[Federal Register Volume 71, Number 207 (Thursday, October 26, 2006)]
[Notices]
[Pages 62593-62594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17907]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0535]


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.

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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

[[Page 62594]]

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.
[FR Doc. E6-17907 Filed 10-25-06; 8:45 am]
BILLING CODE 4160-01-S