[Federal Register Volume 78, Number 50 (Thursday, March 14, 2013)]
[Proposed Rules]
[Pages 16205-16208]
[FR Doc No: 2013-05710]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2013-0102]
RIN 1625-AA08

Special Local Regulations; Dragging on the Waccamaw, Atlantic
Intracoastal Waterway; Bucksport, SC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish special local
regulations on the Atlantic Intracoastal Waterway in Bucksport, South
Carolina during the Outboard Drag Boat Association (ODBA) dragging on
the Waccamaw, a series of high-speed boat races. The event is scheduled
to take place on 11:00 a.m. Saturday, June 22, 2013, through 7:30 p.m.
Sunday, June 23, 2013. Approximately 50 high-speed race boats are
anticipated to participate in the races. These special local
regulations are necessary to provide for the safety of life and
property on navigable waters of the United States during the event.
These special local regulations would temporarily restrict vessel
traffic in a portion of the Atlantic Intracoastal Waterway. Persons and
vessels that are not participating in the races would be prohibited
from entering, transiting through, anchoring in, or remaining within
the restricted area unless authorized by the Captain of the Port
Charleston or a designated representative.

DATES: Comments and related material must be received by the Coast
Guard on or before April 30, 2013. Requests for public meetings must be
received by the Coast Guard on or before April 15, 2013.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries

accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

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

SUPPLEMENTARY INFORMATION:

Table of Acronyms

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

A. Public Participation and Request for Comments

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

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2013-0102] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2013-0102) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

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

4. Public Meeting

    We do not now plan to hold a public meeting, but you may submit a
request for one on or before April 15, 2013 using one of the four
methods specified under ADDRESSES. Please explain why you believe a
public meeting would be beneficial. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register. For information on facilities or
services for individuals with disabilities or to request special
assistance at the public meeting, contact the person named in the FOR
FURTHER INFORMATION CONTACT section, above.

B. Basis and Purpose

    The legal basis for the proposed rule is the Coast Guard's
authority to establish special local regulations: 33 U.S.C. 1233. The
purpose of the proposed rule is to ensure safety of life and property
on the navigable waters of the United States during the ODBA Dragging
on the Waccamaw boat races.

C. Discussion of Proposed Rule

    On Saturday, June 22, 2013, and Sunday, June 23, 2013 the Outboard
Drag Boat Association (ODBA) will host ``Dragging on the Waccamaw,'' a
series of high-speed boat races. The event will be held on a portion of
the Atlantic Intracoastal Waterway in Bucksport, South Carolina.
Approximately 50 high-speed race boats are anticipated to participate
in the races.
    The proposed rule would establish a special local regulation that
encompass certain waters of the Intracoastal Waterway in Bucksport,
South Carolina. The special local regulation would be enforced daily
from 10:30 a.m. until 7:30 p.m. on June 22, 2013 through June 23, 2013.
The special local regulation would consist of a regulated area around
vessels participating in the event. The regulated area would be as
follows: All waters of the Atlantic Intracoastal Waterway encompassed
within an imaginary line connecting the following points; starting at
point 1 in position 33[deg]39'11.46'' N 079[deg]05'36.78'' W; thence
west to point 2 in position 33[deg]39'12.18'' N 079[deg]05'47.76'' W;
thence south to point 3 in position 33[deg]38'39.48'' N
079[deg]05'37.44'' W; thence east to point 4 in position
33[deg]38'42.3'' N 079[deg]05'30.6'' W; thence north back to origin.
All coordinates are North American Datum 1983. Persons and vessels,
except those participating in the race, would be prohibited from
entering, transiting through, anchoring, or remaining within the
regulated area unless specifically authorized by the Captain of the
Port Charleston or a designated representative. Persons and vessels
would be able to request authorization to enter, transit through,
anchor in, or remain within the regulated area by contacting the
Captain of the Port Charleston by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16. If authorization
to enter, transit through, anchor in, or remain within the regulated
area is granted by the Captain of the Port Charleston or a designated
representative, all persons and vessels receiving such authorization
would be required to comply with the instructions of the Captain of the
Port Charleston or a designated representative. The Coast Guard would
provide notice of the regulated areas by Local Notice to Mariners,
Broadcast Notice to Mariners,

and on-scene designated representatives.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

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

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that
this proposed rule would not have a significant economic impact on a
substantial number of small entities. This rule may affect the
following entities, some of which may be small entities: The owners or
operators of vessels intending to enter, transit through, anchor in, or
remain within that portion of the Atlantic Intracoastal Waterway
encompassed within the regulated area from 10:30 a.m. until 7:30 p.m.
on June 22, 2013 and June 23, 2013. For the reasons discussed in the
Regulatory Planning and Review section above, this proposed rule would
not have a significant economic impact on a substantial number of small
entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

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

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

5. Federalism

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

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children From Environmental Health Risks

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

11. Indian Tribal Governments

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

12. Energy Effects

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

13. Technical Standards

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

14. Environment

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

List of Subjects in 33 CFR Part 100

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

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

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

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

    Authority:  33 U.S.C. 1233.

0
2. Add a temporary Sec.  100.35T07-0102 to read as follows:

Sec.  100.35T07-0102  Special Local Regulations; ODBA Dragging on the
Waccamaw, Atlantic Intracoastal Waterway, Bucksport, SC.

    (a) Regulated area. The rule establishes a special local regulation
on certain waters of the Atlantic Intracoastal Waterway in Bucksport,
South Carolina. The special local regulation will consist of a
regulated area which will be enforced daily from 10:30 a.m. until 8:00
p.m., on June 22, 2013 and June 23, 2013. The special local regulation
would consist of a regulated area around vessels participating in the
event. The following location is a regulated area: All waters of the
Atlantic Intracoastal Waterway encompassed within an Imaginary line
connecting the following points; starting at point 1 in position
33[deg]39'11.46'' N 079[deg]05'36.78'' W; thence west to point 2 in
position 33[deg]39'12.18'' N 079[deg]05'47.76'' W; thence south to
point 3 in position 33[deg]38'39.48'' N 079[deg]05'37.44'' W; thence
east to point 4 in position 33[deg]38'42.3'' N 079[deg]05'30.6'' W;
thence north back to origin. All coordinates are North American Datum
1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Charleston in the enforcement of the regulated
areas.
    (c) Regulations.
    (1) All persons and vessels, except those participating in the
Dragging on the Waccamaw, or serving as safety vessels, are prohibited
from entering, transiting through, anchoring in, or remaining within
the regulated area. Persons and vessels desiring to enter, transit
through, anchor in, or remain within the regulated area may contact the
Captain of the Port Charleston by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16, to request
authorization. If authorization to enter, transit through, anchor in,
or remain within the regulated area is granted by the Captain of the
Port Charleston or a designated representative, all persons and vessels
receiving such authorization must comply with the instructions of the
Captain of the Port Charleston or a designated representative.
    (2) The Coast Guard will provide notice of the regulated area by
Marine Safety Information Bulletins, Local Notice to Mariners,
Broadcast Notice to Mariners, and on-scene designated representatives.
    (d) Enforcement Date. This rule will be enforced daily from 10:30
a.m. until 8:00 p.m. on June 22, 2013 through June 23, 2013.

    Dated: March 1, 2013.
M.F. White,
Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2013-05710 Filed 3-13-13; 8:45 am]
BILLING CODE 9110-04-P


SUPPORTING STATEMENT FOR THE

RENEWABLE FUELS STANDARD (RFS2) PROGRAM (FINAL RULE)

A.	JUSTIFICATION

1.	Identification of the Information Collection

a.	Title:  Renewable Fuels Standard (RFS2) Program, EPA ICR No. 2333.02,
OMB Control Number 2060-NEW.

b. 	Short characterization:

	The Energy Policy Act (EPAct) of 2005 amended the Clean Air Act,
section 211(o), and required the existing RFS program.  The existing RFS
program is referred to in this supporting statement as "RFS1". The RFS1
program started in 2006 and was covered by EPA ICR No. 2242.02, OMB
Control Number 2060-0600. Please refer to “Regulation of Fuels and
Fuel Additives: Renewable Fuel Standard Program – Notice of Proposed
Rulemaking” and “Regulation of Fuels and Fuel Additives: Renewable
Fuel Standard Program – Final Rule” (both available in docket number
EPA-HQ-OAR-2005-0161) for a detailed discussion of the RFS1 program.

	The Energy Independence and Security Act (EISA) of 2007 further amends
the Clean Air Act, section 211(o), and has required EPA to propose new
regulations for renewable fuels.  The new RFS program is referred to in
this supporting statement as "RFS2."  Under RFS2, the volume requirement
and types of renewable fuels are expanded; non-road uses are included
(RFS1 only affected motor vehicle fuel); there are additional types of
waivers and special provisions for renewable fuel types; and EPA will
implement an EPA-Moderating Transaction System (EMTS) for RINs.
Additional parties will be required to register, keep records, and
report.  Please refer to the Final Rule (available in docket number
EPA-HQ-OAR-2005-0161) for a detailed discussion of the RFS2 program.

For compliance purposes, under both RFS1 and RFS2, volumes of renewable
fuel are identified through the use of renewable identification numbers
(RINs) that are initially generated by the producer of the renewable
fuel.  However, under RFS2, there are additional types of RINs and the
volume of RINs traded is expected to be greater.

	This supporting statement provides tables that break down reporting
items by party (e.g. producer, importer, refiner, etc.)  Parties who are
interested in recordkeeping and reporting burden will want to review the
tables containing our estimates carefully.  The RFS2 program includes
provisions for EMTS for RINs, which was not a feature of RFS1.  It also
includes third-party disclosure provisions applicable to biofuel
feedstock producers , who were not covered by recordkeeping and
reporting under RFS1.

	The Regulatory Impact Analysis (RIA), which was prepared for the Final
Rule, has been placed in the public docket.  This document was consulted
to provide additional detailed information about the regulated universe
(see Chapter 1 of the draft RIA).  We also considered the actual number
of reporting parties under RFS1 and similar reporting programs.

2.  Need For, and Use of, the Collection

Authority for the Collection

	  SEQ CHAPTER \h \r 1 Sections 114 and 208 of the Clean Air Act (CAA),
42 U.S.C. §§ 7414 and 7542, authorize EPA to require recordkeeping and
reporting regarding enforcement of the provisions of Title II of the
CAA.

	b. 	Practical Utility/Uses of the Data

	The recordkeeping and reporting requirements of this regulation will
allow EPA to monitor compliance with the RFS program.

3.  Non-duplication, Consultation, and other Collection Criteria

	a. 	Non-duplication

	  SEQ CHAPTER \h \r 1 Efforts have been made to eliminate duplication
in this information collection.

b. 	Public Notice

	EPA sought comment on reporting requirements via the NPRM.  We also
docketed a copy of our draft ICR supporting statement based upon the
NPRM.

	c. 	Consultations

	We have drawn upon our experience with RFS1 and with similar fuels
regulations to develop the estimates in this supporting statement.
Interested parties may also be interested in reviewing "Chapter 1 –
Industry Characterization" of the draft Regulatory Impact Analysis (RIA)
available in the public docket.  Some assumptions from the RIA were used
for this supporting statement.

	d. 	Effects of Less Frequent Data Collection

	We have designed the reporting schedule to coincide with existing
reporting deadlines applicable to many of the same parties under such
programs as RFG and anti-dumping and diesel fuel.  Less frequent
collection of data would make it impossible to carry out the provisions
of the CAA and EISA.

	e. 	General Guidelines

	This rule does not exceed any of the OMB guidelines.

	f. 	Confidentiality

	We inform respondents that they may assert claims of business
confidentiality (CBI) for information they submit. Under RFS2, actual
RINs should not be treated as confidential business information under
RFS2, as they are necessary identifiers to accompany renewable fuels.
Any information claimed as confidential will be treated in accordance
with 40 CFR Part 2 and established Agency procedures.  Information that
is received without a claim of confidentiality may be made available to
the public without further notice to the submitter under 40 CFR §
2.203.

g. 	Sensitive Information

	This information collection does not require submission of any
sensitive information.

4.	The Respondents and the Information Requested

	a.	Respondents/with NAICS and SIC Codes

  SEQ CHAPTER \h \r 1 The respondents to this information collection
fall into the following general industry categories:  petroleum
refineries (324110/2911), ethyl alcohol manufacturers (325193/2869),
other basic organic chemical manufacturing (325110/2869), chemical and
allied products merchant wholesalers (426990/5169), petroleum bulk
stations and terminals (422710/5171), petroleum and petroleum products
merchant wholesalers (422720/5172), and other fuel dealers
(454319/5989).

	Using the terminology associated with the RFS2 Final Rule, we have
assumed the following classes of party, with the number of each in
parenthesis:

Producers of renewable fuels (1010, of which 310 are biodiesel
producers)

Importers (120)

Obligated Parties (450, of which 400 are refineries and 50 exporters)

Parties who own RINs (1500)

Foreign Refiners (10)

Foreign RIN Owners (5)

[Note:  The above estimates are derived from the number of registered
parties as of December 17, 2009, rounded up.  The number of biodiesel
producers is the number registered as of January 11, 2010, rounded up.]

For biofuel feedstock producers, we have assumed the following classes
of party, with the number of each in parenthesis:

1,000,000 plantation and private forest owners

30,966 foreign biofuel feedstock producers

[Note:  The above estimates are derived from the following sources:  A
presentation given by Brent Butler, United States Forest Service,
entitled “Private Forest Owners:  Past Present, and Future,” dated
October 23-27, 2009 estimates a 10,000,000 population of plantation and
private forest owners.  We have assumed 10% participation in RFS2.  We
estimated the number of foreign biofuel feedstock producers to be
30,000, which is 3% of the total of domestic feedstock producers (i.e.,
3% of 1,000,000.)]

	This supporting statement includes estimates reporting involving
biofuel feedstock producers, who must provide certain information about
their feedstocks and source to biofuel producers and to EPA upon
request.  The RFS2 final rule contains provisions requiring
recordkeeping/reporting and the mapping of certain plots of land (e.g.
generating a Google map or similar representation), based upon an
aggregate baseline approach.  Although we expect that this could lead to
future burden on the part of certain biofuel producers who use croplands
 (i.e., farmers), we do not expect that any party will be required to
engage in recordkeeping and reporting activities under this provision
until the fourth year of the program or later.  Therefore, we have not
provided an estimate related to this provision, since it is not expected
to result in any cost during the three year period covered by this ICR.
Estimates for future recordkeeping and reporting will be provided when
the recordkeeping and reporting is expected to occur.

	b.	Information Requested

		A)	Reporting:  The individual reports required from regulated parties
are described in the preamble.  The following reports are required by
the Final Rule:  annual compliance reports (obligated parties only),
quarterly reports regarding generation and assignment of RINs (producers
and importers only), quarterly RIN reports summarizing transactions and
activity, and “real time” RIN transactional activity reporting
within EMTS.  Reporting items include registration of parties engaged in
activities covered by the RFS2 regulation and reporting related to
transactions involving RINs and associated volumes of fuel.

The exact reports filed will depend upon the activity engaged in by the
party. A party must file reports appropriate for each activity it
engages in – for example, if a party is both an exporter of renewable
fuel and a producer of renewable fuel, then that party must file the
reports applicable to both activities.

In the Final Rule, we establish hat “real time” reporting within
EMTS will be construed as within five (5) business days of a reportable
event (e.g. generation and assignment of RINs, transfer of RINs).  This
means that some parties may elect to “batch” real time reports,
similar to how businesses batch credit card transactions at the end of
the day.  We estimate that an average party would report daily,
resulting in 365 instances of reporting in EMTS per year.  These
estimates are reflected in the tables below.

Quarterly reports are due as follows:

Quarterly Reporting Schedule for RFS2 Program

Quarter Covered by Quarterly Report	Due Date for Quarterly Report

January - March	May 31

April - June	August 31

July - September	November 30

October - December	February 28

Annual reports are due on February 28 for the preceding year.

For some reports, e.g. involving biofuel feedstock producers (see Table
VII), the frequency of reporting is “on occasion” (i.e., when a
transaction requiring disclosure occurs).  As discussed above, for EMTS
purpose, we have assumed one instance of reporting per day for each day
of the year. (i.e., 365 instances of reporting).

Tables I - VII estimate the recordkeeping and reporting burden by party.
 We will provide respondents the opportunity to engage in simplified,
secure, electronic reporting via the Agency's Central Data Exchange
(CDX) and its exchange network protocol.  An attachment explaining the
exchange network protocol is provided with this supporting statement.
Respondents must keep copies of all reports filed for five (5) years.

		B)	Recordkeeping: Respondents must retain underlying records related
to reports they file for five (5) years.  This period is consistent with
other fuels programs and with customary business practices (CBP) for the
industry.  Respondents must transfer volumes of fuel with product
transfer documentation or bills of lading, which is already done in the
course of business. However, parties will have to actually develop and
include new codes on product transfer documents and this supporting
statement includes estimates for that burden.

5.  The Information Collected, Agency Activities, Collection
Methodology, and Information Management

a.	Agency Activities

All reports and registrations will be reviewed by EPA for completeness
and for potential violations.

Potential violations will be referred to enforcement personnel.

Registration numbers will be issued for new registrants.

Contacting reporting parties if there is a problem with their
submission.

b. 	Collection and Methodology and Management

	We anticipate receiving data in a simplified and secure fashion via the
Agency's CDX.  Information claimed as CBI will be stored in
appropriately controlled areas.

c.	Small Entity Flexibility

	This collection will not adversely affect small entities.  The Final
Rule describes flexibility provisions available to small entities.

d.	Collection Schedule

	Registrations are received on a rolling basis, as updates may be sent
in at any time and new parties may enter the regulated industry at any
time.   Reporting is as-needed, monthly, quarterly, and annual.

6.	Estimating the Burden and Cost of Collection

a.	Estimating the Respondent Universe

	We drew upon experience implementing similar regulations among the same
entities to develop estimates of the burden associated with this
collection.

b.	Estimating the Respondent Burden and Cost

	Three labor categories are involved:  managerial (includes legal and
professional review), technical, and clerical. The estimates use the
Bureau of Labor Statistics figures from "Employer Costs for Employee
Compensation - Table 12 - Private Industry, Manufacturing, and
Non-Manufacturing Industries by Occupational Group” (December 2003),
with a 3% annual inflation factor applied to bring the values to the
present.  Using this method, the following wages and benefits apply by
category:

Wages and Benefits

Managerial 		$53.87 per hour

Technical		$35.29 per hour

Clerical		$24.56 per hour

Doubling for company overhead beyond wages and benefits, and for
convenience, rounding up to the dollar, gives the following rates for
this ICR:

Total Employer Cost

Managerial		$108 per hour

Technical		$71 per hour

Clerical		$49 per hour

It is assumed that for each hour of activity the mix will be about 0.1
hour managerial, 0.7 hour technical, and 0.2 hour clerical.  This gives
an average labor cost of $71 per hour, which will be used in this ICR.
For purchased services related to attest engagements and some items of
registration, we have doubled this hourly cost to $142 in order to more
accurately reflect the cost of a certified public accountant's (CPA) or
licensed professional engineer's (PE) services.

c.  	Estimating the Agency Burden and Cost

	EPA must generate company and facility registration number(s) for new
registrants and notify them of these numbers, which must appear on
reports. Report formats and instructions/guidance must be prepared by
Agency personnel.  Reports will be processed by contractors and must be
reviewed by Agency personnel.  Reporting parties must be contacted if
there is a problem with their submission.

	We anticipate that many of our activities related to RFS2 will be
similar to that of RFS1.  We have not yet developed forms for RFS2, but
have attached RFS1 forms which will be used in the first year of RFS2.
The RFS2 reporting templates would not be very different, except that
reporting would include four types, rather than one type, of RIN.  We
have provided RFS1 reporting templates as an attachment to this
document.

This supporting statement considers costs associated with accepting new
registrants and new reports associated with RFS2. Using the RFS1, and
the RFG and anti-dumping ICR, and other recent fuels-related ICRs as a
guide in developing these initial estimates for RFS, we anticipate that
RFS2 may require the equivalent labor of one full time GS-13 technical
employees for a total of $161,000, and labor costs of $76,000 in the
clerical category and $28,000 in the management category.  Since we are
using the CDX, some costs incurred by the Agency will be tied to the
number of registrants who send us reports.  Specifically, there is an
annual "subscription cost" associated with the use of CDX that is passed
on to the EPA program office and we estimate that registrants due to
RFS2 will cost our office approximately $200,000 per year in 2010, 2011
and 2012.  We anticipate $266,666 in annual contract costs related to
registration and reporting activities.  We anticipate IT development and
testing costs at $2,200,000 divided by three years to yield an annual
cost of $733,333.  Adding the following values results in an annual
estimated Agency burden as follows:

One GS-13 technical employee (full time)  = 	$161,000

One GS-7 clerical worker (half time) 	 = 	   76,000

One GS-15 manager (1/8 time) 	 = 		   28,000

Annual CDX subscription fee = 			  200,000

Annual contract costs = 				  266,666

Testing and development= 				 733,333

TOTAL = 						$1,464,999

  As with all items in this supporting statement, we strongly encourage
comment on the estimated Agency burden and on the Agency activities
associated with this proposed information collection.

d.	Estimating the Respondent Universe

	We were able to estimate the number of regulated entities drawing upon
experience regulating the same or similar entities.

e.	Bottom Line Burden Hours and Costs

	From the tables, we estimate the following totals:

TOTAL NO. OF RESPONDENTS:    	1,060,026

TOTAL NO. OF RESPONSES:		4,781,126

TOTAL BURDEN HOURS:    	    	1,485,008

TOTAL COST TO RESPONDENTS:  	$ 112,877,105

f.	Reason for Change in Burden

	The change in burden is due to regulations that give effect to the EISA
provisions for RFS2.

g.	Burden Statement

	The annual public reporting and recordkeeping burden for this
collection of information is estimated to be 3.2 hours per response (the
total number of responses divided by the total hours).  Burden means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or for
a Federal agency.  This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.  An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number.  The OMB control
numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR
chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID number
EPA-HQ-OAR-2005-0161, which is available for online viewing at
HYPERLINK "http://www.regulations.gov" www.regulations.gov , or in
person viewing at the Air Docket in the EPA Docket Center in Washington,
DC (EPA/DC).  The docket is located in the EPA West Building, 1301
Constitution Avenue, NW, Room 3334, and is open from 8:30 a.m. to 4:30
p.m., Eastern Standard Time, Monday through Friday, excluding legal
holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Air Docket is<PHONE_NUMBER>.

	You may use www.regulations.gov to submit or view public comments,
access the index listing of the contents of the public docket, and to
access those documents in the public docket that are available
electronically.  When in the system, select “search,” then key in
the Docket ID Number EPA-HQ-OAR-2005-0161.  Also, you can send comments
to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, D.C. 20503,
Attention: Desk Officer for EPA.  Please include the EPA Docket ID
Number EPA-HQ-OAR-2005-0161 and OMB Control Number 2060-NEW in any
correspondence.

.

  These estimates are derived from "OPM Salary Table 2006-DCB,"
effective January 2006.  This table may be found at
http://www.opm.gov/oca/06tables/indexGS.asp.  The extreme of step 10 was
assumed for all categories.  We have assumed a half-time GS-7 clerical
worker, one full-time GS-13 technical worker, and a GS-15 manager
working one-eighth of his/her time managing this project (0.125).  All
values were multiplied by 1.6 (which is a common factor utilized in ICRs
to account for overhead costs). We rounded the resulting dollar value to
the nearest thousand.  This cost is per year.

 PAGE


Technical Support Document (TSD)

For the Modeling and Weight of Evidence (WOE) Portions of the Document
Entitled “Revision to the Allegheny County Portion of the Pennsylvania
State Implementation Plan Attainment Demonstration for the
Liberty-Clairton PM2.5 Nonattainment Area”

April 2011

TSD Prepared October 2011

Timothy A. Leon Guerrero

Office of Air Monitoring & Analysis, 3AP40

U.S. Environmental Protection Agency, Region 3

1650 Arch Street

Philadelphia, Pennsylvania 19103

/s/

____________________________________________

Reviewed by Andrew Hass, Acting Associate Director

Office of Air Monitoring & Analysis (3AP40)

October 24, 2011

_________________

Date Signed

Purpose of the Technical Support Document

This Technical Support Document (TSD) describes the Environmental
Protection Agency’s (EPA’s) evaluation of the modeling and
Weight-of-Evidence (WOE) portions of Pennsylvania’s State
Implementation Plan (SIP) entitled “Attainment Demonstration for the
Liberty-Clairton PM2.5 Nonattainment Area”.

The Liberty-Clairton, PA PM-2.5 nonattainment area is comprised of a
small portion of Allegheny County that includes the boroughs of
Glassport, Liberty, Lincoln, Port Vue, and the City of Clairton (see
figure below).  The area was designated as nonattainment for the 1997
PM-2.5 National Ambient Air Quality Standard (NAAQS) in the January 5,
2005 Federal Register [70 FR 944], effective April 5, 2005.

EPA requires states with nonattainment areas to submit an attainment
demonstration and associated air-quality modeling, adopted state
regulations to reduce emissions of PM-2.5 and its precursors, and other
supporting information demonstrating that the area will attain the
standards as expeditiously as practical.  The Allegheny County Health
Department (ACHD) prepared its PM-2.5 SIP in cooperation with the
Pennsylvania Department of Environmental Protection to comply with the
CAAA of 1990 and with EPA requirements for the nonattainment area as
stated in EPA’s 2005 designation of the PM-2.5 nonattainment area and
EPA’s Clean Air Fine Particle Implementation Rule [72 FR 20586,
25APR2007].

The purpose of this TSD is to provide more detailed information than can
be contained in the official notice published in the Federal Register.
Readers who need more information than we provide in this TSD or want to
review the modeling should consult the ACHD’s Revision to the
Allegheny County Portion of the Pennsylvania State Implementation Plan
(April 2011) for the Liberty-Clairton, PA PM-2.5 nonattainment area.

The Regulatory Framework

EPA established the PM-2.5 NAAQS on July 18, 1997 (62 FR 36852).  This
included an annual PM-2.5 standard of 15.0 µg/m3 based on an annual
arithmetic mean, averaged over 3 years, and a 24-hour (or daily)
standard of 65 µg/m3 based on a 3-year average of the 98th percentile
of 24-hour concentrations. These standards were decided upon after
reviewing numerous health studies demonstrating that serious health
effects are associated with exposures to PM-2.5.

Following promulgation of a new or revised NAAQS, EPA is required by the
CAA to designate areas throughout the United States as attaining or not
attaining the NAAQS.  This designation process is described in section
107(d)(1) of the CAA.  In 1999, EPA and state air-quality agencies
initiated the monitoring process for the 1997 PM-2.5 NAAQS, and, by
January 2001, established a complete set of air-quality monitors. On
January 5, 2005, EPA published initial air-quality designations for the
1997 PM-2.5 NAAQS (70 FR 944), based on air-quality monitoring data for
calendar years 2001-03.

The nonattainment designation for an area starts the process whereby a
state or tribe must develop an implementation plan that includes, among
other things, a demonstration showing how it will attain the ambient
standards by the attainment dates required in the CAA.  Under section
172(b), states have up to three years after the EPA’s final
designations to submit their SIPs to EPA.  These SIPs were due on April
5, 2008, three years from the effective date of the designations.

Section 172(a)(2) of the Act requires states to attain the standards as
expeditiously as practicable but within 5 years of designation (i.e.
attainment date of April 5, 2010 based on air quality data for
2007–09), or within up to 10 years of designation (i.e. to April 2015)
if the EPA Administrator extends an area’s attainment date by 1–5
years based upon the severity of the nonattainment problem or the
feasibility of implementing control measures.

Introduction to the Liberty-Clairton, PA PM-2.5 State Implementation
Plan

Pennsylvania’s SIP for the Liberty-Clairton, PA PM-2.5 nonattainment
area outlines plans to reduce emissions that contribute to PM-2.5
nonattainment.  The SIP includes a modeling demonstration that is used
to show that the Liberty-Clairton area will meet the 1997 annual PM-2.5
standard as expeditiously as practical.  The Liberty-Clairton
nonattainment area has some of the highest annual and 24-hour design
values in the United States.  This TSD reviews the modeling and WOE
portions of Pennsylvania’s SIP for the Liberty-Clairton, PA PM-2.5
nonattainment area.

ase year design values (2000-02) were 21.4 μg/m3 for the annual NAAQS
and 63 μg/m3 24-hour NAAQ at the Liberty monitor.

What Are The Components Of A Modeled Attainment Demonstration?

Modeling Process Overview

EPA’s Guidance on the Use of Models and Other Analyses for
Demonstrating Attainment of Air Quality Goals for Ozone, PM2.5, and
Regional Haze (2007) describes how to construct a model attainment
demonstration.  The air quality modeling used in the Liberty-Clairton
area’s attainment demonstration consisted of two components; a
regional photochemical grid model and a local-scale model with
sufficient resolution to examine the impacts of local emission sources.
Model results were used in a “relative” rather than “absolute”
sense.  Following this methodology the ratio of the model’s future to
current (baseline) predictions at both of the nonattainment area’s
PM-2.5 monitors determines if the Liberty-Clairton SIP’s proposed
local and regional emission controls are likely to lead to compliance
with the 1997 PM-2.5 NAAQS.

The Liberty-Clairton modeling demonstration used a regional
photochemical grid model (CMAQ) for part of its modeling demonstration.
Baseline and future CMAQ modeling scenarios were run by the Bureau of
Air Quality Analysis and Research Division of Air Resources New York
State Department of Environmental Conservation with emissions
information compiled by the Mid-Atlantic/Northeast Visibility Union
Regional Planning Organization (MANE-VU).  CMAQ provided results for the
chemically reactive PM-2.5 species such as sulfates and nitrates.

Local sources in the Liberty-Clairton nonattainment area create steep
gradients in the PM-2.5 concentrations.  These gradients cannot be
properly resolved in CMAQ whose model grid cells are roughly twelve
square kilometers.  Local scale meteorology is also not well simulated
by the regional model due to steep topography within the nonattainment
area that often contributes to strong temperature inversions and complex
flow patterns within the valleys. A local-scale model, CALPUFF, was used
in the attainment demonstration to better gauge the local impacts of
direct PM-2.5 emissions and provide some meteorological enhancements
within the nonattainment area.  ACHD was responsible for running
CALPUFF.

Steps Required in a Modeled Attainment Demonstration

EPA guidance encourages states to take certain steps when preparing a
modeling analysis to demonstrate attainment of the PM-2.5 NAAQS.
Recommendations include the following nine steps:

Formulate a conceptual description of an area’s nonattainment problem.

Develop a modeling/analysis protocol.

Select an appropriate air quality model to use.

Select appropriate meteorological episodes to model.

Choose a modeling domain with appropriate horizontal and vertical
resolution and establish the initial and boundary conditions to be used.

Generate meteorological and air quality inputs to the air quality model.

Generate emissions inputs to the air quality model.

Evaluate performance of the air quality model and perform diagnostic
tests, as necessary.

Perform future year modeling (including additional control strategies,
if necessary) and apply the attainment test.

How Did Allegheny County Address All of the Modeled Attainment
Demonstration Components?

ACHD’s PM-2.5 SIP for the Liberty-Clairton, PA PM-2.5 nonattainment
area addressed all of the modeled attainment demonstration elements.
Each of these elements will be discussed in the following sections.

Conceptual Description of the Problem

"Particulate matter," also known as particle pollution or PM, is a
complex mixture of extremely small particles and liquid droplets.
Particle pollution is made up of a number of components, including acids
(such as nitrates and sulfates), organic chemicals, metals, and soil or
dust particles.  Particle pollution exposure is linked to a variety of
health problems, including increased respiratory symptoms, such as
irritation of the airways, coughing, or difficulty breathing, decreased
lung function, aggravated asthma, development of chronic bronchitis,
irregular heartbeat, nonfatal heart attacks, and premature death in
people with heart or lung disease.

ACHD’s conceptual description of its PM-2.5 nonattainment problem is
detailed in Appendix C (Modeling Protocol) of its SIP document.  Two
additional reports prepared by the ACHD are included in Appendix E
present data from two speciated PM-2.5 monitors in Allegheny County.

The Liberty-Clairton Area is made up of complex river valley terrain
encompassing an area roughly three by five miles in size.  It includes a
four mile winding portion of the Monongahela River south of the City of
Pittsburgh and is bordered on the east by the Youghiogheny River. The
area includes rural land interspersed with densely populated residential
areas and industrial facilities.

There are significant differences in terrain elevations within the
nonattainment area; river valley elevations average just over 700 feet
above mean sea level while adjacent hilltops can rise up to 1250 feet.
Under weak synoptic forcing these sharp elevation differences can
generate strong nocturnal temperature inversions.  Temperature
differences between the valley floors and nearby hilltops can range from
2 to 7° F under these conditions.  Cold air drainage flows often occur
during these periods of strong nocturnal cooling.  Under these
circumstances air flows within the valleys can become quite complex with
down slope flows reaching 3-4 mph and wind directions veering up to
180° within each valley’s vertical profile.

Episodes of poor air quality often occur within the Liberty-Clairton, PA
PM-2.5 nonattainment area during periods of strong nocturnal inversions.
 Under these conditions, air dispersion is often minimized allowing
emissions to “build up” within the river valleys contributing to
episodes of poor air quality, which lead to the nonattainment area’s
high PM-2.5 design values.  On some occasions PM-2.5 concentrations
within the Liberty-Clairton area are significantly higher than
concentrations in the nearby City of Pittsburgh.  These differences in
air quality are one of the reasons why the Liberty-Clairton, PA PM-2.5
nonattainment area was separated from the surrounding Pittsburgh-Beaver
Valley, PA PM-2.5 nonattainment area.

ACHD performed source apportionment modeling for the Liberty and
Lawrenceville monitors in Allegheny County using the Positive Matrix
Factorization Model (PMF Version 1.1).  The monitors are approximately
eleven miles apart from each other with the Liberty monitor located in
the Liberty-Clairton area and the Lawrenceville monitor located to the
north near Pittsburgh.

Local impacts were gauged by comparing both monitors’ speciation data
with each other using PMF.  ACHD’s analysis found that the Liberty
monitor’s PM-2.5 concentrations are impacted by regional loading
(mainly sulfates) based on similarities in both monitor’s speciation
data.  Sources near the Liberty monitor, both stationary and mobile,
were thought to be responsible for the speciation differences observed
between two Allegheny County monitors.  On peak concentration days at
Liberty, carbons and ammonium are prominent species while chorine is
more prominent on cold-weather peak days.

Models Used in the Attainment Demonstration

ACHD utilized two models in its attainment demonstration; a regional
photochemical grid model used to simulate regional PM-2.5 concentrations
and a local scale model used to simulate the effects of local sources of
direct PM-2.5 emissions.

The photochemical grid model used in ACHD’s modeling demonstration is
the CMAQ (version 4.5.1) model with CB4 chemistry, aerosol module for
PM-2.5 and RADM cloud scheme.  Photochemical modeling was performed by
the Bureau of Air Quality Analysis and Research, New York State
Department of Environmental Conservation (DEC).

The CMAQ modeling system has been designed to approach air quality as a
whole by including state-of-the-science capabilities for modeling
multiple air quality issues, including tropospheric ozone, fine
particles, toxics, acid deposition, and visibility degradation.  This
system includes input from both meteorological and emissions models,
which are detailed in the following sections.

EPA recommends using air-quality models such as CMAQ in a “relative”
rather than “absolute” sense.  That is, take the ratio of the
model’s future to current (baseline) predictions at each monitor
within the nonattainment area using relative response factors (RRF), a
ratio of model projected concentrations over model base-line
concentrations.  Future PM-2.5 concentrations are estimated at existing
monitor sites by multiplying the modeled relative response factor at
locations “near” each monitor by the observation-based,
monitor-specific, “baseline” design value. The resulting predicted
“future concentrations” are then compared to the NAAQS.

ACHD’s analysis of its PM-2.5 monitors within Allegheny County showed
significant local impacts in the Liberty-Clairton PM-2.5 nonattainment
area.  A more detailed modeling analysis was needed to account for these
important local source impacts.  As noted previously, atmospheric
circulation in the Liberty-Clairton area during periods of high PM-2.5
concentrations is quite complex and beyond the resolution capabilities
of most regional photochemical models, which typically contain model
grid cells on the order of twelve square kilometers.  Additionally,
regional scale photochemical models are unable to fully resolve
important local topographic features that influence emission dispersion.
 Important spatial relationships between local sources and the affected
monitors within the Liberty-Clairton, PA PM-2.5 nonattainment area are
also not properly resolved in the regional photochemical grid model.
For these reasons, ACHD decided to do local scale modeling using EPA’s
CALPUFF modeling system to help better resolve local atmospheric
circulation, local terrain features and local emission source
contributions.

The CALPUFF modeling system was used to create near-field and some long
range transport simulations for the Liberty-Clairton area. CALPUFF
Version 5.8 (dated June 29, 2007) is the most recent EPA-approved
version for regulatory applications. CALPUFF is currently not EPA’s
preferred near-field model to use for sources within 50 kilometers of
the affected monitor (see August 14, 2008 EPA Clarification Memo
entitled “Clarification of Regulator Status of CALPUFF for Near-field
Applications”).  The use of CALPUFF in this SIP, however, was granted
since the modeling protocol outlining the modeling methodology was
established before the issuance of this EPA memorandum.

The CALPUFF modeling system is comprised of CALMET (meteorological
model), CALPUFF (dispersion model), geophysical data preprocessors,
meteorological data preprocessors, and several postprocessors such as
CALPOST.  The CALPro GUI (dated June 29, 2007) comprises CALPUFF and
associated preprocessors and postprocessors in a central interface and
was utilized for the near field modeling analysis.

ACHD followed modeling procedures outlined in its PM-2.5 Model Protocol
(Appendix C) for the Liberty-Clairton, PA PM-2.5 nonattainment area and
EPA’s modeling guidance.  The modeling analysis utilized a combination
of regional CMAQ modeling using the MANE-VU inventory and local CALPUFF
modeling using a local revised ACHD inventory (for direct PM-2.5
emissions only).  ACHD listed several deviations from its original
modeling protocol in section 7.1.1 of its main SIP document.  These were
necessary to account for several issues that came up during the modeling
demonstration.

ACHD’s modeling methodology for its attainment demonstration followed
roughly the same methodology used in the Philadelphia Air Toxics study.
Average impacts from the uncorrected MANE-VU inventory across an
“equivalent grid” were subtracted from the CMAQ impacts on a
concurrent basis.  The corrected ACHD inventory impacts for Liberty and
Clairton were then added to the CMAQ results.

Meteorological Time Periods Used in the Modeling

The EPA’s 2007 Modeling Guidance recommends modeling an entire year
or, at a minimum, several days in each quarter of a year, to adequately
represent the range of meteorological conditions that contribute to
elevated levels of fine particulate matter.  MANE-VU regional modeling
efforts were based on a base year of 2002.  This was the year used for
all PM-2.5 modeling efforts in EPA’s Region 3 and was also used in the
modeling demonstration submitted for the Liberty-Clairton, PA PM-2.5
nonattainment area.

Meteorological Models Used in the Air Quality Model

Meteorological data for the regional photochemical grid model and local
scale model were constructed for the modeling demonstration.  The
regional photochemical grid model was driven by output from the
Pennsylvania State University/National Center for Atmospheric Research
(PSU/NCAR) Mesoscale Meteorological Model, also known as MM5.  The
meteorological model for the local scale modeling was derived using
CALMET, which used a combination of MM5 data coupled with local
observations from nearby met stations.   The MM5 simulation included
“nudging”, which uses observations in the tendency equations to
force the model solution closer to observed values.

Additional information regarding the MM5 set up can be found in Appendix
K-2 of ACHD’s SIP document.

The following is a short list of MM5 options used in the modeling
demonstration simulation:

Kain-Fritsch (1993) convective scheme for both 36 and 12 km domains with
some adjustments to correct diurnal phase shifts in surface winds and
temperatures

Explicit moisture scheme (without the mixed phase) containing prognostic
equations for cloud water (ice) and rainwater (snow)

Modified version of the Blackadar PBL scheme

Simple radiative cooling scheme

Multi-layer soil model to predict land surface temperatures using the
surface energy budget equation

MM5 met data was also used in the near field analysis using CALPUFF
though the CALMET processor.  CALMET was initialized with MM5 met fields
and supplemented with meteorological data from the Liberty monitoring
site, the Allegheny County Airport and USX Clairton.  The CALMET
processor is used to try and recreate some of the more complex
atmospheric flows in the Liberty-Clairton nonattainment area that cannot
be resolved in the MM5 simulation.  Further details of the
meteorological data processing for CALMET can be found in Appendix D of
ACHD’s SIP document.

Model Domain, Horizontal/Vertical Resolution and the Initial and
Boundary Conditions

MM5 (version 3.6) was run by the University of Maryland in consultation
with New York DEC staff.  The model was applied using a Lambert
conformal map projection.  The two nested domain consisted of coarse (36
km) and fine (12 km) mesh corresponding to 149 x 129 and 175 x 175 grids
respectively.  The Lambert projection used in this work followed the
Regional Planning Organization (RPO) national domain setup.

MM5 uses a terrain following σ-coordinate system with the pressure at
each σ-level determined from a reference state that is estimated using
the hydrostatic equation from a given sea-level pressure and temperature
with a standard lapse rate. There are 30 unevenly spaced σ-levels
yielding 29 vertical layers with higher resolution within the planetary
boundary layer (PBL).  The surface layer was set at about 10 m, the
level at which surface winds were typically observed, and the model top
was set at 50 hPa with a radiative top boundary condition.

CMAQ simulations were performed using a one-way nesting approach for a
continental simulation at 36 km grid spacing with a finer 12 km grid
centered over the eastern portion of the US.  Both domains utilized 22
layers in the vertical extending to about 16 km with 16 layers placed
within the lower three kilometers.

The continental CMAQ simulation utilized clean initial conditions with
boundary conditions extracted from a GEOS-CHEM global chemical model
simulation. The CMAQ 36 km simulation was initiated from December 15,
2001 with the first 15 days used as a spin up period and terminated on
December 31, 2002.  RPO emissions data from 2002 was used with
corresponding MM5 meteorological fields developed by the University of
Maryland.

Hourly boundary fields for the 12 km CMAQ domain were obtained from the
concentration fields generated by the 36 km CMAQ simulation.  The 12 km
simulations for both base and future year were assigned the boundary
conditions based on the 36 km CMAQ simulation with clean initial
conditions.  A more detailed description of the CMAQ runs can be found
in Appendix K-4 of ACHD’s SIP document.

Model resolution for CALPUFF, the near field model, was on a much finer
scale than the regional model.  CALPUFF grid spacing for the 150 km
regional source analysis domain was one kilometer and 100 meters for the
20 kilometer local scale analysis domain.  Both CALPUFF runs contained
11 vertical layers spaced within the first three km.  More information
on ACHD’s CALPUFF settings can be found in Appendix I of ACHD’s SIP
document.

Emissions Used in the Air Quality Models

Northeastern US emissions inventories for all source classifications
were developed by MANE-VU for use in regional analyses and SIPs. The
MANE-VU emission inventory was originally developed for regional haze
but was also used for ozone and PM-2.5 modeling efforts in the
Northeast.  A report by MARAMA located in Appendix G of the SIP document
provides additional details on the regional emission inventories.

The year 2002 was used for the baseline emissions inventory and 2014 for
the projected inventory for the Liberty-Clairton area.  Regional
projections utilized on-the-books/on-the-way (OTB/W) controls through
the 2012 timeframe. Since no additional projections were available at
the time, and since Liberty-Clairton controls focus on direct PM-2.5
emissions, regional projections for 2012 were used for precursors and
non-point PM-2.5 emissions in combination with local projections for
2014 for stationary point PM-2.5 emissions.

A more detailed inventory was developed by the ACHD for the extended
Liberty-Clairton area as part of its near scale modeling analysis.  This
inventory was limited to direct PM-2.5 emissions and was developed from
both the regional MANE-VU inventories and projections along with
ACHD’s inventories for stationary point sources.  These emissions
represent “actual” values based on pollutant emission factors and
throughputs or capacities of each emission source.  Emission values do
not necessarily represent permitted or “allowable” limits.

Regional controls for SO2 and NOx in the MANE-VU inventory were based on
CAIR.  On July 6, 2011, EPA finalized a rule that protects the health of
millions of Americans by helping states reduce air pollution and attain
clean air standards.  This rule, known as the Cross-State Air Pollution
Rule (CSAPR or Cross State Rule), requires 27 states to significantly
improve air quality by reducing power plant emissions that contribute to
ozone and/or fine particle pollution in other states.

Base Case Run Model Performance Evaluation

Model performance evaluations were done for MM5 and the regional CMAQ
runs as well as the local scale runs using CALPUFF.  Regional model
performance was based on matrices outlined in EPA’s Guidance on the
use of models and other analyses for demonstrating attainment of air
quality goals for ozone, PM-2.5, and regional haze (EPA-454/B-07-002)
and was summarized in Appendix K-1.

NY DEC examined the MM5 output to determine how well the simulation was
performing.  Only meteorological fields from the ozone season (May
through September) were examined.  The nudging process used National
Weather Service data so as expected the model did relatively well
compared with this data set.  Meteorological data from the Clean Air
Status and Trends Network or CASTNET was also used to assess model
accuracy since this data set was not included in the nudging process.
Vertical parameters were also included in the analysis as well as cloud
cover data, precipitation and simulated calm periods.

The meteorological assessment showed that in general, MM5’s
performance was reasonable both at the surface and in the vertical.  It
was therefore concluded that MM5 performed adequately and the data could
be used in the CMAQ simulations.

Regional model evaluation statistics for the entire 2002 simulation were
calculated over a wide region for PM-2.5 mass and major species. In
general, CMAQ did a reasonable job simulating daily average PM-2.5 and
SO4 (sulfate) mass.  CMAQ, however, did not appear to be able to
reproduce the day-to-day or seasonal variation in other species like
NO3, OM, EC, or crustal mass.  The model appeared to meet model
performance criteria for PM-2.5 reasonably well over the Ozone Transport
Region (OTR) as a whole but not as well if one focused on an
emissions-dense, complex urban setting such as the New York City area.
This finding appears to support ACHD’s local scale modeling efforts
for the Liberty-Clairton area.

ACHD examined CALPUFF’s ability to simulate local monitor
concentrations, specifically the model’s ability to simulate the
strong diurnal variations that contribute to the area’s high PM-2.5
design values.  A comparison of CALPUFF hourly averaged modeled and TEOM
(monitor) concentrations showed the local scale modeling generally
provided a better simulation of the strong diurnal contrasts (high
overnight concentrations) than did the regional model though the CALPUFF
model tended to over predict PM-2.5 concentrations.  This over
prediction, however, was not considered a problem since the local scale
modeling was used in a relative sense for attainment demonstration
purposes.  CALPUFF model performance using EPA matrices was judged to be
adequate overall with the 2nd and 3rd quarters showing better
performance than the 1st and 4th quarters.

2014 Control Case Modeling and the Modeled Attainment Test

The monitored attainment test for PM-2.5 utilizes both PM-2.5 and
individual PM-2.5 component species.  EPA refers to the attainment test
for PM-2.5 as the Speciated Modeled Attainment Test (SMAT).  A separate
relative response factor (RRF) is calculated for each PM-2.5 species.

In order to perform the recommended modeled attainment test, it is
recommended that states divide observed mass concentrations of PM-2.5
into seven (7) components plus passive mass:

mass associated with sulfates

mass associated with nitrates

mass associated with ammonium

mass associated with organic carbon

mass associated with elemental carbon

mass associated with particle bound water

mass associated with “other” primary inorganic particulate matter

and passively collected mass

To apply the test, states must first run an air quality model at least
twice to simulate current emissions and to simulate future year
emissions.   RRF values are then calculated for each PM-2.5 species.
These RRF values are then multiplied by the base year concentrations for
each monitor within the nonattainment area.

Data analyses by Frank have noted that the FRM monitors do not measure
the same components and do not retain all of the PM-2.5 that is measured
by routine speciation samplers.  EPA recommends using the sulfate,
adjusted nitrate, derived water, inferred carbonaceous material balance
approach or SANDWICH to account for these differences in the SMAT.  A
more detailed description of this process can be found in EPA’s
Guidance on the Use of Models and Other Analyses for Demonstrating
Attainment of Air Quality Goals for Ozone, PM-2.5, and Regional Haze,
EPA -454/B-07-002 April 2007.

ACHD’s modeled attainment test included an additional step to account
for the two models used in its analysis.  The direct PM-2.5 component
was taken from the CALPUFF modeling while CMAQ provided results for the
other PM-2.5 components.

The Liberty-Clairton nonattainment area has two PM-2.5 monitoring sites,
Liberty and Clairton.  Speciation data from Liberty was used for the
Clairton monitor since this site does not collect speciation data.
Details on how the modeling attainment demonstration was conducted are
included in section 8 of the main PM-2.5 SIP document.

Projected monitor concentrations were calculated for both monitors in
the Liberty-Clairton area following EPA guidance.  EPA has developed the
Modeled Attainment Test Software (MATS) to automatically calculate
design values and interpolate for unmonitored areas.  Testing of MATS
version 2.2.1 showed inconsistent results with the methodology given in
the EPA Modeling Guidance.  EPA’s MATS software, therefore, was not
used by ACHD in this attainment demonstration though the general
methodology was followed to calculate the projected PM-2.5
concentrations.

Summary of the Combined Photochemical and CALPUFF Modeling Results

Annual and 24-hour PM-2.5 concentrations for both the Liberty and
Clairton monitors were calculated from the quarterly base-year averaged
monitor concentrations and the RRFs calculated from CMAQ and CALPUFF for
each PM-2.5 species components.  Results for the annual and 24-hour
PM-2.5 NAAQS are summarized in the following table and show that the
projected 2014 annual and 24-hour design values are below the 1997
PM-2.5 NAAQS.

Model Projected PM-2.5 Concentrations

For the Liberty-Clairton, PA PM-2.5 Nonattainment Area

Monitor	Annual Standard	24-Hour Standard

	Projected	1997 NAAQS	Projected	1997 NAAQS

Liberty	14.3 μg/m3	15.0 μg/m3	42 μg/m3	65 μg/m3

Clairton	11.8 μg/m3	15.0 μg/m3	27 μg/m3	65 μg/m3

EPA’s CSAPR rule was published after ACHD submitted their PM-2.5 SIP
for Liberty-Clairton.  ACHD did provide an analysis of EPA’s Transport
Rule, which had replaced EPA’s CAIR regional emission control
proposal, in its Weight of Evidence (WOE) section (13.3).  EPA’s
Transport Rule was the proposal in effect at the time of the SIP
document’s preparation.

EPA Region 3 suggests that ACHD submit an addendum to their current SIP
document that examines EPA’s most recent regional emission control
proposal (CSAPR) to ensure that its SIP modeling analysis is at least as
controlled as EPA’s current proposal.  This addendum should reexamine
the elements included in section 13.3 of ACHD’s main SIP document and
could additionally include a comparison of model results for the
Liberty-Clairton area from EPA’s CAIR and CSAPR modeling analyses.

Local Area Analysis

EPA guidance calls for additional analyses in areas where large sources
of primary particulates could cause substantial spatial gradients in
PM-2.5 concentrations.  These are often referred to as “hot spots”,
which could impact an area’s ability to comply with the NAAQS.
Analysis of these hot spots could necessitate additional photochemical
grid modeling using a finer modeling grid scale, down to 1 to 2
kilometers, or alternatively the use of a Gaussian dispersion model.

ACHD conducted a local area analysis using EPA’s CALPUFF model.  This
analysis examined the impacts on direct PM-2.5 emissions in the
Liberty-Clairton, PA nonattainment area.  These impacts were coupled
with the regional CMAQ modeling analysis to demonstrate that the
nonattainment area would comply with the 1997 PM-2.5 NAAQS.

Unmonitored Area Analyses

The unmonitored area analysis is intended to be the primary means for
identifying high PM-2.5 concentrations outside of traditionally
monitored locations. The spatial resolution of the model that is the
underlying basis of the unmonitored area analysis will determine how
well it addresses primary PM-2.5 hotspots.

The size of the Liberty-Clairton, PA PM-2.5 nonattainment area is much
smaller than most of the neighboring nonattainment areas.  As a
consequence of its size, the Liberty-Clairton, PA PM-2.5 nonattainment
area has a much higher density of monitors within it.  This partially
negates the necessity of doing this analysis though ACHD detailed an
assessment of the area in section 8.6 of its main SIP document.

ACHD examined modeled PM-2.5 reductions in the vicinity of the Liberty
monitor.  Several large sources of direct PM-2.5 emissions lie southwest
of the monitor near steep terrain adjacent to the Monongahela River.
ACHD examined percent reductions in these areas and noted that shutdowns
and plant emission reductions would produce much greater improvements in
air quality in these areas than what are projected to occur at the
Liberty monitor itself.

Weight of Evidence Demonstration

ACHD conducted a Weight of Evidence (WOE) demonstration in accordance
with section 2.3 of EPA’s modeling guidance.  The WOE demonstration is
detailed in section 13 of ACHD’s main SIP document.  ACHD’s WOE
demonstration consisted of an analysis of monitor trends, local and
national emission control programs, population trends and monitoring
concentrations during periods of low production.  These results were
used as further evidence supporting the ACHD’s conclusion that their
SIP modeling analysis demonstrates compliance with the 1997 PM-2.5
NAAQS.

ACHD examined PM-2.5 monitoring trends within the nonattainment area and
the surrounding region.  PM-2.5 concentrations at most of the regional
monitors appear to be declining though ACHD noted these trends may not
be statistically significant at this time.

ACHD included a summary of various local and regional emission control
programs being implemented in the area.  Some of these control measures
may extend beyond the Liberty-Clairton, PA PM-2.5 nonattainment area and
therefore may have a lesser impact.  Emission control programs noted in
the WOE section include Pennsylvania’s enactment of a wood boiler
rule, a wood stove change out program in southwest Pennsylvania, EPA’s
recently proposed Transport Rule, Allegheny County’s diesel fuel
engine retrofit program, local and state anti-idling campaigns and
Allegheny County’s grant program to reduce diesel particulate
emissions.  ACHD contends that the combined effects of these controls
add additional support for their attainment demonstration.

Recent population trends are declining in the Pittsburgh region.  ACHD
noted that these population declines, if they continue, would help
reduce emissions in the area that contribute to the nonattainment
problem; fewer people equates to less driving and other activities that
contribute to emissions in the area.

ACHD also looked at the effect of lower emissions on its PM-2.5
monitoring network during the recent economic downturn.  This was done
by comparing TEOM data from 2009, a period of lower production due to
the economic downturn, to the unaffected 2000-2008 time period.
Production levels at the local and regional level have fallen due to the
recent economic downturn.  These emission reductions appear to have
lowered monitor concentrations when compared to previous time periods.
ACHD interprets these declines as demonstrating the future effectiveness
of their proposed local source emission controls.

Recommendation of Conditional Approval of Liberty-Clairton PM-2.5
Attainment Demonstration

below 15.0 μg/m3 and 65 μg/m3 respectively indicating the
nonattainment area satisfies the Clean Air Act’s requirement that
State Implementation Plans provide for attainment of the NAAQS by the
applicable attainment date.

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Anal CMAQ modeling included emission controls from EPA’s CAIR program.
 Since ACHD’s SIP submittal, EPA has proposed CSAPR to replace CAIR.
To ensure that the modeling demonstration is still valid EPA is
requesting that ACHD redo the analysis it included in section 13.3 of
its main SIP document and consider examining the modeling technical
support documents for CAIR and the recently proposed Cross State Rule to
ensure that the more recently proposed rule provides at least the same
or possibly lower model concentrations in the Liberty-Clairton area as
the modeling analysis used in the April 2011 SIP modeling demonstration.

Based on the technical information provided in the Liberty-Clairton SIP
document, EPA concludes that the modeling and WOE analyses demonstrate
attainment of the 1997 PM-2.5 NAAQS.  EPA, therefore, should
conditionally approve the model attainment demonstration portion of
Liberty-Clairton, PA PM-2.5 SIP.  Final approval of the model attainment
demonstration portion of the SIP will be contingent on ACHD’s
reanalysis of the elements included in section 13.3 of its main SIP
document and an examination of modeled PM-2.5 concentrations from
EPA’s proposed CSAPR Rule.

 See section 10.0 of EPA’s Guidance on the Use of Models and Other
Analyses for Demonstrating Attainment of Air Quality Goals for Ozone,
PM2.5, and Regional Haze Attainment of Air Quality Goals for Ozone,
PM2.5, and Regional Haze, April 2007 (EPA -454/B-07-002)

 http://www.epa.gov/airtransport

   Frank, N., 2006: “Retained Nitrate, Hydrated Sulfates, and
Carbonaceous Mass in Federal Reference Method Fine Particulate Matter
for Six Eastern U.S. Cities” J. Air Waste Mange. Assoc., 56, 500-511.

EPA Technical Support Document for the Modeling Portion of
Pennsylvania’s

 Revision to the Allegheny County Portion of the Pennsylvania State
Implementation Plan Entitled “Attainment Demonstration for the
Liberty-Clairton PM2.5 Nonattainment Area”

TSD Prepared October 2011

Page   PAGE  6  of   NUMPAGES  16


[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50142-50144]
[FR Doc No: 2017-23526]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0880]

Assessing User Fees Under the Generic Drug User Fee Amendments of
2017; 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 ``Assessing User Fees Under the Generic
Drug User Fee Amendments of 2017.'' This draft guidance provides
stakeholders information regarding the implementation of the Generic
Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures
surrounding its application.

DATES: Submit either electronic or written comments on the guidance
December 29, 2017 to ensure that the Agency considers your comment on
this draft 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-2012-D-0880 for ``Assessing User Fees Under the Generic Drug User
Fee Amendments of 2017.'' 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 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 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to 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.
    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: Mehrban Iranshad, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 4145, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Assessing User Fees Under the Generic Drug User Fee
Amendments of 2017.'' GDUFA II (Pub. L. 115-52, Title III) was signed
into law by the President on August 18, 2017. GDUFA II continues FDA's
and industry's goal to improve the public's access to safe and
effective generic drugs and to improve upon the predictability of the
review process. GDUFA II extends FDA's authority to collect user fees
from fiscal year (FY) 2018 to FY 2022 and introduces a number of
technical revisions that affect what fees are collected and how some
fees are collected. GDUFA II authorizes fees for abbreviated new drug
applications (ANDAs), drug master files (DMFs), annual facility fees, a
one-time fee for original ANDAs pending with FDA on October 1, 2012
(backlog fees), and the Generic Drug Applicant Program Fee (GDUFA
Program Fee).
    The draft guidance announced in this notice addresses changes in
user fee assessments from GDUFA I, user fees incurred by industry under
GDUFA II, payment procedures, reconsideration and appeals, and other
additional information to assist industry in complying with GDUFA II.
FDA will issue separate guidance documents regarding GDUFA II non-user
fee requirements and processes.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance, when finalized,
will represent the Agency's current thinking on ``Assessing User Fees
Under the Generic Drug User Fee Amendments of 2017.'' 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. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that 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 guidance refers to collections of information for filling
out and submitting Form FDA 3913 (User Fee Payment Refund Request),
previously approved under OMB control number 0910-0805, and Form FDA
3914 (User Fee Payment Transfer Request), previously approved under OMB
control number 0910-0805.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: October 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23526 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P