E6-17907. Agency Information Collection Activities; Announcement of Office of Management and Budget; Extension of Expiration Date for MedWatch (Food and Drug Administration Medical Products Reporting Program) Form

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; extension of expiration date.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that, under the Paperwork Reduction Act of 1995 (the PRA), the Office of Management and Budget (OMB) has extended the expiration date to May 1, 2007, for the use of the prior version of Form FDA 3500A for “MedWatch: Food and Drug Administration Medical Products Reporting Program” (the MedWatch Program).

FOR FURTHER INFORMATION CONTACT:

Elizabeth Berbakos, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

In the Federal Register of August 16, 2005 (70 FR 48157), FDA announced that a proposed collection of information entitled “MedWatch: Food and Drug Administration Medical Products Reporting Program” had been submitted to OMB for approval under the PRA. The collection of information included the use of two forms used in the MedWatch Program—Form FDA 3500 and Form FDA 3500A. In that notice, we responded to public comments pertaining to proposed revisions to Form FDA 3500 and Form FDA 3500A. Several comments from industry stated that considerable resources would be required to modify computer systems and processes to begin using the mandatory reporting form—Form FDA 3500A. In response to these comments, we stated: “[T]o allow mandatory reporters time to make the necessary changes to their computer systems and processes to conform to the revised Form FDA 3500A, FDA is granting a grace period of 1 year. During this transition period FDA will accept both the newly effective Form FDA 3500A and the prior version of the form.”

In the Federal Register of December 7, 2005 (70 FR 72843), FDA announced that OMB had approved the information collection for the MedWatch Program as submitted to OMB on August 16, 2005. In that notice, we stated: “As requested by the agency, in addition to the approval of the revised forms, the existing forms are approved for continued use for the next 12 months to allow for the industry to make necessary changes to their computerized systems.” In response to several recent requests from industry that we grant more time to make necessary changes to computerized systems, we requested and OMB has agreed to extend approval to use the prior version of Form FDA 3500A until May 1, 2007. The expiration date for the newly revised Form FDA 3500A remains unchanged—October 31, 2008. The prior version of Form FDA 3500A is available for downloading at http://www.fda.gov/​medwatch/​getforms.htm, and the expiration date on the form has been revised to May 1, 2007.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Dated: October 19, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.