§ 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 ad

ministration 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 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 limi

tations 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.

(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 compris

ing 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.

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APPENDIX C-CRITERIA FOR DESIGNATION OF AREAS HAVING SHORTAGES OF PSYCHIATRIC MANPOWER

APPENDIX D-CRITERIA FOR DESIGNATION OF AREAS HAVING SHORTAGES OF VISION CARE MANPOWER

APPENDIX E-CRITERIA FOR DESIGNATION OF AREAS HAVING SHORTAGES OF PODIATRIC MANPOWER

APPENDIX F-CRITERIA FOR DESIGNATION OF AREAS HAVING SHORTAGES OF PHARMACY MANPOWER

APPENDIX G-CRITERIA FOR DESIGNATION OF AREAS HAVING SHORTAGES OF VETERINARY MANPOWER

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. 2770-2772 (42 U.S.C. 254e).

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

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 which has been designated by the Office of Management and Budget as a standard metropolitan statistical area (SMSA). All other areas are "nonmetropolitan 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 manpower 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 manpower 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 individual may request the Secretary to designate (or withdraw the designation of) a particular geographic area, population group, or facility as a health manpower shortage area. Each request will be forwarded by the Secretary to the appropriate HSA, SHPDA, and Governor, who will be asked to review it and offer their recommendations, if any, within 30 days. An information copy will also be made available to other interested parties, upon request, for their use in providing comments or recommendations to the Secretary and/or to the appropriate HSA, SHPDA, or Governor.

(c) In each case where the designation of a public facility (including a Federal medical facility) is under consideration, the Secretary will give written notice of the proposed designation to the chief administrative officer of the facility, who will be asked to review it and offer their recommendations, if any, within 30 days.

(d) After review of the available information and consideration of the comments and recommendations submitted, the Secretary will designate health manpower shortage areas and withdraw the designation of any areas which have been determined no longer to have a shortage of health manpow

er.

§ 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 manpower 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 located;

(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 designated is in whole or in part located; and

(4) Appropriate public or nonprofit private entities which are located in or which have a demonstrated interest in the area so designated.

(b) The Secretary will periodically publish updated lists of designated health manpower shortage areas in the FEDERAL REGISTER, by type of manpower shortage. An updated list of areas for each type of manpower shortage will be published at least once annually.

(c) The effective date of the designation of an area shall be the date of the notification letter to the individual or agency which requested the designation, or the date of publication in the FEDERAL REGISTER, Whichever comes first.

(d) Once an area is listed in the FEDERAL REGISTER as a designated health manpower shortage area, the effective date of any later withdrawal of the area's designation shall be the date when notification of the withdrawal, or an updated list of designated areas which does not include it, is published in the FEDERAL REGISTER.