Federal Register / Vol. 78, No. 2 / Thursday, January 3, 2013 / Proposed Rules 277 

France; telephone: 03.26.48.46.65; fax: 

03.26.49.18.57; Internet: http:// 

www.geciaviation.com/en/. You may review 

copies of the referenced service information 

at the FAA, Small Airplane Directorate, 901 

Locust, Kansas City, Missouri 64106. For 

information on the availability of this 

material at the FAA, call (816) 329–4148. 

Issued in Kansas City, Missouri, on 

December 27, 2012. 

John Colomy, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–31602 Filed 1–2–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2012–N–1148] 

Food and Drug Administration Actions 

Related to Nicotine Replacement 

Therapies and Smoking-Cessation 

Products; Report to Congress on 

Innovative Products and Treatments 

for Tobacco Dependence; Public 

Hearing; Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public hearing; 

Extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

comment period for the notice of public 

hearing that appeared in the Federal 

Register of November 28, 2012 (77 FR 

70955). In the public hearing notice, 

FDA requested comments on FDA 

consideration of applicable approval 

mechanisms and additional indications 

for nicotine replacement therapies 

(NRTs), and input on a report to 

Congress examining the regulation and 

development of innovative products and 

treatments for tobacco dependence. The 

Agency is taking this action to allow 

interested persons additional time to 

submit comments. 

DATES: Submit either electronic or 

written comments by January 16, 2013. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Ayanna Augustus, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 22, Rm. 3219, 

Silver Spring, MD 20993, 301–796– 

3980, FAX: 301–796–2310, email: 

Section918PublicMeeting@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

28, 2012, FDA published a document 

announcing a public meeting on 

December 17, 2012, and the opening of 

a public docket to receive comments 

related to the implementation of section 

918 of the FD&C Act (21 U.S.C. 387r), 

as amended by the Tobacco Control Act 

(Pub. L. 111–31). Under Section 918(a), 

the Secretary of the Department of 

Health and Human Services (the 

Secretary of HHS) is required to 

consider certain new approval 

mechanisms and additional indications 

for NRTs. Several NRTs, including 

nicotine-containing gums, patches, and 

lozenges, are already marketed for 

smoking cessation. Section 918(b) 

requires that the Secretary of HHS, after 

consultation with recognized scientific, 

medical, and public health experts, 

submit a report to Congress examining 

how best to regulate, promote, and 

encourage the development of 

‘‘innovative products and treatments 

(including nicotine-based and nonnicotine-based products and 

treatments)’’ to better achieve the 

following three goals: (1) Total 

abstinence from tobacco use, (2) 

reductions in consumption of tobacco, 

and (3) reductions in the harm 

associated with continued tobacco use. 

FDA will consider the information it 

obtains from the public hearing and 

related docket submissions in its 

implementation of the requirements of 

section 918, including in drafting the 

report to Congress required by section 

918(b). 

II. Submission of Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 

Dated: December 27, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–31578 Filed 1–2–13; 8:45 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9, 63, 80, 85, 122, 123, 

and 412 

[EPA–HQ–OW–2012–0813, FRL–9764–8] 

Section 610 Review of NPDES Permit 

Regulation and Effluent Limitations 

Guidelines Standards for Concentrated 

Animal Feeding Operations (CAFOs); 

Extension of Comment Period 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Extension of public comment 

period. 

SUMMARY: On October 31, 2012 the EPA 

published a request for comments on a 

Regulatory Flexibility Act section 610 

review titled, Section 610 Review of 

NPDES Permit Regulation and Effluent 

Limitations Guidelines Standards for 

Concentrated Animal Feeding 

Operations (CAFOs). As initially 

published in the Federal Register, 

written comments were to be submitted 

to the EPA on or before December 31, 

2012 (a 60-day public comment period). 

Since publication, the EPA has received 

a request for additional time to submit 

comments. Therefore, the EPA is 

extending the public comment period 

for 60 days until March 1, 2013. 

DATES: The public comment period for 

the review published October 31, 2012 

(77 FR 65840) is being extended for 60 

days to March 1, 2013 in order to 

provide the public additional time to 

submit comments and supporting 

information. 

ADDRESSES: 

Comments: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OW–2012–0813, by one of the following 

methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• Email: rfa-sbrefa@epa.gov, 

Attention Docket ID No. EPA–HQ–OW– 

2012–0813. 

• Fax: (202) 566–9744. 

• Mail: Water Docket, Environmental 

Protection Agency, Mailcode: 28221T, 

Attention Docket ID No. EPA–HQ–OW– 

2012–0813, 1200 Pennsylvania Ave. 

NW., Washington, DC 20460. 

• Hand Delivery: EPA Docket Center, 

EPA West, Room 3334, 1301 


emcdonald on DSK67QTVN1PROD with 
278 Federal Register / Vol. 78, No. 2 / Thursday, January 3, 2013 / Proposed Rules 

Constitution Avenue NW., Washington, 

DC, Attention Docket ID No. EPA–HQ– 

OW–2012–0813. Such deliveries are 

accepted only during the Docket 

Center’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–HQ–OW–2012– 

0813. The EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

could 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 that the 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 the 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, the 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 the EPA 

cannot read your comment because of 

technical difficulties and cannot contact 

you for clarification, the EPA might 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. For additional information 

about the EPA’s public docket visit the 

EPA Docket Center homepage at http: 

//www.epa.gov/epahome/dockets.htm. 

For additional instructions on 

submitting comments, go to the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the Water Docket, EPA/DC, EPA West, 

Room 3334, 1301 Constitution Ave. 

NW., Washington, DC 20004. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding federal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the Water 

Docket is (202) 566–2426. 

FOR FURTHER INFORMATION CONTACT: For 

additional information contact, Hema 

Subramanian, Office of Wastewater 

Management (4203M), U.S. 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460; telephone number: (202) 

564–5041; fax number: (202) 564–6384; 

email address: 

subramanian.hema@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

Section 610 of the Regulatory 

Flexibility Act requires that an agency 

review, within 10 years of 

promulgation, each rule that has or will 

have a significant economic impact on 

a substantial number of small entities 

(SISNOSE). The EPA undertakes section 

610 reviews to decide whether the 

agency should continue a rule 

unchanged, amend it, or withdraw it. 

We encourage small entities to provide 

comments on the need to change these 

rules, and in particular, how the rules 

could be made clearer, more effective, or 

if there is need to remove conflicting or 

overlapping requirements with other 

Federal or State regulations. 

The EPA promulgated revised 

regulations for CAFOs on February 12, 

2003 (68 FR 7175). The ‘‘2003 CAFO 

Rule’’ expanded the number of 

operations covered by the CAFO 

regulations and included requirements 

to address the land application of 

manure from CAFOs. The 2003 CAFO 

Rule required all CAFOs to seek NPDES 

permit coverage. The EPA developed a 

Final Regulatory Flexibility Analysis 

(FRFA) for the 2003 CAFO Rule. In the 

2003 CAFO Rule, the EPA took several 

steps to minimize its impacts on small 

businesses, including regulatory 

revisions designed to focus on the 

largest producers, eliminating the 

‘‘mixed’’ animal calculation for 

operations with more than a single 

animal type for determining which 

AFOs are CAFOs, raising the duck 

threshold for dry manure handling duck 

operations, and adopting a dry-litter 

chicken threshold higher than proposed. 

Subsequently, a series of court 

decisions based on legal challenges to 

the rulemaking have limited the 

requirement for NPDES permit coverage 

specifically to CAFOs that discharge. In 

response to these court decisions, the 

EPA made revisions to the CAFO 

regulations in 2008 (73 FR 70418) and 

2012 (77 FR 44494). In promulgating the 

2008 regulatory revision, the EPA 

certified that the 2008 rule would not 

have a significant adverse economic 

impact on a substantial number of small 

entities. In promulgating the 2012 

regulatory revision, the 2012 rule was 

not subject to the RFA because the RFA 

applies only to rules subject to notice 

and comment rulemaking requirements 

under the Administrative Procedure Act 

(APA) or any other statute, and the 2012 

rule was not subject to notice and 

comment requirements. Both rules 

reduced the potential impact of the 

EPA’s CAFO regulations on small 

entities by reducing the universe of 

CAFOs that must apply for NPDES 

permits. Although the EPA has made 

these subsequent revisions to the CAFO 

regulations, the scope of this 610 review 

is limited to the impacts on small 

entities of the 2003 CAFO Rule as 

amended. 

II. Extension of Comment Period for the 

Section 610 Review of the 2003 CAFO 

Rule 

The EPA is extending the deadline for 

submitting comments on the section 610 

review of the CAFO Rule to March 1, 

2013. The original deadline for 

comments, based on a 60-day comment 

period, was December 31, 2012. The 

EPA’s decision responds to a request to 

extend the comment deadline. The EPA 

believes that this 60-day extension will 

assist in providing an adequate amount 

of additional time for the public to 

review the action and to provide written 

comments. 

Dated: December 19, 2012. 

Alexander Cristofaro, 

Director, Office of Regulatory Policy and 

Management. 

[FR Doc. 2012–31091 Filed 1–2–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R4–ES–2012–0020; 

92220–1113–0000–C6] 

RIN 1018–AX60 

Endangered and Threatened Wildlife 

and Plants; Reclassification of the 

Continental United States Breeding 

Population of the Wood Stork From 

Endangered to Threatened; Correction 

AGENCY: Fish and Wildlife Service, 

Interior. 


emcdonald on DSK67QTVN1PROD with