S. 3496 – Promoting ACCESS to Diagnostics Act

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Updated February 8, 2026 at 8:52 AM UTC

The Promoting ACCESS to Diagnostics Act aims to speed up research and development of medical countermeasures for new infectious diseases. It requires the Health and Human Services Secretary to create and publish rules for how public and private groups can obtain pathogen specimens or suitable substitutes, and to issue guidance on requesting them. The bill also lets the Secretary contract with partners to quickly develop, validate, produce, and distribute diagnostic tests for emerging threats, helping state, local, tribal, and other health agencies respond faster.

Key Provisions

Within one year, HHS must make public policies and procedures for accessing pathogen specimens or suitable surrogates to support public‑health preparedness and biomedical research.
HHS must issue guidance detailing how to request samples, considerations for availability and security, and required information for access.
Amends the Public Health Service Act to allow the Secretary to contract with public and private entities to expand rapid development, validation, manufacturing, and distribution of diagnostic tests for emerging infectious diseases.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 13, 2022

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SenateIntro Referral

Introduced in Senate

January 13, 2022

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 13, 2022

Bill Text

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Introduced in SenateIssued January 13, 2022

II

117th CONGRESS

2d Session

S. 3496

IN THE SENATE OF THE UNITED STATES

January 13 (legislative day, January 10), 2022

Mr. Braun (for himself and Mr. Kaine) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To improve research and development of medical countermeasures for novel pathogens.

1.

Short title

This Act may be cited as the Promoting Access to Critical Countermeasures by Ensuring Specimen Samples to Diagnostics Act or the Promoting ACCESS to Diagnostics Act.

2.

Accessing specimen samples and diagnostic tests

(a)

Improving research and development of medical countermeasures for novel pathogens

(1)

Sample access

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the Secretary) shall make publicly available policies and procedures related to public and private entities accessing specimens of, or specimens containing, pathogens or suitable surrogates for, or alternatives to, such pathogens as the Secretary determines appropriate to support public health preparedness and response activities or biomedical research for purposes of the development and validation, as applicable, of medical products to address emerging infectious diseases and for use to otherwise respond to emerging infectious diseases. Such policies and procedures shall take into account, as appropriate, any applicable existing Federal resources.

(2)

Guidance

The Secretary shall issue guidance regarding the procedures for carrying out paragraph (1), including—

(A)

the method for requesting such samples;

(B)

considerations for sample availability and use of suitable surrogates or alternatives to such pathogens, as appropriate, including applicable safeguard and security measures; and

(C)

information required to be provided in order to receive such samples or suitable surrogates or alternatives.

(b)

Earlier development of diagnostic tests

Title III of the Public Health Service Act is amended by inserting after section 319A (42 U.S.C. 247d–1) the following:

319B.

Earlier development of diagnostic tests

The Secretary may contract with public and private entities, as appropriate, to increase capacity in the rapid development, validation, manufacture, and dissemination of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address emerging infectious diseases that have significant potential to cause a public health emergency.

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