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governmental functions to the extent necessary to carry out such related functions.

(2) Information and data obtained and tentative and final conclusions reached in course of or in connection with the conduct of research projects, surveys and investigations may be disclosed at such times and to such extent as the Surgeon General or his designee may determine to be in the public interest.

(3) Information obtained in connection with applications for employment, fellowships, traineeships or commissions or for research or other grants and information obtained for similar purposes may be disclosed upon consent of the person concerned.

§ 1.104

Disclosure upon court or other official order.

Notwithstanding any other provisions of this part, information in the records or in the possession of the Service, except information described in § 1.103 (a) and (b) and information the disclosure of which the Surgeon General determines would impair national security, shall be disclosed upon the order of a judge of a court of competent jurisdiction or of a responsible officer of any agency or body having power to compel appearances before it: Provided, however, That (a) clinical information shall be disclosed only in accord with applicable local law regarding the confidentiality of communications to physicians as expressly determined by the court, agency or body, and (b) in the case of an order requiring production of records other than to the court, agency or body involved, the Surgeon General or his designee may determine, in the light of the need to assure the integrity and safety of the records or the efficient administration of the Service, that the records shall be made available for examination or copying at such place as may be designated by him.

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or other compulsory process, to produce records of the Service or to disclose any information described in § 1.102 § 1.103, he shall respond, call attention to the provisions of this part, and respectfully decline to produce records or disclose information inconsistent with such provisions: Provided, That where a patient (or, in the case of a deceased patient, his next of kin or an authorized representative of his estate) is a party to litigation or other proceedings in which any other person or party seeks to require the production of records of the Service or the disclosure of information described in § 1.102 before a court, agency or other body described in § 1.104, the patient (or, in the case of a deceased patient, his next of kin or an authorized representative of his estate) or his attorney shall be notified promptly, by mail or other reasonable means at his last address known to the Service, of the demand for the records or information and the officer or employee shall respond to the compulsory process in accordance with its terms, without prejudice, however, to any claim of the patient or his representative to the protection against the disclosure of clinical information set forth in the proviso to § 1.104.

[21 F.R. 9805, Dec. 12, 1956. Redesignated at 25 F.R. 12292, Dec. 1, 1960]

§ 1.107 Limitations on release of records.

(a) Records of the Service containing inform ticʼn described or referred to in § 1.102 or § 1.103 shall not be released to or deposited with anyone not an authorized officer or employee of the Service except: (1) As may be temporarily necessary for purposes of examination or copying; (2) for purposes of storage at General Services Administration Federal Records Centers under conditions assuring the continuation of the limitations on disclosure set forth in this part: Provided, That release or disclosure of records so stored shall be made by the Federal Records Centers only to authorized officers or employees of the Public Health Service.

(b) Where official records of the Service other than X-rays are produced in accordance with subpoena or other compulsory process, their release to or deposit with anyone not an officer or employee of the Service is prohibited except as may be temporarily necessary for the purpose of examination during sessions of the court, body, agency, or other au

thority before which such records are produced or unless release or deposit is otherwise authorized by the Surgeon General.

(c) When the production of official records of the Service in response to a subpoena or other compulsory process is authorized by § 1.106, arrangements shall be made for the procurement of certified copies if so requested by a party litigant. Except when the United States is the requesting party, such copies shall be made at the expense of the requesting party. The records may be released for copying for this purpose in accordance with paragraph (a) of this section.

(d) The Chief, Medical Records Library Service at any hospital or station, or any other officer or employee of the Service designated as local custodian of the records by the Medical Officer in Charge of a hospital or station is authorized to certify copies of records. No fee shall be charged for such certification.

(Sec. 501, 65 Stat. 290; 31 U.S.C. 483a) [25 F.R. 12292, Dec. 1, 1960]

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Sec. 3.1

Authorization services. 3.2 Charges for special statistical services. AUTHORITY: The provisions of this Part 3 issued under sec. 3, 49 Stat. 293, as amended; 15 U.S.C. 192a. Reorg. Plan No. 2 of 1946, 11 F.R. 7873, 60 Stat. 1095, Reorg. Plan No. 1 of 1953, 18 F.R. 2053, 63 Stat. 631; 3 CFR 1943-1948 Comp., 1949-1953 Comp.

for special statistical

SOURCE: The provisions of this Part 3 appear at 27 F.R. 3739, Apr. 19, 1962, unless otherwise noted.

§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

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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.

PART 4-NATIONAL LIBRARY OF MEDICINE

Sec.

4.1

4.2

4.3

4.4

Applicability and scope.
Purpose of the Library.
Definitions.

Access to Library facilities and collec-
tions.

4.5 Reference, bibliographic, reproduction and consultation services; fees. 4.6 Publications of the Library and information about the Library.

AUTHORITY: The provisions of this Part 4 issued under sec. 215, 58 Stat. 690, as amended, sec. 382, 70 Stat. 960, as amended; 42 U.S.C. 216, 276.

SOURCE: The provisions of this Part 4 appear at 36 F.R. 3894, Mar. 2, 1971, unless otherwise noted.

§ 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.

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(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 Audiovis

ual 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 collections, 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 subparagraph (2) of this paragraph, 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 applications through their Regional Medical Library.

(4) Loans to health sciences professionals. Except as provided in subparagraph (2) of this paragraph, 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 subparagraph (3) of this paragraph.

(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

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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 scientific 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 bibliographies on topics of general interest to group users, such as public or nonprofit health related professional societies 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 System (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 recover 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 biblographies 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.

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