63348 Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE RULEMAKING

DOCKETS

Date Electronic address Address Other information 

Public meeting ..................... November 13, 2014 http://www.fda.gov/Food/

NewsEvents/Workshops

MeetingsConferences/default.htm.

Wiley Building, 5100 Paint 

Branch Pkwy., College 

Park, MD 20740.

Onsite registration from 8 

a.m.–8:30 a.m. 

Advance registration ............ By November 7, 2014 Individuals who wish to participate in person are 

asked to preregister at 

http://www.fda.gov/Food/

NewsEvents/Workshops

MeetingsConferences/default.htm.

We encourage you to use 

electronic registration if 

possible.1

There is no registration fee 

for the public meetings. 

Early registration is recommended because seating is limited. 

Request to make an oral 

presentation.

By October 27, 2014 http://www.fda.gov/Food/ 

NewsEvents/Workshops

MeetingsConferences/default.htm 2.

............................................. Requests made on the day 

of the meeting to make 

an oral presentation will 

be granted only if time 

permits. Information on 

requests to make an oral 

presentation may be 

posted without change to 

http:// 

www.regulations.gov, including any personal information provided. 

Request special accommodations due to a disability.By October 27, 2014 Juanita Yates, email: Juanita.yates@fda.hhs.gov.See FOR FURTHER INFORMATION CONTACT.

Submit electronic or written 

comments.

By December 15, 

2014 

Docket Nos. FDA–2011–N– 

0920, FDA–2011–N– 

0921, FDA–2011–N– 

0922, and FDA–2011–N– 

0143; http:// 

www.regulations.gov.

Division of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852.

1You may also register via email, mail, or FAX. Please include your name, title, firm name, address, and phone and FAX numbers in your registration information and send to: Courtney Treece, Planning Professionals Ltd., 1210 W. McDermott St., Suite 111, Allen, TX 75013, 704–258– 

4983, FAX: 469–854–6992, email: ctreece@planningprofessionals.com. Onsite registration will also be available. 2You may also request to make an oral presentation at the public meeting via email. Please include your name, title, firm name, address, and 

phone and FAX numbers as well as the full text, comprehensive outline, or summary of your oral presentation and send to: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1731, 

email: Juanita.yates@fda.hhs.gov. 

III. Comments, Transcripts, and 

Recorded Video 

Information and data submitted 

voluntarily to FDA during the public 

meeting will become part of the 

administrative record for the relevant 

rulemaking and will be accessible to the 

public at http://www.regulations.gov. 

The transcript of the proceedings from 

the public meeting will become part of 

the administrative record for each of the 

rulemakings. Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov and at FDA’s 

FSMA Web site at: http://www.fda.gov/ 

Food/GuidanceRegulation/FSMA/ 

ucm247568.htm. It may also be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. A transcript 

will also be available in either hardcopy 

or on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. Additionally, 

FDA will be live Webcasting the event. 

When available, the Webcast video 

recording of the public meeting will be 

accessible at FDA’s FSMA Web site at 

http://www.fda.gov/Food/ 

GuidanceRegulation/FSMA/ 

ucm247568.htm. 

Dated: October 20, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25261 Filed 10–22–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1271 

[Docket No. FDA–2014–D–1584] 

Same Surgical Procedure Exception 

Questions and Answers Regarding the 

Scope of the Exception; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Request for comment on draft 

guidance. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

document entitled ‘‘Same Surgical 

Procedure Exception Questions and 

Answers Regarding the Scope of the 

Exception’’ dated October 2014. The 

draft guidance document is intended for 

tissue establishments and healthcare 

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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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