Page images
PDF
EPUB

spection or other source of information has disclosed a need for follow-up, or which has been refused access to patient records, to obtain the necessary authorization for access and copying. There may also be rare instances, such as those involving financial fraud, tax evasion, or other offenses where access by other investigative agencies is necessary, subject to the requirements and protections of this part.

§2.67 Undercover agents and informants-Rules.

(a) Applicability. This section applies to any application by an administrative, regulatory, supervisory, investigative, or law enforcement agency for an order to permit such agency to have an undercover agent or informant in a program under circumstances which would otherwise be prohibited under § 2.19.

(b) Notice. An order under this section may be granted without notice where the criminal conduct for the investigation of which it is granted is believed to be carried on by the program director or by any employee or agent of the program with the knowledge of the program director or under such circumstances that in the exercise of reasonable care the program director should know of such conduct. Under any other circumstances, an order under this section may be granted only after the program director has been afforded notice and opportunity for hearing.

(c) Criteria. An order under this section may be granted only where there is reason to believe that a program or any principal, agent, or employee thereof is engaged in serious criminal misconduct, and that other means of securing evidence of such criminal misconduct are not available or would not be effective.

(d) Scope. An order granted pursuant to this section may authorize the use by the applicant of an undercover agent or informant, either as a patient or as an employee, of the program in question.

(e) Time periods. An order under this section may not authorize the use of an undercover agent for an initial period exceeding 60 days. At any time

prior to the expiration of such 60-day period, the applicant may apply for an order extending such period for an additional period not to exceed 60 days, but in no event may the use of an undercover agent in any program be authorized for more than 180 days in any period of 12 consecutive months.

(f) Duty of agent. Except to the extent expressly authorized in an order under this section, which shall be limited to disclosure of information directly related to the purpose for which the order is granted, an undercover agent or informant shall for the purposes of this part be deemed an agent of the program within which he is acting as such, and as such shall be subject to all of the prohibitions of this part applicable to disclosures of any information which he may acquire.

§ 2.67-1 Undercover agents and informants-Basis and purpose.

The legal rationale underlying this section has been set forth in § 2.19–1. It is expected that this section will find its principal and perhaps its exclusive application in the area of drug law enforcement. Experience has demonstrated that medical personnel, no matter how credentialed, can engage in the illicit sale of drugs on a large scale, and that the use of undercover agents and informants is normally the only effective means of securing evidence sufficient to support a successful prosecution.

PART 3-NATIONAL CENTER FOR HEALTH STATISTICS; SPECIAL STATISTICAL SERVICES

Sec.

3.1 Authorization for special statistical ser

vices.

3.2 Charges for special statistical services.

§3.1 Authorization for special statistical

services.

Upon the receipt of a written request by any person, firm or corporation the Director of the National Center for Health Statistics may furnish special statistical services if he determines that: (a) The services requested are within the scope of authorized activities of the center, (b) facili

ties necessary for the performance of the services are available, (c) the performance of such services will not interfere with the performance of the regular duties of the Center, and (d) the data or statistics requested are not confidential.

(Sec. 3, 49 Stat. 293, as amended; 15 U.S.C. 192a, Reorg. Plan No. 2 of 1946, 11 FR 7873, 60 Stat. 1095, Reorg. Plan No. 1 of 1953, 18 FR 2053, 63 Stat. 631; 3 CFR 1943-1948 Comp.)

[27 FR 3739, Apr. 19, 1962]

§ 3.2 Charges for special statistical services.

The Director of the National Center for Health Statistics will establish a charge for each authorized special statistical service which shall be based on the estimated cost of the service. No services will be undertaken prior to the prepayment of the estimated cost or of such portion of the estimated cost as the Director may require. Adjustments in the prepaid charge resulting in a refund to the requesting party or a further billing by the Center may be made at any time during the progress of the services or upon their completion if necessary to reflect the actual cost of the services.

(Sec. 3, 49 Stat. 293, as amended; 15 U.S.C. 192a, Reorg. Plan No. 2 of 1946, 11 FR 7873, 60 Stat. 1095, Reorg. Plan No. 1 of 1953, 18 FR 2053, 63 Stat. 631; 3 CFR 1943-1948 Comp.)

[27 FR 3739, Apr. 19, 1962]

[blocks in formation]

§ 4.1 Applicability and scope.

(a) The regulations of this part relate to access to the facilities and library collections, including audiovisual materials, of the National Library of Medicine and the availability of its bibliographic, reproduction, reference, and related services. Such services are those functions performed by the Library directly for the benefit of the general public or health sciences professionals as described in section 382(a)(3)-(5) of the Public Health Service Act.

(b) Such services do not include, and the regulations in this part do not apply to:

(1) Except as provided in § 4.5, functions which relate to the Library's internal processing activities, whether by manual, photographic, or electronic means, as required by section 382(a) (1) and (2) of the Act.

(2) The availability of "records" of the Library as defined in, and available in accordance with, rules and procedures set forth in 45 CFR Part 5 and Part 1 of this chapter.

(3) Federal assistance for medical library construction and other purposes authorized by sections 390-398 of the Act (Parts 59a, 61, 63, and 64 of this chapter).

(4) The availability of facilities, collections and related services of Regional Medical Libraries established or maintained by grants authorized by section 397 of the Act (see Part 59a, Subpart C, of this chapter).

§ 4.2 Purpose of the Library.

In order to assist the advancement of medical and related sciences and to aid the dissemination and exchange of scientific and other information important to the progress of medicine and the public health, the National Library of Medicine, established by section 381 of the Public Health Service Act, acquires and maintains library materials, including audiovisual materials, pertinent to medicine; compiles, publishes, and makes available catalogs, indices, and bibliographies of such materials as appropriate; provides reference and other assistance to research, and engages in other activities in furtherance of the Library's overall purpose.

§ 4.3 Definitions.

As used in this part:

(a) "Act" means the Public Health Service Act, as amended.

(b) "Library" means the National Library of Medicine, established by section 381 of the Act (42 U.S.C. 275).

(c) "Director" means the Director of the Library.

(d) "Collections" means all books, periodicals, prints, films, videotapes, recordings, manuscripts, and other resource materials of the Library, including audio and visual materials produced or developed by the National Medical Audiovisual Center located in Atlanta, Ga., but excluding data processing tapes used solely for internal processing activities to generate reference materials. It does not include "records" as that term is defined in 45 CFR 5.5.

(e) "Historical collection" means materials in the collections published or printed prior to 1871, including manuscripts and prints, and the archival film collection of the National Medical Audiovisual Center and other materials of the collections which, because of age, or unique or unusual value, require special handling, storage, or protection for their preservation, as determined by the Director.

(f) "Health sciences professional" means any person engaged in the administration of health activities, the provision of health services, or in research, teaching or education concerned with the advancement of medicine or other sciences related to health or improvement of the public health.

(g) "Regional Medical Library" means a medical library established or maintained as a regional medical library under section 397 of the Act (42 U.S.C. 280b-8).

§ 4.4 Access to Library facilities and collections.

(a) General. The Library facilities and collections are available to any person seeking to make use of the collection, subject to such reasonable rules, consistent with the regulations in this part, as the Director may prescribe to assure the most effective use of such resources by health sciences professionals and to protect the collections from misuse or damage.

(b) Reading rooms. Public reading rooms are available for obtaining and reading materials from the collections, subject to rules of the Director designed to provide adequate reading space and orderly conditions and procedures for those using the collections.

(c) Study rooms. A limited number of study rooms are available for assignment to individuals requiring extensive use of the collections, or other Library resources. Priority shall be given to persons engaged in “special scientific projects" under section 395 of the Act (42 U.S.C. 280b-5), and to health sciences professionals. Applications for use of study rooms shall be addressed to the Director.

(d) Use of materials from the collections-(1) Materials generally. Except as otherwise provided in this paragraph, materials from the collections are available for use only in facilities provided by the Library for such purposes.

(2) Audiovisual materials. Audio and visual materials in the collections are available for loan application setting forth to the Director's satisfaction that the material will be safeguarded from misuse, damage, loss or misappropriation, and will promptly be returned as required after use or upon request of the Library. Applications for such material may be made to the National Medical Audiovisual Center, Atlanta, Ga. 30333.

(3) Interlibrary loans. Materials from the collections, or copies thereof, not specified in paragraph (d)(2) of this section, may be made available for use through libraries of public or private agencies or institutions upon application by such libraries setting forth to the Director's satisfaction that the requesting party has exhausted all other reasonably available local or regional library resources (including Regional Medical Libraries) and, when so prescribed, providing satisfactory assurances that the requested material will be safeguarded from misuse, damage, loss or misappropriation, and will be promptly returned to the Library as required after use or upon request of the Library. Libraries served by a Regional Medical Library are encouraged to file such applica

tions through their Regional Medical Library.

(4) Loans to health sciences professionals. Except as provided in paragraph (d)(2) of this section, loans of materials, or copies thereof, from the collections may be made directly to health sciences professionals upon application to the Director setting forth to his satisfaction that the requesting individual is geographically isolated, in terms of distance or available transportation, from all medical literature resources likely to contain the desired material, and providing the assurances to the Director required in paragraph (d)(3) of this section.

(5) Historical collection. In addition to the rules specified above with respect to availability of the Library's collections generally, materials from the historical collection are available only in accordance with such other rules as the Director may prescribe to assure their maximum preservation and protection. Such materials may also be made available in the form of microfilm and paper print copies, for which reasonable fees may be levied.

(6) Gifts and restricted materials. In addition to the rules specified above, materials in the collections, whether acquired by the Library as the result of gift or purchase, shall be made available only in accordance with limitations imposed as a condition of such gift or purchase.

§ 4.5 Reference, bibliographic, reproduction and consultation services; fees.

(a) General. Reference, bibliographic, reproduction (in addition to those reproduction services discussed in § 4.4(d)) and consultation services provided by the Library, whether provided by professional medical librarians, through the use of computerized systems, or otherwise, are available upon request to the extent Library resources permit. In the provisions of services not reasonably available through local or regional library resources, priority shall be given to health sciences professionals.

(b) Specialized bibliographic services. (1) Requests for bibliographies on individually selected medical or sci

entific topics may be filled by use of a reference retrieval system, upon determination by the Director, on the basis of information submitted with the request, that use of such system would be appropriate and effective in the circumstances. Requests must be made upon such forms and in such manner as the Director may from time to time prescribe. Searches determined by the Director to be of general interest may be published and made available for general distribution by the Library.

(2) A limited number of computerized bibilographies on topics of general interest to group users, such as public or nonprofit health related professional socieites and research organizations, may be produced on a regularly recurring basis pursuant to contractual arrangements between the Library and public or nonprofit agencies, when determined in each case by the Director to be necessary to assure more effective distribution of the bibliographic information involved, in furtherance of the Library's special purposes.

(c) MEDLARS tapes. To the extent Library resources permit, where deemed necessary by the Director to further the dissemination of scientific and other information important to the progress of medicine and the public health, or to assist research and investigations in the field of medical library science, copies of all or part of the Library's magnetic tapes comprising the Medical Literature Analysis and Retrieval Systen (MEDLARS) may be made available to agencies, organizations and institutions upon application by such persons providing assurances that (1) such tapes will be utilized to provide reference or bibliographic services pertinent to medicine not otherwise available from the Library or a Regional Medical Library, or (2) such tapes are necessary to carry out such research or investigation. The use of such tapes shall be subject to such further conditions as the Director may prescribe when in his judgment necessary to further the purpose of the Library.

(d) Fees for services. The Director may, in accordance with schedules available at the Library on request, charge fees reasonably designed to re

cover all or a portion of the cost to the Library, including the employment of personnel, of providing any of the above or other reference, bibliographic and reproduction services. Such fees shall be charged only where the nature of the service in question is beyond that normally provided to the general public or health sciences professionals or where Library resources are limited or unduly taxed.

§ 4.6 Publications of the Library and information about the Library.

Lists of bibliographies or Library publications sold by the Government Printing Office, and other information concerning the organization, operation, functions and services of the Library, including necessary application forms, are available from the National Library of Medicine, Bethesda, Md. 20014.

« PreviousContinue »