Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules 63349 

professionals and discusses one of the 

exceptions for establishments from 

certain regulatory requirements. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by December 22, 

2014 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Lori 

J. Churchyard, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Same 

Surgical Procedure Exception under 21 

CFR 1271.15(b): Questions and Answers 

Regarding the Scope of the Exception’’ 

dated October 2014. The draft guidance 

document is intended for use by tissue 

establishments and healthcare 

professionals. When finalized, the 

guidance document will provide our 

current thinking with respect to the 

exception set forth in Title 21 of the 

Code of Federal Regulations 1271.15(b) 

(21 CFR 1271.15(b)). The draft guidance 

is presented in question and answer 

format and includes examples based on 

inquiries received by the Agency since 

the final rule, ‘‘Human Cells, Tissues, 

and Cellular and Tissue Based Products; 

Establishment Registration and Listing’’ 

published in the Federal Register of 

January 19, 2001 (66 FR 5447). 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

The draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 1271 have 

been approved under OMB control 

number 0910–0543. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://

www.regulations.gov. 

Dated: October 17, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25217 Filed 10–22–14; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2012–0542; FRL–9917–76– 

Region 9] 

Revisions to the California State 

Implementation Plan; Imperial County; 

Ozone Precursor Emissions 

Inventories 

AGENCY: Environmental Protection 

Agency. 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

revision to the Imperial County portion 

of the California State Implementation 

Plan (SIP). This revision concerns Clean 

Air Act (CAA) requirements for volatile 

organic compounds and oxides of 

nitrogen emissions inventories in areas 

designated nonattainment for the 1997 

8-hour ozone National Ambient Air 

Quality Standard (NAAQS). We are 

proposing to approve the 2002 volatile 

organic compound and oxides of 

nitrogen emissions inventories as 

submitted by Imperial County and 

California. 

DATES: Any comments on this proposal 

must arrive by November 24, 2014. 

ADDRESSES: Submit comments, 

identified by docket number EPA–R09– 

OAR–2012–0542, by one of the 

following methods: 

1. Federal eRulemaking Portal: 

www.regulations.gov. Follow the on-line 

instructions. 

2. Email: wamsley.jerry@epa.gov. 

3. Mail or deliver: Jerry Wamsley (Air2), U.S. Environmental Protection 

Agency Region IX, 75 Hawthorne Street, 

San Francisco, CA 94105–3901. 

Instructions: All comments 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 

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 

www.regulations.gov or email. 

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 

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63350 Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules 

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: 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 94105–3901. 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: Jerry 

Wamsley, EPA Region IX, (415) 947– 

4111, wamsley.jerry@epa.gov. 

SUPPLEMENTARY INFORMATION: This 

proposal concerns the volatile organic 

compound (VOC) and oxides of nitrogen 

(NOX) 2002 emissions inventories 

submitted by California on December 

21, 2010 in the document ‘‘Final 2009 

1997 8-hour Ozone Modified Air 

Quality Management Plan’’ for Imperial 

County. California submitted these 

emissions inventories to meet CAA 

requirements under the 1997 8-hour 

ozone NAAQS. In the Rules and 

Regulations section of this Federal 

Register, we are approving these VOC 

and NOX emissions inventories 

provided by California in a direct final 

action without prior proposal because 

we believe these SIP revisions are not 

controversial. If we receive adverse 

comments, however, we will publish a 

timely withdrawal of the direct final 

rule and address the comments in 

subsequent action based on this 

proposed rule. Please note that if we 

receive adverse comment on a portion of 

the state’s submittal and if that 

provision may be severed from the 

remainder of the submittal, we may 

adopt as final those provisions of the 

submittal that are not the subject of an 

adverse comment. 

We do not plan to open a second 

comment period, so anyone interested 

in commenting should do so at this 

time. If we do not receive adverse 

comments, no further activity is 

planned. For further information, please 

see the direct final action. 

Dated: September 24, 2014. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

[FR Doc. 2014–24752 Filed 10–22–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2014–0547; FRL–9918–39– 

Region 9] 

Partial Approval and Partial 

Disapproval of Air Quality State 

Implementation Plans; California; 

Infrastructure Requirements for Ozone, 

Fine Particulate Matter (PM2.5), Lead 

(Pb), Nitrogen Dioxide (NO2), and 

Sulfur Dioxide (SO2) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to partially 

approve and partially disapprove 

several State Implementation Plan (SIP) 

revisions submitted by the State of 

California pursuant to the requirements 

of the Clean Air Act (CAA or the Act) 

for the implementation, maintenance, 

and enforcement of national ambient air 

quality standards (NAAQS) for ozone, 

fine particulate patter (PM2.5), lead (Pb), 

nitrogen dioxide (NO2), and sulfur 

dioxide (SO2). We refer to such SIP 

revisions as ‘‘infrastructure’’ SIPs 

because they are intended to address 

basic structural SIP requirements for 

new or revised NAAQS including, but 

not limited to, legal authority, 

regulatory structure, resources, permit 

programs, and monitoring necessary to 

assure attainment and maintenance of 

the standards. In addition, we are 

proposing to reclassify certain regions of 

the state for emergency episode 

planning purposes with respect to 

ozone, NO2, SO2, and particulate matter 

(PM). Finally, we are proposing to 

approve into the SIP several state 

provisions addressing CAA conflict of 

interest requirements into the California 

SIP and an emergency episode planning 

rule for Great Basin Unified Air 

Pollution Control District (APCD) for 

PM. We are taking comments on this 

proposal and, after considering any 

comments submitted, plan to take final 

action. 

DATES: Written comments must be 

received on or before November 24, 

2014. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R09–OAR–2014–0547, by one of the 

following methods: 

1. http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

2. Email: mays.rory@epa.gov. 

3. Mail or deliver: Rory Mays (AIR–2), 

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: Rory 

Mays, Air Planning Office (AIR–2), U.S. 

Environmental Protection Agency, 

Region IX, (415) 972–3227, mays.rory@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, the terms 

‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to EPA. 

Table of Contents 

I. EPA’s Approach to the Review of 

Infrastructure SIP Submittals 

II. Background 

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