Use of Ozone-Depleting Substances, 74298-74302 [2016-25851]
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[FR Doc. 2016–25785 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:
Direct final rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is amending 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 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. The products
that will no longer constitute an
essential use are: Sterile aerosol talc
administered intrapleurally by
thoracoscopy for human use and
metered-dose atropine sulfate aerosol
human drugs administered by oral
inhalation. FDA is taking 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: This direct final rule is effective
February 23, 2017. Submit either
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SUMMARY:
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electronic or written comments on the
direct final rule by December 27, 2016.
If FDA receives no significant adverse
comments within the specified
comment period, the Agency will
publish a document confirming the
effective date of the final rule in the
Federal Register within 30 days after
the comment period on this direct final
rule ends. If timely significant adverse
comments are received, the Agency will
publish a document in the Federal
Register withdrawing this direct final
rule before its effective date.
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
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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 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
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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.
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).
Firms that wish to use ODSs
manufactured after the phase-out date in
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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.CC. 7671i)
must receive exemptions for essential
uses under the Montreal Protocol. EPA
regulations implementing the provisions
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)
(21 CFR 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).
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).
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.
Faced with the statutorily mandated
phase-out of the production of ODSs,
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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 ODSs means that certain
drug products listed in § 2.125(e) are no
longer essential uses of ODSs.
Therefore, due to lack of marketing of
approved products containing ODSs,
and the availability of alternative
products that do not contain ODSs, FDA
is amending 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
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
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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
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 amending 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.
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II. Direct Final Rulemaking
FDA has determined that the subject
of this rulemaking is suitable for a direct
final rule. FDA is amending § 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
rule is intended to make
noncontroversial changes to existing
regulations. The Agency does not
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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 proposed
rule. The companion proposed rule and
this direct final rule are substantively
identical. The 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 direct final rule
runs concurrently with the comment
period of the companion proposed rule.
Any comments received in response to
the companion proposed rule will also
be considered as comments regarding
this direct final rule.
FDA is providing a comment period
for the direct final rule of 60 days after
the date of publication in the Federal
Register. If we receive any significant
adverse comment, we intend to
withdraw this direct final rule before its
effective date by publishing a notice in
the Federal Register within 30 days
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
direct final 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 direct
final rule would not be considered a
significant adverse comment unless the
comment states why the rule would be
ineffective without the additional
change. In addition, if a significant
adverse comment applies to an
amendment, paragraph, or section of
this rule and that provision can be
severed from the remainder of the rule,
FDA may adopt as final the provisions
of the rule that are not the subject of a
significant adverse comment.
If FDA does not receive any
significant adverse comment in
response to the direct final rule, the
Agency will publish a document in the
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Federal Register confirming the
effective date of the 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 on https://
www.fda.gov/RegulatoryInformation/
Guidances/ucm125166.htm) that was
announced in the Federal Register of
November 21, 1997 (62 FR 62466).
III. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the
direct final 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 final 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
certify that the direct final 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 issuing ‘‘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 direct final 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
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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 direct final
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 the 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 an 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
§ 2.125(g)(1). With the adoption of this
direct final 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 requirements to
comply with the ban of products from
containing ODSs.
C. Benefits and Costs
1. Number of Affected Entities
The affected entities covered by this
direct final 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.
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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
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any remaining product inventory that
remains after the effective date of the
direct final rule. We lack data about the
remaining stocks of product inventory
that are likely to remain after the
effective date of the direct 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 publically
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. Because it is
unlikely that their 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 this product would not present the
public, consumers, insurers, or
producers with any costs.
3. Health Benefits
The direct final rule implements 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 direct final 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 final rule is likely
to be small, the incremental health
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74301
impact is likely to be too small to
measure.
D. Economic Summary
The direct final rule 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 direct final 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 direct rule is likely to be
too small to measure. The potential
social costs of the direct final 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 direct final 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
direct final 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. Final Regulatory Flexibility
Analysis
FDA has examined the economic
implications of the direct final 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 direct
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 final
regulatory flexibility analysis, as
required under the Regulatory
Flexibility Act.
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Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Rules and Regulations
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 concludes that this direct final
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 final rule in
accordance with the principles set forth
in Executive Order 13132. We have
determined that this final 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.
Lhorne on DSK30JT082PROD with RULES
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, 21 CFR part 2 is
amended as follows:
PART 2—GENERAL ADMINISTRATIVE
RULINGS AND DECISIONS
1. The authority citation for part 2
continues to read as follows:
■
VerDate Sep<11>2014
15:02 Oct 25, 2016
Jkt 241001
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. 2016–25851 Filed 10–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
30 CFR Part 901
[SATS No. AL–079–FOR; Docket ID:
OSMRE–2016–0005; S1D1S SS08011000
SX064A000 178S180110; S2D2S
SS08011000 SX064A000 17XS501520]
Alabama Regulatory Program
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Final rule; approval of
amendment.
AGENCY:
We, the Office of Surface
Mining Reclamation and Enforcement
(OSMRE), are approving an amendment
to the Alabama regulatory program
(Alabama program) under the Surface
Mining Control and Reclamation Act of
1977 (SMCRA or the Act). Alabama
proposed revisions to its Program to
closely follow the Federal regulations
regarding awarding of appropriate costs
and expenses including attorneys’ fees.
Alabama is revising its program to be no
less effective than the Federal
regulations.
DATES: Effective Date: October 26, 2016.
FOR FURTHER INFORMATION CONTACT:
Sherry Wilson, Director, Birmingham
Field Office, Office of Surface Mining
Reclamation and Enforcement, 135
Gemini Circle, Suite 215, Homewood,
AL 35209. Telephone: (205) 290–7282.
Email: swilson@osmre.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background on the Alabama Program
II. Submission of the Amendment
III. OSMRE’s Findings
IV. Summary and Disposition of Comments
V. OSMRE’s Decision
VI. Procedural Determinations
I. Background on the Alabama Program
Section 503(a) of the Act permits a
State to assume primacy for the
regulation of surface coal mining and
reclamation operations on non-Federal
and non-Indian lands within its borders
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
by demonstrating that its program
includes, among other things, State laws
and regulations that govern surface coal
mining and reclamation operations in
accordance with the Act and consistent
with the Federal regulations. See 30
U.S.C. 1253(a)(1) and (7). On the basis
of these criteria, the Secretary of the
Interior conditionally approved the
Alabama program effective May 20,
1982. You can find background
information on the Alabama program,
including the Secretary’s findings, the
disposition of comments, and the
conditions of approval of the Alabama
program in the May 20, 1982, Federal
Register (47 FR 22030). You can also
find later actions concerning the
Alabama program and program
amendments at 30 CFR 901.10 and
901.15.
II. Submission of the Amendment
By letter dated March 18, 2016
(Administrative Record No. AL–0669),
Alabama sent us an amendment to its
program under SMCRA (30 U.S.C. 1201
et seq.) at its own initiative.
We announced receipt of the
proposed amendment in the May 20,
2016, Federal Register (81 FR 31881). In
the same document, we opened the
public comment period and provided an
opportunity for a public hearing or
meeting on the adequacy of the
amendment. We did not hold a public
hearing or meeting because no one
requested one. The public comment
period ended on June 20, 2016. We
received one public comment
(Administrative Record No. AL–0669–
04) that is addressed in the ‘‘Public
Comments’’ section of part IV. Summary
and Disposition of Comments.
III. OSMRE’s Findings
We are approving the amendment as
described below. The following are the
findings we made concerning Alabama’s
amendment under SMCRA and the
Federal regulations at 30 CFR 732.15
and 732.17. Any revisions that we do
not specifically discuss below
concerning non-substantive wording or
editorial changes can be found in the
full text of the program amendment
available at www.regulations.gov.
1. Alabama Code 880–X–5A–.35—
Assessment of Costs
Alabama revised this section to allow
any party the opportunity to be awarded
costs and expenses by a final appellate
body. Additionally, language was added
to protect the public by including a
‘‘bad faith’’ clause so that expenses may
only be assessed against any person in
favor of the permittee or the regulatory
authority upon demonstration that the
E:\FR\FM\26OCR1.SGM
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Agencies
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Rules and Regulations]
[Pages 74298-74302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25851]
=======================================================================
-----------------------------------------------------------------------
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: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending 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 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. The products that will no longer constitute an
essential use are: Sterile aerosol talc administered intrapleurally by
thoracoscopy for human use and metered-dose atropine sulfate aerosol
human drugs administered by oral inhalation. FDA is taking 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: This direct final rule is effective February 23, 2017. Submit
either electronic or written comments on the direct final rule by
December 27, 2016. If FDA receives no significant adverse comments
within the specified comment period, the Agency will publish a document
confirming the effective date of the final rule in the Federal Register
within 30 days after the comment period on this direct final rule ends.
If timely significant adverse comments are received, the Agency will
publish a document in the Federal Register withdrawing this direct
final rule before its effective date.
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
[[Page 74299]]
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).
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.CC. 7671i) must receive exemptions for essential uses under the
Montreal Protocol. EPA regulations implementing the provisions 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) (21 CFR 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).
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).
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.
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 ODSs means that certain drug products listed in Sec. 2.125(e) are
no longer essential uses of ODSs. Therefore, due to lack of marketing
of approved products containing ODSs, and the availability of
alternative products that do not contain ODSs, FDA is amending 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
[[Page 74300]]
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 amending 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. Direct Final Rulemaking
FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. FDA is amending 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 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
proposed rule. The companion proposed rule and this direct final rule
are substantively identical. The 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 direct final rule runs
concurrently with the comment period of the companion proposed rule.
Any comments received in response to the companion proposed rule will
also be considered as comments regarding this direct final rule.
FDA is providing a comment period for the direct final rule of 60
days after the date of publication in the Federal Register. If we
receive any significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publishing a notice in
the Federal Register within 30 days 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 direct final 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 direct final rule would not be
considered a significant adverse comment unless the comment states why
the rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to an amendment,
paragraph, or section of this rule and that provision can be severed
from the remainder of the rule, FDA may adopt as final the provisions
of the rule that are not the subject of a significant adverse comment.
If FDA does not receive any significant adverse comment in response
to the direct final rule, the Agency will publish a document in the
Federal Register confirming the effective date of the 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 on https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm) that was announced in
the Federal Register of November 21, 1997 (62 FR 62466).
III. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the direct final 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 final 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 certify that the direct final 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 issuing ``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 direct final 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
[[Page 74301]]
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 direct final
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 the 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 an 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 direct final 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 requirements to
comply with the ban of products from containing ODSs.
C. Benefits and Costs
1. Number of Affected Entities
The affected entities covered by this direct final 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 direct final rule. We lack data about the remaining stocks of
product inventory that are likely to remain after the effective date of
the direct 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 publically 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. Because it is unlikely that their 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 this product would not present the public, consumers,
insurers, or producers with any costs.
3. Health Benefits
The direct final rule implements 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 direct
final 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 final rule is likely to be
small, the incremental health impact is likely to be too small to
measure.
D. Economic Summary
The direct final rule 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 direct final 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 direct
rule is likely to be too small to measure. The potential social costs
of the direct final 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 direct final 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 direct final 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. Final Regulatory Flexibility Analysis
FDA has examined the economic implications of the direct final 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 direct 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 final regulatory flexibility analysis, as required under
the Regulatory Flexibility Act.
[[Page 74302]]
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 concludes that this direct final 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 final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that this final
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, 21 CFR part
2 is 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. 2016-25851 Filed 10-25-16; 8:45 am]
BILLING CODE 4164-01-P