This section of the FEDERAL REGISTER
contains notices to the public of the proposedissuance of rules and regulations. Thepurpose of these notices is to give interestedpersons an opportunity to participate in therule making prior to the adoption of the finalrules.Proposed RulesFederal Register51146 
Vol. 80, No. 163 
Monday, August 24, 2015 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Parts 1100, 1140, and 1143 
[Docket No. FDA–2015–N–1514] 
RIN 0910–AH24 
Nicotine Exposure Warnings and 
Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E- Liquid(s), and Other Tobacco Products; Request for Comments; 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 (ANPRM) entitled ‘‘Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E- Liquid(s), and Other Tobacco Products’’ that appeared in the Federal Register of July 1, 2015. In the ANPRM, FDA requested comments, data, research results, or other information, that may inform regulatory actions that FDA might take with respect to nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. 
DATES : FDA is extending the comment 
period on the ANPRM published July 1, 2015 (80 FR 37555). Submit either electronic or written comments by September 30, 2015. ADDRESSES : You may submit comments 
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: 
•Mail/Hand delivery/Courier (for 
paper 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 Docket No. FDA– 2015–N–1514 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 ‘‘Requests for Comments and Information’’ 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 : 
Bryant M. Godfrey or Courtney S. Smith, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1–877–CTP–1373, CTPRegulations@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
In the Federal Register of July 1, 2015 
(80 FR 37555), FDA published an ANPRM with a 60-day comment period to request comments, data, research results, or other information, that may inform regulatory actions that FDA might take with respect to nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. 
The Agency has received several 
comments requesting an extension of the comment period for the ANPRM. These comments convey concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to questions raised in the ANPRM. 
FDA has considered the requests and 
is extending the comment period for the ANPRM for 30 days, until September 30, 2015. The Agency believes that a 30- day extension allows adequate time for interested persons to submit comments without significantly delaying any potential regulatory action on these important issues. 
II. Requests for Comments and 
Information 
A. General Information About 
Submitting 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. 
B. Public Availability of Comments 
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. As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on http://www.regulations.gov . This is 
determined by information indicating that the submission is written by an individual, for example, the comment is identified with the category ‘‘Individual Consumer’’ under the field entitled ‘‘Category (Required)’’, on the ‘‘Your Information’’ page on http://www.regulations.gov; for this ANPRM, 
however, FDA will not be following this general practice. Instead, FDA will post on http://www.regulations.gov 
comments to this docket that have been submitted by individuals in their individual capacity. If you wish to submit any information under a claim of 
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162 FR 36852 (July 18, 1997) and 40 CFR 50.7. 
Effective December 18, 2006, EPA strengthened the 
24-hour PM 2.5NAAQS by lowering the level to 35 
mg/m3. 71 FR 61144 (October 17, 2006) and 40 CFR 
50.13. Effective March 18, 2013, EPA strengthened the annual PM
2.5NAAQS by lowering the level to 
12 mg/m3. 78 FR 3086 (January 15, 2013) and 40 
CFR 50.18. In this preamble, all references to the PM
2.5NAAQS, unless otherwise specified, are to 
the 1997 24-hour standard (65 mg/m3) and annual 
standard (15.0 mg/m3) as codified in 40 CFR 50.7. 
270 FR 944 (January 5, 2005). 
3Id. 
4The SJV area encompasses over 23,000 square 
miles and includes all or part of eight counties in California’s central valley: San Joaquin, Stanislaus, 
Merced, Madera, Fresno, Tulare, Kings, and Kern. For a precise description of the geographic boundaries of the San Joaquin Valley nonattainment area, see 40 CFR 81.305. 
540 CFR 81.305. confidentiality, please refer to 21 CFR 
10.20. 
C. Information Identifying the Person 
Submitting the Comment 
Please note that your name, contact 
information, and other information identifying you will be posted on  http://www.regulations.gov if you 
include that information in the body of your comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the 
body of your comment on http://www.regulations.gov along with your 
State/province and country (if provided), the name of your representative (if any), and the category identifying you (e.g., individual, 
consumer, academic, industry). For written submissions submitted to the Division of Dockets Management, FDA will post the body of your comments on http://www.regulations.gov, but you can 
put your name and/or contact information on a separate cover sheet and not in the body of your comments. 
Dated: August 18, 2015. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2015–20759 Filed 8–21–15; 8:45 am] 
BILLING CODE 4164–01–P 
ENVIRONMENTAL PROTECTION 
AGENCY 
40 CFR Part 52 
[EPA–R09–OAR–2015–0489; FRL–9932–74– 
Region 9] 
Revision to the California State 
Implementation Plan; San Joaquin Valley; Demonstration of Creditable Emission Reductions from Economic Incentive Programs 
AGENCY : Environmental Protection 
Agency (EPA). 
ACTION : Proposed rule. 
SUMMARY : The Environmental Protection 
Agency (EPA) is proposing to approve a demonstration of creditable emission reductions submitted by California for approval into the San Joaquin Valley (SJV) portion of the California State Implementation Plan (SIP). This SIP submittal demonstrates that certain state mobile source incentive funding programs have achieved specified amounts of reductions in emissions of nitrogen oxides (NO
X) and fine 
particulate matter (PM 2.5) in the SJV area 
by 2014. The effect of this action would be to approve these amounts of emission reductions for credit toward an emission reduction commitment in the California SIP. We are taking comments on this proposal and plan to follow with a final action. 
DATES : Written comments must be 
received on or before September 23, 2015. 
ADDRESSES : Submit your comments, 
identified by Docket ID Number EPA–R09–OAR–2015–0489, by one of the following methods: 
1. http://www.regulations.gov: Follow 
the on-line instructions for submitting comments. 
2. Email: steckel.andrew@epa.gov 
3. Mail or deliver: Andrew Steckel 
(AIR–4), U.S. Environmental Protection Agency, Region IX, 75 Hawthorne Street, San Francisco, CA 94105–3901. Deliveries are only accepted during the Regional Office’s normal hours of operation. 
Instructions: All comments will be 
included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through http:// www.regulations.gov or email. http:// 
www.regulations.gov is an anonymous 
access system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send email directly to EPA, your email address will be automatically captured and included as part of the public comment. 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. 
Docket: Generally, documents in the 
docket for this action are available electronically at www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed at www.regulations.gov, some information 
may be publicly available only at the hard copy location (e.g., copyrighted 
material, large maps), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy 
materials, please schedule an appointment during normal business hours with the contact listed in the 
FOR 
FURTHER INFORMATION CONTACT section. 
FOR FURTHER INFORMATION CONTACT : 
Idalia Perez, EPA Region IX, perez.idalia@epa.gov, (415) 972–3248. SUPPLEMENTARY INFORMATION : 
Throughout this document, ‘‘we’’, ‘‘us’’ 
and ‘‘our’’ refer to EPA. 
Table of Contents 
I. Background 
II. The State’s Submittal III. EPA’s Evaluation of the State’s Submittal 
A. SIP Procedural Requirements B. EPA Policy on Economic Incentives C. Sections 110(l) and 193 of the Act 
IV. Proposed Action and Public Comment V. Statutory and Executive Order Reviews 
I. Background 
On July 18, 1997, EPA established 
new national ambient air quality standards (NAAQS) for particles less than or equal to 2.5 micrometers (mm) in diameter (PM
2.5), including an annual 
standard of 15.0 micrograms per cubic meter (mg/m
3) based on a 3-year average 
of annual mean PM 2.5concentrations, 
and a 24-hour (daily) standard of 65 mg/ 
m3based on a 3-year average of 98th 
percentile 24-hour PM 2.5 
concentrations.1EPA established these 
standards after considering substantial evidence from numerous health studies demonstrating that serious health effects are associated with exposures to PM
2.5 
concentrations above these levels. 
Following promulgation of a new or 
revised NAAQS, EPA is required under Clean Air Act (CAA) section 107(d) to designate areas throughout the nation as attaining or not attaining the NAAQS. On January 5, 2005, EPA published initial air quality designations for the 1997 annual and 24-hour PM
2.5NAAQS, 
using air quality monitoring data for the three-year periods of 2001–2003 and 2002–2004.
2These designations became 
effective April 5, 2005.3EPA designated 
the San Joaquin Valley (SJV) area4as 
nonattainment for both the 1997 annual PM
2.5standard (15.0 mg/m3) and the 
1997 24-hour PM 2.5standard (65 mg/
m3).5 
Between 2007 and 2011, California 
made six SIP submittals to address nonattainment area planning 
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