29560 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices 

(OCRA), Attention to Detail, 5319 

University Dr., suite 641, Irvine, CA 

92612, Voice: 949–387–9046, FAX: 949– 

387–9047, Web site: www.ocra-dg.org. 

Registration and Meeting Information: 

See OCRA’s Web site at www.ocradg.org. Contact Attention to Detail at 

949–387–9046. 

Registrations fees are as follows: 

$725.00 for members, $775.00 for nonmembers, and $475.00 for FDA/ 

Government/Students. OCRA student 

rate applies to those individuals 

enrolled in a regulatory or quality 

related academic program at an 

accredited institution. Proof of 

enrollment is required. 

The registration fee will cover actual 

expenses including refreshments, lunch, 

materials, parking, and speaker 

expenses. 

If you need special accommodations 

due to a disability, please contact Linda 

Hartley (see Contact) at least 10 days in 

advance. 

Dated: May 20, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–12615 Filed 5–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0237] 

Identifying Unmet Public Health Needs 

and Facilitating Innovation in Medical 

Device Development; Notice of Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Identifying Unmet Public 

Health Needs and Facilitating 

Innovation in Medical Device 

Development.’’ The purpose of the 

workshop is to obtain public input on 

what are the most important unmet 

public health needs and what are the 

barriers to the development of medical 

devices that can cure, significantly 

improve, or prevent these illnesses and 

injuries. 

Dates and Times: This workshop will 

be held on June 24, 2010, from 8 a.m. 

to 5 p.m. Persons interested in attending 

the meeting must register by 5 p.m. on 

June 10, 2010. Submit electronic or 

written comments by July 23, 2010. 

Location: The public workshop will 

be held at Hilton Washington DC/North 

Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Melanie Fleming, 

Office of the Center Director, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 5407, 

Silver Spring, MD 20993, 301–796– 

5424, FAX: 301–847–8510, 

melanie.fleming@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Interested persons may 

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

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm 

(select the appropriate meeting from the 

list). Registrants must provide the 

following information: (1) name, (2) 

title, (3) company or organization (if 

applicable), (4) mailing address, (5) 

telephone number, and (6) e-mail 

address. There is no registration fee for 

the public workshop. Early registration 

is recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 7:30 

a.m. 

If you wish to make an oral 

presentation during any of the open 

comment sessions at the meeting (see 

section II of this document), you must 

indicate this at the time of registration. 

FDA requests that presentations focus 

on the areas defined in section III of this 

document. You should also identify 

which discussion topic you wish to 

address in your presentation and you 

must submit a brief statement that 

describes your experience and/or 

expertise relevant to your proposed 

presentation. In order to keep each open 

session focused on the discussion topic 

at hand, each oral presentation should 

address only one discussion topic. FDA 

will do its best to accommodate requests 

to speak. 

If you need special accommodations 

due to a disability, please contact 

Melanie Fleming (see Contact Person) at 

least 7 days in advance. 

Comments: FDA is holding this public 

workshop to obtain information on a 

number of specific questions regarding 

unmet public health needs and steps the 

Federal Government can take to reduce 

barriers to the development of medical 

devices that can cure, significantly 

improve, or prevent these illnesses and 

injuries. The deadline for submitting 

comments regarding this public 

workshop is July 23, 2010. 

Regardless of attendance at the public 

workshop, interested persons may 

submit electronic comments to http:// 

www.regulations.gov, or 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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. In addition, 

when responding to specific questions 

as outlined in section III of this 

document, please identify the question 

you are addressing. 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 

FDA’s Center for Devices and 

Radiological Health (CDRH) has 

undertaken an initiative to proactively 

facilitate medical device innovation to 

address unmet public health needs 

defined as illnesses and injuries that 

meet the following criteria: (1) Are 

serious or have moderate adverse 

impact on health, but affect many 

individuals; (2) could be cured, 

significantly improved, or prevented by 

the development or redesign of a device; 

and (3) the device(s) is not being 

developed or redesigned due to barriers 

that the Federal Government can 

directly or indirectly remove or 

minimize, where those barriers are out 

of proportion to what is warranted 

based on the public health needs. 

Medical device development and/or 

redesign is responsible for significant 

public health benefits, including the 

prevention, treatment, diagnosis, and 

monitoring of serious or life-threatening 

diseases and improved quality of life. 

However, unnecessary barriers to 

market may exist either due to market 

failures or regulatory inefficiencies. For 

example, payment practices can affect 

financial incentives for manufacturers to 

develop a new or improved technology. 

A predictable and consistent regulatory 

pathway can encourage would-be 

innovators to invest in the development 

of an innovative device. 

As part of this initiative, CDRH 

established a Council on Medical Device 

Innovation composed of participants 

from federal agencies. Agencies 

represented include the National 

Institutes of Health, the Centers for 

Disease Control and Prevention, the 

Centers for Medicare and Medicaid 

Services, the Agency for Healthcare 

Research and Quality, the Department of 

Defense, the Defense Advanced 

Research Projects Agency, and the 

Department of Veterans Affairs. The 

purpose of the Council is to identify the 

most important unmet public health 

needs, the barriers to innovative 

medical device development or redesign 

that could address those needs, and 

actions the Federal Government can 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices 29561 

take to reduce those barriers while 

assuring the safety, effectiveness, and 

quality of medical devices marketed in 

the United States. 

The Council seeks input from a wide 

range of constituencies to include but 

not be limited to industry, academia, 

patient/consumer advocacy groups, 

professional organizations, and other 

State and Federal bodies under aligned 

public health missions, to address the 

issues outlined in this document. 

During the public workshop, there 

will be an open dialogue between 

Federal Government Council members 

and experts from the private and public 

sectors regarding the topics described in 

this document. Workshop participants 

will not be expected to develop 

consensus recommendations, but rather 

to provide their perspectives on priority 

areas in which medical device 

innovations can have the highest 

positive impact on public health. 

Participants will also be encouraged to 

comment on devices not being 

developed or redesigned due to barriers 

that the Federal Government can and 

should directly or indirectly remove or 

minimize. 

Additional information on the public 

workshop, including an agenda, will be 

made available in advance of June 24, 

2010, at http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm 

(select the appropriate meeting from the 

list). 

II. Public Participation 

If you wish to make an oral 

presentation during the public 

workshop, you must indicate this at the 

time of registration. There are two types 

of opportunities for participation 

planned for the public workshop. In 

one, formal presentations will address 

one of the two topics (see section III of 

this document) that will be limited to 15 

minutes and require submission of the 

presentation in advance of the meeting. 

The other will be time-limited, based on 

the number of requests, as part of the 

public comment period. When 

registering, you will be required to 

identify the title of the topic you wish 

to address in your presentation and 

answer all the related questions on the 

web registration form. FDA will do its 

best to accommodate requests to present 

and will focus discussions to the topics 

described in this document (see section 

III of this document). Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and to request time for 

joint presentations. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is to begin. 

III. Issues for Discussion 

The workshop will focus on three 

topics: (1) Identification of the most 

important unmet public health needs; 

(2) delineation of the barriers to the 

development, redesign, and patient and 

healthcare professional access to 

medical devices that can cure, 

significantly improve, or prevent these 

illnesses or injuries; and (3) 

identification of the actions the Federal 

Government can take to remove or 

minimize these barriers. The discussion 

of these general topics should not be 

limited by current statutes or 

regulations and will include, but not be 

limited to, discussion of the following 

questions: 

1. Identifying areas of public health 

need: 

a. Which unmet public health needs 

could be most effectively addressed by 

the development of new, or the redesign 

of existing, medical devices? 

b. How should the Council set 

priorities amongst the identified public 

health needs? Are there specific factors 

that should be considered? If so, which 

and why? 

2. Addressing barriers to development 

and/or redesign of medical devices: 

a. What are the significant barriers 

facing innovators, academics, and/or 

industry that limit the availability and 

clinical use of medical devices that have 

the potential to improve public health? 

b. How should any perceived or 

actual barriers be evaluated to 

determine whether federal intervention 

is appropriate? 

c. How should federal agencies— 

including those present and others not 

represented—address those barriers that 

are out of proportion to what is 

warranted based on the public health 

needs? 

IV. Transcripts 

Please be advised that as soon as a 

transcript is available, it can be obtained 

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. A transcript 

of the public workshop will be available 

on the Internet at http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm 

(select the appropriate meeting from the 

list). 

Dated: May 20, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–12588 Filed 5–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Surveillance, 

Natural History, Quality of Care and 

Outcomes of Diabetes Mellitus with 

Onset in Childhood and Adolescence, 

RFA DP 10–001, Initial Review 

Correction: This notice was published 

in the Federal Register on March 22, 

2010, volume 75, Number 54, Page 

13560. The Place and time should read 

as follows: 

Time and Date: 8:30 a.m.–6 p.m., June 

15, 2010 (Closed). 

Place: W Hotel, 3377 Peachtree Road, 

NE., Atlanta, GA 30326, Telephone: 

678–500–3100. 

Contact Person for More Information: 

Donald Blackman, Ph.D., Scientific 

Review Officer, National Center for 

Chronic Disease Prevention and Health 

Promotion, Office of the Director, 

Extramural Research Program Office, 

4770 Buford Highway, NE., Mailstop K– 

92, Atlanta, GA 30341, Telephone: (770) 

488–3023, E-mail: DBY7@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: May 20, 2010. 

Andre Tyler, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2010–12627 Filed 5–25–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0004] 

[FDA 225–09–0012] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and Drugs.Com 

AGENCY: Food and Drug Administration, 

HHS. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1