a.5. Cooled turbine blades, vanes or ``tip-shrouds'', other than
those described in 9E003.a.1, designed to operate at a `gas path
temperature' of 1,693 K (1,420 [deg]C) or more;

    Technical Note:  `Gas path temperature' is the bulk average gas
path total (stagnation) temperature at the leading edge plane of the
turbine component when the engine is running in a ``steady state
mode'' of operation at the certificated or specified maximum
continuous operating temperature.

    a.6. Airfoil-to-disk blade combinations using solid state
joining;
    a.7. Gas turbine engine ``parts'' or ``components'' using
``diffusion bonding'' ``technology'' controlled by 2E003.b;
    a.8. `Damage tolerant' gas turbine engine rotor ``parts'' or
``components'' using powder metallurgy materials controlled by
1C002.b; or

    Technical Note:  `Damage tolerant' ``parts'' and ``components''
are designed using methodology and substantiation to predict and
limit crack growth.

    a.9. [Reserved]

    N.B.:  For ``FADEC systems'', see 9E003.h.

    a.10. [Reserved]

    N.B.:  For adjustable flow path geometry, see 9E003.i.

    a.11. Hollow fan blades;
    b. ``Technology'' ``required'' for the ``development'' or
``production'' of any of the following:
    b.1. Wind tunnel aero-models equipped with non-intrusive sensors
capable of transmitting data from the sensors to the data
acquisition system; or
    b.2. ``Composite'' propeller blades or propfans, capable of
absorbing more than 2,000 kW at flight speeds exceeding Mach 0.55;
    c. ``Technology'' ``required'' for manufacturing cooling holes,
in gas turbine engine ``parts'' or ``components'' incorporating any
of the ``technologies'' specified by 9E003.a.1, 9E003.a.2 or
9E003.a.5, and having any of the following:
    c.1. Having all of the following:
    c.1.a. Minimum `cross-sectional area' less than 0.45 mm\2\;
    c.1.b. `Hole shape ratio' greater than 4.52; and
    c.1.c. `Incidence angle' equal to or less than 25[deg]; or
    c.2. Having all of the following:
    c.2.a. Minimum `cross-sectional area' less than 0.12 mm\2\;
    c.2.b. `Hole shape ratio' greater than 5.65; and
    c.2.c. `Incidence angle' more than 25[deg];

    Note:  9E003.c does not apply to ``technology'' for
manufacturing constant radius cylindrical holes that are straight
through and enter and exit on the external surfaces of the
component.

    Technical Notes:
    1. For the purposes of 9E003.c, the `cross-sectional area' is
the area of the hole in the plane perpendicular to the hole axis.
    2. For the purposes of 9E003.c, `hole shape ratio' is the
nominal length of the axis of the hole divided by the square root of
its minimum `cross-sectional area.'
    3. For the purposes of 9E003.c, `incidence angle' is the acute
angle measured between the plane tangential to the airfoil surface
and the hole axis at the point where the hole axis enters the
airfoil surface.
    4. Methods for manufacturing holes in 9E003.c include ``laser''
beam machining, water jet machining, Electro-Chemical Machining
(ECM) or Electrical Discharge Machining (EDM).

    d. ``Technology'' ``required'' for the ``development'' or
``production'' of helicopter power transfer systems or tilt rotor or
tilt wing ``aircraft'' power transfer systems;
    e. ``Technology'' for the ``development'' or ``production'' of
reciprocating diesel engine ground vehicle propulsion systems having
all of the following:
    e.1. `Box volume' of 1.2 m\3\ or less;
    e.2. An overall power output of more than 750 kW based on 80/
1269/EEC, ISO 2534 or national equivalents; and
    e.3. Power density of more than 700 kW/m\3\ of `box volume';

    Technical Note:  `Box volume' is the product of three
perpendicular dimensions measured in the following way:
    Length: The length of the crankshaft from front flange to
flywheel face;
    Width: The widest of any of the following:
    a. The outside dimension from valve cover to valve cover;
    b. The dimensions of the outside edges of the cylinder heads; or
    c. The diameter of the flywheel housing;
    Height: The largest of any of the following:
    a. The dimension of the crankshaft center-line to the top plane
of the valve cover (or cylinder head) plus twice the stroke; or
    b. The diameter of the flywheel housing.

    f. ``Technology'' ``required'' for the ``production'' of
``specially designed'' ``parts'' or ``components'' for high output
diesel engines, as follows:
    f.1. ``Technology'' ``required'' for the ``production'' of
engine systems having all of the following ``parts'' and
``components'' employing ceramics materials controlled by 1C007:
    f.1.a Cylinder liners;
    f.1.b. Pistons;
    f.1.c. Cylinder heads; and
    f.1.d. One or more other ``part'' or ``component'' (including
exhaust ports, turbochargers, valve guides, valve assemblies or
insulated fuel injectors);
    f.2. ``Technology'' ``required'' for the ``production'' of
turbocharger systems with single-stage compressors and having all of
the following:

    f.2.a. Operating at pressure ratios of 4:1 or higher;
    f.2.b. Mass flow in the range from 30 to 130 kg per minute; and
    f.2.c. Variable flow area capability within the compressor or
turbine sections;
    f.3. ``Technology'' ``required'' for the ``production'' of fuel
injection systems with a ``specially designed'' multifuel (e.g.,
diesel or jet fuel) capability covering a viscosity range from
diesel fuel (2.5 cSt at 310.8 K (37.8[deg]C)) down to gasoline fuel
(0.5 cSt at 310.8 K (37.8[deg]C)) and having all of the following:
    f.3.a. Injection amount in excess of 230 mm\3\ per injection per
cylinder; and
    f.3.b. Electronic control features ``specially designed'' for
switching governor characteristics automatically depending on fuel
property to provide the same torque characteristics by using the
appropriate sensors;
    g. ``Technology'' ``required'' for the development'' or
``production'' of `high output diesel engines' for solid, gas phase
or liquid film (or combinations thereof) cylinder wall lubrication
and permitting operation to temperatures exceeding 723 K (450
[deg]C), measured on the cylinder wall at the top limit of travel of
the top ring of the piston;

    Technical Note: `High output diesel engines' are diesel engines
with a specified brake mean effective pressure of 1.8 MPa or more at
a speed of 2,300 rpm, provided the rated speed is 2,300 rpm or more.

    h. ``Technology'' for gas turbine engine ``FADEC systems'' as
follows:
    h.1. ``Development'' ``technology'' for deriving the functional
requirements for the ``parts'' or ``components'' necessary for the
``FADEC system'' to regulate engine thrust or shaft power (e.g.,
feedback sensor time constants and accuracies, fuel valve slew
rate);
    h.2. ``Development'' or ``production'' ``technology'' for
control and diagnostic ``parts'' or ``components'' unique to the
``FADEC system'' and used to regulate engine thrust or shaft power;
    h.3. ``Development'' ``technology'' for the control law
algorithms, including ``source code'', unique to the ``FADEC
system'' and used to regulate engine thrust or shaft power;

    Note: 9E003.h does not apply to technical data related to
engine-``aircraft'' integration required by civil aviation
authorities of one or more Wassenaar Arrangement Participating
States (See Supplement No. 1 to part 743 of the EAR) to be published
for general airline use (e.g., installation manuals, operating
instructions, instructions for continued airworthiness) or interface
functions (e.g., input/output processing, airframe thrust or shaft
power demand).

    i. ``Technology'' for adjustable flow path systems designed to
maintain engine stability for gas generator turbines, fan or power
turbines, or propelling nozzles, as follows:
    i.1. ``Development'' ``technology'' for deriving the functional
requirements for the ``parts'' or ``components'' that maintain
engine stability;
    i.2. ``Development'' or ``production'' ``technology'' for
``parts'' or ``components'' unique to the adjustable flow path
system and that maintain engine stability;
    i.3. ``Development'' ``technology'' for the control law
algorithms, including ``source code'', unique to the adjustable flow
path system and that maintain engine stability;

    Note: 9E003.i does not apply to ``technology'' for any of the
following:
    a. Inlet guide vanes;
    b. Variable pitch fans or prop-fans;
    c. Variable compressor vanes;
    d. Compressor bleed valves; or
    e. Adjustable flow path geometry for reverse thrust.

    j. ``Technology'' ``required'' for the ``development'' of wing-
folding systems designed for fixed-wing ``aircraft'' powered by gas
turbine engines.

    N.B.: For ``technology'' ``required'' for the ``development'' of
wing-folding systems designed for fixed-wing ``aircraft'' specified
in USML Category VIII (a), see USML Category VIII (i).

    k. ``Technology'' not otherwise controlled in 9E003.a.1 through
a.8, a.10, and .h and used in the ``development'', ``production'',
or overhaul of hot section ``parts'' or ``components'' of civil
derivatives of military engines controlled on the U.S. Munitions
List.

0
69. In supplement no. 6 to part 774, paragraphs (1) and (2) are revised
to read as follows:

Supplement No. 6 to Part 774--Sensitive List

* * * * *

(1) Category 1

    (i) 1A002.a.1.
    (ii) 1C001.
    (iii) 1C007.c.
    (iv) 1C010.c and .d.
    (v) 1C012.
    (vi) 1D002--``Software'' for the ``development'' of organic
``matrix'', metal ``matrix'', or carbon ``matrix'' laminates or
composites controlled under 1A002, 1C007.c, 1C010.c or 1C010.d.
    (vii) 1E001--``Technology'' according to the General Technology
Note for the ``development'' or ``production'' of equipment and
materials controlled under 1A002, 1C001, 1C007.c, 1C010.c, 1C010.d,
or 1C012.
    (viii) 1E002.e and .f.

(2) Category 2

    (i) 2D001--``Software'', other than that controlled by 2D002,
``specially designed'' for the ``development'' or ``production'' of
equipment as follows:
    (A) Specified by 2B001.a, 2B001.b.1, or 2B001.b.2, and having a
``unidirectional positioning repeatability'' equal to or less
(better) than 0.9 [micro]m along one or more linear axis;
    (B) Specified by 2B001.b.3, 2B001.d, 2B001.f or 2B003.
    (ii) 2E001--``Technology'' according to the General Technology
Note for the ``development'' of equipment or ``software'', as
follows:
    (A) Equipment specified by 2B001.a, 2B001.b.1 or 2B001.b.2, and
having a ``unidirectional positioning repeatability'' equal to or
less (better) than 0.9 [micro]m along one or more linear axis;
    (B) Equipment specified by 2B001.b.3, 2B001.d, 2B001.f or 2B003.
    (C) ``Software'' specified by 2D001 of this Supplement;
    (iii) 2E002--``Technology'' according to the General Technology
Note for the ``production'' of equipment as follows:
    (A) Specified by 2B001.a, 2B001.b.1, or 2B001.b.2, and having a
``unidirectional positioning repeatability'' equal to or less
(better) than 0.9 [micro]m along one or more linear axis;
    (B) Specified by 2B001.b.3, 2B001.d, 2B001.f or 2B003.
* * * * *

0
70. Supplement no. 7 to part 774 is amended by:
0
a. Revising paragraph (1)(i); and
0
b. Removing the phrase ``user accessible programmability'' and adding
in its place ``user-accessible programmability'' in paragraphs (3)(iv)
and (vi).
    The revision reads as follows:

Supplement No. 7 to Part 774--Very Sensitive List

* * * * *
    (1) * * *
    (i) 1A002.a.1.
* * * * *

    Dated: October 4, 2018.
Richard E. Ashooh,
Assistant Secretary for Export Administration.
[FR Doc. 2018-22163 Filed 10-23-18; 8:45 am]
 BILLING CODE 3510-33-P


[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62378-62379]
[FR Doc No: 2023-19456]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-3391]

Clinical Pharmacology Considerations for Peptide Drug Products;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Clinical
Pharmacology Considerations for Peptide Drug Products.'' This guidance
describes FDA's recommendations regarding clinical pharmacology
considerations for peptide drug product development programs, including
hepatic impairment, drug-drug interactions (DDIs), assessing QTc
prolongation risk, and immunogenicity risk and impact on the
pharmacokinetics (PK), safety, and efficacy assessment. The intent of
this draft guidance, when finalized, is to assist industry in the
conduct of these development programs.

DATES: Submit either electronic or written comments on the draft
guidance by December 11, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-3391 for ``Clinical Pharmacology Considerations for Peptide
Drug Products.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Daphne Guinn, Center for Drug

Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Pharmacology Considerations for Peptide Drug
Products.'' This draft guidance, when finalized, will represent FDA's
current thinking on the conduct of certain clinical pharmacology
studies during the development of peptide drug products.
    The term ``peptide'' refers to any polymer composed of 40 or fewer
amino acids. In general, if a peptide meets the definition of a drug
and does not otherwise meet the statutory definition of a ``biological
product'' or a ``device,'' it would be regulated as a drug under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and be subject to all
the ``drug'' requirements under the FD&C Act and FDA's regulations,
including the requirement that new drugs must be approved under section
505(c) of the FD&C Act before they can be marketed in interstate
commerce. However, peptide drug products can have product
characteristics that may be similar, in certain respects, to biological
products, and as such, there are other FDA guidances on biological
products that discuss scientific principles that could also be
applicable to peptide drug products.
    The ``Clinical Pharmacology Considerations for Peptide Drug
Products'' draft guidance, when finalized, will provide recommendations
to assist industry in the development of peptide drug products.
Specifically, this guidance describes FDA's recommendations regarding
clinical pharmacology considerations for peptide drug product
development programs, including organ impairment, DDIs, assessing QTc
prolongation risk, and immunogenicity risk and impact on PK, safety,
and efficacy assessment. This guidance provides recommendations on when
these assessments may be appropriate.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance,
when finalized, will represent the current thinking of FDA on
``Clinical Pharmacology Considerations for Peptide Drug Products.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
OMB under the PRA. The collections of information in 21 CFR part 312
have been approved under OMB Control No. 0910-0014. The collections of
information in 21 CFR part 314 have been approved under OMB Control No.
0910-0001. The collections of information in 21 CFR part 201 have been
approved under OMB Control No. 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19456 Filed 9-8-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Notices]
[Page 52094-52095]
[DOCID:fr12se07-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER07-1212-000]

Forked River Power LLC; Notice of Issuance of Order

August 31, 2007.
    Forked River Power LLC (Forked River) filed an application for
market-based rate authority, with an accompanying tariff. The proposed
market-based rate tariff provides for the sale of energy, capacity and
ancillary services at market-based rates. Forked River also requested
waivers of various Commission regulations. In particular, Forked River
requested that the Commission grant blanket approval under 18 CFR part
34 of all future issuances of securities and assumptions of liability
by Forked River.
    On August 30, 2007, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development-West, granted the requests
for blanket approval under part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any

person desiring to be heard concerning the blanket approvals of
issuances of securities or assumptions of liability by Forked River,
should file a protest 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, 385.214 (2004).
    Notice is hereby given that the deadline for filing protests is
October 1, 2007.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Forked River is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Forked River, compatible with
the public interest, and is reasonably necessary or appropriate for
such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Fork River's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-17928 Filed 9-11-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 132 (Tuesday, July 10, 2012)]
[Proposed Rules]
[Pages 40550-40552]
[FR Doc No: 2012-16809]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2012-0468; FRL-9698-1]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Revision for the Control of Volatile Organic Compounds
Emissions From Vehicle Refinishing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of Maryland. The SIP revision amends
Maryland's COMAR <IP_ADDRESS> ``Control of Volatile Organic Compounds
Emissions from Vehicle Refinishing'' to establish new volatile organic
compounds (VOC) content limits for coating and cleaning solvents used
in vehicle refinishing and standards for coating application, work
practices, monitoring, and recordkeeping. This action is being taken
under the Clean Air Act (CAA).

DATES: Written comments must be received on or before August 9, 2012.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2012-0468 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-2012-0468, Donna Mastro, Acting 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-
2012-0468. 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: Emlyn V[eacute]lez-Rosa, (215) 814-
2038, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Maryland was designated nonattainment with respect to the 1-hour
ozone NAAQS on November 15, 1990, with several serious nonattainment
areas, including: the Baltimore, Maryland area, the Maryland portion of
the Philadelphia-Wilmington-Atlantic City area, and the Maryland
portion of the Washington, DC area. Section 182(b)(1) of the CAA
requires states with ozone nonattainment areas classified as moderate
or above to submit a SIP revision that provides VOC emissions
reductions of at least 15 percent from the baseline emissions of 1990.
In Maryland, the 15 percent plans (the 15% rate-of-progress plans) were
required for the 1-hour ozone nonattainment areas.
    Pursuant to this requirement, Maryland revised its SIP on August 4,
1997 to adopt COMAR <IP_ADDRESS> ``Control of Volatile Organic Compounds
Emissions from Vehicle Refinishing.'' The regulation would achieve
fully enforceable VOC emissions reductions from vehicle refinishing
sources throughout the State of Maryland, which were creditable towards
the 15% rate-of-progress plans. The rule, which followed EPA's
``Alternative Control Techniques (ACT) Document: Automobile Body
Refinishing'' (EPA-453/R-94-031, April 1994), established standards for
vehicle refinishing based on VOC content of coatings, methods for
calculating the VOC content of a coating system, and standards for
operating, monitoring, reporting, and recordkeeping. The coating
categories included: pretreatment coatings, precoatings, primer
surfacers, primer sealers, topcoats, multi-stage coating systems, and
specialty coatings.
    Section 183(e) of the Act authorizes EPA to establish national
standards to

reduce VOC emissions from consumer and commercial products, including
the automobile refinishing coatings. On September 11, 1998, a final
rule ``National Volatile Organic Compound Emissions Standards for
Automobile Refinish Coatings'' (EPA's National Rule) was published by
EPA under the authority of section 183(e) of the CAA (63 FR 48806), as
identified in 40 CFR part 59, subpart B. The federal rule applies to
all automobile refinish coatings that are manufactured or imported for
sale or distribution in the United States, and sets VOC content limits
by automotive refinish category. See EPA's August 1998 report
``Volatile Organic Compound Emissions from Automobile Refinishing--
Background Information for Promulgated Standards'' (EPA-453/R-96-011b).
    On January 9, 2008, EPA published the final rule 40 CFR part 63
subpart HHHHHH ``National Emission Standards for Hazardous Air
Pollutants: Paint Stripping and Miscellaneous Surface Coating
Operations at Area Sources'' (EPA's 6H NESHAP), which includes
automobile refinishing. This Federal rule specifically applies to area
sources that engage in paint stripping operations that use methylene
chloride (MeCl) containing paint stripping formulations, and in spray
application of coatings to motor vehicle and mobile equipment, plastic
and or metal substrate, where the coatings contain compounds of
chromium, lead, manganese, nickel, or cadmium. Motor vehicle or mobile
equipment surface coating operations may petition the EPA's
Administrator for an exemption from this rule if the owner or operator
can demonstrate, to the satisfaction of the EPA's Administrator, that
the spray applied does not include coatings containing any of these
compounds. This rule establishes important requirements for these types
of facilities, among the following: Training certification of all new
and existing personnel who spray surface coatings, minimum training
requirements, and installation to all facilities of a filtered spray
booth and enclosed spray gun cleaner.
    Maryland's 1997 SIP-approved regulation COMAR <IP_ADDRESS> ``Control
of Volatile Organic Compounds Emissions from Vehicle Refinishing''
complies with the federal standards established in EPA's rules. On May
8, 2012, EPA received a revision to the Maryland SIP submitted by the
Maryland Department of Environment (MDE). The SIP revision
(12-04) amends Maryland's COMAR <IP_ADDRESS> ``Control of
Volatile Organic Compounds from Vehicle Refinishing,'' in order to
establish new standards and requirements for VOC, including: VOC
content limits for coatings and solvents, controls on emissions from
equipment cleaning, the use of coating application methods,
recordkeeping, maintenance activities, and operator training. These
amendments are based on the 2009 ``Model Rule for Motor Vehicle and
Mobile Equipment Non-Assembly Line Coating Operations'' (MVMERR)
developed in conjunction with member states of the Ozone Transport
Commission (OTC). The MVMERR established requirements which comply with
those established in EPA's National Rule and 6H NESHAP.

II. Summary of SIP Revision

    The proposed SIP revision establishes VOC content limits for
automotive coatings and cleaning solvents used in vehicle refinishing,
and standards for coating application, work practices, monitoring, and
recordkeeping, to be effective for all affected sources as of July 1,
2013. Sources subject to the requirements of this regulation include:
auto body and repair facilities, fleet operator repair and paint
facilities, new and used auto dealer repair and paint facilities, and
after-market auto customizing and detailing facilities located
throughout the State of Maryland; manufacturers, suppliers,
distributors of coatings and cleaning solvents intended for use and
application to motor vehicles, mobile equipment, and associated
components within the State of Maryland; and manufacturers, suppliers,
and distributors of application equipment and materials storage such as
spray booths, spray guns, and sealed containers for cleaning rags for
use within Maryland.
    The regulation establishes VOC content limits for 11 categories of
automotive coatings and two categories of cleaning solvents which are
used in the preparation, application, and drying phases of vehicle
refinishing. The VOC content limits established for the automotive
coatings and solvents exclude water and exempt compounds as listed in
40 CFR 51.100(s), and are provided in Table 1 and Table 2,
respectively.

  Table 1--VOC Content Limits for Automotive Coatings for Motor Vehicle
  and Mobile Equipment Refinishing and Recoating VOC Content Limit for
                           Automotive Coatings
------------------------------------------------------------------------
                                                Maximum VOC content
            Coating category             -------------------------------
                                              lbs/gal           g/L
------------------------------------------------------------------------
Adhesion promoter.......................             4.5             540
Automotive pretreatment coating.........             5.5             660
Automotive primer.......................             2.1             250
Clear coating...........................             2.1             250
Color coating, including metallic/                   3.5             420
 iridescent color coating...............
Multicolor coating......................             5.7             680
Other automotive coating type...........             2.1             250
Single-stage coating, including single-              2.8             340
 stage metallic/iridescent coating......
Temporary protective coating............             0.5              60
Truck bed liner coating.................             1.7             200
Underbody coating.......................             3.6             430
------------------------------------------------------------------------

 Table 2--VOC Content Limits for Cleaning Solvents for Motor Vehicle and
    Mobile Equipment Refinishing and Recoating VOC Content Limit for
                            Cleaning Solvents
------------------------------------------------------------------------

------------------------------------------------------------------------
Solvent category                           Maximum VOC content
------------------------------------------------------------------------
Cleaning solvent (other than     0.21 lbs/gal.......  25 g/L.
 bug and tar removers).
------------------------------------------------------------------------
Bug and tar removers**.........             40% VOC by weight.
------------------------------------------------------------------------

    The regulation provides methods for calculating the VOC content of
coatings and cleaning solvents and a list of test methods to be used
for demonstrating compliance with provisions of this regulation.
Instead of complying with the VOC content limits specified, a person
subject to this regulation may use an emission control device that has
been approved by MDE, which achieves an overall emission control
efficiency of 85 percent or greater, as determined in accordance with
the approved test methods. The regulation requires using at least one
of the approved methods for applying an automotive coating, including:
Flow or curtain coating, dip coating, brush coating, cotton-tipped swab
application, electrodeposition coating, high volume-low pressure (HVLP)
spraying, electrostatic spraying, airless spraying, or an alternate
spray equipment method approved by MDE. Work practice standards include
procedures for cleaning the spray gun equipment for applying automotive
coatings. Affected facilities are also required to keep extensive
records on the total amount of coating used, VOC actual and regulatory
contents, purchase records, and system operating parameters of any
emission control device installed. Additional information concerning
EPA's review and rationale for proposing to approve this SIP revision
may be found in the Technical Support Document (TSD) for this action
which is available on line at www.regulations.gov, Docket number EPA-
R03-OAR-2012-0468.

III. Proposed Action

    The Maryland SIP revision for the control of VOC emissions from
vehicle refinishing under Regulation COMAR <IP_ADDRESS>, as adopted by
the State of Maryland on March 26, 2012, meets the applicable
requirements of the CAA and the applicable EPA regulations. The SIP
revision will achieve emission reductions of VOC throughout the State
of Maryland. EPA is proposing to approve this Maryland SIP revision
submitted on May 8, 2012. EPA is soliciting public comments on the
issues discussed in this document. These comments will be considered
before taking final action.

IV. 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 Maryland's COMAR
<IP_ADDRESS> ``Control of Volatile Organic Compounds Emissions from
Vehicle Refinishing,'' 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, Ozone, Reporting
and recordkeeping requirements, Volatile organic compounds.

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

    Dated: June 27, 2012.
 W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2012-16809 Filed 7-9-12; 8:45 am]
BILLING CODE 6560-50-P