clude a statement of the dosages to be administered to the research subjects;

(2) Evidence that individuals who administer drugs are authorized to do so under applicable Federal and State law; and

(3) In the case of a controlled drug, a copy of the Drug Enforcement Administration Certificate of Registration (BND Form 223) under which the research project will be conducted.

(b) An application for an authorization of confidentiality with respect to a research project which involves the administering of a controlled drug may include a request for exemption of persons engaged in the research from State or Federal prosecution for possession, distribution, and dispensing of controlled drugs as authorized under section 502(d) of the Controlled Substances Act (21 U.S.C. 872(d)) and 21 CFR 1316.22. If the request is in such form, and is supported by such information, as is required by 21 CFR 1316.22, the Secretary will forward it, together with his or her recommendation that such request be approved or disapproved, for the consideration of the Administrator of the Drug Enforcement Administration.

§ 28.6 Issuance of Confidentiality Certificates; single project limitation.

(a) In reviewing the information provided in the application for a Confidentiality Certificate, the Secretary will take into account:

(1) The scientific or other appropriate training and experience of all personnel having major responsibilities in the research project;

(2) Whether the project constitutes bona fide "research" which is within the scope of the regulations of this part; and

(3) Such other factors as he or she may consider necessary and appropriate. All applications for Confidentiality Certificates shall be evaluated by the Secretary through such officers and employees of the Department and such experts or consultants engaged for this purpose as he or she determines to be appropriate.

(b) After consideration and evaluation of an application for an authorization of confidentiality, the Secretary will either issue a Confidentiality Cer

tificate or a letter denying a Confidentiality Certificate, which will set forth the reasons for such denial, or will request additional information from the person making application. The Confidentiality Certificate will include:

(1) The name and address of the person making application;

(2) The name and address of the individual primarily responsible for conducting the research, if such individual is not the person making application;

(3) The location of the research project;

(4) A brief description of the research project;

(5) A statement that the Certificate does not represent an endorsement of the research project by the Secretary;

(6) The Drug Enforcement Administration registration number for the project, if any; and

(7) The date or event upon which the Confidentiality Certificate becomes effective, which shall not be before the later of either the commencement of the research project or the date of issuance of the Certificate, and the date or event upon which the Certificate will expire.

(c) A Confidentiality Certificate is not transferable and is effective only with respect to the names and other identifying characteristics of those individuals who are the subjects of the single research project specified in the Confidentiality Certificate. The recipient of a Confidentiality Certificate shall, within 15 days of any completion or discontinuance of the research project which occurs prior to the expiration date set forth in the Certificate, provide written notification to the Director of the Institute to which application was made. If the recipient determines that the research project will not be completed by the expiration date set forth in the Confidentiality Certificate he or she may submit a written request for an extension of the expiration date which shall include a justification for such extension and a revised estimate of the date for completion of the project. Upon approval of such a request, the Secretary will issue an amended Confidentiality Certificate.

(d) The protection afforded by a Confidentiality Certificate does not extend to significant changes in the research project as it is described in the application for such Certificate (e.g., changes in the personnel having major responsibilities in the research project, major changes in the scope or direction of the research protocol, or changes in the drugs to be administered and the persons who will administer them). The recipient of a Confidentiality Certificate shall notify the Director of the Institute to which application was made of any proposal for such a significant change by submitting an amended application for a Confidentiality Certificate in the same form and manner as an original appliIcation. On the basis of such application and other pertinent information the Secretary will either:

(1) Approve the amended application and issue an amended Confidentiality Certificate together with a Notice of Cancellation terminating original the Confidentiality Certificate in accordance with § 2a.8; or

(2) Disapprove the amended application and notify the applicant in writing that adoption of the proposed significant changes will result in the issuance of a Notice of Cancellation terminating the original Confidentiality Certificate in accordance with § 2a.8.

§ 28.7 Effect of Confidentiality Certificate. (a) A Confidentiality Certificate authorizes the withholding of the names and other identifying characteristics of individuals who participate as subjects in the research project specified in the Certificate while the Certificate is in effect. The authorization applies to all persons who, in the performance of their duties in connection with the research project, have access to information which would identify the subjects of the research. Persons so authorized may not, at any time, be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify the research subjects encompassed by the Certificate, except in those circumstances specified in paragraph (b) of this section.

(b) A Confidentiality Certificate granted under this part does not au

thorize any person to refuse to reveal the name or other identifying characteristics of any research subject in the following circumstances: (1) The subject (or, if he or she is legally incompetent, his or her guardian) consents, in writing, to the disclosure of such information, (2) Authorized personnel of DHHS request such information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors and their employees or agents carrying out such a project. (See 45 CFR 5.71 for confidentiality standards imposed on such DHHS personnel), or (3) Release of such information is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or the regulations promulgated thereunder (Title 21, Code of Federal Regulations).

(c) Neither a Confidentiality Certificate nor the regulations of this part govern the voluntary disclosure of identifying characteristics of research subjects.

§ 28.8 Termination.

(a) A Confidentiality Certificate is in effect from the date of its issuance until the effective date of its termination. The effective date of termination shall be the earlier of:

(1) The expiration date set forth in the Confidentiality Certificate; or

(2) Ten days from the date of mailing a Notice of Cancellation to the applicant, pursuant to a determination by the Secretary that the research project has been completed or discontinued or that retention of the Confidentiality Certificate is otherwise no longer necessary or desirable.

(b) A Notice of Cancellation shall inIclude: an identification of the Confidentiality Certificate to which it applies; the effective date of its termination; and the grounds for cancellation. Upon receipt of a Notice of Cancellation the applicant shall return the Confidentiality Certificate to the Secretary.

(c) Any termination of a Confidentiality Certificate pursuant to this section is operative only with respect to the names and other identifying characteristics of individuals who begin

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) facilities 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]

§ 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).

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 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 applications 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 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 bibilographies 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.