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Letter dated - 12/06/2012 Policy and Review Division of NTP

December 6, 2012



­Dr. Lori White

Designated Federal Officer for the BSC

Office of Liaison,

Policy and Review Division of NTP, NIEHS

P.O. Box 12233, K2-03

Research Triangle Park, NC 27709


RE:  Comments on the Board of Scientific Counselor’s Anticipated Adoption of the National Toxicology Program’s “Approach for Systematic Review and Evidence Integration for Literature-based Health Assessments”


Dear Dr. White,


The Small Business Administration (SBA), Office of Advocacy (Advocacy) appreciates the opportunity to submit comments to the National Toxicology Program (NTP) Board of Scientific Counselors (BSC) in advance of their December 11, 2012 meeting.  Advocacy has heard from small businesses that are concerned that the very short time period NTP has provided for review of and comment on NTP’s “Approach for Systematic Review and Evidence Integration for Literature-based Health Assessments” (Systematic Approach) will negatively affect their interests and will not promote openness and transparency as outlined in Executive Order 13563.  Advocacy respectfully requests that the BSC extend time for consideration of the Systematic Approach in order to allow for a more robust public comment process.


Office of Advocacy


Congress established the Office of Advocacy (Advocacy) under Pub. L. No. 94-305 to advocate the views of small entities before Federal agencies and Congress.  As Advocacy is an independent body within the U.S. Small Business Administration (SBA), the views expressed by Advocacy do not necessarily reflect either the position of the Administration or SBA.


NTP Should Allow Further Review of the Systematic Approach in Favor of a Transparent Public Process


Small entities are concerned with the lack of meaningful opportunity for all stakeholders, including small businesses, to participate in the development of, and to comment on, the NTP’s new approach for systematic review and evidence integration for literature-based health assessments.  Although the Federal Register notice announcing the BSC meeting was published on October 4, 2012, with public comments due by November 27, 2012, NTP did not post the appropriate documents on its website until late November.  Although NTP extended the deadline for public comment to Thursday, December 6, the extension still did not provide enough time to comment on the Systematic Approach. 


Advocacy supports the application of the President’s Memorandum on Transparency and Open Government which requires a greater consideration of the views of stakeholders in the NTP processes.  Although Advocacy appreciates NTP’s intent to publish timely public comments on its website, the principles of transparency, participation, and collaboration are well served only if the timeline signals that those comments will be given appropriate consideration.


In light of the impact that the adoption of the Systematic Approach will have on the subsequent decisions and publications of the NTP and other federal agencies, and in turn small businesses, Advocacy respectfully requests that the BSC delay its consideration of the Systematic Approach.  A more robust public comment process, with sufficient time for all stakeholders to review and comment on the Systematic Approach, would provide NTP with valuable input for the entire record for the members of the BSC.


If my office can be of any further assistance, please contact me or Sarah Bresolin Silver at (202) 205-6790 or






Winslow Sargeant, Ph.D.

Chief Counsel for Advocacy



Sarah Bresolin Silver

Assistant Chief Counsel

Office of Advocacy