HHS 21 CFR PART 1401-2011 PUBLIC AVAILABILITY OF INFORMATION《信息的公开提供》.pdf

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1、249 PART 1400 RESERVED PART 1401PUBLIC AVAILABILITY OF INFORMATION Sec. 1401.1 Purpose. 1401.2 The Office of National Drug Control Policyorganization and functions. 1401.3 Definitions. 1401.4 Access to information. 1401.5 How to request records. 1401.6 Expedited process. 1401.7 Prompt response. 1401

2、.8 Extension of time. 1401.9 Appeals. 1401.10 Fees to be chargedgeneral. 1401.11 Fees to be chargedmiscellaneous provisions. 1401.12 Fees to be chargedcategories of re-questers. 1401.13 Waiver or reduction of fees. AUTHORITY: 5 U.S.C. 552, as amended. SOURCE: 64 FR 69901, Dec. 15, 1999, unless other

3、wise noted. 1401.1 Purpose. The purpose of this part is to pre-scribe rules, guidelines and procedures to implement the Freedom of Informa-tion Act (FOIA), as amended, 5 U.S.C. 552. 1401.2 The Office of National Drug Control Policyorganization and functions. (a) The Office of National Drug Con-trol

4、Policy (ONDCP) was created by the Anti-Drug Abuse Act of 1988, 21 U.S.C. 1501 et seq., and reestablished under 21 U.S.C. 1701 et seq. The mission of ONDCP is to coordinate the anti- drug efforts of the various agencies and departments of the Federal govern-ment, to consult with States and local-itie

5、s and assist their anti-drug efforts, to conduct a national media campaign, and to annually promulgate the Na-tional Drug Control Strategy. (b) ONDCP is headed by the Director of National Drug Control Policy. The Director is assisted by a Deputy Direc-tor of National Drug Control Policy, a Deputy Di

6、rector for Supply Reduction, a Deputy Director for Demand Reduc-tion, and a Deputy Director for State and Local Affairs. (c) Offices within ONDCP include Chief of Staff, and the Offices of Legal Counsel, Strategic Planning, Legisla-tive Affairs, Programs Budget and Evaluation, Supply Reduction, Dema

7、nd Reduction, Public Affairs, State and Local Affairs, and the Financial Man-agement Office. (d) The Office of Public Affairs is re-sponsible for providing information to the press and to the general public. If members of the public have general questions about ONDCP that can be an-swered by telepho

8、ne, they may call the Office of Public Affairs at (202) 3956618. This number should not be used to make FOIA requests. All oral requests for information under FOIA will be re-jected. 1401.3 Definitions. For the purpose of this part: (a) All the terms defined in the Free-dom of Information Act apply.

9、 (b) Commercial-use request means a re-quest from or on behalf of one who seeks information for a cause or pur-pose that furthers the commercial, trade or profit interests of the re-quester or the person or institution on whose behalf the request is made. In determining whether a requester prop-erly

10、 belongs in this category, ONDCP will consider the intended use of the in-formation. (c) Direct costs means the expense ac-tually expended to search, review, or duplicate in response to a FOIA re-quest. For example, direct costs in-clude 116% of the salary of the em-ployee performing work and the ac

11、tual costs incurred while operating equip-ment. (d) Duplicate means the process of making a copy of a document. Such copies may take the form of paper, microform, audio-visual materials, or machine-readable documentation. ONDCP will provide a copy of the ma-terial in a form that is usable by the req

12、uester. (e) Educational institution means pre-school, a public or private elementary or secondary school, an institution of undergraduate higher education, an in-stitution of graduate higher education, an institution of professional edu-cation, or an institution of vocational education that operates

13、 a program or programs of scholarly research. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00259 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-250 21 CFR Ch. II

14、I (4111 Edition) 1401.4 (f) Noncommercial scientific institution means an institution that is not oper-ated on a commercial basis as that term is defined in this section, and that is operated solely for the purpose of conducting scientific research not intended to promote any particular product or i

15、ndustry. (g) Records and any other terms used in this part in reference to information includes any information that would be an agency record subject to the re-quirements of this part when main-tained in any format, including elec-tronic format. (h) Representative of the news media means any person

16、 actively gathering news for an entity that is organized and operated to publish or broadcast news to the public. News is information about current events or information that would be of interest to the public. Examples of the news media include television or radio stations that broad-cast to the pu

17、blic at large and pub-lishers of news periodicals that make their products available to the general public for purchase or subscription. Freelance journalists may be regarded as working for the news media where they demonstrate a reasonable basis for expecting publication through that organization,

18、even though not actually employed by it. (i) Request means a letter or other written communication seeking records or information under FOIA. (j) Review means the process of exam-ining documents that are located dur-ing a search to determine if any por-tion should lawfully be withheld. It is the pro

19、cessing of determining disclosability. (k) Search means to review, manually or by automated means, agency records for the purpose of locating those records responsive to a request. 1401.4 Access to information. The Office of National Drug Control Policy makes available information pertaining to matt

20、ers issued, adopted, or promulgated by ONDCP, that are within the scope of 5 U.S.C. 552(a)(2). A public reading area and the ONDCP FOIA Handbook are located at http:/ www.whitehousedrugpolicy.gov/about/ about.html. 1401.5 How to request records. (a) Each request must reasonably de-scribe the record(

21、s) sought including the type of document, specific event or action, originator of the record, date or time period, subject matter, location, and all other pertinent data. (b) Requests must be received by ONDCP through the mail or by elec-tronic facsimile transmission. Mailed requests must be address

22、ed to Execu-tive Office of the President, Office of National Drug Control Policy, Office of Legal Counsel, Washington, DC 20503. The applicable fax number is (202) 395 5543. (c) The words FOIA REQUEST or REQUEST FOR RECORDS must be clearly marked on the cover-letter, let-ter and envelope. The time l

23、imitations imposed by 1401.7 will not begin until the Office of the General Counsel iden-tifies a letter or fax as a FOIA request. 1401.6 Expedited process. (a) Requests and appeals will be given expedited treatment whenever ONDCP determines either: (1) The lack of expedited treatment could reasonab

24、ly be expected to pose an imminent threat to the life or phys-ical safety of an individual; or (2) An urgency to inform the public about an actual or alleged federal gov-ernment activity occurs and the re-quest is made by a person primarily en-gaged in disseminating information. (b) A request for ex

25、pedited processing may be made at the time of the initial request for records or at a later time. (c) A requester who seeks expedited processing must submit a statement, certified to be true and correct to the best of that persons knowledge and be-lief, explaining in detail the basis for requesting

26、expedited processing. A re-quester within the category in para-graph (a)(2) of this section also must establish a particular urgency to in-form the public about the government activity involved in the request, be-yond the publics right to know about government activity generally. The formality of ce

27、rtification may be waived as a matter of administrative discretion. (d) Within ten days of receipt of a re-quest for expedited processing, ONDCP will decide whether to grant it and will VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00260 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe o

28、n DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-251 Office of National Drug Control Policy 1401.10 notify the requester of the decision. If a request for expedited treatment is granted, the request will be given pri-ority and

29、 will be processed as soon as practicable. If a request for expedited processing is denied, any appeal of that decision will be acted on expeditiously. 1401.7 Prompt response. The General Counsel, or designee, will determine within 20 days (except-ing Saturdays, Sundays and legal pub-lic holidays) a

30、fter the receipt of a FOIA request whether it is appropriate to grant the request and will provide writ-ten notification to the person making the request. If the request is denied, the written notification will include the names of the individuals who par-ticipated in the determination, the rea-sons

31、 for the denial, and that an appeal may be lodged within the Office of Na-tional Drug Control Policy. 1401.8 Extension of time. (a) In unusual circumstances, the Of-fice of General Counsel may extend the time limit prescribed in 1401.7 or 1401.9 by written notice to the FOIA requester. The notice wi

32、ll state the reasons for the extension and the date a determination is expected. The ex-tension period may be divided among the initial request and an appeal but will not exceed a total of 10 working days (excepting Saturdays, Sundays, or legal public holidays). (b) The phrase unusual cir-cumstances

33、 means: (1) The requested records are located in establishments that are separated from the office processing the request; (2) A voluminous amount of separate and distinct records are demanded in a single request; or (3) Another agency or two or more components in the same agency have substantial in

34、terest in the determina-tion of the request. (c) Where unusual circumstance exist, ONDCP may provide an oppor-tunity for amendment of the initial re-quest so that the request may be time-ly processed. Refusal by the person to reasonably modify the request or ar-range an alternative time frame shall

35、be considered as a factor for purposes of 5 U.S.C. 552 (a)(6)(C). (d) ONDCP may aggregate requests by a requester or a group of requestors where multiple requests reasonably ap-pear to be a single request. 1401.9 Appeals. An appeal to the ONDCP must ex-plain in writing the legal and factual basis fo

36、r the appeal. It must be re-ceived by mail at the address specified in 1401.5 within 30 days of receipt of a denial. The Director or designee will decide the appeal within 20 days (ex-cepting Saturdays, Sundays, and legal public holidays). If the Director or des-ignee deny an appeal in whole or in p

37、art, the written determination will contain the reason for the denial, the names of the individuals who partici-pated in the determination, and the provisions for judicial review. 1401.10 Fees to be chargedgeneral. ONDCP will recoup the full allowable costs it incurs in response to a FOIA request. (

38、a) Manual search for records. ONDCP will charge 116% of the salary of the in-dividual(s) making a search. (b) Computerized search for records. ONDCP will charge 116% of the salary of the programmer/operator and the apportionable time of the central proc-essing unit directly attributed to the search.

39、 (c) Review of records. ONDCP will charge 116% of the salary of the indi-vidual(s) conducting a review. Records or portions of records withheld under an exemption subsequently determined not to apply may be reviewed to deter-mine the applicability of exemptions not considered. The cost for a subse-q

40、uent review is assessable. (d) Duplication of records. Request for copies prepared by computer will cost 116% of the apportionable operator time and the cost of the tape or disk. Other methods of duplication will cost 116% of the salary of the individual copying the data plus 15 cents per copy of 81

41、211 inch original. (e) Other charges. ONDCP will recover the costs of providing other services such as certifying records or sending records by special methods. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00261 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFR

42、Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-252 21 CFR Ch. III (4111 Edition) 1401.11 1401.11 Fees to be chargedmiscella-neous provisions. (a) Remittance shall be mailed to the Office of Legal Counsel, ONDCP, Wash-ington DC 20503, and made payabl

43、e to the order of the Treasury of the United States on a postal money order or per-sonal check or bank draft drawn on a bank in the United States. (b) ONDCP may require advance pay-ment where the estimated fee exceeds $250, or a requester previously failed to pay within 30 days of the billing date.

44、(c) ONDCP may assess interest charges beginning the 31st day of bill-ing. Interest will be at the rate pre-scribed in section 3717 of title 31 of the United States Code and will accrue from the date of the billing. (d) ONDCP may assess search charges where records are not located or where records ar

45、e exempt from disclosure. (e) ONDCP may aggregate individual requests and charge accordingly for re-quests seeking portions of a document or documents. 1401.12 Fees to be chargedcat-egories of requesters. (a) There are four categories of FOIA requesters: commercial use requesters; educational and no

46、n-commercial sci-entific institutions; representatives of the news media; and all other request-ers. (b) The specific levels of fees for each of these categories are: (1) Commercial use requesters. ONDCP will recover the full direct cost of pro-viding search, review and duplication services. Commerc

47、ial use requesters will not receive free search-time or free reproduction of documents. (2) Educational and non-commercial sci-entific institution requesters. ONDCP will charge the cost of reproduction, ex-cluding charges for the first 100 pages. Requesters must demonstrate the re-quest is authorize

48、d by and under the auspices of a qualifying institution and that the records are sought for schol-arly or scientific research not a com-mercial use. (3) Requesters who are representatives of the news media. ONDCP will charge the cost of reproduction, excluding charges for the first 100 pages. Reques

49、t-ers must meet the criteria in 1401.3(h), and the request must not be made for a commercial use. A request that sup-ports the news dissemination function of the requester shall not be considered a commercial use. (4) All other requesters. ONDCP will re-cover the full direct cost of the search and the reproduction of records, ex-cluding the first 100 pages of reproduc-tion and the first two hours of search time. Requests for records c