2020-06047. Solicitation for Public Comments on Section 209 of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act

AGENCY:

Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

ACTION:

Request for public comment.

SUMMARY:

The Office of the Assistant Secretary for Health in the Department of Health and Human Services seeks public comment regarding Section 209 of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act.

Congress passed the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) in June 2019. Section 209 of this legislation states that the Secretary of Health and Human Services shall submit to Congress a report containing recommendations related to maintaining an adequate national blood supply. The legislation poses four specific questions regarding the adequacy of the national blood supply. HHS welcomes any public feedback related to how these questions should be addressed and/or potential solutions. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.

DATES:

To be assured consideration, electronic or written/paper comments must be submitted no later than midnight Eastern Standard Time (EST) on April 22, 2020.

ADDRESSES:

Individuals are encouraged to submit responses electronically to [e-mail]. Please indicate “RFI RESPONSE” in the subject line of your email. Written responses should be addressed to: U.S. Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW, Room L600, Washington, DC 20024 Attn: ACBTSA-PAHPAIA Sec. 209. Mailed paper submissions and electronic submissions received after the deadline will not be reviewed. Responses to this notice are not offers and cannot be accepted by the federal government to form a binding contract or issue a grant.

FOR FURTHER INFORMATION CONTACT:

Mr. James Berger, Designated Federal Officer, Office of Infectious Disease and HIV/AIDS Policy, [phone].

SUPPLEMENTARY INFORMATION:

(1) Challenges associated with the continuous recruitment of blood donors (including those newly eligible to donate);

(2) Ensuring the adequacy of the blood supply in the case of public health emergencies;

(3) Implementation of the transfusion transmission monitoring system; and

(4) Other measures to promote safety and innovation, such as the development, use, or implementation of new technologies, processes, and procedures to improve the safety and reliability of the blood supply.

Dated: March 11, 2020.

James J. Berger,

Senior Advisor for Blood and Tissue Policy, Office of Infectious Disease and HIV/AIDS Policy.