October 26, 2020 - Letter to the HHS Secretary

Dear Mr. Azar:

On behalf of the Secretary's Advisory Commitee on Human Research Protections (SACHRP), I respectfully submit for your consideration recommedations relevant to the Department of Healt and Human Services (HHS) human subjects protection regulations at 45 CFR Part 46.  These recommendations were presented at SACHRP by SACHRP's Subcommittee on Harmonization, and were approved at the meeting held October 20, 2020.

1.  Interpretation of Public Health Authority and Public Health Surveillance Activities, 45 CFR Part 46.102 (k),  46.102 (L)(2) - Attachment A

On behalft of SACHRP, I would like to thank you for your consideration of these recommendations.  The Committee, the Subpart A Subcommittee and the Subcommittee of Harmonization have been actively working in pursuit of their charges, and remain dedicated in continuing this work to enhance human subjects protections for the benefit of all Americans.

Sincerely,

/s/

Stephen Rosenfeld, M.D.
Chair
Secretary's Advisory Commitee on Human Research Protections (SACHRP)

cc:
Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRP
Julia Gorey, J.D., Executive Director, SACHRP