PHE PRA Waiver Memo

Attachment 3. PHE PRA Waiver Memo 20190329

DEPARTMENT OF HEALTH & HUMAN SERVICES

Office of the Secretary

The Assistant � for
Plwming and Evaluation
Washington, D.C. 20201

DATE:

March 20, 2019

TO:

Alex M. Azar II, Secretary

THROUGH: Ann C. Agnew, Executive Secretary

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FROM:

Brenda Destro ;:jj..k-7 ,,_"'--;v . .
Deputy Assistant S�cretary for Plannin�d Evaluation (HSP)

SUBJECT:

Paperwork Reduction Act Waiver During a Public Health Emergency:
Distribution ofTraceable Opioid Material Kits across U.S. Laboratories DECISION

ISSUE

This memorandum seeks your decision regarding a request from the Centers for Disease Control
and Prevention (CDC) to waive certain Paperwork Reduction Act (PRA) requirements related to
the Public Health Emergency (PHE) declaration for the opioid epidemic.
BACKGROUND

Section 3 l 9(t) ofthe Public Health Service (PHS) Act authorizes you to waive PRA (44 USC
§ 3501 et seq.) requirements with respect to voluntary collection ofinformation during a public
health emergency (PHE) or when a disease or disorder is significantly likely to become a public
health emergency (SLPHE). This authority provides HHS with the ability quickly to address
actual or likely public health emergencies by conducting voluntary collections ofinformation.
Without this authority, many of the voluntary collections ofinformation conducted by or for
HHS during these critical times would likely require approval by the Office ofManagement and
Budget (0MB) consistent with the PRA. 0MB approval usually talces a minimum ofsix months
and sometimes up to a year for a typical request.
According to section 319( t) ofthe PHS Act, use ofthe PRA waiver authority requires your
determination that the circumstances ofa PHE/SLPHE, including the specific preparation for and
response to such PHE/SLPHE, necessitate a waiver ofthe PRA requirements.