81_FR_74575 81 FR 74368 - Use of Ozone-Depleting Substances

81 FR 74368 - Use of Ozone-Depleting Substances

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 207 (October 26, 2016)

Page Range74368-74372
FR Document2016-25852

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.

Federal Register, Volume 81 Issue 207 (Wednesday, October 26, 2016)
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Proposed Rules]
[Pages 74368-74372]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25852]


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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.

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[[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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 http://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 http://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: http://www.thefederalregister.org/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 http://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, 
[email protected].

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 http://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



                                               74368               Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules

                                               Because it is unlikely that the                         estimate of the foregone annual profit of             policies that have federalism
                                               company’s total profits are exclusively                 the company that manufactures the                     implications as defined in the Executive
                                               from the sterile aerosol talc, it is more               sterile aerosol talc or $1 million.                   order and, consequently, a federalism
                                               likely that the foregone profits are at                 Because the metered-dose atropine                     summary impact statement is not
                                               most one-third of the $1 million; in fact,              sulfate aerosol is not currently in the               required.
                                               the true social cost could be                           market, there would be no social cost for
                                               significantly less than the total foregone                                                                    VIII. References
                                                                                                       removing its exemption from the ban.
                                               profit of this product.                                    Imposing no new federal requirement                   The following reference is on display
                                                  Metered-dose atropine sulfate aerosol                is the baseline for a regulatory analysis.            in the Division of Dockets Management
                                               human drugs that would be affected by                   With no new regulation, there are no                  (see ADDRESSES) and is available for
                                               this rule are no longer marketed;                       compliance costs or benefits to the                   viewing by interested persons between
                                               consequently, removal of the exemption                  proposed rule. However, because sterile               9 a.m. and 4 p.m., Monday through
                                               for these products would not present the                aerosol talc is no longer an essential use            Friday; it is also available electronically
                                               public, consumers, insurers, or                         of ODSs, under the Clean Air Act, there               at http://www.regulations.gov. FDA has
                                               producers with any costs.                               is no longer a pathway for sterile aerosol            verified the Web site address, as of the
                                               3. Health Benefits                                      talc products containing ODSs to remain               date this document publishes in the
                                                                                                       on the market.                                        Federal Register, but Web sites are
                                                  The proposed rule would implement                                                                          subject to change over time.
                                               the requirements of the Clean Air Act                   IV. Regulatory Flexibility Analysis
                                               that ban the use of products containing                                                                       1. Bryan Corporation (http://
                                                                                                         FDA has examined the economic                            listings.findthecompany.com/l/
                                               ODSs that no longer meet the                            implications of the proposed rule as                       12165972/Bryan-Corporation-in-
                                               requirements for essential use. The                     required by the Regulatory Flexibility                     Woburn-MA, accessed on February 24,
                                               social benefits of the proposed rule                    Act. If a rule will have a significant                     2016).
                                               derive from greater compliance with the                 economic impact on a substantial
                                               Clean Air Act. The ODSs that either                     number of small entities, the Regulatory              List of Subjects in 21 CFR Part 2
                                               would have been emitted by sterile                      Flexibility Act requires Agencies to                    Administrative practice and
                                               aerosol talcs that contain them, or from                analyze regulatory options that would                 procedure, Cosmetics, Drugs, Foods.
                                               potential market entrants that would                    lessen the economic effect of the rule on               Therefore, under the Federal Food,
                                               have manufactured metered-dose                          small entities. We certify that the final             Drug, and Cosmetic Act and under
                                               atropine sulfate aerosols that contain                  rule will not have a significant                      authority delegated to the Commissioner
                                               ODSs will no longer be emitting them,                   economic impact on a substantial                      of Food and Drugs, we propose that 21
                                               which will help reduce the depletion of                 number of small entities. This analysis,              CFR part 2 be amended as follows:
                                               the ozone layer and the ultraviolet                     together with other relevant sections of
                                               radiation reaching the Earth. We lack                   this document, serves as the proposed                 PART 2—GENERAL ADMINISTRATIVE
                                               the ability to quantify the health                      regulatory flexibility analysis, as                   RULINGS AND DECISIONS
                                               benefits from the reduced exposure to                   required under the Regulatory
                                               and from the reduced risk associated                    Flexibility Act.                                      ■ 1. The authority citation for part 2
                                               with ultraviolet light that result from                                                                       continues to read as follows:
                                               removing the exemptions to the ban.                     V. Analysis of Environmental Impact
                                                                                                                                                               Authority: 15 U.S.C. 402, 409; 21 U.S.C.
                                               Because the change in exposure and                        We have determined under 21 CFR                     321, 331, 335, 342, 343, 346a, 348, 351, 352,
                                               resulting risk from the proposed rule is                25.30(h) that this action is of a type that           355, 360b, 361, 362, 371, 372, 374; 42 U.S.C.
                                               likely to be small, the incremental                     does not individually or cumulatively                 7671 et seq.
                                               health impact is likely to be too small                 have a significant effect on the human
                                               to measure.                                                                                                   § 2.125    [Amended]
                                                                                                       environment. Therefore, neither an
                                                                                                       environmental assessment nor an                       ■ 2. In § 2.125, remove and reserve
                                               D. Economic Summary                                                                                           paragraphs (e)(4)(vi) and (ix).
                                                                                                       environmental impact statement is
                                                 The proposed rule, if finalized, will                 required.                                               Dated: October 20, 2016.
                                               remove the exemptions for sterile
                                                                                                       VI. Paperwork Reduction Act of 1995                   Leslie Kux,
                                               aerosol talc products and for metered-
                                               dose atropine sulfate aerosol human                                                                           Associate Commissioner for Policy.
                                                                                                         FDA tentatively concludes that this
                                               drugs containing ODSs. The primary                                                                            [FR Doc. 2016–25850 Filed 10–25–16; 8:45 am]
                                                                                                       proposed rule contains no collection of
                                               public health benefit from adoption of                  information. Therefore, clearance by the              BILLING CODE 4164–01–P
                                               the proposed rule is to reduce the                      Office of Management and Budget under
                                               depletion of the ozone layer to decrease                the Paperwork Reduction Act of 1995 is
                                               human exposure to ultraviolet radiation.                                                                      DEPARTMENT OF HEALTH AND
                                                                                                       not required.
                                               The reduction in exposure to ultraviolet                                                                      HUMAN SERVICES
                                               radiation because of the rule is likely to              VII. Federalism
                                                                                                                                                             Food and Drug Administration
                                               be too small to measure. The potential                    We have analyzed this proposed rule
                                               social costs of the proposed rule would                 in accordance with the principles set                 21 CFR Part 2
                                               occur if patient consumers or their                     forth in Executive Order 13132. We
                                               health care insurers would have to pay                  have determined that this proposed rule               [Docket No. FDA–2015–N–1355]
                                               more for otherwise comparable products                  does not contain policies that have
Lhorne on DSK30JT082PROD with PROPOSALS




                                               and if the product manufacturers would                  substantial direct effects on the States,             RIN 0910–AH36
                                               have to safely destroy any remaining                    on the relationship between the
                                               product inventories after the effective                 National Government and the States, or                Use of Ozone-Depleting Substances
                                               date of the rule. We estimate that the                  on the distribution of power and                      AGENCY:     Food and Drug Administration,
                                               social cost of the proposed rule is likely              responsibilities among the various                    HHS.
                                               to be significantly less than $1 million                levels of government. Accordingly, we
                                                                                                                                                             ACTION:    Proposed rule.
                                               but no more than the upper-bound                        conclude that the rule does not contain


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                                                                   Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules                                           74369

                                               SUMMARY:    The Food and Drug                           and Drug Administration, 5630 Fishers                 FOR FURTHER INFORMATION CONTACT:
                                               Administration (FDA, the Agency, or                     Lane, Rm. 1061, Rockville, MD 20852.                  Daniel Orr, Center for Drug Evaluation
                                               we) is proposing to amend its regulation                   • For written/paper comments                       and Research, Food and Drug
                                               on uses of ozone-depleting substances                   submitted to the Division of Dockets                  Administration, 10903 New Hampshire
                                               (ODSs), including chlorofluorocarbons                   Management, FDA will post your                        Ave., Bldg. 51, Rm. 6246, Silver Spring,
                                               (CFCs), to remove the designation for                   comment, as well as any attachments,                  MD 20993, 240–402–0979, daniel.orr@
                                               certain products as ‘‘essential uses’’                  except for information submitted,                     fda.hhs.gov.
                                               under the Clean Air Act. Essential-use                  marked and identified, as confidential,
                                                                                                                                                             SUPPLEMENTARY INFORMATION:
                                               products are exempt from the ban by                     if submitted as detailed in
                                               FDA on the use of CFCs and other ODS                    ‘‘Instructions.’’                                     I. Background
                                               propellants in FDA-regulated products                      Instructions: All submissions received
                                                                                                                                                                Production of ODSs has been phased
                                               and from the ban by the Environmental                   must include the Docket No. FDA–
                                                                                                                                                             out worldwide under the terms of the
                                               Protection Agency (EPA) on the use of                   2015–N–1355 for ‘‘Use of Ozone-
                                                                                                                                                             Montreal Protocol on Substances that
                                               ODSs in pressurized dispensers. This                    Depleting Substances.’’ Received
                                                                                                                                                             Deplete the Ozone Layer (Montreal
                                               action, if finalized, will remove the                   comments will be placed in the docket
                                                                                                                                                             Protocol) (September 16, 1987, S. Treaty
                                               essential-use exemption for anesthetic                  and, except for those submitted as
                                                                                                                                                             Doc. No. 10, 100th Cong., 1st sess., 26
                                               drugs for topical use on accessible                     ‘‘Confidential Submissions,’’ publicly
                                                                                                                                                             I.L.M. 1541 (1987)). In accordance with
                                               mucous membranes of humans where a                      viewable at http://www.regulations.gov
                                                                                                       or at the Division of Dockets                         the provisions of the Montreal Protocol,
                                               cannula is used for application. FDA is                                                                       under authority of Title VI of the Clean
                                               proposing this action because these                     Management between 9 a.m. and 4 p.m.,
                                                                                                       Monday through Friday.                                Air Act (section 601 et seq.), the
                                               products are no longer being marketed                                                                         manufacture of ODSs, including CFCs,
                                               in approved versions that contain ODSs                     • Confidential Submissions—To
                                                                                                       submit a comment with confidential                    in the United States was generally
                                               and because alternative products that do                                                                      banned as of January 1, 1996. To receive
                                               not use ODSs are now available.                         information that you do not wish to be
                                                                                                       made publicly available, submit your                  permission to manufacture CFCs in the
                                               DATES: Submit either electronic or                      comments only as a written/paper                      United States after the phase-out date,
                                               written comments on the proposed rule                   submission. You should submit two                     manufacturers must obtain an
                                               by December 27, 2016.                                   copies total. One copy will include the               exemption from the phase-out
                                               ADDRESSES: You may submit comments                      information you claim to be confidential              requirements from the parties to the
                                               as follows:                                             with a heading or cover note that states              Montreal Protocol. Procedures for
                                                                                                       ‘‘THIS DOCUMENT CONTAINS                              securing an essential-use exemption
                                               Electronic Submissions                                                                                        under the Montreal Protocol are
                                                                                                       CONFIDENTIAL INFORMATION.’’ The
                                                 Submit electronic comments in the                     Agency will review this copy, including               described in a request by EPA for
                                               following way:                                          the claimed confidential information, in              applications for exemptions (60 FR
                                                 • Federal eRulemaking Portal: http://                 its consideration of comments. The                    54349, October 23, 1995).
                                               www.regulations.gov. Follow the                         second copy, which will have the                         Firms that wished to use ODSs
                                               instructions for submitting comments.                   claimed confidential information                      manufactured after the phase-out date in
                                               Comments submitted electronically,                      redacted/blacked out, will be available               medical devices (as defined in section
                                               including attachments, to http://                       for public viewing and posted on http://              601(8) of the Clean Air Act (42 U.S.C.
                                               www.regulations.gov will be posted to                   www.regulations.gov. Submit both                      7671(8)) covered under section 610 of
                                               the docket unchanged. Because your                      copies to the Division of Dockets                     the Clean Air Act (42 U.S.C. 7671i) must
                                               comment will be made public, you are                    Management. If you do not wish your                   receive exemptions for essential uses
                                               solely responsible for ensuring that your               name and contact information to be                    under the Montreal Protocol. EPA
                                               comment does not include any                            made publicly available, you can                      regulations implementing the provisions
                                               confidential information that you or a                  provide this information on the cover                 of section 610 of the Clean Air Act
                                               third party may not wish to be posted,                  sheet and not in the body of your                     contain a general ban on the use of
                                               such as medical information, your or                    comments and you must identify this                   ODSs in pressurized dispensers, such as
                                               anyone else’s Social Security number, or                information as ‘‘confidential.’’ Any                  metered-dose inhalers (MDIs) (40 CFR
                                               confidential business information, such                 information marked as ‘‘confidential’’                82.64(c) and 82.66(d)). These EPA
                                               as a manufacturing process. Please note                 will not be disclosed except in                       regulations exempt from the general ban
                                               that if you include your name, contact                  accordance with 21 CFR 10.20 and other                ‘‘medical devices’’ that FDA considers
                                               information, or other information that                  applicable disclosure law. For more                   essential and that are listed in § 2.125(e)
                                               identifies you in the body of your                      information about FDA’s posting of                    (21 CFR 2.125(e)). Section 601(8) of the
                                               comments, that information will be                      comments to public dockets, see 80 FR                 Clean Air Act defines ‘‘medical device’’
                                               posted on http://www.regulations.gov.                   56469, September 18, 2015, or access                  as any device (as defined in the Federal
                                                 • If you want to submit a comment                     the information at: http://www.gpo.gov/               Food, Drug & Cosmetic Act (the FD&C
                                               with confidential information that you                  fdsys/pkg/FR-2015-09-18/pdf/2015-                     Act) (21 U.S.C. 321)), diagnostic
                                               do not wish to be made available to the                 23389.pdf.                                            product, drug (as defined in the FD&C
                                               public, submit the comment as a                            Docket: For access to the docket to                Act), and drug delivery system, if such
                                               written/paper submission and in the                     read background documents or the                      device, diagnostic product, drug, or
                                               manner detailed (see ‘‘Written/Paper                    electronic and written/paper comments                 drug delivery system uses a class I or
                                               Submissions’’ and ‘‘Instructions’’).                    received, go to http://                               class II ODS for which no safe and
Lhorne on DSK30JT082PROD with PROPOSALS




                                                                                                       www.regulations.gov and insert the                    effective alternative has been developed
                                               Written/Paper Submissions                               docket number, found in brackets in the               (and, where necessary, has been
                                                 Submit written/paper submissions as                   heading of this document, into the                    approved by the Commissioner of Food
                                               follows:                                                ‘‘Search’’ box and follow the prompts                 and Drugs), and if such device,
                                                 • Mail/Hand delivery/Courier (for                     and/or go to the Division of Dockets                  diagnostic product, drug, or drug
                                               written/paper submissions): Division of                 Management, 5630 Fishers Lane, Rm.                    delivery system has, after notice and
                                               Dockets Management (HFA–305), Food                      1061, Rockville, MD 20852.                            opportunity for public comment, been


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                                               74370               Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules

                                               approved and determined to be essential                 use on accessible mucous membranes of                 has been marketing CETACAINE
                                               by the Commissioner in consultation                     humans where a cannula is used for                    without an approved new drug
                                               with the Administrator of EPA. Class I                  application are no longer being sold in               application.
                                               substances include CFCs, halons, carbon                 an approved ODS formulation. Under                       In 1979, based on a citizen petition
                                               tetrachloride, methyl chloroform,                       § 2.125(g)(1), an active moiety may no                submitted by Cetylite regarding its
                                               methyl bromide, and other chemicals                     longer constitute an essential use                    CETACAINE product, FDA proposed
                                               not relevant to this document (see 40                   (§ 2.125(e)) if it is no longer marketed in           that anesthetic drugs for topical use on
                                               CFR part 82, appendix A to subpart A).                  an approved ODS formulation. The                      accessible mucous membranes of
                                               Class II substances include                             failure to market indicates                           humans where a cannula is used for
                                               hydrochlorofluorocarbons (see 40 CFR                    nonessentiality because the absence of a              application were essential uses of ODSs
                                               part 82, appendix B to subpart A).                      demand sufficient for even one                        (44 FR 33114, June 8, 1979) (1979
                                                  A drug, device, cosmetic, or food                    company to market the product is                      Proposed Rule). In the preamble to the
                                               contained in an aerosol product or other                highly indicative that the use is not                 1979 Proposed Rule, FDA noted that its
                                               pressurized dispenser that releases a                   essential.                                            tentative finding as to CETACAINE’s
                                               CFC or other ODS propellant generally                                                                         essentiality under § 2.125 was
                                               is not considered an essential use of the               II. Comment on the June 2015 Notice
                                                                                                       and FDA Response                                      ‘‘conditional’’ on the product being
                                               ODS under the Clean Air Act except as                                                                         found effective. Similarly, in the
                                               provided in § 2.125(c) and (e). This                       FDA received one comment                           preamble to the Final Rule amending
                                               prohibition is based on scientific                      concerning its tentative finding that                 § 2.125, FDA stated that ‘‘the
                                               research indicating that CFCs and other                 anesthetic drugs for topical use on                   determination in this document that
                                               ODSs reduce the amount of ozone in the                  accessible mucous membranes of                        CETACAINE Aerosol is an essential use
                                               stratosphere and thereby increase the                   humans where a cannula is used for                    of a chlorofluorocarbon is also
                                               amount of ultraviolet radiation reaching                application are no longer marketed in an              conditional’’ on a finding that
                                               the Earth. An increase in ultraviolet                   approved ODS formulation and,                         CETACAINE is effective for the use
                                               radiation will increase the incidence of                therefore, no longer constitute an                    described in § 2.125(e)(4)(iii) (45 FR
                                               skin cancer, and produce other adverse                  essential use (see June 2015 notice). On              22902, April 4, 1980).
                                               effects of unknown magnitude on                         August 21, 2015, Cetylite Industries,                    To date, FDA has not made a finding
                                               humans, animals, and plants (80 FR                      Inc. (Cetylite) submitted a comment                   that CETACAINE is effective for the use
                                               36937, June 29, 2015). Sections 2.125(c)                stating that ‘‘FDA’s belief that no                   described in § 2.125(e)(4)(iii). There is
                                               and (e) provide exemptions for essential                products are marketed under this                      no investigational new drug application
                                               uses of ODSs for certain products                       exemption is incorrect’’ (Comment 1).                 or approved marketing application in
                                               containing ODS propellants that FDA                     According to the comment, Cetylite                    effect for the ODS formulation of
                                               determines provide unique health                        manufactures Cetacaine Spray                          CETACAINE, as required for a finding of
                                               benefits that would not be available                    (CETACAINE), a topical anesthetic                     essentiality under § 2.125(c).
                                               without the use of an ODS.                              spray with an active ingredient                       Accordingly, CETACAINE does not
                                                  Faced with the statutorily mandated                  combination of benzocaine, tetracaine                 meet the conditions to qualify as an
                                               phase-out of the production of ODSs,                    HCl, and butamben that uses a blend of                essential use of ODSs under
                                               drug manufacturers have developed                       CFCs as the propellant under the                      § 2.125(e)(4)(iii), and FDA believes that
                                               alternatives to MDIs and other self-                    essential-use exemption found in                      its proposed finding that anesthetic
                                               pressurized drug dosage forms that do                   § 2.125(e)(4)(iii). However, CETACAINE                drugs for topical use on accessible
                                               not contain ODSs. Examples of these                     is not an approved drug product and                   mucous membranes of humans where a
                                               alternative dosage forms are MDIs that                  does not qualify as an essential use                  cannula is used for application are no
                                               use non-ODSs as propellants and dry-                    under § 2.125(e)(4)(iii). As described in             longer marketed in an approved ODS
                                               powder inhalers. The availability of                    § 2.125(c), an aerosol drug product or
                                                                                                                                                             formulation remains correct. Moreover,
                                               alternatives to ODSs means that certain                 other pressurized dispenser that releases
                                                                                                                                                             alternative products for the same use
                                               drug products listed in § 2.125(e) are no               an ODS is an essential use of the ODS
                                                                                                                                                             that do not use ODSs, such as lidocaine,
                                               longer essential uses of ODSs.                          under the Clean Air Act only if it is
                                                                                                                                                             are now available, further suggesting
                                               Therefore, due to lack of marketing of an               listed in § 2.125(e) and if an
                                                                                                                                                             that anesthetic drugs for topical use are
                                               approved product containing an ODS,                     investigational application or an
                                                                                                                                                             no longer an essential use of ODSs. In
                                               and the availability of alternative                     approved marketing application is in
                                                                                                                                                             addition, a recently completed
                                               products that do not contain an ODS,                    effect.
                                                                                                          Cetylite states that CETACAINE has                 laboratory study demonstrated that
                                               FDA is proposing to amend its
                                                                                                       been marketed continuously since the                  lidocaine may be a safer alternative to
                                               regulations to remove the essential-use
                                                                                                       mid-1950s under a request for a Drug                  benzocaine (Ref. 1). The study found
                                               designation for anesthetic drugs for
                                                                                                       Efficacy Study Implementation (DESI)                  that benzocaine was substantially more
                                               topical use on accessible mucous
                                                                                                       review that was submitted in 1976. FDA                likely than lidocaine to form
                                               membranes of humans where a cannula
                                               is used for application                                 published a DESI notice (DESI 8076                    methemoglobin, the cause of the serious
                                               (§ 2.125(e)(4)(iii)).                                   (Docket No. 75N–0203) in the Federal                  blood disorder called
                                                  On June 29, 2015, FDA published a                    Register of December 9, 1975 (40 FR                   methemoglobinemia.
                                               notice and request for comment                          57379)) in which the Agency offered an                III. Economic Analysis of Impacts
                                               concerning its tentative conclusion that                opportunity for a hearing on a proposal
                                               anesthetic drugs for topical use on                     to withdraw approval of a combination                 A. Introduction
Lhorne on DSK30JT082PROD with PROPOSALS




                                               accessible mucous membranes of                          drug product containing two of the three                We have examined the impacts of the
                                               humans where a cannula is used for                      ingredients contained in CETACAINE.                   proposed rule under Executive Order
                                               application no longer constitute an                     In response to this DESI notice, Cetylite             12866, Executive Order 13563, the
                                               essential use under the Clean Air Act                   requested a hearing regarding the                     Regulatory Flexibility Act (5 U.S.C.
                                               (June 2015 notice). FDA requested                       effectiveness of CETACAINE. While                     601–612), and the Unfunded Mandates
                                               comment concerning its tentative                        FDA’s review of the product’s                         Reform Act of 1995 (Pub. L. 104–4).
                                               finding that anesthetic drugs for topical               effectiveness has been pending, Cetylite              Executive Orders 12866 and 13563


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                                                                   Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules                                              74371

                                               direct us to assess all costs and benefits              available, the product is nonessential                number of small entities, the Regulatory
                                               of available regulatory alternatives and,               under § 2.125(g)(1). With the adoption                Flexibility Act requires Agencies to
                                               when regulation is necessary, to select                 of this rule, any potential manufacturers             analyze regulatory options that would
                                               regulatory approaches that maximize                     of these anesthetic drugs will have                   lessen the economic effect of the rule on
                                               net benefits (including potential                       notice about their requirements to                    small entities. We propose to certify that
                                               economic, environmental, public health                  comply with the ban of products from                  this proposed rule will not have a
                                               and safety, and other advantages;                       containing ODSs.                                      significant economic impact on a
                                               distributive impacts; and equity). We                                                                         substantial number of small entities.
                                                                                                       C. Costs and Benefits
                                               have developed a comprehensive                                                                                This analysis, together with other
                                               Economic Analysis of Impacts that                       1. Number of Affected Entities
                                                                                                                                                             relevant sections of this document,
                                               assesses the impacts of the proposed                       There are no affected entities covered             serves as the proposed regulatory
                                               rule. We believe that this proposed rule                by this rule because there are no current
                                               is not a significant regulatory action as                                                                     flexibility analysis.
                                                                                                       manufacturers of approved products
                                               defined by Executive Order 12866.                       that would qualify as ‘‘essential’’                   V. Analysis of Environmental Impacts
                                                  The Regulatory Flexibility Act                       products under the current regulation.
                                               requires Agencies to analyze regulatory                                                                         We have determined under 21 CFR
                                               options that would minimize any                         2. Costs                                              25.30(h) that this action is of a type that
                                               significant impact of a rule on small                      ODS-containing anesthetic products                 does not individually or cumulatively
                                               entities. We propose to certify that the                for topical use on accessible mucous                  have a significant effect on the human
                                               proposed rule will not have a significant               membranes of humans where a cannula                   environment. Therefore, neither an
                                               economic impact on a substantial                        is used for application are not marketed              environmental assessment nor an
                                               number of small entities.                               under an IND, NDA, or ANDA and                        environmental impact statement is
                                                  The Unfunded Mandates Reform Act                     would not qualify as ‘‘essential’’                    required.
                                               of 1995 (section 202(a)) requires us to                 products under the current regulation;
                                               prepare a written statement, which                      consequently, removal of the exemption                VI. Paperwork Reduction Act of 1995
                                               includes an assessment of anticipated                   for such drugs would not present the
                                               costs and benefits, before proposing                                                                            FDA tentatively concludes that this
                                                                                                       public, consumers, insurers, or
                                               ‘‘any rule that includes any Federal                                                                          proposed rule contains no collection of
                                                                                                       producers with any costs.
                                               mandate that may result in the                                                                                information. Therefore, clearance by the
                                               expenditure by State, local, and tribal                 3. Health Benefits                                    Office of Management and Budget under
                                               governments, in the aggregate, or by the                   The proposed rule would implement                  the Paperwork Reduction Act of 1995 is
                                               private sector, of $100,000,000 or more                 the requirements of the Clean Air Act                 not required.
                                               (adjusted annually for inflation) in any                that ban the use of products containing
                                               one year.’’ The current threshold after                                                                       VII. Federalism
                                                                                                       ODSs that no longer meet the
                                               adjustment for inflation is $146 million,               requirements for essential use. The                     We have analyzed this proposed rule
                                               using the most current (2015) Implicit                  benefits stem from preventing the ODSs                in accordance with the principles set
                                               Price Deflator for the Gross Domestic                   that would have been emitted by                       forth in Executive Order 13132. We
                                               Product. This proposed rule would not                   potential market entrants. The social                 have determined that this proposed rule
                                               result in an expenditure in any year that               benefits of the proposed rule derive                  does not contain policies that have
                                               meets or exceeds this amount.                           from greater compliance with the Clean                substantial direct effects on the States,
                                               B. Need for the Regulation                              Air Act. Because there will not be any
                                                                                                                                                             on the relationship between the
                                                                                                       change in exposure and any resulting
                                                  This rule is necessary to comply with                                                                      National Government and the States, or
                                                                                                       risk from the proposed rule, there will
                                               the Montreal Protocol under authority of                not be any direct public health benefits.             on the distribution of power and
                                               Title VI of the Clean Air Act (section                                                                        responsibilities among the various
                                               601 et seq.), which banned the                          D. Economic Summary                                   levels of government. Accordingly, we
                                               manufacture of ODSs, including CFCs,                      The proposed rule, if finalized, will               conclude that the rule does not contain
                                               to reduce the depletion of the ozone                    remove the essential-use exemption for                policies that have federalism
                                               layer in the United States as of January                anesthetic drugs for topical use on                   implications as defined in the Executive
                                               1, 1996. EPA regulations exempted from                  accessible mucous membranes of                        Order and, consequently, a federalism
                                               the ban medical devices, diagnostic                     humans where a cannula is used for                    summary impact statement is not
                                               products, drugs, and drug delivery                      application. The primary public health                required.
                                               systems that FDA considered essential                   benefit from adoption of the proposed
                                               and that are listed in § 2.125(e) when                  rule is to reduce the depletion of the                VIII. Reference
                                               they use a class I or class II ODS for                  ozone layer to decrease human exposure                  The following reference is on display
                                               which no safe and effective alternative                 to ultraviolet radiation. Because                     in the Division of Dockets Management
                                               has been developed.                                     anesthetic drugs for topical use are not
                                                  Anesthetic drugs for topical use on                                                                        (see ADDRESSES) and are available for
                                                                                                       currently sold in the market in an                    viewing by interested persons between
                                               accessible mucous membranes of                          approved form, there would be no
                                               humans where a cannula is used for                                                                            9 a.m. and 4 p.m., Monday through
                                                                                                       health benefit or social cost for
                                               application are not available in the                                                                          Friday; it are also available
                                                                                                       removing the exemption for such
                                               product market in an approved ODS                                                                             electronically at http://
Lhorne on DSK30JT082PROD with PROPOSALS




                                                                                                       products from the ban.
                                               formulation. Because the product is not                                                                       www.regulations.gov.
                                               marketed under an investigational new                   IV. Regulatory Flexibility Analysis                   1. Hartman, N. R., J. J. Mao, H. Zhou, et al.,
                                               drug (IND), new drug application                          FDA has examined the economic                           ‘‘More Methemoglobin is Produced by
                                               (NDA), or abbreviated new drug                          implications of the proposed rule as                      Benzocaine Treatment Than Lidocaine
                                               application (ANDA) and alternative                      required by the Regulatory Flexibility                    Treatment in Human In Vitro Systems.’’
                                               products for the same use that do not                   Act. If a rule will have a significant                    Regulatory Toxicology and
                                               use ODSs, such as lidocaine, are now                    economic impact on a substantial                          Pharmacology, 70:182–188, 2014.



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                                               74372               Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Proposed Rules

                                               List of Subjects                                        vouchers, the right of enhanced voucher               via TTY by calling the Federal Relay
                                                                                                       holders to remain in their units,                     Service, toll-free, at 800–877–8339.
                                               In 21 CFR Part 2
                                                                                                       procedures for addressing over-housed                 Copies of all comments submitted are
                                                 Administrative practice and                           families, and the calculation of the                  available for inspection and
                                               procedure, Cosmetics, Drugs, Foods.                     enhanced voucher housing assistance                   downloading at www.regulations.gov.
                                                 Therefore, under the Federal Food,                    payment.                                              FOR FURTHER INFORMATION CONTACT: For
                                               Drug, and Cosmetic Act and under                        DATES: Comment Due Date: December                     information about HUD’s Public
                                               authority delegated to the Commissioner                 27, 2016.                                             Housing and Voucher programs, contact
                                               of Food and Drugs, we propose that 21                   ADDRESSES: Interested persons are                     Rebecca Primeaux, Director, Housing
                                               CFR part 2 be amended as follows:                       invited to submit comments regarding                  Voucher Management and Operations
                                                                                                       this proposed rule to the Regulations                 Division, Office of Public and Indian
                                               PART 2—GENERAL ADMINISTRATIVE                                                                                 Housing, Department of Housing and
                                                                                                       Division, Office of General Counsel,
                                               RULINGS AND DECISIONS                                                                                         Urban Development, 451 7th Street,
                                                                                                       Department of Housing and Urban
                                                                                                       Development, 451 7th Street SW., Room                 Room 4226, Washington, DC 20140,
                                               ■ 1. The authority citation for part 2                                                                        telephone number 202–708–0477. The
                                               continues to read as follows:                           10276, Washington, DC 20410–0500.
                                                                                                       Communications must refer to the above                listed telephone number is not a toll-
                                                 Authority: 15 U.S.C. 402, 409; 21 U.S.C.              docket number and title. There are two                free number. Persons with hearing or
                                               321, 331, 335, 342, 343, 346a, 348, 351, 352,                                                                 speech impairments may access this
                                               355, 360b, 361, 362, 371, 372, 374; 42 U.S.C.
                                                                                                       methods for submitting public
                                                                                                       comments. All submissions must refer                  number through TTY by calling the toll-
                                               7671 et seq.                                                                                                  free Federal Relay Service at 1–800–
                                                                                                       to the above docket number and title.
                                               § 2.125   [Amended]                                       1. Submission of Comments by Mail.                  877–8339.
                                               ■ 2. In § 2.125, remove and reserve                     Comments may be submitted by mail to                  SUPPLEMENTARY INFORMATION:
                                               paragraph (e)(4)(iii).                                  the Regulations Division, Office of                   I. Background
                                                                                                       General Counsel, Department of
                                                 Dated: October 20, 2016.                                                                                       General. Section 8(t) of the U.S.
                                                                                                       Housing and Urban Development, 451
                                               Leslie Kux,
                                                                                                       7th Street SW., Room 10276,                           Housing Act of 1937 (1937 Act) (42
                                               Associate Commissioner for Policy.                      Washington, DC 20410–0500.                            U.S.C. 1437f(t)) provides unified
                                               [FR Doc. 2016–25852 Filed 10–25–16; 8:45 am]              2. Electronic Submission of                         authority for families to be offered
                                               BILLING CODE 4164–01–P                                  Comments. Interested persons may                      enhanced vouchers upon the occurrence
                                                                                                       submit comments electronically through                of an ‘‘eligibility event,’’ which is
                                                                                                       the Federal eRulemaking Portal at                     defined in section 8(t)(2) as one of four
                                               DEPARTMENT OF HOUSING AND                               www.regulations.gov. HUD strongly                     categories of events that results in
                                               URBAN DEVELOPMENT                                       encourages commenters to submit                       families in the project being eligible for
                                                                                                       comments electronically. Electronic                   enhanced voucher assistance under one
                                               24 CFR Part 982                                         submission of comments allows the                     of three statutes: (1) The Low-Income
                                                                                                       commenter maximum time to prepare                     Housing Preservation and Resident
                                               [Docket No. FR–5585–P–01]
                                                                                                       and submit a comment, ensures timely                  Homeownership Act of 1990, 12 U.S.C.
                                               RIN 2577–AD00                                           receipt by HUD, and enables HUD to                    4101 et seq. (LIHPRHA), (2) the
                                                                                                       make them immediately available to the                Multifamily Assisted Housing Reform
                                               Tenant-Based Assistance: Enhanced                                                                             and Affordability Act of 1997, 42 U.S.C.
                                                                                                       public. Comments submitted
                                               Vouchers                                                                                                      1437f note (MAHRA), or (3) of the
                                                                                                       electronically through the
                                               AGENCY:  Office of the Assistant                        www.regulations.gov Web site can be                   Housing and Community Development
                                               Secretary for Public and Indian                         viewed by other commenters and                        Amendments of 1978, 42 U.S.C. 5301
                                               Housing, HUD.                                           interested members of the public.                     note (HCDA). The four categories of
                                                                                                       Commenters should follow the                          events are: (1) The prepayment of a
                                               ACTION: Proposed rule.
                                                                                                       instructions provided on that site to                 mortgage that results in families
                                               SUMMARY:   This rule proposes to codify                 submit comments electronically.                       residing in the project being eligible
                                               HUD’s policy regarding enhanced                                                                               under section 223(f) of LIHPRHA for an
                                                                                                         Note: To receive consideration as public
                                               vouchers, a type of tenant-based                        comments, comments must be submitted
                                                                                                                                                             enhanced voucher; (2) the voluntary
                                               voucher provided for under section 8 of                 through one of the two methods specified              termination of the insurance contract
                                               the U.S. Housing Act of 1937 in the                     above. Again, all submissions must refer to           that results in families residing in the
                                               following four scenarios, which are                     the docket number and title of the rule.              project being eligible under section
                                               prescribed and limited by statute: The                    No Facsimile Comments. Facsimile                    223(f) of LIHPRHA for an enhanced
                                               prepayment of certain mortgages, the                    (FAX) comments are not acceptable.                    voucher; (3) the termination or
                                               voluntary termination of the insurance                    Public Inspection of Public                         expiration of a project-based section 8
                                               contract for the mortgage, the                          Comments. All properly submitted                      rental assistance contract that results in
                                               termination or the expiration of a                      comments and communications                           assisted families residing in the project
                                               project-based section 8 rental assistance               submitted to HUD will be available for                being eligible under section 515(c)(3) or
                                               contract, and the transaction under                     public inspection and copying between                 section 524(d) of MAHRA for an
                                               which a project that receives or has                    8 a.m. and 5 p.m. weekdays at the above               enhanced voucher; 1 and (4) a
                                               received assistance under the Flexible                  address. Due to security measures at the
Lhorne on DSK30JT082PROD with PROPOSALS




                                                                                                                                                               1 Section 515(c)(3) pertains to a determination by
                                               Subsidy Program is preserved as                         HUD Headquarters building, an advance                 the Department to renew an expiring project-based
                                               affordable housing. Specifically, this                  appointment to review the public                      section 8 contract with tenant-based assistance,
                                               rule would codify existing policy                       comments must be scheduled by calling                 whereas section 524(d) applies when a rental
                                               concerning the eligibility criteria for                 the Regulations Division at 202–402–                  assistance contract to which a covered project is
                                                                                                                                                             subject expires and is not renewed, whether the
                                               enhanced vouchers, as well as provide                   3055 (this is not a toll-free number).                owner opts out by giving the notice required under
                                               rental payment standards and subsidy                    Individuals with speech or hearing                    42 U.S.C. 1437f(c)(8)(A) or the HAP contract simply
                                               standards applicable to enhanced                        impairments may access this number                    expires. If the HAP contract expires without the



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Document Created: 2016-10-26 02:17:16
Document Modified: 2016-10-26 02:17:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesSubmit either electronic or written comments on the proposed rule by December 27, 2016.
ContactDaniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240-402-0979, [email protected]
FR Citation81 FR 74368 
RIN Number0910-AH36
CFR AssociatedAdministrative Practice and Procedure; Cosmetics; Drugs and Foods

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