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(b) After consideration and evaluation of an application for an authorization of confidentiality, the Secretary will either issue a Confidentiality Certhea tificate or a letter denying a ConfidenSetiality Certificate, which will set forth in 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 pervre son making application;

(2) The name and address of the individual primarily responsible for conDi ducting the research, if such individual is not the person making application; (3) The location of the research proj

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(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 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 authorize 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.

§2a.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 include: 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 Sec

retary.

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

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§4.1 Programs to which these regula tions apply.

(a) The regulations of this part govern access to the National Library of Medicine's facilities and library collections and the availability of its bibliographic, reproduction, reference, and related services. These functions are ! performed by the Library directly for the benefit of the general public and health-sciences professionals as 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 UT

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2a). These matters are covered in 45 R parts 5 and 5b.

(3) Federal assistance for medical liIsaries and other purposes which are

thorized by sections 469-477 of the ct (42 U.S.C. 286b to 286b-8). (See parts a, 61 and 64 of this chapter.)

(4) The availability of facilities, colictions, and related services of Re

onal Medical Libraries established or aintained under the authority in secon 475 of the Act (42 U.S.C. 286b-6). See part 59a, subpart B of this chaper.)

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As used in this part: IBRA Act means the Public Health Service

ct, as amended (42 U.S.C. 201 et seq.). Collections means all books, periodials, prints, audiovisual materials, ilms, videotapes, recordings, manuScripts, and other resource materials of he 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 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, or 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 a medical library established or mai

tained as a regional medical library under section 475 of the Act (42 U.S.C. 286b-6).

§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.

84.4 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.

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§4.5 Use of materials from the collections.

(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, 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 collec resources, those of other local librar in the geographic area, and those of Regional Medical Library network. cluding Regional and Resource Lizz ies) before making a request for a in (4) Loans to health-sciences p sionals. The Director may make la of materials directly to health-scie professionals. An individual wishing loan of library materials must as to the satisfaction of the Director the individual is geographically = lated, in terms of distance or avail transportation, from medical: erature resources likely to contain: desired material.

(Approved by the Office of Management Budget under control number 0925–0276) $4.6 Reference, bibliographic, rep

duction, and consultation service (a) General. To the extent resourd permit, the Library will make an able, upon request, reference, bib graphic, reproduction, and consu> tion services. Priority will be given: requests from health-sciences profe sionals for services not reasonab available through local or regional! braries.

(b) Specialized bibliographic service The Director may provide bibli raphies on individually selected me. cal or scientific topics upon reques where it is consistent with the L brary's purpose. The Director may può lish and make available for general d tribution by the Library, bibliograph searches determined to be of genera interest. The Library may also produc and distribute a limited number of bit liographies on topics of general inte est to public or nonprofit health-rela ed professional societies, research ar ganizations, and other group users These bibliographies may be produced on a regularly recurring or intermit tent basis under contract 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.

(c) Information retrieval system computer tapes. To the extent Library re sources permit and in order the Library's purpose, may make available u

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3 Procedures for designation of health professional(s) shortage areas.

4 Notification and publication of designations and withdrawals.

APPENDIX A TO PART 5-CRITERIA FOR DES-
IGNATION OF AREAS HAVING SHORTAGES OF
PRIMARY MEDICAL CARE PROFESSIONAL(S)
APPENDIX B TO PART 5-CRITERIA FOR DES-
IGNATION OF AREAS HAVING SHORTAGES OF
DENTAL PROFESSIONAL(S)

APPENDIX C TO PART 5 CRITERIA FOR DES-
IGNATION OF AREAS HAVING SHORTAGES OF
MENTAL HEALTH PROFESSIONALS
APPENDIX D TO PART 5 CRITERIA FOR DES-
IGNATION OF AREAS HAVING SHORTAGES OF
VISION CARE PROFESSIONAL(S)
APPENDIX E TO PART 5-CRITERIA FOR DES-
IGNATION OF AREAS HAVING SHORTAGES OF
PODIATRIC PROFESSIONAL(S)
APPENDIX F TO PART 5-CRITERIA FOR DES-
IGNATION OF AREAS HAVING SHORTAGES OF
PHARMACY PROFESSIONAL(S)

APPENDIX G TO PART 5-CRITERIA FOR DES-
IGNATION OF AREAS HAVING SHORTAGES OF
VETERINARY PROFESSIONAL(S)

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SOURCE: 45 FR 76000, Nov. 17, 1980, unless otherwise noted.

EDITORIAL NOTE: Nomenclature changes to part 5 appear at 57 FR 2480, Jan. 22, 1992.

$5.1 Purpose.

These regulations establish criteria and procedures for the designation of geographic areas, population groups, medical facilities, and other public facilities, in the States, as health professional(s) shortage areas.

$5.2 Definitions.

Act means the Public Health Service Act, as amended.

Health professional(s) shortage area means any of the following which the Secretary determines has a shortage of health professional(s): (1) An urban or rural area (which need not conform to the geographic boundaries of a political subdivision and which is a rational area for the delivery of health services); (2) a population group; or (3) a public or nonprofit private medical facility.

Health service area means a health service area whose boundaries have been designated by the Secretary, under section 1511 of the Act, for purposes of health planning activities.

Health systems agency or HSA means the health systems agency designated, under section 1515 of the Act, to carry out health planning activities for a specific health service area.

Medical facility means a facility for the delivery of health services and includes: (1) A community health center, public health center, outpatient medical facility, or community mental health center; (2) a hospital, State mental hospital, facility for long-term care, or rehabilitation facility; (3) a migrant health center or an Indian Health service facility; (4) a facility for delivery of health services to inmates in a U.S. penal or correctional institution (under section 323 of the Act) or a State correctional institution; (5) a Public Health Service medical facility (used in connection with the delivery of health services under section 320, 321, 322, 324, 325, or 326 of the Act); or (6) any other Federal medical facility. Metropolitan area means an area hich has been designated by the Of

of Management and Budget as a

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