[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Page 48325]
[FR Doc No: 2015-19768]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0882]

Generic Drug User Fees; Stakeholder Meetings on Generic Drug User
Fee Amendments of 2012 Reauthorization; Request for Notification of
Stakeholder Intent To Participate; Extension of Closing Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for notification of intent to participate;
extension of closing date.

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SUMMARY: The Food and Drug Administration (FDA) is extending the
closing date for the document that appeared in the Federal Register of
June 3, 2015. In that document, FDA requested that public stakeholders,
including patient and consumer advocacy groups, health care
professionals, and scientific and academic experts, notify FDA of their
intent to participate in periodic consultation meetings on the
reauthorization of the Generic Drug User Fee Amendments of 2012
(GDUFA). The statutory authority for GDUFA expires at the end of
September 2017. At that time, new legislation will be required for FDA
to continue collecting user fees for the generic drug program. The
Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA
consult with a range of stakeholders in developing recommendations for
the next GDUFA program. The FD&C Act also requires that FDA hold
continued discussions with patient and consumer advocacy groups at
least monthly during FDA's negotiations with the regulated industry.
The purpose of the request for notification is to ensure continuity and
progress in these monthly discussions by establishing consistent
stakeholder representation.

DATES: FDA is extending the closing date in the notice published June
3, 2015 (80 FR 31602). Submit notification of intent to participate by
April 30, 2016.

ADDRESSES: Submit notification of intent to participate in monthly
stakeholder meetings by email to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Connie Wisner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993-0002, 240-
402-7946<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is requesting that public stakeholders, including patient and
consumer advocacy groups, health care professionals, and scientific and
academic experts, notify the Agency of their intent to participate in
periodic consultation meetings on the reauthorization of GDUFA. GDUFA
authorizes FDA to collect fees from drug companies that submit
marketing applications for certain generic human drug applications,
certain drug master files, and certain facilities. GDUFA requires that
generic drug manufacturers pay user fees to finance critical and
measurable generic drug program enhancements. The statutory authority
for GDUFA expires at the end of September 2017. Without new
legislation, FDA will no longer be able to collect user fees for future
fiscal years to fund the human generic drug review process. Section
744C(d) (21 U.S.C. 379j-43(d)) of the FD&C Act requires that FDA
consult with a range of stakeholders in developing recommendations for
the next GDUFA program, including representatives from patient and
consumer groups, health care professionals, and scientific and academic
experts. FDA initiated this process on June 15, 2015, by holding a
public meeting at which stakeholders and other members of the public
were given an opportunity to present their views on reauthorization
(April 21, 2015, 80 FR 22204). The FD&C Act further requires that FDA
continue meeting with these stakeholders at least once every month
during negotiations with the regulated industry to continue discussions
of stakeholder views on the reauthorization.
    FDA is issuing this Federal Register notice to request that
stakeholder representatives from patient and consumer groups, health
care professional associations, as well as scientific and academic
experts notify FDA of their intent to participate in periodic
consultation meetings on GDUFA reauthorization. FDA believes that
consistent stakeholder representation at these meetings will be
important to ensuring progress in these discussions. If you wish to
participate in this part of the reauthorization process, please
designate one or more representatives from your organization who will
commit to attending these meetings and preparing for the discussions as
needed. Stakeholders who identify themselves through this notice will
be included in all stakeholder discussions while FDA negotiates with
the regulated industry. Stakeholders who decide to participate in these
monthly meetings at a later time may still participate in remaining
monthly meetings by notifying FDA (see ADDRESSES). These stakeholder
discussions will satisfy the requirement in section 744C(d)(3) of the
FD&C Act.

II. Notification of Intent To Participate in Periodic Consultation
Meetings

    If you intend to participate in continued periodic stakeholder
consultation meetings regarding GDUFA reauthorization, please provide
notification by email to<EMAIL_ADDRESS>by April 30,
2016. Your email should contain complete contact information, including
name, title, affiliation, address, email address, phone number, and
notice of any special accommodations required because of disability.
Stakeholders will receive confirmation and additional information about
the first meeting once FDA receives their notification.

    Dated: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19768 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Proposed Rules]
[Pages 18277-18280]
[FR Doc No: 2013-06799]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2013-0052
RIN 1625-AA08

Special Local Regulation; Low Country Splash, Wando River, Cooper
River, and Charleston Harbor, Charleston, SC

AGENCY: Coast Guard, DHS.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: The Coast Guard proposes to issue a special local regulation
on the waters of the Wando River, Cooper River, and Charleston Harbor
in Charleston, SC during the Low Country Splash in Charleston, SC, on
June 1, 2013. This special local regulation is necessary to ensure the
safety of participants, spectators, and the general public during the
event. The special local regulation will temporarily restrict vessel
traffic in a portion of the Wando River and Charleston Harbor,
preventing non-participant vessels from entering, transiting through,
anchoring in, or remaining within the regulated area unless authorized
by the Captain of the Port Charleston or a designated representative.

DATES: Comments and related material must be received by the Coast
Guard on or before April 25, 2013.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Warrant Officer Christopher Ruleman, Sector
Charleston Office of Waterways Management, Coast Guard; telephone (843)
740-3184, email<EMAIL_ADDRESS>If you have questions
on viewing or submitting material to the docket, call Barbara Hairston,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, 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 at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number USCG-2013-0052 in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8[frac12] 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. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number USCG-2013-0052 in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Basis and Purpose

    The legal basis for the rule is the Coast Guard's Authority to
establish special local regulations: 33 U.S.C 1233. The purpose of the
rule is to ensure safety of life on the navigable water of the United
States during the Low Country Splash.

C. Discussion of Proposed Rule

    On Saturday, June 1, 2013, the Low Country Splash is scheduled to
take place on the waters of the Wando River, Cooper River, and
Charleston Harbor. The race will commence at Daniel Island Pier,
transit south in the Wando River, crossing the navigational channel at
Hobcaw Point and continuing South into Charleston Harbor. The race will
finish at Charleston Harbor Resort Marina. The event consists of a
large number of swimmers. There will be safety vessels preceding the
participating swimmers, and following the last participating swimmers.
This event poses significant risks to participants, spectators, and the
boating public because of the large number of swimmers and recreational
vessels that are expected in the area of the event. The special local
regulation is necessary to ensure the safety of participants,
spectators, and vessels from the hazards associated with the event.
    The special local regulation will designate a temporary regulated
area on the Wando River, Cooper River, and Charleston Harbor in
Charleston, South Carolina. The special local regulation will be
enforced from 7:00 a.m. until 10:00 a.m. on June 1, 2013. Persons and
vessels may not enter, transit through, anchor in, or remain within the
safety zone unless authorized by the Captain of the Port Charleston or
a designated representative.
    Persons and vessels desiring to enter, transit through, anchor in,
or remain within the regulated area may contact the Captain of the Port
Charleston by telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain within
the regulated area is granted by the Captain of the Port Charleston or
a designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Charleston or a designated representative. The Coast Guard will
provide notice of the special local regulation by Local Notice to
Mariners, Broadcast Notice to Mariners, and on-scene designated
representatives.

D. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The economic impact of this proposed rule is not significant for
the following reasons: (1) The special local regulations will be
enforced for a maximum of 3 hours for only one day; (2) non-participant
persons and vessels may enter, transit through, anchor in, or remain
within the regulated area during the enforcement periods if authorized
by the Captain of the Port Charleston or a designated representative;
(3) vessels not able to enter, transit through, anchor in, or remain
within the regulated area without authorization from the Captain of the
Port Charleston or a designated representative may operate in the
surrounding areas during the enforcement period; and (4) the Coast
Guard will provide advance notification of the special local regulation
to the local maritime community by Local Notice to Mariners and
Broadcast Notice to Mariners.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities. This rule may affect the following entities, some of
which may be small entities: the owner or operators of vessels
intending to enter, transit through, anchor in, or remain within the
regulated area during the enforcement period. For the reasons discussed
in Regulatory Planning and Review section above, this rule will not
have a significant economic impact on a substantial number of small
entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the

Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use * * *.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have
made a preliminary determination that this action is one of a category
of actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a special
local regulation issued in conjunction with a regatta or marine parade.
This rule is categorically excluded from further review under paragraph
34(h) of Figure 2-1 of the Commandant Instruction. We seek any comments
or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 100

    Marine Safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233

0
2. Add a temporary Sec.  100.35T07-0052 to read as follows:

Sec.  100.35T07-0052  Special Local Regulation; Low Country Splash,
Wando River, Cooper River, and Charleston Harbor, Charleston, SC.

    (a) Regulated Area. The following regulated area is established as
a special local regulation. All waters within a moving zone, beginning
at Daniel Island Pier in approximate position 32[deg]51'20'' N,
079[deg]54'06''W, South along the coast of Daniel Island, across the
Wando River to Hobcaw Yacht Club, in approximate position
32[deg]49'20'' N, 079[deg]53'49'' W, South along the coast of Mt.
Pleasant, S.C., to Charleston Harbor Resort Marina, in approximate
position 32[deg]47'20'' N, 079[deg]54'39'' W. There will be a temporary
Channel Closer from 0730 to 0815 on June 1, 2013 between Wando River
Terminal Buoy 3 (LLNR 3305), and Wando River Terminal Buoy 5 (LLNR
3315). The zone will at all times extend 75 yards both in front of the
lead safety vessel preceding the first race participants; 75 yards
behind the safety vessel trailing the last race participants; and at
all times extending 100 yards on either side of participating race and
safety vessels. Information regarding the identity of the lead safety
vessel and the last safety vessel will be provided 2 days prior to the
race via broadcast notice to mariners and marine safety information
bulletins.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Charleston in the enforcement of the regulated
areas.
    (c) Regulations.
    (1) All persons and vessels, except those participating in the Low
Country Splash or serving as safety vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area. Persons and vessels desiring to enter, transit through,
anchor in, or remain within the regulated area may contact the Captain
of the Port Charleston by telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain within
the regulated area is granted by the Captain of the Port Charleston or
a designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the

Captain of the Port Charleston or a designated representative.
    (2) The Coast Guard will provide notice of the regulated area by
Marine Safety Information Bulletins, Local Notice to Mariners,
Broadcast Notice to Mariners, and on-scene designated representatives.
    (d) Enforcement Date. This rule will be enforced from 7:00 a.m. to
10:00 a.m. June 1, 2013.

    Dated: March 5, 2013.
M.F. White,
Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2013-06799 Filed 3-25-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Proposed Rules]
[Pages 28773-28775]
[FR Doc No: 2013-11789]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0066; FRL- 9814-8]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Adoption of Control Techniques Guidelines for Miscellaneous
Metal and Plastic Parts Which Includes Pleasure Craft Coating
Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the Maryland State
Implementation Plan (SIP) submitted by the Maryland Department of the
Environment (MDE) on January 10, 2013. The SIP revision consists of a
new regulation pertaining to control of volatile organic compound
emissions from pleasure craft coating operations. This action is being
taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before June 17, 2013.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2013-0066 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2013-0066, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
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-R03-OAR-
2013-0066. 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 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, 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 EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, 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.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Maryland Department of the Environment, 1800
Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. EPA Action
II. Background
III. SIP Revision Submitted by the State of Maryland
IV. Proposed Action
V. Statutory and Executive Order Review

I. EPA Action

    EPA is proposing to approve revisions to Maryland's SIP which were
submitted by MDE on January 10, 2013. The SIP revision submittal adopts
the requirements as recommended by EPA's control technique guidelines
(CTG) for Miscellaneous Metal Parts and Plastic Coating (MMPPC)
operations and as recommended by trade associations representing the
pleasure craft industry.

Specifically, MDE has added Regulation .27-1 under COMAR 26.11.19 to
reduce further volatile organic compound (VOC) emissions from pleasure
craft coating operations. This revision reflects technology
developments and expands VOC emission controls, as well as reflects the
recommended reasonably available control technology (RACT) requirements
in EPA's CTG for MMPPC.

II. Background

    Section 172(c)(1) of the CAA provides that SIPs for nonattainment
areas must include reasonably available control measures (RACM),
including RACT, for sources of emissions. Section 182(b)(2)(A) provides
that for certain nonattainment areas, states must revise their SIP to
include RACT for sources of VOC emissions covered by a CTG document
issued after November 15, 1990 and prior to the area's date of
attainment. EPA defines RACT as ``the lowest emission limitation that a
particular source is capable of meeting by the application of control
technology that is reasonably available considering technological and
economic feasibility.'' (44 FR 53761, September 17, 1979).
    CTGs are documents issued by EPA intended to provide state and
local air pollution control authorities information that should assist
them in determining RACT for VOC from various sources. Section
183(e)(3)(c) provides that EPA may issue a CTG in lieu of a national
regulation as RACT for a product category where EPA determines that the
CTG will be substantially as effective as regulations in reducing
emissions of VOC in ozone nonattainment areas. The recommendations in
the CTG are based upon available data and information and may not apply
to a particular situation based upon the circumstances. States can
follow the CTG and adopt state regulations to implement the
recommendations contained therein, or they can adopt alternative
approaches. In either case, states must submit their RACT rules to EPA
for review and approval as part of the SIP process.
    EPA developed the CTG for MMPPC in September 2008. The
miscellaneous metal product and plastic parts surface coatings
categories under section 183(e) of the CAA include the coatings that
are applied to the surfaces of a varied range of metal and plastic
parts and products. Such parts or products are constructed either
entirely or partially from metal or plastic. These miscellaneous metal
products and plastic parts include, but are not limited to, metal and
plastic components of the following types of products as well as the
products themselves: Fabricated metal products, molded plastic parts,
small and large farm machinery, commercial and industrial machinery and
equipment, automotive or transportation equipment, interior or exterior
automotive parts, construction equipment, motor vehicle accessories,
bicycles and sporting goods, toys, recreational vehicles, pleasure
craft (recreational boats), extruded aluminum structural components,
railroad cars, heavier vehicles, lawn and garden equipment, business
machines, laboratory and medical equipment, electronic equipment, steel
drums, metal pipes, and numerous other industrial and household
products.
    The pleasure craft coating category does not include coatings that
are a part of other product categories listed under Section 183(e) of
the CAA for which CTGs have been published or included in other CTGs.
As a result, members of the pleasure craft coatings industry contacted
EPA requesting reconsideration of the pleasure craft VOC limits
contained in EPA's 2008 MMPPC CTG. In response, EPA issued a memorandum
on June 1, 2010, titled ``Control Technique Guidelines for
Miscellaneous Metal and Plastic Part Coatings--Industry Request for
Reconsideration,'' recommending that the pleasure craft industry work
with state agencies during their RACT rule development process to
assess what is reasonable for the specific sources regulated. EPA has
stated that states can use the recommendations from the MMPPC CTG to
form their own determinations as to what constitutes RACT for pleasure
craft coating operations in their particular ozone nonattainment area.
CTGs impose no legally binding requirements on any entity, including
pleasure craft coating facilities. As stated in the memorandum, EPA
will evaluate state-developed RACT rules and determine whether the
submitted rules meet the RACT requirements of the CAA.

III. SIP Revision Submitted by the State of Maryland

    On January 10, 2013, MDE submitted a SIP revision adopting the
recommendations contained in both EPA's MMPPC CTG and in comments from
trade associations representing the pleasure craft industry for the
control of VOC as RACT. The SIP revision adds Regulation .27-1 under
COMAR 26.11.19 in order to: (1) Establish applicability for pleasure
craft and fiberglass boat coating operations at facilities with actual
VOC emissions of 15 pounds or more per day (15 lb/day) from coating
operations as determined on a monthly average on or after January 1,
2013; (2) establish exemptions for certain types of coatings; (3) add
definitions and terms to reflect pleasure craft coating operations; (4)
incorporate by reference the standard test method for Specular Gloss;
(5) establish that the least stringent emission limitation is
applicable if more than one emission limitation applies to a specific
coating; (6) establish application methods; and (7) specify VOC limit
requirements for pleasure craft coating operations in Table 1 below.

                Table 1--Pleasure Craft Coating Standards
[Expressed in terms of mass of VOC per volume of coating excluding water
                    and exempt compounds, as applied]
------------------------------------------------------------------------
                                   Pounds (lbs) VOC/  Kilograms (kg) VOC/
          Coating types                 gallon               liter
------------------------------------------------------------------------
Extreme high gloss topcoat......                 5.0                0.60
High gloss topcoat..............                 3.5                0.42
Pretreatment wash primers.......                 6.5                0.78
Finish primer/surface:
    Applicable through March 31,                 5.0                0.60
     2014.......................
    Applicable through March 31,                 3.5                0.42
     2014.......................
High build primer/surface.......                 2.8                0.34
Aluminum substrate antifoulant                   4.7                0.56
 coating........................
Antifouling sealer/tiecoat......                 3.5                0.42
Other substrate antifoulant                      3.3                0.40
 coating........................
All other pleasure craft surface                 3.5                0.42
 coatings.......................
------------------------------------------------------------------------

    More detailed information on these provisions can be found in the
technical support document located in the docket prepared for this
rulemaking action.

IV. Proposed Action

    EPA is proposing to approve the State of Maryland SIP revision
submitted on January 10, 2013, adopting the requirements as recommended
by the MMPPC CTG and adopting the pleasure craft industry
recommendations for the following four coating categories: Finish
Primer/Surfacer; Antifouling Sealer/Tiecoat; Other Substrate
Antifoulant; and Extreme High Gloss. For these four categories,
Maryland reviewed industry data and determined that for the purpose of
functionality, cost, and VOC emissions, the alternative limits adopted
for these four coating categories constitute RACT. EPA believes that
Maryland's approach is consistent with the guidance memorandum
entitled, ``Control Technique Guidelines for Miscellaneous Metal and
Plastic Part Coatings--Industry Request for Reconsideration,'' and
therefore, believes that these regulations reflect RACT. EPA concurs
with MDE's analysis in the SIP submittal that this regulation reflects
RACT. EPA is soliciting public comments on the issues discussed in this
document. These comments will be considered before taking final action.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, pertaining to the State of
Maryland's amendments to regulations for the control of VOCs for MMPPC,
does not have tribal implications as specified by Executive Order 13175
(65 FR 67249, November 9, 2000), because the SIP is not approved to
apply in Indian country located in the state, and EPA notes that it
will not impose substantial direct costs on tribal governments or
preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Volatile organic
compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: May 2, 2013.
W.C. Early,
Acting, Regional Administrator, Region III.
[FR Doc. 2013-11789 Filed 5-15-13; 8:45 am]
BILLING CODE 6560-50-P