63346 Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules 

the Commission’s standards in more 

specific, codified, and readily accessible 

form, the amendment safeguards against 

accountants professing lack of 

knowledge of the applicable standards— 

or exploiting perceived ambiguities in 

them—to the detriment of market 

participants and the public. 

(2) Efficiency, Competitiveness, and 

Financial Integrity of Futures Markets 

Threats to the safety of customer 

funds generate public distrust in 

financial market integrity. To the extent 

this rule amendment better informs 

accountants and fosters their 

understanding of the Commission’s 

standards and the consequences of 

improper actions—actions that 

potentially could threaten the safety of 

customer funds—the proposed 

amendment promotes the integrity of 

financial markets. 

(3) Price Discovery 

The Commission does not foresee that 

the proposed amendment will directly 

impact price discovery. 

(4) Sound Risk Management Practices 

As noted, improper accounting 

practices may lead to unnecessary risks 

being undertaken, as certain risk 

measures or managerial decisions are 

based on accounting data. To the extent 

the proposed amendment improves 

accountants’ understanding of the 

Commission’s standards, thereby 

deterring improper conduct that 

potentially could result in unnecessary 

risks being undertaken, the proposed 

amendment promotes sound risk 

management practices. 

(5) Other Public Interest Considerations 

By harmonizing the CFTC Rule 

14.8(c) standard for accountants with 

that of SEC Rule 102(e), the proposed 

amendment helps to ensure consistency 

and reduces potential for confusion. 

The Commission requests comment 

on all aspects of this consideration of 

costs and benefits, including whether 

any alternative is perceived as more 

beneficial, less costly, or otherwise 

better suited to serve the public interests 

articulated in CEA section 15(a) than the 

amendment herein proposed. 

List of Subjects in 17 CFR Part 14 

Administrative practice and 

procedure, Professional conduct and 

competency standards, Ethical conduct, 

Penalties. 

For the reasons discussed in the 

preamble, the Commodity Futures 

Trading Commission proposes to amend 

17 CFR part 14 as set forth below: 

PART 14—RULES RELATING TO 

SUSPENSION OR DISBARMENT FROM 

APPEARANCE AND PRACTICE 

■ 1. The authority citation for part 14 

continues to read as follows: 

Authority: Pub. L. 93–463, sec. 101(a)(11), 

88 Stat. 1391, 7 U.S.C. 4a(j), unless otherwise 

noted. 

■ 2. Amend § 14.8 by revising paragraph 

(c) to read as follows: 

§ 14.8 Lack of requisite qualifications, 

character and integrity. 

* * * * * 

(c) To have engaged in unethical or 

improper professional conduct either in 

the course of any adjudicatory, 

investigative, or rulemaking or other 

proceeding before the Commission or 

otherwise. With respect to the 

professional conduct of persons 

licensed to practice as accountants, 

‘‘unethical or improper professional 

conduct’’ means: 

(1) Intentional or knowing conduct, 

including reckless conduct, that results 

in a violation of applicable professional 

principles or standards; or 

(2) Either of the following two types 

of negligent conduct: 

(i) A single instance of highly 

unreasonable conduct that results in a 

violation of applicable professional 

principles or standards in circumstances 

in which an accountant knows, or 

should know, that heightened scrutiny 

is warranted. 

(ii) Repeated instances of 

unreasonable conduct, each resulting in 

a violation of applicable professional 

principles or standards, which indicate 

a lack of competence to practice before 

the Commission. 

Issued in Washington, DC, on October 17, 

2014, by the Commission. 

Christopher J. Kirkpatrick, 

Secretary of the Commission. 

Note: The following appendix will not 

appear in the Code of Federal Regulations. 

Appendix to Proceedings Before the 

Commodity Futures Trading 

Commission; Rules Relating to 

Suspension or Disbarment From 

Appearance and Practice—Commission 

Voting Summary 

On this matter, Chairman Massad and 

Commissioners Wetjen, Bowen, and 

Giancarlo voted in the affirmative. No 

Commissioner voted in the negative. 

[FR Doc. 2014–25194 Filed 10–22–14; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 16, 112, 117, and 507 

[Docket Nos. FDA–2011–N–0920, FDA– 

2011–N–0921, FDA–2011–N–0922, and FDA– 

2011–N–0143] 

RIN 0910–AG36, RIN 0910–AG35, RIN 0910– 

AG10, and RIN 0910–AG64 

Food and Drug Administration Food 

Safety Modernization Act; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to discuss proposed 

revisions to four rules originally 

proposed in 2013 to implement the FDA 

Food Safety Modernization Act (FSMA). 

In response to the comments received 

on these foundational FSMA proposed 

rules, FDA issued supplemental notices 

of proposed rulemaking that propose 

significant changes to four of the 

proposed rules including: Current Good 

Manufacturing Practice and Hazard 

Analysis and Risk-Based Preventive 

Controls for Human Food (Preventive 

Controls for Human Food); Standards 

for the Growing, Harvesting, Packing, 

and Holding of Produce for Human 

Consumption (Produce Safety); Current 

Good Manufacturing Practice and 

Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals (Preventive Controls for 

Animal Food); and Foreign Supplier 

Verification Programs for Importers of 

Food for Humans and Animals (Foreign 

Supplier Verification Programs). The 

purpose of the public meeting is to 

solicit oral stakeholder and public 

comments on the new content of the 

supplemental proposed rules and to 

inform the public about the rulemaking 

process (including how to submit 

comments, data, and other information 

to the rulemaking dockets), and to 

respond to questions about the 

supplemental proposed rules. 

DATES: See section II, ‘‘How to 

Participate in the Public Meeting,’’ in 

the SUPPLEMENTARY INFORMATION section 

of this document for the date and time 

of the public meeting, closing dates for 

advance registration, and information 

on deadlines for submitting either 

electronic or written comments to FDA’s 

Division of Dockets Management. 

ADDRESSES: See section II, ‘‘How to 

Participate in the Public Meeting,’’ in 

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Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules 63347 

the SUPPLEMENTARY INFORMATION section 

of this document. 

FOR FURTHER INFORMATION CONTACT: 

For questions about registering for the 

meeting; to register by telephone; or to 

submit a notice of participation by mail, 

FAX, or email: 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. 

For general questions about the 

meeting; to request an opportunity to 

make an oral presentation at the public 

meeting; to submit the full text, 

comprehensive outline, or summary of 

an oral presentation; or for special 

accommodations due to a disability: 

Juanita Yates, Center for Food Safety 

and Applied Nutrition (HFS–009), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–1731, email: 

Juanita.yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FSMA (Pub. L. 111–353) was signed 

into law by President Obama on January 

4, 2011, to better protect public health 

by helping to ensure the safety and 

security of the U.S. food supply. FSMA 

amends the Federal Food, Drug, and 

Cosmetic Act to establish the foundation 

of a modernized, prevention-based food 

safety system. Among other things, 

FSMA requires FDA to issue regulations 

requiring preventive controls for human 

food and animal food, setting standards 

for produce safety, and requiring 

importers to verify that their foreign 

suppliers produce food that is as safe as 

food produced in the United States. 

FSMA was the first major legislative 

reform of FDA’s food safety authorities 

in more than 70 years, even though FDA 

has increased the focus of its food safety 

efforts on prevention over the past 

several years. Since January 2013, FDA 

has proposed seven foundational rules 

to implement FSMA: Produce Safety, 

Preventive Controls for Human Food, 

Preventive Controls for Animal Food, 

Foreign Supplier Verification Programs, 

Accreditation of Third-Party Auditors/ 

Certification Bodies to Conduct Food 

Safety Audits and to Issue 

Certifications, Focused Mitigation 

Strategies to Protect Food Against 

Intentional Adulteration, and Sanitary 

Transportation of Human and Animal 

Food. FDA conducted extensive 

outreach to industry, growers, academia, 

consumer groups, tribal governments, 

and the Agency’s counterparts at the 

Federal, State and local levels, and 

received thousands of comments on the 

proposals. 

In response to the comments received 

on some of the foundational FSMA 

proposed rules, which FDA continues to 

review, FDA issued supplemental 

notices of proposed rulemaking that 

propose significant changes to four of 

the proposed rules: Preventive Controls 

for Human Food, Produce Safety, 

Preventive Controls for Animal Food, 

and Foreign Supplier Verification 

Programs. FDA’s proposed changes are 

intended to provide more flexible, 

practical, and targeted approaches to 

ensuring a safe food supply system. 

In the Federal Register of September 

29, 2014 (79 FR 58523, 58433, 58475, 

and 58573), FDA announced the 

reopening of these four dockets so that 

the public can review the supplemental 

proposed rules and submit comments to 

the Agency. The Agency is accepting 

comments on the revised provisions of 

all four proposed rules until December 

15, 2014. No additional comments will 

be accepted on the original proposed 

rules. 

FDA is announcing a public meeting 

entitled ‘‘Food and Drug Administration 

Food Safety Modernization Act’’ so that 

the food industry, consumers, foreign 

governments, and other stakeholders 

can evaluate and comment on the 

supplemental proposals. The meeting is 

intended to facilitate and support the 

supplemental proposed rules’ 

evaluation and commenting process. 

For information on the supplemental 

proposed rules and related fact sheets, 

see FDA’s FSMA Web page located at 

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

FSMA/default.htm. 

II. How To Participate in the Public 

Meeting 

FDA is holding the public meeting on 

the supplemental proposed rules to 

inform the public about the rulemaking 

process, including how to submit 

comments, data, and other information 

to the rulemaking dockets; to respond to 

questions about the supplemental 

proposed rules; and to provide an 

opportunity for interested persons to 

make oral presentations. Due to limited 

space and time, FDA encourages all 

persons who wish to attend the meeting 

to register in advance. There is no fee 

to register for the public meetings, and 

registration will be on a first-come, firstserved basis. Early registration is 

recommended because seating is 

limited. Onsite registration will be 

accepted, as space permits, after all 

preregistered attendees are seated. Live 

Webcasting of the event is also being 

offered through the registration process. 

Those requesting an opportunity to 

make an oral presentation during the 

time allotted for public comment at the 

meeting are asked to submit a request 

and to provide the specific topic or 

issue to be addressed. Due to the 

anticipated high level of interest in 

presenting public comment and the 

number of supplemental proposals 

being addressed at the public meeting, 

time for making public comment is 

necessarily limited. FDA is allocating 3 

minutes to each speaker to make an oral 

presentation. Speakers will be limited to 

making oral remarks; there will not be 

an opportunity to display materials such 

as slide shows, videos, or other media 

during the meeting. If time permits, 

individuals or organizations that did not 

register in advance may be granted the 

opportunity to make an oral 

presentation. FDA would like to 

maximize the number of individuals 

who make a presentation at the meeting 

and will do our best to accommodate all 

persons who wish to make a 

presentation or express their opinions at 

the meeting. 

FDA encourages persons and groups 

who have similar interests to 

consolidate their information for 

presentation by a single representative. 

After reviewing the presentation 

requests, FDA will notify each 

participant before the meeting of the 

approximate time their presentation is 

scheduled to begin and remind them of 

the presentation format (i.e., 3-minute 

oral presentation without visual media). 

While oral presentations from specific 

individuals and organizations will be 

necessarily limited due to time 

constraints during the public meeting, 

stakeholders may submit electronic or 

written comments discussing any issues 

of concern to the administrative record 

(the docket) for the relevant rulemaking. 

All relevant data and documentation 

should be submitted with the comments 

to the appropriate docket (Docket Nos. 

FDA–2011–N–0920, FDA–2011–N– 

0921, FDA–2011–N–0922, and FDA– 

2011–N–0143). 

Table 1 of this document provides 

information on participation in the 

public meeting: 

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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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