FACA

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.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”

HHS - 29125 - National Cancer Institute Clinical Trials and Translational Research Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	National Cancer Institute Clinical Trials and Translational Research Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2022	Committee Number	29125
Original Establishment Date	11/20/1985	Committee Status	Chartered
Actual Termination Date		Committee URL	http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm
New Committee This FY	No	Presidential Appointments*	No
Terminated This FY	No	Max Number of Members*	33
Current Charter Date	4/14/2022	Designated Fed Officer Position Title*	DIRECTOR, COORDINATING CENTER FOR CLINICAL TRIALS
Date Of Renewal Charter	4/14/2024	Designated Federal Officer Prefix
Projected Termination Date		Designated Federal Officer First Name*	SHEILA
Exempt From Renewal*	No	Designated Federal Officer Middle Name	A.
Specific Termination Authority		Designated Federal Officer Last Name*	PRINDIVILLE
Establishment Authority*	Authorized by Law	Designated Federal Officer Suffix	MD, MPH
Specific Establishment Authority*	42 USC 285a-2(b)(7)	Designated Federal Officer Phone*	240-276-6173
Effective Date Of Authority*	11/20/1985	Designated Federal Officer Fax*	240-276-6274
Exempt From EO 13875 Discretionary Cmte	Not Applicable	Designated Federal Officer Email*	prindivs@mail.nih.gov
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The Committee is composed of scientific leaders and public members knowledgeable in the fields of community oncology, surgical oncology, medical oncology, radiation oncology, patient advocacy, extramural clinical investigation, regulatory agencies, pharmaceutical industry, public health, clinical trials design, management and evaluation, drug development and developmental therapeutics, cancer education, cancer information services, community outreach, vaccine development, cellular oncology, molecular oncology, pediatric oncology, clinical, basic and translational research, cancer center administration, cancer biology and diagnosis, cancer epidemiology, chemotherapy, oncology health care providers, pharmacology, pathology, biostatistics, quality of life, health care outcomes, pain management, cancer treatment and restorative care, and education of health professionals. The Committee provides advice to the NCI Director, NCI Deputy Directors, and the Director of each NCI Division on the NCI-supported national clinical trials enterprise to build a strong scientific infrastructure by bringing together a broadly developed and engaged coalition of stakeholders involved in the clinical trials process. In FY2022, the Committee met twice on November 10, 2021 (virtual meeting) and March 16, 2022 (virtual meeting). The Committee’s discussions were focused on the following items: the Early Stage Surgeon Scientist program, the R50 Clinician Scientist Research award, the future direction of the Cancer Clinical Investigator Team Leadership award (CCITLA), progress toward implementation of the Strategic Planning Working Group (SPWG) report, Cancer Therapy Evaluation Program (CTEP) analysis of implementing the American Society of Clinical Oncology (ASCO)-FRIENDS broadened eligibility criteria in CTEP-sponsored trials, FDA draft guidance on the inclusion of patient-reported outcomes (PROs) in cancer clinical trials, the NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE) program, the telehealth initiative in the SPWG report, and challenges with the clinical trials operations workforce. The CTAC meeting summaries from the meetings held on November 10, 2021 and March 16, 2022 were approved.
How is membership balanced?*	The Committee consists of up to 25 members. When necessary, five members will hold concurrent membership on either the National Cancer Advisory Board, Board of Scientific Advisors, NCI Board of Scientific Counselors, or NCI Council of Research Advocates. Members are leaders knowledgeable in the fields of community oncology, surgical oncology, medical oncology, radiation oncology, patient advocacy, extramural clinical investigation, regulatory agencies, pharmaceutical industry, public health, clinical trials design, management and evaluation, drug development and developmental therapeutics, cancer education, cancer information services, community outreach, vaccine development, cellular oncology, molecular oncology, pediatric oncology, clinical, basic and translational research, cancer center administration, cancer biology and diagnosis, cancer epidemiology, chemotherapy, oncology health care providers, pharmacology, pathology, biostatistics, quality of life, health care outcomes, pain management, cancer treatment and restorative care, and education of health professionals.
How frequent & relevant are cmte mtgs?*	The Committee meets approximately three times each fiscal year. In FY2022, the Committee met twice virtually on November 10, 2021 and March 16, 2022. The Committee's deliberations are an indispensable part of the review of a very large clinical trials and translational research program. In addition to the CTAC parent meetings, the Ad Hoc Gastric and Esophageal Cancers Working Group met on December 13, 2021 and June 29, 2022. Additionally, the Ad Hoc Streamlining Clinical Trials Working Group met on July 13, 2022.
Why advice can't be obtained elsewhere?*	This Committee is composed of recognized biomedical research authorities from outside the NIH in order to secure unbiased and objective evaluations of clinical trials and translational research programs. Their recommendations are invaluable because the complex nature of the research requires a unique balance and breadth of expertise not available at NIH or from other established sources.
Why close or partially close meetings?	N/A
Recommendation Remarks	Max Number of Members Total: The Charter allows the Committee to have 33 authorized members including but not limited to 25 SGEs and 8 Ex Officio Members. There is currently no Ex Officio Member from the Department of Defense, as such there are only seven Ex Officio Members (James Doroshow, Paulette Gray, James Gulley, Michael Kelly, Anthony Keverlage, Richard Pazdur, and Xiufen Sui), which is a total of 32 members, one less than the Max number of members. Members Rotating Off/On-Boarding: Two members rotated-off (Anjelica Davis and Debra Barton) and five more were on-boarded (Gary Doolittle, Robert Mannel, Ruben Mesa, Patricia Spears, and George Wilding). This is why the Charter states 33 potential members, but this ACR lists 32. Members: The term for Nancy E. Davidson has changed due to an administrative extension. The terms for Angelica Davis and Neal Meropol changed due to reappointments. As such their terms are different than what was reported in FY21. The term for Neal Meropol changed due to a reappointment as Chair. As such, his term is different than what was reported in FY21. Ex Officio Member: William Dahut left the committee on May 1, 2022. As such, his term is different then what was reported in FY21 Meetings: The committee was unable to meet three times during the fiscal year due to agenda topic scheduling difficulties. The DFO and Committee Decision Maker positions are held by the same individual because of the assignment of responsibilities within the Institute.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	No	Action Reallocate Resources	No
Outcome Major Policy Changes	Yes	Action Issued New Regulations	No
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	No	Action Comment	The committee makes recommendations to federal staff on the NCI-supported national clinical trials enterprise to build a strong scientific infrastructure by bringing together a broadly developed and engaged coalition of stakeholders involved in the clinical trials process. Based on the recommendations of this committee, NCI has restructured its clinical trials infrastructure to enhance efficiency and scientific quality, instituted policy changes, developed scientific frameworks for recalcitrant cancers, and constituted oversight working groups.
Outcome Implement Laws/Reg Requirements	No	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	N/A	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	NIH-supported basic and clinical research accomplishments often take many years to unfold into new diagnostic tests and new ways to treat and prevent diseases.	Grants Review Comment	N/A
Number Of Recommendations*	98	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	In addition to some general recommendations, the committee made the following recommendation: approved the formation of an Ad hoc Working Group on Streamlining Clinical Trials.	Access Agency Website	Yes
% of Recs Fully Implemented*	98.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The percentage of recommendations implemented stated above was developed at the time the Annual Comprehensive Review report was prepared. Additional information is available through the RePORT (Research Portfolio Online Reporting Tool) website. RePORT provides access to reports, data, and analyses of NIH research activities that advance the mission of the NIH, including information on NIH expenditures, strategic plans, reports on NIH funding, and reports on the organization and people involved in NIH research and research training. The RePORT website is located at http://report.nih.gov.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	2.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The percentage of recommendations implemented stated above was developed at the time the Annual Comprehensive Review report was prepared. Additional information is available through the RePORT (Research Portfolio Online Reporting Tool) website. RePORT provides access to reports, data, and analyses of NIH research activities that advance the mission of the NIH, including information on NIH expenditures, strategic plans, reports on NIH funding, and reports on the organization and people involved in NIH research and research training. The RePORT website is located at http://report.nih.gov.	Access Other	Yes
Agency Feedback*	Yes	Access Comment	Information on CTAC can be found at the NCI Division of Extramural Activities: Advisory Boards, Committees and Review Groups website at http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm. Each NCI committee’s charter, minutes, agenda, roster, future meeting dates, meeting Power Points and reports are located here. Additionally, the public may view the CTAC meetings (both live and on demand) via the NIH Videocast at the following website: http://videocast.nih.gov/.
Agency Feedback Comment*	The agency provided feedback to the various NCI advisory boards with periodic updates at meetings. Information is provided to the public at each meeting. The public can also view information related to the Committee through the committee’s official website.	Narrative Description*	The goal of the NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability, from the rarest genetic disorder to the common cold. The NIH works toward that mission by utilizing the National Cancer Institute Clinical Trials and Translational Research Advisory Committee (CTAC). The CTAC conducts and provides oversight and implementation of clinical trials across the Institute. The Committee consists of up to 25 members. When necessary, five members will hold concurrent membership on either the National Cancer Advisory Board, Board of Scientific Advisors, Board of Scientific Counselors, or NCI Council of Research Advocates. Members will be authorities in the fields of community oncology, surgical oncology, medical oncology, radiation oncology, patient advocacy, extramural clinical investigation, regulatory agencies, pharmaceutical industry, public health, clinical trials design, management and evaluation, drug development and developmental therapeutics, cancer education, cancer information services, community outreach, vaccine development, cellular oncology, molecular oncology, pediatric oncology, clinical, basic and translational research, cancer center administration, cancer biology and diagnosis, cancer epidemiology, chemotherapy, oncology health care providers, pharmacology, pathology, biostatistics, quality of life, health care outcomes, pain management, cancer treatment and restorative care, and education of health professionals.

COSTS

Payments to Non-Federal Members*	$7,600.00	Est Payments to Non-Fed Members Next FY*	$7,600.00
Payments to Federal Members*	$8,788.00	Est. Payments to Fed Members Next FY*	$8,788.00
Payments to Federal Staff*	$95,059.00	Estimated Payments to Federal Staff*	$88,454.00
Payments to Consultants*	$1,800.00	Est. Payments to Consultants Next FY*	$1,800.00
Travel Reimb. For Non-Federal Members*	$0.00	Est Travel Reimb Non-Fed Members nextFY*	$33,113.00
Travel Reimb. For Federal Members*	$0.00	Est Travel Reimb For Fed Members*	$0.00
Travel Reimb. For Federal Staff*	$0.00	Est. Travel Reimb to Fed Staff Next FY*	$0.00
Travel Reimb. For Consultants*	$0.00	Est Travel Reimb to Consultants Next FY*	$13,245.00
Other Costs	$14,922.00	Est. Other Costs Next FY*	$15,437.00
Total Costs	$128,169.00	Est. Total Next FY*	$168,437.00
Date Cost Last Modified	9/9/2022 3:01 PM	Est. Fed Staff Support Next FY*	0.40
Federal Staff Support (FTE)*	0.50	Est Cost Remarks	Projected costs for FY23 were increased in the event that inperson/hybrid meetings resume. The projected Federal Staff Costs and Total Staff Support Years decreased due to the departure of staff. Projected daily salary costs have been estimated for Federal and/or Ex Officio members of this committee. The dollar figure represents a portion of their annual salary. No funds will be transferred between the committee and the agency. No additional funds will be paid to Federal employee due to membership on this committee.
Cost Remarks	Meetings were held virtually in FY22 due to the ongoing COVID-19 pandemic as such the FY22 Operating Costs are lower than what was projected on the FY21 FOP. Daily salary costs have been estimated for Federal and/or Ex Officio members of this committee. The dollar figure represents a portion of their annual salary. No funds have been transferred between the committee and the agency. No additional funds are paid to Federal employee due to membership on this committee.

Interest Areas

Category Area Health Treatment Medicine Diseases Health and Health Research

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