59156 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Proposed Rules 

business hours (8:30 a.m. to 5:00 p.m. 

Eastern time) at 888 First Street NE., 

Room 2A, Washington DC 20426. 

36. From the Commission’s Home 

Page on the Internet, this information is 

available on eLibrary. The full text of 

this document is available on eLibrary 

in PDF and Microsoft Word format for 

viewing, printing, and/or downloading. 

To access this document in eLibrary, 

type the docket number excluding the 

last three digits of this document in the 

docket number field. 

37. User assistance is available for 

eLibrary and the Commission’s Web site 

during normal business hours from the 

Commission’s Online Support at (202) 

502–6652 (toll free at 1–866–208–3676) 

or email at ferconlinesupport@ferc.gov, 

or the Public Reference Room at (202) 

502–8371, TTY (202) 502–8659. Email 

the Public Reference Room at 

public.referenceroom@ferc.gov. 

By direction of the Commission. 

Nathaniel J. Davis, Sr., 

Deputy Secretary. 

[FR Doc. 2012–23647 Filed 9–25–12; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 514 

[Docket No. FDA–2012–N–0447] 

Antimicrobial Animal Drug Sales and 

Distribution Reporting; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

comment period for the advance notice 

of proposed rulemaking that appeared 

in the Federal Register of July 27, 2012. 

In the advance notice of proposed 

rulemaking, FDA requested comments 

regarding potential changes to its 

regulations relating to records and 

reports for approved antimicrobial new 

animal drugs. The Agency is taking this 

action in response to requests for an 

extension to allow interested persons 

additional time to submit comments. 

DATES: The comment period for the 

advance notice of proposed rulemaking 

that published July 27, 2012 (77 FR 

44177) is extended. Submit written or 

electronic comments by November 26, 

2012. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

0447, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2012–N–0447 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Request for 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

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. 

FOR FURTHER INFORMATION CONTACT: Neal 

Bataller, Center for Veterinary Medicine 

(HFV–210), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9062, 

email: neal.bataller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 27, 

2012 (77 FR 44177), FDA published an 

advance notice of proposed rulemaking 

with a 60-day comment period to 

request comments regarding potential 

changes to its regulations relating to 

records and reports for approved new 

animal drugs. FDA is considering 

revisions to this regulation to 

incorporate the requirements of section 

105 of the Animal Drug User Fee 

Amendments of 2008 (ADUFA 105). 

The Agency is also seeking public 

comment on how best to compile and 

present the summary information as 

directed by ADUFA 105, and on 

alternative methods available to the 

Agency for obtaining additional data 

and information about the extent of 

antimicrobial drug use in foodproducing animals. 

The Agency has received requests for 

a 60-day extension of the comment 

period for the advance notice of 

proposed rulemaking. The requests 

conveyed concern that the current 60- 

day comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the advance 

notice of proposed rulemaking. 

FDA has considered the requests and 

is extending the comment period for the 

advance notice of proposed rulemaking 

for 60 days, until November 26, 2012. 

The Agency believes that a 60-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying 

rulemaking on these important issues. 

II. Request for Comments 

Interested persons may submit either 

written comments regarding this 

document to the Division of Dockets 

Management (see ADDRESSES) or 

electronic comments to http:// 

www.regulations.gov. 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: September 20, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–23740 Filed 9–21–12; 4:15 pm] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2010–0154; FRL–9732–8] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Maryland; The Washington County 

2002 Base Year Inventory 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

the fine particulate matter (PM2.5) 2002 

base year emissions inventory portion of 

the State of Maryland State 

Implementation Plan (SIP) revision 

submitted by the State of Maryland, 

through the Maryland Department of the 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Proposed Rules 59157 

Environment (MDE), on June 6, 2008 for 

Washington County, Maryland. The 

emissions inventory is part of 

Maryland’s June 6, 2008 SIP revision 

that was submitted to meet 

nonattainment requirements related to 

the Washington County nonattainment 

area (hereafter referred to as Washington 

County Area or Area) for Maryland’s 

1997 PM2.5 National Ambient Air 

Quality Standard (NAAQS) SIP. EPA is 

proposing to approve the 2002 base year 

PM2.5 emissions inventory for 

Washington County submitted by MDE 

in accordance with the requirements of 

the Clean Air Act (CAA). 

DATES: Written comments must be 

received on or before October 26, 2012. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2010–0154 by one of the 

following methods: 

A. www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Email: mastro.donna@epa.gov. 

C. Mail: EPA–R03–OAR–2010–0154, 

Donna Mastro, Acting Associate 

Director, Office of Air Program 

Planning, Mailcode 3AP30, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2010– 

0154. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to EPA without going 

through www.regulations.gov, your 

email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the 

electronic docket are listed in the 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in www.regulations.gov or 

in hard copy during normal business 

hours at the Air Protection Division, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the Maryland Department of 

the Environment, 1800 Washington 

Boulevard, Suite 705, Baltimore, 

Maryland 21230. 

FOR FURTHER INFORMATION CONTACT: 

Asrah Khadr, (215) 814–2071, or by 

email at khadr.asrah@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. Summary of SIP Revision 

III. Proposed Action 

IV. Statutory and Executive Order Reviews 

I. Background 

Throughout this document, whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. On July 18, 1997 (62 FR 38652), 

EPA promulgated the 1997 PM2.5

NAAQS, including an annual standard 

of 15.0 micrograms per cubic meter (mg/ 

m3) based on a 3-year average of annual 

mean PM2.5 concentrations, and a 24- 

hour (or daily) standard of 65 mg/m3

based on a 3-year average of the 98th 

percentile of 24-hour concentrations. 

EPA established the standards based on 

significant evidence and numerous 

health studies demonstrating that 

serious health effects are associated 

with exposures to PM2.5. 

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 airquality agencies initiated the monitoring 

process for the 1997 PM2.5 NAAQS and, 

by January 2001, established a complete 

set of air-quality data. On January 5, 

2005, EPA published initial air-quality 

designations for the 1997 PM2.5 NAAQS 

(70 FR 944), which became effective on 

April 5, 2005, based on air-quality 

monitoring data for calendar years 

2001–03. 

On April 14, 2005, EPA promulgated 

a supplemental rule amending the 

agency’s initial designations (70 FR 

19844), with the same effective date 

(April 5, 2005) as that which was 

promulgated at 70 FR 944. As a result 

of this supplemental rule, PM2.5

nonattainment designations are in effect 

for 39 areas, comprising 208 counties 

within 20 states (and the District of 

Columbia) nationwide, with a combined 

population of approximately 88 million. 

The Washington County Area which is 

the subject of this rulemaking was 

included in the list of areas not attaining 

the 1997 PM2.5 NAAQS. 

On June 6, 2008, the State of 

Maryland submitted a revision to the 

Maryland SIP (#08–05) to meet 

nonattainment requirements for the 

Washington County Area. On November 

20, 2009 (74 FR 60199), EPA determined 

that Maryland had attained the 1997 

PM2.5 NAAQS in the Washington 

County Area. That determination was 

based upon quality assured, quality 

controlled and certified ambient air 

monitoring data that showed the Area 

had monitored attainment of the 1997 

PM2.5 NAAQS for the 2004–2006 

monitoring period and that continued to 

show attainment of the 1997 PM2.5

NAAQS based on the 2005–2007 data. 

The November 20, 2009 determination 

suspended the requirements for 

Maryland to submit an attainment 

demonstration, associated reasonably 

available control measures, a reasonable 

further progress plan, contingency 

measures, and other planning SIP 

revisions related to attainment of the 

standard for so long as the 

nonattainment area continues to meet 

the 1997 PM2.5 NAAQS. On February 

29, 2012, MDE withdrew portions of the 

June 6, 2008 Washington County, 

Maryland 1997 PM2.5 SIP revisions 

including the attainment plan, analysis 

of reasonably available control 

measures, attainment demonstration, 

contingency plans and mobile source 

budgets. To meet the requirements of 

CAA section 172(c)(3), MDE did not 

request the withdrawal of the 2002 base 

year emission inventory portion of the 

June 6, 2008 1997 PM2.5 SIP revision. 

Section 172(c)(3) of the CAA requires 

submission and approval of a 

comprehensive, accurate, and current 

inventory of actual emissions. 


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59158 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Proposed Rules 

II. Summary of SIP Revision 

The 2002 base year emission 

inventory submitted by MDE on June 6, 

2008 for Washington County, Maryland 

includes emissions estimates that cover 

the general source categories of 

stationary point sources, stationary 

nonpoint sources, nonroad mobile 

sources and onroad mobile sources. The 

pollutants that comprise the inventory 

are nitrogen oxides (NOX), volatile 

organic compounds (VOCs), PM2.5, 

coarse particles (PM10), ammonia (NH3), 

and sulfur dioxide (SO2). EPA has 

reviewed the results, procedures and 

methodologies for the 2002 base year 

emissions inventory submitted by MDE 

for Washington County, Maryland. The 

year 2002 was selected by MDE as the 

base year for the emissions inventory 

per 40 CFR 51.1008(b). A discussion of 

the emissions inventory development as 

well as the emissions inventory can be 

found in the June 6, 2008 SIP submittal. 

The CAA section 172(c)(3) emissions 

inventory is developed by the 

incorporation of data from multiple 

sources. States were required to develop 

and submit to EPA a triennial emissions 

inventory according to the Consolidated 

Emissions Reporting Rule (CERR) for all 

source categories (i.e., point, area, 

nonroad mobile and on-road mobile). 

The 2002 emissions inventory was 

based on data developed by MDE. The 

data were developed according to 

current EPA emissions inventory 

guidance, ‘‘Emissions Inventory 

Guidance for Implementation of Ozone 

and Particulate Matter NAAQS and 

Regional Haze Regulations,’’ August 

2005. EPA agrees that the process used 

to develop this emissions inventory is 

adequate to meet the requirements of 

CAA section 172(c)(3), the 

implementing regulations, and EPA 

guidance for emission inventories. More 

information regarding the review of the 

base year inventory can be found in the 

technical support document (TSD) that 

is located in this docket. 

III. Proposed Action 

EPA is proposing to approve the 2002 

base year emissions inventory portion of 

the SIP revision submitted by Maryland 

through MDE on June 6, 2008 for 

Washington County, Maryland. We have 

made the determination that this action 

is consistent with section 110 of the 

CAA. EPA is soliciting public comments 

on the issues discussed in this 

document. These comments will be 

considered before taking final action. 

IV. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely proposes to approve state law as 

meeting Federal requirements and does 

not impose additional requirements 

beyond those imposed by state law. For 

that reason, this proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this proposed rule, 

pertaining to the PM2.5 2002 base year 

emissions inventory portion of the 

Washington County, Maryland June 6, 

2008 SIP submittal, does not have tribal 

implications as specified by Executive 

Order 13175 (65 FR 67249, November 9, 

2000), because the SIP is not approved 

to apply in Indian country located in the 

state, and EPA notes that it will not 

impose substantial direct costs on tribal 

governments or preempt tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Nitrogen dioxide, 

Particulate matter, Reporting and 

recordkeeping requirements, Sulfur 

oxides, Volatile organic compounds. 

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

Dated: August 30, 2012. 

W.C. Early, 

Acting Regional Administrator, Region III. 

[FR Doc. 2012–23698 Filed 9–25–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 20 

[Dockets No. FWS–R9–MB–2012–0028 and 

FWS–R9–MB–2012–0038; FF09M21200– 

123–FXMB1231099BPP0L2] 

RINs 1018–AY61, 1018–AY66 

Migratory Bird Hunting; Application for 

Approval of Copper-Clad Iron Shot and 

Fluoropolymer Shot Coatings as 

Nontoxic for Waterfowl Hunting 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule; availability of 

draft environmental assessments. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service, propose to approve 

copper-clad iron shot and 

fluoropolymer coatings for hunting 

waterfowl and coots. We published a 

notice of application for nontoxic shot 

approval for copper-clad iron shot in the 

Federal Register on June 20, 2012 (77 

FR 36980), and one for the 

fluoropolymer shot coatings on July 6, 

2012 (77 FR 39983). Having completed 

our review of the application materials 

for both, we have concluded that neither 

the shot nor the coatings are likely to 

adversely affect fish, wildlife, or their 

habitats. 

DATES: Electronic comments on this 

proposal via http://www.regulations.gov 

must be submitted by 11:59 p.m. Eastern 

time on October 26, 2012. Comments 

submitted by mail must be postmarked 

no later than October 26, 2012. 

ADDRESSES: Document Availability. You 

may view the application and our draft 

environmental assessments by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Search for Docket 

No. FWS–R9–MB–2012–0028 for 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS