Use of Ozone-Depleting Substances, 74368-74372 [2016-25852]
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74368
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
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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
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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:
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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
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 exemption for anesthetic
drugs for topical use on accessible
mucous membranes of humans where a
cannula is used for application. FDA is
proposing this action because these
products are no longer being marketed
in approved versions that contain ODSs
and because alternative products that do
not use ODSs are now available.
DATES: Submit either electronic or
written comments on the proposed rule
by December 27, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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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
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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
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).
Firms that wished 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
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 & 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
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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 generally
is 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). Sections 2.125(c)
and (e) provide exemptions for essential
uses of ODSs for certain products
containing ODS propellants that FDA
determines provide unique health
benefits that would not be available
without the use of an ODS.
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 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 an
approved product containing an ODS,
and the availability of alternative
products that do not contain an ODS,
FDA is proposing to amend its
regulations to remove the essential-use
designation for anesthetic drugs for
topical use on accessible mucous
membranes of humans where a cannula
is used for application
(§ 2.125(e)(4)(iii)).
On June 29, 2015, FDA published a
notice and request for comment
concerning its tentative conclusion that
anesthetic drugs for topical use on
accessible mucous membranes of
humans where a cannula is used for
application no longer constitute an
essential use under the Clean Air Act
(June 2015 notice). FDA requested
comment concerning its tentative
finding that anesthetic drugs for topical
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use on accessible mucous membranes of
humans where a cannula is used for
application are no longer being sold 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.
II. Comment on the June 2015 Notice
and FDA Response
FDA received one comment
concerning its tentative finding that
anesthetic drugs for topical use on
accessible mucous membranes of
humans where a cannula is used for
application are no longer marketed in an
approved ODS formulation and,
therefore, no longer constitute an
essential use (see June 2015 notice). On
August 21, 2015, Cetylite Industries,
Inc. (Cetylite) submitted a comment
stating that ‘‘FDA’s belief that no
products are marketed under this
exemption is incorrect’’ (Comment 1).
According to the comment, Cetylite
manufactures Cetacaine Spray
(CETACAINE), a topical anesthetic
spray with an active ingredient
combination of benzocaine, tetracaine
HCl, and butamben that uses a blend of
CFCs as the propellant under the
essential-use exemption found in
§ 2.125(e)(4)(iii). However, CETACAINE
is not an approved drug product and
does not qualify as an essential use
under § 2.125(e)(4)(iii). As described in
§ 2.125(c), an aerosol drug product or
other pressurized dispenser that releases
an ODS is an essential use of the ODS
under the Clean Air Act only if it is
listed in § 2.125(e) and if an
investigational application or an
approved marketing application is in
effect.
Cetylite states that CETACAINE has
been marketed continuously since the
mid-1950s under a request for a Drug
Efficacy Study Implementation (DESI)
review that was submitted in 1976. FDA
published a DESI notice (DESI 8076
(Docket No. 75N–0203) in the Federal
Register of December 9, 1975 (40 FR
57379)) in which the Agency offered an
opportunity for a hearing on a proposal
to withdraw approval of a combination
drug product containing two of the three
ingredients contained in CETACAINE.
In response to this DESI notice, Cetylite
requested a hearing regarding the
effectiveness of CETACAINE. While
FDA’s review of the product’s
effectiveness has been pending, Cetylite
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has been marketing CETACAINE
without an approved new drug
application.
In 1979, based on a citizen petition
submitted by Cetylite regarding its
CETACAINE product, FDA proposed
that anesthetic drugs for topical use on
accessible mucous membranes of
humans where a cannula is used for
application were essential uses of ODSs
(44 FR 33114, June 8, 1979) (1979
Proposed Rule). In the preamble to the
1979 Proposed Rule, FDA noted that its
tentative finding as to CETACAINE’s
essentiality under § 2.125 was
‘‘conditional’’ on the product being
found effective. Similarly, in the
preamble to the Final Rule amending
§ 2.125, FDA stated that ‘‘the
determination in this document that
CETACAINE Aerosol is an essential use
of a chlorofluorocarbon is also
conditional’’ on a finding that
CETACAINE is effective for the use
described in § 2.125(e)(4)(iii) (45 FR
22902, April 4, 1980).
To date, FDA has not made a finding
that CETACAINE is effective for the use
described in § 2.125(e)(4)(iii). There is
no investigational new drug application
or approved marketing application in
effect for the ODS formulation of
CETACAINE, as required for a finding of
essentiality under § 2.125(c).
Accordingly, CETACAINE does not
meet the conditions to qualify as an
essential use of ODSs under
§ 2.125(e)(4)(iii), and FDA believes that
its proposed finding that anesthetic
drugs for topical use on accessible
mucous membranes of humans where a
cannula is used for application are no
longer marketed in an approved ODS
formulation remains correct. Moreover,
alternative products for the same use
that do not use ODSs, such as lidocaine,
are now available, further suggesting
that anesthetic drugs for topical use are
no longer an essential use of ODSs. In
addition, a recently completed
laboratory study demonstrated that
lidocaine may be a safer alternative to
benzocaine (Ref. 1). The study found
that benzocaine was substantially more
likely than lidocaine to form
methemoglobin, the cause of the serious
blood disorder called
methemoglobinemia.
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
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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 Agencies 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.
Anesthetic drugs for topical use on
accessible mucous membranes of
humans where a cannula is used for
application are not available in the
product market in an approved ODS
formulation. Because the product is not
marketed under an investigational new
drug (IND), new drug application
(NDA), or abbreviated new drug
application (ANDA) and alternative
products for the same use that do not
use ODSs, such as lidocaine, are now
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available, the product is nonessential
under § 2.125(g)(1). With the adoption
of this rule, any potential manufacturers
of these anesthetic drugs will have
notice about their requirements to
comply with the ban of products from
containing ODSs.
C. Costs and Benefits
1. Number of Affected Entities
There are no affected entities covered
by this rule because there are no current
manufacturers of approved products
that would qualify as ‘‘essential’’
products under the current regulation.
2. Costs
ODS-containing anesthetic products
for topical use on accessible mucous
membranes of humans where a cannula
is used for application are not marketed
under an IND, NDA, or ANDA and
would not qualify as ‘‘essential’’
products under the current regulation;
consequently, removal of the exemption
for such drugs 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
benefits stem from preventing the ODSs
that would have been emitted by
potential market entrants. The social
benefits of the proposed rule derive
from greater compliance with the Clean
Air Act. Because there will not be any
change in exposure and any resulting
risk from the proposed rule, there will
not be any direct public health benefits.
D. Economic Summary
The proposed rule, if finalized, will
remove the essential-use exemption for
anesthetic drugs for topical use on
accessible mucous membranes of
humans where a cannula is used for
application. 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. Because
anesthetic drugs for topical use are not
currently sold in the market in an
approved form, there would be no
health benefit or social cost for
removing the exemption for such
products from the ban.
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
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74371
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 propose to certify that
this proposed 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.
V. Analysis of Environmental Impacts
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. Reference
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it are also available
electronically at https://
www.regulations.gov.
1. Hartman, N. R., J. J. Mao, H. Zhou, et al.,
‘‘More Methemoglobin is Produced by
Benzocaine Treatment Than Lidocaine
Treatment in Human In Vitro Systems.’’
Regulatory Toxicology and
Pharmacology, 70:182–188, 2014.
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Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules
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
paragraph (e)(4)(iii).
■
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25852 Filed 10–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 982
[Docket No. FR–5585–P–01]
RIN 2577–AD00
Tenant-Based Assistance: Enhanced
Vouchers
Office of the Assistant
Secretary for Public and Indian
Housing, HUD.
ACTION: Proposed rule.
AGENCY:
This rule proposes to codify
HUD’s policy regarding enhanced
vouchers, a type of tenant-based
voucher provided for under section 8 of
the U.S. Housing Act of 1937 in the
following four scenarios, which are
prescribed and limited by statute: The
prepayment of certain mortgages, the
voluntary termination of the insurance
contract for the mortgage, the
termination or the expiration of a
project-based section 8 rental assistance
contract, and the transaction under
which a project that receives or has
received assistance under the Flexible
Subsidy Program is preserved as
affordable housing. Specifically, this
rule would codify existing policy
concerning the eligibility criteria for
enhanced vouchers, as well as provide
rental payment standards and subsidy
standards applicable to enhanced
Lhorne on DSK30JT082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
15:05 Oct 25, 2016
Jkt 241001
vouchers, the right of enhanced voucher
holders to remain in their units,
procedures for addressing over-housed
families, and the calculation of the
enhanced voucher housing assistance
payment.
DATES: Comment Due Date: December
27, 2016.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposed rule to the Regulations
Division, Office of General Counsel,
Department of Housing and Urban
Development, 451 7th Street SW., Room
10276, Washington, DC 20410–0500.
Communications must refer to the above
docket number and title. There are two
methods for submitting public
comments. All submissions must refer
to the above docket number and title.
1. Submission of Comments by Mail.
Comments may be submitted by mail to
the Regulations Division, Office of
General Counsel, Department of
Housing and Urban Development, 451
7th Street SW., Room 10276,
Washington, DC 20410–0500.
2. Electronic Submission of
Comments. Interested persons may
submit comments electronically through
the Federal eRulemaking Portal at
www.regulations.gov. HUD strongly
encourages commenters to submit
comments electronically. Electronic
submission of comments allows the
commenter maximum time to prepare
and submit a comment, ensures timely
receipt by HUD, and enables HUD to
make them immediately available to the
public. Comments submitted
electronically through the
www.regulations.gov Web site can be
viewed by other commenters and
interested members of the public.
Commenters should follow the
instructions provided on that site to
submit comments electronically.
Note: To receive consideration as public
comments, comments must be submitted
through one of the two methods specified
above. Again, all submissions must refer to
the docket number and title of the rule.
No Facsimile Comments. Facsimile
(FAX) comments are not acceptable.
Public Inspection of Public
Comments. All properly submitted
comments and communications
submitted to HUD will be available for
public inspection and copying between
8 a.m. and 5 p.m. weekdays at the above
address. Due to security measures at the
HUD Headquarters building, an advance
appointment to review the public
comments must be scheduled by calling
the Regulations Division at 202–402–
3055 (this is not a toll-free number).
Individuals with speech or hearing
impairments may access this number
PO 00000
Frm 00058
Fmt 4702
Sfmt 4702
via TTY by calling the Federal Relay
Service, toll-free, at 800–877–8339.
Copies of all comments submitted are
available for inspection and
downloading at www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
information about HUD’s Public
Housing and Voucher programs, contact
Rebecca Primeaux, Director, Housing
Voucher Management and Operations
Division, Office of Public and Indian
Housing, Department of Housing and
Urban Development, 451 7th Street,
Room 4226, Washington, DC 20140,
telephone number 202–708–0477. The
listed telephone number is not a tollfree number. Persons with hearing or
speech impairments may access this
number through TTY by calling the tollfree Federal Relay Service at 1–800–
877–8339.
SUPPLEMENTARY INFORMATION:
I. Background
General. Section 8(t) of the U.S.
Housing Act of 1937 (1937 Act) (42
U.S.C. 1437f(t)) provides unified
authority for families to be offered
enhanced vouchers upon the occurrence
of an ‘‘eligibility event,’’ which is
defined in section 8(t)(2) as one of four
categories of events that results in
families in the project being eligible for
enhanced voucher assistance under one
of three statutes: (1) The Low-Income
Housing Preservation and Resident
Homeownership Act of 1990, 12 U.S.C.
4101 et seq. (LIHPRHA), (2) the
Multifamily Assisted Housing Reform
and Affordability Act of 1997, 42 U.S.C.
1437f note (MAHRA), or (3) of the
Housing and Community Development
Amendments of 1978, 42 U.S.C. 5301
note (HCDA). The four categories of
events are: (1) The prepayment of a
mortgage that results in families
residing in the project being eligible
under section 223(f) of LIHPRHA for an
enhanced voucher; (2) the voluntary
termination of the insurance contract
that results in families residing in the
project being eligible under section
223(f) of LIHPRHA for an enhanced
voucher; (3) the termination or
expiration of a project-based section 8
rental assistance contract that results in
assisted families residing in the project
being eligible under section 515(c)(3) or
section 524(d) of MAHRA for an
enhanced voucher; 1 and (4) a
1 Section 515(c)(3) pertains to a determination by
the Department to renew an expiring project-based
section 8 contract with tenant-based assistance,
whereas section 524(d) applies when a rental
assistance contract to which a covered project is
subject expires and is not renewed, whether the
owner opts out by giving the notice required under
42 U.S.C. 1437f(c)(8)(A) or the HAP contract simply
expires. If the HAP contract expires without the
E:\FR\FM\26OCP1.SGM
26OCP1
Agencies
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Proposed Rules]
[Pages 74368-74372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25852]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
[[Page 74369]]
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 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 exemption for anesthetic drugs for topical use on
accessible mucous membranes of humans where a cannula is used for
application. FDA is proposing this action because these products are no
longer being marketed in approved versions that contain ODSs and
because alternative products that do not use ODSs are now available.
DATES: Submit either electronic or written comments on the proposed
rule by December 27, 2016.
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).
Firms that wished 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 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 & 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
[[Page 74370]]
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 generally is 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). Sections
2.125(c) and (e) provide exemptions for essential uses of ODSs for
certain products containing ODS propellants that FDA determines provide
unique health benefits that would not be available without the use of
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 an approved product containing an ODS, and the availability of
alternative products that do not contain an ODS, FDA is proposing to
amend its regulations to remove the essential-use designation for
anesthetic drugs for topical use on accessible mucous membranes of
humans where a cannula is used for application (Sec.
2.125(e)(4)(iii)).
On June 29, 2015, FDA published a notice and request for comment
concerning its tentative conclusion that anesthetic drugs for topical
use on accessible mucous membranes of humans where a cannula is used
for application no longer constitute an essential use under the Clean
Air Act (June 2015 notice). FDA requested comment concerning its
tentative finding that anesthetic drugs for topical use on accessible
mucous membranes of humans where a cannula is used for application are
no longer being sold 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.
II. Comment on the June 2015 Notice and FDA Response
FDA received one comment concerning its tentative finding that
anesthetic drugs for topical use on accessible mucous membranes of
humans where a cannula is used for application are no longer marketed
in an approved ODS formulation and, therefore, no longer constitute an
essential use (see June 2015 notice). On August 21, 2015, Cetylite
Industries, Inc. (Cetylite) submitted a comment stating that ``FDA's
belief that no products are marketed under this exemption is
incorrect'' (Comment 1). According to the comment, Cetylite
manufactures Cetacaine Spray (CETACAINE), a topical anesthetic spray
with an active ingredient combination of benzocaine, tetracaine HCl,
and butamben that uses a blend of CFCs as the propellant under the
essential-use exemption found in Sec. 2.125(e)(4)(iii). However,
CETACAINE is not an approved drug product and does not qualify as an
essential use under Sec. 2.125(e)(4)(iii). As described in Sec.
2.125(c), an aerosol drug product or other pressurized dispenser that
releases an ODS is an essential use of the ODS under the Clean Air Act
only if it is listed in Sec. 2.125(e) and if an investigational
application or an approved marketing application is in effect.
Cetylite states that CETACAINE has been marketed continuously since
the mid-1950s under a request for a Drug Efficacy Study Implementation
(DESI) review that was submitted in 1976. FDA published a DESI notice
(DESI 8076 (Docket No. 75N-0203) in the Federal Register of December 9,
1975 (40 FR 57379)) in which the Agency offered an opportunity for a
hearing on a proposal to withdraw approval of a combination drug
product containing two of the three ingredients contained in CETACAINE.
In response to this DESI notice, Cetylite requested a hearing regarding
the effectiveness of CETACAINE. While FDA's review of the product's
effectiveness has been pending, Cetylite has been marketing CETACAINE
without an approved new drug application.
In 1979, based on a citizen petition submitted by Cetylite
regarding its CETACAINE product, FDA proposed that anesthetic drugs for
topical use on accessible mucous membranes of humans where a cannula is
used for application were essential uses of ODSs (44 FR 33114, June 8,
1979) (1979 Proposed Rule). In the preamble to the 1979 Proposed Rule,
FDA noted that its tentative finding as to CETACAINE's essentiality
under Sec. 2.125 was ``conditional'' on the product being found
effective. Similarly, in the preamble to the Final Rule amending Sec.
2.125, FDA stated that ``the determination in this document that
CETACAINE Aerosol is an essential use of a chlorofluorocarbon is also
conditional'' on a finding that CETACAINE is effective for the use
described in Sec. 2.125(e)(4)(iii) (45 FR 22902, April 4, 1980).
To date, FDA has not made a finding that CETACAINE is effective for
the use described in Sec. 2.125(e)(4)(iii). There is no
investigational new drug application or approved marketing application
in effect for the ODS formulation of CETACAINE, as required for a
finding of essentiality under Sec. 2.125(c). Accordingly, CETACAINE
does not meet the conditions to qualify as an essential use of ODSs
under Sec. 2.125(e)(4)(iii), and FDA believes that its proposed
finding that anesthetic drugs for topical use on accessible mucous
membranes of humans where a cannula is used for application are no
longer marketed in an approved ODS formulation remains correct.
Moreover, alternative products for the same use that do not use ODSs,
such as lidocaine, are now available, further suggesting that
anesthetic drugs for topical use are no longer an essential use of
ODSs. In addition, a recently completed laboratory study demonstrated
that lidocaine may be a safer alternative to benzocaine (Ref. 1). The
study found that benzocaine was substantially more likely than
lidocaine to form methemoglobin, the cause of the serious blood
disorder called methemoglobinemia.
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
[[Page 74371]]
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 Agencies 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.
Anesthetic drugs for topical use on accessible mucous membranes of
humans where a cannula is used for application are not available in the
product market in an approved ODS formulation. Because the product is
not marketed under an investigational new drug (IND), new drug
application (NDA), or abbreviated new drug application (ANDA) and
alternative products for the same use that do not use ODSs, such as
lidocaine, are now available, the product is nonessential under Sec.
2.125(g)(1). With the adoption of this rule, any potential
manufacturers of these anesthetic drugs will have notice about their
requirements to comply with the ban of products from containing ODSs.
C. Costs and Benefits
1. Number of Affected Entities
There are no affected entities covered by this rule because there
are no current manufacturers of approved products that would qualify as
``essential'' products under the current regulation.
2. Costs
ODS-containing anesthetic products for topical use on accessible
mucous membranes of humans where a cannula is used for application are
not marketed under an IND, NDA, or ANDA and would not qualify as
``essential'' products under the current regulation; consequently,
removal of the exemption for such drugs 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 benefits stem from preventing
the ODSs that would have been emitted by potential market entrants. The
social benefits of the proposed rule derive from greater compliance
with the Clean Air Act. Because there will not be any change in
exposure and any resulting risk from the proposed rule, there will not
be any direct public health benefits.
D. Economic Summary
The proposed rule, if finalized, will remove the essential-use
exemption for anesthetic drugs for topical use on accessible mucous
membranes of humans where a cannula is used for application. 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. Because anesthetic drugs for topical use are not
currently sold in the market in an approved form, there would be no
health benefit or social cost for removing the exemption for such
products from the ban.
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 propose to certify that this proposed 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.
V. Analysis of Environmental Impacts
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. Reference
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it are also
available electronically at https://www.regulations.gov.
1. Hartman, N. R., J. J. Mao, H. Zhou, et al., ``More Methemoglobin
is Produced by Benzocaine Treatment Than Lidocaine Treatment in
Human In Vitro Systems.'' Regulatory Toxicology and Pharmacology,
70:182-188, 2014.
[[Page 74372]]
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 paragraph (e)(4)(iii).
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25852 Filed 10-25-16; 8:45 am]
BILLING CODE 4164-01-P