21 st Century Cures Act NIH-USDA-FDA Listening Session on Animal - - PowerPoint PPT Presentation

▶
21 st century cures act
SMART_READER_LITE
LIVE PREVIEW

21 st Century Cures Act NIH-USDA-FDA Listening Session on Animal - - PowerPoint PPT Presentation

Nov 03, 2022 209 likes •321 views

21 st Century Cures Act NIH-USDA-FDA Listening Session on Animal Research Patricia Brown, VMD, OLAW, NIH Betty Goldentyer, DVM, Animal Care, APHIS, USDA Estella Jones, DVM, FDA 21 st Century Cures Act What is it? Bipartisan legislation

slide-1
SLIDE 1

21st Century Cures Act

NIH-USDA-FDA Listening Session on Animal Research Patricia Brown, VMD, OLAW, NIH Betty Goldentyer, DVM, Animal Care, APHIS, USDA Estella Jones, DVM, FDA

slide-2
SLIDE 2
  • Bipartisan legislation signed in December, 2016
  • Mandates federal efforts to reduce

administrative burden for researchers

  • Section 2034(d) assigns NIH as lead agency in

cooperation with USDA and FDA to focus on animal care and use in research

21st Century Cures Act What is it?

slide-3
SLIDE 3

What Does it Ask?

  • SEC. 2034. REDUCING ADMINISTRATIVE BURDEN

FOR RESEARCHERS. (d) Animal Care And Use In Research.—Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, shall complete a review of applicable regulations and policies for the care and use of laboratory animals…

slide-4
SLIDE 4

What Does it Ask, cont.

…and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In carrying out this effort, the Director of the National Institutes of Health shall seek the input

  • f experts, as appropriate.
slide-5
SLIDE 5

21st Century Cures Act - Details

The Director of the National Institutes of Health shall — 1) identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations; 2) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and 3) take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.

slide-6
SLIDE 6
  • 21st Century Cures Working Group convened in

February 2017

  • Working Group meets quarterly or as needed
  • Public Request for Information (RFI) to be

announced in early 2018 in Federal Register

  • Listening sessions planned for 2018

21st Century Cures Act

slide-7
SLIDE 7

What could OLAW, USDA & FDA change to reduce burden on RESEARCHERS?

7 Photo: Howard Lake on Flickr.com https://goo.gl/A1SJbL

slide-8
SLIDE 8

S peakers

8

  • Ellen Paul

Ornithological Council

  • Norman Peterson

MedImmune

  • Sue Leary

Alternatives Research & Development Foundation & the American Anti-Vivisection Society

  • Alka Chandna

People for the Ethical Treatment of Animals

  • Jennifer Ball

The Humane Society of the United States

  • Cathy Liss

Animal Welfare Institute

  • Ryan Merkley

Physicians Committee for Responsible Medicine

  • JR Haywood

Michigan State University

  • Molly Greene

Michigan State University

  • Stuart Leland

Princeton University and American College

  • f Laboratory Animal Medicine
slide-9
SLIDE 9

Contacts - 21st Century Cures Act

  • E-mail: olaw@od.nih.gov
  • Phone: 301-496-7163
  • Website: https://olaw.nih.gov
  • Twitter: @NIH_OLAW
  • ListServ or RSS feed:

subscribe through OLAW webpage for current announcements, notices, policy interpretations.

9

Photo: The Barking Lounge on Flickr.com https://goo.gl/2FNRCm