HHS 21 CFR PART 1316-2011 ADMINISTRATIVE FUNCTIONS PRACTICES AND PROCEDURES《行政职能 实践和规程》.pdf

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1、222 21 CFR Ch. II (4111 Edition) 1315.62 1315.62 Final order. As soon as practicable after the pre-siding officer has certified the record to the Administrator, the Adminis-trator shall issue his order on the de-termination or adjustment of the as-sessment of annual needs or on the issuance, adjustm

2、ent, suspension, or denial of the procurement, import, or individual manufacturing quota, as the case may be. The order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. The Administrator shall ser

3、ve one copy of his order upon each party in the hearing. PART 1316ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Subpart AAdministrative Inspections Sec. 1316.01 Scope of subpart A. 1316.02 Definitions. 1316.03 Authority to make inspections. 1316.04 Exclusion from inspection. 1316.05 Entry. 131

4、6.06 Notice of inspection. 1316.07 Requirement for administrative in-spection warrant; exceptions. 1316.08 Consent to inspection. 1316.09 Application for administrative in-spection warrant. 1316.10 Administrative probable cause. 1316.11 Execution of warrants. 1316.12 Refusal to allow inspection with

5、 an administrative warrant. 1316.13 Frequency of administrative inspec-tions. Subpart BProtection of Researchers and Research Subjects 1316.21 Definitions. 1316.22 Exemption. 1316.23 Confidentiality of identity of re-search subjects. 1316.24 Exemption from prosecution for re-searchers. Subpart CEnfo

6、rcement Proceedings 1316.31 Authority for enforcement pro-ceeding. 1316.32 Notice of proceeding; time and place. 1316.33 Conduct of proceeding. 1316.34 Records of proceeding. Subpart DAdministrative Hearings 1316.41 Scope of subpart D. 1316.42 Definitions. 1316.43 Information; special instructions.

7、1316.44 Waiver or modification of rules. 1316.45 Filings; address; hours. 1316.46 Inspection of record. 1316.47 Request for hearing. 1316.48 Notice of appearance. 1316.49 Waiver of hearing. 1316.50 Appearance; representation; author-ization. 1316.51 Conduct of hearing and parties; ex parte communica

8、tions. 1316.52 Presiding officer. 1316.53 Time and place of hearing. 1316.54 Prehearing conference. 1316.55 Prehearing ruling. 1316.56 Burden of proof. 1316.57 Submission of documentary evidence and affidavits and identification of wit-nesses subsequent to prehearing con-ference. 1316.58 Summary of

9、testimony; affidavits. 1316.59 Submission and receipt of evidence. 1316.60 Objections; offer of proof. 1316.61 Exceptions to rulings. 1316.62 Appeal from ruling of presiding offi-cer. 1316.63 Official transcript; index; correc-tions. 1316.64 Proposed findings of fact and conclu-sions of law. 1316.65

10、 Report and record. 1316.66 Exceptions. 1316.67 Final order. 1316.68 Copies of petitions for judicial re-view. Subpart ESeizure, Forfeiture, and Disposition of Property 1316.71 Definitions. 1316.72 Officers who will make seizures. 1316.73 Custody and other duties. 1316.74 Appraisement. 1316.75 Adver

11、tisement. 1316.76 Requirements as to claim and bond. 1316.77 Administrative forfeiture. 1316.78 Judicial forfeiture. 1316.79 Petitions for remission or mitiga-tion of forfeiture. 1316.80 Time for filing petitions. 1316.81 Handling of petitions. Subpart FExpedited Forfeiture Proceedings for Certain P

12、roperty 1316.90 Purpose and scope. 1316.91 Definitions. 1316.92 Petition for expedited release in an administrative forfeiture action. 1316.93 Ruling on petition for expedited re-lease in an administrative forfeiture ac-tion. 1316.94 Posting of substitute res in an ad-ministrative forfeiture action.

13、 VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00232 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-223 Drug Enforcement Administration, Justice 1316.03 1316.95 P

14、etition for expedited release of a conveyance in a judicial forfeiture ac-tion. 1316.96 Ruling on a petition for expedited release of a conveyance in a judicial for-feiture action. 1316.97 Initiating judicial forfeiture pro-ceeding against a conveyance within 60 days of the filing of a claim and cos

15、t bond. 1316.98 Substitute res bond in a judicial for-feiture action against a conveyance. 1316.99 Notice provisions. SOURCE: 36 FR 7820, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. Subpart AAdministrative Inspections AUTHORITY: 21 U.S.C. 822(f), 830(a), 871(b

16、), 880, 958(f), 965. 1316.01 Scope of subpart A. Procedures regarding administrative inspections and warrants pursuant to sections 302(f), 510, 1008(d), and 1015 of the Act (21 U.S.C. 822(f), 880, 958(d), and 965) are governed generally by those sections and specifically by the sec-tions of this sub

17、part. 1316.02 Definitions. As used in this subpart, the following terms shall have the meanings speci-fied: (a) The term Act means the Con-trolled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Sub-stances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951). (b) The term Admini

18、stration means the Drug Enforcement Administration. (c) The term controlled premises means (1) Places where original or other records or documents required under the Act are kept or required to be kept, and (2) Places, including factories, ware-houses, or other establishments and conveyances, where

19、persons registered under the Act or exempted from reg-istration under the Act, or regulated persons may lawfully hold, manufac-ture, or distribute, dispense, admin-ister, or otherwise dispose of controlled substances or listed chemicals or where records relating to those activities are maintained. (

20、d) The term Administrator means the Administrator of the Administration. The Administrator has been delegated authority under the Act by the Attor-ney General (28 CFR 0.100). (e) The term inspector means an offi-cer or employee of the Administration authorized by the Administrator to make inspection

21、s under the Act. (f) The term register and registration refer to registration required and per-mitted by sections 303 and 1008 of the Act (21 U.S.C. 823 and 958). (g) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this

22、chapter. 36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 60 FR 32465, June 22, 1995; 60 FR 36334, July 14, 1995; 62 FR 13969, Mar. 24, 1997 1316.03 Authority to make inspec-tions. In carrying out his functions under the Act, the Administrator, through his inspec

23、tors, is authorized in accord-ance with sections 510 and 1015 of the Act (21 U.S.C. 880 and 965) to enter con-trolled premises and conduct adminis-trative inspections thereof, for the pur-pose of: (a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required

24、 to be kept or made under the Act and regulations promulgated under the Act, including, but not limited to, inventory and other records required to be kept pursuant to part 1304 of this chapter, order form records required to be kept pursuant to part 1305 of this chapter, prescription and distributi

25、on records required to be kept pursuant to part 1306 of this chap-ter, records of listed chemicals, tableting machines, and encapsulating machines required to be kept pursuant to part 1310 of this chapter, import/ex-port records of listed chemicals re-quired to be kept pursuant to part 1313 of this

26、chapter, shipping records identi-fying the name of each carrier used and the date and quantity of each ship-ment, and storage records identifying the name of each warehouse used and the date and quantity of each storage. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00233 Fmt 8010 Sfmt

27、8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-224 21 CFR Ch. II (4111 Edition) 1316.04 (b) Inspecting within reasonable lim-its and to a reasonable manner all per-tinent equipment, finishe

28、d and unfin-ished controlled substances, listed chemicals, and other substances or ma-terials, containers, and labeling found at the controlled premises relating to this Act; (c) Making a physical inventory of all controlled substances and listed chemicals on-hand at the premises; (d) Collecting sam

29、ples of controlled substances or listed chemicals (in the event any samples are collected during an inspection, the inspector shall issue a receipt for such samples on DEA Form 84 to the owner, operator, or agent in charge of the premises); (e) Checking of records and informa-tion on distribution of

30、 controlled sub-stances or listed chemicals by the reg-istrant or regulated person (i.e., has the distribution of controlled sub-stances or listed chemicals increased markedly within the past year, and if so why); (f) Except as provided in 1316.04, all other things therein (including records, files,

31、 papers, processes, controls and fa-cilities) appropriate for verification of the records, reports, documents re-ferred to above or otherwise bearing on the provisions of the Act and the regu-lations thereunder. 36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 5

32、1 FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, 1990; 60 FR 32465, June 22, 1995 1316.04 Exclusion from inspection. (a) Unless the owner, operator or agent in charge of the controlled prem-ises so consents in writing, no inspec-tion authorized by these regulations shall extend to: (1) Financial data

33、: (2) Sales data other than shipping data; or (3) Pricing data. (b) Reserved 1316.05 Entry. An inspection shall be carried out by an inspector. Any such inspector, upon (a) stating his purpose and (b) pre-senting to the owner, operator or agent in charge of the premises to be in-spected (1) appropri

34、ate credentials, and (2) written notice of his inspection au-thority under 1316.06 of this chapter, and (c) receiving informed consent under 1316.08 or through the use of ad-ministrative warrant issued under 1316.091316.13, shall have the right to enter such premises and conduct in-spections at reas

35、onable times and in a reasonable manner. 36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973; 62 FR 13970, Mar. 24, 1997 1316.06 Notice of inspection. The notice of inspection (DEA (or DNB) Form 82) shall contain: (a) The name and title of

36、 the owner, operator, or agent in charge of the con-trolled premises; (b) The controlled premises name; (c) The address of the controlled premises to be inspected; (d) The date and time of the inspec-tion; (e) A statement that a notice of in-spection is given pursuant to section 510 of the Act (21 U

37、.S.C. 880); (f) A reproduction of the pertinent parts of section 510 of the Act; and (g) The signature of the inspector. 1316.07 Requirement for administra-tive inspection warrant; exceptions. In all cases where an inspection is contemplated, an administrative in-spection warrant is required pursuan

38、t to section 510 of the Act (21 U.S.C. 880), except that such warrant shall not be required for establishments applying for initial registration under the Act, for the inspection of books and records pursuant to an administrative sub-poena issued in accordance with sec-tion 506 of the Act (21 U.S.C.

39、 876) nor for entries in administrative inspec-tions (including seizures of property): (a) With the consent of the owner, op-erator, or agent in charge of the con-trolled premises as set forth in 1316.08; (b) In situations presenting imminent danger to health or safety; (c) In situations involving i

40、nspection of conveyances where there is reason-able cause to obtain a warrant; (d) In any other exceptional or emer-gency circumstance or time or oppor-tunity to apply for a warrant is lack-ing; or VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00234 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 2

41、23073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-225 Drug Enforcement Administration, Justice 1316.12 (e) In any other situations where a warrant is not constitutionally re-quired. 1316.08 Consent to inspection. (a

42、) An administrative inspection war-rant shall not be required if informed consent is obtained from the owner, op-erator, or agent in charge of the con-trolled premises to be inspected. (b) Wherever possible, informed con-sent shall consist of a written state-ment signed by the owner, operator, or ag

43、ent in charge of the premises to be inspected and witnessed by two per-sons. The written consent shall contain the following information: (1) That he (the owner, operator, or agent in charge of the premises) has been informed of his constitutional right not to have an administrative in-spection made

44、 without an administra-tive inspection warrant; (2) That he has right to refuse to con-sent to such an inspection; (3) That anything of an incriminating nature which may be found may be seized and used against him in a crimi-nal prosecution; (4) That he has been presented with a notice of inspection

45、 as set forth in 1316.06; (5) That the consent is given by him is voluntary and without threats of any kind; and (6) That he may withdraw his consent at any time during the course of in-spection. (c) The written consent shall be pro-duced in duplicate and be distributed as follows: (1) The original

46、will be retained by the inspector; and (2) The duplicate will be given to the person inspected. 36 FR 7820, Apr. 24, 1971, as amended at 37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973 1316.09 Application for administra-tive inspection warrant. (a) An administrative inspection

47、 war-rant application shall be submitted to any judge of the United States or of a State court of record, or any United States magistrate and shall contain the following information: (1) The name and address of the con-trolled premises to be inspected; (2) A statement of statutory author-ity for the

48、 administrative inspection warrant, and that the fact that the par-ticular inspection in question is de-signed to insure compliance with the Act and the regulations promulgated thereunder; (3) A statement relating to the na-ture and extent of the administrative inspection, including, where necessary

49、, a request to seize specified items and/or to collect samples of finished or unfin-ished controlled substances or listed chemicals; (4) A statement that the establish-ment either: (i) Has not been previously inspected, or (ii) Was last inspected on a particular date. (b) The application shall be sub-mitted under oath to an appropriate judge or magistrate. 36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38