20588 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Proposed Rules 

investigator has presented adequate 

assurances that the investigator will 

employ all test articles, and will 

conduct any clinical investigation that 

supports an application for a research or 

marketing permit for products regulated 

by FDA, solely in compliance with the 

applicable provisions of this chapter. 

Dated: April 7, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–8786 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2011–N–0251] 

FDA Food Safety Modernization Act: 

Focus on Preventive Controls for 

Facilities; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comment. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘FDA Food 

Safety Modernization Act: Focus on 

Preventive Controls for Facilities.’’ The 

purpose of the public meeting is to 

provide interested persons an 

opportunity to discuss implementation 

of the preventive controls for facilities 

provisions of the recently enacted FDA 

Food Safety Modernization Act (FSMA). 

FDA is seeking information on 

preventive controls used by facilities to 

identify and address hazards associated 

with specific types of food and specific 

processes. The public will have an 

opportunity to provide information and 

share views that will inform the 

development of guidance and 

regulations on preventive controls for 

food facilities that manufacture, process, 

pack or hold human food or animal food 

and feed (including pet food). 

DATES: See ‘‘How to Participate in the 

Meeting’’ in the SUPPLEMENTARY

INFORMATION section of this document. 

FOR FURTHER INFORMATION CONTACT: 

Patricia M. Kuntze, Office of External 

Affairs, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

rm. 5322, Silver Spring, MD 20993, 

301–796–8641, 

Patricia.Kuntze@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FSMA (Pub. L. 111–353) amends the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to establish the 

foundation for a modernized, 

prevention-based food safety system and 

gives FDA for the first time a legislative 

mandate to require comprehensive, 

science-based preventive controls across 

the food supply. 

In particular, section 103 of FSMA 

requires the owner, operator, or agent in 

charge of a facility that is required to 

register under section 415 of the FD&C 

Act (21 U.S.C. 350d) to take certain 

preventive actions, including to 

evaluate the hazards that could affect 

food manufactured, processed, packed, 

or held by the facility, and to identify 

and implement preventive controls to 

significantly minimize or prevent the 

occurrence of such hazards. FDA is 

required to develop regulations to 

establish science-based standards for 

conducting a hazard analysis, 

documenting hazards, implementing 

preventive controls, and documenting 

their implementation. 

In addition, FDA is required to issue 

guidance with respect to hazard analysis 

and preventive controls. Given the 

diversity of registered facilities and 

regulated foods, FDA will use the 

guidance to assist the food and feed 

industries in complying with the 

preventive controls regulations, when 

they are finalized. FDA will leverage, 

where appropriate, best practices for 

hazards and controls identified by 

industry for specific types of food and 

feed and specific methods in 

manufacturing, processing, packing, and 

holding food and feed. FDA is interested 

in making appropriate best practices 

publicly available. FDA is particularly 

interested in preventive control 

practices that are applicable and 

practical for small and very small 

businesses to implement. 

II. Purpose and Format of the Meeting 

If you wish to attend and/or present 

at the meeting scheduled for April 20, 

2011, please register by e-mail at 

http://www.blsmeetings.net/ 

FDAPreventiveControls by April 15, 

2011. FDA is holding the public meeting 

on section 103 of FSMA to receive input 

from the public to inform the 

development of the regulations and 

guidance identified previously in this 

document. FDA will also consider input 

it has received previously through its 

engagement of stakeholders as part of 

the process to examine and update 

current good manufacturing practice 

requirements and to develop an animal 

feed safety system. 

In general, the meeting format will 

include introductory presentations by 

FDA. Listening to our stakeholders is 

the primary purpose of this meeting. In 

order to meet this goal, FDA will 

provide multiple opportunities for 

individuals to actively express their 

views by making presentations at the 

meeting, participating in a total of three 

75-minute break-out sessions on the 

provisions discussed at the meeting, and 

submitting written comments to the 

docket within 30 days after this 

meeting. (Participants can select up to 

three of the following five break-out 

sessions: Preventive Controls Guidance, 

On-Farm Manufacturing and Small 

Business, Product Testing and 

Environmental Monitoring, Training 

and Technical Assistance, and 

Preventive Controls and the 

Relationship to cGMPs.) There will be 

an interactive Webcast; see section III of 

this document, ‘‘How to Participate in 

the Meeting.’’ In order to provide 

Webcast participants with information 

before and after the meeting, we request 

attendees provide their name, their 

affiliation, and email when registering. 

III. How To Participate in the Meeting 

Stakeholders will have an opportunity 

to provide oral comments. Due to 

limited space and time, FDA encourages 

all persons who wish to attend the 

meeting, including those requesting an 

opportunity to make an oral 

presentation during the time allotted for 

public comment at the meeting, to 

register in advance and to provide the 

specific topic or issue to be addressed 

and the approximate desired length of 

their presentation. Depending on the 

number of requests for such oral 

presentations, there may be a need to 

limit the time of each oral presentation 

(e.g., 3 minutes each). If time permits, 

individuals or organizations that did not 

register in advance may be granted the 

opportunity for such an oral 

presentation. FDA would like to 

maximize the number of stakeholders 

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 views at 

the meeting. FDA anticipates that there 

will be several opportunities to speak in 

break-out sessions and an interactive 

Webcast will also be available for 

stakeholders who are not onsite. 

FDA encourages persons and groups 

who have similar interests to 

consolidate their information for 

presentation through a single 

representative. After reviewing the 

presentation requests, FDA will notify 

each participant before the meeting of 

the amount of time available and the 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Proposed Rules 20589 

approximate time their presentation is 

scheduled to begin. 

There is no fee to register for the 

public meeting and registration will be 

on a first-come, first-served basis. Early 

registration is recommended because 

seating is limited. Onsite registration 

will be accepted after all preregistered 

attendees are seated. 

Table 1 of this document provides 

information on participating in the 

meeting and on submitting comments to 

the docket. 

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

Date Electronic address Address (non-electronic) Other information 

Date of Public Meeting ............ April 20, 2011, 9 a.m. to 5:30 

p.m.

.................................................. FDA White Oak Campus, The 

Great Room, Bldg. 31, rm. 

1503, 10903 New Hampshire Ave., Silver Spring, MD 

20993.

Registration begins at 7:30 

a.m. 

Webcast ................................... April 20, 2011, 9 a.m. to 5:30 

p.m.

https://collaboration.fda.gov/ 

preventivecontrols/.

.................................................. • If you have never attended a 

ConnectPRO meeting: Test 

your connection: https://collaboration.fda.gov/common/

help/en/support/meeting_test.htm. Get a quick 

overview: http://

www.adobe.comgo/ 

connectpro_overview.1

• The webcast will provide 

closed captioning. 

Advance Registration ............... By April 15, 2011 ..................... http://www.blsmeetings.net/

FDAPreventiveControls.

.................................................. Registration to attend the 

meeting will also be accepted onsite on the day of the 

meeting, as space permits. 

Registration information may 

be posted without change to 

http://www.regulations.gov, 

including any personal information provided. 

Request special accommodations due to disability.By April 15, 2011 ..................... .................................................. Patricia M. Kuntze, 301–796– 

8641, email: Patricia.Kuntze

@fda.hhs.gov.

Make a request for oral presentation.By April 15, 2011 ..................... http://www.blsmeetings.net/

FDAPreventiveControls.

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

the meeting to make an oral 

presentation may be granted 

as 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. 

Provide a brief description of 

the oral presentation and 

any written material for the 

presentation.

By April 15, 2011 ..................... http://www.blsmeetings.net/

FDAPreventiveControls.

.................................................. Written material associated 

with an oral presentation 

should be submitted in 

Microsoft PowerPoint, Microsoft Word, or Adobe Portable Document Format 

(PDF) and may be posted 

without change to http:// 

www.regulations.gov, including any personal information 

provided. 

Submit electronic or written 

comments.

Submit comments by May 20, 

2011.

Federal eRulemaking Portal: 

http://www.regulations.gov. 

Follow the instructions for 

submitting comments.

FAX: 301–827–6870. Mail/ 

Hand delivery/Courier (for 

paper, disk, or CD–ROM 

submissions): Division of 

Dockets Management (HFA– 

305), Food and Drug Administration, 5630 Fishers Lane, 

rm. 1061, Rockville, MD 

20852.

All comments must include the 

Agency name and the docket number in brackets in the 

heading of this document. All 

received comments may be 

posted without change to 

http://www.regulations.gov, 

including any personal information provided. FDA encourages the submission of 

electronic comments by 

using the Federal 

eRulemaking Portal. For additional information on submitting comments, see the 

‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of this document. 

1Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or 

other countries. 


srobinson on DSKHWCL6B1PROD with PROPOSALS
20590 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Proposed Rules 

IV. Comments 

Regardless of attendance at the public 

meeting, interested persons may submit 

to the Division of Dockets Management 

(see table 1 of this document) either 

electronic or written comments for 

consideration at or after the meeting in 

addition to, or in place of, a request for 

an opportunity to make an oral 

presentation. It is only necessary to send 

one set of comments. It is no longer 

necessary to send two copies of mailed 

comments. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

V. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http://www.regulations.gov 

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

FoodSafety/FSMA/default.htm. It may 

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 Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: April 7, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–8785 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF STATE 

22 CFR Parts 120 and 124 

[Public Notice: 7415] 

RIN 1400–AC80 

International Traffic in Arms 

Regulations: Defense Services 

AGENCY: Department of State. 

ACTION: Proposed rule. 

SUMMARY: The Department of State 

proposes to amend the International 

Traffic in Arms Regulations (ITAR) to 

update the policy regarding defense 

services, to clarify the scope of activities 

that are considered a defense service, 

and to provide definitions of 

‘‘Organizational-Level Maintenance,’’ 

‘‘Intermediate-Level Maintenance,’’ and 

‘‘Depot-Level Maintenance,’’ and to 

make other conforming changes. 

DATES: The Department of State will 

accept comments on this proposed rule 

until June 13, 2011. 

ADDRESSES: Interested parties may 

submit comments within 60 days of the 

date of the publication by any of the 

following methods: 

• E-mail: 

DDTCResponseTeam@state.gov with the 

subject line, ‘‘Regulatory Changes— 

Defense Services.’’ 

• Mail: PM/DDTC, SA–1, 12th Floor, 

Directorate of Defense Trade Controls, 

Office of Defense Trade Controls Policy, 

ATTN: Regulatory Changes—Defense 

Services, Bureau of Political Military 

Affairs, U.S. Department of State, 

Washington, DC 20522–0112. 

• Internet: View this notice by 

searching for its RIN on the U.S. 

Government regulations Web site at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Director Charles B. Shotwell, Office of 

Defense Trade Controls Policy, 

Department of State, Telephone (202) 

663–1282 or Fax (202) 261–8199; E-mail 

DDTCResponseTeam@state.gov. ATTN: 

Regulatory Changes—Defense Services. 

SUPPLEMENTARY INFORMATION: As part of 

the President’s Export Control Reform 

effort, the Department of State is 

proposing to amend parts 120 and 124 

of the ITAR to reflect new policy 

regarding coverage of defense services. 

The Department reviewed the ITAR’s 

treatment of defense services with a 

view to enhancing support to allies and 

friends, improving efficiency in 

licensing, and reducing unintended 

consequences. As a result, it was 

determined that the current definition of 

defense services in § 120.9 is overly 

broad, capturing certain forms of 

assistance or services that do not 

warrant ITAR control. The proposed 

change in subpart (a) of the definition of 

‘‘defense services’’ narrows the focus of 

services to furnishing of assistance 

(including training) using ‘‘other than 

public domain data’’, integrating items 

into defense articles, or training of 

foreign forces in the employment of 

defense articles. Consequently, services 

based solely upon the use of public 

domain data would not constitute 

defense services under this part of the 

definition and, therefore, would not 

require a license, technical assistance 

agreement, or manufacturing license 

agreement to provide to a foreign 

person. The proposed new definition of 

defense service also includes a new 

provision that would control the 

‘‘integration’’ of items, whether 

controlled by the U.S. Munitions List 

(USML) or the Commerce Control List 

(CCL), into USML controlled defense 

articles even if ITAR-controlled 

‘‘technical data’’ is not provided to a 

foreign person during the provision of 

such services. Additionally, the new 

rule specifies that training for foreign 

‘‘units or forces’’ will be considered a 

defense service only if the training 

involves the employment of a defense 

article, regardless of whether technical 

data is involved. This operational 

definition improves upon the current 

open-ended wording of § 120.9(a)(3), 

which covers ‘‘military training of 

foreign units and forces.’’ Also, 

significantly, the proposed new rule 

specifies in subpart (b) examples of 

activities that do not constitute defense 

services. For example, the proposed 

new rule would prevent the anomalous 

situation where foreign companies are 

reluctant to hire U.S. citizens for fear 

that such employment alone constitutes 

a defense service, even where no 

technical data would be transferred to 

the employer. 

A new § 120.38 is proposed to provide 

definitions for ‘‘Organizational-Level 

Maintenance’’ (or basic level 

maintenance), ‘‘Intermediate-Level 

Maintenance,’’ and ‘‘Depot-Level 

Maintenance,’’ terms used in the 

proposed revision of § 120.9. 

The Department proposes to make 

several other conforming changes to the 

ITAR. The proposed rule modifies 

§ 124.1(a), which describes the approval 

requirements of manufacturing license 

agreements and technical assistance 

agreements. The proposed change 

removes the requirement in § 124.1(a) to 

seek the Directorate of Defense Trade 

Controls’ approval if the defense service 

that is being rendered uses public 

domain data or data otherwise exempt 

from ITAR licensing requirements. This 

change would be made to conform with 

the revisions made to § 120.9. The 

Department proposes to delete 

§ 124.2(a), as this requirement is no 

longer applicable as a result of proposed 

changes to § 120.9. Conforming changes 

are to be made to § 124.2(c) to reflect the 

proposed deletion of § 124.2(a). 

This proposed rule was presented to 

the Defense Trade Advisory Group 

(DTAG), a Department of State advisory 

committee, for purposes of comment 

and evaluation. The DTAG commented 

favorably on most aspects of this 

proposed rule, but also recommended 

certain changes. Having thoroughly 

reviewed and evaluated the comments 

and the recommended changes, the 

Department has determined that it will 

proceed with the proposed rule per the 

Department’s evaluation of the written 

comments and recommendations as 

follows: 


srobinson on DSKHWCL6B1PROD with PROPOSALS