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  <FDSYS>
    <CFRTITLE>21</CFRTITLE>
    <CFRTITLETEXT>Food and Drugs</CFRTITLETEXT>
    <VOL>9</VOL>
    <DATE>1998-04-01</DATE>
    <ORIGINALDATE>1998-04-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>PUBLIC AVAILABILITY OF INFORMATION</TITLE>
    <GRANULENUM>1401</GRANULENUM>
    <HEADING>PART 1401</HEADING>
    <ANCESTORS>
      <PARENT HEADING="" SEQ="1"/>
    </ANCESTORS>
  </FDSYS>
  <PART>
    <EAR>Pt. 1401</EAR>
    <HD SOURCE="HED">PART 1401—PUBLIC AVAILABILITY OF INFORMATION</HD>
    <CONTENTS>
      <SECHD>Sec.</SECHD>
      <SECTNO>1401.1</SECTNO>
      <SUBJECT>Purpose.</SUBJECT>
      <SECTNO>1401.2</SECTNO>
      <SUBJECT>The Office of National Drug Control Policy—Organization and functions.</SUBJECT>
      <SECTNO>1401.3</SECTNO>
      <SUBJECT>Definitions.</SUBJECT>
      <SECTNO>1401.4</SECTNO>
      <SUBJECT>Records of other agencies.</SUBJECT>
      <SECTNO>1401.5</SECTNO>
      <SUBJECT>How to request records—form and content.</SUBJECT>
      <SECTNO>1401.6</SECTNO>
      <SUBJECT>Initial determination.</SUBJECT>
      <SECTNO>1401.7</SECTNO>
      <SUBJECT>Prompt response.</SUBJECT>
      <SECTNO>1401.8</SECTNO>
      <SUBJECT>Responses—form and content.</SUBJECT>
      <SECTNO>1401.9</SECTNO>
      <SUBJECT>Appeal procedures.</SUBJECT>
      <SECTNO>1401.10</SECTNO>
      <SUBJECT>Fee schedule.</SUBJECT>
      <SECTNO>1401.11</SECTNO>
      <SUBJECT>Payment of fees.</SUBJECT>
      <SECTNO>1401.12</SECTNO>
      <SUBJECT>Waiver of fees.</SUBJECT>
      <SECTNO>1401.13</SECTNO>
      <SUBJECT>Aggregation of requests.</SUBJECT>
      <SECTNO>1401.14</SECTNO>
      <SUBJECT>Records that are exempt from disclosure.</SUBJECT>
      <SECTNO>1401.15</SECTNO>
      <SUBJECT>Deletion of exempted information.</SUBJECT>
    </CONTENTS>
    <AUTH>
      <HD SOURCE="HED">Authority: </HD>
      <P>5 U.S.C. 552, as amended.</P>
    </AUTH>
    <SOURCE>
      <HD SOURCE="HED">Source: </HD>
      <P>57 FR 59803, Dec. 16. 1992, unless otherwise noted.</P>
    </SOURCE>
    <SECTION>
      <SECTNO>§ 1401.1</SECTNO>
      <SUBJECT>Purpose.</SUBJECT>
      <P>The purpose of this part is to prescribe rules, guidelines and procedures to implement the Freedom of Information Act (FOIA), 5 U.S.C. 552, as amended.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.2</SECTNO>
      <SUBJECT>The Office of National Drug Control Policy—Organization and functions.</SUBJECT>

      <P>(a) The Office of National Drug Control Policy (ONDCP) was created by the Anti-Drug Abuse Act of 1988, 21 U.S.C. 1501 <E T="03">et seq.</E> The mission of ONDCP is to coordinate the anti-drug efforts of the various agencies and departments of the Federal government, to consult with States and localities and assist their anti-drug efforts, and to annually promulgate the National Drug Control Strategy. ONDCP is headed by the Director of National Drug Control Policy. The Director is assisted by a Deputy Director for Supply Reduction, a Deputy Director for Demand Reduction, and an Associate Director for State and Local Affairs.</P>
      <P>(b) ONDCP has an Office of Public Affairs that is responsible for providing information to the press and to the general public. If members of the public have general questions about ONDCP that can be answered by telephone, they may call the Office of Public Affairs at (202) 467-9890. This number should not be used to make FOIA requests. All oral requests for information under FOIA will be rejected.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.3</SECTNO>
      <SUBJECT>Definitions.</SUBJECT>
      <P>As used in this part, the following definitions shall apply:</P>
      <P>(a) <E T="03">Commercial-use request</E> means a request from or on behalf of one who seeks information for a cause or purpose that furthers the commercial, trade or profit interests of the requester or the person or institution on whose behalf the request is made. In determining whether a requester properly belongs in this category, ONDCP will consider how the requester intends to use the documents.</P>
      <P>(b) <E T="03">Direct costs</E> means those expenditures that ONDCP actually incurs in searching for and duplicating (and in the case of commercial requesters, reviewing) documents to respond to a FOIA request. Direct costs include, for example, the salary of the employee performing work (the basic rate of pay for the employee plus 16 percent of that rate to cover benefits) and the cost of operating duplicating machinery. Not included in direct costs are overhead expenses such as costs of space, and heating or lighting the facility in which the records are stored.</P>
      <P>(c) <E T="03">Duplication</E> means the process of making a copy of a document in response to a FOIA request. Such copies can take the form of paper copy, microform, audio-visual materials, or machine readable documentation. ONDCP will provide a copy of the material in a form that is usable by the requester unless it is administratively burdensome to do so.</P>
      <P>(d) <E T="03">Educational institution</E> means preschool, a public or private elementary <PRTPAGE P="164"/>or secondary school, an institution of graduate higher education, an institution of undergraduate higher education, an institution of professional education, or an institution of vocational education, which operates a program or programs of scholarly research.</P>
      <P>(e) <E T="03">Noncommercial scientific institution</E> means an institution that is not operated on a “commercial” basis as that term is referenced above, and that is operated solely for the purpose of conducting scientific research the results of which are not intended to promote any particular product or industry.</P>
      <P>(f) <E T="03">Records</E> and/or <E T="03">information</E> means all books, papers, manuals, maps, photographs, or other documentary materials, regardless of physical form or characteristics, made or received by ONDCP and preserved or appropriate for preservation by ONDCP as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the Government or because of the information value of the data in them, but does not include books, magazines or other material acquired solely for library purposes and through other sources, and does not include analyses, computations, or compilations of information not extant at the time of the request. The term “records” does not include objects or articles such as structures, furniture, paintings, sculptures, three-dimensional models, vehicles, and equipment.</P>
      <P>(g) <E T="03">Representative of the news media</E> means any person actively gathering news for an entity that is organized and operated to publish or broadcast news to the public. The term “news” means information that is about current events or that would be of current interest to the public. Examples of news media include television or radio stations broadcasting to the public at large, and publishers of periodicals (but only in those instances when they can qualify as disseminators of “news”) that make their products available for purchase or subscription by the general public. Freelance journalists may be regarded as working for a news organization if they can demonstrate a reasonable basis for expecting publication through that organization, even though not actually employed by it.</P>
      <P>(h) <E T="03">Request</E> means a letter or other written communication seeking records or information under FOIA.</P>
      <P>(i) <E T="03">Review</E> means the process of examining documents located in response to a commercial-use request to determine if that document or any portion of that document is permitted to be withheld. It also includes processing any document for disclosure (i.e., doing all that is necessary to excise those portions of the document not subject to disclosure under FOIA and otherwise preparing them for release). Review does not include time spent resolving general legal or policy issues regarding the application of exemptions.</P>
      <P>(j) <E T="03">Search</E> means all time spent looking for material that is responsive to a request, including page-by-page or line-by-line identification of material within documents. Searches should be performed in the most efficient and least expensive manner so as to minimize costs for both ONDCP and the requester; for example, line-by-line searches should not be undertaken when it would be more efficient to duplicate the entire document. Searches should be distinguished from “review” of material in order to determine whether the material is exempt from disclosure. Searches may be done manually or by computer using existing programming.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.4</SECTNO>
      <SUBJECT>Records of other agencies.</SUBJECT>
      <P>Requests for records that originated in another agency and are in the custody of ONDCP shall be referred to the originating agency for processing, and the person submitting the request shall be so notified. Any decision made by the originating agency with respect to such records will be honored by ONDCP.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.5</SECTNO>
      <SUBJECT>How to request records—form and content.</SUBJECT>

      <P>(a) Requests for records under FOIA must be submitted in writing, addressed to: Office of the General Counsel, Office of National Drug Control Policy, Executive Office of the President, Washington, DC 20500. The words “FOIA REQUEST” or “REQUEST FOR RECORDS” must be clearly marked on both the letter and the envelope. If the <PRTPAGE P="165"/>request is not so marked and addressed, the 10-day time limit imposed by § 1401.7 of this part shall not begin to run until the request has been received by the Office of the General Counsel and identified as a FOIA request. Due to security requirements, FOIA requests may not be delivered in person.</P>
      <P>(b) Any ONDCP employee who receives a request shall promptly forward it to the Office of the General Counsel. Any ONDCP employee who receives an oral request made under the FOIA shall inform the person making the request of the provisions of this part requiring a written request.</P>
      <P>(c) Each request must reasonably describe the record(s) sought, including when known: The specific event or action to which the request refers, if any; the name of the agency, office, organization or person that originated the record; the date or time period to which the request refers; the subject matter of the records requested; the type of document requested; the location of the record(s) requested; and any other pertinent information that would assist in promptly locating the record(s).</P>
      <P>(d) When a request is not considered reasonably descriptive, or requires the production of voluminous records, or places an extraordinary burden on ONDCP, seriously interfering with its normal functioning to the detriment of the business of the Government, ONDCP may require the person or agent making the FOIA request to confer with an ONDCP representative in order to attempt to verify, and, if possible, narrow the scope of the request.</P>
      <P>(e) Upon initial receipt of a request, the Office of the General Counsel shall determine which official or officials within ONDCP shall have the primary responsibility for collecting and reviewing the requested information and drafting a proposed response.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.6</SECTNO>
      <SUBJECT>Initial determination.</SUBJECT>
      <P>The General Counsel or his or her designee shall have the authority to approve or deny requests received pursuant to these regulations. The decision of the General Counsel shall be final, subject only to administrative review as provided in § 1401.9.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.7</SECTNO>
      <SUBJECT>Prompt response.</SUBJECT>
      <P>(a) The General Counsel or his or her designee shall either approve or deny a request for records within 10 working days (excluding Saturday, Sunday and Federal holidays) after receipt of the request unless additional time is required for one of the following reasons:</P>
      <P>(1) It is necessary to search for, collect, and appropriately examine a voluminous amount of separate and distinct records that are demanded in a single request; or</P>
      <P>(2) It is necessary to consult with another agency having a substantial interest in the determination of the request or among two or more components of ONDCP that have a substantial interest in the subject matter of the request.</P>
      <P>(b) When additional time is required for one of the reasons stated in paragraph (a) of this section, the General Counsel or his or her designee shall acknowledge receipt of the request within the 10 working day period and include a brief explanation of the reason for delay, indicating the date by which a determination will be forthcoming. An extended deadline adopted for one of the reasons set forth above may not exceed 10 additional working days.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.8</SECTNO>
      <SUBJECT>Responses—form and content.</SUBJECT>
      <P>(a) When a requested record has been identified and is available, the General Counsel or his or her designee shall notify the person making the request as to where and when the record will be available for inspection or the copies will be available. The notification shall also advise the person making the request of any fees assessed under § 1401.10 of this part.</P>
      <P>(b) A denial or partial denial of a request for a record shall be in writing signed by the General Counsel or his or her designee and shall include:</P>
      <P>(1) The name and title of the person making the determination;</P>

      <P>(2) Either a reference to the specific exemption under FOIA authorizing the withholding of the record and a brief explanation of how the exemption applies to the record withheld, or a statement that, after diligent effort, the requested records have not been found or have not been adequately examined during the time allowed by § 1401.7, and <PRTPAGE P="166"/>that the denial will be reconsidered as soon as the search or examination is complete; and</P>
      <P>(3) A statement that the denial may be appealed to the Director within 30 days of its receipt by the requester.</P>
      <P>(c) If a requested record cannot be located from the information supplied, or is known to have been destroyed or otherwise disposed of, the person making the request shall be so notified and the legal authority for disposition shall be cited.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.9</SECTNO>
      <SUBJECT>Appeal procedures.</SUBJECT>
      <P>(a) When the General Counsel or his or her designee denies a request for records in whole or in part, the person making the request may, within 30 days of receipt of the notice of denial, appeal the denial to the Director of ONDCP. The appeal must be in writing, addressed to the Director, Office of National Drug Control Policy, Executive Office of the President, Washington, DC 20500. The envelope should be clearly labeled as a “Freedom of Information Act Appeal.”</P>
      <P>(b) The Director will act upon the appeal within 20 working days of its receipt. The Director may extend the 20-day period of time by any number of working days which could have been used by the General Counsel or his or her designee under § 1401.7 but which were not used in making the initial determination. The Director's action on an appeal shall be in writing and signed.</P>
      <P>(c) If the decision is in favor of the requester, the Director shall order records promptly made available to the requester.</P>
      <P>(d) A denial in whole or in part of a request on appeal shall set forth a brief explanation of the reasons for the decision, and shall inform the requester of his or her right to seek judicial review of the denial and ruling on appeal as provided in 5 U.S.C. 552(a)(4).</P>
      <P>(e) No personal appearance, oral argument or hearing will ordinarily be permitted in connection with an appeal to the Director.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.10</SECTNO>
      <SUBJECT>Fee schedule.</SUBJECT>
      <P>(a) There are four categories of requesters: Commercial use requesters; educational and non-commercial scientific institutions; representatives of the news media; and all other requesters. FOIA prescribes different levels of fees for each of these categories.</P>
      <P>(1) <E T="03">Commercial use requesters.</E> When a request for records is made for commercial use, charges will be assessed to cover all the costs of searching for, reviewing for release, and duplicating the records sought.</P>
      <P>(2) <E T="03">Educational and non-commercial scientific institutions.</E> When a request for records is made by an educational or a non-commercial scientific institution in furtherance of scholarly or scientific research, charges will be assessed to cover the cost of duplication alone, excluding charges for duplication of the first 100 pages.</P>
      <P>(3) <E T="03">Requests by representatives of the news media.</E> When a request for records is made by a representative of the news media for the purpose of news dissemination, charges will be assessed to cover the cost of duplication alone, excluding charges for duplication of the first 100 pages.</P>
      <P>(4) <E T="03">All other requests.</E> When a request for records is made by a requester who does not fit into any of the preceding categories, charges will be assessed to cover the costs of searching for and duplicating the records sought, excluding charges for the first two hours of search time and the duplication of the first 100 pages. Moreover, requests from individuals for records about themselves will be treated under the Privacy Act of 1974, 5 U.S.C. 552a, which permits the assessment of fees for duplication costs only, regardless of the requester's characterization of the search.</P>
      <P>(b) Fees for searches, review of records and duplication of records are charged as follows:</P>
      <P>(1) <E T="03">Search for records.</E> The charge for a manual search is calculated by determining the search time to the nearest quarter hour and multiplying that figure by the sum of the basic rate of pay per hour of the employee conducting the search plus 16 percent of that rate. The charge for a computer search is calculated by determining the search time to the nearest quarter hour and multiplying that figure by the sum of the basic rate of pay per hour of the employee conducting the search, plus <PRTPAGE P="167"/>16 percent of that rate, plus the direct cost of the operation of the computer for that portion of time attributable to the search.</P>
      <P>(2) <E T="03">Review of records.</E> Only requesters who are seeking documents for commercial use will be charged for time spent reviewing records to determine whether they are exempt from mandatory disclosure. Charges will be assessed only for the initial review; i.e., the review undertaken the first time ONDCP analyzes the applicability of a specific exemption to a particular record or portion of a record. Charges will not be assessed for review at the administrative appeal level of the exemption(s) already applied. The cost for review will be calculated based on the salary of the category of the employee who actually performed the review plus 16 percent of that rate.</P>
      <P>(3) <E T="03">Duplication of records.</E> Copies made by routine photostatic copying shall be charged at the rate of $0.15 per page. If copies need to be made by other methods, the direct costs of such copies will be charged to the requester, as determined by the General Counsel.</P>
      <P>(4) <E T="03">Unsuccessful searches.</E> Requesters may be charged for unsuccessful or unproductive searches or for searches when records located are determined to be exempt from disclosure.</P>
      <P>(5) <E T="03">Other charges.</E> ONDCP will recover the direct costs of providing special services such as certifying that records are true copies, and sending records by special methods such as express mail.</P>
      <P>(c) No fee will be charged by ONDCP when the routine costs of collecting and processing the fee equal to or exceed the amount of the fee. For purposes of this section, the routine costs of collecting and processing a fee chargeable under FOIA are estimated to be $15.00 for each FOIA request.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.11</SECTNO>
      <SUBJECT>Payment of fees.</SUBJECT>
      <P>(a) The requester must agree to pay all fees that are chargeable under this section prior to issuance of the requested copies.</P>
      <P>(b) Payment of fees shall be in the form either of a personal check or bank draft drawn on a bank in the United States, or a postal money order. Remittances shall be made payable to the order of the Treasurer of the United States and mailed to the General Counsel, Office of National Drug Control Policy, Executive Office of the President, Washington, DC 20500.</P>
      <P>(c) If it is anticipated that the fees chargeable under this section will amount to more than $25.00, and the requester has not indicated in advance his willingness to pay such fees, the requester shall be promptly notified of the amount of the anticipated fee or such portion thereof as can readily be estimated. In instances where the estimated fees will exceed $250.00, an advance deposit may be required. The notice or request for an advance deposit shall extend to the requester an offer to consult with ONDCP personnel in order to reformulate the request in a manner which will reduce the fees. A reformulated request shall be considered a new request, thus beginning a new 10 workday period for responding to the request.</P>
      <P>(d) When a requester has previously failed to pay a fee in a timely fashion (i.e., within 30 days of the date of the billing), ONDCP may require the requester to demonstrate that he or she has, in fact, paid any outstanding fees from past requests, and to make an advance payment of the full amount of the estimated fee for the present request before ONDCP responds to that request.</P>
      <P>(e) Interest charges on an unpaid bill may be assessed starting on the 31st day following the day on which the billing was sent. Interest shall be assessed at the rate prescribed in 31 U.S.C. 3717, and shall accrue from the date of the billing. The fact that a fee has been received by ONDCP, even if not processed, will suffice to stay the accrual of interest.</P>
      <P>(f) To encourage the repayment of delinquent fees, ONDCP shall use the procedures described in the Debt Collection Act of 1982, 31 U.S.C. 3716-3719, including the use of collection agencies and disclosure to consumer reporting agencies.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.12</SECTNO>
      <SUBJECT>Waiver of fees.</SUBJECT>

      <P>(a) Records shall be furnished without charge, or at a reduced charge, upon a determination by the General Counsel of ONDCP that:<PRTPAGE P="168"/>
      </P>
      <P>(1) Waiver or reduction of the fees is in the public interest because release of the requested information is likely to contribute significantly to public understanding of the operations or activities of ONDCP and is not primarily in the commercial interest of the requester; or</P>
      <P>(2) Assessment of fees is not feasible.</P>
      <P>(b) Upon written request, a written explanation will be provided as to why a request for waiver or reduction of FOIA fees was not granted.</P>
      <P>(c) There is no right to an administrative appeal from a decision not to waive or reduce fees.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.13</SECTNO>
      <SUBJECT>Aggregation of requests.</SUBJECT>
      <P>(a) When the General Counsel reasonably believes that a requester, or a group of requesters acting in concert, is attempting to break down a request into a series of requests for the purpose of evading the assessment of fees, such requests may be aggregated and fees may be charged accordingly.</P>
      <P>(b) In determining whether a series of requests shall be aggregated, the General Counsel will consider two factors: whether the requests concern a single subject or two or more closely related subjects; and whether the requests were all made within a 30-day period. If a series of requests is made by multiple requesters, the General Counsel will also consider whether there is substantial evidence to support the conclusion that the requesters are acting in concert.</P>
    </SECTION>
    <SECTION>
      <SECTNO>§ 1401.14</SECTNO>
      <SUBJECT>Records that are exempt from disclosure.</SUBJECT>
      <P>(a) Records described in 5 U.S.C. 552(b) are exempt from disclosure under FOIA. These include the following categories of records:</P>
      <P>(1) Records that are specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy and are in fact properly classified pursuant to such Executive order;</P>
      <P>(2) Records related solely to the internal personnel rules and practices of an agency;</P>
      <P>(3) Records specifically exempted from disclosure by statute (other than 5 U.S.C. 552b), provided that such statute:</P>
      <P>(i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or</P>
      <P>(ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld;</P>
      <P>(4) Records of trade secrets and commercial or financial information obtained from a person and privileged or confidential;</P>
      <P>(5) Inter-agency or intra-agency memoranda or letters which would not be available by law to a party other than in litigation with the agency;</P>
      <P>(6) Personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy; and</P>
      <P>(7) Records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information:</P>
      <P>(i) Could reasonably be expected to interfere with enforcement proceedings,</P>
      <P>(ii) Would deprive a person of a right to a fair trial or an impartial adjudication,</P>
      <P>(iii) Could reasonably be expected to constitute an unwarranted invasion of personal privacy,</P>
      <P>(iv) Could reasonably be expected to disclose the identity of a confidential source including a state, local, or foreign agency or authority or any private institution which furnished information on a confidential basis, 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, information furnished by a confidential source,</P>
      <P>(v) Would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law, or</P>
      <P>(vi) Could reasonably be expected to endanger the life or physical safety of any individual.</P>
    </SECTION>
    <SECTION>
      <PRTPAGE P="169"/>
      <SECTNO>§ 1401.15</SECTNO>
      <SUBJECT>Deletion of exempted information.</SUBJECT>
      <P>When requested records contain matters that are exempted under 5 U.S.C. 552(b), but such exempted matters are reasonably segregable from the remainder of the records, the records shall be disclosed by ONDCP with the necessary deletions. ONDCP shall attach to each such record a written justification for making the deletion or deletions. A single such justification shall suffice for deletions made in a group of similar or related records.</P>
    </SECTION>
  </PART>
</CFRGRANULE>
