American Society for Clinical Laboratory Science

The SciCodes Consortium (https://scicodes.net/) recognizes the need for editors and maintainers of software registries and repositories to share knowledge of best practices and create standards. Our 37 members represent science organizations and institutions across disciplines including biological, medical, mathematical and physical sciences and engineering. These repositories play a pivotal role in strengthening research by enhancing the discoverability of software, thereby supporting transparency, reproducibility, and fostering efficiency through software reuse. Hence, through their stewardship of software, our members pursue common goals including the recognition of software as a first-class citizen in research and establishing metadata standards to enable searching across multiple software registriesSciCodes grew from the Best Practices for Registries Task Force as part of the FORCE11 Software Citation Implementation Working Group. These best practices (Garijo et al., 2022. https://doi.org/10.7717/peerj-cs.1023) are:Provide a public scope statementProvide guidance for usersProvide guidance to software contributorsEstablish an authorship policy Share your metadata schema Stipulate conditions of use State a privacy policyProvide a retention policy Disclose your end-of-life policy The group regularly self assesses for compliance. Examples of how these best practices are implemented in practice are linked to from our website.We invite the community to join our monthly discussions to:Discuss challenges and share solutions to common issues that arise in managing our resourcesStrengthen resources through implementation of identified best practicesKeep up with and share advances through monthly presentationsSpeed adoption of CodeMeta and CFF standards to improve software citation and discoverability

1. Elissa Passiment, EdM CLS(NCA)[⇑][1] 1. is Executive Vice President of the American Society for Clinical Laboratory Science 1. Address for correspondence: Elissa Passiment EdM CLS(NCA), American Society for Clinical Laboratory Science, 6701 Democracy Boulevard, Suite 300, Bethesda MD 20817. (301) 657-2768, (301) 657-2909 (fax). ElissaP{at}ascls.org Passing legislation in Congress is only the beginning of law-making. Crafting of rules and regulations turns ideas into actual, enforceable laws. Rules and regulations can be thought of as the operator's manual for laws and have the full force of law. Two laws, the Administrative Procedures Act (APA) and the Negotiated Rulemaking Act (“neg reg”) control the writing of rules and regulations.1 The APA defines rules and regulations as statements from federal agencies that “regulate the future conduct of either groups of persons or a single person” and “implement, interpret or prescribe law or policy”.2 They are written by executive branch agency staff, not by members of Congress. The Negotiated Rulemaking Act of 1990 describes a voluntary process that brings interested parties and government together to negotiate the language of a regulation. The committee is chartered under the Federal Advisory Committee Act (FACA) and consists of representatives from groups that will be affected by the regulation such as the public sector, public interest groups, industry and practitioners, or individuals. THE EXECUTIVE BRANCH The structure of the federal government in the United States is divided into the executive branch, legislative branch, and judicial branch. Each is autonomous and has agencies and commissions that deal with the day-to-day business of government. The agencies of the executive branch are in departments created with the consent of Congress (Table 1).3 Each department is administered by a secretary who serves at the designation of the President and must be approved by Congress.4 Each department is… ABBREVIATIONS: APA = Administrative Procedures Act; APC = ambulatory payment classifications; CBER = Center for Biological Evaluation and Research; CDC = Centers for Disease Control and Prevention; CMS = Centers for Medicare and Medicaid Services; CLIA '88 = Clinical Laboratory Improvement Amendments of 1988; CFR = Code of Federal Regulations; DRG = diagnosis-related groups; FACA = Federal Advisory Committee Act; FDA = Food and Drug Administration; HHS = Department of Health and Human Services; OIVD = Offce of In Vitro Diagnostics Device Evaluation [1]: #corresp-1

The history of approaches to evaluating the hazards and risks of chemicals is briefly reviewed. The role of default options (generic approaches based on general knowledge in the absence of specific knowledge to the contrary) is discussed as a part of the risk assessment paradigm advanced by the National Academy of Science/National Research Council in 1983 and 1994. Examples are given of the impact of acquiring specific science to replace default options. An argument is made for developing specific science that would reduce uncertainty in risk assessments. Research on specific science would be guided by identified sources of uncertainty in the risk assessment process. The importance of using a research strategy that builds on human data is emphasized for validating new molecular and cellular biological assessment methods. The paper closes with a discussion of the tension between a hazard-based approach versus quantitative risk assessment in guiding risk management decisions. The former requires limited data, is qualitative, and easy to communicate, while the latter requires substantial data and is difficult to communicate. However, quantitative risk assessment provides a more rational basis for decisions on the allocation of both public and private resources for actions that will effectively minimize overall health risks to the public.