Year-End Information Quality Report

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Year-End Information Quality Report

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Cover Sheet: Requests for Correction by Agency

Department Name: Department of Health and Human Services

Period Covered: October 2002 through September 2003

Agency Name	Number of Requests Received	Number Designated as Influential [list agencies]
CDC	3
CMS	1
FDA	1	1
NIH	4
OPHS	1
TOTALS	10	1

Agency Receiving Petition: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science
Petitioner: The Center for Regulatory Effectiveness, an advocacy organization.
Date Received: Received by postal mail dated 9/8/03 and logged in on 9/17/03.
Summary of Request: The Center for Regulatory Effectiveness (CRE) states that the Secretaries of HHS and USDA announced an intent to base what they would include in the 2005 Dietary Guidelines for Americans on the World Health Organization (WHO) Technical Report on Diet, Nutrition and the Prevention of Chronic Diseases. CRE states the WHO report does not meet USDA, HHS and OPHS data quality standards and should be subject to a pre-dissemination review
Description of Requested Correction: The CRE requests three corrections. The first is a pre-dissemination review of the WHO report with corrections made to the report before basing any policy guidance on the report. The second is a retraction of the HHS/USDA press release that announced the Dietary Guidelines Committee and mentioned the WHO report as one possible source of information for the Committee's recommendations. The third request is for a letter from the Secretaries of HHS and USDA to WHO and the U.N. Food and Agriculture Organization informing the latter that the report is subject to pre-dissemination review before it can be used by the Dietary Guidelines Committee.
Influential: ____Yes __X__ No _____ undecided/unsure [based on the Agency's definition of influential, as provided in your Information Quality Guidelines]
First Agency Response: _X___ in progress _______ completed
Resolution:
Appeal Request: ____ none ____in progress ____ completed
Summary of Request for Reconsideration:
Type of Appeal Process Used:
Appeal Resolution

Agency Receiving Petition: Department of Health and Human Services, Centers for Disease Control and Prevention (CDC)
Petitioner: A private citizen
Date Received: Received by email dated 11/19/02 and logged in on 11/19/02.
Summary of Request: The request states that many cases of arthritis are misdiagnosed and are actually cases of chronic fluoride poisoning that exhibit symptoms of joint pain. "There has been no scientific method available in the United States which is capable of detecting the pre-crippling phases of chronic fluoride poisoning." "The myth of hundreds of legitimate safety studies (regarding water fluoridation) has denied me access to effective health care services because the vast majority of health care practitioners have been taught that no harm can come from typical daily doses of fluoride..."
Description of Requested Correction: Documentation published by the CDC that make claims for the safety of fluoridation based on safety studies should be modified to indicate that "a) the methods used were not capable of detecting the arthritic pre-crippling phases of skeletal fluorosis, and b) there is no data available regarding the prevalence of fluoride-induced arthritis..."
Influential: ____Yes __X__ No _____ undecided/unsure
First Agency Response: ____ in progress ____X____ completed, CDC responded on 12/03/02.
Resolution: The request was answered by the Associate Director for Science, National Center for Chronic Disease Prevention and Health Promotion, CDC. The response indicated that CDC has published statements regarding the fact that for over the past 50 years, fluoridation of public water supplies is a safe and effective way to reduce tooth decay for all community residents. This approach is supported by extensive peer-reviewed scientific research.
Appeal Request: ____ none ____in progress __X__ completed, appeal received on 1/19/03 by email, CDC responded to the appeal on 3/16/03.
Summary of Request for Reconsideration: The appeal stated that the CDC response to the information quality request for correction of scientific information is false. None of the documents cited in the response contain references or details about any fluoridation safety study using methods capable of distinguishing between a person whose arthritis was caused by fluoride and a person whose arthritis was caused by something else.
Type of Appeal Process Used: The appeal was responded to by the Acting Deputy Director for Science and Public Health, CDC.
Appeal Resolution: The CDC response advised that "...the 1991 Department of Health and Human Services document Review of Flouride: Benefits and Risks discusses the topic of skeletal flourosis in more detail and provides references. Only 5 cases of skeletal flourosis have ever been reported in the U.S. In these cases, the total fluoride intake was 15 to 20 mg./fluoride per day for 20 years." The response also indicated that "...the 1997 Institute of Medicine (IOM) report on Dietary Reference Intakes for Calcium, Phosphorus, Vitamin D, and Flouride stated that: The development of skeletal flourosis and its severity is directly related to the level and duration of exposure... at least 10 mg. per day for 10 or more years is needed to produce clinical signs of the milder form (arthritis like symptoms... ). This daily intake level necessary to produce skeletal flourosis or even its early signs far exceeds that level of fluoride received by people on fluoridated community water systems even when factoring in other daily fluoride exposures typical in the U.S."

Agency Receiving Petition: Department of Health and Human Services, Centers for Disease Control and Prevention (CDC)
Petitioner: Kent McClure, Animal Health Institute, a trade association.
Date Received: Received by postal mail dated 12/06/02 and logged in on 12/13/02. The amendment to the request was received by postal mail on 1/08/03.
Summary of Request: The Animal Health Institute (AHI) is requesting that CDC cease disemmination of views in opposition to the use of fluoroquinolones (antibiotics) in livestock feed in general, and in poultry in particular.
Description of Requested Correction: The request states that CDC is mistakenly concerned that the widespread use of these antibiotics could lead to fluoroquinolone resistant food borne bacteria, such as Campylobacter making it more difficult to treat persons who developed campylobacteriosis as a result of eating undercooked poultry. CDC is incorrect in attributing human health effects to animal drugs. Reports in the media regarding CDC's position harm the poultry industry by the creation of an erroneous conclusion by the public that poultry may be unsafe. CDC should cease from stating its position on these antibiotics in public forums.
Influential: ____Yes __X__ No _____ undecided/unsure
First Agency Response: ____ in progress __X__ completed. The response was sent on 03/13/03.
Resolution: The Associate Director for Epidemiologic Science at the National Center for Infectious Diseases, CDC responded on March 13, 2003. The response advised that statements made by CDC are supported by the analysis of data from the National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS-EB) Further, CDC agrees that the presentation of results should clearly state that some data are preliminary and that final results may differ from preliminary reports. CDC plans to include a discussion of the limitations inherent to surveillance and to NARMS-EB in particular in future reports. CDC plans to review documents related to this issue on its website to ensure that they are accompanied by appropriate discussion of data limitations.
Appeal Request: ____ none ____in progress __X__ completed. The appeal was received on 3/27/03. CDC responded to the appeal on 7/11/03.
Summary of Request for Reconsideration: The appeal indicated that the CDC assessment failed to take into account the effect of foreign travel as a confounder for the relation between flouroquinolone-resistance and excess days of illness in its data sets. Since CDC fails to take this element into consideration, CDC's analysis is flawed.
Type of Appeal Process Used: The appeal was answered by the Acting Deputy Director for Science and Public Health, CDC.
Appeal Resolution: The response stated that CDC does not find that the statements made in CDC abstracts or presentations misrepresent the available data or require corrective action. However, CDC agrees that presentations should clearly state what data are preliminary and that final results may differ from preliminary reports. CDC also agrees that the use of estimates of incidence published in 1999 should be noted as dating from that time, until they are replaced by a new set of estimates. Future CDC statements also should note the challenges of assessing trends in the absence of reliable information about amounts of flouroquinolone agents used in animal production.

Agency Receiving Petition: Department of Health and Human Services, Centers for Disease Control and Prevention, CDC
Petitioner: An individual who works as a contractor for CDC.
Date Received: Received by email dated 1/8/03 and logged in on 1/8/03.
Summary of Request: The request asks for the re-direction of a link on the CDC website to make it easier for the public to obtain general information about gonorrhea.
Description of Requested Correction: The health topic "gonorrhea" on the main CDC health topics web page should be re-directed to the fact sheet on the Division of STD Prevention website. Currently, it is linked to the page that deals with antimicrobial resistance diseases and the clinical aspects of gonorrhea. This re-direction will allow members of the public interested in obtaining general information on gonorrhea to do so easily.
Influential: ____Yes __X__ No _____ undecided/unsure
First Agency Response: ____ in progress ____X____ completed. CDC responded on 3/3/03.
Resolution: The Deputy Associate Director for Science, National Center for HIV, STD, and TB Prevention responded. The response said that a new topic titled "Gonorrheal (Info)" would be added to the CDC Health Topics and would link to the Division of STD Prevention's website.
Appeal Request: ____ none ____in progress __X__ completed. The appeal was received on 03/28/03. The CDC response was sent on 5/18/03.
Summary of Request for Reconsideration: The appeal requested that the web link be re-directed and that the new link be re-named Division of AIDS, STD, and TB Laboratory Research.
Type of Appeal Process Used: The appeal was answered by the Acting Deputy Director for Science and Public Health, CDC.
Appeal Resolution: The CDC response states that CDC review indicates that there is no need to re-name the link.

Agency Receiving Correction Request: Department of Health and Human Services, Centers for Medicare & Medicaid Services(CMS)
Requestor:
SafeBlood Technologies
Debby Thetford Nye, Lawyer
Mitchell, Williams, Selig, Gates, and Woodyard, P.L.L.C.
Date Received: The request was dated 11/14/02 and was delivered via express mail. The request was logged in on 11/18/02.
Summary of Request: SafeBlood complained that Arkansas BlueCross and BlueShield, the CMS Fiscal Intermediary, in a Local Medical Review Policy (LMRP) addressed reimbursement for wound care inappropriately by categorized Autologous Tissue Grafting^TM, a SafeBlood product, as a platelet derived formula.
Description of Requested Correction: SafeBlood requested that the agency rescind the LMRP and reimburse providers for Autologous Tissue Grafting^TM services provided to Medicare enrollees.
Influential: ___Yes __X__ No ____ Undetermined
First Agency Response: ___ in progress _X _ completed. The initial CMS response was sent on 1/14/03. The final CMS response was sent on 5/17/03.
Resolution: On January 14, 2003, SafeBlood was advised that much of the relief they requested was outside the scope of the Information Quality Correction Process and that administrative procedures exist to address coverage policy and LMRP reconsiderations. They were directed to the appropriate contacts to initiate such requests. The original material was forwarded to the Arkansas Fiscal Intermediary Contractor Medical Director (CMD) for the purpose of reviewing the allegedly erroneous information.

On January 23, SafeBlood replied to this letter with a request to appeal the decision. SafeBlood stated that their original complaints were (a) that Autologous Tissue Grafting^TM was not covered by the national coverage decision, so that reconsideration was beside the point, and (b) that the Arkansas CMD had failed to follow procedures in implementing the LMRP and should not be making a payment determination.

On February 13, CMS responded that an appeal was premature, given that a determination of the Information Quality issue had not been completed. The response noted that SafeBlood had met with national CMS officials to present further information and that a final decision would be given in 60 days.

On April 17, a final reply was sent to SafeBlood. It stated, in part, that to address "that portion of your request concerning posting of information regarding Autologous Tissue Grafting^TM, now termed SafeBlood Graft^TM, and platelet-derived wound healing formula (e.g. Procuren^TM) in the Arkansas Fiscal Intermediary draft LMRP titled "Chronic Would Care - Draft" (the "LMRP") ... Upon reviewing the materials submitted, we have determined that sufficient clinical differences exist between SafeBlood and Procuren to justify correction of the information contained in the LMRP on the Arkansas Blue Cross and Blue Shield website. We consequently have requested Arkansas Blue Cross and Blue Shield to remove immediately the incorrect information from their website, which they have done."
Appeal Request: _X_ none _ in progress _ completed
Summary of Request for Reconsideration:
Type of Appeal Process Used:
Appeal Resolution:

Agency Receiving Correction Request: Department of Health and Human Services, the Food and Drug Administration (FDA)
Requestor:
Kent D. McClure
Animal Health Institute, a trade association
Date Received: January 22, 2003 and was delivered via messenger.
Summary of Request: The Animal Health Institute (AHI) requests correction of a Campylobacter risk assessment titled, "The Human Health Impact of Flouroquinolone Resistant Campylobacter Attributed to the Consumption of Chicken" (Vose Risk Assessment). "The Vose Risk Assessment is methodologically flawed." "The Vose Risk Assessment and related materials are inaccurate and should be corrected."

The Vose Risk Assessment is available on the Center for Veterinary Medicine' s (CVM) Website. "...[T]he Vose Risk Assessment has been widely relied upon, quoted, and otherwise referenced and disseminated many times in additional publications and presentations ..."
Description of Requested Correction: AHI requests that a qualified and independent risk assessment expert should be appointed to review the Vose Risk Assessment.
Influential: ___X_Yes ____ No ____ Undetermined
First Agency Response: ____ in progress __X__ completed. The FDA responded on 3/20/03.
Resolution: Prior to receiving the AHI request for correction, the FDA had began conducting a formal evidentiary hearing under 21 CFR Part 12 on CVM's proposal to withdraw approval of the new animal drug application (NADA) for the flouroquinolone enrofloxacin. The purpose of the Vose Risk Assessment was to assist in establishing the extent of the adverse human health impact of flouroquinolone use in poultry. The initial response letter was issued by the Director of the Center for Veterinary Medicine. The letter stated that a decision on the request would be made within 60 days of the final decision in the hearing on the proposal to withdraw approval of the NADA for enrofloxacin.
Appeal Request: ____ none __X __ in progress ____ completed, AHI appealed the decision on 4/16/03 via hand delivery and e-mail. FDA sent a response on 9/16/03.
Summary of Request for Reconsideration: AHI stated that a deferral of a decision until after the conclusion of the hearing to withdraw the NADA for enrofloxacin constitutes a denial of the request for correction. AHI also stated that a decision on the Request by the employee who made the initial decision (i.e., Director of CVM) constitutes a denial of the request and a failure to follow the FDA= s regulation at 21 CFR 10.75.
Type of Appeal Process Used: The FDA response indicated that the decision on the appeal of the request has been referred to the Administrative Law Judge who also will rule on the Part 12 Hearing to withdraw approval for enrofloxacin.
Appeal Resolution:

Agency Receiving Correction Request: Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Environmental Health Science (NIEHS), National Toxicology Program (NTP)
Requestor:
Jerry Cook
Chemical Products Corporation
Date Received: The request was received electronically on 11/15/02.
Summary of Request: Chemical Products Corporation (CPC) " requests that the abstract of Draft Technical Report TR-494...be withdrawn from the NTP web site and all other locations where it is available to the public." "The Anthraquinone sample tested in the long term NTP studies reported in Draft TR-494 contains a mutagenic contaminant which has rendered the Draft TR-494 report and the peer review of that Draft report invalid."
Description of Requested Correction: "CPC requests that the abstract of Draft Technical Report TR-494...be withdrawn from the NTP web site and all other locations where it is available to the public. We request that it be replaced with a statement explaining that a contaminant in the Anthraquinone sample tested by NTP confounded the results of the testing and that Draft TR-494 will be withdrawn, rewritten, and resubmitted for peer review."
Influential: ____Yes ___X_ No ____ Undetermined/Unsure
First Agency Response: ____ in progress _X___ completed

NTP responded on 3/19/03.
Resolution: NTP added the following information to the NTP web site: 1) a statement that the anthraquinone sample used in our two-year study and in the Salmonella mutagencity test giving positive results contained 0.1% contamination by 9-nitroanthracene and 2) a description of follow-up mutagenicity and metabolism studies. NTP's response stated that the findings from those studies would be added to the web site after they are finalized."

Appeal Request: ____ none ____ in progress ___X_ completed. The appeal was received on 3/27/03. NIEHS responded on 9/8/03.
Summary of Request for Reconsideration: "Anthraquinone, was itself not mutagenic, but instead was contaminated with a strong mutagen. Incorrect information concerning Anthraquinone has been offered to the public on the NTP website for over 3 years... We have asked, once again, that the abstract of draft TR494 be removed from the NTP website and replaced with an explanation of the non-mutagenic nature of Anthraquinone and contamination of the test material with a mutagen..."
Type of Appeal Process Used: The appeal was answered by the Deputy Director, NIEHS.
Appeal Resolution: The response to the appeal stated that "The abstract of draft TR-494 will immediately be removed from the NTP website. Further studies are underway on the metabolism of anthraquinone in rodents and on the relative mutagenic potency of this compound, its major metabolites, the contaminant 9-nitroanthracene, and two isomers of 9-nitroanthracene. Additional information from this work will eventually be incorporated into a revised abstract and technical report which will be submitted for peer review and subsequent publication."

Agency Receiving Correction Request: Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Environmental Health Science (NIEHS), National Toxicology Program (NTP)
Requestor:
Nickel Development Institute (NiDi),
Nickel Producers Environment Research Association (NiPERA), and Inco,United States
Neil J. King, Lawyer
Wilmer, Cutler & Pickering
Date Received: The request was dated 4/9/03 and received electronically on 4/18/03.
Summary of Request: The request indicates that the discussion accompanying the10^th Report on Carcinogens (RoC) listings of Nickel Compounds and Metallic Nickel does not comply with the Information Quality Guidelines in the following respects:

"1. It does not comply with the "objectivity" requirement of the OMB Guidelines because: A) It is not 'presented in an accurate, clear, complete and unbiased manner'; and B) It does not present 'accurate, reliable, and unbiased information.' 2. Although the 10^th RoC presents 'influential' scientific information relating to an analysis of risks to human health allegedly posed by exposure to nickel compounds and metallic nickel, it fails to comply with the scientific quality principles established by Congress in the Safe Drinking Water Act Amendments of 1996, as required by the OMB Guidelines, in that: A) It does not use the best available peer reviewed science; B) It does not identify studies that fail to support the carcinogenic effect; and C) It is not comprehensive, informative, and understandable."
Description of Requested Correction: "NiDi, NiPERA, and Inco request that the material identified in the request be corrected (as indicated herein) and that an appropriately revised discussion of Nickel Compounds and Metallic Nickel be published and disseminated as a correction to the 10^th RoC."
Influential: ____Yes __X__ No ____ Undetermined/Unsure
First Agency Response: __X__ in progress* ____ completed

The NTP response was sent on 10/24/03 but was still in progress by 09/30/03, the end of the reporting year for this report.
Appeal Request: ____ none ____ in progress ____ completed
Summary of Request for Reconsideration:
Type of Appeal Process Used:
Appeal Resolution:

Agency Receiving Correction Request: Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Environmental Health Science (NIEHS), National Toxicology Program (NTP)
Requestor:
John O. Snyder
Styrene Information and Research Center, a trade association.
Date Received: The request was dated 6/10/03 and received electronically on 6/12/03.
Summary of Request: "The Styrene Information and Research Center, Inc. (SIRC) requests that the National Toxicology Program (NTP) make an important technical correction to the press release and fact sheet, currently on NTP=s website, announcing the publication of the tenth edition of the National Toxicology Program's (NTP's) Report on Carcinogens (ROC)."
Description of Requested Correction: "SIRC requests that the NTP delete this sentence from the fact sheet and press release. The sentence to be deleted is: "Styrene -7,8-oxide is used in producing reinforced plastics and as a chemical intermediate for cosmetics, surface coatings, agricultural and biological chemicals. "In the alternative, NTP could state that Styrene oxide may be present in reinforced plastic operations."
Influential: ____Yes _X___ No ____ Undetermined/Unsure
First Agency Response: ____ in progress __X__ completed. NTP sent a response on 8/14/03.
Resolution: The NTP agreed that information in the press release and fact sheet is incorrect and corrected both documents to read as follows: "Styrene-7,8-oxide, is used primarily in the production of styrene glycol and its derivatives, as a reactive diluent in epoxy resins, as a treatment for textiles and fibers, and as a chemical intermediate in the manufacture of such materials as perfumes and surface coatings."
Appeal Request: ___X_ none ____ in progress ____ completed
Summary of Request for Reconsideration:
Type of Appeal Process Used:
Appeal Resolution:

10.

Agency Receiving Petition: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute (NHLBI)
Requestor:
William L. Kovacs,
Chamber of Commerce of the United States of America, an advocacy organization and
Richard L. Hanneman,
Salt Institute, a trade association.
Date Received: The request was received on 5/15/03.
Summary of Request: The request challenges information contained in six documents that discuss the effect of salt intake on human blood pressure that, Adirectly states and otherwise suggests that reduced sodium consumption will result in lower blood pressure in all individuals." The documents are: (a) two clinical practice guidelines released by the National High Blood Pressure Education Program (NHBPEP), both of which were published in the Journal of the American Medical Association (JAMA); (b) two consumer-oriented materials that NHLBI developed from the practice guidelines; and (c) two press releases.
Description of Requested Correction: The request was Abased solely on the agency's failure to make study data publicly available," and the complainants did not Arequest or recommend that the challenged information be removed from public view." Instead, they asked NIH to release copies of data from the grant-funded DASH-Sodium trial concerning Aall DASH-Sodium blood pressure data for each subgroup... at each of the three levels of dietary sodium intake, including the missing 2,400 mg/day intake level, on both the control diet and the DASH diet."
Influential: ____ Yes __X__ No _____ undecided/unsure
First Agency Response ____ in progress __X__ completed.

NHLBI responded on 8/19/03. The NIH FOIA Office responded on 9/3/03.
Resolution: Because the request did not seek the correction of any agency-disseminated information, but instead sought copies of data produced in grant-funded research, NHLBI found that the Freedom of Information Act (FOIA) is the appropriate administrative mechanism for handling the request and stated that it would refer the request to the FOIA office for review. In addition, NHLBI noted that the grantees had already provided the data to two public requestors and would be making a public access data set available in January 2004.

Although NHLBI found that a request for underlying grantee data is properly handled under FOIA, the agency also addressed the Request under NIH's Information Quality Guidelines. NHLBI said that the two press releases fell outside the scope of the Guidelines. In the case of the remaining documents, NHBLI noted that the NIH Guidelines presume that analytic information that is "subject to formal, independent external peer review" is of "reasonable quality" and sufficiently objective: "[f]or scientific and technical documents," the "the scientific community recognizes peer review as the primary means of quality control" and NIH follows this standard. The two practice guidelines were published in JAMA. They were subjected to rigorous and independent peer review as well as to an NHLBI internal peer review. The consumer materials received similar rigorous peer review and they were based upon a wide range of research.
Appeal Request: ____ none __X_in progress^* ___ completed
* An appeal was received on 10/22/03, after the 2003 FY period of this report.
Summary of Request for Reconsideration:
Type of Appeal Process Used:
Appeal Resolution:

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