13638 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

Internet for easy access to information 

including text, graphics, and files that 

you may download to a personal 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards related 

documents. After publication in the 

Federal Register, this notice 

announcing ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 026’’ will be available on the 

CDRH home page. You may access the 

CDRH home page at http://www.fda.gov/ 

MedicalDevices. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ at http://www.fda.gov/

MedicalDevices/DeviceRegulationand

Guidance/Standards. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

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

DeviceRegulationandGuidance/ 

Standards/ucm123792.htm. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) 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. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

026. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: March 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5815 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0135] 

Ensuring the Safety of Imported Foods 

and Animal Feed: Comparability of 

Food Safety Systems and Import 

Practices of Foreign Countries; Public 

Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing regarding new FDA 

initiatives for ensuring the safety of 

foods and animal feed imported into the 

United States. The purpose of the public 

hearing is 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. In a separate notice 

published elsewhere in this issue of the 

Federal Register, FDA is announcing a 

1-day public meeting to discuss 

implementation of the imports 

provisions found in the FDA Food 

Safety Modernization Act (FSMA). 

DATES: See ‘‘How to Participate in the 

Hearing’’ in the SUPPLEMENTARY

INFORMATION section of this document. 

FOR FURTHER INFORMATION CONTACT: For 

questions about registration, to register 

orally, or to submit a notice of 

participation by mail, fax, or by e-mail: 

Courtney Treece, Planning Professionals 

Ltd., 1210 W. McDermott, suite 111, 

Allen, TX 75013, 704–258–4983, FAX: 

469–854–6992, e-mail: 

ctreece@planningprofessionals.com. 

For questions about the hearing, if 

special accommodations are needed 

due to a disability, to request onsite 

parking, or to submit the full text, 

comprehensive outline, or summary of 

an oral presentation: Juanita Yates, 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administation, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Federal Government and the food 

industry are pursuing proactive efforts 

to reduce the incidence of food borne 

illness. The President’s Food Safety 

Working Group (FSWG) has 

recommended that food regulators shift 

towards prioritizing prevention and 

move aggressively to implement 

sensible measures designed to prevent 

problems before they occur (Ref. 1). The 

newly enacted FSMA (Pub. L. 111–353) 

also embodies the principle of 

prevention by requiring those who 

produce and import food to have 

systems of preventive controls in place 

and empowering FDA to hold them 

accountable to meet their new 

responsibilities. 

FDA recognizes that to ensure the 

safety of imported foods and animal 

feed and fulfill its public health mission 

in a global age, it must embrace new 

approaches that take into account the 

entire supply chain and its complexity. 

Consistent with FSMA and the 

recommendation of the President’s 

FSWG, FDA is focusing on preventing 

problems at appropriate points along the 

global food supply chain. This public 

hearing is an opportunity for the Agency 

to obtain views from interested persons 

concerning certain key aspects of these 

food safety initiatives: (1) International 

comparability assessments and (2) 

gathering information on the policies, 

practices, and programs used by foreign 

regulators to ensure the safety of 

imported foods and animal feed. The 

public hearing will be conducted in 

accordance with part 15 (21 CFR part 

15), as described in the following 

paragraphs. (See ‘‘Notice of Hearing 

Under Part 15’’ in section III of this 

document.) 

FDA’s initiatives discussed at the 2- 

day public hearing align with and help 

support FSMA implementation. Day 

One of the hearing will open with a 

general discussion of FSMA from the 

perspectives of consumers, industry, 

legislators, and U.S. trading partners. 

Day Two will cover policies, practices, 

and programs used by foreign regulators 

to ensure the safety of imported foods 

and animal feed. In a separate notice 

published elsewhere in this issue of the 

Federal Register, FDA is announcing a 

1-day public meeting to discuss 

implementation of the imports 

provisions found in title III of FSMA. 

II. Topics for Discussion at the Hearing 

A. Day One of Hearing: International 

Comparability Assessments 

Under FDA’s proposed model, FDA 

will consider the food safety system of 

a foreign country to be ‘‘comparable’’ to 

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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13639 

the U.S. food safety system if, based on 

a complete assessment, FDA determines 

the foreign food safety system is: (1) 

Similar, though not identical, to the U.S. 

food safety system, (2) comprises 

elements that are analogous to those 

within the U.S. food safety system, and 

(3) a system for which FDA has 

determined provides the same level of 

public health protection as that of the 

United States. To help set regulatory 

priorities and improve the efficient use 

of FDA resources for import safety, FDA 

has developed a tool it proposes to use 

in assessing the overall food safety 

systems of other countries and 

comparing them to the U.S. food safety 

system. FDA will post the agenda prior 

to the hearing at http://www.fda.gov/ 

Food/NewsEvents/ 

WorkshopsMeetingsConferences/ 

ucm243781.htm. 

At this hearing, FDA will seek public 

comment on FDA’s proposed 

comparability assessment process. In 

particular, FDA will be inviting the 

public to share its views on the 

following topic areas: 

Comparability as a Tool 

1. What are the perceived benefits 

and/or disadvantages to FDA’s proposed 

comparability model? 

2. What would be reasonable 

incentives for a country to participate in 

a comparability assessment? 

3. What are the potential costs to the 

country undergoing a comparability 

determination and what would make 

the investment worthwhile? 

4. Is there a more appropriate term for 

comparability? If so, what is the more 

appropriate term and why is it more 

appropriate? 

5. How should comparability findings 

relate to the FSMA import safety 

provisions in title III (e.g., the importer 

verification and accredited third party 

provisions)? 

Maintaining Comparability Status 

1. For cases where a country’s food 

safety system has been determined to be 

comparable: How often should FDA 

review assessments? Are there specific 

changes to a food safety system or 

regulatory system that should trigger a 

visit to the country? 

2. Under what circumstances should 

comparability be revoked, and by what 

process? 

3. What are reasonable expectations 

for ongoing communication, updating, 

and affirmation of a comparability 

determination? 

Lessons Learned Through Equivalence 

The Agency recognizes that 

comparability determinations represent 

a novel construct, albeit there may be 

corollaries with certain equivalence 

determinations, such as those made by 

the United States Department of 

Agriculture’s Food Safety and 

Inspection Service under its statutory 

authorities. 

To gain insight from earlier work on 

equivalence and to inform efforts to 

assess comparability, FDA is requesting 

that countries share information on their 

experience with equivalence. FDA seeks 

information on the following issues: 

1. What measures do other countries 

take to ensure transparency throughout 

the equivalence determination process? 

2. What are the current practices in 

requesting translation of documents? 

3. What are the perceived resource 

savings associated with finding a 

country equivalent? 

4. Are cost benefit analyses available 

on equivalence determinations? 

5. Have any equivalence 

determinations been reversed, and, if so, 

under what circumstances? 

6. Are there data that demonstrate that 

equivalence determinations provide 

meaningful public health protections? 

B. Day One of Hearing: Update on Pilot: 

Comparability Review of New Zealand 

The United States and New Zealand 

have several Cooperative Arrangements 

with each other relating to food safety. 

To facilitate the renewal of existing 

Arrangements between the United 

States and New Zealand, the New 

Zealand Food Safety Authority agreed to 

participate in a pilot comparability 

assessment using FDA’s proposed 

model for international comparability 

assessment. An update on this 

comparability assessment process will 

be provided during the public hearing. 

C. Day One of Hearing: Update on 

European Union (EU) Molluscan Bivalve 

Equivalence Determination With 

Comparability Component 

During bilateral discussions early in 

2010, the United States and the EU 

addressed issues related to possible 

approaches to equivalence assessments. 

During these discussions, it was noted 

that the Codex Guidelines on the 

Judgment of Equivalence of Sanitary 

Measures Associated with Food 

Inspection and Certification systems 

(CAC/GL 53/2003) (Ref. 2) provides 

guidance on equivalence 

determinations. It was determined that 

the comparability framework would 

allow FDA to apply the Codex concept 

to its equivalence determinations, by 

providing an objective basis for 

documenting the knowledge, 

experience, and confidence that can be 

used to underpin further equivalence 

determinations. Currently, the United 

States and EU are in the process of 

conducting equivalence assessments of 

each other’s systems for shellfish. An 

update on the United States and EU 

equivalence assessments of each other’s 

systems for shellfish will be provided at 

the public hearing. 

D. Day Two of Hearing: Policies, 

Practices, and Programs Used by 

Foreign Regulators To Ensure the Safety 

of Imported Foods and Animal Feed 

FDA is interested in learning more 

about the policies, practices, and 

programs (including import and export 

certification programs) used by foreign 

regulators to ensure the safety of foods 

and animal feed imported into their 

countries and will engage directly with 

countries over the next several months 

to learn about their programs. Through 

these conversations with regulators from 

other countries, FDA is also interested 

in learning how countries measure the 

effectiveness of their import control and 

export certification activities. The 

information obtained from these 

conversations will allow FDA to explore 

using the innovation and improvements 

that are being adopted in other countries 

to improve the safety of imported food 

and animal feed products. For example, 

FDA seeks to better understand the 

control systems used by other countries 

for importation of ingredients used in 

processed food as well as the control 

systems for transshipment of products. 

During Day Two of the public hearing, 

FDA will seek input from countries and 

international organizations that have 

undertaken activities to gather 

information on currently implemented 

import policies, practices, and 

programs, and to provide capacity 

building assistance in support of safe 

imports. 

III. Notice of Hearing Under Part 15 

The Commissioner of Food and Drugs 

(the Commissioner) is announcing that 

the public hearing will be held in 

accordance with part 15. The hearing 

will be conducted by a presiding officer, 

accompanied by FDA senior 

management and staff with relevant 

expertise. 

Persons who wish to participate in the 

hearing (either by making an oral 

presentation or as a member of the 

audience) must file a notice of 

participation. (See table 1 and FOR

FURTHER INFORMATION CONTACT of this 

document, and ‘‘How to Participate in 

the Hearing’’ in section IV of this 

document.) By delegation from the 

Commissioner (Staff Manual Guide 

1410.21, section 1(G)(5)), the Assistant 

Commissioner for Policy has 

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13640 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

determined under § 15.20(c) that 

advance submissions of oral 

presentations are necessary for the panel 

to formulate useful questions to be 

posed at the hearing under § 15.30(e), 

and that the submission of a 

comprehensive outline or summary is 

an acceptable alternative to the 

submission of the full text of the oral 

presentation. FDA requests that 

individuals and organizations with 

common interests consolidate their 

requests for oral presentations and 

request time for a joint presentation 

through a single representative. After 

reviewing the notices of participation 

and accompanying information, the 

Agency will schedule each oral 

presentation and notify each participant 

of the time allotted to the presenter and 

the approximate time that the 

presentation is scheduled to begin. If 

time permits, interested persons who 

attend the hearing but did not submit a 

notice of participation in advance may 

be permitted to make an oral 

presentation at the conclusion of the 

hearing. The hearing schedule will be 

available at the hearing. After the 

hearing, the hearing schedule and a list 

of participants will be placed on file at 

the Division of Dockets Management 

(see table 1 of this document) under the 

docket number listed in brackets in the 

heading of this notice. To ensure timely 

handling of any mailed notices of 

participation, presentations, or 

comments, any outer envelope should 

be clearly marked with the docket 

number listed in brackets in the heading 

of this notice along with the statement 

‘‘Ensuring the Safety of Imported Foods 

and Animal Feed; Comparability of 

Food Safety Systems; Public Hearing 

Request for Comments.’’ Under 

§ 15.30(f), the hearing is informal, and 

the rules of evidence do not apply. No 

participant may interrupt the 

presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. 

Public hearings under part 15 are 

subject to the Agency’s policy and 

procedures for electronic media 

coverage of public administrative 

proceedings in part 10, subpart C (21 

CFR part 10, subpart C). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to the 

procedures and limitations in § 10.206, 

to videotape, film, or otherwise record 

Agency public administrative 

proceedings, including presentations by 

participants. The hearing will be 

transcribed as stipulated in § 15.30(b). 

Any persons requiring special 

accommodations to attend the hearing 

due to a disability should direct those 

needs to the contact person (see FOR

FURTHER INFORMATION CONTACT). 

To the extent that the conditions for 

the hearing, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

these provisions as specified in §§ 10.19 

and 15.30(h). In particular, § 15.21(a) 

states that the notice of hearing will 

provide persons an opportunity to file a 

written notice of participation with the 

Division of Dockets Management within 

a specified period of time. If the public 

interest requires, e.g., if a hearing is to 

be conducted within a short period of 

time, the notice may name a specific 

FDA employee and telephone number to 

whom an oral notice of participation 

may be given. If the public interest 

requires, the notice may also provide for 

submitting notices of participation at 

the time of the hearing. In this 

document, the conditions for the 

hearing specify that notices of 

participation be submitted 

electronically to an Agency Internet site, 

to a contact person (outside of FDA) 

who will accept notices of participation 

by mail, telephone, fax, or e-mail, or in 

person on the day of the hearing (as 

space permits). FDA is using these 

procedures for submitting notices of 

participation, rather than providing for 

the submission of notices of 

participation to the Division of Dockets 

Management, because the hearing is to 

be conducted within a short period of 

time and these procedures are more 

efficient. In addition, these procedures 

provide more flexibility to persons who 

wish to participate in the hearing than 

would be provided if participants were 

required to submit the notice of 

participation in writing to the Division 

of Dockets Management. By delegation 

from the Commissioner (Staff Manual 

Guide 1410.21, section 1(G)(5)), the 

Assistant Commissioner for Policy finds 

under § 10.19 that no participant will be 

prejudiced, the ends of justice will 

thereby be served, and the action is in 

accordance with law if notices of 

participation are submitted by the 

procedures listed in this notice rather 

than to the Division of Dockets 

Management. 

IV. How To Participate in the Hearing 

Advance registration by submission of 

a notice of participation is necessary to 

ensure participation and will be 

accepted on a first-come, first-served 

basis. Notices of participation may be 

submitted electronically (see table 1 of 

this document); FDA encourages the use 

of electronic means of advance 

registration. Notices of participation 

may also be submitted orally or by mail, 

fax, or e-mail (see FOR FURTHER

INFORMATION CONTACT). See table 1 of 

this document for the dates by which 

notices of participation must be 

submitted. A single copy of any notice 

of participation is sufficient. 

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

Date Electronic address Address (non-electronic) Other information 

Date of Hearing March 30, 

2011, 9 a.m. 

to 5 p.m.

March 31, 

2011, 9 a.m. 

to 1 p.m.

................................................... Harvey W. Wiley Building, First 

Floor Auditorium, Center for 

Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, 

MD 20740–3835.

Across the street from the College Park/University of Maryland Metro Station (Green 

Line).

Registration begins at 8:30 a.m. 

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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13641 

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

Date Electronic address Address (non-electronic) Other information 

Advance Registration.By March 21, 

2011.

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

NewsEvents/ 

WorkshopsMeetingsConferences/ucm243781.htm.

FDA encourages the use of 

electronic registration, if possible.1.

Registration to attend the hearing will 

also be accepted onsite on the day 

of the hearing, 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 21, 

2011.

................................................... Juanita Yates, 301–436–1731, 

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

Make a request 

for onsite 

parking.

By March 23, 

2011.

................................................... Juanita Yates (see previous 

row in the fourth column of 

this table).

Make a request 

for oral presentations.

By March 14, 

2011.

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

Provide a brief 

description of 

the oral presentation and 

any written 

material for 

the presentation.

By March 23, 

2011.

................................................... Juanita Yates, 301–436–1731, 

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

Written material associated with an oral 

presentation may be posted without 

change to http://www.regulations.gov. 

Submit written 

comments.

Submit comments by 

June 30, 

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 found 

in brackets in the heading of this 

document. All comments received 

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 ‘‘Request for 

Comments’’ heading of the SUPPLEMENTARY INFORMATION section 

of this document. 

1 Registrations or requests to make an oral presentation may be submitted by mail, fax, e-mail, or telephone by providing registration information (including name, title, business affiliation (if applicable), address, telephone number, fax number (if available), and e-mail address (if available)) (see FOR FURTHER INFORMATION CONTACT). 

The notice of participation must 

include the participant’s name, title, 

business affiliation (if applicable), 

address, telephone number, fax number 

(if available), and e-mail address (if 

available). If the participant wishes to 

request an opportunity to make an oral 

presentation during the open public 

comment period of the hearing, their 

notice of participation also must include 

the title of their presentation, the 

sponsor of the oral presentation (e.g., 

the organization paying travel expenses 

or fees), if any; and the approximate 

amount of time requested for the 

presentation. Presentations must be 

limited to the questions and subject 

matter identified in this document. 

Under § 15.20(c), if an opportunity to 

make an oral presentation is requested, 

the presentation must be submitted 

(either as the full text of the 

presentation, or as a comprehensive 

outline or summary). This may be done 

by e-mail or in writing. See table 1 of 

this document for the dates by which a 

presentation must be submitted. See 

table 1 and FOR FURTHER INFORMATION

CONTACT of this document for 

information on where to send a 

presentation. 

Individuals who request an 

opportunity to make an oral 

presentation will be notified of the 

scheduled time for their presentation 

prior to the hearing. Depending on the 

number of oral presentations, FDA may 

need to limit the time allotted for each 

oral presentation (e.g., 5 minutes each). 

Depending on the content of the 

presentations, the time allotted for oral 

presentations may vary. The Agency 

requests that interested persons and 

groups having similar interests 

consolidate their requests for oral 

presentation and present them through 

a single representative. If special 

accommodations are needed due to a 

disability, please inform the Agency (see 

table 1 and FOR FURTHER INFORMATION

CONTACT of this document). 

FDA will also accept registration 

onsite; however, space is limited. Onsite 

registration will be accepted on a firstcome, first-served basis and will be 

closed when the maximum seating 

capacity is reached. Requests for an 

opportunity to make a presentation from 

individuals or organizations that did not 

register in advance to make an oral 

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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 

mstockstill on DSKH9S0YB1PROD with NOTICES