Sec. 101. Improving earlier access to diagnostic tests
397 words·~2 min read·
/bill/116/s/4322/is/section-101·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 319D of the Public Health Service Act ( 42 U.S.C. 247d–4 ) is amended by adding at the end the following: Not later than 180 days after the date of enactment of this subsection, the Secretary shall, in coordination with the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs, establish and make publicly available policies and procedures for public and private entities to access samples of specimens containing infectious disease agents, or suitable surrogates or alternatives, as appropriate, that may support the development of products, including the development of diagnostic tests, treatments, or vaccines, to address emerging infectious diseases for biomedical research purposes, and for use to otherwise respond to emerging infectious diseases, as the Secretary determines appropriate.
The Secretary shall issue guidance regarding the procedures for carrying out paragraph (1), including— the method for requesting samples of specimens containing infectious disease agents; criteria for sample availability and use of suitable surrogates or alternatives, as appropriate; and information required to be provided in order to receive such samples or suitable surrogates or alternatives. The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may contract with public and private entities, as appropriate, to assist in the immediate and rapid development, validation, and dissemination of diagnostic tests, as appropriate, for purposes of biosurveillance and other immediate public health response activities to address an emerging infectious disease that has significant potential to cause a public health emergency.
The Secretary, in coordination with the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention, shall, as appropriate, consult with medical product manufacturers, suppliers, and other relevant stakeholders, as appropriate, to— identify specific supplies or components needed, including specimen collection and transport materials, reagents, or other supplies related to the development, validation, or administration of a diagnostic test to detect an infectious disease for which an emergency use authorization is in effect under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ); identify projected demand for and availability of such supplies and communicate such information to medical product manufacturers, suppliers, and other relevant stakeholders during a public health emergency; and support activities to increase the availability of such supplies or alternative products that may be appropriately substituted for such supplies during a public health emergency. .
Connections2 off-index
2 references not yet in our index
- 42 USC 247d–4
- 21 USC 360bbb–3
Citation graph
cites case law
Sec. 101
Improving earlier access to diagnostic tests
Cite42 USC 247d–4
Cite21 USC 360bbb–3
Cites 2Cited by 0 across 0 sources