Year-End Information Quality Report
[ HHS Information Quality Main Page
]
I.
Cover Sheet: Requests for Correction by Agency
Department Name: Department of Health and Human Services
Period Covered: Fiscal Year 2004, October 2003 through September 2004
Web page location of agency information quality correspondence:
http://aspe.hhs.gov/infoquality/requests.shtml
Agency Name |
Number of
Requests Received |
Number Designated
as Influential* |
FDA |
2 |
|
NIH |
7 |
|
OPHS |
1 |
|
TOTALS |
10 |
1 |
* Does not include information quality requests currently beeing reviewed
due to a request for reconsideration
II.
If you received correction requests or appeals and did not provide a final
response in FY03, please list those correction requests below and provide
a detailed summary in Section III ofthis template.
Agency Name |
Number of FY03 Requests
Responded to in 04 |
Number of FY03 Appeals
Responded to in 04* |
NIH |
|
1 |
|
|
|
OPHS |
|
1 |
TOTALS |
0 |
2 |
* See Sections III. 3 and 11.
III.
Template
1.
-
Agency Receiving Correction Request: Department of Health and Human Services,
Food and Drug Administration
-
Requestor: Environmental Working Group (EWG), an advocacy group
-
Date Received: Letter dated December 22,2003, delivered by u.S. Postal Mail
and logged in by the Office ofthe Ombudsman, FDA on January 5, 2004.
-
Summary of Request: EWA requests correction of the 2003 FDA Consumption Draft
Advisory regarding the risks of mercury contaminated fish and shellfish,
specifically entitled "Advice For Women Who Are Pregnant, Who Might Become
Pregnant, And Nursing Mothers, About A voiding Harm To Your Baby Or Young
Child From Mercury In Fish And Shellfish."
-
Description of Requested Correction: EWG recommended the following:
1) FDA should conduct an updated, comprehensive sampling program for seafood.
2) FDA should provide consumption advice that consumers can follow without
appreciable risk to their health.
3) FDA should provide specific advice on how much seafood young children
can safely consume.
4) FDA should provide specific advice on canned tuna.
5) Calculation of risk on "exceedences" of the reference dose for the last
half of the third trimester of pregnancy should be consistent with
interpretations of the National Academy of Sciences 2000 report.
6) FDA should develop and make public documentation of a scientific assessment
conducted in correcting the 2003 Advisory.
-
Influential: ___Yes ___No ___ Undetermined _X_ Under Appeal
-
First Agency Response: _X_ in progress* ___ completed
* The response was sent on February 15, 2005
-
Resolution:
-
Appeal Request: ___ none ___ in progress _X_ completed
-
Judicial Review:
-
Summary of Request for Reconsideration:
-
Type of Appeal Process Used:
-
Appeal Resolution
2.
-
Agency Receiving Correction Request: Department of Health and Human
Services, Food and Drug Administration
-
Requestor: Buc & Beardsley, a law firm on behalf of their client,
McNeil Consumer & Specialty Products.
-
Date Received: Letter dated May 18, 2004, logged in by the Office
of the Ombudsman, FDA on May 19,2004.
-
Summary of Request: The request concerns FDA's "Consumer Campaign
on Safe Use of OTC Pain Products." The request maintains that the campaign
misrepresents the relative safety of various OTC pain products by suggesting
that acetaminophen products are less safe than nonsteroidal anti-inflammatory
drugs (NSAIDs).
-
Description of Requested Correction:The complainant requests the
following: (1) FDA should halt distribution of the current campaign which
consists of advertisements entitled"Why is it important to know that all
these medicines contain acetaminophen?" and "The best way to take your
over-the-counter pain reliever? Seriously;" an article in the FDA Consumer
magazine, a memo to State Boards of Pharmacy on this issue, "Questions and
Answers on Using Over-theCounter Human Drug Products Containing
Analgesic/Antipyretic Active Ingredients Safely;" and a brochure entitled,
"The best way to take your over-thecounter pain reliever? Seriously,"
(2) FDA should correct the relevant documents before restarting the campaign,
and (3) FDA should provide an opportunity for McNeil and other companies
whose products are affected to comment prior to restarting the campaign and
prior to the release of any future OTC pain relief drug campaigns.
-
Influential: ___Yes _X_ No ___Undetermined
-
First Agency Response: ___ in progress _X_completed
FDA responded on August 25, 2004
-
Resolution:The FDA did not agree that the campaign violates the Data
Quality Act or Guidelines. Based on suggestions from the Nonprescription
Drug Advisory Committee, which met on Sept. 19-20, 2002, the educational
campaign was developed in accordance with agency policies and procedures.
The documents were developed by a team of experts familiar with the drugs
and communication specialists, it was focus group tested with the public,
circulated and cleared by senior leaders within the FDA as well as by the
Office ofthe Secretary of the Department of Health and Human Services.
-
Appeal Request:* ___ none ___ in progress ___ completed.
-
Judicial Review:
-
Summary of Request for Reconsideration:
-
Type of Appeal Process Used:
-
Appeal Resolution:
* In fiscal year 2005 (October 22, 2004), an electronic version of a request
for "Reconsideration of Complaint and Request for Correction to Federal Data
Quality Act Concerning "Consumer Campaign on Safe Use ofOTC Pain Products"
was received by the FDA's Office ofthe Ombudsman
3.
4.
-
Agency Receiving Correction Request: Department of Health and Human Services,
National Institutes of Health, National Institute on Aging
-
Requestor:
Ken Boehm, Chairman
National Legal and Policy Center
Public Interest Group
-
Date Received: March 16,2004 received March 17,2004 by U.S. mail
-
Summary of Request: The requestor challenged information regarding
the risks of using smokeless tobacco as compared to smoking cigarettes. The
requestor maintained that the statement that smokeless tobacco is not safer
than cigarettes is erroneous and not supported by sound scientific evidence.
According to the requestor, there is a scientific consensus that the use
of smokeless tobacco involves significantly fewer risks of adverse health
effects than cigarette smoking.
-
Description of Requested Correction: The requestor asked that the
agency delete the heading and paragraph containing the challenged information
and substitute language that smokeless tobacco "is significantly less hazardous
than smoking" and that there are "significantly less risk of adverse health
effects" associated with using smokeless tobacco as compared to smoking
cigarettes.
-
Influential: ___ Yes _x_ No ___ Undetermined
-
First Agency Response: ___ in progress _X_ completed June 29, 2004
-
Resolution: The agency did not accept the requestor's suggested language
but did agree to update the challenged language based on the current scientific
literature. The revised language notes that smokeless tobacco products "are
not safe" and describes the risks associated with using such products without
making an affirmative comparison of those risks to the risks associated with
smoking cigarettes.
-
Appeal Request: _X_ none ___ in progress ___ completed
-
Judicial Review: _X_ none
-
Summary of Request for Reconsideration:
-
Type of Appeal Process Used:
-
Appeal Resolution:
5.
-
Agency Receiving Correction Request: Department of Health and Human
Services, National Institutes of Health, Office of the Director
-
Requestor:
Jerry A. Cook
Chemical Products Corporation
Corporation
-
Date Received: Request received February 6, 2004 by electronic submission
-
Summary of Request: The requestor challenged the information posted
electronically in draft Technical Report (TR494) regarding toxicity and
carcinogenicity studies of anthraquinone. The requestor claimed the draft
TR494 lacked "transparency and objectivity" and contained incomplete information
necessary to evaluate the effects of anthraquinone.
-
Description of Requested Correction: The requester asked that Draft
TR494 be withdrawn and completely revised.
-
Influential: ___ Yes _X_ No ___ Undetermined
-
First Agency Response: ___ in progress _x_ completed July 16,2004
-
Resolution: NIH determined that the agency's Guidelines were not
applicable to the request because the challenge concerned a draft
report, not a final statement representing the views of the NIH. In addition,
because the draft report at issue was subject to notice and public
comment, these procedures were the appropriate mechanism forconsidering the
requestor's comments on the draft TR494. Accordingly, the agency included
the requestor's submission in the public comment process.
-
Appeal Request: ___ none _X_ in progress ___ completed
-
Judicial Review: _X_ none
-
Summary of Request for Reconsideration: The requestor maintains that
although TR494 was a draft, the underlying scientific information contained
in the draft was not and must be clear and accurate in order for public comment
and peer review to be effective. According to the requestor, the alternative
process of public comment and peer review will be flawed ifthe draft is not
subject to the processes set forth in the Information Quality Guidelines.
-
Type of Appeal Process Used: Senior Official Review
-
Appeal Resolution: N/A - Request for Reconsideration is pending
6.
-
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:
The Nickel Development Institute (NiDi),
The NickelProducers 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 maintains that discussion in the 10th
Report on Carcinogens (RoC) listings of Nickel Compounds and Metallic Nickel
does not comply with the OMB Guidelines or with the HHS and NIH 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 lnco 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: ___in progress _X_ completed. The NTP response
was sent by mail on 10/24/03.
-
Appeal Request: ___ none ___ in progress _X_completed. The NTP received
the appeal dated November 17, 2003, by electronic mail on December 9, 2003
from NIH. The appeal response was sent October 27,2004.
-
Summary of Request for Reconsideration: The Petitioner claims that
"the lOth RoC's discussion of Nickel Compounds and Metallic Nickel fails
to comply with requirements of the Data Quality Act, as implemented in the
OMB, HHS, and NIH Guidelines." The request asks that the "appeal of NTP's
denial of my April 9, 2003 request for correction of information be granted,"
the issues identified the April 9, 2003 letter be corrected in the profiles
of Nickel Compounds and Metallic Nickel in the 1 Oth RoC, and the revised
profile "be published and disseminated as a correction to the 10th RoC."
-
Type of Appeal Process Used: Senior Official Review
-
Appeal Resolution: (Completed in FY 2005)
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)
-
Requestor:
Vinyl Chloride Health Committee
American Chemistry Council
Courtney M. Price
Vice President, CHEMSTAR
-
Date Received: The request was dated July 1,2004 and received by
electronic mail on July 7, 2004.
-
Summary of Request: The request asks for the correction of information
in the profile for vinyl chloride in the 11th and future editions of the
Report on Carcinogens.
-
Description of Requested Correction: The requestor asks that the NTP
delete information in the carcinogenicity section of the profile for vinyl
chloride.
-
Influential: ___ Yes _X_ No ___ Undetermined
-
First Agency Response: ___ none _X_ in progress ___ completed
-
Resolution:
-
Appeal Request: ___ in progress ____completed
-
Judicial Review:
-
Summary of Request for Reconsideration:
-
Type of Appeal Process Used:
-
Appeal Resolution:
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:
Jim 1. Tozzi
Center for Regulatory Effectiveness
Jere White
Kansas Corn Growers Association Garry Marshall
Missouri Corn Growers Association Stephanie Whalen
Hawaii Agriculture Research Center Joel Nelsen
California Citrus Mutual
-
Date Received: The request was dated July 16,2004 and received by
electronic mail on July 19,2004.
-
Summary of Request: The request maintains that the information about
atrazine and cancer published by the NTP in the Federal Register (69
FR 28940) is misleading and incomplete. The notice announces the NTP's intent
to consider review of atrazine for possible listing in the 12th Report on
Carcinogens and gives the basis for the nomination. The request states that
the notice should provide additional background about ongoing studies of
atrazine and details about reviews by other scientific panels.
-
Description of Requested Correction: The requestor asks that the NTP
correct information in NTP's Federal Register notice that pertains
to atrazine and withdraw that part of the notice that addresses review of
atrazine in the 12th Report on Carcinogens.
-
Influential: ___ Yest _X_ No ___ Undetermined
-
First Agency Response: _X_in progress ___ completed
-
Resolution:
-
Appeal Request: ___ in progress ___ completed
-
Judicial Review:
-
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:
Jim J. Tozzi
Center for Regulatory Effectiveness
Jere White
Kansas Corn Growers Association
Garry Marshall
Missouri Corn Growers Association Stephanie Whalen
Hawaii Agriculture Research Center
Greg Shelor
Kansas Grain Sorghum Products Association
Joel Nelsen
California Citrus Mutual
-
Date Received: The request was dated June 28, 2004 and received by
electronic mail on July 1,2004.
-
Summary of Request: The request maintains that the NTP published in
the Federal Register (69 FR 28940) conflicting information about the
procedures that will be used for review of nominations to the 12th Report
on Carcinogens.
-
Description of Requested Correction: The requestor asks that the NTP
withdraw the Federal Register notice (69 FR 28940) and not publish
another notice until the program decides what procedures will apply for review
of nominations to the 12th Report on Carcinogens and publishes them as final.
-
Influential: ___ Yes ___No ___ Undetermined
-
First Agency Response: _X_in progress ___ completed
-
Resolution:
-
Appeal Request: ___ none ___ in progress ___ completed
-
Judicial Review:
-
Summary of Request for Reconsideration:
-
Type of Appeal Process Used:
-
Appeal Resolution:
10.
-
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:
Naphthalene Panel
American Chemistry Council
Courtney M. Price
Vice President, CHEMST AR
-
Date Received: The request was dated July 1,2004 and received by
electronic mail on April I, 2004.
-
Summary of Request: The request asks that I) the NTP correct three
documents: the Background Document for Naphthalene and Summaries of the NIEHS/NTP
Review Group I and NTP Executive Committee Interagency Working Group (RG2)
for the Report on Carcinogens (RoC) meetings, 2) the NTP rescind the meetings
of the RG2 and the NTP Board of Scientific Counselors RoC Subcommittee and
hold new meetings of both groups. 3) As an alternative, the request asks
that the NTP staff, NIH's Office of Communications and Public Liaison (OPCL),
and the NTP Executive Committee "undertake a comprehensive pre-dissemination
review ofthe entire record of the listing proceeding as it relates to naphthalene
before any recommendation is made concerning listing naphthalene in the Eleventh
RoC by the NTP Director."
-
Description of Requested Correction: The request states that "[t]he
best and only appropriate solution to these violations is for the NTP to
rescind the November 19, 2002, vote of the RoC Subcommittee on the listing
of naphthalene, rescind the RG2 review summary, withdraw the Background Document
from the NTP's website and otherwise cease dissemination of that document,
correct the Background Document so that it comports with the OMB, NIH, and
HHS Guidelines, make the corrected document publicly available, and arrange
for repeats of the RG2 and NTP RoC Subcommittee meetings that comport with
the OMB, NIH, and HHS Guidelines, to be held after issuance of the corrected
Background Document. NTP should also correct the RG I and, if not rescinded,
the RG2 review summaries to provide the necessary detail to satisfy the
objectivity and utility requirements."
"Alternatively, if this remedy is not granted, the Panel requests that NTP
staff, NIH's OPCL, and the NTP Executive Committee engage in a well-defined
process of pre-dissemination review of the entire naphthalene record with
regard to the data quality standards under the NIH, OMB, and HHS Guidelines
before the NTP Executive Committee makes its recommendation to the NTP Director."
-
Influential: ___Yes ___No ___ Undetermined _X_ Under Appeal
-
First Agency Response: _X_in progress* ___ completed
The response was sent on January 18, 2005
-
Resolution:
-
Appeal Request: ___ none ___ in progress ___ Completed
-
Judicial Review:
-
Summary of Request for Reconsideration:
-
Type of Appeal Process Used:
-
Appeal Resolution:
11.
12.
-
Agency Receiving Correction Request: U.S. Department of Health and
Human Services, Office of Public Health and Science, Office of Disease Prevention
and Health Promotion
-
Requestor: A Private Citizen
-
Date Received: Letter sent by postal mail dated July 14, 2004 and
logged in on July 26,2004
-
Summary of Request: The requestor states that, as of the date of his
letter, the organizations and Web sites in healthfinder@ pertaining to
complementary and alternative medicine do not meet the published healthfinder@
selection criteria.
-
Description of Requested Correction: The request seeks the de-listing
from healthfinder@ of the complementary and alternative medicine organizations
and Web sites identified by the requestor in his letter as not meeting
healthfinder@ selection standards, and the inclusion of other sites identified
by the requestor as meeting the standards
-
Influential: ___ Yes _X_ No ___ Undetermined
-
First Agency Response: _X_in progress ___ Completed
-
Resolution
-
Appeal Request: ___ none ___ in progress ___ completed
-
Judicial Review:
-
Summary of Request for Reconsideration
-
Type of Appeal Process Used
-
Appeal Resolution
Notes:
1. Because the standard for review in
a motion to dismiss construes the complaint in the light most favorable to
plaintiffs, the Court accepted plaintiffs' assertion that the available
publications do not contain all the data sought and, therefore, it rejected
HHS' argument that the complaint is moot. Opinion ("Op.") at 15.
2. The Court also ruled that plaintiffs
do not have "organizational standing." Organizational standing may arise
when members of an organization suffer an injury in fact that would give
the individuals standing to sue on their own behalf. The Court dismissed
this theory because plaintiffs did not properly allege it, a finding that
may be read by some to allow that organizational standing may arise in a
case with different facts.
3 3. Thus, this case stands firmly for
the proposition that IQA challenges to "informal" agency information are
not subject to judicial review, but it might be read to allow review of "formal"
agency information, like a rulemaking. In its briefing, HHS acknowledged
that formal agency actions might be considered differently, but it did not
reach a conclusion. Whether an IQA challenge to a rulemaking under the APA
can survive if it is lacks separately permissible challenges, e.g., of arbitrary
and capricious reasoning, will need to be considered carefully.
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