Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13643 

plan to continue this activity in 2011 in 

three different locations. In March 2011, 

the meeting will be held in Dallas, TX. 

After this meeting, CDRH will host one 

more this year in the San Francisco, CA, 

area. 

II. Public Meeting 

The objective of this public meeting is 

to engage in a dialogue about issues that 

are of importance to the public. 

The public meeting will open with an 

introduction of CDRH senior staff in 

attendance. Following introductions, Dr. 

Jeffrey Shuren, the Director of CDRH, 

will describe CDRH’s strategic priorities 

for 2011. Members of the public will 

then be given the opportunity to present 

comments to CDRH senior staff followed 

by a question and answer session during 

which any member of the public may 

ask questions of the CDRH senior staff 

on any topic of interest. 

In advance of the meeting, additional 

information, including a meeting agenda 

with a speakers’ schedule, will be made 

available on the Internet. This 

information will be placed on file in the 

public docket (docket number found in 

brackets in the heading of this 

document), which is available at 

http://www.regulations.gov. This 

information will also be available at 

http://www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm (select the appropriate 

meeting from the list). 

III. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. 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: March 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5735 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2011–N–0134, FDA– 

2011–N–0143, FDA–2011–N–0144, FDA– 

2011–N–0145, and FDA–2011–N–0146] 

FDA Food Safety Modernization Act: 

Title III—A New Paradigm for 

Importers; 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: Title III—A 

New Paradigm for Importers.’’ The 

purpose of the public meeting is to 

provide interested persons an 

opportunity to discuss implementation 

of the import safety provisions of the 

recently enacted FDA Food Safety 

Modernization Act (FSMA). FDA is 

seeking information on importer 

verification, the Voluntary Qualified 

Importer Program, import certifications 

for food, and third-party accreditation. 

In a separate notice published elsewhere 

in this issue of the Federal Register, 

FDA is announcing a public hearing to 

provide stakeholders the opportunity to 

discuss FDA’s use of international 

comparability assessments as a 

mechanism to enhance the safety of 

imported foods and animal feed and 

lessons learned through equivalence 

determinations. The public hearing will 

include a separate discussion of FDA’s 

efforts to gather information from 

regulators in other countries regarding 

the regulatory policies, practices, and 

programs they currently use to ensure 

the safety of foods and animal feed 

imported into their countries. 

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 

that emphasizes accountability for 

domestic and foreign food and animal 

feed firms in the supply chain from farm 

to U.S. table. In particular, title III of 

FSMA significantly enhances FDA’s 

authority for oversight of the millions of 

food products that enter the United 

States each year and, among other 

things, requires FDA to develop 

regulations, guidance, and to otherwise 

implement the following provisions: 

Section 301. Foreign Supplier 

Verification Program (FSVP) requires 

importers to conduct risk-based foreign 

supplier verification activities to verify 

that imported food is not adulterated 

under section 402 of the FD&C Act (21 

U.S.C. 342) or misbranded under section 

403(w) of the FD&C Act (21 U.S.C. 

343(w)) (relating to allergens) and is 

produced in compliance with FDA’s 

preventive controls requirements and 

produce safety standards, where 

applicable. Facilities in compliance 

with FDA’s seafood, juice, or low-acid 

canned food products requirements are 

exempted in whole or in part from the 

FSVP requirements. The statute directs 

FDA to exempt, by notice in the Federal 

Register, importers of food imported 

into the United States in small 

quantities for research uses or for 

personal consumption. The statute 

further directs FDA to issue 

implementing regulations and guidance 

on FSVPs. 

Section 302. Voluntary qualified 

importer program (VQIP) requires FDA 

to establish a voluntary, user-fee funded 

program to expedite entry into the 

United States of imported food from 

eligible, qualified importers. To be 

eligible to participate in VQIP, an 

importer must offer food for importation 

from a facility that has a certification by 

an accredited third party. FDA will 

qualify eligible importers to participate 

in VQIP based on risk considerations. 

The statute directs FDA to issue 

guidance on participation in and 

compliance with VQIP. 

Section 303. Authority to require 

import certifications for food authorizes 

FDA, based on risk considerations, to 

require an article of food offered for 

import into the United States to be 

accompanied by certifications or other 

assurances that the food complies with 

relevant provisions of the FD&C Act. 

Certifications may be issued by 

designated foreign governments or 

accredited third parties. 

Section 307. Accreditation of thirdparty auditors directs FDA to establish 

a system for the recognition of 

accreditation bodies that accredit thirdparty auditors to issue certifications for 

purposes of the import certification for 

food and VQIP provisions described 

previously in this document. Foreign 

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13644 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

governments, foreign cooperatives, and 

any other third parties (including 

private entities) are eligible to be 

considered for accreditation as thirdparty auditors. The statute further 

provides that if FDA has not, within a 

specified timeframe, identified and 

recognized an accreditation body to 

meet the requirements of this provision, 

FDA may directly accredit third-party 

auditors. The statute directs FDA to 

issue implementing regulations, 

including provisions on conflicts of 

interest, financial ties, and 

unannounced audits, as well as model 

accreditation standards, including 

requirements for regulatory audit 

reports. 

In a separate notice published 

elsewhere in this issue of the Federal 

Register, FDA is announcing a public 

hearing March 30 and 31, 2011, to 

provide stakeholders the opportunity to 

discuss FDA’s use of international 

comparability assessments as a 

mechanism to enhance the safety of 

imported foods and animal feed and 

lessons learned through equivalence 

determinations. In addition, there will 

be a separate discussion of FDA’s efforts 

to gather information from regulators in 

other countries regarding the regulatory 

policies, practices, and programs they 

currently use to ensure the safety of 

foods and animal feed imported into 

their countries. 

II. Purpose and Format of the Meeting 

If you wish to attend and/or present 

at the meeting scheduled for March 29, 

2011, please register by e-mail to http:// 

www.blsmeetings.net/FDAImportSafety 

by March 22, 2011. FDA is holding the 

public meeting on the FSMA imports 

provisions to receive input from the 

public to inform the development of the 

regulations and guidance identified 

previously in this document. 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 break-out 

sessions on the provisions discussed at 

the meeting, and submitting written 

comments to the docket(s) (see table 2 

of this document for a list of docket 

numbers and corresponding sections of 

FSMA) within 30 days after this 

meeting. There will be an interactive 

webcast; see section III of this 

document, ‘‘How to Participate in the 

Meeting.’’ 

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 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. 

Table 1 of this document provides 

information on participating in the 

meeting and on submitting comments to 

the docket (see table 2 of this document 

for a list of docket numbers and 

corresponding sections of FSMA). 

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

Date Electronic address Address (non-electronic) Other information 

Date of Public 

Meeting.

March 29, 

2011, 9 a.m. 

to 5 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 ......... March 29, 

2011, 9 a.m. 

to 5 p.m.

https://collaboration.fda.gov/ 

foodsafety/.

................................................ • 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.com/go/connectpro_overview 1

• The webcast will provide closed captioning. 

Advance Registration.By March 22, 

2011.

http://www.blsmeetings.net/ 

FDAImportSafety.

................................................ 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 March 22, 

2011.

................................................ Patricia M. Kuntze, 301–796– 

8641, email: Patricia.

Kuntze@fda.hhs.gov.

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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13645 

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

Date Electronic address Address (non-electronic) Other information 

Make a request for 

oral presentation.

By March 22, 

2011.

http://www.blsmeetings.net/ 

FDAImportSafety.

................................................ 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 March 22, 

2011.

http://www.blsmeetings.net/ 

FDAImportSafety.

................................................ 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 

April 29, 

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 corresponding with 

the section of FSMA on which you are 

commenting (see table 2 of this document 

for a list of docket numbers and corresponding sections of FSMA). 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. 

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. Because multiple docket 

numbers are associated with this 

document, please include with your 

comments the docket number(s) that 

corresponds with the section of FSMA 

on which you are commenting (see table 

2 of this document for a list of docket 

numbers and corresponding sections of 

FSMA). 

TABLE 2 

Section of 

FSMA Topic Docket No. 

301 .................................................... Foreign supplier verification program ....................................................................... FDA–2011–N–0143 

302 .................................................... Voluntary qualified importer program ....................................................................... FDA–2011–N–0144 

303 .................................................... Authority to require import certifications for food ..................................................... FDA–2011–N–0145 

307 .................................................... Accreditation of third-party auditors ......................................................................... FDA–2011–N–0146 

Comments that address more than one 

docket must be filed with each docket 

to ensure consideration. 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: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5942 Filed 3–10–11; 4:15 pm] 

BILLING CODE 4160–01–P 

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