0595_non-sub_change_justification HHS requested change 9-30-10

0595_non-sub_change_justification HHS requested change 9-30-10.doc

Draft Guidance: Emergency Use Authorization of Medical Products

0595_non-sub_change_justification HHS requested change 9-30-10

OMB: 0910-0595

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0910-0595

Non-Substantive Change

Authorized by Bridget Dooling, OMB via email on September 7, 2010


FDA is requesting to amend this ICR to increase the number of respondents (State and Local Public Health Officials; Unapproved EUA (Emergency Use Authorization)) product. FDA would like to amend the ICR to increase by 80 the number of respondents who administered an unapproved product and are required to report to FDA under the conditions of an authorization issued during the H1N1 influenza pandemic. The increase of 80 respondents is due to an unforeseen number of respondents administering the drug for H1N1. The total number of State and Local Public Health Officials (currently approved at 30) plus 80, totals 110.

File Typeapplication/msword
File Title0910-0595
Authorjcapezzu
Last Modified Byjcapezzu
File Modified2010-09-30
File Created2010-09-30

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