 301 et seq.) and, consequently, medical gases have been 
        marketed for many years without new drug approval.

SEC. 3. REGULATION OF MEDICAL GASES.

    (a) Adulteration.--
            (1) In general.--Section 501(a)(2) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)) is amended by 
        striking ``; or (3)'' and inserting ``; or (D) if it is a 
        medical gas (as defined in section 575) and it is manufactured, 
        prepared, processed, packed, or held in violation of subchapter 
        G or regulations thereunder; or (3)''.
            (2) Applicability.--The amendment made by paragraph (1) 
        applies beginning on the date that is 2 years after the date of 
        the enactment of this Act.
    (b) Regulation.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

                     ``Subchapter G--Medical Gases

``SEC. 575. DEFINITIONS.

    ``In this subchapter:
            ``(1) The term `designated medical gas' means any of the 
        following:
                    ``(A) Oxygen, as defined in the United States 
                Pharmacopeia (or any successor publication).
                    ``(B) Nitrogen, as defined in the National 
                Formulary (or any successor publication).
                    ``(C) Nitrous oxide, as defined in the United 
                States Pharmacopeia (or any successor publication).
                    ``(D) Carbon dioxide, as defined in the United 
                States Pharmacopeia (or any successor publication).
                    ``(E) Helium, as defined in the United States 
                Pharmacopeia (or any successor publication).
                    ``(F) Medical air, as defined in the United States 
                Pharmacopeia (or any successor publication).
                    ``(G) Any other medical gas deemed appropriate by 
                the Secretary.
            ``(2) The term `medical gas' means a drug that is--
                    ``(A) manufactured or stored in a liquefied, non-
                liquefied, or cryogenic state; and
                    ``(B) is administered as a gas.
            ``(3) The term `Medical Gas Advisory Committee' means the 
        Medical Gas Advisory Committee established under section 577.
            ``(4) The term `medical gas manufacturer' means an entity 
        that owns or operates an establishment registered under section 
        510 that manufactures, prepares, processes, packages, 
        repackages, or labels a medical gas or that fills high-pressure 
        medical gas cylinders or cryogenic medical gas containers by 
        any of the following methods: liquid to liquid, liquid to gas, 
        or gas to gas.

``SEC. 576. REGULATION OF MEDICAL GASES.

    ``(a) Certification of Designated Medical Gases.--
            ``(1) Submission.--Any person may file with the Secretary a 
        certification that a medical gas is a designated medical gas.
            ``(2) Approval of certification.--The Secretary shall 
        approve a certification submitted under paragraph (1) with 
        respect to a medical gas if the certification demonstrates to 
        the Secretary's satisfaction that the medical gas is a 
        designated medical gas.
            ``(3) Effect of approval of certification.--
                    ``(A) In general.--A medical gas subject to a 
                certification for which an approval is in effect under 
                paragraph (2) is deemed to be approved pursuant to an 
                application filed pursuant to section 505(b) or 
                512(b)(1), as applicable, for--
                            ``(i) those indications for which the 
                        medical gas has been marketed to a material 
                        extent for a material time; or
                            ``(ii) for administration in a supervised 
                        clinical setting under the direction of a 
                        medical or veterinary, as applicable, 
                        professional.
                    ``(B) Inapplicability of exclusivity provisions.--
                Sections 505(c)(3)(E), 505(j)(5)(F), and 512(c)(2)(F) 
                do not apply with respect to the approval of a 
                designated medical gas under this subsection.
            ``(4) Registration and listing under section 510.--To the 
        greatest extent possible, the Secretary shall streamline the 
        certification and approval process under this subsection with 
        the registration and listing process under section 510.
    ``(b) Approval of Non-Designated Medical Gases.--
            ``(1) Procedures.--Not later than 2 years after the date of 
        the enactment of this subchapter, the Secretary, in 
        consultation with the Medical Gas Advisory Committee, shall 
        establish by rule appropriate procedures for the approval of 
        medical gases that are not designated medical gases pursuant to 
        section 505 or 512, as applicable.
            ``(2) Submission of new drug applications and abbreviated 
        new drug applications.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the Secretary shall not require the 
                submission of a new drug application or an abbreviated 
                new drug application under subsection (b) or (j) of 
                section 505, or a new animal drug application or an 
                abbreviated new animal drug application under 
                subsection (b)(1) or (b)(2) of section 512, for any 
                medical gas that is not a designated medical gas during 
                the period ending on the later of--
                            ``(i) 4 years after the date of the 
                        enactment of this subchapter; or
                            ``(ii) 2 years after the date on which the 
                        Secretary establishes applicable procedures 
                        under paragraph (1).
                    ``(B) Exceptions.--Nothing in this subchapter--
                            ``(i) prohibits the voluntary submission of 
                        an application under subsection (b) or (j) of 
                        section 505 or subsection (b)(1) or (b)(2) of 
                        section 512 for a medical gas; or
                            ``(ii) constitutes an exemption from the 
                        requirements under section 505(i) or section 
                        512(j) (relating to investigational new drugs 
                        and investigational new animal drugs, 
                        respectively).
    ``(c) Separate Regulations for Medical Gases.--
            ``(1) In general.--Not later than 2 years after the date of 
        the enactment of this subchapter, the Secretary, in 
        consultation with the Medical Gas Advisory Committee, shall 
        establish by separate and specific regulation--
                    ``(A) appropriate current good manufacturing 
                practice requirements for medical gases;
                    ``(B) separate labeling requirements for medical 
                gases;
                    ``(C) separate wholesale distribution requirements 
                for medical gases;
                    ``(D) a streamlined electronic process for 
                registration, and listing of medical gases, under 
                section 510 by medical gas manufacturers that are small 
                business concerns (as defined in section 3 of the Small 
                Business Act); and
                    ``(E) separate and proportionate product tracking 
                and anticounterfeiting rules for medical gases.
            ``(2) Evaluation in rulemaking.--In any regulation of the 
        Food and Drug Administration pertaining to drugs or drug 
        manufacturers that is pending finalization as of the date of 
        the enactment of this subchapter or is proposed after such 
        date, the Secretary shall specifically evaluate the effect of 
        such regulation on, and the suitability of such regulation for, 
        medical gases and medical gas manufacturers. Based on such 
        evaluation, the Secretary shall include in the regulation an 
        accommodation, unique application, or exemption for medical 
        gases and medical gas manufacturers as appropriate given the 
        special characteristics of medical gases.
            ``(3) Coordination with states.--
                    ``(A) In general.--The Secretary, in consultation 
                with the Medical Gas Advisory Committee, shall 
                establish a separate risk-based inspection regime 
                specific to medical gas manufacturers that ensures 
                coordination with State and local inspection activities 
                and seek to enter into partnership agreements in order 
                to improve the coordination and efficiency of Federal 
                and State efforts to regulate medical gas manufacturers 
                and medical gases. Such agreements shall--
                            ``(i) ensure consistent inspector training 
                        between State and Federal authorities;
                            ``(ii) eliminate, to the extent 
                        practicable, any overlapping fees or inspection 
                        fees or activities between State and Federal 
                        inspectors;
                            ``(iii) promote current good manufacturing 
                        practice compliance;
                            ``(iv) ensure consistent application of 
                        Federal regulations with respect to medical gas 
                        manufacturers; and
                            ``(v) include any mechanisms determined by 
                        the Secretary, in consultation with the Medical 
                        Gas Advisory Committee, to improve the 
                        coordination and efficiency of Federal and 
                        State efforts to regulate medical gas 
                        manufacturers and medical gases.
                    ``(B) Dissemination of information.--The Secretary 
                shall disseminate appropriate information to States 
                regarding application of Federal regulations to medical 
                gas manufacturers and medical gases in order to improve 
                the consistency of enforcement of applicable 
                regulations.

``SEC. 577. MEDICAL GAS ADVISORY COMMITTEE.

    ``(a) Establishment.--Not later than 6 months after the date of the 
enactment of this subchapter, the Secretary shall establish a permanent 
advisory committee to be known as the Medical Gas Advisory Committee.
    ``(b) Membership.--The Medical Gas Advisory Committee--
            ``(1) shall include representatives of medical gas 
        manufacturers and medical gas safety standards development 
        organizations; and
            ``(2) may include representatives of patient advocacy 
        groups, professional associations, physicians, scientists, 
        other medical professionals licensed to manufacture or use 
        medical gases (such as pulmonologists, respiratory therapists, 
        veterinarians, and anesthesiologists), and other stakeholders 
        as determined appropriate by the Secretary.
    ``(c) Duties.--The Medical Gas Advisory Committee shall provide the 
Secretary with regular guidance and specific advice on medical gas 
regulatory initiatives, including with respect to regulations 
concerning the approval of medical gases under sections 505 and 512, 
the manufacture of medical gases, and related activities.
    ``(d) FACA.--Except as inconsistent with this section, the Medical 
Gas Advisory Committee shall be subject to the Federal Advisory 
Committee Act.''.

SEC. 4. FEES RELATING TO MEDICAL GAS REGULATION.

    (a) Finding.--The Congress finds that the fees authorized by the 
amendment made in subsection (b) will be dedicated towards the costs of 
the Food and Drug Administration's regulation of non-designated medical 
gases, as set forth in the goals identified for purposes of part 6 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and Human Services to 
the Chairman of the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Congressional 
Record.
    (b) Authority To Assess and Collect Fees.--Subchapter C of chapter 
VII (21 U.S.C. 379f et seq.) is amended by adding at the end the 
following:

                ``PART 6--FEES RELATING TO MEDICAL GASES

``SEC. 744. AUTHORITY TO ASSESS AND COLLECT FEES.

    ``(a) Fees Relating to Non-Designated Medical Gases.--For fiscal 
year 2013 and each subsequent fiscal year, the Secretary, in 
consultation with the Medical Gas Advisory Committee, shall assess and 
collect fees under this section from each category of persons that, 
with respect to drugs that are non-designated medical gases, would be 
subject to a fee under section 736(a), 740(a), or 741(a) but for the 
operation of subsection (c).
    ``(b) Exemption for Designated Medical Gases.--Subsection (a) does 
not authorize the assessment or collection of any fee with respect to 
drugs that are designated medical gases.
    ``(c) Inapplicability of Other Drug Fees to Medical Gases.--Fees 
under sections 736(a), 740(a), and 741(a) shall not be assessed or 
collected insofar as such fees relate to drugs that are medical gases.
    ``(d) Establishment.--The Secretary shall by regulation establish 
the amount of fees under this section for a fiscal year--
            ``(1) so as to generate a total revenue amount not 
        exceeding the Secretary's estimate of 100 percent of the costs 
        of the Food and Drug Administration's regulation of non-
        designated medical gases during such year; and
            ``(2) taking into consideration the special characteristics 
        of non-designated medical gases, including the unique 
        manufacturing and distribution system required to produce non-
        designated medical gases.
    ``(e) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the costs of the Food and Drug Administration's 
        regulation of non-designated medical gases.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                            ``(i) shall be retained in each fiscal year 
                        in an amount not to exceed the amount specified 
                        in appropriation Acts, or otherwise made 
                        available for obligation, for such fiscal year; 
                        and
                            ``(ii) shall only be collected and 
                        available to pay the costs of the Food and Drug 
                        Administration's regulation of non-designated 
                        medical gases.
                    ``(B) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (A)(ii) in any fiscal year if the costs funded by 
                appropriations and allocated for the costs of the Food 
                and Drug Administration's regulation of non-designated 
                medical gases--
                            ``(i) are not more than 3 percent below the 
                        level specified in subparagraph (A)(ii); or
                            ``(ii)(I) are more than 3 percent below the 
                        level specified in subparagraph (A)(ii), and 
                        fees assessed for the fiscal year following the 
                        subsequent fiscal year are decreased by the 
                        amount in excess of 3 percent by which such 
                        costs fell below the level specified in such 
                        subparagraph; and
                            ``(II) such costs are not more than 5 
                        percent below the level specified in such 
                        subparagraph.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2013 through 2017, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total revenue amount determined under subsection (d) for the 
        fiscal year.
            ``(4) Offset.--If the sum of the cumulative amount of fees 
        collected under this section for the fiscal years 2013 through 
        2015 and the amount of fees estimated to be collected under 
        this section for fiscal year 2016 exceeds the cumulative amount 
        appropriated under paragraph (3) for the fiscal years 2013 
        through 2016, the excess shall be credited to the appropriation 
        account of the Food and Drug Administration as provided in 
        paragraph (1), and shall be subtracted from the amount of fees 
        that would otherwise be authorized to be collected under this 
        section pursuant to appropriation Acts for fiscal year 2017.
    ``(f) Definitions.--In this section:
            ``(1) The terms `designated medical gas' and `medical gas' 
        have the meanings given to such terms in section 575.
            ``(2) The term `non-designated medical gas' means a medical 
        gas that is not a designated medical gas.''.
    (c) Reauthorization; Reporting Requirements.--Part 6 of subchapter 
C of chapter VII (21 U.S.C. 379f et seq.), as added by subsection (a), 
is further amended by adding at the end the following:

``SEC. 744A. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Performance Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 4(a) of the Medical Gas Safety Act during such 
fiscal year and the future plans of the Food and Drug Administration 
for meeting the goals.
    ``(b) Fiscal Report.--Beginning with fiscal year 2013, not later 
than 120 days after the end of each fiscal year for which fees are 
collected under this part, the Secretary shall prepare and submit to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report on the implementation of the authority for such fees 
during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
Internet Web site of the Food and Drug Administration.
    ``(d) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and plans 
        for meeting the goals, for the Food and Drug Administration's 
        regulation of non-designated medical gases for the first 5 
        fiscal years after fiscal year 2017, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Prior public input.--Prior to beginning negotiations 
        with the regulated industry on the reauthorization of this 
        part, the Secretary shall--
                    ``(A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                    ``(B) hold a public meeting at which the public may 
                present its views on the reauthorization, including 
                specific suggestions for changes to the goals referred 
                to in subsection (a);
                    ``(C) provide a period of 30 days after the public 
                meeting to obtain written comments from the public 
                suggesting changes to this part; and
                    ``(D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
            ``(3) Periodic consultation.--Not less frequently than once 
        every month during negotiations with the regulated industry, 
        the Secretary shall hold discussions with representatives of 
        patient and consumer advocacy groups to continue discussions of 
        their views on the reauthorization and their suggestions for 
        changes to this part as expressed under paragraph (2).
            ``(4) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(5) Transmittal of recommendations.--Not later than 
        January 15, 2017, the Secretary shall transmit to the Congress 
        the revised recommendations under paragraph (4), a summary of 
        the views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
            ``(6) Minutes of negotiation meetings.--
                    ``(A) Public availability.--Before presenting the 
                recommendations developed under paragraphs (1) through 
                (5) to the Congress, the Secretary shall make publicly 
                available, on the public Web site of the Food and Drug 
                Administration, minutes of all negotiation meetings 
                conducted under this subsection between the Food and 
                Drug Administration and the regulated industry.
                    ``(B) Content.--The minutes described under 
                subparagraph (A) shall summarize any substantive 
                proposal made by any party to the negotiations as well 
                as significant controversies or differences of opinion 
                during the negotiations and their resolution.''.
    (d) Sunset Dates.--
            (1) Authorization.--The amendment made by subsection (b) 
        ceases to be effective October 1, 2017.
            (2) Reporting requirements.--The amendment made by 
        subsection (c) ceases to be effective January 31, 2018.

SEC. 5. MISCELLANEOUS PROVISIONS.

    (a) Rule of Construction.--Nothing in this Act and the amendments 
made by this Act shall be construed to impair any approval of an 
application submitted under section 505 or 512 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) for a medical gas (as defined in 
section 575 of the Federal Food, Drug, and Cosmetic Act, as added by 
section 3(b) of this Act) that occurred prior to the date of the 
enactment of this Act.
    (b) Savings Clause.--Except as expressly set forth in this Act and 
the amendments made by this Act, a medical gas (as defined in section 
575 of the Federal Food, Drug, and Cosmetic Act, as added by section 
3(b) of this Act) shall be subject to all applicable requirements for 
drugs under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.).
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