E6-11640. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Need for Online Medical Device Survey

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by August 23, 2006.

ADDRESSES:

OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone].

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Survey of Need for Online Medical Device Information

Executive Order 12862 directs agencies to identify the customers who are, or should be, served by the agency, and to survey customers to determine the kind and quality of services they want.

This proposed survey will collect data about the information customers want when looking up medical devices on the Internet. It will focus on the ways individuals find, use, and rate existing sources of online medical device information. FDA will use this data to understand more about its customers and to make improvements to its own Web site.

FDA will administer this survey to individuals who use the Internet to look for information about medical devices. The survey will consist of three components: A screening tool of 5,000 to identify appropriate respondents, an online survey of 500 customers, and a telephone followup interview with 50 customers.

In the Federal Register of April 20, 2005 (70 FR 20573), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received in response to that notice.

FDA estimates the burden for this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

21 CFR (Or FDA Form #)	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Screening Tool	5,000	1	5,000	0.05	250
Online Survey	500	1	500	0.25	125
Telephone2 Follow-Up	-	-	-	-	-
Total					375
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 This was listed in the Federal Register announcement but is no longer required in the survey.

Dated: July 17, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.