PHE PRA Waiver

Attachment 4. TOM Kits PHE PRA Waiver and Notice

Waiver Notice
Pursuant to section 319 of the PHS Act, Secretary Azar determined that, as the result of the
consequences of opioid epidemic, a PHE has existed in the nation since October 26, 2017. 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 opioid epidemic. This waiver applies to information being collected from
laboratories that request Traceable Opioid Material Kits.
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 March 29, 2019 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 Centers for Disease Control and Prevention.
This notice will be updated as needed.

Waiver Notice
Pursuant to section 319 of the PHS Act, Secretary Azar determined that, as the result of the
consequences of the opioid epidemic, a PHE has existed in the nation since October 26, 2017.
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 the opioid epidemic. This waiver applies to information being collected from
laboratories that request Traceable Opioid Material Kits.
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 March 29, 2019 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 Centers for Disease Control and Prevention.
This notice will be updated as needed.
Addendum
This Paperwork Reduction Act waiver for the opioid epidemic is terminated effective May 10, 2019.