I 
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 Representa-
tives 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’’. 
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(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, con-
sequently, 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 in-
serting ‘‘; 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)’’. 
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(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 amend-
ed 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 publica-
tion). 
‘‘(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 publica-
tion). 
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‘‘(F) Medical air, as defined in the United 
States Pharmacopeia (or any successor publica-
tion). 
‘‘(G) Any other medical gas deemed appro-
priate 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 Com-
mittee’ means the Medical Gas Advisory Committee 
established under section 577. 
‘‘(4) The term ‘medical gas manufacturer’ 
means an entity that owns or operates an establish-
ment registered under section 510 that manufac-
tures, prepares, processes, packages, repackages, or 
labels a medical gas or that fills high-pressure med-
ical gas cylinders or cryogenic medical gas con-
tainers by any of the following methods: liquid to liq-
uid, liquid to gas, or gas to gas. 
‘‘SEC. 576. REGULATION OF MEDICAL GASES. 
‘‘(a) CERTIFICATION
OF
DESIGNATED
MEDICAL 
GASES.— 
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‘‘(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 SEC-
TION 510.—To the greatest extent possible, the Sec-
retary 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 appro-
priate 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 re-
quire the submission of a new drug application 
or an abbreviated new drug application under 
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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 en-
actment of this subchapter; or 
‘‘(ii) 2 years after the date on which 
the Secretary establishes applicable proce-
dures under paragraph (1). 
‘‘(B) EXCEPTIONS.—Nothing in this sub-
chapter— 
‘‘(i) prohibits the voluntary submis-
sion 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.— 
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‘‘(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 manufac-
turing practice requirements for medical gases; 
‘‘(B) separate labeling requirements for 
medical gases; 
‘‘(C) separate wholesale distribution re-
quirements 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 sec-
tion 3 of the Small Business Act); and 
‘‘(E) separate and proportionate product 
tracking and anticounterfeiting rules for med-
ical 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 
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such regulation on, and the suitability of such regu-
lation for, medical gases and medical gas manufac-
turers. 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 con-
sultation with the Medical Gas Advisory Com-
mittee, shall establish a separate risk-based in-
spection regime specific to medical gas manu-
facturers 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 manufac-
turers and medical gases. Such agreements 
shall— 
‘‘(i) ensure consistent inspector train-
ing between State and Federal authorities; 
‘‘(ii) eliminate, to the extent prac-
ticable, any overlapping fees or inspection 
fees or activities between State and Fed-
eral inspectors; 
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‘‘(iii) promote current good manufac-
turing practice compliance; 
‘‘(iv) ensure consistent application of 
Federal regulations with respect to medical 
gas manufacturers; and 
‘‘(v) include any mechanisms deter-
mined 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 in-
formation to States regarding application of 
Federal regulations to medical gas manufactur-
ers and medical gases in order to improve the 
consistency of enforcement of applicable regula-
tions. 
‘‘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. 
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‘‘(b) MEMBERSHIP.—The Medical Gas Advisory 
Committee— 
‘‘(1) shall include representatives of medical gas 
manufacturers and medical gas safety standards de-
velopment organizations; and 
‘‘(2) may include representatives of patient ad-
vocacy 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 de-
termined appropriate by the Secretary. 
‘‘(c) DUTIES.—The Medical Gas Advisory Committee 
shall provide the Secretary with regular guidance and spe-
cific advice on medical gas regulatory initiatives, including 
with respect to regulations concerning the approval of 
medical gases under sections 505 and 512, the manufac-
ture of medical gases, and related activities. 
‘‘(d) FACA.—Except as inconsistent with this sec-
tion, 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 au-
thorized by the amendment made in subsection (b) will 
be dedicated towards the costs of the Food and Drug Ad-
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ministration’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 MED-
ICAL 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 
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or collection of any fee with respect to drugs that are des-
ignated 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 regu-
lation 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 per-
cent of the costs of the Food and Drug Administra-
tion’s regulation of non-designated medical gases 
during such year; and 
‘‘(2) taking into consideration the special char-
acteristics of non-designated medical gases, includ-
ing the unique manufacturing and distribution sys-
tem required to produce non-designated medical 
gases. 
‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
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sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation 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 regula-
tion 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 avail-
able to pay the costs of the Food and Drug 
Administration’s regulation of non-des-
ignated 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 
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the costs of the Food and Drug Administra-
tion’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 fol-
lowing the subsequent fiscal year are de-
creased by the amount in excess of 3 per-
cent 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 fis-
cal 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 
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fees estimated to be collected under this section for 
fiscal year 2016 exceeds the cumulative amount ap-
propriated under paragraph (3) for the fiscal years 
2013 through 2016, the excess shall be credited to 
the appropriation account of the Food and Drug Ad-
ministration 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 med-
ical gas.’’. 
(c) 
REAUTHORIZATION; 
REPORTING
REQUIRE-
MENTS.—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 REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2013, not later than 120 days after the end of each 
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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 Sec-
retary shall prepare and submit to the Committee on En-
ergy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pen-
sions 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.— 
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‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with re-
spect 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 reauthoriza-
tion of this part for such fiscal years, the Secretary 
shall consult with— 
‘‘(A) the Committee on Energy and Com-
merce 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 con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 
negotiations with the regulated industry on the reau-
thorization of this part, the Secretary shall— 
‘‘(A) publish a notice in the Federal Reg-
ister requesting public input on the reauthoriza-
tion; 
‘‘(B) hold a public meeting at which the 
public may present its views on the reauthoriza-
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tion, 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 fre-
quently than once every month during negotiations 
with the regulated industry, the Secretary shall hold 
discussions with representatives of patient and con-
sumer advocacy groups to continue discussions of 
their views on the reauthorization and their sugges-
tions for changes to this part as expressed under 
paragraph (2). 
‘‘(4) 
PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the regulated indus-
try, the Secretary shall— 
‘‘(A) present the recommendations devel-
oped under paragraph (1) to the Congressional 
committees specified in such paragraph; 
‘‘(B) publish such recommendations in the 
Federal Register; 
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‘‘(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 recommenda-
tions; and 
‘‘(E) after consideration of such public 
views and comments, revise such recommenda-
tions as necessary. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 
Not later than January 15, 2017, the Secretary 
shall transmit to the Congress the revised rec-
ommendations under paragraph (4), a summary of 
the views and comments received under such para-
graph, and any changes made to the recommenda-
tions in response to such views and comments. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—Before pre-
senting 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 Adminis-
tration, minutes of all negotiation meetings con-
ducted under this subsection between the Food 
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and Drug Administration and the regulated in-
dustry. 
‘‘(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 amend-
ment 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 Cos-
metic 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. 
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(b) SAVINGS CLAUSE.—Except as expressly set forth 
in this Act and the amendments made by this Act, a med-
ical 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.). 
Æ 
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