Use of Ozone-Depleting Substances, 74364-74368 [2016-25850]
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74364
Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules
Part A, Subpart III, Section 44701:
General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
Airbus Helicopters (Previously Eurocopter
France): Docket No. FAA–2016–3343;
Directorate Identifier 2015–SW–078–AD.
Regulatory Findings
(b) Unsafe Condition
We determined that this proposed AD
would not have federalism implications
under Executive Order 13132. This
proposed AD would not have a
substantial direct effect on the States, on
the relationship between the national
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed, I certify
this proposed regulation:
1. Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
2. Is not a ‘‘significant rule’’ under the
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in
Alaska to the extent that it justifies
making a regulatory distinction; and
4. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared an economic evaluation
of the estimated costs to comply with
this proposed AD and placed it in the
AD docket.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
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■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by
removing Airworthiness Directive (AD)
2014–12–12, Amendment 39–17873 (79
FR 36638, June 30, 2014), and adding
the following new AD:
■
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(a) Applicability
This AD applies to the following
helicopters, certificated in any category,
except those with modification A00565, 07
3796, or 07 2921 installed:
(1) Model EC120B helicopters with a
sliding door part number (P/N)
C526A2370101 installed; and
(2) Model EC130B4 helicopters with a
sliding door P/N C526S1101051 installed.
This AD defines the unsafe condition as a
failure of the sliding door star axle support.
This condition could prevent operation of a
sliding door from inside, which could delay
evacuation of passengers during an
emergency.
(c) Affected ADs
This AD supersedes AD 2014–12–12,
Amendment 39–17873 (79 FR 36638, June
30, 2014).
(d) Comments Due Date
We must receive comments by December
27, 2016.
(e) Compliance
You are responsible for performing each
action required by this AD within the
specified compliance time unless it has
already been accomplished prior to that time.
(f) Required Actions
(1) Within 165 hours time-in-service:
(i) Visually inspect each upper and lower
locking pin control rod end fitting (control
end fitting) for a bend, twist, or breakage. If
a control end fitting is bent, twisted, or
broken, before further flight, replace the
control end fitting with an airworthy control
end fitting.
(ii) Clean and dye penetrant inspect the
star support pin for a crack in the areas
identified as Zone X and Zone Y in Figure
3 of Eurocopter Alert Service Bulletin No.
EC120–52A014, Revision 2, dated October
28, 2013 (ASB No. EC120–52A014) or
Eurocopter Alert Service Bulletin No. EC130–
52A009, Revision 1, dated January 25, 2013
(ASB No. EC130–52A009), as applicable to
your model helicopter. If there is a crack in
the star support pin, before further flight,
replace the star support pin with an
airworthy star support pin.
(iii) Reinforce the sliding door star support
stringer by installing three carbon fiber plies
and re-identify the sliding door by following
the Accomplishment Instructions, paragraphs
3.B.2.d. and 3.B.2.e of ASB No. EC120–
52A014, or paragraph 3.B.2.d. and the table
under paragraph 3.C of ASB No. EC130–
52A009, whichever is applicable to your
model helicopter.
(2) After the effective date of this AD, do
not install a sliding door P/N C526A2370101
on an EC120B helicopter, or a sliding door
P/N C526S1101051 on an EC130B4
helicopter, unless the sliding door has been
reinforced as required by paragraph (f)(1)(iii)
of this AD.
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(g) Credit for Actions Previously Completed
Compliance with AD 2014–12–12 (79 FR
366838, June 30, 2014) before the effective
date of this AD is considered acceptable for
compliance with the corresponding actions
specified in paragraph (f)(1) of this AD.
(h) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Safety Management
Group, FAA, may approve AMOCs for this
AD. Send your proposal to: David Hatfield,
Aviation Safety Engineer, Safety Management
Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177;
telephone (817) 222–5116; email 9-ASWFTW-AMOC-Requests@faa.gov.
(2) For operations conducted under a 14
CFR part 119 operating certificate or under
14 CFR part 91, subpart K, we suggest that
you notify your principal inspector, or
lacking a principal inspector, the manager of
the local flight standards district office or
certificate holding district office before
operating any aircraft complying with this
AD through an AMOC.
(i) Additional Information
The subject of this AD is addressed in
European Aviation Safety Agency (EASA) AD
No. 2015–0020, dated February 11, 2015. You
may view the EASA AD on the Internet at
https://www.regulations.gov in Docket No.
FAA–2016–3343.
(j) Subject
Joint Aircraft Service Component (JASC)
Code: 5220, Emergency Exits.
Issued in Fort Worth, Texas, on October 18,
2016.
James A. Grigg,
Acting Manager, Rotorcraft Directorate,
Aircraft Certification Service.
[FR Doc. 2016–25748 Filed 10–25–16; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 2
[Docket No. FDA–2015–N–1355]
RIN 0910–AH36
Use of Ozone-Depleting Substances
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is proposing to amend its regulation
on uses of ozone-depleting substances
(ODSs), including chlorofluorocarbons
(CFCs), to remove the designation for
certain products as ‘‘essential uses’’
under the Clean Air Act. Essential-use
products are exempt from the ban by
SUMMARY:
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Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules
FDA on the use of CFCs and other ODS
propellants in FDA-regulated products
and from the ban by the Environmental
Protection Agency (EPA) on the use of
ODSs in pressurized dispensers. This
action, if finalized, will remove the
essential-use exemptions for sterile
aerosol talc administered intrapleurally
by thoracoscopy for human use and for
metered-dose atropine sulfate aerosol
human drugs administered by oral
inhalation. FDA is proposing this action
because alternative products that do not
use ODSs are now available and because
these products are no longer being
marketed in versions that contain ODSs.
DATES: Submit either electronic or
written comments on the proposed rule
by December 27, 2016. If FDA receives
any significant adverse comments, the
Agency will publish a document
withdrawing the direct final rule before
its effective date. FDA will then proceed
to respond to comments under this
proposed rule using the usual noticeand-comment procedures.
ADDRESSES: You may submit comments
as follows:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public submit the comment as a written/
paper submission and in the manner
detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–1355 for ‘‘Use of OzoneDepleting Substances.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, 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.
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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, daniel.orr@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Production of ODSs has been phased
out worldwide under the terms of the
Montreal Protocol on Substances that
Deplete the Ozone Layer (Montreal
Protocol) (September 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.), the
manufacture of ODSs, including CFCs,
in the United States was generally
banned 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 a request by EPA for
applications for exemptions (60 FR
54349, October 23, 1995).
A drug, device, cosmetic, or food
contained in an aerosol product or other
pressurized dispenser that releases a
CFC or other ODS propellant is
generally not considered an essential
use of the ODS under the Clean Air Act
except as provided in § 2.125(c) and (e)
(21 CFR 2.125(c) and (e)). This
prohibition is based on scientific
research indicating that CFCs and other
ODSs 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 (80 FR
36937, June 29, 2015). Section 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 an ODS.
Firms that wish to use ODSs
manufactured after the phase-out date in
medical devices (as defined in section
601(8) of the Clean Air Act (42 U.S.C.
7671(8)) covered under section 610 of
the Clean Air Act (42 U.S.C. 7671i) must
receive exemptions for essential uses
under the Montreal Protocol. EPA
regulations implementing the provisions
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Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules
of section 610 of the Clean Air Act
contain a general ban on the use of
ODSs 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
§ 2.125(e). Section 601(8) of the Clean
Air Act defines ‘‘medical device’’ as any
device (as defined in the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 321), 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, has been approved by
the Commissioner of Food and Drugs),
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. 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).
Faced with the statutorily mandated
phase-out of the production of ODSs,
drug manufacturers have developed
alternatives to MDIs and other selfpressurized drug dosage forms that do
not contain ODSs. Examples of these
alternative dosage forms are MDIs that
use non-ODSs as propellants and drypowder inhalers. The availability of
alternatives to the ODSs means that
certain drug products listed in § 2.125(e)
are no longer essential uses of ODSs.
Therefore, due to the lack of marketing
of approved products containing ODSs,
and the availability of alternative
products that do not contain ODSs, FDA
is proposing to amend its regulations to
remove essential-use designations for
sterile aerosol talc administered
intrapleurally by thoracoscopy for
human use (§ 2.125(e)(4)(ix)) and for
metered-dose atropine sulfate aerosol
human drugs administered by oral
inhalation (§ 2.125(e)(4)(vi)).
There is currently one sterile aerosol
talc product containing ODSs that is
approved for administration
intrapleurally by thoracoscopy for
human use for the treatment of recurrent
malignant pleural effusion in
symptomatic patients. Section 2.125(g)
sets forth standards for determining
whether the use of an ODS in a medical
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product is no longer essential. Under
§ 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;
• 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 (§ 2.125(g)(3)).
On June 29, 2015, FDA published a
notice and request for comment
concerning its tentative conclusion that
sterile aerosol talc administered
intrapleurally by thoracoscopy for
human use no longer constitutes an
essential use under the Clean Air Act
under the criteria in (§ 2.125(g)(3). FDA
requested comment on its findings that
sterile aerosol talc is currently marketed
for intrapleural administration in two
non-ODS formulations and on its
finding that 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. FDA also requested comment on its
finding that the non-ODS products are
available in sufficient quantities to serve
the current patient population. FDA
received no comments on these findings
or on its tentative conclusion that sterile
aerosol talc administered intrapleurally
by thoracoscopy for human use no
longer constitutes an essential use of
ODSs under the Clean Air Act.
In the same document published on
June 29, 2015, FDA requested comments
concerning its tentative conclusion that
metered-dose atropine sulfate aerosol
human drugs administered by oral
inhalation no longer constitute an
essential use under the Clean Air Act
under the criteria in (§ 2.125(g)(1). FDA
requested comment concerning its
finding that metered-dose atropine
sulfate aerosol human drugs
administered by oral inhalation are no
longer marketed in an approved ODS
formulation. Under § 2.125(g)(1), an
active moiety may no longer constitute
an essential use (§ 2.125(e)) if it is no
longer marketed in an approved ODS
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formulation. The failure to market
indicates nonessentiality 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 received no comments
concerning its finding that metered-dose
atropine sulfate aerosol human drugs
administered by oral inhalation are no
longer marketed in an ODS formulation
or concerning its tentative conclusion
that these drugs no longer constitute an
essential use of ODSs under the Clean
Air Act.
Accordingly, FDA is proposing to
amend its regulation to remove sterile
aerosol talc administered intrapleurally
by thoracoscopy for human use
(§ 2.125(e)(4)(ix)) and to remove
metered-dose atropine sulfate aerosol
human drugs administered by oral
inhalation (§ 2.125(e)(4)(vi)) as essential
uses under the Clean Air Act.
II. Companion Rule to Direct Final
Rulemaking
This proposed rule is a companion
document to the direct final rule
published elsewhere in this issue of the
Federal Register. FDA is proposing to
amend § 2.125 to remove essential-use
designations for sterile aerosol talc
administered intrapleurally by
thoracoscopy for human use and for
metered-dose atropine sulfate aerosol
human drugs administered by oral
inhalation. This proposed rule is
intended to make noncontroversial
changes to existing regulations. The
Agency does not anticipate receiving
any significant adverse comment on this
rule.
Consistent with FDA’s procedures on
direct final rulemaking, we are
publishing elsewhere in this issue of the
Federal Register a companion direct
final rule. The direct final rule and this
companion proposed rule are
substantively identical. This companion
proposed rule provides the procedural
framework within which the proposed
rule may be finalized in the event the
direct final rule is withdrawn because of
any significant adverse comment. The
comment period for this proposed rule
runs concurrently with the comment
period of the companion direct final
rule. Any comments received in
response to the companion direct final
rule will also be considered as
comments regarding this proposed rule.
FDA is providing a comment period
for the proposed rule of 60 days after the
date of publication in the Federal
Register. If we receive a significant
adverse comment, we intend to
withdraw the direct final rule before its
effective date by publishing a notice in
the Federal Register within 30 days
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Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules
after the comment period ends. A
significant adverse comment explains
why the rule either would be
inappropriate, including challenges to
the rule’s underlying premise or
approach, or would be ineffective or
unacceptable without a change. In
determining whether an adverse
comment is significant and warrants
withdrawing a direct final rule, the
Agency will consider whether the
comment raises an issue serious enough
to warrant a substantive response in a
notice-and-comment process in
accordance with section 553 of the
Administrative Procedure Act (5 U.S.C.
553).
Comments that are frivolous,
insubstantial, or outside the scope of the
proposed rule will not be considered
significant or adverse under this
procedure. For example, a comment
recommending a regulation change in
addition to the changes in the proposed
rule would not be considered a
significant adverse comment unless the
comment states why the proposed rule
would be ineffective without the
additional change. In addition, if a
significant adverse comment applies to
an amendment, paragraph, or section of
this proposed rule and that provision
can be severed from the remainder of
the rule, FDA may adopt as final the
provisions of the proposed rule that are
not the subject of a significant adverse
comment.
If FDA does not receive any
significant adverse comment in
response to the proposed rule, the
Agency will publish a document in the
Federal Register confirming the
effective date of the direct final rule.
The Agency intends to make the direct
final rule effective 30 days after
publication of the confirmation
document in the Federal Register.
A full description of FDA’s policy on
direct final rule procedures may be
found in a guidance for FDA and
industry entitled ‘‘Direct Final Rule
Procedures’’ (available at https://
www.fda.gov/RegulatoryInformation/
Guidances/ucm125166.htm) that was
announced in the Federal Register on
November 21, 1997 (62 FR 62466).
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III. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the
proposed rule under Executive Order
12866, Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
Executive Orders 12866 and 13563
direct us to assess all costs and benefits
of available regulatory alternatives and,
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when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). We
have developed a comprehensive
Economic Analysis of Impacts that
assesses the impacts of the proposed
rule. We believe that this proposed rule
is not a significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities. We
propose to certify that the proposed rule
will not have a significant economic
impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before proposing
‘‘any rule that includes any Federal
mandate that may result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100,000,000 or more
(adjusted annually for inflation) in any
one year.’’ The current threshold after
adjustment for inflation is $146 million,
using the most current (2015) Implicit
Price Deflator for the Gross Domestic
Product. This proposed rule would not
result in an expenditure in any year that
meets or exceeds this amount.
B. Need for the Regulation
This rule is necessary to comply with
the Montreal Protocol under authority of
Title VI of the Clean Air Act (section
601 et seq.), which banned the
manufacture of ODSs, including CFCs,
to reduce the depletion of the ozone
layer in the United States as of January
1, 1996. EPA regulations exempted from
the ban medical devices, diagnostic
products, drugs, and drug delivery
systems that FDA considered essential
and that are listed in § 2.125(e) when
they use a class I or class II ODS for
which no safe and effective alternative
has been developed. The proposed rule
would remove the exemptions for sterile
aerosol talc products and for metereddose atropine sulfate aerosol human
drugs containing ODSs.
There is currently at least one sterile
aerosol talc product not containing
ODSs approved for administration
intrapleurally by thoracoscopy for
human use that is a safe and effective
alternative, and which meets the criteria
outlined in § 2.125(g)(3). Accordingly,
the sterile aerosol talc product
containing ODSs no longer meets the
requirements for essential use and
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74367
should no longer be exempted from the
ban.
Metered-dose atropine sulfate aerosol
human drugs administered by oral
inhalation are no longer available in the
product market in an approved ODS
formulation. The current absence of the
product in the market indicates both a
lack of demand for the product and that
the product is nonessential, under
§ 2.125(g)(1). With the adoption of this
rule, the manufacturer of the sterile
aerosol talc with ODSs and any
potential future manufacturers of
metered-dose atropine sulfate aerosols
will have notice of the requirement to
comply with the ban of products from
containing ODSs.
C. Costs and Benefits
1. Number of Affected Entities
The affected entities covered by this
rule are the manufacturing facilities of
the products that would have
exemptions from the ban removed. Only
one manufacturer, the Bryan
Corporation that manufactures the
sterile aerosol talc product containing
ODSs at a single facility, would be
affected. Currently, there are no
manufacturers of metered-dose atropine
sulfate aerosols.
2. Costs
The potential social costs from
removing the exemptions are (1) the
costs to patient consumers or to their
insurers for paying a higher price for
alternative non-ODS formulations of
sterile aerosol talc products and (2) the
costs for disposing of and destroying
any remaining product inventory that
remains after the effective date of the
final rule. We lack data about the stocks
of product inventory that are likely to
remain after the effective date of the
final rule and the relative price that
consumers or their insurers would pay.
Because significant notice has been
given to the manufacturer about the
impending removal of the exemptions,
we do not believe a significant stock of
inventory will remain for the sterile
aerosol talc product. The most recent
publicly available information shows
that the annual revenues for Bryan
Corporation are about $10 million (Ref.
1). Public information about this
company shows that it manufactures
three different surgical and medical
instruments including the talc. If total
profits for the exempt talc product are
10 percent of the total annual revenues,
and if total revenues are exclusively
from the exempt talc, then $1 million
represents an upper bound for the total
social cost of removing the sterile
aerosol talc product from the market.
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Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules
Because it is unlikely that the
company’s total profits are exclusively
from the sterile aerosol talc, it is more
likely that the foregone profits are at
most one-third of the $1 million; in fact,
the true social cost could be
significantly less than the total foregone
profit of this product.
Metered-dose atropine sulfate aerosol
human drugs that would be affected by
this rule are no longer marketed;
consequently, removal of the exemption
for these products would not present the
public, consumers, insurers, or
producers with any costs.
Lhorne on DSK30JT082PROD with PROPOSALS
3. Health Benefits
The proposed rule would implement
the requirements of the Clean Air Act
that ban the use of products containing
ODSs that no longer meet the
requirements for essential use. The
social benefits of the proposed rule
derive from greater compliance with the
Clean Air Act. The ODSs that either
would have been emitted by sterile
aerosol talcs that contain them, or from
potential market entrants that would
have manufactured metered-dose
atropine sulfate aerosols that contain
ODSs will no longer be emitting them,
which will help reduce the depletion of
the ozone layer and the ultraviolet
radiation reaching the Earth. We lack
the ability to quantify the health
benefits from the reduced exposure to
and from the reduced risk associated
with ultraviolet light that result from
removing the exemptions to the ban.
Because the change in exposure and
resulting risk from the proposed rule is
likely to be small, the incremental
health impact is likely to be too small
to measure.
D. Economic Summary
The proposed rule, if finalized, will
remove the exemptions for sterile
aerosol talc products and for metereddose atropine sulfate aerosol human
drugs containing ODSs. The primary
public health benefit from adoption of
the proposed rule is to reduce the
depletion of the ozone layer to decrease
human exposure to ultraviolet radiation.
The reduction in exposure to ultraviolet
radiation because of the rule is likely to
be too small to measure. The potential
social costs of the proposed rule would
occur if patient consumers or their
health care insurers would have to pay
more for otherwise comparable products
and if the product manufacturers would
have to safely destroy any remaining
product inventories after the effective
date of the rule. We estimate that the
social cost of the proposed rule is likely
to be significantly less than $1 million
but no more than the upper-bound
VerDate Sep<11>2014
15:05 Oct 25, 2016
Jkt 241001
estimate of the foregone annual profit of
the company that manufactures the
sterile aerosol talc or $1 million.
Because the metered-dose atropine
sulfate aerosol is not currently in the
market, there would be no social cost for
removing its exemption from the ban.
Imposing no new federal requirement
is the baseline for a regulatory analysis.
With no new regulation, there are no
compliance costs or benefits to the
proposed rule. However, because sterile
aerosol talc is no longer an essential use
of ODSs, under the Clean Air Act, there
is no longer a pathway for sterile aerosol
talc products containing ODSs to remain
on the market.
IV. Regulatory Flexibility Analysis
FDA has examined the economic
implications of the proposed rule as
required by the Regulatory Flexibility
Act. If a rule will have a significant
economic impact on a substantial
number of small entities, the Regulatory
Flexibility Act requires Agencies to
analyze regulatory options that would
lessen the economic effect of the rule on
small entities. We certify that the final
rule will not have a significant
economic impact on a substantial
number of small entities. This analysis,
together with other relevant sections of
this document, serves as the proposed
regulatory flexibility analysis, as
required under the Regulatory
Flexibility Act.
V. Analysis of Environmental Impact
We have determined under 21 CFR
25.30(h) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VI. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
proposed rule contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
VII. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. We
have determined that this proposed rule
does not contain policies that have
substantial direct effects on the States,
on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the rule does not contain
PO 00000
Frm 00054
Fmt 4702
Sfmt 4702
policies that have federalism
implications as defined in the Executive
order and, consequently, a federalism
summary impact statement is not
required.
VIII. References
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and is available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it is also available electronically
at https://www.regulations.gov. FDA has
verified the Web site address, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
1. Bryan Corporation (https://
listings.findthecompany.com/l/
12165972/Bryan-Corporation-inWoburn-MA, accessed on February 24,
2016).
List of Subjects in 21 CFR Part 2
Administrative practice and
procedure, Cosmetics, Drugs, Foods.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, we propose that 21
CFR part 2 be amended as follows:
PART 2—GENERAL ADMINISTRATIVE
RULINGS AND DECISIONS
1. The authority citation for part 2
continues to read as follows:
■
Authority: 15 U.S.C. 402, 409; 21 U.S.C.
321, 331, 335, 342, 343, 346a, 348, 351, 352,
355, 360b, 361, 362, 371, 372, 374; 42 U.S.C.
7671 et seq.
§ 2.125
[Amended]
2. In § 2.125, remove and reserve
paragraphs (e)(4)(vi) and (ix).
■
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25850 Filed 10–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 2
[Docket No. FDA–2015–N–1355]
RIN 0910–AH36
Use of Ozone-Depleting Substances
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\26OCP1.SGM
Proposed rule.
26OCP1
Agencies
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Proposed Rules]
[Pages 74364-74368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25850]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 2
[Docket No. FDA-2015-N-1355]
RIN 0910-AH36
Use of Ozone-Depleting Substances
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend its regulation on uses of ozone-depleting substances
(ODSs), including chlorofluorocarbons (CFCs), to remove the designation
for certain products as ``essential uses'' under the Clean Air Act.
Essential-use products are exempt from the ban by
[[Page 74365]]
FDA on the use of CFCs and other ODS propellants in FDA-regulated
products and from the ban by the Environmental Protection Agency (EPA)
on the use of ODSs in pressurized dispensers. This action, if
finalized, will remove the essential-use exemptions for sterile aerosol
talc administered intrapleurally by thoracoscopy for human use and for
metered-dose atropine sulfate aerosol human drugs administered by oral
inhalation. FDA is proposing this action because alternative products
that do not use ODSs are now available and because these products are
no longer being marketed in versions that contain ODSs.
DATES: Submit either electronic or written comments on the proposed
rule by December 27, 2016. If FDA receives any significant adverse
comments, the Agency will publish a document withdrawing the direct
final rule before its effective date. FDA will then proceed to respond
to comments under this proposed rule using the usual notice-and-comment
procedures.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-1355 for ``Use of Ozone-Depleting Substances.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, 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,
daniel.orr@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Production of ODSs has been phased out worldwide under the terms of
the Montreal Protocol on Substances that Deplete the Ozone Layer
(Montreal Protocol) (September 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.), the manufacture of ODSs, including
CFCs, in the United States was generally banned 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 a request by EPA for applications for
exemptions (60 FR 54349, October 23, 1995).
A drug, device, cosmetic, or food contained in an aerosol product
or other pressurized dispenser that releases a CFC or other ODS
propellant is generally not considered an essential use of the ODS
under the Clean Air Act except as provided in Sec. 2.125(c) and (e)
(21 CFR 2.125(c) and (e)). This prohibition is based on scientific
research indicating that CFCs and other ODSs 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 (80 FR
36937, June 29, 2015). Section 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 an ODS.
Firms that wish to use ODSs manufactured after the phase-out date
in medical devices (as defined in section 601(8) of the Clean Air Act
(42 U.S.C. 7671(8)) covered under section 610 of the Clean Air Act (42
U.S.C. 7671i) must receive exemptions for essential uses under the
Montreal Protocol. EPA regulations implementing the provisions
[[Page 74366]]
of section 610 of the Clean Air Act contain a general ban on the use of
ODSs 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 Sec. 2.125(e). Section 601(8) of the Clean Air Act
defines ``medical device'' as any device (as defined in the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321), 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, has been approved by the
Commissioner of Food and Drugs), 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. 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).
Faced with the statutorily mandated phase-out of the production of
ODSs, 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 availability of alternatives
to the ODSs means that certain drug products listed in Sec. 2.125(e)
are no longer essential uses of ODSs. Therefore, due to the lack of
marketing of approved products containing ODSs, and the availability of
alternative products that do not contain ODSs, FDA is proposing to
amend its regulations to remove essential-use designations for sterile
aerosol talc administered intrapleurally by thoracoscopy for human use
(Sec. 2.125(e)(4)(ix)) and for metered-dose atropine sulfate aerosol
human drugs administered by oral inhalation (Sec. 2.125(e)(4)(vi)).
There is currently one sterile aerosol talc product containing ODSs
that is approved for administration intrapleurally by thoracoscopy for
human use for the treatment of recurrent malignant pleural effusion in
symptomatic patients. Section 2.125(g) sets forth standards for
determining whether the use of an ODS in a medical product is no longer
essential. Under Sec. 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;
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 (Sec. 2.125(g)(3)).
On June 29, 2015, FDA published a notice and request for comment
concerning its tentative conclusion that sterile aerosol talc
administered intrapleurally by thoracoscopy for human use no longer
constitutes an essential use under the Clean Air Act under the criteria
in (Sec. 2.125(g)(3). FDA requested comment on its findings that
sterile aerosol talc is currently marketed for intrapleural
administration in two non-ODS formulations and on its finding that 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. FDA also requested comment on its finding that the non-ODS
products are available in sufficient quantities to serve the current
patient population. FDA received no comments on these findings or on
its tentative conclusion that sterile aerosol talc administered
intrapleurally by thoracoscopy for human use no longer constitutes an
essential use of ODSs under the Clean Air Act.
In the same document published on June 29, 2015, FDA requested
comments concerning its tentative conclusion that metered-dose atropine
sulfate aerosol human drugs administered by oral inhalation no longer
constitute an essential use under the Clean Air Act under the criteria
in (Sec. 2.125(g)(1). FDA requested comment concerning its finding
that metered-dose atropine sulfate aerosol human drugs administered by
oral inhalation are no longer marketed in an approved ODS formulation.
Under Sec. 2.125(g)(1), an active moiety may no longer constitute an
essential use (Sec. 2.125(e)) if it is no longer marketed in an
approved ODS formulation. The failure to market indicates
nonessentiality 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 received no comments concerning its finding that
metered-dose atropine sulfate aerosol human drugs administered by oral
inhalation are no longer marketed in an ODS formulation or concerning
its tentative conclusion that these drugs no longer constitute an
essential use of ODSs under the Clean Air Act.
Accordingly, FDA is proposing to amend its regulation to remove
sterile aerosol talc administered intrapleurally by thoracoscopy for
human use (Sec. 2.125(e)(4)(ix)) and to remove metered-dose atropine
sulfate aerosol human drugs administered by oral inhalation (Sec.
2.125(e)(4)(vi)) as essential uses under the Clean Air Act.
II. Companion Rule to Direct Final Rulemaking
This proposed rule is a companion document to the direct final rule
published elsewhere in this issue of the Federal Register. FDA is
proposing to amend Sec. 2.125 to remove essential-use designations for
sterile aerosol talc administered intrapleurally by thoracoscopy for
human use and for metered-dose atropine sulfate aerosol human drugs
administered by oral inhalation. This proposed rule is intended to make
noncontroversial changes to existing regulations. The Agency does not
anticipate receiving any significant adverse comment on this rule.
Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
direct final rule. The direct final rule and this companion proposed
rule are substantively identical. This companion proposed rule provides
the procedural framework within which the proposed rule may be
finalized in the event the direct final rule is withdrawn because of
any significant adverse comment. The comment period for this proposed
rule runs concurrently with the comment period of the companion direct
final rule. Any comments received in response to the companion direct
final rule will also be considered as comments regarding this proposed
rule.
FDA is providing a comment period for the proposed rule of 60 days
after the date of publication in the Federal Register. If we receive a
significant adverse comment, we intend to withdraw the direct final
rule before its effective date by publishing a notice in the Federal
Register within 30 days
[[Page 74367]]
after the comment period ends. A significant adverse comment explains
why the rule either would be inappropriate, including challenges to the
rule's underlying premise or approach, or would be ineffective or
unacceptable without a change. In determining whether an adverse
comment is significant and warrants withdrawing a direct final rule,
the Agency will consider whether the comment raises an issue serious
enough to warrant a substantive response in a notice-and-comment
process in accordance with section 553 of the Administrative Procedure
Act (5 U.S.C. 553).
Comments that are frivolous, insubstantial, or outside the scope of
the proposed rule will not be considered significant or adverse under
this procedure. For example, a comment recommending a regulation change
in addition to the changes in the proposed rule would not be considered
a significant adverse comment unless the comment states why the
proposed rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to an amendment,
paragraph, or section of this proposed rule and that provision can be
severed from the remainder of the rule, FDA may adopt as final the
provisions of the proposed rule that are not the subject of a
significant adverse comment.
If FDA does not receive any significant adverse comment in response
to the proposed rule, the Agency will publish a document in the Federal
Register confirming the effective date of the direct final rule. The
Agency intends to make the direct final rule effective 30 days after
publication of the confirmation document in the Federal Register.
A full description of FDA's policy on direct final rule procedures
may be found in a guidance for FDA and industry entitled ``Direct Final
Rule Procedures'' (available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm) that was announced in
the Federal Register on November 21, 1997 (62 FR 62466).
III. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the proposed rule. We believe that this
proposed rule is not a significant regulatory action as defined by
Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We propose to certify that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $146 million, using the most current (2015) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
B. Need for the Regulation
This rule is necessary to comply with the Montreal Protocol under
authority of Title VI of the Clean Air Act (section 601 et seq.), which
banned the manufacture of ODSs, including CFCs, to reduce the depletion
of the ozone layer in the United States as of January 1, 1996. EPA
regulations exempted from the ban medical devices, diagnostic products,
drugs, and drug delivery systems that FDA considered essential and that
are listed in Sec. 2.125(e) when they use a class I or class II ODS
for which no safe and effective alternative has been developed. The
proposed rule would remove the exemptions for sterile aerosol talc
products and for metered-dose atropine sulfate aerosol human drugs
containing ODSs.
There is currently at least one sterile aerosol talc product not
containing ODSs approved for administration intrapleurally by
thoracoscopy for human use that is a safe and effective alternative,
and which meets the criteria outlined in Sec. 2.125(g)(3).
Accordingly, the sterile aerosol talc product containing ODSs no longer
meets the requirements for essential use and should no longer be
exempted from the ban.
Metered-dose atropine sulfate aerosol human drugs administered by
oral inhalation are no longer available in the product market in an
approved ODS formulation. The current absence of the product in the
market indicates both a lack of demand for the product and that the
product is nonessential, under Sec. 2.125(g)(1). With the adoption of
this rule, the manufacturer of the sterile aerosol talc with ODSs and
any potential future manufacturers of metered-dose atropine sulfate
aerosols will have notice of the requirement to comply with the ban of
products from containing ODSs.
C. Costs and Benefits
1. Number of Affected Entities
The affected entities covered by this rule are the manufacturing
facilities of the products that would have exemptions from the ban
removed. Only one manufacturer, the Bryan Corporation that manufactures
the sterile aerosol talc product containing ODSs at a single facility,
would be affected. Currently, there are no manufacturers of metered-
dose atropine sulfate aerosols.
2. Costs
The potential social costs from removing the exemptions are (1) the
costs to patient consumers or to their insurers for paying a higher
price for alternative non-ODS formulations of sterile aerosol talc
products and (2) the costs for disposing of and destroying any
remaining product inventory that remains after the effective date of
the final rule. We lack data about the stocks of product inventory that
are likely to remain after the effective date of the final rule and the
relative price that consumers or their insurers would pay. Because
significant notice has been given to the manufacturer about the
impending removal of the exemptions, we do not believe a significant
stock of inventory will remain for the sterile aerosol talc product.
The most recent publicly available information shows that the annual
revenues for Bryan Corporation are about $10 million (Ref. 1). Public
information about this company shows that it manufactures three
different surgical and medical instruments including the talc. If total
profits for the exempt talc product are 10 percent of the total annual
revenues, and if total revenues are exclusively from the exempt talc,
then $1 million represents an upper bound for the total social cost of
removing the sterile aerosol talc product from the market.
[[Page 74368]]
Because it is unlikely that the company's total profits are exclusively
from the sterile aerosol talc, it is more likely that the foregone
profits are at most one-third of the $1 million; in fact, the true
social cost could be significantly less than the total foregone profit
of this product.
Metered-dose atropine sulfate aerosol human drugs that would be
affected by this rule are no longer marketed; consequently, removal of
the exemption for these products would not present the public,
consumers, insurers, or producers with any costs.
3. Health Benefits
The proposed rule would implement the requirements of the Clean Air
Act that ban the use of products containing ODSs that no longer meet
the requirements for essential use. The social benefits of the proposed
rule derive from greater compliance with the Clean Air Act. The ODSs
that either would have been emitted by sterile aerosol talcs that
contain them, or from potential market entrants that would have
manufactured metered-dose atropine sulfate aerosols that contain ODSs
will no longer be emitting them, which will help reduce the depletion
of the ozone layer and the ultraviolet radiation reaching the Earth. We
lack the ability to quantify the health benefits from the reduced
exposure to and from the reduced risk associated with ultraviolet light
that result from removing the exemptions to the ban. Because the change
in exposure and resulting risk from the proposed rule is likely to be
small, the incremental health impact is likely to be too small to
measure.
D. Economic Summary
The proposed rule, if finalized, will remove the exemptions for
sterile aerosol talc products and for metered-dose atropine sulfate
aerosol human drugs containing ODSs. The primary public health benefit
from adoption of the proposed rule is to reduce the depletion of the
ozone layer to decrease human exposure to ultraviolet radiation. The
reduction in exposure to ultraviolet radiation because of the rule is
likely to be too small to measure. The potential social costs of the
proposed rule would occur if patient consumers or their health care
insurers would have to pay more for otherwise comparable products and
if the product manufacturers would have to safely destroy any remaining
product inventories after the effective date of the rule. We estimate
that the social cost of the proposed rule is likely to be significantly
less than $1 million but no more than the upper-bound estimate of the
foregone annual profit of the company that manufactures the sterile
aerosol talc or $1 million. Because the metered-dose atropine sulfate
aerosol is not currently in the market, there would be no social cost
for removing its exemption from the ban.
Imposing no new federal requirement is the baseline for a
regulatory analysis. With no new regulation, there are no compliance
costs or benefits to the proposed rule. However, because sterile
aerosol talc is no longer an essential use of ODSs, under the Clean Air
Act, there is no longer a pathway for sterile aerosol talc products
containing ODSs to remain on the market.
IV. Regulatory Flexibility Analysis
FDA has examined the economic implications of the proposed rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires Agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. We certify that the final rule will not have a significant
economic impact on a substantial number of small entities. This
analysis, together with other relevant sections of this document,
serves as the proposed regulatory flexibility analysis, as required
under the Regulatory Flexibility Act.
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
VII. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
VIII. References
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. Bryan Corporation (https://listings.findthecompany.com/l/12165972/Bryan-Corporation-in-Woburn-MA, accessed on February 24, 2016).
List of Subjects in 21 CFR Part 2
Administrative practice and procedure, Cosmetics, Drugs, Foods.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR part 2 be amended as follows:
PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
0
1. The authority citation for part 2 continues to read as follows:
Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342,
343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42
U.S.C. 7671 et seq.
Sec. 2.125 [Amended]
0
2. In Sec. 2.125, remove and reserve paragraphs (e)(4)(vi) and (ix).
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25850 Filed 10-25-16; 8:45 am]
BILLING CODE 4164-01-P