FACA

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HHS - 5255 - National Toxicology Program Special Emphasis Panel - Authorized by Law

GENERAL INFORMATION

Committee Name	National Toxicology Program Special Emphasis Panel	Agency Name	Department of Health and Human Services
Fiscal Year	2021	Committee Number	5255
Original Establishment Date	1/7/1997	Committee Status	Chartered
Actual Termination Date		Committee URL	https://ntp.niehs.nih.gov/events/panels/index.cfm
New Committee This FY	No	Presidential Appointments*	No
Terminated This FY	No	Max Number of Members*	Unlimited
Current Charter Date	1/7/2021	Designated Fed Officer Position Title*	Health Scientist
Date Of Renewal Charter	1/7/2023	Designated Federal Officer Prefix
Projected Termination Date		Designated Federal Officer First Name*	Sheena
Exempt From Renewal*	No	Designated Federal Officer Middle Name
Specific Termination Authority		Designated Federal Officer Last Name*	Scruggs
Establishment Authority*	Authorized by Law	Designated Federal Officer Suffix	PHD
Specific Establishment Authority*	42 USC 217a	Designated Federal Officer Phone*	(984) 287-3355
Effective Date Of Authority*	1/7/1997	Designated Federal Officer Fax*	919-541-0295
Exempt From EO 13875 Discretionary Cmte	Exempt: Merit Review Panel	Designated Federal Officer Email*	sheena.scruggs@nih.gov
Committee Type*	Continuing
Presidential*	No
Committee Function*	Special Emphasis Panel

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The National Toxicology Program (NTP) convenes ad hoc Special Emphasis Panels (SEPs) to provide independent peer review and advise NTP on agents of public health concern, new/revised toxicological test methods, or other issues. They help ensure transparent, unbiased, and scientifically rigorous input to the program for its use in making credible decisions about human health, setting research and testing priorities, and providing information to regulatory agencies about alternative methods for toxicity screening. The panels provide opinions and recommendations that include, but are not limited to, the strength of the scientific evidence that exposure to an agent is a hazard for human health, the adequacy of new/revised/alternative toxicological test methods relative to current methods for assessing specific toxicities, or the validation status of test methods. They may also advise on the quality, reproducibility, and limitations of scientific findings; identify critical knowledge gaps and data needs; identify areas where improved or new test methods are needed; or advise on the design, conduct, and adequacy of validation studies for proposed test methods. These panels are comprised of members designated to serve for individual meetings based on their expertise, and they are not appointed for fixed terms of service.
How is membership balanced?*	The panels have a fluid membership with members designated to serve for individual meetings rather than formally appointed for fixed terms of service. The panelists for each meeting are selected to address specific issues, such as to evaluate test methods for toxicological assessments, to develop consensus on usefulness of test methods to generate information for specific human health and/or ecological risk assessment purposes, or to evaluate the potential hazard for human health from exposure to a specific environmental substance. Participants on the panel are assembled from experts in the various disciplines and fields relative to the issue under review.
How frequent & relevant are cmte mtgs?*	Meetings are held 1-3 times each fiscal year. The flexibility in review allows the NTP to hold panel meetings as programmatic needs dictate to ensure efficiency and effectiveness in the review process.
Why advice can't be obtained elsewhere?*	Because of the unique function and objectives of the NTP within the public sector, an independent advisory panel is required that includes a breadth of relevant scientific expertise and a panel that can evaluate and advise on activities ranging from identification of human health hazards to methods for use in regulatory safety testing.
Why close or partially close meetings?	N/A
Recommendation Remarks	DFO and Committee Decision Maker positions are held by the same individual based on the assignment of responsibilities within the National Toxicology Program. Reports: This committee did not produce any public reports during the fiscal year. Member(s): Dr. Gabriele Ludewig was the designated Chair for the April 2021 meeting. Costs: FY22 Travel and Per Diem Projections include estimates for the possibility for approximately 50% of meetings to occur as in-person meetings FY22. With additional guidance forthcoming, these projected Travel and Per Diem costs are subject to change.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	No
Outcome Trust In Government	Yes	Action Reallocate Resources	No
Outcome Major Policy Changes	No	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	Yes	Action Comment	The Committee makes recommendations to federal staff. The National Toxicology Program (NTP) convenes Special Emphasis Panels (SEPs) to provide independent peer review and advise the NTP on agents of public health concern, new/revised toxicological test methods, or other issues.
Outcome Implement Laws/Reg Requirements	No	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	None	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	NA
Number Of Recommendations*	131	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The NTP Technical Reports Peer Review Meeting was held on April 2, 2021, by webcast, to review the Draft NTP Technical Reports on the Toxicology and Carcinogenesis Studies of Sodium Tungstate Dihydrate, Di-n-butyl Phthalate, and Di(2-ethylhexyl) Phthalate. Tungsten occurs naturally in the environment and can enter waterways through the weathering of rocks and soil. It was nominated for study due to concerns about potential widespread human exposure via contaminated drinking water. Sodium tungstate dihydrate was selected because it is a naturally occurring, water soluble form of tungsten. The panel agreed with NTP’s four draft conclusions, which included four recommendations regarding the level of evidence of carcinogenic activity of sodium tungstate dihydrate in male and female rats and mice. Di-n-butyl phthalate (DBP) is commonly used as a plasticizer and is found in a variety of consumer products, such as vinyl fabrics and flooring, personal care products, pharmaceuticals, and food packaging. The panel had four recommendations and agreed with NTP’s four draft conclusions on the level of evidence of carcinogenic activity of DBP in female and male rats and mice. Di(2-ethylhexyl) phthalate (DEHP) is a phthalate ester that was widely used in manufacturing of PVC polymers and corresponding products, such as cosmetics and toys. The panel agreed with NTP’s draft conclusions. The panel had five recommendations regarding the level of evidence of carcinogenic activity of DEHP in male and female rats and mice, as well as a comparative study on perinatal and postweaning exposure. The panel recommended two minor changes on the NTP’s draft conclusion regarding the effect DEHP in female rats.	Access Agency Website	Yes
% of Recs Fully Implemented*	0.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The results of NTP studies and recommendations can be found at http://ntp.niehs.nih.gov.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	0.00%	Access Publications	No
% of Recs Partially Implemented Comment	N/A	Access Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	The NTP sends a copy of the NTP Monograph containing the NTP opinion to the Panel.	Narrative Description*	NTP Special Emphasis Panels are technical, scientific advisory bodies established on an as needed basis to provide independent scientific peer review and advise the NTP on agents of public health concern, new/revised toxicological test methods, or issues. These panels help ensure transparent, unbiased, and scientifically rigorous input to the program for its use in making credible decisions about human hazard, setting research and testing priorities, and providing information to regulatory agencies about alternative methods for toxicity screening.

COSTS

Payments to Non-Federal Members*	$3,250.00	Est Payments to Non-Fed Members Next FY*	$3,250.00
Payments to Federal Members*	$0.00	Est. Payments to Fed Members Next FY*	$0.00
Payments to Federal Staff*	$47,738.00	Estimated Payments to Federal Staff*	$48,215.00
Payments to Consultants*	$0.00	Est. Payments to Consultants Next FY*	$0.00
Travel Reimb. For Non-Federal Members*	$0.00	Est Travel Reimb Non-Fed Members nextFY*	$7,898.00
Travel Reimb. For Federal Members*	$0.00	Est Travel Reimb For Fed Members*	$331.00
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*	$949.00
Other Costs	$25,881.00	Est. Other Costs Next FY*	$26,698.00
Total Costs	$76,869.00	Est. Total Next FY*	$87,341.00
Date Cost Last Modified	8/27/2021 11:25 AM	Est. Fed Staff Support Next FY*	0.30
Federal Staff Support (FTE)*	0.30	Est Cost Remarks	As all meetings were held virtually in FY21 due to the ongoing COVID-19 pandemic, projected costs for FY22 were increased in the event that face-to-face meetings resume.
Cost Remarks

Interest Areas

Category Area Health Health Care Medicine Health and Health Research

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