Section 3087 of the 21st Century Cures Act, signed into law in December 2016, added subsection (f) to section 319 of the Public Health Service Act. This new subsection gives the HHS Secretary the authority to waive Paperwork Reduction Act (PRA) (44 USC 3501 et seq.) requirements with respect to voluntary collection of information during a public health emergency (PHE), as declared by the Secretary, or when a disease or disorder is significantly likely to become a public health emergency (SLPHE).
Under this new authority, the HHS Secretary may waive PRA requirements for the voluntary collection of information if the Secretary determines that: (1) a PHE exists according to section 319(a) of the PHS Act or determines that a disease or disorder, including a novel and emerging public health threat, is a SLPHE under section 319(f) of the PHS Act; and (2) the PHE/SLPHE, including the specific preparation for and response to it, necessitates a waiver of the PRA requirements. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) has been designated as the office that will coordinate the process for the Secretary to approve or reject each request.
Please contact ASPE with any questions regarding this process at: PRAWaiverRequests@hhs.gov.
All PRA waiver requests approved by the Secretary under this authority will be posted below.
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, September 16, 2024 (FDA)
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, September 3, 2024 (FDA)
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, March 29, 2024 (FDA)
- Notice of Paperwork Reduction Act Waiver - Opioid Epidemic, March 12, 2024 (FDA)
- Notice of Paperwork Reduction Act Waiver - Opioid Epidemic, February 27, 2024 (SAMHSA)
- Notice of Paperwork Reduction Act Waiver - Coronavirus Disease 2019 (COVID-19), October 24, 2022 (ASPA)
- Notice of Paperwork Reduction Act Waiver - Monkeypox Outbreak, October 17, 2022 (HRSA)
- Notice of Paperwork Reduction Act Waiver - Opioid Epidemic, September 22, 2022
- Notice of Paperwork Reduction Act Waiver - Opioid Epidemic, August 29, 2022
- Notice of Paperwork Reduction Act Waiver - Monkeypox Outbreak, August 19, 2022 (CDC)
- Notice of Paperwork Reduction Act Waiver - Monkeypox Outbreak, August 19, 2022 (FDA)
- Notice of Paperwork Reduction Act Waiver - Coronavirus Disease 2019 (COVID-19), June 17, 2022
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), June 14, 2022
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), May 13, 2022
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, November 29, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), November 23, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), November 1, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), September 23, 2021
- Notice of Paperwork Reduction Act Waiver - Coronavirus Disease 2019 (COVID-19), August 6, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), July 2, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), June 14, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), May 14, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 16, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 12, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 8, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 7, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 6, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 2, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), February 18, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), January 14, 2021
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), December 11, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), October 29, 2020
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, September 1, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), August 19, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), August 19, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), July 30, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), July 21, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), July 17, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), June 9, 2020
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic and Coronavirus Disease 2019 (COVID-19), June 9, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), May 26, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 29, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 28, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 24, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), April 9, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), March 31, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), March 20, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), March 19, 2020
- Notice of Paperwork Reduction Act Waiver – Coronavirus Disease 2019 (COVID-19), March 18, 2020
- Notice of Paperwork Reduction Act Waiver – 2019 Novel Coronavirus, January 17, 2020
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, August 21, 2019
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, March 29, 2019
- Notice of Paperwork Reduction Act Waiver – Hurricane Florence, October 4, 2018
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, August 3, 2018
- Notice of Paperwork Reduction Act Waiver – Hurricane Maria, May 21, 2018
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, May 8, 2018
- Notice of Paperwork Reduction Act Waiver – Opioid Epidemic, March 16, 2018