05-7882. Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Need for Online Medical Device Information

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of customers who should be served by FDA's Center for Devices and Radiological Health (CDRH) Web site, in order to determine the kind and quality of services they want.

DATES:

Submit written or electronic comments on the collection of information by June 20, 2005.

ADDRESSES:

Submit electronic comments on the collection of information to: http://www.fda.gov/​dockets/​ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

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.

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

Table 1.—Estimated Annual Reporting Burden¹

Activity	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Screening tool	5,000	1	5,000	.05	250
Online survey	500	1	500	.25	125
Telephone followup	50	1	50	.5	25
Total					400
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 13, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.