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/ 


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