21st Century Cures Act

The 21st Century Cures Act was signed into law on December 13, 2016. It’s purpose was to accelerate research to improve human health, and to that end, it contained the mandate that federal agencies reduce the administrative burden on investigators.

About the 21st Century Cures Act

The 21st Century Cures Act (PDF, 929 KB) was signed into law on December 13, 2016. It’s purpose was to accelerate research to improve human health, and to that end, it contained the mandate that federal agencies reduce the administrative burden on investigators. 

Regarding research with animals, Section 2034(d) of the law mandated that the NIH, USDA, and FDA review policies and procedures and identify steps to reduce administrative burden on investigators. It also mandated that any actions in response to the 21st Century Cures Act must maintain the integrity and credibility of research findings and the protection of research animals. 

Working Group

The NIH, FDA, and USDA convened a Working Group of federal subject matter experts that carried out a review and prepared a draft report of its recommendations as directed by the 21st Century Cures Act. To identify inconsistent, overlapping, and unnecessarily duplicative regulations and policies, the Working Group:

  • reviewed published reports, communications, and surveys highlighting the regulations and policies that contribute to investigators' administrative burden;
  • conducted listening sessions and met with organizations and stakeholders; and
  • issued a Request for Information on possible actions and analyzed stakeholder responses. 

These efforts are described in more detail below. 

Following this research and analysis, the Working Group sought input through a Request for Information on the draft report and proposed recommendations to reduce the administrative burden associated with research activities with laboratory animals.

The Working Group reviewed numerous reports and surveys that have been published over the last several years addressing the topic of administrative and investigator burden.
The following documents were reviewed:

The Working Group conducted listening sessions and met with organizations and stakeholders to obtain their individual perspectives.

Listening Session: January 9, 2018
Representatives from the NIH OLAW, USDA APHIS AC, and FDA held a public listening session at the Hyatt Regency Capitol Hill, Washington, DC, immediately following the Federal Demonstration Partnership (FDP) sessions on January 9th. Provided here are the 01/09/2018 introductory slides (PDF, 166.76 KB) and a list of registered speakers with their written comments if provided.

Speakers and Comments 

Listening Session: January 29, 2018
Representatives from the NIH OLAW, USDA APHIS AC, and FDA joined the AAALAC International Council Meeting for a listening session on January 29th. Provided here are the 01/29/18 introductory slides (PDF, 157.97 KB) and a 01/29/18 summary of the comments (PDF, 99.60 KB).

Q&A Session: March 12, 2018
Representatives from the NIH OLAW, USDA APHIS AC, and FDA met with the Animal Welfare Institute, Humane Society Legislative Fund, Physicians Committee for Responsible Medicine, and Humane Society of the United States for a Q&A session on March 12th. Provided here are the 03/12/18 meeting notes (PDF, 152.15 KB).

21st Century Cures Act Initiatives

 

Note

See the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research (PDF, 928.32 KB) for detailed information on identified sources of burden and Agency commitments to action.

Initiative

Overview

What We’ve Done...

60 Day Comment Period

The NIH Office of Laboratory Animal Welfare (OLAW) committed to providing a minimum of 60 days for comments to significant policy guidance.

The 60-day  comment period includes,
but is not limited to any new interpretations of the:

Such guidance will focus on high-risk animal welfare concerns affecting institutions, IACUC functions, and updates to guidance as an outcome of the 21st Century Cures Act. 

AAALAC Program DescriptionOLAW committed to encouraging AAALAC-accredited institutions to use sections of the AAALAC International (AAALAC) Program Description (PD) in applicable parts of the OLAW Animal Welfare Assurance (Assurance).OLAW provided information on using sections of the AAALAC International AAALAC PD) to complete parts of the OLAW Domestic Animal Welfare Assurance. Institutions must ensure that all information requested in the Assurance document is provided, including information that is not requested in the AAALAC PD but is required by OLAW.
 
See NOT-OD-21-130

Animal Activities Exempt from IACUC Review Under the PHS Policy

OLAW committed to clarifying animal activities that are exempt from the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) requirements for Institutional Animal Care and Use Committee (IACUC) review.

The NIH Office of Laboratory Animal Welfare (OLAW) proposed guidance clarifying animal activities that are exempt from the PHS Policy requirements for IACUC review.

Comments were accepted through a Request for Information (RFI) between April 25 and July 31, 2023.
 
See NOT-OD-23-119
 
The comment period is now closed.
 
The final guidance will be published along with a new webpage once comments have been considered.

Annual Report to OLAWThe 21st Century Cures Act Working Group identified harmonizing the OLAW and USDA annual reporting schedules as an opportunity to decrease administrative burden.The reporting period for the Annual Report to OLAW has been harmonized with that of USDA.
 
The reporting period is now October 1 – September 30 of each year and must be submitted to OLAW by December 1.
 
See NOT-OD-20-109
Departures from the GuideThe public identified departures from the Guide for the Care and Use of Laboratory Animals (Guide) as an area to reduce administrative burden, and
OLAW committed to clarifying the guidance for the reporting requirements of departures from the Guide.

The NIH Office of Laboratory Animal Welfare (OLAW) proposed updates to NOT-OD-12-148 for Departures from the Guide through a Request for Information (RFI) between July 20 and November 1, 2021.
 
See NOT-OD-21-161
 
The comment period is now closed.
 

Grant and Contract to Protocol Congruence ReviewOLAW clarified the requirements, responsibility, timing, and conduct of grant and contract to protocol congruency review for NIH grant applications and contract proposals involving research with live vertebrate animals in response to the 21st CCA.Clarifications are described in these notices:
 
See NOT-OD-22-005 and NOT-OD-22-006
OLAW Guidance DisclaimerOLAW committed to clarifying its guidance disclaimer.Clarifications are described in these notice:
 
See also NOT-OD-25-145
Reporting NoncomplianceOLAW committed to providing clarification on noncompliance reporting.OLAW provided updated guidance with additional examples of reportable situations, situations where reporting is not normally required, the time frame for reporting, and the information to be reported.
 
See NOT-OD-25-148
Semiannual Animal Facility Inspection

OLAW and USDA committed to clarifying existing flexibilities for conducting semiannual facility inspections.

The Agencies clarified existing flexibilities while maintaining protection for research animals and data integrity.
 
See NOT-OD-24-075
Semiannual Program ReviewOLAW and USDA committed to clarifying flexibilities for conducting semiannual program reviews as an opportunity to reduce administrative burden.The Agencies clarified flexibilities to reduce burden while maintaining protection for research animals and data integrity.
 
See NOT-OD-24-076
Streamlining Protocol ReviewOLAW committed to reviewing  and revising the current guidance on streamlining the IACUC protocol review process for animal activities.The NIH Office of Laboratory Animal Welfare (OLAW)  proposed updates to NOT-OD-09-035 between July 11, 2023 and October 11, 2023.
 
See NOT-OD-23-152
 
The comment period is now closed.
 
The final guidance will be published along with a new webpage once comments have been considered. Until comments have been considered and new guidance has been finalized, OLAW expects institutions to comply with applicable existing guidance.
ZebrafishOne action identified by the research community was to consider changing the applicability of the PHS Policy to zebrafish larvae from immediately after hatching (typically 3 days post fertilization [dpf] under optimal conditions) to when larvae begin free feeding (at approximately 5 – 7 dpf).
 
OLAW committed to review existing guidance, clarify the requirements, and seek public comment on updated guidance.		While OLAW encourages institutions to use flexibilities to reduce administrative burden while using zebrafish in research), the PHS Policy continues to cover zebrafish larvae immediately after hatching.
 
OLAW sought input on flexibilities to reduce administrative burden while continuing to apply the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) to zebrafish (Danio rerio) immediately after hatching in a request for information between May 7, 2021 and August 9, 2021.
 
See NOT-OD 21-118
 
The comment period is now closed.
 
Additional information on flexibilities will be provided once comments have been considered.

Policies and Laws

Public Law 114-255 Section 2034(d) (PDF, 929.25 KB) ANIMAL CARE AND USE IN RESEARCH - Not later than 2 years after the date of enactment of this Act, the Director of 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 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 of experts, as appropriate. 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. 

Federal Register Notice 2019-18611 - Laboratory Animal Welfare: Report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research

Federal Register Notice 2018-26557 - Laboratory Animal Welfare: Draft Report on Recommendations to Reduce Administrative Burden on Researchers. 

Federal Register Notice 2021-25614 - AWA Research Facility Registration Updates, Reviews, and Reports

Get Started

An online Qualtrics survey was distributed from June 1-September 15, 2023, to individuals (e.g., IACUC administrators, coordinators, etc.) whose responsibilities include a direct role in the oversight of their IACUC program and/or IACUC policies and operations at approximately 1,470 OLAW Domestic Assured and USDA-Registered institutions or facilities. The objective of this survey was to determine if: 

  • institutions implemented optional OLAW flexibilities in their animal care and use programs and
  • the OLAW flexibilities and USDA updates directly and/or indirectly reduced administrative workload for administrative staff and investigators.

The results of the IACUC Administrator surveys will help to inform the development of a survey geared towards investigators.

Quick References: Results from the IACUC Administrator Survey

 

IACUC Administrator Survey: Read about the 2018 FDP Faculty Workload Survey and the 21st Century Cures Act , which directed NIH, along with the USDA and FDA, to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. OLAW developed flexibilities and guidance, and the USDA developed updates to address administrative burden, and a follow-up survey was sent to IACUC Administrators to evaluate the effects of these actions.
Graphic titled “IACUC Administrator Survey” about whether NIH-OLAW and USDA reduced administrative burden under the 21st Century Cures Act, with icons representing research and administration.
An informational graphic explaining that FDP Faculty Workload Survey results helped shape Section 2034(d) of the 21st Century Cures Act, directing NIH, USDA, and FDA to review and revise regulations for laboratory animal care to reduce administrative burden. The Act instructs NIH to seek expert input, identify regulatory inconsistencies, eliminate duplication, and improve coordination of policies for research with laboratory animals.
An informational graphic with a magnifying glass icon stating that following policy and regulatory changes, federal agencies pledged to evaluate the outcome of efforts to reduce administrative burden while maintaining scientific integrity and animal welfare.

NIH-OLAW and USDA Survey: Read about the demographics for NIH-OLAW and USDA Survey to IACUC Administrators
Infographic showing NIH-OLAW and USDA survey participation, including 285 IACUC administrators from 285 institutions of varying sizes.
An infographic titled 'IACUC Administrator Survey,' describing its purpose as evaluating the outcome of federal agencies' efforts to reduce administrative burden while maintaining scientific integrity and animal welfare following policy and regulatory changes. Below, three statistics show survey respondent institution types: 233 OLAW Assured institutions (81.2%), represented by an illustration of laboratory animals; 243 USDA Registered institutions (84.7%), shown with the USDA logo; and 175 AAALAC International Accredited institutions (61%), shown with the AAALAC International logo.

OLAW Guidance and Flexibilities: Read about OLAW Flexibilities that were included in the survey.
Timeline graphic titled “OLAW Guidance and Flexibilities” outlining key actions taken to reduce administrative burden, with dates from 2020 to 2021.
An infographic featuring a clipboard with checkmarks icon and a flexing arm icon labeled 'indicates optional flexibility.' The text states that 70% of Assured Institutions are using or plan to use an optional flexibility described in OLAW Guidance developed from the 6 action items.
An infographic titled 'Reducing Workload' presenting two side-by-side line charts. The left chart shows IACUC Administrators' perception of OLAW flexibilities at reducing their own administrative workload: 52% found them very to extremely effective, 38% slightly to moderately effective, and 9% not effective. The right chart shows their perception of OLAW flexibilities at reducing workload for researchers: 25% very to extremely effective, 35% slightly to moderately effective, and 40% not effective, indicating less direct benefit for researchers.

USDA Animal Welfare Act Updates: Read about USDA updates that were included in the survey.
Infographic titled “USDA Animal Welfare Act Updates” summarizing regulatory changes effective December 27, 2021, aimed at reducing administrative burden while maintaining humane animal care.
An infographic titled 'Reducing Workload' presenting two side-by-side line charts about IACUC Administrators' perceptions of USDA Updates' effectiveness. The headline states that IACUC Administrators felt USDA updates directly reduced their workload, with overall less direct workload-reducing effects for researchers. The left chart shows effectiveness at reducing administrators' own workload: 60% very to extremely effective, 29% slightly to moderately effective, and 11% not effective. The right chart shows effectiveness at reducing workload for researchers: 33% very to extremely effective, 22% slightly to moderately effective, and 45% not effective, indicating the updates had considerably less direct impact on researchers.

Redirected Assistance and Increased Support Reduces Burden for Investigators: Read about the survey results, and how the flexibilities directly benefitted animal care and use programs. These programs then redirected their support to investigators to reduce their administrative burden.
Graphic titled “Redirected Assistance and Increased Support Reduces Burden for Investigators,” explaining that policy flexibilities had direct institutional impact and indirect benefits for researchers.
An infographic titled 'Increased Administrative Support for Researchers' featuring a stacked horizontal bar chart. It explains that IACUC Administrators felt they could redirect time toward helping researchers with burdensome administrative tasks due to OLAW flexibilities and USDA updates. The chart shows the level of additional support provided across five task categories — assistance with IACUC software and forms (22% significant, 41% minimal to moderate, 37% none), initial protocol submission and review (24%, 41%, 35%), significant protocol amendments (24%, 44%, 33%), minor amendments (25%, 40%, 35%), and 3-year protocol resubmission (28%, 41%, 31%).
An infographic titled 'Increased Administrative Support for Animal Care Programs,' featuring an illustration of a person at a computer redirecting time toward documents and a mouse icon. It states that IACUC Administrators felt they could redirect time toward improving animal care programs, specifically increasing support for areas identified in the 2018 FDP Workload Survey as having the highest priorities for change to reduce unnecessary administrative burden.
A horizontal stacked bar chart showing IACUC Administrators' perceptions of improvement across nine program areas, with three categories: 'A good amount to Significant improvement' (dark blue), 'Minimal to Moderate improvement' (light blue), and 'No improvement' (gray). Results are as follows: Turn-around time for IACUC protocols and significant changes/amendments: 25% significant, 47% minimal to moderate, 28% no improvement; Number of rounds of protocol review prior to approval: 18% significant, 43% minimal to moderate, 39% no improvement; Quality of IACUC protocol review: 27% significant, 44% minimal to moderate, 29% no improvement; Quality of veterinary and husbandry support: 26% significant, 39% minimal to moderate, 35% no improvement; Quality of training in animal care and use: 25% significant, 40% minimal to moderate, 35% no improvement; Assignment of appropriate IACUC processes to type of research and level of risk: 21% significant, 46% minimal to moderate, 33% no improvement; Enhanced IACUC meeting efficiency: 28% significant, 46% minimal to moderate, 26% no improvement; Improved communications with research staff: 26% significant, 44% minimal to moderate, 31% no improvement; Working relationship/cooperation between researchers and animal care and use program personnel: 30% significant, 44% minimal to moderate, 26% no improvement.

Read about the survey results, and how the flexibilities directly benefitted animal care and use programs. These programs then redirected their support to investigators to reduce their administrative burden.
Graphic titled “Next Steps” stating that NIH-OLAW, USDA, and FDA will continue working together to harmonize regulations, protect animal welfare, and reduce regulatory burden, with a focus on education initiatives based on survey findings.
An informational graphic with two sections. The top section notes that OLAW plans to re-survey IACUC administrators and assess the effectiveness of federal efforts to reduce administrative workload, accompanied by a 'Continuing Feedback' icon showing two people in conversation. The bottom section, titled 'What Researchers Think,' explains that IACUC Administrator survey results will inform the development of a future survey targeting researchers to evaluate their perception of federal agencies' efforts at reducing administrative workload.

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