13642 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

presentation may be granted if time 

permits. 

Persons who registered in advance for 

the hearing should check in at the onsite 

registration desk between 8:30 a.m. and 

9 a.m. Persons who wish to register 

onsite on the day of the hearing should 

do so at the registration desk between 

8:30 a.m. and 9 a.m. FDA encourages all 

participants to attend the entire hearing. 

V. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

table 1 of this document) either 

electronic or written comments 

regarding this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed 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. 

VI. 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. 

VII. References 

The following references are on 

display at the Division of Dockets 

Management (see Transcripts), between 

9 a.m. and 4 p.m., Monday through 

Friday. (FDA has verified the following 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. President’s Food Safety Working 

Group findings, http:// 

www.foodsafetyworkinggroup.gov/ 

ContentKeyFindings/ 

HomeKeyFindings.htm. 

2. Codex Guidelines on the Judgment 

of Equivalence of Sanitary Measures 

Associated with Food Inspection and 

Certification systems (CAC/GL 53/2003): 

http://www.codexalimentarius.net/ 

download/standards/10047/ 

CXG_053e.pdf. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5943 Filed 3–10–11; 4:15 pm] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Town Hall Discussion With the Director 

of the Center for Devices and 

Radiological Health and Other Senior 

Center Management 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘Town Hall Discussion With the 

Director of the Center for Devices and 

Radiological Health and Other Senior 

Center Management.’’ The purpose of 

this public meeting in the Orlando, FL, 

area is to engage in a dialogue about 

issues of importance to FDA’s Center for 

Devices and Radiological Health (CDRH) 

and to members of the public, including 

the medical device industry, health care 

professionals, patients, and consumers. 

Date and Time: The public meeting 

will be held on May 5, 2011, from 8 a.m. 

to 12 noon EST. 

Location: The public meeting will be 

held at the Sheraton Orlando Downtown 

Hotel, 400 West Livingston St., Orlando, 

FL 32801. Attendees requiring sleeping 

rooms should call 401–843–6664 and 

request the group rate for the ‘‘Food & 

Drug Administration Town Hall 

Meeting’’ room block. The meeting will 

not be videotaped or Web cast. 

Contact: Heather Howell, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4320, 

Silver Spring, MD 20993, 301–796– 

5718, e-mail: 

heather.howell@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: If you wish to attend the 

public meeting, you must register online 

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

NewsEvents/WorkshopsConferences/ 

ucm244462.htm. Persons without 

Internet access may call Heather Howell 

at 301–796–5718 to register for the 

meeting. 

Provide complete contact information 

for each attendee, including name, title, 

company or organization, address, 

email, and telephone and fax number. 

Registration requests must be received 

by 5 p.m. EST on Friday, April 22, 2011. 

If you wish to make an oral 

presentation during any of the sessions 

at the meeting (see section II of this 

document), you must indicate this at the 

time of registration. FDA will do its best 

to accommodate requests to speak. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. 

Registration is free and will be on a 

first-come-first-served basis. Early 

registration is recommended because 

seating is limited. FDA may limit the 

number of participants from each 

organization based on space limitations. 

Registrants will receive confirmation 

once they have been accepted. Onsite 

registration the day of the public 

meeting will be provided on a spaceavailable basis beginning at 7 a.m. EST. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan, 301–796–5661 or 

susan.monahan@fda.hhs.gov, at least 7 

days in advance of the meeting. 

Comments: FDA is holding this public 

meeting to share information and 

discuss issues of importance to the 

public, including the medical device 

industry, health care professionals, 

patients, and consumers. 

Regardless of attendance at the public 

meeting, interested persons may submit 

either electronic or written comments. 

Submit electronic comments 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. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In 2010, CDRH held three Town Hall 

meetings in Minneapolis, MN, Boston, 

MA, and Los Angeles, CA, to provide 

the public with a new venue to discuss 

issues of interest with the Center. Any 

member of the public was invited to 

provide comments to or ask questions of 

CDRH participants. We received 

positive feedback on these meetings and 

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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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