(i) determine within ten days (excepting Saturdays, Sundays, and legal public holidays) after the receipt of any such request whether to comply with such request and shall immediately notify the person making such request of such determination and the reasons therefor, and of the right of such to appeal to the head of the agency any adverse determination; and (ii) make a determination with respect to any appeal within twenty days (excepting Saturdays, Sundays, and legal public holidays) after the receipt of such appeal. If on appeal the denial of the request for records is in whole or in part upheld, the agency shall notify the person making such request of the provisions for judicial review of that determination under paragraph (4) of this subsection. (B) In unusual circumstances as specified in this subparagraph, the time limits prescribed in either clause (i) or clause (ii) of subparagraph (A) may be extended by written notice to the person making such request setting forth the reasons for such extension and the date on which a determination is expected to to be dispatched. No such notice shall specify a date that would result in an extension for more than ten working days. As used in this subparagraph, “unusual circumstances" means, but only to the extent reasonably necessary to the proper processing of the particular request (i) the need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the requests; (iii) the need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or (iii) the need for consultation, which shall be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request or among two or more components of the agency having substantial subject-matter interest therein. (C) Any person making a request to any agency for records under paragraph (1), (2), or (3) of this subsection shall be deemed to have exhausted his administrative remedies with request to such request if the agency fails to comply with the application time limit provisions of this paragraph. If the Government can show exceptional circumstances exist and that the agency is exercising due diligence in responding to the request, the court may retain jurisdiction and allow the agency additional time to complete its review of the records. Upon any determination by an agency to comply with a request for records, the records shall be made promptly available to such person making such request. Any notification of denial of any such request. (b) This section does not apply to matters that are (1)(A) specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy and (B) are in fact properly classified pursuant to such Executive order; (2) related solely to the internal personnel rules and practices of an agency; (3) specifically exempted from disclosure by statute (other than section 552b of this title), provided that such statute (A) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (B) establishes particular criteria for withholding or refers to particular types of matters to be withheld; (4) trade secrets and commercial or financial information obtained from a person and privileged or confidential; (5) inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency; (6) personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy; (7) investigatory records compiled for law enforcement purposes, but only to the extent that the production of such records would (A) interfere with enforcement proceedings, (B) deprive a person of a right to a fair trial or an impartial adjudication, (C) constitute an unwarranted invasion of personal privacy, (D) disclose the identity of a confidential source and, in the case of a record compiled by a criminal law enforcement authority in the course of a criminal investigation, or by an agency conducting a lawful national security intelligence investigation, confidential information fur nished only by the confidential source, (E) disclose investigative techniques and procedures, or (F) endanger the life or physical safety of law enforcement personnel; (8) contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; or (9) geological and geophysical information and data, including maps, concerning wells. Any reasonably segregable portion of a record shall be provided to any person requesting such record after deletion of the portions which are exempt under this subsection. (c) This section does not authorize withholding of information or limit the availability of records to the public, except as specifically stated in this section. This section is not authority to withhold information from Congress. (d) On or before March 1 of each calendar year, each agency shall submit a report covering the preceding calendar year to the Speaker of the House of Representatives and President of the Senate for referral to the appropriate committee of the Congress. The report shall include (1) the matter of determinations made by such agency not to comply with requests for records made to such agency under subsection (a) and the reasons for each such determination; (2) the number of appeals made by persons under subsection (a) (6), the result of such appeals, and the reason for the action upon each appeal that results in a denial of information; (3) the names and titles or positions of each person responsible for the denial of records requested under this section, and the number of instances of participation for each; (4) the results of each proceeding conducted pursuant to subsection (a) (4) (F), including a report of the disciplinary action taken against the officer or employee who was primarily responsible for improperly withholding records or an explanation of why disciplinary action was not taken; (5) a copy of every rule made by such agency regarding this section; (6) a copy of the fee schedule and the total amount of fees collected by the agency for making records available under this section; and (7) such other information as indicates efforts to administer fully this section. The Attorney General shall submit an annual report on or before March 1 of each calendar year which shall include for the prior calendar year a listing of the number of cases arising under this section, the exemption involved in each case, the disposition of such case, and the cost, fees, and penalties assessed under subsection (a) (4) (E), (F) and (G). Such report shall also include a description of the efforts undertaken by the Department of Justice to encourage agency compliance with this section. (e) For purposes of this section, the term 'agency' as defined in section 551 (1) of this title includes any executive department, military department, Government corporation, Government controlled corporation, or other establishment in the executive branch of the Government (including the Executive Office of the President), or any independent regulatory agency. JUSTICE DEPARTMENT MEMORANDUM [Exhibit 2] ATTORNEY GENERAL'S MAY 5, 1977, MEMORANDUM ON FOIA OFFICE OF THE ATTORNEY GENERAL, LETTER TO HEADS OF ALL FEDERAL DEPARTMENTS AND AGENCIES Re Freedom of Information Act. I am writing in a matter of great mutual concern to seek your cooperation. Freedom of Information Act litigation has increased in recent years to the point where there are over 600 cases now pending in federal courts. The actual cases represent only the "tip of the iceberg" and reflect a much larger volume of administrative disputes over access to documents. I am convinced that we should jointly seek to reduce these disputes through concerted action to impress upon all levels of government the requirements, and the spirit, of the Freedom of Information Act. The government should not withhold documents unless it is important to the public interest to do so, even if there is some arguable legal basis for the withholding. In order to implement this view, the Justice Department will defend Freedom of Information Act suits only when disclosure is demonstrably harmful, even if the documents technically fall within the exemptions in the Act. Let me assure you that we will certainly counsel and consult with your personnel in making the decision whether to defend. To perform our job adequately, however, we need full access to documents that you desire to withhold, as well as the earliest possible response to our information requests. In the past, we have often filed answers in court without having an adequate exchange with the agencies over the reasons and necessity for the withholding. I hope that this will not occur in the future. In addition to setting these guidelines, I have requested Barbara Allen Babcock, Assistant Attorney General for the Civil Division, to conduct a review of all pending Freedom of Information Act litigation being handled by the Division. One result of that review may be to determine that litigation against your agency should no longer be continued and that information previously withheld should be released. In that event, I request that you ensure that your personnel work cooperatively with the Civil Division to bring the litigation to an end. Please refer to 28 CFR 50.9 and accompanying March 9, 1976 memorandum from the Deputy Attorney General. These documents remain in effect, but the following new and additional elements are hereby prescribed: In determining whether a suit against an agency under the Act challenging its denial of access to requested records merits defense consideration shall be given to four criteria: (a) Whether the agency's denial seems to have a substantial legal basis, (b) Whether defense of the agency's denial involves an acceptable risk of adverse impact on other agencies, (c) Whether there is a sufficient prospect of actual harm to legitimate public or private interests if access to the requested records were to be granted to justify the defense of the suit, and (d) Whether there is sufficient information about the controversy to support a reasonable judgment that the agency's denial merits defense under the three preceding criteria. The criteria set forth above shall be considered both by the Freedom of Information Committee and by the litigating divisions. The Committee shall, so far as practical, employ such criteria in its consultations with agencies prior to litigation and in its review of complaints thereafter. The litigating divisions shall promptly and independently consider these factors as to each suit filed. Together I hope that we can enhance the spirit, appearance and reality of open government. Yours sincerely, GRIFFIN B. BELL, Attorney General. (b) (4) EXEMPTION ADDITIONAL MATERIAL SUBMITTED FOR THE RECORD [Exhibit 3] EXCERPT FROM FINAL REPORT OF HEW REVIEW PANEL ON NEW DRUG REGULATION, MAY 1977 V. OPENNESS AND PUBLIC ACCOUNTABILITY Openness, candor, and public accountability should be basic principles associated with the operation of any system of government regulation. The regulation of new drugs should be no exception. For FDA to gain public confidence, its decisionmaking process should be impartial, open to public scrutiny, and receptive to outside opinion and participation. A. Openness and FDA's Trade Secrets Policy FDA has long taken the position that the law requires all scientific data relating to drug safety and effectiveness submitted by a drug sponsor to be treated as a trade secret. It therefore maintains that those data cannot be disclosed publicly without the consent of the sponsor. Indeed, the very existence of an IND or NDA is regarded as a trade secret.19 Where a drug sponsor maintains the confidentiality of its safety and effectiveness data, it can substantially delay the introduction of a competing drug sponsored by another firm, by forcing that firm to replicate the data needed to support approval of the drug. Keeping exclusive control over safety and effectiveness data thus affords the owner of the data a significant commercial advantage over its competitors. This policy might contribute to the incentive to invest in research and development of new drugs by giving drug companies temporary protection against market competition from rapidly approved "me-too" drugs. This so-called "second patent," created by preserving the confidentiality of safety and effectiveness data, is especially important for drugs which have no other patent protection. FDA has described the potential social benefits which may flow from its trade secrets policy as follows: "The public is dependent upon private pharmaceutical manufacturers for development of drugs. In some instances they may not be patented. If a manufacturer's safety and effectiveness data are to be released upon request, thus permitting "me-too" drugs to be marketed immediately, it is entirely possible that the incentive for private pharmaceutical research will be adversely affected." On the other hand, restricting public access to safety and effectiveness data presents numerous serious problems for the agency and the public. Under present policy, most day-to-day decision-making remains closed to public participation and outside review. Present policy thus places FDA in the untenable position of having to justify its decisions without being able to refer publicly to the data on which the decisions are based. FDA's trade secrets policy also deprives the agency of valuable opinions and criticism from sources outside the agency by preventing 19 Review Panel on New Drug Regulation, Department of Health, Education, and Welfare. Interim Report: An Evaluation of FDA's Trade Secrets and Freedom of Information Policies 1, 15-17 (Nov. 15, 1976) [hereinafter cited as Trade Secrets report]. |