Frequent Questions

HHS Information Quality Web Site

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: October 2002 through September 2003

Web page location of agency information quality correspondence: http://aspe.hhs.gov/infoquality/requests .shtml

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.

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.

• * Agency Receiving Correction Request: 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 indicates 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), which were published in the Journal of the American Medical Association (JAMA); (b) two consumer-oriented materials that NHLBI developed ITom the practice guidelines; and (c) two press releases.
• Description of Requested Correction: The request was based solely on the agency's failure to make study data publicly available. The complainants did not request or recommend that the challenged information be removed from public view. Instead, they asked NIH to release copies of the data from the grant-funded DASH (Dietary Approaches to Stop Hypertension)-Sodium trial concerning all DASH-Sodium blood pressure data for each subgroup Y at each of the three levels of dietary sodium intake, including the missing 2,400 mglday intake level, on both the control diet and the DASH diet.
• Influential: ___ Yes _X_ No ___ Undetermined
• 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 agency­disseminated information, but instead sought copies of data produced in grant­funded research, NHLBI found that the Freedom ofInformation 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 indicated 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 ofthe 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 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 ___ in progress _X_ completed
  Appeal dated on 9/22/03.
  NHLBI responded on 2/11/04.
• Summary of Request for Reconsideration:
  The requestors restated the claims made in the initial request for correction. In addition, they challenged the agency's decisIon to handle the request for data under the procedures of the Freedom ofInformation Act: "Simply because Petitioners seek to obtain the missing piece of data from a study used to support the dissemination of scientific information does not automatically render the petition a FOIA request."
• Type of Appeal Process Used: Senior official review.
• Appeal Resolution:
  The appeal official affirmed the findings and conclusions of the request response. The appeal official also informed the petitioner that they could obtain the data requested by writing directly to the grantees or submitting a request to the NHLBI "Limited Data Set" web-site.
• Judicial Review: Following receipt ofNIH's response to the appeal, the requestors filed a lawsuit in Eastern District of Virginia. On November 15,2004, the Eastern District of Virginia granted HHS' motion to dismiss in Salt Institute v. Tommy G. Thompson, the first case involving HHS in a challenge under the Information Quality Act (IQA) and the first case to focus exclusively on the justiciability ofIQA claims. In ruling for HHS, the court concluded that IQA claims are not subject to judicial review. Following is a brief summary of the case and the Court's opinion.
• In March 2004, following completion of an administrative complaint process, the Salt Institute and the u.S. Chamber of Commerce filed suit against HHS in the Eastern District of Virginia alleging that the agency, and the National Heart Lung and Blood Institute (NHLBI) in particular, violated the IQA and applicable agency guidelines. Specifically, the plaintiffs complained that NHLBI violated the law when it declined to obtain, and release to plaintiffs, the raw data of grant-funded studies that NHLBI cited in public health messages concerning salt intake and hypertension. The plaintiffs also alleged that the agency violated the "Shelby Amendment," a separate Appropriations rider directing OMB to require federal agencies to make available research data produced by grantees under the Freedom of Information Act in certain circumstances
• HHS filed a motion to dismiss in June. In its brief, HHS argued that plaintiffs have no standing and that the court has no jurisdiction to hear the IQA claims directly or under the Administrative Procedures Act (AP A). The agency made similar arguments with respect to the Shelby Amendment claims
• The Court's November 15,2004 opinion affirmed nearly all of the HHS arguments. l First, the Court found that plaintiffs lacked standing to pursue their claims. Specifically, the Court ruled that plaintiffs' alleged harms were not sufficiently: (1) concrete and particularized (as well as being too speculative and hypothetical); (2) traceable to the NIH's actions; and (3) redressable by the requested action or other judicial remedy.2 Op. at 15-23.
• Second, the Court concluded that judicial review is not available for IQA claims. Judicial review will be permitted, the court found, if the law itself provides a private right of action or if the procedures of the AP A allow for review. As noted above, the law does not include a private right of action. The Court agreed, stating: "The language of the IQA reflects Congress's intent that any challenged to the quality of information disseminated by federal agencies should take place in administrative proceedings before federal agencies and not in the courts." Op. at 24.
• With respect to the AP A, the Court found that the two prerequisites for judicial review cannot be met. Specifically, to obtain review under the AP A an activity must be a "final agency action" that is not "committed to agency discretion by law." Op. at 25. With regard to final agency action, the Court held that NHLBl's actions in this case, e.g., dissemination of advisory information regarding salt intake, were not final agency actions subject to APA review. Op. at 25-26. This conclusion reflects long-standing interpretations of the weight that such documents carry.
• Regarding agency discretion, the Court found that HHS' "informal agency decisions concerning NHLBl's statements... were matters 'committed to agency discretion by law.'" Op. at 26. Further, the Court stated: "Neither the IQA nor the OMB Guidelines provide judicially manageable standards that would allow meaningful judicial review to determine whether an agency properly exercised its discretion in deciding a request to correct a prior communication." Op. at 27. Quoting the OMB Guidelines' directive allowing agencies to "reject claims made in bad faith or without justification" and requiring agencies to "undertake only the degree of correction that they conclude is appropriate," the Court concluded that "regulations containing similar language" are committed to agency discretion and not subject to AP A review. Id. The Court concluded: "Judicial review of [NIH' s] discretionary decisions is not available under the AP A because the IQA and OMB guidelines at issue insulate the agency's determinations of when correction of information contained in informal agency statements is warranted." Op. at 28.3
• Finally, the Court also dismissed the Shelby Amendment claims. The Court found that the plaintiffs lacked standing, for the same reasons that standing did not exist for the IQA claims. Further, the Court agreed that OMB, not NHLBI, "is responsible for implementing" the law and that the claim against NHLBI fails to state a claim upon which relief can be granted.
  

  * Appeal initially submitted in FY 2003

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.

• * Agency Receiving Petition: Department of Health and Human Services, Office of Public Health and Science, Office of Disease Prevention and Health Promotion
• Requestor: The Center for Regulatory Effectiveness
• Date Received:Letter sent by postal mail September 8, 2003 and logged in on September 17,2003
• Summary of Request: The Center for Regulatory Effectiveness (CRE) states that the Secretaries of the Department of Health and Human Services (HHS) and the United States Department of Agriculture (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 that the WHO report does not meet USDA, HHS and Office of Public Health and Science (OPHS) data quality standards and is subject to a pre-dissemination review
• Description of Requested Correction:
  The CRE requests three corrections:1) A pre-dissemination review ofthe WHO report with corrections made to the report before any policy guidance is based on the report;
  2) 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;
  3) A letter from the Secretaries ofHHS and USDA to WHO and the U.N. Food and Agriculture Organization (FAO) 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
• First Agency Response: ___ in progress _X_ completed
• Resolution: Response to requestor sent on January 8, 2004
• Appeal Request: _X_ none ___ in progress ___ completed
• Judicial Review: ___ none
• Summary of Request for Reconsideration:
• Type of Appeal Process Used:

  * Request initially submitted in FY 2003

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.