Year-End Information Quality Report
[ HHS Information Quality
Main Page ]
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 |
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.
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Influential: ____Yes __X__ No _____ undecided/unsure [based on the
Agency's definition of influential, as provided in your Information Quality
Guidelines]
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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
2.
-
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."
3.
-
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.
4.
-
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.
5.
-
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 GraftingTM, 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
GraftingTM 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 GraftingTM 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 GraftingTM, now termed SafeBlood
GraftTM, and platelet-derived wound healing formula (e.g.
ProcurenTM) 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:
6.
-
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
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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.
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Influential: ___X_Yes ____ No ____ Undetermined
-
First Agency Response: ____ in progress __X__ completed. The FDA responded
on 3/20/03.
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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.
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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:
7.
-
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)
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Requestor:
Jerry Cook
Chemical Products Corporation
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Date Received: The request was received electronically on 11/15/02.
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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."
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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."
8.
-
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
the10th 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 10th 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 10th
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:
9.
-
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:
Last Revised: August, 2004