NTP–Anthraquinone Study: HHS Response to RFC

04/21/2005

Date: APR 21 2005

To: Mr. Ken Ballinger, Vice President Airepel 
3521 Silverside Road, Concord Plaza - Quillen Building, Wilmington, Delaware 19810

Re: Request for Correction dated January 18,2005

Dear Mr. Ballinger:

I am responding to your Request for Correction of Information filed by Airepel Humane Bird Management Services pursuant to Section 515(a) of the Treasury and General Government Appropriations Act for Fiscal Year 2001 1(the Information Quality Act or IQA) and the implementing guidelines issued by the Office of Management and Budget (OMB Guidelines), 2 the U.S. Department of Health and Human Services (HHS Guidelines) 3, and the HHS' National Institutes of Health (NIH Guidelines) 4 Your request concerns revisions being requested to a draft National Toxicology Program (NTP) Technical Report on anthraquinone (TR494). 5

The NIB Guidelines, consistent with HHS and OMB Guidelines, apply to information that the Agency disseminates to the public and represents as “fact or the agency's views.” 6 Information that does not fall into this category, e.g., scientific research papers that do not constitute agency views, should include “disclaimers alerting the audience that [the papers] do not represent official views of the NIB.” 7With this in mind, draft TR 494, which was peer reviewed by the NTP Board of Scientific Counselors Technical Reports Review Subcommittee on December 4, 2004, does not a represent “fact or agency views.” The front cover of draft TR 494 displayed a disclaimer explaining that the information contained in the draft report is not the official view of the government. Instead, the draft was circulated for purposes of obtaining public comment and peer review.

Consistent with its practice, the NTP posted the Subcommittee's actions on the draft TR 494 on its website 8 following the meeting and is currently reviewing the recommendation and comments Page 2 - Mr. Ken Ballinger

from the Subcommittee and the public to make necessary edits to the report, including the abstract, prior to finalizing and publishing TR 494. However, we have forwarded your letter and comments on this draft report to the NTP for consideration. Once the NTP finalizes TR 494, it will be available electronically on the NTP website (http://ntp.niehs.nih.gov) and in hardcopy from the NTP Central Data Management (919-541-3419).

Thank you again for bringing your concerns to our attention and for providing info11l1ation on anthraquinone and comments on draft TR 494. If you have additional comments on this draft report, you may mail or fax them to:

NTP Liaison and Scientific Review Office 
National Institute of Environmental Health Sciences 
P.O. Box 12233 
111 T.W. Alexander Drive Research Triangle Park, NC 27709 
Fax: 919-541-0295

I would like to Jet you know that you may appeal the agency's decision either in writing or electronically within 30 days of receiving this response. Your request should state the reasons for your appeal. It does not need to reference a tracking number. The request may be sent electronically to InfoQuality@od.nih.gov or in hard copy to Lora Kutkat, Office of Science Policy and Planning, Office of the Director, National Institutes of Health, Building 1, Room 218, 9000 Rockville Pike, Bethesda, Maryland 20892. If the appeal is sent in hard copy, please clearly mark the appeal and outside envelope with the phrase "Information Quality Appeal."

Sincerely,

Lora Kutkat

Office of Science Policy and Planning 
National Institutes of Health 
Building 1, Room 218 
9000 Rockville Pike 
Bethesda, MD 20892

cc: Christopher J. Portier, Ph.D., NIEHS/NTP

1 44 U.S.C. 3516 note.

2Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information by Federal Agencies, 67 Fed, Reg. 8452 (February 22, 2002), available at http://www.whitehouse.gov/omb/fedreg/reproducible2.pdf.

3Guidelines for Ensuring the Quality of Information Dissemination to the Public, available at http://aspe.hhs.gov/infoquality/Guidelines/part1.shtml.

4Guidelines for Ensuring the Quality of Information Dissemination to the Public: National Institutes of Health, avail able at http://aspe.hhs.gov/infoquality/Guidelines/NIHinfo2.shtml.

5Toxicology and Carcinogenesis Studies of Anthraquinone (CAS No, 84-65-1) in F3441N Rats and B6C3FI Mice (Feed Studies) NTP TR 494 NIH Publication No. 04-393.

6OMB Guidelines, Section V (5), 67 Fed, Reg. 8460; HHS Guidelines, Section D(2)(e); NTH Guidelines, Section 11(2).

7NIH Guide1ines, Section II (1).

8Available at http://ntp.niehs.nih.gov select "Advisory Board & Committees."