80 FR 36937 - Use of Ozone-Depleting Substances; Request for Comment Concerning Essential-Use Designations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 124 (June 29, 2015)

Page Range		36937-36939
FR Document		2015-15902

The Food and Drug Administration (FDA or Agency) is seeking public comment on whether the uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), in certain FDA-regulated products currently designated essential are no longer essential under the Clean Air Act due to the availability of alternatives that do not use CFCs or because the products are no longer being marketed. Essential-use products are exempt from FDA's ban on the use of CFC propellants in FDA-regulated products and the Environmental Protection Agency's (EPA's) ban on the use of CFCs in pressurized dispensers. FDA is seeking public comment because it is responsible for determining which FDA-regulated products that release CFCs or other ODSs are essential uses under the Clean Air Act. FDA is soliciting comments to assist the Agency in striking an appropriate balance that will best protect the public health, both by ensuring the availability of an adequate number of alternatives and by curtailing the release of ODSs.

Federal Register, Volume 80 Issue 124 (Monday, June 29, 2015)

[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Proposed Rules]
[Pages 36937-36939]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. FDA-2015-N-1355]


Use of Ozone-Depleting Substances; Request for Comment Concerning 
Essential-Use Designations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice and request for public comment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is seeking 
public comment on whether the uses of ozone-depleting substances 
(ODSs), including chlorofluorocarbons (CFCs), in certain FDA-regulated 
products currently designated essential are no longer essential under 
the Clean Air Act due to the availability of alternatives that do not 
use CFCs or because the products are no longer being marketed. 
Essential-use products are exempt from FDA's ban on the use of CFC 
propellants in FDA-regulated products and the Environmental Protection 
Agency's (EPA's) ban on the use of CFCs in pressurized dispensers. FDA 
is seeking public comment because it is responsible for determining 
which FDA-regulated products that release CFCs or other ODSs are 
essential uses under the Clean Air Act. FDA is soliciting comments to 
assist the Agency in striking an appropriate balance that will best 
protect the public health, both by ensuring the availability of an 
adequate number of alternatives and by curtailing the release of ODSs.

DATES: Submit written or electronic comments by August 28, 2015.

[[Page 36938]]


ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket 
No(s). ([INSERT]). All comments received may be posted without change 
to http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240-402-0979, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Any drug, device, cosmetic, or food contained in an aerosol product 
or other pressurized dispenser that releases a CFC or other ODS 
propellant is not an essential use of the ODS under the Clean Air Act 
except as provided in 21 CFR 2.125(c) and (e). This prohibition is 
based on scientific research indicating that CFCs reduce the amount of 
ozone in the stratosphere and thereby increase the amount of 
ultraviolet radiation reaching the Earth. An increase in ultraviolet 
radiation will increase the incidence of skin cancer, and produce other 
adverse effects of unknown magnitude on humans, animals, and plants. 
Sections 2.125(c) and (e) provide exemptions for essential uses of ODSs 
for certain products containing ODS propellants that FDA determines 
provide unique health benefits that would not be available without the 
use of a CFC.
    EPA regulations implementing the provisions of section 610 of the 
Clean Air Act (42 U.S.C. 7671i) contain a general ban on the use of 
CFCs in pressurized dispensers, such as metered-dose inhalers (MDIs) 
(40 CFR 82.64(c) and 82.66(d)). These EPA regulations exempt from the 
general ban ``medical devices'' that FDA considers essential and that 
are listed in 21 CFR 2.125(e). Section 601(8) of the Clean Air Act (42 
U.S.C. 7671(8)) defines ``medical device'' as any device (as defined in 
the FD&C Act), diagnostic product, drug (as defined in the FD&C Act), 
and drug delivery system, if such device, diagnostic product, drug, or 
drug delivery system uses a class I or class II ODS for which no safe 
and effective alternative has been developed (and, where necessary, 
approved by the Commissioner of Food and Drugs (the Commissioner)); and 
if such device, diagnostic product, drug, or drug delivery system has, 
after notice and opportunity for public comment, been approved and 
determined to be essential by the Commissioner in consultation with the 
Administrator of EPA (the Administrator). Class I substances include 
CFCs, halons, carbon tetrachloride, methyl chloroform, methyl bromide, 
and other chemicals not relevant to this document (see 40 CFR part 82, 
appendix A to subpart A). Class II substances include 
hydrochlorofluorocarbons (see 40 CFR part 82, appendix B to subpart A).
    Production of ODSs is being phased out worldwide under the terms of 
the Montreal Protocol on Substances that Deplete the Ozone Layer 
(Montreal Protocol), Sept. 16, 1987, S. Treaty Doc. No. 10, 100th 
Cong., 1st sess., 26 I.L.M. 1541 (1987). In accordance with the 
provisions of the Montreal Protocol, under authority of Title VI of the 
Clean Air Act (section 601 et seq.), manufacture of ODSs, including 
CFCs, in the United States was banned generally as of January 1, 1996. 
To receive permission to manufacture CFCs in the United States after 
the phase-out date, manufacturers must obtain an exemption from the 
phase-out requirements from the Parties to the Montreal Protocol. 
Procedures for securing an essential-use exemption under the Montreal 
Protocol are described in the most recent request by EPA for 
applications for exemptions (60 FR 54349, October 23, 1995). Firms that 
wish to use CFCs manufactured after the phase-out date in medical 
devices (as defined in section 601(8) of the Clean Air Act) covered 
under section 610 of the Clean Air Act must receive exemptions for 
essential uses under the Montreal Protocol.
    Faced with the statutorily mandated phase-out of the production of 
CFCs, drug manufacturers have developed alternatives to MDIs and other 
self-pressurized drug dosage forms that do not contain ODSs. Examples 
of these alternative dosage forms are MDIs that use non-ODSs as 
propellants and dry-powder inhalers. The current and future 
availability of technically feasible alternatives to the use of a CFC 
may mean that the existing listing of an essential use in 21 CFR 
2.125(e) no longer reflects current conditions. It is with this 
situation in mind that FDA is seeking public comment regarding the 
Agency's consideration of whether certain uses of ODSs are no longer 
essential.
    FDA is soliciting comments to assist the Agency in striking an 
appropriate balance that will best protect the public health by 
ensuring the availability of an adequate number of treatment 
alternatives and by curtailing the release of ODSs.

II. Listed Uses That May No Longer Be Considered Essential

    There are certain uses of CFCs currently listed in 21 CFR 2.125(e) 
as essential that may no longer be considered as essential. Section 
2.125(g) sets forth standards for determining whether the use of an ODS 
in a medical product is no longer essential. FDA is seeking public 
comment concerning whether the following uses should still be 
considered essential:

A. Sterile Aerosol Talc Administered Intrapleurally by Thoracoscopy for 
Human Use (21 CFR 2.125(e)(4)(ix))

    There is currently one sterile aerosol talc product containing ODSs 
which is approved for administration intrapleurally by thoracoscopy for 
human use for the treatment of recurrent malignant pleural effusion 
(MPE) in symptomatic patients. Under 21 CFR 2.125(g)(3), an essential-
use designation for individual active moieties marketed as ODS products 
and represented by one new drug application may no longer be essential 
if:
     At least one non-ODS product with the same active moiety 
is marketed with the same route of administration, for the same 
indication, and with approximately the same level of convenience of use 
as the ODS product containing that active moiety;
     Supplies and production capacity for the non-ODS 
product(s) exist or will exist at levels sufficient to meet patient 
need;

[[Page 36939]]

     Adequate U.S. postmarketing-use data are available for the 
non-ODS product(s); and
     Patients who medically require the ODS product are 
adequately served by the non-ODS product(s) containing that active 
moiety and other available products (21 CFR 2.125(g)(3)).
    Sterile aerosol talc is currently marketed for intrapleural 
administration in two non-ODS formulations--powder and aerosol. Sterile 
aerosol talc is a powder formulation of talc available for intrapleural 
administration via chest tube. Sclerosol Intrapleural Aerosol (sterile 
talc powder) is an aerosol formulation which contains the propellant, 
hydrofluoroalkane (HFA) 134a and is approved for intrapleural 
administration. Sclerosol Intrapleural Alcohol, a form of aerosol 
sterile talc, is indicated for the treatment of recurrent MPE in 
symptomatic patients.
    The route of administration, indications, and level of convenience 
appear to be the same for the ODS and non-ODS formulations of sterile 
aerosol talc. Moreover, because production of non-ODS formulations are 
not limited by restrictions on the use of ODSs, the Agency believes 
that non-ODS formulations can be produced at greater quantities and 
have the potential to be more widely available than prior formulations 
that contained ODSs. In addition, there is adequate U.S. postmarketing-
use data indicating that the non-ODS products are available in 
sufficient quantities to serve the current patient population. For 
these reasons, we believe that patients may be adequately served by the 
non-ODS products containing sterile aerosol talc. Thus, FDA is seeking 
public comment concerning whether sterile aerosol talc administered 
intrapleurally by thoracoscopy for human use is no longer an essential 
use of ODSs described in 21 CFR 2.125(e).

B. Drug Products That Are No Longer Being Marketed

    Under 21 CFR 2.125(g)(1), an active moiety may no longer be an 
essential-use (21 CFR 2.125(e)) if it is no longer marketed in an 
approved ODS formulation. FDA believes failure to market indicates non-
essentiality because the absence of a demand sufficient for even one 
company to market the product is highly indicative that the use is not 
essential.
    FDA is seeking public comment as to whether metered-dose atropine 
sulfate aerosol human drugs administered by oral inhalation (21 CFR 
2.125(e)(4)(vi)) and anesthetic drugs for topical use on accessible 
mucous membranes of humans where a cannula is used for application (21 
CFR 2.125(e)(4)(iii)) are no longer essential uses as described at 21 
CFR 2.125(e). FDA has information that these products are not currently 
being marketed in an approved form that releases ODSs, and, under 21 
CFR 2.125(g)(1), they may no longer constitute an essential-use. 
Because these products are no longer being marketed, FDA does not 
believe that loss of essential use status would not result in any drugs 
being made unavailable to patients.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15902 Filed 6-26-15; 8:45 am]
 BILLING CODE 4164-01-P

36937

Proposed Rules Federal Register
Vol. 80, No. 124

Monday, June 29, 2015

This section of the FEDERAL REGISTER • Fax: (202) 482–0827. Include RIN this notice must be resubmitted in order
contains notices to the public of the proposed 0605–AA38 in the subject line. to be considered.
issuance of rules and regulations. The • Mail: Dr. Michael Toland, Office of If no comments are received, a rule
purpose of these notices is to give interested will be published, effective as proposed
Privacy and Open Government, 1401
persons an opportunity to participate in the in 80 FR 26499 (May 8, 2015) on the
rule making prior to the adoption of the final Constitution Ave. NW., Washington, DC
20230. date of publication, in the Federal
rules.
Instructions: All submissions received Register.
must include the agency name and Dated: June 19, 2015.
DEPARMENT OF COMMERCE docket number or RIN for this Catrina D. Purvis,
rulemaking. All comments received will Department of Commerce, Chief Privacy
Office of the Secretary be posted without change to Officer and Director for Open Government.
regulations.gov, including any personal [FR Doc. 2015–15865 Filed 6–26–15; 8:45 am]
15 CFR Part 4 information received. For detailed BILLING CODE 3510–BX–P
[Docket No. 150324296–5527–02] instructions on submitting comments
and additional information on the
RIN 0605–AA38 rulemaking process, see the ‘‘Public DEPARTMENT OF HEALTH AND
Public Information, Freedom of Participation’’ heading of the HUMAN SERVICES
Information Act and Privacy Act SUPPLEMENTARY INFORMATION section for
Regulations the proposed rule published May 8, Food and Drug Administration
2015 (80 FR 26499).
AGENCY: Office of the Secretary, U.S. FOR FURTHER INFORMATION CONTACT: Dr. 21 CFR Part 2
Department of Commerce. Michael Toland, Office of Privacy and [Docket No. FDA–2015–N–1355]
ACTION: Proposed rule; reopening of Open Government, 1401 Constitution
public comment period. Ave. NW., Washington, DC 20230, (202) Use of Ozone-Depleting Substances;
SUMMARY: On May 8, 2015, the 482–3842. Request for Comment Concerning
Department of Commerce (Department) SUPPLEMENTARY INFORMATION: On May 8, Essential-Use Designations
published in the Federal Register a 2015, the Department of Commerce AGENCY: Food and Drug Administration,
proposed rule to revise the Department’s published in the Federal Register a rule HHS.
regulations under the Privacy Act. In proposing revisions to the Department’s Notice and request for public
ACTION:
particular, the Department proposed to Privacy Act regulations under the comment.
amend its regulations regarding Privacy Act. The revisions of the
applicable exemptions to the Privacy Privacy Act regulations in subpart B of SUMMARY: The Food and Drug
Act to reflect new Department wide part 4 incorporate changes to the Administration (FDA or Agency) is
systems of records notices published language in the regulations in the seeking public comment on whether the
since the last time the regulations were following provisions: § 4.33 (General uses of ozone-depleting substances
updated. The Department opened a exemptions); and § 4.34 (Specific (ODSs), including chlorofluorocarbons
public comment period through June 8, Exemptions). See 80 FR 26499, May 8, (CFCs), in certain FDA-regulated
2015. The Department is reopening the 2015. In the original proposal, the products currently designated essential
original public comment period of 30 Department requested comment on or are no longer essential under the Clean
days for the proposed rulemaking for an before June 8, 2015. The public Air Act due to the availability of
additional 30 days from the date of comment period is being reopened alternatives that do not use CFCs or
publication of this notice. The because not all interested parties may because the products are no longer
reopening is necessary because not all have been given adequate notice, as well being marketed. Essential-use products
interested parties may have been given as time to respond with comments about are exempt from FDA’s ban on the use
appropriate notification about this the Department’s proposal to revise its of CFC propellants in FDA-regulated
proposed new system of records, as well regulations under the Privacy Act of products and the Environmental
as time to respond with comments prior 1974. This reopening will provide an Protection Agency’s (EPA’s) ban on the
to the closing date of the original public opportunity for appropriate review and use of CFCs in pressurized dispensers.
comment period of June 8, 2015. comment of the proposed rulemaking FDA is seeking public comment because
DATES: The comment period for the now posted in regulations.gov, RIN it is responsible for determining which
proposed rule published May 8, 2015 0605–AA38, or in the public docket, FDA-regulated products that release
(80 FR 26499), is reopened. To be Docket ID No. 150324296–5265–01, for CFCs or other ODSs are essential uses
considered, written comments must be 30 days from the date of today’s under the Clean Air Act. FDA is
Lhorne on DSK7TPTVN1PROD with PROPOSALS

submitted on or before July 29, 2015. publication. soliciting comments to assist the Agency
ADDRESSES: You may submit written All previously submitted comments in striking an appropriate balance that
comments, identified by Regulatory will be responded to as appropriate, and will best protect the public health, both
Identification Number (RIN) 0605– members of the public who have by ensuring the availability of an
AA38, by any of the following methods: submitted comments during the prior adequate number of alternatives and by
• Federal eRulemaking Portal: http:// comment period need not resubmit curtailing the release of ODSs.
www.regulations.gov. Follow the them at this time. Comments received DATES: Submit written or electronic
instructions for submitting comments. after June 8, but before publication of comments by August 28, 2015.

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Federal Register / Vol. 80, No. 124 / Monday, June 29, 2015 / Proposed Rules 36939

• Adequate U.S. postmarketing-use application (21 CFR 2.125(e)(4)(iii)) are ADDRESSES: To ensure that you do not
data are available for the non-ODS no longer essential uses as described at duplicate your docket submissions,
product(s); and 21 CFR 2.125(e). FDA has information please submit them by only one of the
• Patients who medically require the that these products are not currently following means:
ODS product are adequately served by being marketed in an approved form • Federal eRulemaking Portal: Go to
the non-ODS product(s) containing that that releases ODSs, and, under 21 CFR http://www.regulations.gov and follow
active moiety and other available 2.125(g)(1), they may no longer the online instructions for submitting
products (21 CFR 2.125(g)(3)). constitute an essential-use. Because comments.
Sterile aerosol talc is currently these products are no longer being • Mail: Docket Management Facility,
marketed for intrapleural administration marketed, FDA does not believe that U.S. Department of Transportation, 1200
in two non-ODS formulations—powder loss of essential use status would not New Jersey Ave. SE., West Building
and aerosol. Sterile aerosol talc is a result in any drugs being made Ground Floor Room W12–140,
powder formulation of talc available for unavailable to patients. Washington, DC 20590–0001;
intrapleural administration via chest • Hand Delivery: West Building
tube. Sclerosol Intrapleural Aerosol III. Comments Ground Floor, Room W12–140, 1200
(sterile talc powder) is an aerosol Interested persons may submit either New Jersey Ave. SE., between 9 a.m. 5
formulation which contains the electronic comments regarding this p.m., Monday through Friday, except
propellant, hydrofluoroalkane (HFA) document to http://www.regulations.gov Federal holidays. The telephone number
134a and is approved for intrapleural or written comments to the Division of is (202) 366–9329;
administration. Sclerosol Intrapleural Dockets Management (see ADDRESSES). It • Instructions: You must include the
Alcohol, a form of aerosol sterile talc, is is only necessary to send one set of agency name and docket number DOT–
indicated for the treatment of recurrent comments. Identify comments with the FHWA-or the Regulatory Identification
MPE in symptomatic patients. docket number found in brackets in the Number (RIN) for the rulemaking at the
The route of administration, heading of this document. Received beginning of your comments. All
indications, and level of convenience comments may be seen in the Division comments received will be posted
appear to be the same for the ODS and of Dockets Management between 9 a.m. without change to http://
non-ODS formulations of sterile aerosol and 4 p.m., Monday through Friday, and www.regulations.gov, including any
talc. Moreover, because production of will be posted to the docket at http:// personal information provided.
non-ODS formulations are not limited www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Mr.
by restrictions on the use of ODSs, the
Agency believes that non-ODS Dated: June 24, 2015. Gerald Yakowenko, Contract
formulations can be produced at greater Leslie Kux, Administration Team Leader, Office of
quantities and have the potential to be Associate Commissioner for Policy. Program Administration, (202) 366–
more widely available than prior [FR Doc. 2015–15902 Filed 6–26–15; 8:45 am] 1562, or Ms. Janet Myers, Office of the
formulations that contained ODSs. In BILLING CODE 4164–01–P
Chief Counsel, (202) 366–2019, Federal
addition, there is adequate U.S. Highway Administration, 1200 New
postmarketing-use data indicating that Jersey Avenue SE., Washington, DC
the non-ODS products are available in 20590. Office hours are from 8 a.m. to
DEPARTMENT OF TRANSPORTATION
sufficient quantities to serve the current 4:30 p.m., E.T., Monday through Friday,
patient population. For these reasons, Federal Highway Administration except Federal holidays.
we believe that patients may be SUPPLEMENTARY INFORMATION:
adequately served by the non-ODS 23 CFR Parts 630 and 635 Summary
products containing sterile aerosol talc. [Docket No. FHWA–2015–0009; FHWA RIN
Thus, FDA is seeking public comment This regulatory action is undertaken
2125–AF61
concerning whether sterile aerosol talc to fulfill the statutory requirement in
administered intrapleurally by Construction Manager/General Section 1303(b) of MAP–21 requiring
thoracoscopy for human use is no longer Contractor Contracting the Secretary to promulgate a regulation
an essential use of ODSs described in 21 to implement the CM/GC method of
CFR 2.125(e). AGENCY: Federal Highway contracting. The CM/GC is a contracting
Administration, DOT. method that allows a contracting agency
B. Drug Products That Are No Longer ACTION: Notice of proposed rulemaking to use a single procurement to secure
Being Marketed (NPRM); request for comments. pre-construction and construction
Under 21 CFR 2.125(g)(1), an active services. In the pre-construction
moiety may no longer be an essential- SUMMARY: Section 1303 of the Moving services phase, a contracting agency
use (21 CFR 2.125(e)) if it is no longer Ahead for Progress in the 21st Century procures the services of a construction
marketed in an approved ODS Act (MAP–21) amends 23 U.S.C. 112 to contractor early in the design phase of
formulation. FDA believes failure to require the Secretary of Transportation a project in order to obtain the
market indicates non-essentiality to promulgate regulations as necessary contractor’s input on constructability
because the absence of a demand to implement the Construction issues that may be affected by the
sufficient for even one company to Manager/General Contractor (CM/GC) project design. A CM/GC contractor
market the product is highly indicative contracting method. This NPRM does not provide any preliminary or
initiates the formal rulemaking process
Lhorne on DSK7TPTVN1PROD with PROPOSALS

that the use is not essential. final design services. As part of the
FDA is seeking public comment as to to fulfill the legislative requirement and preconstruction services phase of a CM/
whether metered-dose atropine sulfate establish such regulations as are GC contract, the CM/GC contractor
aerosol human drugs administered by necessary for the FHWA’s approval of provides information for consideration
oral inhalation (21 CFR 2.125(e)(4)(vi)) projects using the CM/GC method of in the design and environmental review
and anesthetic drugs for topical use on contracting. processes on construction-related
accessible mucous membranes of DATES: Comments must be received on aspects of a project, including the
humans where a cannula is used for or before August 28, 2015. potential effects of design elements on

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Document Created: 2015-12-15 14:24:58
Document Modified: 2015-12-15 14:24:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice and request for public comment.
Dates		Submit written or electronic comments by August 28, 2015.
Contact		Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240-402-0979, [email protected]
FR Citation		80 FR 36937

80 FR 36937 - Use of Ozone-Depleting Substances; Request for Comment Concerning Essential-Use Designations

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 124 (June 29, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration