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Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.


HHS - 12153 - Scientific Advisory Committee on Alternative Toxicological Methods - Statutory (Congress Created)
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameScientific Advisory Committee on Alternative Toxicological MethodsAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number12153
Original Establishment Date12/19/2000Committee StatusChartered
Actual Termination Date Committee URLhttp://ntp.niehs.nih.gov/about/org/sacatm/index...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*32
Current Charter Date12/18/2019Designated Fed Officer Position Title*Director, NTP Office of Liaison, Policy and Review
Date Of Renewal Charter12/18/2021Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Mary
Exempt From Renewal*NoDesignated Federal Officer Middle NameS
Specific Termination AuthorityDesignated Federal Officer Last Name*Wolfe
Establishment Authority*Statutory (Congress Created)Designated Federal Officer SuffixPHD
Specific Establishment Authority*42USC 285l-3(d), as amendedDesignated Federal Officer Phone*(984) 287-3209
Effective Date Of Authority*12/19/2000Designated Federal Officer Fax*(301) 451-5759
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*wolfe@niehs.nih.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The scope and objectives of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) are to advise the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, and national and international harmonization of new, revised, and alternative toxicological test methods. Alternative methods are those that reduce, refine (lessen or avoid pain and/or distress), or replace the use of animals in testing. SACATM also provides input on ways to foster partnerships and communication with interested parties. Meeting information can be found at http://ntp.niehs.nih.gov/go/32822.
How is membership balanced?*Members are selected from recognized authorities knowledgeable in academia, industry, state government, public health, environmental communities or organizations using new or alternative test methods, as appropriate, in accordance with the statutorily mandated requirements for representation on the SACATM.
How frequent & relevant are cmte mtgs?*Meetings are held at least once each fiscal year. The NIEHS Director appoints voting members to the SACATM, and membership is defined in the ICCVAM Authorization Act of 2000 to include representatives from academia, state government, industry, and animal protection organizations. There was one ICCVAM Public Forum meeting during this reporting period.
Why advice can't be obtained elsewhere?*The quality, scope and balance of advice provided cannot be obtained from NIH staff or from other established sources. Its membership is constituted to meet the specific requirements of the mandated mission of the committee and the Institute.
Why close or partially close meetings?NA
Recommendation RemarksThe DFO and Committee Decision Maker positions are held by the same individual due to the assignment of responsibilities within this Institute.

This committee did not produce any reports this fiscal year.

Ex Officio Members: According to the charter language NIH has determined there are 17 Ex Officio positions associated with this committee and the max number of positions to includes these members. No Ex Officio members have been identified and there are no Ex Officio members in the list of current members in this report. It has been the practice of ICCVAM members to send ad hoc attendees according to the topics being discussed rather than having ex officio members formally identified.

Chair: Dr. Nadira K. DeAbrew is serving as Acting Chair while waiting for the approval of the 2020 SACATM nomination slate. Pamela Spencer served as Chair until 11/30/2019.

Members: Dr. Spencer’s appointment to this committee was reported as 2/7/16-11/30/19 in the FY19 ACR. The Chair appointment 12/1/2018-11/30/19 was inadvertently omitted in the FY19 ACR Report. Because the member appointment period falls outside FY20, only the Chair appointment is included in this report.

Costs: Due to the COVID-19 pandemic and converting meetings from in-person to virtual, the projected FY21 committee expenses are subject to change.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*No
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesNoAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentThe Committee makes recommendations to federal staff regarding the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods. Alternative methods are those that reduce, refine (lessen or avoid pain and/or distress), or replace the use of animals in testing. SACATM also provides input on ways to foster partnerships and communication with interested parties.
Outcome Implement Laws/Reg RequirementsNoGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentMany of the alternative test methods promoted by SACATM may in theory reduce the cost of individual toxicity tests, but it is unclear whether reduced cost per agent tested will be offset by increasing number of agents tested.Grants Review CommentNA
Number Of Recommendations*70Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentSACATM met on September 2-3, 2020, by webcast. Agenda topics included: (1) SACATM: past, present, and future; (2) fostering international partnerships; (3) curating and characterizing data for alternative methods use; and (4) computational resources.

SACATM provided several recommendations on activities and proposed projects presented at the meeting and in the background material provided before the meeting.

Recommendations from SACATM 2020 were in four major areas:

I. SACATM recognized the opportunity to reduce animal use by facilitating the adoption of recombinant (or non-animal derived) antibodies (rAb). Their recommendations included:
a. Educational outreach including state-of-the-science papers on the applicability, availability, and reproducibility of experimental rAb, including a description of the costs of rAb.
b. Investigations of antibody production by organ-based chip systems, including manageability and scalability.
c. Additional efforts to support the acceptance of rAb.

II. SACATM was impressed by the degree of progress made in addressing previously identified limitations within the Integrated Chemical Environment database and analysis resource. They recommended applying a combination of computational approaches along with the Globally Harmonized System’s methods to predict LD50 concentrations for mixtures.

III. SACATM encouraged ICCVAM and NICEATM to facilitate adoption of new alternative methodologies (NAMs) through the following recommendations:
a. Incentivization of NAM’s adoption by regulatory agencies.
b. Within agencies with grant authority, embed requirements for NAMs within programs.
c. Provide educational outreach on NAMs to stakeholders in the form of symposia, white papers, state-of-the-science papers, guidelines, etc.

IV. SACATM recognized the efforts of the ICCVAM Metrics Workgroup. They encouraged them to:
a. Consider in their planning what would constitute success and develop metrics to capture that success.
Access Agency WebsiteYes
% of Recs Fully Implemented*0.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentDue to the complexity of the recommendations made by this committee, staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*0.00%Access PublicationsNo
% of Recs Partially Implemented CommentDue to the complexity of the recommendations made by this committee, staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback Comment*Staff identifies key outcomes of the meeting and reports back to SACATM at the next meeting on developments on the recommendations or advice (either by formal presentation or during discussion).Narrative Description*This committee advises the NIEHS, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicology Methods (Center) regarding ICCVAM activities. They also advise the NIEHS and the NTP Center on the NTP Center's activities.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$3,000.00Est Payments to Non-Fed Members Next FY*$3,000.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$94,568.00Estimated Payments to Federal Staff*$97,026.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$0.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$12,980.00Est. Other Costs Next FY*$13,110.00
Total Costs$110,548.00Est. Total Next FY*$113,136.00
Federal Staff Support (FTE)*0.60Est. Fed Staff Support Next FY*0.60
Cost RemarksEst Cost RemarksIf in-person meetings resume, the projected FY21 committee expenses are subject to change.
Hide Section - Interest Areas

Interest Areas

Category
Area
Medicine
Health and Health Research
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-036544Scientific Advisory Committee on Alternative Toxicological Methods2019
 COM-034756Scientific Advisory Committee on Alternative Toxicological Methods2018
 COM-001880Scientific Advisory Committee on Alternative Toxicological Methods2017
 COM-002329Scientific Advisory Committee on Alternative Toxicological Methods2016
 COM-004151Scientific Advisory Committee on Alternative Toxicological Methods2015
 COM-004681Scientific Advisory Committee on Alternative Toxicological Methods2014
 COM-006100Scientific Advisory Committee on Alternative Toxicological Methods2013
 COM-006534Scientific Advisory Committee on Alternative Toxicological Methods2012
 COM-007999Scientific Advisory Committee on Alternative Toxicological Methods2011
 COM-008856Scientific Advisory Committee on Alternative Toxicological Methods2010
 COM-010230Scientific Advisory Committee on Alternative Toxicological Methods2009
 COM-011048Scientific Advisory Committee on Alternative Toxicological Methods2008
 COM-011951Scientific Advisory Committee on Alternative Toxicological Methods2007
 COM-012548Scientific Advisory Committee on Alternative Toxicological Methods2006
 COM-013733Scientific Advisory Committee on Alternative Toxicological Methods2005
 COM-014458Scientific Advisory Committee on Alternative Toxicological Methods2004
 COM-015713Scientific Advisory Committee on Alternative Toxicological Methods2003
 COM-016545Scientific Advisory Committee on Alternative Toxicological Methods2002