62844 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 

record of the ACBSCT meeting. Meeting 

summary notes will be made available on the 

HRSA’s Program Web site at http:// 

bloodcell.transplant.hrsa.gov/ABOUT/ 

Advisory_Council/index.html. 

Those planning to attend are requested to 

register in advance. The draft meeting agenda 

and a registration form are available on the 

HRSA’s Program Web site at http:// 

bloodcell.transplant.hrsa.gov/ABOUT/ 

Advisory_Council/index.html. 

Registration also can be completed 

electronically at http://www.acbsct.com or 

submitted by facsimile to Lux Consulting 

Group, Inc., the logistical support contractor 

for the meeting, at fax number (301) 585– 

7741 Attn: Tristan Alexander. Individuals 

without access to the Internet who wish to 

register may call Tristan Alexander at (301) 

585–1261. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Stroup, Executive Secretary, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

5600 Fishers Lane, Room 12C–06, 

Rockville, Maryland 20857; telephone 

(301) 443–1127. 

Dated: October 6, 2010. 

Wendy Ponton, 

Director, Office of Management. 

[FR Doc. 2010–25646 Filed 10–12–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the CDC announces 

the following meeting of the 

aforementioned committee: 

Time and Date: 8:30 a.m.–3 p.m., October 

28, 2010. 

Place: CDC, 1600 Clifton Road, NE., 

Building 21, Rooms 1204 A/B, Atlanta, 

Georgia 30333. 

Status: Open to the public, limited only by 

the space available. The meeting room 

accommodates approximately 50 people. The 

public is welcome to participate during the 

public comment period. The public comment 

period is tentatively scheduled for 2:30 to 

2:45 p.m. 

Purpose: The committee will provide 

advice to the CDC Director on strategic and 

other broad issues facing CDC. 

Matters to be Discussed: The ACD, CDC 

will receive updates from the Global 

Workgroup; State, Tribal, Local and 

Territorial Workgroup; Surveillance and 

Epidemiology Workgroup; and the Policy 

Workgroup. The Ethics Subcommittee and 

National Biosurveillance Advisory 

Subcommittee will provide updates on their 

current activities. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Carmen Villar, M.S.W., Designated Federal 

Officer, ACD, CDC, 1600 Clifton Road, NE., 

M/S D–14, Atlanta, Georgia 30333. 

Telephone 404/639–7000. E-mail: 

GHickman@cdc.gov. The deadline for 

notification of attendance is October 25, 

2010. 

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 the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: October 5, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–25703 Filed 10–12–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Innovations in Technology for the 

Treatment of Diabetes: Clinical 

Development of the Artificial Pancreas 

(an Autonomous System); Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) and the National Institutes of 

Health (NIH) are announcing a public 

workshop entitled ‘‘Innovations in 

Technology for the Treatment of 

Diabetes: Clinical Development of the 

Artificial Pancreas (an Autonomous 

System).’’ The topics to be discussed are 

the current state of device systems for 

autonomous systems for the treatment of 

diabetes mellitus, the challenges in 

developing this expert system using 

existing technology, a discussion of the 

clinical expectations and success 

criteria for these systems, and a 

discussion of development plans for the 

transition of this device system toward 

an outpatient setting. 

Date and Time: The public workshop 

will be held on November 10, 2010, 

from 8 a.m. to 5 p.m. Persons interested 

in attending this meeting must register 

by 5 p.m. on November 3, 2010. 

Location: The meeting will be held at 

the Hilton Washington, DC North/ 

Gaithersburg Hotel, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact: Charles Zimliki, Food and 

Drug Administration, Center for Devices 

and Radiological Health (CDRH), 10903 

New Hampshire Ave., Bldg. 66, rm. 

2556, Silver Spring, MD 20993–0002, 

301–796–6297, Fax: 301–847–8109, email: Charles.Zimliki@fda.hhs.gov. 

Registration: Registration is free and 

will be on a first-come, first-served 

basis. To register for the public 

workshop, webinar or onsite attendance, 

please visit the following Web site: 

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

NewsEvents/WorkshopsConferences/ 

ucm226251.htm (select the appropriate 

meeting from the list). Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, e-mail, and 

telephone number. For those without 

Internet access, please call Victoria 

Wagman at 301–796–6581 to register. 

Registration requests should be received 

by 5 p.m. on November 3, 2010. Early 

registration is recommended because 

seating is limited and therefore FDA/ 

NIH may limit the number of 

participants from each organization. If 

time and space permits, onsite 

registration on the day of the public 

meeting will be provided beginning at 7 

a.m. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan (e-mail: 

Susan.Monahan@fda.hhs.gov) at least 7 

days in advance. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH has undertaken an initiative to 

proactively facilitate medical device 

innovation to address unmet public 

health needs. As part of this initiative, 

CDRH with NIH have focused on the 

development of the artificial pancreas 

(or Autonomous System) for the 

treatment of diabetes mellitus. An 

artificial pancreas is a medical device 

that links a glucose monitor to an 

insulin infusion pump where the pump 

automatically takes action (using a 

control algorithm) based upon the 

glucose monitor reading. As control 

algorithms can vary significantly, there 

are a variety of artificial pancreas 

systems currently under development. 

These systems can range from low 

glucose suspend, to control-to-range, to 

control-to-target, to bihormonal control 

where each device has different 

purposes or intended uses for 

controlling blood sugars. In addition, 

most research in this area uses existing 

medical device technology, which might 

limit the performance and evaluation of 

these systems. Given these device 

limitations, preliminary research has 

focused on evaluating these systems in 

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Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices 62845 

a hospital-based environment, where 

the risks to the patient are minimized. 

CDRH and NIH seek feedback on ways 

to overcome obstacles in the 

development of an artificial pancreas 

and what might be considered 

reasonable clinical expectations for 

systems considering the available 

existing technology. 

This public workshop is to seek input 

from a wide range of constituencies 

including 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 

notice. During the public workshop, 

there will be an open dialogue between 

Federal Government 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 the clinical 

development of these device systems. 

II. Issues for Discussion 

The workshop will focus on three 

topics: (1) Technical considerations 

when developing a clinical study 

design; (2) expectations of the various 

artificial pancreas device systems; and 

(3) a discussion of the various 

development plans for the Artificial 

Pancreas System. 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 preceding 

questions. 

III. Where can I find more information 

about this public workshop? 

Background information on the public 

workshop, registration information, the 

agenda, and other relevant information 

will be posted, as it becomes available, 

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

MedicalDevices/NewsEvents/ 

WorkshopsConferences/ 

ucm226251.htm. 

IV. 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. 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: October 5, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–25600 Filed 10–12–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Toxicology Program (NTP) 

Interagency Center for the Evaluation 

of Alternative Toxicological Methods 

(NICEATM): Workshop Series on Best 

Practices for Regulatory Safety 

Testing: Assessing the Potential for 

Chemically Induced Eye Injuries and 

Chemically Induced Allergic Contact 

Dermatitis (ACD) 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH), Department of Health and Human 

Services. 

ACTION: Announcement of a Workshop 

Series. 

SUMMARY: NICEATM and the 

Interagency Coordinating Committee on 

the Validation of Alternative Methods 

(ICCVAM) announce a planned series of 

workshops on ‘‘Best Practices for 

Regulatory Safety Testing.’’ The first two 

workshops in this series, ‘‘Best Practices 

for Assessing the Potential for 

Chemically Induced Eye Injuries’’ and 

‘‘Best Practices for Assessing the 

Potential for Chemically Induced 

Allergic Contact Dermatitis,’’ are 

planned for January 19 and 20, 2011, 

respectively. These one-day workshops 

will help participants gain a practical 

understanding of the theory and 

application of available in vitro and in 

vivo alternative test methods that can be 

used to evaluate the hazard potential of 

chemicals and products while avoiding 

or minimizing animal use and animal 

pain and distress. Participants will learn 

the strengths and weaknesses of 

available alternative test methods, 

become familiar with the types of data 

they provide, and learn how to use these 

data in regulatory safety assessments. 

Workshop topics will be of particular 

interest to those involved in conducting 

safety tests for chemically induced eye 

injuries and/or chemically induced 

ACD, those responsible for reviewing 

and approving study protocols prior to 

testing, and regulators who are expected 

to review data generated by the tests. 

The workshops are free and open to the 

public with attendance limited only by 

the space available. Those interested 

may register for one or both workshops. 

DATES: The workshop on ‘‘Assessing the 

Potential for Chemically Induced Eye 

Injuries’’ will be held on January 19, 

2011. The workshop on ‘‘Assessing the 

Potential for Chemically Induced 

Allergic Contact Dermatitis’’ will be held 

on January 20, 2011. Sessions for both 

workshops will begin at 8:30 a.m. and 

end at approximately 5 p.m. Individuals 

who plan to attend either or both 

workshops are asked to register with 

NICEATM by January 6, 2011. 

ADDRESSES: The workshops will be held 

at the William H. Natcher Conference 

Center, 45 Center Drive, NIH Campus, 

Bethesda, MD 20892. Persons needing 

special assistance in order to attend, 

such as sign language interpretation or 

other reasonable accommodation, 

should contact 919–541–2475 voice, 

919–541–4644 TTY (text telephone), 

through the Federal TTY Relay System 

at 800–877–8339, or e-mail to 

niehsoeeo@niehs.nih.gov. Requests 

should be made at least 14 days before 

the event. 

FOR FURTHER INFORMATION CONTACT: 

Correspondence should be sent by mail, 

fax, or e-mail to Dr. William S. Stokes, 

NICEATM Director, NIEHS, P.O. Box 

12233, MD K2–16, Research Triangle 

Park, NC 27709, (phone) 919–541–2384, 

(fax) 919–541–0947, (e-mail) 

niceatm@niehs.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

To protect workers and consumers, 

regulatory agencies require testing to 

determine if chemicals and products 

may cause illnesses or injuries. Each 

year, approximately 2 million eye 

injuries occur in the U.S., of which 

more than 40,000 result in permanent 

visual impairment. Data on consumer 

product-related eye injuries indicate 

that the most common products causing 

eye injuries in children under the age of 

10 are household cleaning chemicals 

and other chemical products. ACD is 

also a significant concern because skin 

diseases, including ACD, constitute the 

second most common category of 

occupational disease. ACD frequently 

develops in workers and consumers 

exposed to skin sensitizing products 

and chemicals, results in lost workdays, 

and can significantly diminish quality 

of life. 

To address these concerns, regulatory 

authorities require safety testing that 

can identify substances that may present 

these hazards. Tests for ocular and ACD 

hazards are two of the four most 

frequently conducted product safety 

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