[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21576-21577]
[FR Doc No: 2016-08335]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1005]

Safety Considerations for Product Design To Minimize Medication
Errors; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a guidance for industry entitled
``Safety Considerations for Product Design to Minimize Medication
Errors.'' The guidance is intended for sponsors of investigational new
drug applications (INDs); applicants of new drug applications (NDAs),
biologics licensing applications (BLAs), and abbreviated new drug
applications (ANDAs); and manufacturers of prescription drugs marketed
without an approved application or over-the-counter (OTC) monograph
drugs. This guidance provides sponsors, applicants, and manufacturers
with a set of principles to consider while developing drug products
using a systems approach to minimize medication errors relating to
product design and container closure design. The recommendations in
this guidance document are intended to provide best practices on how to
improve the drug product and container closure design for all
prescription and nonprescription drug products. This guidance also
provides examples of product designs that resulted in postmarketing
error.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-D-1005 for ``Safety Considerations for Product Design to
Minimize Medication Errors.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the

``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Irene Z. Chan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993-0002, 301-
796-3962.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Safety Considerations for Product Design to Minimize
Medication Errors.'' The guidance is intended for sponsors of INDs;
applicants of NDAs, BLAs, and ANDAs; and manufacturers of prescription
drugs marketed without an approved application or OTC monograph drugs.
This guidance provides sponsors, applicants, and manufacturers with a
set of principles to consider while developing drug products using a
systems approach to minimize medication errors relating to product
design and container closure design. The recommendations in this
guidance document are intended to provide best practices on how to
improve the drug product and container closure design for all
prescription and nonprescription drug products. The guidance also
provides examples of product designs that resulted in postmarketing
error.
    This guidance document, which focuses on minimizing risks
associated with the design of the drug product and its container
closure system, is the first in a series of three planned guidances to
minimize or eliminate hazards contributing to medication errors. The
second guidance focuses on minimizing risks with the design of drug
product container labels and carton labeling. The third guidance
focuses on minimizing risks when developing and selecting proposed
proprietary names for drugs.
    In the Federal Register of December 13, 2012 (77 FR 74196), FDA
announced the availability of the draft guidance entitled ``Safety
Considerations for Product Design to Minimize Medication Errors.'' The
Agency has carefully reviewed and considered the comments it received
in developing this final version of the guidance. The Agency has made
revisions to the guidance to address public comments requesting
clarifications and implement formatting changes for improved
readability as it deemed appropriate. The Agency also moved
recommendations appropriate for labels and labeling to a separate
guidance. The guidance announced in this notice finalizes the draft
guidance dated December 2012.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on addressing safety achieved through drug
product design to minimize medication errors. 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. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in 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 312 have been approved under
OMB control number 0910-0014. The collections of information in 21 CFR
part 314 have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

IV. Electronic Access

    You may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08335 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 19, 2010 (Volume 75, Number 160)]
[Proposed Rules]
[Page 51187-51188]
[DOCID:fr19au10-16]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0829; Directorate Identifier 2010-NE-23-AD]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Canada Corp. (P&WC)
PW305A and PW305B Turboprop Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) issued by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as: As a result of a change in the low-cycle fatigue lifing
methodology for the IMI 834 material, the recommended service life of
certain PW305A and PW305B Impellers has been reduced, as published in
the Airworthiness Limitations (AWL) section of Engine Maintenance
Manual (EMM). The in-service life of impellers P/N 30B2185, 30B2486 and
30B2858-01 has been reduced from 12,000 to 7,000 cycles; and of P/N
30B4565-01 from 8,500 to 7,000 cycles. We are proposing this AD to
prevent failure of the impeller, which could result in an uncontained
event and possible damage to the airplane.

DATES: We must receive comments on this proposed AD by October 4, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Contact Pratt & Whitney Canada Corp., 1000 Marie-Victorin,
Longueuil, Quebec, Canada, J4G 1A1; telephone<PHONE_NUMBER>; fax 450-
647-2888; Web site: www.pwc.ca, for the service information identified
in this proposed AD.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (phone<PHONE_NUMBER>) is the
same as the Mail address provided in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: James Lawrence, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0829;
Directorate Identifier 2010-NE-23-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    Transport Canada, which is the aviation authority for Canada, has
issued Canada Airworthiness Directive CF-2010-09, dated March 17, 2010,
(referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    As a result of a change in the low-cycle fatigue lifing
methodology for the IMI 834 material, the recommended service life
of certain PW305A and PW305B Impellers has been reduced, as
published in the Airworthiness Limitations (AWL) section of Engine
Maintenance Manual (EMM).
    The in-service life of impellers P/N 30B2185, 30B2486 and
30B2858-01 has been reduced from 12,000 to 7,000 cycles; and of P/N
30B4565-01 from 8,500 to 7,000 cycles.
    This Airworthiness Directive (AD) is issued to mandate the
incorporation of the revised in-service life limits for the affected
impellers, in the AWL section of EMM, as introduced by Temporary
Revision (TR) AL-8.
    Within 30 days from the effective date of this AD, update AWL
section of your PW305 EMM P/N 30B1402, to incorporate TR AL-8 for
compliance with the revised in-service limits for the affected
Impellers, installed on PW305A and PW305B engine.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Pratt & Whitney Canada has issued Maintenance Manual Part Number
30B1402 Temporary Revision No. AL-8, dated January 20, 2010. The
reduced cycle limits described in this service information are intended
to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of Canada,
and is approved for operation in the United

States. Pursuant to our bilateral agreement with Canada, they have
notified us of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all information provided by Canada and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 114 products of U.S. registry. We also estimate that
it would take about 0 work-hours per product to comply with this
proposed AD. The average labor rate is $85 per work-hour. Required
parts would cost about $54,288 per product. Based on these figures, we
estimate the cost of the proposed AD on U.S. operators to be
$6,188,832. Our cost estimate is exclusive of possible warranty
coverage.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Pratt & Whitney Canada Corp. (Formerly Pratt & Whitney Canada,
Inc.): Docket No. FAA-2010-0829; Directorate Identifier 2010-NE-23-
AD.

Comments Due Date

    (a) We must receive comments by October 4, 2010.

Affected Airworthiness Directives (ADs)

    (b) None.

Applicability

    (c) This AD applies to Pratt & Whitney Canada Corp. (P&WC)
PW305A and PW305B turboprop engines with certain impellers, part
numbers (P/Ns) 30B2185, 30B2486, 30B2858-01, or 30B4565-01
installed. These engines are installed on, but not limited to,
Hawker-Beech Corporation BAe.125 series 1000A, 1000B, and Hawker
1000 airplanes and Learjet Inc. Learjet 60 airplanes.

Reason

    (d) This AD results from:
    As a result of a change in the low-cycle fatigue lifing
methodology for the IMI 834 material, the recommended service life
of certain PW305A and PW305B Impellers has been reduced, as
published in the Airworthiness Limitations (AWL) section of Engine
Maintenance Manual (EMM).
    The in-service life of impellers P/N 30B2185, 30B2486 and
30B2858-01 has been reduced from 12,000 to 7,000 cycles; and of P/N
30B4565-01 from 8,500 to 7,000 cycles.
    We are issuing this AD to prevent failure of the impeller, which
could result in an uncontained event and possible damage to the
airplane.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (f) Within 30 days from the effective date of this AD, update
AWL section of your PW305 EMM P/N 30B1402, to incorporate Temporary
Revision (TR) AL-8, dated January 20, 2010, for compliance with the
revised in-service limits for the affected Impellers, installed on
PW305A and PW305B engine.

FAA AD Differences

    (g) None.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (i) Alternative Methods of Compliance (AMOCs): The Manager,
Engine Certification Office, FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures found in 14 CFR
39.19.

Related Information

    (j) Refer to MCAI Transport Canada Airworthiness Directive CF-
2010-09, dated March 17, 2010, and P&WC Temporary Revision No. AL-8,
dated January 20, 2010, to P&WC EMM P/N 30B1402 for related
information. Contact Pratt & Whitney Canada Corp., 1000 Marie-
Victorin, Longueuil, Quebec, Canada, J4G 1A1; telephone (800) 268-
8000; fax<PHONE_NUMBER>; or go to: http://www.pwc.ca, for a copy of
this service information.
    (k) Contact James Lawrence, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>,
for more information about this AD.

    Issued in Burlington, Massachusetts, on August 13, 2010.
Francis A. Favara,
Manager, Engine and Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2010-20561 Filed 8-18-10; 8:45 am]
BILLING CODE 4910-13-P


EPA research data for coal units with projected scrubber retrofits prior to 2009 Control Operation in Plant Name ORIS Code Unit ID PlantTypeState Name Capacity MW present 2006 2007 Ghent 1356 1 Coal KY 484 scrubber Cane Run 1363 4 Coal KY 155 scrubber Cane Run 1363 5 Coal KY 168 scrubber Cane Run 1363 6 Coal KY 240 scrubber Mill Creek 1364 1 Coal KY 303 scrubber Mill Creek 1364 2 Coal KY 301 scrubber Mill Creek 1364 3 Coal KY 391 scrubber Mill Creek 1364 4 Coal KY 477 scrubber Elmer 1374 1 Coal KY 144.5 scrubber Elmer 1374 2 Coal KY 269.7 scrubber Paradise 1378 1 Coal KY 619 scrubber Paradise 1378 2 Coal KY 605 scrubber Paradise 1378 3 Coal KY 977 scrubber HMP& L 1382 H1 Coal KY 153 scrubber HMP& L 1382 H2 Coal KY 159 scrubber East Bend 6018 2 Coal KY 600 scrubber Trimble 6071 1 Coal KY 509 scrubber R D Green 6639 G1 Coal KY 231 scrubber R D Green 6639 G2 Coal KY 233 scrubber D B Wilson 6823 W1 Coal KY 420 scrubber H L 6041 2 Coal KY 525 scrubber E W Brown 1355 1 Coal KY 101 E W Brown 1355 2 Coal KY 167 E W Brown 1355 3 Coal KY 429 Ghent 1356 3 Coal KY 493 Ghent 1356 4 Coal KY 493 Chesterfield 3797 6 Coal VA 658 Clover 7213 1 Coal VA 441 scrubber Clover 7213 2 Coal VA 441 scrubber Birchwood 54304 1A Coal VA 237.8 scrubber Altavista 10773 1 Coal VA 63 scrubber Southampto 10774 1 Coal VA 63 scrubber Mecklenbur 52007 BLR1 Coal VA 66 scrubber Mecklenbur 52007 BLR2 Coal VA 66 scrubber Cogentrix 54081 1A Coal VA 26.25 scrubber Cogentrix 54081 1B Coal VA 26.25 scrubber Cogentrix 54081 2A Coal VA 26.25 scrubber Cogentrix 54081 2B Coal VA 26.25 scrubber Chesterfield 3797 B Coal VA 310 John E 3935 1 Coal WV 800 John E 3935 2 Coal WV 800 John E 3935 3 Coal WV 1300 scrubber Harrison 3944 1 Coal WV 640 scrubber Harrison 3944 2 Coal WV 642 scrubber Harrison 3944 3 Coal WV 651 scrubber Mitchell 3948 1 Coal WV 800 scrubber Mitchell 3948 2 Coal WV 800 scrubber Mt Storm 3954 1 Coal WV 524 scrubber Mt Storm 3954 2 Coal WV 524 scrubber Mt Storm 3954 3 Coal WV 521 scrubber Pleasants 6004 1 Coal WV 639 scrubber Pleasants 6004 2 Coal WV 639 scrubber Mountainee 6264 1 Coal WV 1300 scrubber Wansley 6052 1 Coal GA 891 scrubber Wansley 6052 2 Coal GA 892 scrubber Bowen 703 1BLR Coal GA 713 scrubber Bowen 703 2BLR Coal GA 718 scrubber Bowen 703 3BLR Coal GA 902 scrubber Bowen 703 4BLR Coal GA 929 scrubber Yates 728 Y1BR Coal GA 99 scrubber Bull Run 3396 1 Coal TN 881 Cumberlan 3399 1 Coal TN 1232 scrubber Cumberlan 3399 2 Coal TN 1233 scrubber Elrama 3098 3 Coal PA 103 scrubber Elrama 3098 4 Coal PA 173.5 scrubber Conemaugh 3118 1 Coal PA 850 scrubber Conemaugh 3118 2 Coal PA 850 scrubber Homer City 3122 3 Coal PA 650 scrubber Shawville 3131 2 Coal PA 127.5 scrubber Cromby 3159 1 Coal PA 144 scrubber Eddystone 3161 1 Coal PA 279 scrubber Eddystone 3161 2 Coal PA 302 scrubber Mitchell 3181 33 Coal PA 277 scrubber Bruce 6094 1 Coal PA 780 scrubber Bruce 6094 2 Coal PA 780 scrubber Bruce 6094 3 Coal PA 800 scrubber AES 10676 2 Coal PA 43.0070922 scrubber AES 10676 3 Coal PA 43.0070922 scrubber AES 10676 4 Coal PA 43.0070922 scrubber Elrama 3098 1 Coal PA 94 scrubber Elrama 3098 2 Coal PA 94 scrubber PPL 3149 1 Coal PA 774 PPL 3149 2 Coal PA 766 Cardinal Coal OH 600 scrubber Cardinal Coal OH 600 scrubber Conesville Coal OH 780 scrubber Conesville Coal OH 375 scrubber Conesville Coal OH 375 scrubber Muskingum Coal OH 575 scrubber Kyger Coal OH 217 scrubber Kyger Coal OH 217 scrubber Kyger Coal OH 217 scrubber Kyger Coal OH 217 scrubber Kyger Coal OH 217 scrubber W H Coal OH 1300 scrubber General Coal OH 1300 scrubber Niles Coal OH 100 scrubber General Coal OH 1300 scrubber Miami Fort Coal OH 500 Miami Fort Coal OH 500 J M Stuart Coal OH 585 J M Stuart Coal OH 585 J M Stuart Coal OH 585 J M Stuart Coal OH 585 Widows 50 7 Coal AL 473 scrubber Widows 50 8 Coal AL 464 scrubber Charles R 56 2 Coal AL 231 scrubber Charles R 56 3 Coal AL 236 scrubber Gorgas 8 10 Coal AL 723 scrubber Gorgas 8 8 Coal AL 167 scrubber Gorgas 8 9 Coal AL 177 scrubber Cayuga 1001 1 Coal IN 500 scrubber F B Culley 1012 2 Coal IN 90 scrubber F B Culley 1012 3 Coal IN 270 scrubber R M 6085 17 Coal IN 361 scrubber R M 6085 18 Coal IN 361 scrubber Gibson 6113 2 Coal IN 630 scrubber Gibson 6113 3 Coal IN 630 scrubber Gibson 6113 4 Coal IN 622 scrubber Gibson 6113 5 Coal IN 620 scrubber A B Brown 6137 1 Coal IN 250 scrubber A B Brown 6137 2 Coal IN 250 scrubber Merom 6213 1SG1 Coal IN 507 scrubber Merom 6213 2SG1 Coal IN 493 scrubber Petersburg 994 3 Coal IN 510 scrubber Petersburg 994 4 Coal IN 545 scrubber Bailly 995 7 Coal IN 160 scrubber Bailly 995 8 Coal IN 320 scrubber Cayuga 1001 2 Coal IN 495 scrubber Gibson 6113 1 Coal IN 630 scrubber Cross 130 1 Coal SC 620 scrubber Cross 130 2 Coal SC 540 scrubber Winyah 6249 1 Coal SC 295 Winyah 6249 2 Coal SC 295 Winyah 6249 3 Coal SC 295 scrubber Winyah 6249 4 Coal SC 270 scrubber Cope 7210 COP1 Coal SC 410 scrubber in year  2008 post 2008 scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber scrubber Documentation ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS Based on company comments ETS ETS ETS ETS ETS ETS ETS 2003 EIA 767 http:// www. babcockpower. com/ index. php? option= news& task= viewnews& coid= 17& sid= 75 http:// www. babcockpower. com/ index. php? option= news& task= viewnews& coid= 17& sid= 75 http:// www. babcockpower. com/ index. php? option= news& task= viewnews& coid= 17& sid= 75 http:// www. babcockpower. com/ index. php? option= news& task= viewnews& coid= 17& sid= 75 http:// www. babcockpower. com/ index. php? option= news& task= viewnews& coid= 17& sid= 75 Installation of FGD is required in 2010 under NSR settlement with VEPCO ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS Installation of FGD is required in 2010 under NSR settlement with VEPCO Based on company comments Based on company comments Based on company comments ETS ETS ETS Based on company comments Based on company comments ETS ETS ETS ETS ETS Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments ETS Based on company comments ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS http:// www. wapc. com/ news_ PPL. htm http:// www. wapc. com/ news_ PPL. htm ETS ETS ETS ETS ETS Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments ETS ETS ETS ETS http:// www. babcock. com/ pgg/ pr/ cinergyorders. html http:// www. babcock. com/ pgg/ pr/ cinergyorders. html http:// www. chiyoda corp. com/ news/ 0505/ news0505 1 e. shtml http:// www. chiyoda corp. com/ news/ 0505/ news0505 1 e. shtml http:// www. chiyoda corp. com/ news/ 0505/ news0505 1 e. shtml http:// www. chiyoda corp. com/ news/ 0505/ news0505 1 e. shtml ETS ETS ETS ETS Based on company comments Based on company comments Based on company comments Based on company comments ETS ETS ETS ETS http:// www. cinergy. com/ News/ default_ corporate_ news. asp? news_ id= 451 http:// www. babcock. com/ pgg/ pr/ cinergyorders. html ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS http:// www. babcock. com/ pgg/ pr/ cinergyorders. html http:// www. babcock. com/ pgg/ pr/ cinergyorders. html ETS ETS Installation of FGD is required by2009 under the NSR settlement with Santee Cooper Installation of FGD is required by2009 under the NSR settlement with Santee Cooper Installation of FGD is required by2009 under the NSR settlement with Santee Cooper Installation of FGD is required by2009 under the NSR settlement with Santee Cooper ETS Secondary Source http:// www. burnsmcd. com/ airpollutioncontrol/ fluegasdesulfur. html http:// www. burnsmcd. com/ airpollutioncontrol/ fluegasdesulfur. html Based on company comments http:// ebb. dom. com/ cgi bin/ ultimatebb. cgi? ubb= get_ topic; f= 9; t= 000022 http:// www. dom. com/ news/ elec2005/ pr1122. jsp Based on company comments Installation of FGD is required in 2005 under NSR settlement with VEPCO Installation of FGD is required in 2005 under NSR settlement with VEPCO Installation of FGD is required in 2005 under NSR settlement with VEPCO Based on company comments Based on company comments Black and Veatch NEEDS NEEDS NEEDS NEEDS NEEDS EPA research data for coal units with projected SCR retrofits prior to 2009 Operation in yea Plant NameORIS Code Unit ID PlantTypeState NameCapacity MW present 2006 2007 Big Sandy 1353 BSU2 Coal KY 800 SCR Ghent 1356 1 Coal KY 484 SCR Ghent 1356 3 Coal KY 493 SCR Ghent 1356 4 Coal KY 493 SCR Mill Creek 1364 3 Coal KY 391 SCR Mill Creek 1364 4 Coal KY 477 SCR Elmer 1374 1 Coal KY 144.5 SCR Paradise 1378 1 Coal KY 619 SCR Paradise 1378 2 Coal KY 605 SCR Paradise 1378 3 Coal KY 977 SCR HMP& L 1382 H1 Coal KY 153 SCR HMP& L 1382 H2 Coal KY 159 SCR East Bend 6018 2 Coal KY 600 SCR H L 6041 1 Coal KY 325 SCR H L 6041 2 Coal KY 525 SCR Trimble 6071 1 Coal KY 509 SCR D B 6823 W1 Coal KY 420 SCR Chesterfie 3797 4 Coal VA 166 SCR Chesterfie 3797 5 Coal VA 310 SCR Chesterfie 3797 6 Coal VA 658 SCR Chesapea 3803 3 Coal VA 156 SCR Chesapea 3803 4 Coal VA 217 SCR Birchwood 54304 1A Coal VA 237.8 SCR John E 3935 1 Coal WV 800 SCR John E 3935 2 Coal WV 800 SCR John E 3935 3 Coal WV 1300 SCR Harrison 3944 1 Coal WV 640 SCR Mitchell 3948 1 Coal WV 800 SCR Mitchell 3948 2 Coal WV 800 SCR Mt Storm 3954 1 Coal WV 524 SCR Mt Storm 3954 2 Coal WV 524 SCR Mt Storm 3954 3 Coal WV 521 SCR Pleasants 6004 1 Coal WV 639 SCR Pleasants 6004 2 Coal WV 639 SCR Mountaine 6264 1 Coal WV 1300 SCR Harrison 3944 2 Coal WV 642 SCR Harrison 3944 3 Coal WV 651 SCR Allen 3393 1 Coal TN 247 SCR Allen 3393 2 Coal TN 247 SCR Allen 3393 3 Coal TN 247 SCR Bull Run 3396 1 Coal TN 881 SCR Cumberla 3399 1 Coal TN 1232 SCR Cumberla 3399 2 Coal TN 1233 SCR Kingston 3407 1 Coal TN 135 SCR Kingston 3407 2 Coal TN 135 SCR Kingston 3407 3 Coal TN 135 SCR Kingston 3407 4 Coal TN 135 SCR Kingston 3407 5 Coal TN 177 SCR Kingston 3407 6 Coal TN 177 SCR Kingston 3407 7 Coal TN 177 SCR Kingston 3407 8 Coal TN 177 SCR Kingston 3407 9 Coal TN 178 SCR Homer 3122 1 Coal PA 620 SCR Homer 3122 2 Coal PA 614 SCR Homer 3122 3 Coal PA 650 SCR Keystone 3136 1 Coal PA 850 SCR Keystone 3136 2 Coal PA 850 SCR PPL 3149 1 Coal PA 774 SCR PPL 3149 2 Coal PA 766 SCR Bruce 6094 1 Coal PA 780 SCR Bruce 6094 2 Coal PA 780 SCR Bruce 6094 3 Coal PA 800 SCR Cheswick 8226 1 Coal PA 580 SCR Wansley 6052 1 Coal GA 891 SCR Wansley 6052 2 Coal GA 892 SCR Bowen 703 1BLR Coal GA 713 SCR Bowen 703 2BLR Coal GA 718 SCR Bowen 703 3BLR Coal GA 902 SCR Bowen 703 4BLR Coal GA 929 SCR Hammond 708 4 Coal GA 510 SCR Cardinal 2828 1 Coal OH 600 SCR Cardinal 2828 2 Coal OH 600 SCR Miami 2832 7 Coal OH 500 SCR J M Stuart 2850 1 Coal OH 585 SCR J M Stuart 2850 2 Coal OH 585 SCR J M Stuart 2850 3 Coal OH 585 SCR Muskingu 2872 5 Coal OH 575 SCR Kyger 2876 1 Coal OH 217 SCR Kyger 2876 2 Coal OH 217 SCR Kyger 2876 3 Coal OH 217 SCR Kyger 2876 4 Coal OH 217 SCR W H 6019 1 Coal OH 1300 SCR General 8102 1 Coal OH 1300 SCR Cardinal 2828 3 Coal OH 630 SCR Miami 2832 8 Coal OH 500 SCR Conesville 2840 4 Coal OH 780 J M Stuart 2850 4 Coal OH 585 SCR Kyger 2876 5 Coal OH 217 SCR Killen 6031 2 Coal OH 600 SCR General 8102 2 Coal OH 1300 SCR E C 26 5 Coal AL 861 SCR Barry 3 5 Coal AL 768 Colbert 47 5 Coal AL 459 SCR Widows 50 7 Coal AL 473 SCR Widows 50 8 Coal AL 464 SCR James H 6002 1 Coal AL 699 SCR James H 6002 2 Coal AL 699 SCR James H 6002 3 Coal AL 701 SCR James H 6002 4 Coal AL 701 SCR Gorgas 8 10 Coal AL 723 SCR F B Culley 1012 3 Coal IN 270 SCR R M 6085 14 Coal IN 431 SCR Gibson 6113 1 Coal IN 630 SCR Gibson 6113 2 Coal IN 630 SCR Gibson 6113 3 Coal IN 630 SCR Gibson 6113 4 Coal IN 622 SCR Gibson 6113 5 Coal IN 620 SCR A B Brown 6137 1 Coal IN 250 SCR A B Brown 6137 2 Coal IN 250 SCR Merom 6213 1SG1 Coal IN 507 SCR Merom 6213 2SG1 Coal IN 493 SCR Warrick 6705 4 Coal IN 150 SCR Clifty 983 1 Coal IN 217 SCR Clifty 983 2 Coal IN 217 SCR Clifty 983 3 Coal IN 217 SCR Clifty 983 4 Coal IN 217 SCR Clifty 983 5 Coal IN 217 SCR Elmer W 990 70 Coal IN 435 SCR Petersbur 994 2 Coal IN 407 SCR Petersbur 994 3 Coal IN 510 SCR Bailly 995 7 Coal IN 160 SCR Bailly 995 8 Coal IN 320 SCR Michigan 997 12 Coal IN 469 SCR Cross 130 1 SC 620 SCR Cross 130 2 SC 540 SCR Wateree 3297 WAT1 SC 350 SCR Winyah 6249 1 SC 295 SCR Winyah 6249 2 SC 295 SCR Winyah 6249 3 SC 295 SCR Winyah 6249 4 SC 270 SCR ear . 2008 post 2008 Documentation ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS ETS Based on company comments Based on company comments ETS ETS Based on company comments Based on company comments ETS ETS ETS http:// www. mmo. kvaerner. com/ eandc/ bulletin/ archive/ issue 08/ news/ news02. html http:// www. mmo. kvaerner. com/ eandc/ bulletin/ archive/ issue 08/ news/ news02. html Based on company comments http:// www. worley. com. au/ v5/ page. aspx? id= 163 http:// www. worley. com. au/ v5/ page. aspx? id= 163 Based on NC Clean Smokestack Act Implementation Plan with Duke Power Based on company comments Based on company comments ETS ETS ETS ETS ETS ETS ETS Based on company comments Based on company comments ETS ETS Based on company comments http:// www. chapmancorporation. com/ html/ projects. html http:// www. chapmancorporation. com/ html/ projects. html http:// www. chapmancorporation. com/ html/ projects. html ETS ETS ETS ETS ETS ETS ETS ETS Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments ETS ETS ETS ETS ETS ETS Based on company comments ETS ETS ETS ETS NEEDS ETS ETS ETS SCR Based on company comments ETS ETS ETS ETS Based on company comments SCR ETS ETS ETS ETS Based on company comments Based on company comments Based on company comments Based on company comments ETS ETS ETS Based on company comments ETS ETS ETS ETS 2003 EIA 767 ETS http:// www. mjelectric. com/ powerplant_ projects. asp# Merom http:// www. mjelectric. com/ powerplant_ projects. asp# Merom http:// www. ewire. com/ display. cfm? Wire_ ID= 1047 ETS ETS ETS ETS ETS 2003 EIA 767 http:// www. pumpengineer. net/ news/ news_ detail. asp? NewsID= 670 http:// www. pumpengineer. net/ news/ news_ detail. asp? NewsID= 670 Based on company comments ETS ETS ETS ETS ETS Installation of SCR is required in 2004 under NSR settlement with Santee Cooper Installation of SCR is required in 2004 under NSR settlement with Santee Cooper Installation of SCR is required in 2004 under NSR settlement with Santee Cooper Installation of SCR is required in 2004 under NSR settlement with Santee Cooper Secondary source ( http:// www. lgeenergy. com/ wke/ wke_ plant_ info. asp) Installation of FGD is required in 2012 under NSR settlement with VEPCO Installation of FGD is required in 2012 under NSR settlement with VEPCO Installation of FGD is required in 2012 under NSR settlement with VEPCO Based on company comments Installation of FGD is required in 2005 under NSR settlement with VEPCO Installation of FGD is required in 2005 under NSR settlement with VEPCO Installation of FGD is required in 2005 under NSR settlement with VEPCO Based on NC Clean Smokestack Act Implementation Plan with Duke Power Based on NC Clean Smokestack Act Implementation Plan with Duke Power Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments NEEDS NEEDS NEEDS Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments http:// www. emissionsonline. org/ nei99v3/ controls/ icac. htm Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments Based on company comments NEEDS Based on company comments Based on company comments Based on company comments Based on company comments 2003 EIA 767 2003 EIA 767 Based on company comments NEEDS Installation of SCR is required in 2004 under NSR settlement with Santee Cooper NEEDS


[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Rules and Regulations]
[Pages 7610-7614]
[FR Doc No: 2018-03524]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2017-0382; FRL-9974-66--Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Revisions To Implement the Revocation of the 1997 Ozone NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the Commonwealth of Virginia (Virginia)
state implementation plan (SIP). The revisions are related to the
implementation of the 2008 ozone national ambient air quality standards
(NAAQS or standards) and the revocation of the 1997 ozone NAAQS. EPA is
approving these revisions updating the Virginia SIP to reflect the
revocation of the 1997 ozone NAAQS in accordance with the requirements
of the Clean Air Act (CAA).

DATES: This final rule is effective on March 26, 2018.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2017-0382. All documents in the docket are listed on
the http://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., confidential business
information (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 through
http://www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Sara Calcinore,<PHONE_NUMBER>, or by
email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under the CAA, EPA establishes NAAQS for criteria pollutants \1\ in
order to protect human health and the environment. In response to
scientific evidence linking ozone exposure to adverse health effects,
EPA promulgated the first ozone NAAQS, the 0.12 part per million (ppm)
1-hour ozone NAAQS, in 1979. See 44 FR 8202 (February 8, 1979). The CAA
requires EPA to review and reevaluate the NAAQS every 5 years in order
to consider updated information regarding the effects of the criteria
pollutants on human health and the environment. On July 18, 1997, EPA
promulgated a revised ozone NAAQS, referred to as the 1997 ozone NAAQS,
of 0.08 ppm averaged over eight hours. 62 FR 38855. This 8-hour ozone
NAAQS was determined to be more protective of public health than the
previous 1979 1-hour ozone NAAQS. In 2008, EPA strengthened the 8-hour
ozone NAAQS from 0.08 to 0.075 ppm. The 0.075 ppm standard is referred
to as the 2008 ozone NAAQS and is more stringent than the previous 1997
ozone NAAQS. See 73 FR 16436 (March 27, 2008).\2\
---------------------------------------------------------------------------

    \1\ The ``criteria pollutants'' include ozone (O3),
particulate matter (PM), sulfur dioxide (SO2), nitrogen
dioxide (NO2), carbon monoxide (CO), and lead (Pb).
    \2\ On October 1, 2015, EPA strengthened the ground-level ozone
NAAQS to 0.070 ppm. See 80 FR 65292 (October 26, 2015). This
rulemaking addresses the 2008 ozone NAAQS and does not address the
2015 ozone NAAQS.
---------------------------------------------------------------------------

    On March 6, 2015, EPA issued a final rule addressing a range of
nonattainment area SIP requirements for the 2008 ozone NAAQS. 80 FR
12264. This final rule also revoked the 1997 ozone NAAQS and
established anti-backsliding requirements for areas not attaining the
1997 ozone NAAQS in 40 CFR 51.1105 that became effective once the 1997
ozone NAAQS was revoked. The anti-backsliding provisions require states
to retain all applicable control requirements for the 1997 ozone NAAQS,
while enabling states, where possible, to focus planning efforts on
meeting the more protective 2008 ozone NAAQS. According to EPA's final
rule, the revocation of the 1997 ozone NAAQS was effective as of April
6, 2015.
    On September 9, 2016, Virginia amended the Virginia Administrative
Code to be consistent with EPA's March 6, 2015 final rule. On February
10, 2017, Virginia, through the Virginia Department of Environmental
Quality (VADEQ), formally submitted a SIP revision (Revision G16)
reflecting these amendments.
    On August 17, 2017 (82 FR 39097 and 82 FR 39031), EPA
simultaneously published a notice of proposed rulemaking (NPR) and a
direct final rule (DFR) for Virginia approving the SIP revision. EPA
received two adverse comments on the rulemaking and attempted to
withdraw the DFR prior to

the effective date of October 16, 2017. However, EPA inadvertently did
not withdraw the DFR prior to that date and the rule automatically and
prematurely became effective on October 16, 2017, revising Virginia's
SIP to reflect the revocation of the 1997 ozone NAAQS. In the NPR, EPA
had proposed to approve the SIP revision, which included amendments
made to provisions in Virginia's State Air Pollution Control Board's
Regulations for the Control and Abatement of Air Pollution including
9VAC5-20-204, 9VAC5-30-55, 9VAC5-151-20, and 9VAC5-160-30. These
revisions to the Virginia Administrative Code amended Virginia's
regulatory provisions to reflect EPA's revocation of the 1997 ozone
NAAQS and the implementation of the 2008 ozone NAAQS. In this final
rulemaking, EPA is responding to the comments submitted on the proposed
revision to the Virginia SIP and is reapproving the revisions to the
Virginia SIP to reflect the revocation of the 1997 ozone NAAQS after
our failure to withdraw the DFR (after EPA received adverse public
comments) prior to the October 16, 2017 effective date of the DFR.

II. Summary of SIP Revision and EPA Analysis

    Virginia's February 10, 2017 SIP submittal included amended
versions of 9VAC5-20-204, 9VAC5-30-55, 9VAC5-151-20, and 9VAC5-160-30.
Virginia requested that EPA approve the SIP revision so that these
amended regulations would become part of the Virginia SIP. The
amendment to 9VAC5-20-204 added text stating that the list of Northern
Virginia moderate nonattainment areas under the 1997 ozone NAAQS is no
longer effective after April 6, 2015, the effective date of the
revocation of the 1997 ozone NAAQS. The amendment to 9VAC5-30-55 added
text stating that the primary and secondary ambient air quality
standard of 0.08 ppm shall no longer apply after April 6, 2015.
Virginia also amended the Regulation for Transportation Conformity and
the Regulation for General Conformity by adding clarifying text to
9VAC5-151-20 and 9VAC5-160-30 stating that ``The provisions of this
chapter shall not apply in nonattainment and maintenance areas that
were designated nonattainment or maintenance under a federal standard
that has been revoked.'' These revisions to the Virginia Administrative
Code reflect EPA's revocation of the 1997 ozone NAAQS.
    EPA's review of this material indicates the February 10, 2017
submittal is approvable as it revises regulations to be consistent with
EPA's final rule implementing the 2008 ozone NAAQS. See 80 FR 12264
(March 6, 2015). The revisions update regulations to reflect the
revocation of the 1997 NAAQS, which was effective April 6, 2015.
Therefore, the revisions do not affect emissions of air pollutants or
interfere with any applicable requirement concerning attainment or
reasonable further progress or any other applicable requirements in the
CAA. Thus, EPA finds the revision approvable in accordance with section
110, including section 110(l), of the CAA.

III. Public Comments and EPA's Responses

    EPA received two anonymous public comments on our action to approve
the February 10, 2017 SIP submittal.
    Comment: The first commenter stated that EPA cannot revoke the 1997
ozone NAAQS and cited a current court case in the United States Court
of Appeals for the District of Columbia Circuit (D.C. Circuit). The
commenter recommended that EPA wait until the D.C. Circuit's decision
and not ``loosen standards.''
    Response: EPA would like to clarify that the proposed revision to
the Virginia SIP does not revoke the 1997 ozone NAAQS as the 1997 ozone
NAAQS were revoked previously by EPA in a separate rulemaking effective
April 6, 2015. See 80 FR 12264. The commenter's ability to challenge
revocation of the 1997 ozone NAAQS was in that prior rulemaking. This
particular rulemaking action is only removing references to the
``revoked'' 1997 ozone NAAQS that had been in Virginia's SIP. Thus, the
commenter's statement that EPA should not revoke the 1997 ozone NAAQS
is not relevant to this rulemaking.
    EPA acknowledges that there is presently a legal challenge in the
D.C. Circuit to the rulemaking which revoked the 1997 ozone NAAQS.\3\
However, EPA disagrees with the commenter that EPA should wait for the
outcome of this litigation before approving the Virginia SIP revision.
As stated above, this SIP revision does not revoke the 1997 ozone NAAQS
as the revocation of the NAAQS was effective on April 6, 2015 per EPA's
March 6, 2015 rule. Additionally, nothing in section 110 of the CAA
prevents Virginia from removing its references to the revoked 1997
ozone NAAQS from its SIP, as the removal does not affect emissions of
air pollutants as it does not impact any applicable SIP requirements
that apply to an area, interfere with any applicable requirements in
the CAA, nor interfere with reasonable further progress. See section
110(l) of the CAA. Thus, EPA finds the revision approvable in
accordance with section 110, including section 110(l), of the CAA.
---------------------------------------------------------------------------

    \3\ South Coast Air Quality Management District v. EPA, Case
Nos. 15-1115, 15-1123 (U.S. Court of Appeals, D.C. Cir.).
---------------------------------------------------------------------------

    In response to the commenter's concern that EPA's approval will
``loosen standards,'' EPA notes that the 2008 ozone NAAQS of 0.075 ppm,
which EPA is presently implementing in collaboration with states such
as Virginia, is more protective of human health and the environment
than the 1997 ozone NAAQS of 0.08 ppm. In addition, the ozone
nonattainment areas in Virginia are the same for the 1997 ozone NAAQS
as for the 2008 ozone NAAQS. Thus, removing the revoked 1997 ozone
NAAQS from the Virginia SIP is not expected to have any emissions
impact nor interfere with reasonable further progress or any applicable
CAA requirement. See also 80 FR 12264.
    Comment Summary: The second commenter requested that EPA not revoke
the ozone NAAQS.
    Response: As discussed in detail in response to the first comment,
EPA's approval of the removal of references in the Virginia SIP to the
revoked 1997 ozone NAAQS does not actually revoke the 1997 ozone NAAQS
as EPA previously effectuated that revocation in a prior, separate
rulemaking. See 80 FR 12264.

IV. Final Action

    EPA is approving the Virginia SIP revision submitted on February
10, 2017, which includes amendments made to several sections of the
Virginia Administrative Code, including 9VAC5-20-204, 9VAC5-30-55,
9VAC5-151-20, and 9VAC5-160-30, as a revision to the Virginia SIP
because the revisions meet the requirements of CAA section 110. EPA is
reapproving the revisions to Virginia's SIP because the revisions were
added to the SIP prematurely on October 16, 2017 when EPA failed to
withdraw its DFR after receiving two adverse comments on our direct
final approval of the revisions to the Virginia SIP to reflect the
revocation of the 1997 ozone NAAQS. This rule, which responds to the
adverse comments received, finalizes our approval.

V. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations

performed by a regulated entity. The legislation further addresses the
relative burden of proof for parties either asserting the privilege or
seeking disclosure of documents for which the privilege is claimed.
Virginia's legislation also provides, subject to certain conditions,
for a penalty waiver for violations of environmental laws when a
regulated entity discovers such violations pursuant to a voluntary
compliance evaluation and voluntarily discloses such violations to the
Commonwealth and takes prompt and appropriate measures to remedy the
violations. Virginia's Voluntary Environmental Assessment Privilege
Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from
disclosure documents and information about the content of those
documents that are the product of a voluntary environmental assessment.
The Privilege Law does not extend to documents or information that: (1)
Are generated or developed before the commencement of a voluntary
environmental assessment; (2) are prepared independently of the
assessment process; (3) demonstrate a clear, imminent and substantial
danger to the public health or environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
federally authorized environmental programs in a manner that is no less
stringent than their federal counterparts. . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

VI. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the revisions
to 9VAC5-20-204, 9VAC5-30-55, 9VAC5-151-20, and 9VAC5-160-30 of the
State Air Pollution Control Board's Regulation for the Control and
Abatement of Air Pollution discussed in Section II of this preamble.
EPA has made, and will continue to make, these materials generally
available through http://www.regulations.gov and at the EPA Region III
Office (please contact the person identified in the For Further
Information Contact section of this preamble for more information).
These materials have been approved by EPA for inclusion in the SIP,
have been incorporated by reference by EPA into that plan, are fully
federally enforceable under sections 110 and 113 of the CAA as of the
effective date of the final rulemaking of EPA's approval, and will be
incorporated by reference by the Director of the Federal Register in
the next update to the SIP compilation.\4\
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    \4\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VII. Statutory and Executive Order Reviews

A. General Requirements

    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 approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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).
    The SIP is not approved to apply on any Indian reservation land as
defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as

specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

B. Submission to Congress and the Comptroller General

    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. EPA will submit a report containing this action 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).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 23, 2018. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action.
    This action to approve revised provisions of the Virginia
Administrative Code including 9VAC5-20-204, 9VAC5-30-55, 9VAC5-151-20,
and 9VAC5-160-30 for inclusion in the Virginia SIP may not be
challenged later in proceedings to enforce its requirements. (See
section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: February 9, 2018.
Cosmo Servidio,
Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (c) is amended by revising
the entries for Sections 5-20-204, 5-30-55, 5-151-20, and 5-160-30. The
revised text reads as follows:

Sec.  52.2420   Identification of plan.

* * * * *
    (c) * * *

                                                     EPA-Approved Virginia Regulations and Statutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                State                                    Explanation [former SIP
        State citation                           Title/subject                  effective date      EPA approval date                citation]
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         9 VAC 5, Chapter 20 General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Part II Air Quality Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
5-20-204......................  Nonattainment Areas...........................        11/16/16  2/22/18, [Insert Federal   Addition of Subdivision C.
                                                                                Register Citation].       Previous approval 8/14/15.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              9 VAC 5, Chapter 30 Ambient Air Quality Standards [Part III]
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
5-30-55.......................  Ozone (8-hour, 0.08 ppm)......................        11/16/16  2/22/18, [Insert Federal   Subdivision D. is revised to
                                                                                Register Citation].        read that the 1997 8-hour
                                                                                ozone NAAQS no longer apply
                                                                                after April 6, 2015.
                                                                                Previous approval 6/11/13.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     9 VAC 5, Chapter 151 Transportation Conformity
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Part II General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
5-151-20......................  Applicability.................................        11/16/16  2/22/18, [Insert Federal   Subdivision B. is amended to
                                                                                Register Citation].        address revoked federal
                                                                                standards.
                                                                                Previous approval 11/20/09.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         9 VAC 5, Chapter 160 General Conformity
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Part II General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
5-160-30......................  Applicability.................................        11/16/16  2/22/18, [Insert Federal   Subdivision A. is amended to
                                                                                Register Citation].        address revoked federal
                                                                                standards.
                                                                                Previous approval 12/12/11.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-03524 Filed 2-21-18; 8:45 am]
 BILLING CODE 6560-50-P


Dispute Resolution Services Arbitrator's Guide, https://www.finra.org/sites/default/files/arbitrators-ref-guide.pdf). The
proposed rule change is not modifying this practice.
    \329\ Id. at 6.
    \330\ Id.
    \331\ Id. This commenter also asked FINRA to develop a mechanism
to remove information from or redact records in its public
arbitration award database. Id. at 7-8. As FINRA has not proposed
rules related to the redaction or removal of information from that
database, this comment is outside the scope of this proposed rule
change.
---------------------------------------------------------------------------

    In response, FINRA acknowledged that the award may not reflect any
defense raised by respondents.\332\ However, FINRA stated that the
Codes permit arbitrators to include a rationale underlying the award to
provide

relevant context.\333\ In addition, FINRA stated that after a panel
dismisses a case at the conclusion of the case-in-chief, the firm must
file an amended Uniform Application for Securities Industry
Registration or Transfer (``Form U4'') for the associated person to
report the final disposition of the case as dismissed.\334\ FINRA
stated that along with the final disposition, an associated person can
provide a brief summary or add context on Form U4 regarding the
circumstances leading to the customer arbitration, as well as the
current status or final disposition.\335\ This updated information is
subsequently disclosed on the associated person's BrokerCheck report,
which is publicly available to investors.\336\
---------------------------------------------------------------------------

    \332\ See FINRA August Letter at 7.
    \333\ See id.; see also FINRA Rules 12904(f) and 13904(f).
    \334\ See FINRA August Letter at 7 (citing FINRA By-Laws,
Article V, Sections 2(c), 3(a) and 3(b)).
    \335\ See id. at 7 n.30.
    \336\ FINRA Rule 8312 (FINRA BrokerCheck Disclosure) governs the
information FINRA releases to the public through its BrokerCheck
system. Information available to investors through BrokerCheck
includes, among other things, information reported on the most
recently filed ``Registration Forms'' (with limited exceptions) for
both member firms and registered individuals, and summary
information about certain arbitration awards against the firm
involving a securities or commodities dispute with a public
customer; see also FINRA Rule 8312(b)(2)(A) (using the term
``Registration Forms'' to refer collectively to Form U4, the Uniform
Termination Notice for Securities Industry Registration (Form U5),
the Uniform Disciplinary Action Reporting Form (Form U6), the
Uniform Application for Broker-Dealer Registration (Form BD), and
the Uniform Request for Broker-Dealer Withdrawal (Form BDW)). The
BrokerCheck website is available at brokercheck.finra.org.
---------------------------------------------------------------------------

    The Commission believes that this proposed rule change should
promote transparency about FINRA's arbitration process and help ensure
consistent treatment of awards. Specifically, the proposed rule change
equally requires all arbitration awards, including awards granting a
motion to dismiss all claims, to be published. These published awards
should provide current and future parties to an arbitration with data
that could help inform the administration of their cases. The
Commission acknowledges the commenter's concern that a published award
granting a motion to dismiss all claims may not reflect any defense
raised by respondents. However, these concerns should be ameliorated by
the fact that the Codes permit arbitrators to include a rationale
underlying the award, providing relevant context to the dismissal of
the claim such as the circumstances under which the claim was
dismissed. In addition, an associated person may provide context on
Form U4 regarding the circumstances leading to the customer
arbitration, as well as the claim's current status or final
disposition. For these reasons, the Commission finds that this proposed
rule change is reasonably designed to protect investors and the public
interest.

IV. Conclusion

    For the reasons set forth above, the Commission finds that the
proposed rule change, as modified by Amendment No. 1, is consistent
with Section 15A(b)(6) of the Exchange Act, which requires, among other
things, that FINRA rules be designed to prevent fraudulent and
manipulative acts and practices, promote just and equitable principles
of trade, and, in general, protect investors and the public
interest.\337\
---------------------------------------------------------------------------

    \337\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    It is therefore ordered pursuant to Section 19(b)(2) of the
Exchange Act \338\ that the proposed rule change (SR-FINRA-2022-033),
as amended by Amendment No. 1, be, and hereby is, approved.
---------------------------------------------------------------------------

    \338\ 15 U.S.C. 78s(b)(2).
    \339\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\339\
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-19729 Filed 9-12-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28276-28277]
[FR Doc No: 2015-11820]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1439]

Adaptive Designs for Medical Device Clinical Studies; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Adaptive Designs for
Medical Device Clinical Studies; Draft Guidance for Industry and Food
and Drug Administration Staff.'' This guidance provides sponsors and
FDA staff with guidance on how to plan and implement adaptive designs
for clinical studies when used in medical device development programs.
An adaptive design for a medical device clinical study is defined as a
clinical trial design that allows for prospectively planned
modifications based on accumulating study data without undermining the
trial's integrity and validity. Adaptive designs, when properly
implemented, can reduce resource requirements and/or increase the
chance of study success. This draft guidance is not final nor is it in
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 17, 2015.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Adaptive Designs for Medical Device Clinical Studies; Draft Guidance
for Industry and Food and Drug Administration Staff'' to the Office of
the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Greg Campbell, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2110, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides sponsors and FDA staff with guidance on how
to plan and implement adaptive designs for clinical studies when used
in medical device development programs. This document addresses
adaptive designs for medical device clinical trials and is applicable
to premarket medical device submissions including premarket approval
applications, premarket notification (510(k)) submissions, de novo
submissions (evaluation of automatic class III designation),
humanitarian device exemption applications, and investigational device
exemption submissions. This guidance can be applied throughout the
clinical development program of a medical device, from feasibility
studies to pivotal clinical trials. This guidance does not apply to
clinical studies of combination products or codevelopment of a
pharmaceutical product with an unapproved diagnostic test.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the adaptive
design of clinical

studies for medical devices. 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
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Adaptive Designs for Medical
Device Clinical Studies; Draft Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number GUD1500005 to identify the guidance you
are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in 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, which have
been approved under 0910-0120; 21 CFR part 812, which have been
approved under 0910-0078; 21 CFR part 814, subparts A, B, and C, which
have been approved under OMB control number 0910-0231; and 21 CFR part
814, subpart H, which have been approved under OMB control number 0910-
0332.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: May 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11820 Filed 5-15-15; 8:45 am]
 BILLING CODE 4164-01-P