PHE waiver

Waiver Notice
Pursuant to section 319 of the PHS Act, Secretary Azar determined that, as the result of the
confirmed cases of 2019 Novel Coronavirus (2019-nCoV), now known as Coronavirus Disease
2019 (COVID-19), a PHE has existed nationwide since January 27, 2020. The Secretary’s
determination to declare the PHE was made after consultation with public health officials as
necessary. As result of the PHE, the Secretary also determined pursuant to section 319(f) of the
PHS Act that circumstances of the PHE necessitate a waiver from the requirements of the
Paperwork Reduction Act, 44 U.S.C. § 3501 et seq., effective as of the date of this notice. The
waiver is justified to collect information to support the Department’s investigation of and
response to COVID-19. This waiver applies to information to be collected by the Food and Drug
Administration pertaining to voluntary surveys to assess a firm’s ability to manufacture critical
medical products.
Pursuant to the waiver, the requirements of 44 U.S.C. § 3501 et seq. shall not be applicable with
respect to voluntary collection of information during the effective time period.
The Paperwork Reduction Act waiver is effective as of April 9, 2020, and is anticipated to
remain in effect throughout the time period of the immediate investigation of and response to the
emergency declared pursuant to section 319(a) of the PHS Act, and for a reasonable length of
time for immediate post response review regarding the public health emergency.
Any initiative subject to this waiver that is ongoing after the termination of the effective period
shall be subject to the requirements of the Paperwork Reduction Act within 30 days of expiration
of the waiver. The waiver applies to the Food and Drug Administration.
This notice will be updated as needed.