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will use that authority to refuse to disclose identifying characteristics of research subjects in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to compel disclosure of the identifying characteristics of research subjects.

(j) An assurance that all research subjects who participate in the project during the period the Confidentiality Certificate is in effect will be informed that:

(1) A Confidentiality Certificate has been issued;

(2) The persons authorized by the Confidentiality Certificate to protect the identity of research subjects may not be compelled to identify research subjects in any civil, criminal, administrative, legislative, or other proceedings whether Federal, State, or local;

(3) If any of the following conditions exist the Confidentiality Certificate does not authorize any person to which it applies to refuse to reveal identifying information concerning research subjects:

(i) The subject consents in writing to disclosure of identifying information,

(ii) Release is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or regulations promulgated thereunder (title 21, Code of Federal Regulations), or

(iii) Authorized personnel of DHHS request identifying 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 $ 2a.7(b));

(4) The Confidentiality Certificate does not govern the voluntary disclosure of identifying characteristics of research subjects;

(5) The Confidentiality Certificate does not represent an endorsement of the research project by the Secretary.

(k) An assurance that all research subjects who enter the project after the termination of the Confidentiality Certificate will be informed that the authorization of confidentiality has ended and that the persons authorized to protect the identity of research subjects by the Confidentiality Certificate may not rely on the Certificate to

refuse to disclose identifying characteristics of research subjects who were not participants in the project during the period the Certificate was in effect. (See $2a.8(c)). $ 2a.5 Contents of application;

search projects in which drugs will

be administered. (a) In addition to the information required by $2a.4 and any other pertinent information which the Secretary may require, each application for an authorization of confidentiality for a research project which involves the administering of a drug shall contain:

(1) Identification of the drugs to be administered in the research project and a description of the methods for such administration, which shall include 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.

§ 2a.6 Issuance of Confidentiality Cer

tificates; 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 Certificate 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 application. 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.

$ 2a.7 Effect of Confidentiality Certifi

cate. (a) A Confidentiality Certificate authorizes the withholding of the names and other identifying characteristics of

individuals who participate as subjects has been completed or discontinued or in the research project specified in the that retention of the Confidentiality Certificate while the Certificate is in Certificate is otherwise no longer neceffect. The authorization applies to all essary or desirable. persons who, in the performance of (b) A Notice of Cancellation shall intheir duties in connection with the re- clude: an identification of the Consearch project, have access to informa- fidentiality Certificate to which it aption which would identify the subjects plies; the effective date of its termiof the research. Persons so authorized nation; and the grounds for cancellamay not, at any time, be compelled in tion. Upon receipt of a Notice of Canany Federal, State, or local civil, cellation the applicant shall return the criminal, administrative, legislative, Confidentiality Certificate to the Secor other proceedings to identify the re- retary search subjects encompassed by the (c) Any termination of a ConfidenCertificate, except in those cir- tiality Certificate pursuant to this seccumstances specified in paragraph (b) tion is operative only with respect to of this section.

the names and other identifying char(b) A Confidentiality Certificate acteristics of individuals who begin granted under this part does not au- their participation as research subjects thorize any person to refuse to reveal after the effective date of such termithe name or other identifying charac- nation. (See $2a.4(k) requiring reteristics of any research subject in the searchers to notify subjects who enter following circumstances:

the project after the termination of the (1) The subject (or, if he or she is le- Confidentiality Certificate of termigally incompetent, his or her guardian) nation of the Certificate). The protecconsents, in writing, to the disclosure tion afforded by a Confidentiality Cerof such information,

tificate is permanent with respect to (2) Authorized personnel of DHHS re- subjects who participated in research quest such information for audit or during any time the authorization was program evaluation of research in effect. project funded by DHHS or for investigation of DHHS grantees or contrac

PART 3 [RESERVED] tors and their employees or agents carrying out such a project. (See 45 CFR

PART 4-NATIONAL LIBRARY OF 5.71 for confidentiality standards im

MEDICINE posed on such DHHS personnel), or

(3) Release of such information is required by the Federal Food, Drug, and

Sec. Cosmetic Act (21 U.S.C. 301) or the reg

4.1 Programs to which these regulations

apply. ulations promulgated thereunder (title

4.2 Definitions. 21, Code of Federal Regulations).

4.3 Purpose of the Library. (c) Neither a Confidentiality Certifi

4.4 Use of Library facilities. cate nor the regulations of this part 4.5 Use of materials from the collections. govern the voluntary disclosure of 4.6 Reference, bibliographic, reproduction, identifying characteristics of research and consultation services. subjects.

4.7 Fees.

4.8 Publication of the Library and informa§ 2a.8 Termination.

tion about the Library. (a) A Confidentiality Certificate is in AUTHORITY: 42 U.S.C. 216, 286. effect from the date of its issuance

SOURCE: 56 FR 29188, June 26, 1991, unless until the effective date of its termi- otherwise noted. nation. The effective date of termination shall be the earlier of:

8 4.1 Programs to which these regula(1) The expiration date set forth in

tions apply. the Confidentiality Certificate; or

(a) The regulations of this part gov(2) Ten days from the date of mailing ern access to the National Library of a Notice of Cancellation to the appli- Medicine's facilities and library colleccant, pursuant to a determination by tions and the availability of its bibliothe Secretary that the research project graphic, reproduction, reference, and

a

as

or

related services. These functions are performed by the Library directly for the benefit of the general public and health-sciences professionals required by sections 465(b) (3)–(6) of the Act (42 U.S.C. 286(b) (3)–(6)).

(b) The regulations of this part do not apply to:

(1) The Library's internal functions relating to the acquisition and preservation of materials and the organization of these materials as required by sections 465(b) (1) and (2) of the Act (42 U.S.C. 286(b) (1) and (2)).

(2) The availability of “records" under the Freedom of Information Act or the Privacy Act of 1974 (5 U.S.C. 552, 552a). These matters are covered in 45 CFR parts 5 and 5b.

(3) Federal assistance for medical libraries and other purposes which are authorized by sections 469 477 of the Act (42 U.S.C. 286b to 286b-8). (See parts 59a, 61 and 64 of this chapter.)

(4) The availability of facilities, collections, and related services of Regional Medical Libraries established or maintained under the authority in section 475 of the Act (42 U.S.C. 286b-6). (See part 59a, subpart B of this chapter.)

sciences related to health or improvement of the public health.

Historical collection means: (1) Materials in the collections published or printed prior to 1914; (2) manuscripts and prints; (3) the archival film collection; and (4) other materials of the collections which, because of age, unique or unusual value, require special handling, storage, or protection for their preservation, as determined by the Director.

Library means the National Library of Medicine, established by section 465 of the Act (42 U.S.C. 286).

Regional Medical Library means medical library established or maintained as a regional medical library under section 475 of the Act (42 U.S.C. 286b-6).

a

$ 4.3 Purpose of the Library.

The purpose of the Library is to assist the advancement of medical and related sciences and aid the dissemination and exchange of scientific and other information important to the progress of medicine and the public health. The Library acquires and maintains library materials pertinent to medicine, including audiovisual materials; compiles, publishes, and disseminates catalogs, indices, and bibliographies of these materials, as appropriate; makes available materials, through loan or otherwise; provides reference and other assistance to research; and engages in other activities in furtherance of this purpose.

$ 4.2 Definitions.

As used in this part:

Act means the Public Health Service Act, as amended (42 U.S.C. 201 et seq.).

Collections means all books, periodicals, prints, audiovisual materials, films, videotapes, recordings, manuscripts, and other resource materials of the library. It does not include data processing tapes or programs used solely for internal processing activities to generate reference materials, nor does it include “records" of the Library as defined in 45 CFR 5.5. Records of the Library are available in accordance with the regulations under the Freedom of Information Act and Privacy Act of 1974. (See 45 CFR parts 5 and 5b.)

Director means the Director of the National Library of Medicine or the Director's delegate.

Health-sciences professional means any person engaged in: (1) The administration of health activities; (2) the provision of health services; or (3) research, teaching, or education concerned with the advancement of medicine or other

$ 4.4 Use of Library facilities.

(a) General. The Library facilities are available to any person seeking to make use of the collections. The Director may prescribe reasonable rules to assure the most effective use of facilities by health-sciences professionals and to protect the collections from misuse or damage. These rules must be consistent with the regulations in this part and applicable Department regulations and policies on nondiscrimination.

(b) Reading rooms. Public reading rooms are available for obtaining and reading materials from the collections. The Director may prescribe reasonable rules designed to provide adequate reading space and orderly conditions and procedures.

(c) Study rooms. Upon request a limited number of study rooms may be made available to individuals requiring extensive use of Library materials. Requests for study rooms shall be addressed in writing to the Director. The Director shall give priority, in the following order, for study room use to:

(1) Persons engaged in "special scientific projects" under section 473 of the Act (42 U.S.C. 286b-4),

(2) Health-sciences professionals, and (3) The general public.

or misappropriation and (ii) the materials will be returned promptly after use or upon request of the Library. The Library may provide copies in lieu of original materials, which need not be returned unless otherwise stated at the time of the loan.

(2) Loans of audiovisual materials. Audiovisual materials are available for loan under the same general terms as printed materials.

(3) Loans to other libraries. Upon request materials or copies are available for use through libraries of public or private agencies or institutions. The requesting library must assure that it has first exhausted its own collection resources, those of other local libraries in the geographic area, and those of the Regional Medical Library network (including Regional and Resource Libraries) before making a request for a loan.

(4) Loans to health-sciences professionals. The Director may make loans of materials directly to health-sciences professionals. An individual wishing a loan of library materials must assure to the satisfaction of the Director that the individual is geographically isolated, in terms of distance or available transportation, from medical literature resources likely to contain the desired material.

(Approved by the Office of Management and Budget under control number 0925_0276)

$4.5 Use of materials from the collec

tions. (a) Unrestricted materials. Except as otherwise provided in this section, materials from the collections are generally available to any interested person only in facilities provided by the Library for this purpose. The Director may prescribe additional reasonable rules to assure the most effective use of the Library's resources by healthsciences professionals and to protect the collections from misuse or damage. The rules must be consistent with the regulations in this part and applicable Department regulations and policies on nondiscrimination. Materials in the collections are available upon each request which assures, to the Director's satisfaction, that the materials will be safeguarded from misuse, damage, loss, or misappropriation, and will be returned promptly after use or upon request of the Library.

(b) Restricted materials—(1) Historical collection. Materials from the historical collection are available only as the Director may permit to assure their maximum preservation and protection. Copies of these materials may be made available in the form of microfilm and other copies, for which reasonable fees may be charged.

(2) Gifts. Materials in the collections are available only in accordance with any limitations imposed as a condition of the acquisition of those materials, whether the acquisition was by gift or purchase.

(c) Loans-(1) General. Requests for loans of materials must assure the Library that (i) the materials will be safeguarded from misuse, damage, loss,

$ 4.6 Reference, bibliographic, repro

duction, and consultation services. (a) General. To the extent resources permit, the Library will make available, upon request, reference, bibliographic, reproduction, and consultation services. Priority will be given to requests from health-sciences professionals for services not reasonably available through local or regional libraries.

(b) Specialized bibliographic services. The Director may provide bibliographies on individually selected medical or scientific topics upon request where it is consistent with the Library's purpose. The Director may publish and make available for general distribution by the Library, bibliographic searches determined to be of general interest. The Library may also produce

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