Natalie
Natalie

SciReg Lab

Applying Science & Tech in Our Courts & Agencies

The purpose of the Science Regulation Lab (“SciReg Lab”) is to teach about the use of emerging science and technology in the courts and regulatory agencies through the drafting and submission of amicus briefs and comments to rule-makings. The project had previously been called the “Amicus Lab”, but the name has been updated to reflect the expansion of its initial focus upon the courts, to include the administrative process.

Under the mentorship of Duke faculty, Interdisciplinary teams of students identify proposed rule-makings and court cases appropriate for the potential submission of comments and amicus briefs. Working in small interdisciplinary teams, the students identify the scientific issues implicated by the pending action, interview relevant scientific and legal experts, and draft comments and/or amicus briefs to be submitted in the proceeding. The Briefs and Comments are unaligned with any party and are intended to provide the courts and regulatory agencies with unbiased, current, accurate and coherent information on the science underlying the pending decision or proposed rule. All Comments and Briefs are submitted in the name of the Duke University SciReg Lab, with attributed student authorship.

 

2019 SciReg Lab Comments

  • February 13 – Comment on the Food and Drug Administration Proposed Rule: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Investigations83 FR 57378
  • February 15 – Comment on the Social Security Administration Advance Notice of Proposed Rulemaking: Consideration of Pain in the Disability Determination Process83 FR 64493
  • February 19 – Comment on the Centers for Medicare and Medicaid Services Proposed Rule: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 202084 FR 227
  • February 25 – Comment on the Department of Transportation Request for Comments: Vehicle-to-Everything (V2X) Communications83 FR 66338
  • April 3 – Comment for a meeting Commodity Futures Trading Commission’s Technology Advisory Committee, 84 FR 4449
  • April 5 – Comment on the Federal Communications Commission Notice of Proposed Rulemaking: Mitigation of Orbital Debris in the New Space Age84 FR 4742
  • April 15 – Comment on the Federal Aviation Administration Notice of Proposed Rulemaking: Operation of Small Unmanned Aircraft Systems Over People84 FR 3856
  • April 17 – Comment on the Environmental Protection Agency Notice of Proposed Rulemaking: National Emission Standards for Hazardous Air Pollutants: Coal- and Oil-Fired Electric Utility Steam Generating Units- Reconsideration of Supplemental Finding and Residual Risk and Technology Review84 FR 2670
  • April 19 – Comment on the Food and Drug Administration Proposed Rule: Sunscreen Drug Products for Over-the-Counter Human Use84 FR 6204

 

2018 SciReg Lab Comments

  • March 19 – Comment on FDA Draft Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials, 82 FR 60019
  • March 20 – Comment on FDA Draft Guidance for Staff and Industry: Drug Products Labeled as Homeopathic, 82 FR 60403

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