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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	2025	Committee Number	5255
Original Establishment Date	1/7/1997	Committee Status	Chartered
Actual Termination Date		Committee URL	https://ntp.niehs.nih.gov/whoweare/advisory/ind...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	Unlimited
Terminated This FY	No	Designated Fed Officer Position Title*	Deputy Director for Policy and Communication, Division of Translational Toxicology; Director, Office of Policy, Review, and Outreach
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	1/7/2025	Designated Federal Officer First Name*	Mary
Date Of Renewal Charter	1/7/2027	Designated Federal Officer Middle Name	S.
Projected Termination Date		Designated Federal Officer Last Name*	Wolfe
Exempt From Renewal*	No	Designated Federal Officer Suffix	Ph.D.
Specific Termination Authority		Designated Federal Officer Phone*	(984) 287-3209
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	(301) 451-5759
Specific Establishment Authority*	42 USC 217a	Designated Federal Officer Email*	wolfe@niehs.nih.gov
Effective Date Of Authority*	1/7/1997
Exempt From EO 13875 Discretionary Cmte	Not Applicable
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 approximately 3-4 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. There were no meetings in FY2024. NTP has spent the last several months reviewing and formalizing the Peer-Review process including SEPs, in accordance with OMB Guidelines. They are now starting to plan for oxybenzone panel early next year (dates TBD) and also anticipate two others for later in the year.
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): No members are being reported due to no meetings occurring in FY 2025. In the years that the committee does meet, the members of this Special Emphasis Panel (SEP) do not have standing appointments and serve on an as needed basis for meetings throughout the fiscal year. Since there was no meeting this fiscal year, there are no listed members. Meetings: None at this time. A meeting is tentatively planned for November 2025.

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*	137	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	No recommendations were reported in FY25. The National Toxicology Program (NTP) is an interagency program with partners from the National Institutes of Health/National Institute of Environmental Health Sciences, Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health, and Food and Drug Administration/National Center for Toxicological Research. In FY2024 we reviewed and formalized our peer review processes, including Special Emphasis Panels (SEPs), in accordance with Office of Management and Budget Information Quality Guidelines for Peer Review. In 2025 we initiated planning for external peer review of the draft NTP Technical Report on Developmental and Reproductive Toxicity Studies on 2-Hydroxy-4-methoxybenzophenone (oxybenzone), including identifying potential panel members and setting a date for the panel’s peer review of the draft report at a public meeting. In March 2025 NIEHS learned that in accordance with the administration transition, the NTP SEP charter would move to NIH Center for Scientific Review (CSR). Transition of the charter to CSR occurred in May 2025. NIEHS is now working with CSR staff to share information and transition conduct of NTP SEP peer review. External peer review of the draft NTP report on oxybenzone is tentatively planned for November 2025.	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*	Information resulting from closed initial peer review meetings is subject to the Freedom of Information Act. The public can view information on research projects funded by NIH on the RePORT (Research Portfolio Online Reporting Tool) website located at http://report.nih.gov.	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

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:45 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Health Health Care Medicine Health and Health Research

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