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.
[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.).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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