(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

§4.1 Programs to which these regulations 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 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.)

§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 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 main

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.

§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 collectio resources, those of other local librarie in the geographic area, and those of the Regional Medical Library network ( cluding Regional and Resource Libra: ies) before making a request for a loa (4) Loans to health-sciences profe sionals. The Director may make loan of materials directly to health-science professionals. An individual wishing loan of library materials must assu to the satisfaction of the Director that the individual is geographically is lated, in terms of distance or available transportation, from medical lit erature resources likely to contain the desired material.

(Approved by the Office of Management and Budget under control number 0925-0276) §4.6 Reference, bibliographic, repro

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

bibliog

(b) Specialized bibliographic services. The Director may provide raphies 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 and distribute a limited number of bibliographies on topics of general interest to public or nonprofit health-related professional societies, research organizations, and other group users. These bibliographies may be produced on a regularly recurring or intermittent 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 resources permit and in order to further the Library's purpose, the Director may make available upon request by

gencies, organizations, and instituions copies of all or part of the Lirary's magnetic tapes.

4.7 Fees.

The Director may charge reasonable ees for any service provided by the Lirary under this part, in accordance with a schedule available at the Lirary upon request, which are designed Co recover all or a portion of the cost Co the Library of providing the service.

4.8 Publication of the Library and information about the Library.

Lists of bibliographies, Library publications sold by the Government PrintVing Office, necessary application forms, and other information concerning the organization, operation, functions, and services of the Library, are available from the National Library of Medicine, Bethesda, Maryland 20894.

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

5.4 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 DESIGNATION 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)

AUTHORITY: Sec. 215 of the Public Health Service Act, 58 Stat. 690 (42 U.S.C. 216); sec. 332 of the Public Health Service Act, 90 Stat. 2270-2272 (42 U.S.C. 254e).

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 which has been designated by the Office of Management and Budget as a

standard metropolitan statistical area (SMSA). All other areas are "non-metropolitan areas."

Poverty level means the povery level as defined by the Bureau of the Census, using the poverty index adopted by a Federal Interagency Committee in 1969, and updated each year to reflect changes in the Consumer Price Index.

Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department to whom the authority involved has been delegated.

State includes, in addition to the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, and the Trust Territory of the Pacific Islands.

State health planning and development agency or SHPDA means a State health planning and development agency designated under section 1521 of the Act.

§ 5.3 Procedures for designation of health professional(s) shortage

areas.

(a) Using data available to the Department from national, State, and local sources and based upon the criteria in the appendices to this part, the Department will annually prepare listings (by State and health service area) of currently designated health professional(s) shortage areas and potentially designatable areas, together with appropriate related data available to the Department. Relevant portions of this material will then be forwarded to each health systems agency, State health planning and development agency, and Governor, who will be asked to review the listings for their State, correct any errors of which they are aware, and offer their recommendations, if any, within 90 days, as to which geographic areas, population groups, and facilities in areas under their jurisdiction should be designated. An information copy of these listings will also be made available, upon request, to interested parties for their use in providing comments or recommendations to the Secretary and/or to the appropriate HSA, SHPDA, or Governor.

(b) In addition, any agency or ind vidual may request the Secretary: designate (or withdraw the designatio of) a particular geographic area, pop lation group, or facility as a healt professional(s) shortage area. Each r quest will be forwarded by the Se retary to the appropriate HSA SHPDA, and Governor, who will > asked to review it and offer their re ommendations, if any, within 30 days An information copy will also be mat available to other interested parties upon request, for their use in providin comments or recommendations to th Secretary and/or to the appropria HSA, SHPDA, or Governor.

(c) In each case where the designe tion of a public facility (including a Federal medical facility) is under con sideration, the Secretary will give written notice of the proposed designtion to the chief administrative office of the facility, who will be asked to re view it and offer their recommenda tions, if any, within 30 days.

(d) After review of the available in formation and consideration of the comments and recommendations submitted, the Secretary will designate health professional(s) shortage areas and withdraw the designation of any areas which have been determined no longer to have a shortage of health professional(s).

§ 5.4 Notification and publication of designations and withdrawals.

(a) The Secretary will give written notice of the designation (or withdrawal of designation) of a health professional(s) shortage area, not later than 60 days from the date of the designation (or withdrawal of designation), to:

(1) The Governor of each State in which the area, population group, medical facility, or other public facility so designated is in whole or in part 10cated;

(2) Each HSA for a health service area which includes all or any part of the area, population group, medical facility, or other public facility so designated;

(3) The SHPDA for each State in which the area, population group, medical facility, or other public facility so