[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 72112-72114]
[FR Doc No: 2019-28159]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-25854; FMCSA-2013-0108; FMCSA-2014-0382; FMCSA-
2015-0115; FMCSA-2015-0116; FMCSA-2015-0119; FMCSA-2017-0252]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew exemptions for 11
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before January
29, 2020.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2006-25854, Docket No. FMCSA-
2013-0108, Docket No. FMCSA-2014-0382, Docket No. FMCSA-2015-0115,
Docket No. FMCSA-2015-0116, Docket No. FMCSA-2015-0119, or Docket No.
FMCSA-2017-0252 using any of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2006-25854; FMCSA-2013-0108; FMCSA-2014-0382;
FMCSA-2015-0115; FMCSA-2015-0116; FMCSA-2015-0119; FMCSA-2017-0252),
indicate the specific section of this document to which each comment
applies, and provide a reason for each suggestion or recommendation.
You may submit your comments and material online or by fax, mail, or
hand delivery, but please use only one of these means. FMCSA recommends
that you include your name and a mailing address, an email address, or
a phone number in the body of your document so that FMCSA can contact
you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-2006-25854; FMCSA-2013-0108; FMCSA-2014-
0382; FMCSA-2015-0115; FMCSA-2015-0116; FMCSA-2015-0119; FMCSA-2017-
0252, in the keyword box, and click ``Search.'' When the new screen
appears, click on the ``Comment Now!'' button and type your comment
into the text box on the following screen. Choose whether you are
submitting your comment as an individual or on behalf of a third party
and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2006-25854; FMCSA-2013-0108; FMCSA-
2014-0382; FMCSA-2015-0115; FMCSA-2015-0116; FMCSA-2015-0119; FMCSA-
2017-0252, in the keyword box, and click ``Search.'' Next, click the
``Open Docket Folder'' button and choose the document to review. If you
do not have access to the internet, you may view the docket online by
visiting Docket Operations in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

    The 11 individuals listed in this notice have requested renewal of
their exemptions from the epilepsy and seizure disorders prohibition in
Sec.  391.41(b)(8), in accordance with FMCSA procedures. Accordingly,
FMCSA has evaluated these applications for renewal on their merits and
decided to extend each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 11
applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The 11
drivers in this notice remain in good standing with the Agency, have
maintained their medical monitoring and have not exhibited any medical
issues that would compromise their ability to safely operate a CMV
during the previous 2-year exemption period. In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License Information System and the Motor Carrier Management Information
System are searched for crash and violation

data. For non-CDL holders, the Agency reviews the driving records from
the State Driver's Licensing Agency. These factors provide an adequate
basis for predicting each driver's ability to continue to safely
operate a CMV in interstate commerce. Therefore, FMCSA concludes that
extending the exemption for each renewal applicant for a period of 2
years is likely to achieve a level of safety equal to that existing
without the exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of December
and are discussed below.
    As of December 16, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following five individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

William Brown (NC)
Robert J. Forney (WI)
Curtis Alan Hartman (MD)
Wendell F. Headley (MO)
Marion Legg (MD)

    The drivers were included in docket numbers FMCSA-2015-0115, FMCSA-
2015-0116, and FMCSA-2015-0119. Their exemptions are applicable as of
December 16, 2019, and will expire on December 16, 2021.
    As of December 23, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following five individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Gary Freeman (WI)
Aaron Gillette (SD)
David Kestner (VA)
Chad Smith (MA)
Trever Williams (MN)

    The drivers were included in docket number FMCSA-2006-25854, FMCSA-
2013-0108, and FMCSA-2014-0382. Their exemptions are applicable as of
December 23, 2019, and will expire on December 23, 2021.
    As of December 28, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following individual has satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers: David
Pamperin (WI).
    This driver was included in docket number FMCSA-2017-0252. His
exemption is applicable as of December 28, 2019, and will expire on
December 28, 2021.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the 2-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified ME, as defined by Sec.  390.5; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy of his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the exemption when driving, for presentation to a
duly authorized Federal, State, or local enforcement official. The
exemption will be rescinded if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the 11 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure disorders prohibition in Sec.  391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for
2 years unless revoked earlier by FMCSA.

    Issued on: December 20, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-28159 Filed 12-27-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61853]
[DOCID:fr17oc08-76]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-20-000]

Dynegy Marketing and Trade; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

October 10, 2008.
    This is a supplemental notice in the above-referenced proceeding of
Dynegy Marketing and Trade's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 30, 2008.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list.
    They are also available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive e-mail notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please e-mail<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-24660 Filed 10-16-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38688-38689]
[FR Doc No: 2019-16901]

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

SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-10666; 34-86552; File No. 265-32]

SEC Small Business Capital Formation Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting.

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

SUMMARY: The Securities and Exchange Commission Small Business Capital
Formation Advisory Committee, established pursuant to Section 40 of the
Securities Exchange Act of 1934 as added by the SEC Small Business
Advocate Act of 2016, is providing notice that it will hold a public
meeting. The public is invited to submit written statements to the
Committee.

DATES: The meeting will be held on Tuesday, August 13, 2019, from 9:30
a.m. to 3:30 p.m. (CT) and will be open to the public. Seating will be
on a first-come, first-served basis. Written statements should be
received on or before August 12, 2019.

ADDRESSES: The meeting will be held at Creighton University, in The
President's Fitzgerald Boardroom on the fourth floor of the Mike and
Josie Harper Center, located at 602 North 20th Street, Omaha, Nebraska
68178. The meeting will be webcast on the Commission's website at
www.sec.gov. Written statements may be submitted by any of the
following methods:

Electronic Statements

     Use the Commission's internet submission form (http://www.sec.gov/rules/other.shtml); or
     Send an email message to<EMAIL_ADDRESS>Please
include File Number 265-32 on the subject line; or

Paper Statements

     Send paper statements to Vanessa A. Countryman, Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File No. 265-32. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method. The Commission will post all statements on the SEC's website at
www.sec.gov. Statements also will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. (ET). All statements received will be posted
without change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: Julie Z. Davis, Senior Special
Counsel, Office of the Advocate for Small Business Capital Formation,
at<PHONE_NUMBER>, Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-3628.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public.
Persons needing special accommodations because of a disability should
notify the contact person listed in the section above entitled FOR
FURTHER INFORMATION CONTACT. The agenda for the meeting includes
matters relating to rules and regulations affecting small and emerging
companies under the federal securities laws.

    Dated: August 2, 2019.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2019-16901 Filed 8-6-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Page 67863]
[FR Doc No: 2023-21614]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[FAA-2023-1929]

Notice of Availability of the Draft Environmental Review Document
for Amended Arrival Routes at Los Angeles International Airport

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation.

ACTION: Public comment period for the FAA's draft environmental review
document.

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

SUMMARY: The FAA announces the release of the draft environmental
review document for the amendments to area navigation (RNAV) arrival
procedures, HUULL, IRNMN, and RYDRR, at Los Angeles International
Airport (KLAX), in Los Angeles, California for public review and
comment. The draft environmental review document is available for
public review beginning on October 2, 2023 and comments can be
submitted on or before November 1, 2023. Comments can be submitted by
email to [email protected] or by mail to Federal
Aviation Administration, Operations Support Group, Western Service
Center, 2200 216th Street, Des Moines, WA 98198. Before including your
address, phone number, email address, or other personal identifying
information in your comment, be advised that your entire comment-
including your personal identifying information-may be made publicly
available at any time. While you can ask us in your comment to withhold
from public review your personal identifying information, we cannot
guarantee that we will be able to do so.

FOR FURTHER INFORMATION CONTACT: Joe Bert, Operations Support Group,
Western Service Center, 2200 216th Street, Des Moines, WA 98198;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with the U.S. Court of Appeals
for the Ninth Circuit's (Court) holding in City of Los Angeles, et al
v. Dickson, No. 19-71581, the FAA is performing a new review of the
potential environmental impacts of the implementation of the
amendments. The Court's decision ``remand[ed] the amended Arrival
Routes to the FAA without vacatur, leaving the amended Arrival Routes
in place while the FAA undertakes the proper National Environmental
Policy Act (NEPA) analysis and National Historic Preservation Act of
1966, 16 U.S.C. 470, et seq., (NHPA) and Department of Transportation
Act of 1966, 49 U.S.C Sec.  303 (Section 4(f)) consultation.
    The draft environmental review document is available on the FAA
website at: https://www.faa.gov/air_traffic/community_engagement/lax.

    Issued in Des Moines, WA, on September 26, 2023.
Ryan Wade Weller,
Environmental Specialist Operations Support Group Western Service
Center.
[FR Doc. 2023-21614 Filed 9-29-23; 8:45 am]
BILLING CODE P


[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Rules and Regulations]
[Pages 14279-14287]
[FR Doc No: 2012-5648]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 59

[EPA-HQ-OAR-2006-0971; FRL-9644-8]
RIN 2060-AR37

National Volatile Organic Compound Emission Standards for Aerosol
Coatings--Addition of Dimethyl Carbonate, Benzotrifluoride, and
Hexamethyldisiloxane to Table of Reactivity Factors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The EPA is taking direct final action to amend the National
Volatile Organic Compound Emission Standards for Aerosol Coatings final
rule, which is a rule that establishes national reactivity-based
emission standards for the aerosol coatings category (aerosol spray
paints) under the Clean Air Act, published elsewhere in the Federal

Register. This direct final action adds three compounds: dimethyl
carbonate, benzotrifluoride and hexamethyldisiloxane, and their
associated reactivity factors to the aerosol coatings reactivity rule's
table of reactivity factors based on petitions received from regulated
entities. This action also revises two tables in the final rule, and
corrects a typographical error in a test method reference.

DATES: This rule is effective on June 7, 2012 without further notice,
unless the EPA receives adverse comment by April 23, 2012. If the EPA
receives adverse comment, we will publish a timely withdrawal in the
Federal Register informing the public that some or all of the
amendments in the final rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2006-0971, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: U.S. Postal Service, send comment to: EPA Docket
Center (6102T), Air and Radiation Docket, National Volatile Organic
Compound Emission Standards for Aerosol Coatings, 1200 Pennsylvania
Avenue NW., Washington, DC 20460. Please include a total of two copies.
     Hand Delivery: In person or by courier, deliver comments
to: EPA Docket Center (6102T), Air and Radiation Docket, National
Volatile Organic Compound Emission Standards for Aerosol Coatings,
Public Reading Room, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2006-0971. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses.

FOR FURTHER INFORMATION CONTACT: For information concerning the aerosol
coatings reactivity rule, contact Ms. J. Kaye Whitfield, U.S. EPA,
Office of Air Quality Planning and Standards, Sector Policies and
Programs Division, Minerals and Manufacturing Group (D243-02), Research
Triangle Park, North Carolina 27711, telephone number:<PHONE_NUMBER>,
fax number<PHONE_NUMBER>, email address<EMAIL_ADDRESS>For
information concerning the Clean Air Act section 183(e) consumer and
commercial products program, contact Ms. Kim Teal, U.S. EPA, Office of
Air Quality Planning and Standards, Sector Policies and Programs
Division, Minerals and Manufacturing Group (D243-04), Research Triangle
Park, North Carolina 27711, telephone number:<PHONE_NUMBER>, fax
number<PHONE_NUMBER>, email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Why is the EPA using a direct final rule?
II. Does this action apply to me?
III. What should I consider as I prepare my comments for the EPA?
    A. Submitting CBI
    B. Tips for Preparing Your Comments
IV. What are the amendments made by this direct final rule?
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act

I. Why is the EPA using a direct final rule?

    The EPA is publishing this direct final rule without a prior
proposed rule because we view this as a noncontroversial action and
anticipate no adverse comment. Section 59.511(j) of the final rule
states that if a regulated entity identifies a VOC that is needed for
an aerosol formulation that is not listed in Tables 2A, 2B, or 2C, it
is assigned a default reactivity factor (RF) of 22.04/Z g
O3/g VOC. However, regulated entities may petition the
Agency to add a compound to Table 2A, 2B, or 2C provided that the
petitions include the chemical name, CAS number, a statement certifying
the intent to use the compound in an aerosol coatings product, and
adequate information to evaluate the reactivity of the compound and
assign a RF value consistent with the values for the other compounds
listed in Table 2A. Since publication of the final rule (73 FR 15604,
March 24, 2008), compounds have been added to Table 2A following the
same procedure (74 FR 29595, June 23, 2009). The amendments to the
aerosol coatings final rule described herein consist of adding three
compounds to Table 2A, and their associated RFs and Chemical Abstract
Service (CAS) numbers, based on petitions received by the Agency and
consistent with Section 59.511(j) of the final rule. The amendments do
not make material changes to the rule. This action also revises Table 1
of the final rule by moving the units from the table heading to the
reactivity limits column, revises Tables 2A, 2B, and 2C by assigning
units to the reactivity factor column, and corrects a typographical
error in a test method reference. However, in the ``Proposed Rules''
section of this Federal Register, we are publishing a separate document
that will serve as the proposed rule to the National Volatile Organic
Compound Emission Standards for Aerosol Coatings (40 CFR part 59) if
adverse comments are received on this direct final rule. We will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document.

    If the EPA receives adverse comment, we will publish a timely
withdrawal in the Federal Register informing the public that some or
all of the amendments in this direct final rule will not take effect.
We would address all public comments in any subsequent final rule based
on the proposed rule.

II. Does this action apply to me?

    The entities potentially affected by this direct final rule are the
same entities that are subject to the aerosol coatings final rule. The
entities affected by the aerosol coatings final rule include:
Manufacturers, processors, distributors or importers of aerosol
coatings for sale or distribution in the United States, and
manufacturers, processors, distributors or importers who supply the
entities listed above with aerosol coatings for sale or distribution in
interstate commerce in the United States.

III. What should I consider as I prepare my comments for the EPA?

    A. Submitting CBI. Do not submit this information to the EPA
through www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-
ROM as CBI and then identify electronically within the disk or CD-ROM
the specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    B. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

IV. What are the amendments made by this direct final rule?

    This direct final rule adds three compounds to Table 2A--Reactivity
Factors: dimethyl carbonate, benzotrifluoride, hexamethyldisiloxane,
and their corresponding CAS numbers and RFs (see Table A). This action
is in accordance with Section 59.511(j) of the final rule which allows
regulated entities to petition the Agency to add compounds to Table 2A,
2B, or 2C provided that the petition includes the chemical name, CAS
number, a statement certifying the intent to use the compound in an
aerosol coatings product, and adequate information to evaluate the
reactivity of the compound and assign a RF value consistent with the
values for the other compounds listed in Table 2A (73 FR 15604, March
24, 2008; 74 FR 29595, June 23, 2009). EPA received petitions from KOWA
America, Raymond Regulatory Resources, Seymour of Sycamore, and 3M,
requesting the addition of the three compounds to Table 2A.
    This action also revises Table 1 of the final rule by moving the
units, expressed as grams of ozone per gram of product (g
O3/g product), from the table heading to the column titled,
``Reactivity Limit''; revises Tables 2A, 2B, and 2C by adding units,
expressed as grams of ozone per gram of VOC (g O3/g VOC), to
the column titled, ``Reactivity Factors''; and corrects a test method
typographical error by replacing the phrase ``California Air Resources
Board Method 3-0'' in 40 CFR 59.515(a)(1) with ``California Air
Resources Board Method 310.''

         Table A--Compounds Added to Table of Reactivity Factors
------------------------------------------------------------------------
                                                            Reactivity
                Compound                      CAS No.     factor (g O3/g
                                                               VOC)
------------------------------------------------------------------------
Benzotrifluoride........................         98-08-8            0.26
Hexamethyldisiloxane....................        107-46-0            0.00
Dimethyl carbonate......................        616-38-6            0.06
------------------------------------------------------------------------

    As is the case for the other compounds in Table 2A, the RFs
assigned to the three compounds are consistent with the maximum
incremental reactivity (MIR) values in California's aerosol coatings
regulation (Title 17, California Code of Regulations, Division 3,
Chapter 1, Subchapter 8.6, Article 1, Sec.  94700).
    In the instance of benzotrifluoride and dimethyl carbonate, their
RFs were previously published in the EPA's original proposal for this
rule; therefore, the information on their reactivity had been
adequately evaluated and RFs assigned (72 FR 38592, July 16, 2007).
When the rule was finalized, only those compounds known to EPA to be
used in aerosol coating formulations were included in Table 2A (73 FR
15604, March 24, 2008). At the time the original rule was finalized,
EPA did not know of any aerosol coating formulations in which
benzotrifluoride and dimethyl carbonate were used, so their RFs were
not included in Table 2A. The RFs for benzotrifluoride and dimethyl
carbonate are consistent with the California MIR values that have been
effective since July 18, 2001.
    For hexamethyldisiloxane, an RF value was not included in the
original proposal for this rule. California assigned an MIR value of
zero to hexamethyldisiloxane, effective October 2, 2010. The most
recent MIR values published by Dr. William Carter at the University of
California at Riverside, upon which the California MIR values are
based, lists the MIR for hexamethyldisiloxane as -0.025 g
O3/g VOC (see  http://www.cert.ucr.edu/~carter/SAPRC/
scales07.xls). This MIR value indicates that hexamethyldisiloxane acts
as a slight inhibitor to ozone formation. Based on this information,
the EPA believes that

a RF of zero is appropriate for the purposes of this regulation.
    Comments on this direct final action are to be limited to issues
directly associated with adding these three compounds, and their
associated RFs to Table 2A.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735 October 4, 1993) and is,
therefore, not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose any new information collection burden
because it serves to add compounds to Table 2A of the rule and make
several clarifying edits. However, the Office of Management and Budget
(OMB) has previously approved the information collection requirements
contained in the existing regulations (40 CFR parts 51 and 59) under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
and has assigned OMB control number 2060-0617. The OMB control numbers
for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.
    For purposes of assessing the impacts of this final rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's regulations at 13 CFR 121.201;
(2) a governmental jurisdiction that is a government of a city, county,
town, school district or special district with a population of less
than 50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
    This rule will not impose any requirements on small entities. We
have determined that small businesses will not incur any adverse
impacts because the EPA is taking this action to amend the aerosol
coatings rule by adding compounds to Table 2A of the rule and making
several clarifying edits. These amendments do not create any new
requirements or burdens, and no costs are associated with these
amendments.
    We have, therefore, concluded that this final rule will relieve
regulatory burden for all affected small entities.

D. Unfunded Mandates Reform Act

    This rule does not contain a federal mandate that may result in
expenditures of $100 million or more for state, local and tribal
governments, in the aggregate, or the private sector in any one year.
Thus, this rule is not subject to the requirements of sections 202 or
205 of UMRA.
    This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. In this action, the
EPA is amending Table 2A by adding three compounds and their associated
reactivity factors, and making several clarifying edits.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not 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, as
specified in Executive Order 13132. This action adds compounds and
corresponding Chemical Abstract Service numbers and reactivity factors
to Table 2A of the aerosol coatings rule, and makes several clarifying
edits. Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action adds
compounds and corresponding Chemical Abstract Service numbers and
reactivity factors to Table 2A of the aerosol coatings rule, and makes
several clarifying edits. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23,
1997) as applying to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Order has the potential to influence the regulation. This action is
not subject to Executive Order 13045 because it is based solely on
technology performance.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs the EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs the EPA to provide
Congress, through OMB, explanations when the agency decides not to use
available and applicable voluntary consensus standards.
    This action does not involve technical standards. Therefore, the
EPA did not consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    The EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. Further, this action adds compounds to Table 2 of the
aerosol coatings rule, and corresponding Chemical Abstract Service
numbers and reactivity factors, and makes several clarifying edits.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this rule and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A Major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective June 7, 2012.

List of Subjects in 40 CFR Part 59

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: March 1, 2012.
Lisa P. Jackson,
Administrator.
    For the reasons set out in the preamble, part 59 of title 40,
Chapter I of the Code of Federal Regulations is amended as follows:

PART 59--[AMENDED]

0
1. The authority citation for part 59 continues to read as follows:

    Authority:  42 U.S.C. 7414 and 7511b(e).

0
2. Section 59.515 is amended by revising paragraph (a)(1) to read as
follows:

Sec.  59.515  Incorporations by reference.

* * * * *
    (a) * * *
    (1) California Air Resources Board Method 310--Determination of
Volatile Organic Compounds (VOC) in Consumer Products and Reactive
Organic Compounds in Aerosol Coating Products (May 5, 2005), IBR
approved for Sec.  59.508.
* * * * *
0
3. Table 1 to Subpart E of Part 59 is revised to read as follows:

             Table 1 to Subpart E of Part 59--Product-Weighted Reactivity Limits by Coating Category
----------------------------------------------------------------------------------------------------------------
                                                                                Reactivity limit
                     Coating category                              Category code \a\           (g O3/g product)
----------------------------------------------------------------------------------------------------------------
Clear Coatings...........................................  CCP                                              1.50
Flat Coatings............................................  FCP                                              1.20
Fluorescent Coatings.....................................  FLP                                              1.75
Metallic Coatings........................................  MCP                                              1.90
Non-Flat Coatings........................................  NFP                                              1.40
Primers..................................................  PCP                                              1.20
Ground Traffic/Marking...................................  GTM                                              1.20
Art Fixatives or Sealants................................  AFS                                              1.80
Auto Body Primers........................................  ABP                                              1.55
Automotive Bumper and Trim Products......................  ABT                                              1.75
Aviation or Marine Primers...............................  AMP                                              2.00
Aviation Propellor Coatings..............................  APC                                              2.50
Corrosion Resistant Brass, Bronze, or Copper Coatings....  CRB                                              1.80
Exact Match Finish--Engine Enamel........................  EEE                                              1.70
Exact Match Finish--Automotive...........................  EFA                                              1.50
Exact Match Finish--Industrial...........................  EFI                                              2.05
Floral Sprays............................................  FSP                                              1.70
Glass Coatings...........................................  GCP                                              1.40
High Temperature Coatings................................  HTC                                              1.85
Hobby/Model/Craft Coatings, Enamel.......................  HME                                              1.45
Hobby/Model/Craft Coatings, Lacquer......................  HML                                              2.70
Hobby/Model/Craft Coatings, Clear or Metallic............  HMC                                              1.60
Marine Spar Varnishes....................................  MSV                                              0.90
Photograph Coatings......................................  PHC                                              1.00
Pleasure Craft Primers, Surfacers or Undercoaters........  PCS                                              1.05
Pleasure Craft Topcoats..................................  PCT                                              0.60
Polyolefin Adhesion Promoters............................  PAP                                              2.50
Shellac Sealers, Clear...................................  SSC                                              1.00
Shellac Sealers, Pigmented...............................  SSP                                              0.95
Slip-Resistant Coatings..................................  SRC                                              2.45
Spatter/Multicolor Coatings..............................  SMC                                              1.05
Vinyl/Fabric/Leather/Polycarbonate Coatings..............  VFL                                              1.55
Webbing/Veiling Coatings.................................  WFC                                              0.85
Weld-Through Primers.....................................  WTP                                              1.00
Wood Stains..............................................  WSP                                              1.40

Wood Touch-up/Repair or Restoration Coatings.............  WTR                                              1.50
----------------------------------------------------------------------------------------------------------------
\a\ Regulated entities may use these category codes or define their own in accordance with Sec.   59.511(b)(6).

0
4. Table 2A to Subpart E of Part 59 is revised to read as follows:

          Table 2A to Subpart E of Part 59--Reactivity factors
------------------------------------------------------------------------
                                                            Reactivity
                Compound                      CAS No.     factor  (g O3/
                                                              g VOC)
------------------------------------------------------------------------
Formaldehyde............................         50-00-0            8.97
Glycerol (1,2,3-Propanetriol)...........         56-81-5            3.27
Propylene Glycol........................         57-55-6            2.75
Ethanol.................................         64-17-5            1.69
Formic Acid.............................         64-18-6            0.08
Acetic Acid.............................         64-19-7            0.71
Methanol................................         67-56-1            0.71
Isopropyl Alcohol (2-Propanol)..........         67-63-0            0.71
Acetone (Propanone).....................         67-64-1            0.43
n-Propanol (n-Propyl Alcohol)...........         71-23-8            2.74
n-Butyl Alcohol (Butanol)...............         71-36-3            3.34
n-Pentanol (Amyl Alcohol)...............         71-41-0            3.35
Benzene.................................         71-43-2            0.81
1,1,1-Trichloroethane...................         71-55-6            0.00
Propane.................................         74-98-6            0.56
Vinyl Chloride..........................         75-01-4            2.92
Acetaldehyde............................         75-07-0            6.84
Methylene Chloride (Dichloromethane)....         75-09-2            0.07
Ethylene Oxide..........................         75-21-8            0.05
Isobutane...............................         75-28-5            1.35
HFC-152A (1,1-Difluoroethane)...........         75-37-6            0.00
Propylene Oxide.........................         75-56-9            0.32
t-Butyl Alcohol.........................         75-65-0            0.45
Methyl t-Butyl Ketone...................         75-97-8            0.78
Isophorone (3,5,5-Trimethyl-2-                   78-59-1           10.58
 Cyclohexenone).........................
Isopentane..............................         78-78-4            1.68
Isobutanol..............................         78-83-1            2.24
2-Butanol (s-Butyl Alcohol).............         78-92-2            1.60
Methyl Ethyl Ketone (2-Butanone)........         78-93-3            1.49
Monoisopropanol Amine (1-Amino-2-                78-96-6           13.42
 Propanol)..............................
Trichloroethylene.......................         79-01-6            0.60
Propionic Acid..........................         79-09-4            1.16
Acrylic Acid............................         79-10-7           11.66
Methyl Acetate..........................         79-20-9            0.07
Nitroethane.............................         79-24-3           12.79
Methacrylic Acid........................         79-41-4           18.78
a-Pinene (Pine Oil).....................         80-56-8            4.29
Methyl Methacrylate.....................         80-62-6           15.84
Naphthalene.............................         91-20-3            3.26
Xylene, ortho-..........................         95-47-6            7.49
o-Cresol................................         95-48-7            2.34
1,2,4-Trimethylbenzene..................         95-63-6            7.18
3-Pentanone.............................         96-22-0            1.45
Methyl Ethyl Ketoxime (Ethyl Methyl              96-29-7           22.04
 Ketone Oxime)..........................
gamma-Butyrolactone.....................         96-48-0            1.15
Ethyl Lactate...........................         97-64-3            2.71
Isobutyl Isobutyrate....................         97-85-8            0.61
Isobutyl Methacrylate...................         97-86-9            8.99
Butyl Methacrylate......................         97-88-1            9.09
Benzotrifluoride........................         98-08-8            0.26
PCBTF (p-Trifluoromethyl-Cl-Benzene)....         98-56-6            0.11
Cumene (Isopropyl Benzene)..............         98-82-8            2.32
a-Methyl Styrene........................         98-83-9            1.72
Ethyl Benzene...........................        100-41-4            2.79
Styrene.................................        100-42-5            1.95
Benzaldehyde............................        100-52-7            0.00
Triethanolamine.........................        102-71-6            2.76

2-Ethyl-Hexyl Acetate...................        103-09-3            0.79
2-Ethyl-Hexyl Acrylate..................        103-11-7            2.42
2-Ethyl-1-Hexanol (Ethyl Hexyl Alcohol).        104-76-7            2.20
Ethyl Propionate........................        105-37-3            0.79
s-Butyl Acetate.........................        105-46-4            1.43
n-Propyl Propionate.....................        106-36-5            0.93
Xylene, para-...........................        106-42-3            4.25
p-Dichlorobenzene.......................        106-46-7            0.20
Dimethyl Succinate......................        106-65-0            0.23
1,2-Epoxybutane (Ethyl Oxirane).........        106-88-7            1.02
n-Propyl Bromide........................        106-94-5            0.35
Butane..................................        106-97-8            1.33
1,3-Butadiene...........................        106-99-0           13.58
Ethylene Glycol.........................        107-21-1            3.36
2-Methyl-2,4-Pentanediol................        107-41-5            1.04
Hexamethyldisiloxane....................        107-46-0            0.00
Isohexane Isomers.......................        107-83-5            1.80
Methyl n-Propyl Ketone (2-Pentanone)....        107-87-9            3.07
Propylene Glycol Monmethyl Ether (1-            107-98-2            2.62
 Methoxy-2-Propanol)....................
n,n-Dimethylethanolamine................        108-01-0            4.76
1-Nitropropane..........................        108-03-2           16.16
Vinyl Acetate...........................        108-05-4            3.26
Methyl Isobutyl Ketone..................        108-10-1            4.31
Isopropyl Acetate.......................        108-21-4            1.12
Propylene Carbonate (4-Methyl-1,3-              108-32-7            0.25
 Dioxolan-2one).........................
Xylene, meta-...........................        108-38-3           10.61
Propylene Glycol Monomethyl Ether               108-65-6            1.71
 Acetate (1-Methoxy-2-Propyl Acetate)...
1,3,5-Trimethyl Benzene.................        108-67-8           11.22
Di-Isobutyl Ketone (2,6-Dimethyl-4-             108-83-8            2.94
 Heptanone).............................
Methylcyclohexane.......................        108-87-2            1.99
Toluene.................................        108-88-3            3.97
Monochlorobenzene.......................        108-90-7            0.36
Cyclohexanol............................        108-93-0            2.25
Cyclohexanone...........................        108-94-1            1.61
n-Butyl Butyrate........................        109-21-7            1.12
Propyl Acetate..........................        109-60-4            0.87
Pentane.................................        109-66-0            1.54
Ethylene Glycol Monomethyl Ether (2-            109-86-4            2.98
 Methoxyethanol)........................
Tetrahydrofuran.........................        109-99-9            4.95
Methyl Isoamyl Ketone (5-Methyl-2-              110-12-3            2.10
 Hexanone)..............................
Isobutyl Acetate........................        110-19-0            0.67
Methyl Amyl Ketone......................        110-43-0            2.80
Hexane..................................        110-54-3            1.45
n-Propyl Formate........................        110-74-7            0.93
2-Ethoxyethanol.........................        110-80-5            3.78
Cyclohexane.............................        110-82-7            1.46
Morpholine..............................        110-91-8           15.43
Dipropylene Glycol......................        110-98-5            2.48
Ethylene Glycol Monoethyl Ether Acetate         111-15-9            1.90
 (2-Ethoxyethyl Acetate)................
Diethylenetriamine......................        111-40-0           13.03
Diethanolamine..........................        111-42-2            4.05
Diethylene Glycol.......................        111-46-6            3.55
n-Octane................................        111-65-9            1.11
2-Butoxy-1-Ethanol (Ethylene Glycol             111-76-2            2.90
 Monobutyl Ether).......................
Diethylene Glycol Methyl Ether (2-(2-           111-77-3            2.90
 Methoxyethoxy) Ethanol)................
n-Nonane................................        111-84-2            0.95
2-(2-Ethoxyethoxy) Ethanol..............        111-90-0            3.19
Ethylene Glycol Monobutyl Ether Acetate         112-07-2            1.67
 (2-Butoxyethyl Acetate)................
2-(2-Ethoxyethoxy) Ethyl Acetate........        112-15-2            1.50
2-(2-Butoxyethoxy)-Ethanol..............        112-34-5            2.70
Dimethyl Ether..........................        115-10-6            0.93
Triethylamine...........................        121-44-8           16.60
2-Phenoxyethanol; Ethylene Glycol Phenyl        122-99-6            3.61
 Ether..................................
Diacetone Alcohol.......................        123-42-2            0.68
2,4-Pentanedione........................        123-54-6            1.02
Butanal.................................        123-72-8            6.74
Butyl Acetate, n........................        123-86-4            0.89
2-(2-Butoxyethoxy) Ethyl Acetate........        124-17-4            1.38
2-Amino-2-Methyl-1-Propanol.............        124-68-5           15.08
Perchloroethylene.......................        127-18-4            0.04

Ethanolamine............................        141-43-5            5.97
Ethyl acetate...........................        141-78-6            0.64
Heptane.................................        142-82-5            1.28
n-Hexyl Acetate (Hexyl Acetate).........        142-92-7            0.87
2-Ethyl Hexanoic Acid...................        149-57-5            4.41
1,2,3-Trimethyl Benzene.................        526-73-8           11.26
t-Butyl Acetate.........................        540-88-5            0.20
Methyl Isobutyrate......................        547-63-7            0.70
Methyl Lactate..........................        547-64-8            2.75
Methyl Propionate.......................        554-12-1            0.71
1,2 Butanediol..........................        584-03-2            2.21
n-Butyl Propionate......................        590-01-2            0.89
Methyl n-Butyl Ketone (2-Hexanone)......        591-78-6            3.55
Dimethyl carbonate......................        616-38-6            0.06
Ethyl Isopropyl Ether...................        625-54-7            3.86
Dimethyl Adipate........................        627-93-0            1.95
Methy n-Butyl Ether.....................        628-28-4            3.66
Amyl Acetate (Pentyl Ethanoate, Pentyl          628-63-7            0.96
 Acetate)...............................
Ethyl n-Butyl Ether.....................        628-81-9            3.86
Ethyl t-Butyl Ether.....................        637-92-3            2.11
1,3-Dioxolane...........................        646-06-0            5.47
Ethyl-3-Ethoxypropionate................        763-69-9            3.61
Methyl Pyrrolidone (n-Methyl-2-                 872-50-4            2.56
 Pyrrolidone)...........................
Dimethyl Gluterate......................       1119-40-0            0.51
Ethylene Glycol 2-Ethylhexyl Ether [2-(2-      1559-35-9            1.71
 Ethylhexyloxy) Ethanol]................
Propylene Glycol Monopropyl Ether (1-          1569-01-3            2.86
 Propoxy-2-Propanol)....................
Propylene Glycol Monoethyl Ether (1-           1569-02-4            3.25
 Ethoxy-2-Propanol).....................
2-Methoxy-1-Propanol....................       1589-47-5            3.01
Methyl t-Butyl Ether....................       1634-04-4            0.78
Ethylcyclohexane........................       1678-91-7            1.75
Isoamyl Isobutyrate.....................       2050-01-3            0.89
2-Propoxyethanol (Ethylene Glycol              2807-30-9            3.52
 Monopropyl Ether)......................
n-Butoxy-2-Propanol.....................       5131-66-8            2.70
d-Limonene (Dipentene or Orange Terpene)       5989-27-5            3.99
Dipropylene Glycol Methyl Ether Isomer        13588-28-8            3.02
 (2-[2Methoxypropoxy]-1-Propanol).......
Texanol (1,3 Pentanediol, 2,2,4-              25265-77-4            0.89
 Trimethyl, 1-Isobutyrate)..............
Isodecyl Alcohol (8-Methyl-1-Nonanol)...      25339-17-7            1.23
Tripropylene Glycol Monomethyl Ether....      25498-49-1            1.90
Glycol Ether DPNB (1-(2-Butoxy-1-             29911-28-2            1.96
 Methylethoxy) 2-Propanol)..............
Propylene Glycol t-Butyl Ether (1-tert-       57018-52-7            1.71
 Butoxy-2-Propanol).....................
2-Methoxy-1-Propyl Acetate..............      70657-70-4            1.12
Oxo-Heptyl Acetate......................      90438-79-2            0.97
2-tert-Butoxy-1-Propanol................      94023-15-1            1.81
Oxo-Octyl Acetate.......................     108419-32-5            0.96
C8 Disubstituted Benzenes...............              na            7.48
C9 Styrenes.............................              na            1.72
------------------------------------------------------------------------

0
5. Table 2B to Subpart E of Part 59 is revised to read as follows:

   Table 2B to Subpart E of Part 59--Reactivity Factors for Aliphatic
                      Hydrocarbon Solvent Mixtures
------------------------------------------------------------------------
            Average  boiling                                Reactivity
    Bin           point*               Criteria           factor (g O3/g
               (degrees F)                                     VOC)
------------------------------------------------------------------------
1.........  80-205            Alkanes (<2% Aromatics)...            2.08
2.........  80-205            N- & Iso-Alkanes (>=90%               1.59
                               and <2% Aromatics).
3.........  80-205            Cyclo-Alkanes (>=90% and              2.52
                               <2% Aromatics).
4.........  80-205            Alkanes (2 to <8%                     2.24
                               Aromatics).
5.........  80-205            Alkanes (8 to 22%                     2.56
                               Aromatics).
6.........  >205-340          Alkanes (<2% Aromatics)...            1.41
7.........  >205-340          N- & Iso-Alkanes (>=90%               1.17
                               and <2% Aromatics).
8.........  >205-340          Cyclo-Alkanes (>=90% and              1.65
                               <2% Aromatics).
9.........  >205-340          Alkanes (2 to <8%                     1.62
                               Aromatics).
10........  >205-340          Alkanes (8 to 22%                     2.03
                               Aromatics).
11........  >340-460          Alkanes (<2% Aromatics)...            0.91

12........  >340-460          N- & Iso-Alkanes (>=90%               0.81
                               and <2% Aromatics).
13........  >340-460          Cyclo-Alkanes (>=90% and              1.01
                               <2% Aromatics).
14........  >340-460          Alkanes (2 to <8%                     1.21
                               Aromatics).
15........  >340-460          Alkanes (8 to 22%                     1.82
                               Aromatics).
16........  >460-580          Alkanes (<2% Aromatics)...            0.57
17........  >460-580          N- & Iso-Alkanes (>=90%               0.51
                               and <2% Aromatics).
18........  >460-580          Cyclo-Alkanes (>=90% and              0.63
                               <2% Aromatics).
19........  >460-580          Alkanes (2 to <8%                     0.88
                               Aromatics).
20........  >460-580          Alkanes (8 to 22%                     1.49
                               Aromatics).
------------------------------------------------------------------------
* Average Boiling Point = (Initial Boiling Point + Dry Point)/2(b)
  Aromatic Hydrocarbon Solvents

0
6. Table 2C to Subpart E of Part 59 is revised to read as follows:

    Table 2C to Subpart E of Part 59--Reactivity Factors for Aromatic
                      Hydrocarbon Solvent Mixtures
------------------------------------------------------------------------
                                                            Reactivity
    Bin         Boiling range            Criteria         factor (g O3/g
                 (degrees F)                                   VOC)
------------------------------------------------------------------------
21.........  280-290             Aromatic Content                   7.37
                                  (>=98%).
22.........  320-350             Aromatic Content                   7.51
                                  (>=98%).
23.........  355-420             Aromatic Content                   8.07
                                  (>=98%).
24.........  450-535             Aromatic Content                   5.00
                                  (>=98%).
------------------------------------------------------------------------

[FR Doc. 2012-5648 Filed 3-8-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Rules and Regulations]
[Pages 22012-22016]
[FR Doc No: 2014-08940]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2013-N-0069]

Medical Devices; Ophthalmic Devices; Classification of the Eyelid
Weight

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
classifying the eyelid weight into class II (special controls). The
Agency is exempting the external eyelid weight from premarket
notification, but continuing to require premarket notification for
implantable eyelid weights in order to provide a reasonable assurance
of safety and effectiveness of the device. Both external and
implantable eyelid weight devices are subject to special controls. The
eyelid weight may be adhered to the outer skin of the upper eyelid
(external eyelid weight) or implanted into the upper eyelid
(implantable eyelid weight), and is intended for the gravity assisted
treatment of lagophthalmos (incomplete eyelid closure).

DATES: Effective Date: July 21, 2014.
    Compliance Dates: Premarket notification submissions (510(k)s) for

eyelid weights filed on or after the effective date of this rule are
expected to comply with the requirement of special controls at the time
that the 510(k) is submitted.
    Premarket notification submissions (510(k)s) for eyelid weights
filed before the effective date of this rule, but not yet cleared for
marketing, are expected to comply with the requirement of special
controls prior to receiving marketing clearance.
    External eyelid weights exempt from premarket notification under
this rule and not currently marketed are expected to comply with the
requirement of special controls prior to introducing devices into
interstate commerce.
    Eyelid weights (both implantable and external) legally marketed
before the effective date of this rule are expected to comply with the
requirement of special controls by April 21, 2015. See section V of
this document, ``Compliance Dates,'' for further information.

FOR FURTHER INFORMATION CONTACT: Tina Kiang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2414, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990
(Pub. L. 101-629), the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107-250), the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food
and Drug Administration Safety and Innovation Act (Pub. L. 112-144),
among other amendments, established a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of
devices, depending on the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Under section 513 of the FD&C Act, FDA refers to devices that were
in commercial distribution before May 28, 1976 (the date of enactment
of the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after the Agency takes the following steps: (1) Receives
a recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
    FDA refers to devices that were not in commercial distribution
before May 28, 1976, as ``postamendments devices.'' These devices are
classified automatically by statute (section 513(f) of the FD&C Act)
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until: (1) FDA
reclassifies the device into class I or II; (2) FDA issues an order
classifying the device into class I or II in accordance with section
513(f)(2) of the FD&C Act, as amended by FDAMA; or (3) FDA issues an
order finding the device to be substantially equivalent, under section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 of the regulations (21 CFR part 807).
    A person may market a preamendments device that has been classified
into class III through premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval.
    Section 510(m) of the FD&C Act (21 U.S.C. 360(m)) provides that a
class II device may be exempted from the premarket notification
requirements under section 510(k) of the FD&C Act, if the Agency
determines that premarket notification is not necessary to assure the
safety and effectiveness of the device.

II. Regulatory History of the Device

    In the Federal Register of February 8, 2013 (78 FR 9349), FDA
proposed to classify eyelid weight devices intended for the gravity-
assisted treatment of lagophthalmos (incomplete eyelid closure) into
class II (special controls) and proposed special controls for these
devices. FDA also proposed to exempt the devices from premarket
notification requirements if the device is an external eyelid weight.
FDA invited interested persons to comment on the proposed regulation by
May 9, 2013. FDA received three comments on the proposed rule.

III. Summary of the Final Rule

    In accordance with 21 CFR 860.84(g)(2), FDA is classifying eyelid
weights into class II (special controls). FDA is codifying the
classification of eyelid weights by adding Sec.  886.5700.

A. External Eyelid Weights

    Under section 510(m) of the FD&C Act, FDA has determined that
premarket notification is not necessary to assure the safety and
effectiveness of external eyelid weights, and the Agency is exempting
these devices from premarket notification requirements. The Agency has
also identified special controls for these devices. On or before the
effective date of this final rule, firms who wish to market external
eyelid weight devices that are not already legally marketed are
required to either (1) comply with the particular mitigation measures
set forth in the special controls in Sec.  886.5700(b)(1) or (2) use
alternative mitigation measures, but demonstrate to the Agency's
satisfaction that those alternative measures identified by the firm
will provide at least an equivalent assurance of safety and
effectiveness. As discussed in sections IV and V, in response to
comments regarding compliance with the special controls for existing
legally marketed devices, FDA has extended the compliance date for
special controls to 1 year from the effective date of this rule to
allow manufacturers of existing legally marketed devices adequate time
to review the design history files and complete any needed testing and
implement any required labeling changes for their devices.
    FDA also made changes to the final rule as related to external
eyelid weights in response to the comments and for clarification.
Proposed Sec.  886.5700(b)(1)(iii) has been edited to remove the words
``required for the safe and effective use of the device as outlined in
Sec.  801.109(c) of this chapter'' to minimize any confusion since this
section describes special controls and the labeling requirements in 21
CFR part 801 are a general control. FDA also removed the special
controls for external eyelid weights related to magnetic resonance (MR)
compatibility testing (see additional discussion in section IV).

B. Implantable Eyelid Weights

    FDA has determined that premarket notification is necessary to
provide

reasonable assurance of safety and effectiveness of implantable eyelid
weights, and, therefore, this device type is not exempt from premarket
notification requirements. The Agency has also identified special
controls for these devices. On or before the effective date of this
final rule, firms who wish to market external eyelid weight devices
that are not already legally marketed are required to either (1) comply
with the particular mitigation measures set forth in the special
controls in Sec.  886.5700(b)(2) or (2) use alternative mitigation
measures, but demonstrate to the Agency's satisfaction that those
alternative measures identified by the firm will provide at least an
equivalent assurance of safety and effectiveness. As discussed in
section IV, in response to comments regarding compliance with the
special controls for existing legally marketed devices, FDA has
extended the compliance date for special controls to 1 year from the
effective date of this rule to allow manufacturers of existing legally
marketed devices adequate time to review the design history files and
complete any needed testing and implement any required labeling changes
for their devices.

IV. Analysis of Comments and FDA's Response

    FDA received three comments on the proposed rule. One of the
comments was supportive of FDA's proposed rule, including the
classification and the special controls for both the external and
implantable eyelid weights and the exemption of external eyelid weights
from premarket notification requirements (510(k)). A second comment
agreed with the proposed classification into class II, but indicated
that the risks associated with long-term use of external eyelid weights
were similar to those for implantable eyelid weights, and that as such
external eyelid weights should not be exempted from the premarket
notification requirements. FDA disagrees with the comment. FDA believes
that the identified special controls adequately mitigate the risks to
health for the device regardless of the duration of use. The increased
risks associated with implanted eyelid weights are related to the need
for the device to be provided sterile and the increased
biocompatibility requirements. These risks are significantly reduced
with external eyelid weight devices. FDA believes that compliance with
the special controls in Sec.  886.5700(b)(1) provides a reasonable
assurance of safety and effectiveness for external eyelid weight
devices without the need for premarket notification.
    The third comment requested clarification on whether existing
eyelid weight manufacturers (for both implantable and external eyelid
weight devices) need to address the identified special controls. The
special controls established in this rule apply to existing legally
marketed devices, as well as to new eyelid weight devices not currently
marketed for which marketing authority is sought and to any
modification of a currently legally marketed eyelid weight. In response
to this comment, FDA has extended the compliance date for special
controls for manufacturers of existing legally marketed devices to 1
year from the effective date of this rule, as outlined in section V,
``Compliance Dates.''
    Submission of a new 510(k) solely to demonstrate conformance to the
special controls is not needed unless complying with the special
controls leads to changes to the device that would independently
trigger the need for a new 510(k) under Sec.  807.81(a)(3). However,
manufacturers should maintain documentation in their design history
file (see Sec.  820.30 (21 CFR 820.30)) to demonstrate that they meet
the special controls. To ensure that manufacturers of existing legally
marketed devices have adequate time to review their design history
files and complete any needed testing and implement any required
labeling changes for their devices, FDA has extended the compliance
date for existing legally marketed devices to comply with the special
controls to 1 year after the effective date of this final rule.
Manufacturers with questions regarding their existing devices are
encouraged to interact with FDA via the pre-submission process.
    The third comment further suggested that the biocompatibility
testing requirements as described in the proposed special controls are
more extensive and burdensome than the requirements under which
existing legally marketed eyelid weights devices were originally
reviewed. The comment stated that, for external eyelid weights, limited
biocompatibility testing with supportive literature review and
reference to material in predicate devices should be acceptable in lieu
of a full battery of biocompatibility testing. FDA agrees that based on
the material and manufacturing processes being used, a full battery of
biocompatibility testing may not be required. Discussion of the
specific biocompatibility testing requirements for existing legally
marketed eyelid weight devices is beyond the scope of this rule;
however, FDA encourages manufacturers to review existing Agency
guidance on this topic and contact FDA via the pre-submission process
to discuss specific biocompatibility requirements for their devices.
    The third comment further requested clarification on whether a
labeling change to address MR compatibility would trigger additional
compliance expectations regarding MR testing and suggested that because
external eyelid weights are removable devices, MR compatibility should
not be a requirement for these devices. FDA agrees with the commenter
that removal of the device when the patient is in the MR environment
would mitigate this risk and has thus removed MR testing compatibility
testing as a special control. However, to ensure that the patient is
aware that the device should be removed in these circumstances, the
special control regarding labeling has been revised to include a
requirement for a warning stating that the patient should be instructed
to remove the device prior to entering an MR environment.
    Finally, the third comment also requested clarification on the
special control for implanted eyelid weights: ``testing demonstrating
the sterility and shelf life of the device'' and suggested that the
shelf life of the implanted device is limited by the ability of the
associated packaging to maintain a protective barrier and not by the
device itself, and therefore, validated packaging and sterilization
procedures would satisfy this requirement. Although FDA agrees that
validation of the packaging and sterilization processes is important to
comply with this special control, each manufacturer must assess the
materials and processes used to manufacture their device when
determining the testing necessary to provide assurance that the
sterility and functionality of the device are maintained over its shelf
life.

V. Compliance Dates

    This final rule will become effective July 21, 2014.
    The special controls established in this rule for external eyelid
weights and the special controls established in this rule for
implantable eyelid weights apply to any external or implantable eyelid
weight respectively, whether the device is an existing legally marketed
device, a new eyelid weight device not currently marketed for which
marketing authority is sought, or a modification of a currently legally
marketed eyelid weight. Devices of this type that were legally marketed
before the effective date of this rule may continue to be legally
marketed; however 1 year after the effective date of this rule, such

devices must comply with applicable special controls in order to
continue to be legally marketed. Submission of a new 510(k) solely to
demonstrate conformance to the special controls is not needed unless
complying with the special controls leads to changes to the device that
would independently trigger the need for a new 510(k) under Sec.
807.81(a)(3). However, manufacturers should maintain documentation in
their design history file (see Sec.  820.30(j)) to demonstrate that
they meet the special controls. One year after the effective date of
this rule, any external eyelid weight that does not comply with the
special controls established in Sec.  886.5700(b)(1) or implantable
eyelid weight that does not comply with the special controls
established in Sec.  886.5700(b)(2) this rule will be considered
adulterated and misbranded (sections 501(f)(1)(B) and 502(o) of the
FD&C Act (21 U.S.C. 351(f)(1)(B) and 352(o)) until such time as the
device: (1) Complies with the special controls and any premarket
notification requirements; (2) is approved in a PMA application; or (3)
is classified into class I or II under section 513(f)(2) or (3) of the
FD&C Act.
    A 510(k) submission for an eyelid weight either filed before the
effective date of this rule, but not yet cleared for marketing or filed
after the effective date of this rule may be cleared for marketing only
if the device complies with the special controls established for this
device type. The submitter may demonstrate that the special controls
have been met by incorporating previously submitted information by
reference, or by providing newly generated information. A submitter's
first 510(k) submission for an implantable eyelid weight filed
following the publication of this final rule should be a traditional
510(k) submission. Filing of a special 510(k) submission for a modified
implantable eyelid weight is only appropriate after FDA has cleared an
initial 510(k) submission that establishes that the device complies
with the special controls established for the device type.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

VII. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies 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). The Agency believes that this final rule is not a significant
regulatory action under 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. Because the final regulation classifies a previously
unclassified pre-amendment device type, there are only five registered
establishments listed in the Establishment Registration and Device
Listing database, and the regulation designating the classification of
eyelid weights as class II is consistent with the historical regulatory
oversight given to this device type, the Agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies 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 $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

VIII. Paperwork Reduction Act of 1995

    This final rule establishes special controls that refer to
currently approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 807, subpart E, have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 801 have been
approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for 21 CFR part 886 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  886.5700 to subpart E to read as follows:

Sec.  886.5700  Eyelid weight.

    (a) Identification. An eyelid weight is a prescription device made
of gold, tantalum, platinum, iridium, or surgical grade stainless steel
that is rectangular in shape and contoured to the shape of the eye. The
device is intended for the gravity assisted treatment of lagophthalmos
(incomplete eyelid closure).
    (1) The external eyelid weight is adhered to the outer skin of the
upper eyelid.
    (2) The implantable eyelid weight is implanted into the upper
eyelid.
    (b) Classification. (1) Class II (special controls) for the
external eyelid weight. The external eyelid weight is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec.  886.9. The special controls
for the external eyelid weight are:
    (i) Testing demonstrating the biocompatibility of the device; and
    (ii) Labeling must include the following information:
    (A) Specific instructions regarding the proper placement, sizing,
and removal of the device; and
    (B) A warning stating that the patient should be instructed to
remove the device prior to entering a magnetic resonance environment.
    (2) Class II (special controls) for the implantable eyelid weight.
The special controls for the implantable eyelid weight are:
    (i) Testing demonstrating the biocompatibility of the device;
    (ii) Testing demonstrating the sterility and shelf life of the
device;
    (iii) Nonclinical testing evaluating the compatibility of the
device in a magnetic resonance environment.
    (iv) Patient labeling to convey information regarding the safety
and compatibility of the device in a magnetic resonance environment,
the conditions under which a patient with

the device can be safely scanned, and a mechanism for a healthcare
provider to obtain detailed information about magnetic resonance safety
and compatibility if needed.

    Dated: April 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08940 Filed 4-18-14; 8:45 am]
BILLING CODE 4160-01-P