Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 8375 

Individuals requiring sign language 

interpretation or other special 

accommodations must contact the DFO via 

the contact information specified in the FOR

FURTHER INFORMATION CONTACT section of this 

notice by the date listed in the DATES section 

of this notice. 

This meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. We 

recommend that confirmed registrants arrive 

reasonably early, but no earlier than 45 

minutes prior to the start of the meeting, to 

allow additional time to clear security. 

Security measures include the following: 

• Presentation of government-issued 

photographic identification to the Federal 

Protective Service or Guard Service 

personnel. 

• Inspection of vehicle’s interior and 

exterior (this includes engine and trunk 

inspection) at the entrance to the grounds. 

Parking permits and instructions will be 

issued after the vehicle inspection. 

• Inspection, via metal detector or other 

applicable means of all persons brought 

entering the building. We note that all items 

brought into CMS, whether personal or for 

the purpose of presentation or to support a 

presentation, are subject to inspection. We 

cannot assume responsibility for 

coordinating the receipt, transfer, transport, 

storage, set-up, safety, or timely arrival of any 

personal belongings or items used for 

presentation or to support a presentation. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting. The public may not enter the 

building earlier than 45 minutes prior to the 

convening of the meeting. 

All visitors must be escorted in areas other 

than the lower and first floor levels in the 

Central Building. 

Authority: (Section 1868 of the Social 

Security Act (42 U.S.C. 1395ee) and section 

10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, 

section 10(a)).) 

Dated: February 18, 2010. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2010–3693 Filed 2–19–10; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0080] 

Device Improvements to Reduce 

Unnecessary Radiation Exposure From 

Medical Imaging; Public Meeting; 

Request for Comments 

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: ‘‘Device Improvements to 

Reduce Unnecessary Radiation 

Exposure From Medical Imaging.’’ The 

purpose of this meeting is to discuss 

steps that could be taken by 

manufacturers of devices used in 

computed tomography (CT) and in 

fluoroscopy that would help reduce 

unnecessary patient exposure to 

ionizing radiation during CT and 

fluoroscopic procedures. FDA is seeking 

input on this topic and requests 

comments on a number of related 

questions. 

Dates and Time: The public meeting 

will be held on March 30 and 31, 2010, 

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

in attending and/or participating in the 

meeting must register by 5 p.m. on 

March 15, 2010. Submit written or 

electronic comments by April 15, 2010. 

Location: The public meeting will be 

held at the Holiday Inn Gaithersburg, 2 

Montgomery Village Ave., Gaithersburg, 

MD 20879. The meeting will not be 

videotaped or webcast. 

Contact Person: Simon Choi, Food 

and Drug Administration, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 5400, 

Silver Spring, MD 20993–0002, 301– 

796–5426, e-mail: 

simon.choi@fda.hhs.gov. 

Registration: If you wish to attend the 

public meeting, you must register by emailing CDRHimaging

initiative@fda.hhs.gov. Provide 

complete contact information for each 

attendee, including name, title, 

company or organization, address, email, and telephone number. 

Registration requests must be received 

by March 15, 2010. 

If you wish to make an oral 

presentation during any of the sessions 

at the meeting (see section II of this 

document, Public Meeting), you must 

indicate this at the time of registration. 

FDA has included specific questions for 

comment in section III 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 roundtable 

discussions (see section II 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 CT or fluoroscopic 

devices. FDA is seeking participants 

interested in engaging in one of four 

wrap-up roundtable discussions related 

to the presentations given during each 

of the earlier sessions of the meeting. 

Each roundtable discussion will include 

no more than 10 nonFDA 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 roundtable 

discussion. 

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 need special accommodations 

due to a disability, please contact Simon 

Choi at 301–796–5426, 

simon.choi@fda.hhs.gov 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 CT and fluoroscopic 

devices could take to help reduce 

unnecessary patient exposure to 

ionizing radiation from these medical 

imaging modalities. The deadline for 

submitting comments related to this 

public meeting is April 15, 2010. 

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 


pwalker on DSK8KYBLC1PROD with NOTICES
8376 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 

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 

Like all medical procedures, medical 

imaging that uses ionizing radiation 

presents both benefits and risks. 

Medical imaging has led to 

improvements in the diagnosis and 

treatment of numerous medical 

conditions. At the same time, exposure 

to ionizing radiation may elevate 

patients’ lifetime risk of developing 

cancer. Overexposure to ionizing 

radiation can also cause injuries in the 

short-term such as skin burns and hair 

loss. In an effort to reduce these risks, 

FDA’s Center for Devices and 

Radiological Health (CDRH) recently 

announced the Initiative to Reduce 

Unnecessary Radiation Exposure from 

Medical Imaging (see http:// 

www.fda.gov/Radiation-Emitting

Products/RadiationSafety/Radiation

DoseReduction/UCM199904 for more 

information). 

FDA is currently exploring steps that 

manufacturers of CT and fluoroscopic 

devices could take to reduce 

unnecessary radiation exposure through 

improved product design, enhanced 

labeling, or improved instructions and 

training for equipment use and quality 

assurance at medical imaging facilities. 

II. Public Meeting 

The objective of this public meeting is 

to receive public input on steps 

manufacturers of CT and fluoroscopic 

devices should take to help reduce 

unnecessary patient exposure to 

ionizing radiation from these medical 

imaging modalities. 

The 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 

CT scanners (morning session) and 

fluoroscopes (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 at medical imaging 

facilities with respect to these two 

modalities (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 III 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). 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 roundtable discussion 

between FDA staff and selected 

participants representing a range of 

constituencies (for more information 

about participating in the roundtable 

discussion, see Registration). The 

participants in each roundtable 

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. Roundtable 

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 roundtable 

discussion. 

In advance of the 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). 

III. Questions for Comment 

A. Device-Specific Elements: Equipment 

Features, Labeling, and Premarket 

Submission Requirements 

Note: The questions in the following 

paragraphs are relevant to both CT and 

fluoroscopic devices. Please clearly 

indicate in your response which 

modality you are discussing. 

Additionally, while the questions are 

worded broadly, please feel free to 

include elements in your response that 

are specific to particular types of 

procedures (e.g., multi-phase contrastenhanced CT examinations, perfusion 

studies, etc.) or devices (e.g., 

multidetector CT devices that allow 

very thin slices, etc.). 

1. What hardware and software 

features should manufacturers build 

into CT and fluoroscopic devices in 

order to reduce unnecessary exposure to 

ionizing radiation during each imaging 

exam, and in order to reduce what may 

be inappropriate prescription of imaging 

exams? Should manufacturers 

incorporate special provisions for 

pediatric and female patients? 

2. Should manufacturers incorporate 

access controls and audit capabilities 

into CT and fluoroscopic equipment in 

order to identify the user(s) of the 

device during any particular exam, and 

to identify those responsible for creating 

and changing imaging protocols and 

exposure settings? If so, why, and what 

access controls and audit capabilities 

should be incorporated? If not, why not? 

3. Should manufacturers incorporate 

warnings, alerts, lockouts, or overrides 

into CT and fluoroscopic equipment 

that would inform users and require 

confirmation or possibly procedure 

modification during an imaging session 

in which the patient could be exposed 

to high levels of radiation? If so, why, 

and what warnings, alerts, lockouts, or 

overrides should be incorporated? If not, 

why not? 

4. Should manufacturers set default 

imaging protocols for CT and 

fluoroscopic procedures so that they 

incorporate the ALARA concept 

(maintaining dose As Low As 

Reasonably Achievable) and utilize or 

provide for incorporation of diagnostic 

reference levels into CT and 

fluoroscopic devices? If so, why and 

how? If not, why not? 

5. Should manufacturers incorporate 

exam referral criteria into CT and 

fluoroscopy equipment to allow users to 

check the appropriateness of an imaging 

exam before it is initiated or flag an 

exam after it is done? If so, why and 

how? If not, why not? 

6. Should manufacturers incorporate 

into CT and fluoroscopic equipment 

features to ensure that exposure settings, 

imaging protocols, and metrics of body 

dose and peak skin dose are displayed 

to the operator(s) of the equipment and 

recorded for physician review? If so, 

why and how? If not, why not? 

7. Should manufacturers incorporate 

features into CT and fluoroscopic 

equipment to facilitate transmission of 

technique parameters, imaging 

protocols, and dose metrics to a 

patient’s imaging record, an electronic 

health record, or other database? If so, 

why and how? If not, why not? 

8. Should manufacturers take steps to 

improve the labeling of CT and 

fluoroscopic devices, such as including 

more information about radiation 

exposure, including more information 


pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 8377 

about the clinical applications of the 

device that have been shown to be safe 

and effective, improving instructions for 

use for each distinct clinical 

application, and including a 

comprehensive quality control manual? 

If so, why and how? If not, why not? 

9. Should manufacturers submit more 

data to FDA as part of their premarket 

submissions for approval or clearance of 

CT and fluoroscopic devices, related to 

the safety and effectiveness of these 

devices (e.g., data demonstrating the 

safety and effectiveness of the device 

specific to each distinct clinical 

indication, or clinical data 

demonstrating the benefit of relatively 

high-dose procedures, for example, 

those with peak skin doses exceeding 1 

Gy)? If so, why, and what data should 

be submitted? If not, why not? 

10. Should manufacturers submit 

technical data to FDA as part of their 

premarket submissions for approval or 

clearance of CT and fluoroscopic 

devices, demonstrating dose reduction 

and image quality claims? If so, why, 

and what data should be submitted? If 

not, why not? 

11. In addition to the already-required 

indications for use statement, should 

manufacturers of CT and fluoroscopic 

devices submit to FDA as part of their 

premarket submissions a list of common 

clinical applications for which the 

device could be used (such as those 

requiring special software supported by 

the device) and the appropriate 

demographics of the likely patient 

populations for those exams? If so, why, 

and what level of information should be 

submitted? If not, why not? 

12. What changes should 

manufacturers make to CT and 

fluoroscopic devices currently on the 

market in order to reduce unnecessary 

patient exposure to ionizing radiation? 

B. User Training 

1. Should manufacturers provide 

training to medical imaging equipment 

users to ensure adequate understanding 

of equipment capabilities, operating 

principles for the technology, general 

information about optimizing patient 

dose and image quality, and specific 

dose-reduction 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 to ensure proper use of 

medical imaging equipment and dose 

reduction features? In your response, 

please consider radiologic technologists 

or technologists in other specialties as 

well as physicians in all medical 

specialties who operate fluoroscopic 

equipment. 

3. If manufacturers provide such 

training, how, when, and how often 

should it be delivered so that it is easily 

and effectively implemented at imaging 

facilities? For example, for software 

upgrades that affect dose, should 

training be performed at each site as 

well as training at the time of equipment 

installation? 

C. Quality Assurance Measures 

1. Should manufacturers provide 

quality assurance (QA) instructions and 

standard operating procedures to 

medical imaging facilities and users of 

CT and fluoroscopic devices? If so, why, 

and what instructions should be 

provided? If not, why not? 

2. Should manufacturers provide 

training on quality assurance practices? 

If so, why, what type of training should 

be provided, and to which personnel? If 

not, why not? 

D. Evaluation 

1. What tools and metrics should 

FDA, in collaboration with others in the 

Federal Government and the healthcare 

professional community, use to evaluate 

the impact of efforts to reduce 

unnecessary radiation exposure from 

medical imaging? 

IV. Transcripts 

Transcripts of the public meeting may 

be requested in writing from the 

Freedom of Information Office (HFI–35), 

Food and Drug Administration, 5600 

Fishers Lane, rm. 6–30, Rockville, MD 

20857, approximately 15 working days 

after the public meeting at a cost of 10 

cents per page. A transcript of the 

public meeting will be available on the 

Internet at http://www.regulations.gov. 

Dated: February 18, 2010. 

Jeffrey Shuren, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. 2010–3674 Filed 2–23–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Pulmonary-Allergy Drugs Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the notice of a meeting of 

the Pulmonary-Allergy Drugs Advisory 

Committee. This meeting was 

announced in the Federal Register of 

February 2, 2010 (75 FR 5334). The 

amendment is being made to reflect a 

change in the Name of Committee 

portion of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: 

Kristine T. Khuc, Center for Drug 

Evaluation and Research (HFD–21), 

Food and Drug Administration, 5600 

Fishers Lane (for express delivery, 5630 

Fishers Lane, rm. 1093), Rockville, MD 

20857, 301–827–7001, FAX: 301–827– 

6776, e-mail: 

Kristine.Khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington DC area), code 3014512545. 

Please call the Information Line for upto-date information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of February 2, 2010, 

FDA announced that a meeting of the 

Pulmonary-Allergy Drugs Advisory 

Committee would be held on March 10 

and 11, 2010. On page 5334, in the 

second column, the Name of Committee 

portion of the document is changed to 

read as follows: 

Name of Committees: Joint Meeting of 

the Pulmonary-Allergy Drugs Advisory 

Committee and the Drug Safety and Risk 

Management Advisory Committee. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: February 18, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–3595 Filed 2–23–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2010–0007] 

Privacy Act of 1974; Department of 

Homeland Security Immigration and 

Customs Enforcement-007 Alien 

Criminal Response Information 

Management System of Records 

AGENCY: Privacy Office, DHS. 

ACTION: Notice of modification to 

existing Privacy Act system of records. 

SUMMARY: In accordance with the 

Privacy Act of 1974 the Department of 

Homeland Security U.S. Immigration 

and Customs Enforcement is updating 

an existing system of records titled, 

Department of Homeland Security/ 


pwalker on DSK8KYBLC1PROD with NOTICES