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Appendix: Statutory Language on Biennial Report

Public Health Service Act

Section 479 NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

  1. BIENNIAL REPORT.—The Center shall publish a report on a biennial basis that, with respect to all research supported by the Center, includes a complete list of—
    1. the molecules being studied;
    2. clinical trial activities being conducted;
    3. the methods and tools in development;
    4. ongoing partnerships, including—
      1. the rationale for each partnership;
      2. the status of each partnership;
      3. the funding provided by the Center to other entities pursuant to each partnership, and
      4. the activities which have been transferred to industry pursuant to each partnership;
    5. known research activity of other entities that is or will expand upon research activity of the Center;
    6. the methods and tools, if any, that have been developed since the last biennial report was prepared; and
    7. the methods and tools, if any, that have been developed and are being utilized by the Food and Drug Administration to support medical product reviews.
  2. INCLUSION OF LIST.—The first biennial report submitted under this section after the date of enactment of the 21st Century Cures Act shall include a complete list of all of the methods and tools, if any, which have been developed by research supported by the Center.
  3. RULE OF CONSTRUCTION.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret, or other privileged or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

Responses to Required Information

(1) the molecules being studied

The NCATS Pharmaceutical Collection (NPC) is a comprehensive collection of approved and investigational drugs for high-throughput screening that provides a valuable resource for both validating new models of disease and better understanding the molecular basis of disease pathology and intervention. The NPC Consists of a physical collection of drugs and an information browser and database. Access the collection is provided through both the TRND program and Tox21 initiative and instructions are available here. Sources for the current collection include traditional chemical suppliers, specialty collections, pharmacies and custom synthesis.

All data generated through this effort are deposited in PubChem (within the NIH’s National Library of Medicine). PubChem consists of three dynamically growing databases:

  1. PubChem Compound: Contains pure and characterized chemical compounds.
  2. PubChem Substance: Contains mixtures, extracts, complexes and uncharacterized substances.
  3. PubChem BioAssay: Contains database results from high-throughput screening programs with several million values.

View a list of NCATS-utilized compounds. 

(2) clinical trial activities being conductedClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. Studies for which NCATS is a sponsor/collaborator are available here.

View a list of clinical research studies being supported by NCATS Rare Diseases Clinical Research Network (RDCRN).
(3) the methods and Tools in developmentThis biennial report highlights many of the ongoing efforts of NCATS to develop methods and tools that will improve the translational research process. View a complete list of all of the active projects funded by NCATS.
4) ongoing
partnerships,
including—

(A) the rationale for
each partnership;
(B) the status of each
partnership;
(C) the funding provided
by the Center
to other entities
pursuant to each
partnership, and
(D) the activities
which have been
transferred to
industry pursuant to
each partnership;		A and B) The NCATS Division of Preclinical Innovation develops approaches that improve the efficiency and effectiveness of translation. To do so, NCATS intramural scientists leverage state-of-the-art laboratories and collaborations among government, industry, academia, and patient and rare disease communities to advance new technologies to make preclinical research more predictive and efficient.

C) Investigators do not receive grant funds through the NCATS intramural program. Instead, selected researchers partner with NCATS experts to generate pre-clinical data and clinical-grade material through government contracts for use in Investigational New Drug (IND) applications to a regulatory authority such as the U.S. Food and Drug Administration (FDA).

View a list of NCATS intramural projects.

D) For information on any activities which have been transferred to industry, please contact NCATS Partnerships.
 
(5) known research activity of other entities that is or will expand upon research activity of the CenterNIH investigators frequently conduct PubMed searches on areas of research interest. However, NIH does not conduct competitive intelligence on for-profit entities.
(6) the methods and
tools, if any, that have
been developed since
the last biennial report
was prepared		Small molecule chemical compounds, which can be used to test or “probe” the effects of increasing or decreasing the activity of a biological target in cells or animals, are some of the most powerful tools for target validation, which is the process of demonstrating that engaging a target provides meaningful therapeutic benefit. Probes enable researchers to investigate protein and cell functions and biological processes. If appropriate, probes can be optimized to become potential drug candidates. Generating these chemical probes requires specialized expertise and facilities, and the NCATS Early Translation Branch (ETB) provides worldleading collaborative services to meet these needs. Collaborators work with ETB scientists to develop screens against promising drug targets and to refine these results into small molecule probes and potential therapies. 

View a list and descriptions of the assays (tests) developed through the ETB.
(7) the methods and
tools, if any, that have
been developed and
are being utilized by
the Food and Drug
Administration to
support medical
product reviews		Global Substance Registration System (GSRS) 

The GSRS resource is a registration system for the ingredients in medicinal products. This project, developed by NCATS scientists, makes it easier for regulators and other stakeholders to exchange information about substances in medicines, supporting scientific research on the use and safety of these products. While the main goal of production software is to assist agencies in registering and documenting information about substances found in medicines, a collaboration with the FDA also has enabled NCATS to publish a public data set of substance records, which is updated on a regular basis and used by collaborators in regulatory science as well as industry. 

EU-SRS is sponsored by EMA and BfArM (Germany). They will use the GSRS software and load the NCATS hosted FDA public GSRS data to EU-SRS for “production” use in order to support their substance curation processes in mid-2022. 

View the GSRS.

CURE ID, created through a collaboration between NCATS and the FDA, enables the crowdsourcing of medical information from health to facilitate the development of new treatments using repurposed drugs for difficult to-treat infectious diseases, including COVID-19. CURE ID is accessible through a website, smartphone or other mobile device. The CURE ID app, which was developed with NCATS’ support, includes information on most clinical trials for COVID-19 drugs, biologics and vaccines.

Last updated on April 20, 2024