Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 25279 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Collaborative 

Interdisciplinary Team Ancillary Study. 

Date: June 10, 2010. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: D.G. Patel, PhD, Scientific 

Review Officer, Review Branch, DEA, 

NIDDK, National Institutes of Health, Room 

756, 6707 Democracy Boulevard, Bethesda, 

MD 20892–5452. (301) 594–7682. 

pateldg@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, NIDDK DEM 

Fellowships. 

Date: June 14–15, 2010. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Robert Wellner, PhD, 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 757, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452. (301) 594–4721. 

rw175w@nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, R13 Conference 

Review. 

Date: June 17, 2010. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892. 

Contact Person: D.G. Patel, PhD, Scientific 

Review Officer, Review Branch, DEA, 

NIDDK, National Institutes of Health, Room 

756, 6707 Democracy Boulevard, Bethesda, 

MD 20892–5452. (301) 594–7682. 

pateldg@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Bio Samples from 

Diabetes Clinical Studies. 

Date: July 13, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: D.G. Patel, PhD, Scientific 

Review Officer, Review Branch, DEA, 

NIDDK, National Institutes of Health, Room 

756, 6707 Democracy Boulevard, Bethesda, 

MD 20892–5452. (301) 594–7682. 

pateldg@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: April 29, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10895 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel, Pharmacogenomics 

of Preterm Birth Prevention and Treatment. 

Date: May 27, 2010. 

Time: 2 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Sathasiva B. Kandasamy, 

PhD, Scientific Review Administrator, 

Division of Scientific Review, National 

Institute of Child Health and Human 

Development, 6100 Executive Boulevard, 

Room 5B01, Bethesda, MD 20892–9304. (301) 

435–6680. skandasa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: April 28, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10893 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0217] 

Device Improvements to Reduce the 

Number of Under-Doses, Over-Doses, 

and Misaligned Exposures From 

Therapeutic Radiation; Public Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

requests for comments. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘Device Improvements to 

Reduce the Number of Under-doses, 

Over-doses, and Misaligned Exposures 

from Therapeutic Radiation.’’ The 

purpose of this meeting is to discuss 

steps that could be taken by 

manufacturers of linear accelerators, 

radiation therapy treatment planning 

systems, and radiation therapy 

simulators to help reduce 

misadministration and misaligned 

exposures. FDA is seeking input on this 

topic and requests comments on a 

number of related questions. 

Date and Time: The public meeting 

will be held on June 9 and 10, 2010, 

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

Location: The public meeting will be 

held at the Hilton Hotel Washington DC 

North/Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Simon Choi, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, rm. 

5400, Silver Spring, MD 20993, 301– 

796–5426; e-mail: 

simon.choi@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Persons interested in 

attending the public meeting must 

register by May 15, 2010. If you wish to 

attend the public meeting, you must 

register by e-mail at 

CDRHRadiationTherapy@fda.hhs.gov or 

by contacting Simon Choi (see Contact 

Person). Provide complete contact 

information for each attendee, including 

name, title, company or organization, 


jlentini on DSKJ8SOYB1PROD with NOTICES
25280 Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 

address, telephone number, and e-mail 

(if appropriate). 

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 on the day of the public 

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

If you wish to make an oral 

presentation during any of the sessions 

at the meeting (see section I of this 

document, Public Meeting), you must 

indicate this at the time of registration. 

FDA has included specific questions for 

comment in section II of this document, 

Questions for Comment. You should 

also identify the session(s) during which 

you would like to present, as well as the 

question(s) you would like to address in 

each session. In order to keep each 

session focused on the topic at hand, 

presentations given during each session 

should address only the topic specified 

for that session. 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. 

If you would like to participate in any 

of the four planned round-table 

discussions (see section I of this 

document, Public Meeting), you must 

indicate this interest at the time of 

registration, and also submit a brief 

statement that describes your 

experience with radiation therapy 

devices. FDA is seeking participants 

interested in engaging in one of four 

round-table discussions related to the 

presentations given during each of the 

earlier sessions of the meeting. Each 

round-table discussion will include no 

more than 10 non-FDA participants. 

Only one participant from an 

organization or company will be 

assigned to each discussion group. FDA 

will attempt to have a range of 

constituencies represented in each 

discussion group. Others in attendance 

at the public meeting will have an 

opportunity to listen to each round-table 

discussion. 

If you need special accommodations 

due to a disability, please contact Simon 

Choi (see Contact Person) at least 7 days 

in advance of the meeting. 

Comments: FDA is holding this public 

meeting to obtain information on a 

number of questions regarding steps 

manufacturers of radiation therapy 

devices could take to help reduce overdoses, under-doses, or misaligned 

exposures from therapeutic radiation. 

The deadline for submitting comments 

related to this public meeting is May 15, 

2010, by 5 p.m. EST. 

Regardless of attendance at the public 

meeting, interested persons may submit 

written or electronic comments. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Submit a single 

copy of electronic comments or two 

paper copies of any mailed comments, 

except that individuals may submit one 

paper copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. In addition, when 

responding to specific questions as 

outlined in section II 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. Public Meeting 

The objective of this public meeting is 

to discuss steps that could be taken by 

manufacturers of linear accelerators, 

radiation therapy treatment planning 

systems, and radiation therapy 

simulators to help reduce 

misadministration and misaligned 

exposures. FDA is seeking input on this 

topic and requests comments on a 

number of related questions. 

The public meeting will be held over 

the course of 2 days. Each day will be 

divided into two sessions. Day 1 will 

focus on equipment features that 

manufacturers should incorporate into 

radiation therapy devices (morning 

session) and software (afternoon 

session). Day 2 will focus on steps 

manufacturers should take to improve 

training of individuals who use these 

devices (morning session) and steps to 

improve quality assurance (QA) at 

medical facilities (afternoon session). 

During each session, members of the 

public may present oral comments 

related to the topic of that session. 

Specific questions for comment are 

listed in section II of this document, 

Questions for Comment. Individuals 

who are interested in giving an oral 

presentation during any of the sessions 

must indicate this interest at the time of 

registration and must also identify the 

session(s) at which they would like to 

present (see Registration and Requests 

for Oral Presentations). In order to keep 

each session focused on the topic at 

hand, each oral presentation should 

address only the topic specified for that 

session. Commentators are free to 

submit written comments on any 

topic(s) to the open docket (see 

Comments). FDA will schedule speakers 

for each session as time permits. 

To close each of the four sessions, 

FDA will hold a round-table discussion 

between FDA staff and selected 

participants representing a range of 

constituencies (for more information 

about participating in the round-table 

discussion, see Registration and 

Requests for Oral Presentations). The 

participants in each round-table 

discussion will remark on the 

presentations given during the session, 

engage in a dialogue with each other 

and FDA staff, and provide closing 

thoughts on the session. Round-table 

participants will not be asked to 

develop consensus opinions during the 

discussion, but rather to provide their 

individual perspectives. Others in 

attendance at the meeting will have an 

opportunity to listen to each round-table 

discussion. 

In advance of the public meeting, 

additional information, including a 

meeting agenda with a speakers’ 

schedule for each session, 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). 

II. Questions for Comment 

A. Device Improvements and Reporting 

1. Describe issues with 

misadministrations and your 

suggestions to address the safety issues. 

2. Are there any hardware and 

software features that manufacturers can 

build into radiation therapy devices to 

reduce underexposures, overexposures, 

or misaligned exposures to ionizing 

radiation during radiation therapy? 

3. What techniques do you 

recommend for improving therapists 

attention (e.g. a dead-man switch to 

assure operator attention). Should 

efforts to improve device safety features 

include: incorporation of access controls 

and audit capabilities into equipment to 

identify the specific user(s) of the device 

during any particular treatment? If so, 

why, and what access controls and audit 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 25281 

capabilities should be incorporated? If 

not, why not? 

4. If certain changes are desirable as 

additional safeguards for the devices, 

how feasible is it to retrofit existing 

units in the field? 

5. Should manufacturers standardize 

their display format to ensure that 

treatment settings, protocols, and 

collimator positions are displayed 

taking human factors into consideration 

and are recorded for physician review? 

6. Should manufacturers submit more 

data to FDA as part of their premarket 

submissions for approval or clearance of 

devices, related to the safety of these 

devices? If so, why, and what data 

should be submitted? If not, why not? 

7. Should there be a mandatory ‘‘timeout’’ built into the equipment, similar to 

what already has been implemented for 

surgical procedures, to confirm that all 

settings for the equipment are correct 

and allow adequate time for QA? If not, 

why not? 

8. Should manufacturers provide 

better instructions and specifics (i.e. QA 

methodology) for acceptance testing 

and/or commissioning due to new and/ 

or unique features/capabilities? If so, 

why and what should be included? 

9. Other than requiring a facility to 

report to FDA, how can FDA ensure that 

facilities report to FDA significant 

under-doses and over-doses? Should 

there be a quantitative metric used to 

define a medical event similar to that 

used by the Nuclear Regulatory 

Commission (e.g. +/- 20% variation 

from intended dose)? 

10. What prevents users from 

participating in voluntary reporting? 

11. How can FDA encourage reporting 

and prevent workarounds even when no 

clinically significant adverse event 

occurs? 

B. User Training 

1. Should manufacturers provide 

training to ensure equipment users have 

adequate understanding of equipment 

capabilities, operating principles for the 

technology, general information about 

patient dose, and specific dose-related 

equipment features? If so, why, and 

what training should be provided? If 

not, why not? 

2. If manufacturers provide such 

training, which personnel should 

receive it? In your response, please 

consider dosimetrists, physicists, 

radiation therapists or technologists in 

other specialties and departmental 

administrators as well as physicians in 

all medical specialties who may operate 

radiation therapeutic equipment. 

3. If manufacturers provide such 

training, what is the most effective 

timing for a new installation and how 

frequently should it be repeated for 

optimum implementation? Should 

manufacturers recommend an internal 

training program for use by the facility 

to insure continued staff competence? 

4. For software patches and upgrades, 

how is the software tested for hazard 

analysis, verification and validation? 

Should manufacturers perform 

additional testing to adequately test 

software patches? 

5. Would standardizing terminology 

and standardizing design of control 

panels facilitate safe use of the 

equipment? 

6. Should custom-tailored educational 

material, such as pamphlets, pocket 

cards, videos etc. that highlight unique 

features of the equipment, be provided 

with new equipment? 

C. Quality Assurance Measures 

1. Is there a model QA program that 

exists which is widely accepted? If so, 

please describe. 

2. What types of QA should be the 

responsibility of the facility, the 

physicist, the operator, others? 

3. Should manufacturers provide QA 

procedures to medical facilities and 

users of radiation therapy devices? If so, 

why, and what instructions should be 

provided? If not, why not? How 

extensive should they be? 

4. Should manufacturers provide 

training on QA practices? If so, why, 

what type of training should be 

provided, and to which personnel? If 

not, why not and who should? 

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. 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: May 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10754 Filed 5–6–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, May 

28, 2010, 12 p.m. to May 28, 2010, 2:30 

p.m., National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

which was published in the Federal 

Register on April 28, 2010, 75 FR 22412. 

The meeting has been changed to an 

Internet assisted meeting. The meeting 

time has been changed to 8 a.m. to 

7 p.m. The meeting location remains the 

same. The meeting is closed to the 

public. 

Dated: April 29, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10873 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, May 

19, 2010, 12 p.m. to May 19, 2010, 

5 p.m., Tata Communications, 2355 

Dulles Corner Boulevard, 7th Floor, 

Herndon, VA 20171 which was 

published in the Federal Register on 

April 26, 2010, 75 FR 21641. 

The meeting has been changed to a 

Hybrid meeting. The meeting date, time 

and location remain the same. The 

meeting is closed to the public. 

Dated: April 29, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10871 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Food Protection Workshop; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 


jlentini on DSKJ8SOYB1PROD with NOTICES