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(b) After consideration and evalua- an amended Confidentiality Certifition of an application for an authoriza- cate. tion of confidentiality, the Secretary (d) The protection afforded by a Conwill either issue a Confidentiality Cer- fidentiality Certificate does not extend tificate or a letter denying a Confiden- to significant changes in the research tiality Certificate, which will set forth project as it is described in the applicathe reasons for such denial, or will re- tion for such Certificate (e.g., changes quest additional information from the in the personnel having major responperson making application. The Con- sibilities in the research project, major fidentiality Certificate will include: changes in the scope or direction of the

(1) The name and address of the per- research protocol, or changes in the son making application;

drugs to be administered and the per(2) The name and address of the indi- sons who will administer them). The vidual primarily responsible for con- recipient of a Confidentiality Certifiducting the research, if such individual cate shall notify the Director of the Inis not the person making application; stitute to which application was made

(3) The location of the research proj- of any proposal for such a significant ect;

change by submitting an amended ap (4) A brief description of the research plication for a Confidentiality Certifiproject;

cate in the same form and manner as (5) A statement that the Certificate an original application. On the basis of does not represent an endorsement of such application and other pertinent the research project by the Secretary; information the Secretary will either:

(6) The Drug Enforcement Adminis- (1) Approve the amended application tration registration number for the and issue an amended Confidentiality project, if any; and

Certificate together with a Notice of (7) The date or event upon which the Cancellation terminating original the Confidentiality Certificate becomes ef- Confidentiality Certificate in accordfective, which shall not be before the ance with $2a.8; or later of either the commencement of (2) Disapprove the amended applicathe research project or the date of issu- tion and notify the applicant in writing ance of the Certificate, and the date or that adoption of the proposed signifievent upon which the Certificate will cant changes will result in the issuance expire.

of a Notice of Cancellation terminating (c) A Confidentiality Certificate is the original Confidentiality Certificate not transferable and is effective only in accordance with $2a.8. with respect to the names and other identifying characteristics of those in- 8 2a.7 Effect of Confidentiality Certifi. dividuals who are the subjects of the

cate. single research project specified in the (a) A Confidentiality Certificate auConfidentiality Certificate. The recipi- thorizes the withholding of the names ent of a Confidentiality Certificate and other identifying characteristics of shall, within 15 days of any completion individuals who participate as subjects or discontinuance of the research in the research project specified in the project which occurs prior to the expi- Certificate while the Certificate is in ration date set forth in the Certificate, effect. The authorization applies to all provide written notification to the Di- persons who, in the performance of rector of the Institute to which appli- their duties in connection with the recation was made. If the recipient deter- search project, have access to informamines that the research project will tion which would identify the subjects not be completed by the expiration of the research. Persons so authorized date set forth in the Confidentiality may not, at any time, be compelled in Certificate he or she may submit a any Federal, State, or local civil, written request for an extension of the criminal, administrative, legislative, expiration date which shall include a or other proceedings to identify the rejustification for such extension and a search subjects encompassed by the revised estimate of the date for com- Certificate, except in those cirpletion of the projer Upon approval of cumstances specified in paragraph (b) such a request,

etary will issue of this section.


(b) A Confidentiality Certificate acteristics of individuals who bez granted under this part does not au- their participation as research subject thorize any person to refuse to reveal after the effective date of such tert the name or other identifying charac- nation. (See $24.4(k) requiring : teristics of any research subject in the searchers to notify subjects who ente following circumstances:

the project after the termination of the (1) The subject (or, if he or she is le- Confidentiality Certificate of ter gally incompetent, his or her guardian) nation of the Certificate). The protet consents, in writing, to the disclosure tion afforded by a Confidentiality Ce of 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 w program evaluation of a 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 imposed on such DHHS personnel), or

MEDICINE (3) Release of such information is re

Sec. quired by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or the reg

4.1 Programs to which these regulation

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 informa2a.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:

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

tions apply. the Confidentiality Certificate; or

(a) The regulations of this part gove (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 has been completed or discontinued or related services. These functions are that retention of the Confidentiality performed by the Library directly for Certificate is otherwise no longer nec- the benefit of the general public and essary or desirable.

health-sciences professionals as re(b) A Notice of Cancellation shall in- quired by sections 465(b) (3)(6) of the clude: an identification of the Con- Act (42 U.S.C. 286(b) (

36)). fidentiality Certificate to which it ap- (b) The regulations of this part do plies; the effective date of its termi- not apply to: nation; and the grounds for cancella- (1) The Library's internal functions tion. Upon receipt of a Notice of Can- relating to the acquisition and presercellation the applicant shall return the vation of materials and the organizaConfidentiality Certificate to the Sec- tion of these materials as required by retary.

sections 465(b) (1) and (2) of the Act (42 (c) Any termination of a Confiden- U.S.C. 286(b) (1) and (2)). tiality Certificate pursuant to this sec- (2) The availability of "records" tion is operative only with respect to under the Freedom of Information Act the names and other identifying char- or the Privacy Act of 1974 (5 U.S

a). These matters are covered in 45 tained as a regional medical library 'R parts 5 and 5b.

under section 475 of the Act (42 U.S.C. 3) Federal assistance for medical li- 286b-6). aries and other purposes which are thorized by sections 469 477 of the $ 4.3 Purpose of the Library. :t (42 U.S.C. 286b to 286b-8). (See parts

The purpose of the Library is to as2, 61 and 64 of this chapter.)

sist the advancement of medical and (4) The availability of facilities, colctions, and related services of Re

related sciences and aid the disseminaonal Medical Libraries established or

tion and exchange of scientific and aintained under the authority in sec

other information important to the on 475 of the Act (42 U.S.C. 286b-6).

progress of medicine and the public lee part 59a, subpart B of this chap

health. The Library acquires and mainr.)

tains library materials pertinent to

medicine, including audiovisual mate1.2 Definitions.

rials; compiles, publishes, and dissemiAs used in this part:

nates catalogs, indices, and bibliogAct means the Public Health Service raphies of these materials, as approict, as amended (42 U.S.C. 201 et seq.). priate; makes available materials,

Collections means all books, periodi- through loan or otherwise; provides als, prints, audiovisual materials, reference and other assistance to reilms, videotapes, recordings, manu- search; and engages in other activities cripts, and other resource materials of in furtherance of this purpose. he library. It does not include data processing tapes or programs used sole- 84.4 Use of Library facilities. y for internal processing activities to

(a) General. The Library facilities are generate reference materials, nor does

available to any person seeking to it include "records” of the Library as

make use of the collections. The Direcdefined in 45 CFR 5.5. Records of the Library are available in accordance

tor may prescribe reasonable rules to

assure the most effective use of faciliwith the regulations under the Freedom of Information Act and Privacy

ties by health-sciences professionals Act of 1974. (See 45 CFR parts 5 and 5b.)

and to protect the collections from Director means the Director of the

misuse or damage. These rules must be National Library of Medicine or the Di

consistent with the regulations in this rector's delegate.

part and applicable Department regulaHealth-sciences professional means any tions and policies on nondiscriminaperson engaged in: (1) The administra- tion. tion of health activities; (2) the provi- (b) Reading rooms. Public reading sion of health services; or (3) research, rooms are available for obtaining and teaching, or education concerned with reading materials from the collections. the advancement of medicine or other The Director may prescribe reasonable sciences related to health or improve- rules designed to provide adequate ment of the public health.

reading space and orderly conditions Historical collection means: (1) Mate- and procedures. rials in the collections published or

(c) Study rooms. Upon request a limprinted prior to 1914; (2) manuscripts ited number of study rooms may be and prints; (3) the archival film collec

made available to individuals requiring tion; and (4) other materials of the collections which, because of age,

extensive use of Library materials. Re

quests for study rooms shall be adunique or unusual value, require spe

dressed in writing to the Director. The cial handling, storage, or protection for their preservation, as determined by

Director shall give priority, in the folthe Director.

lowing order, for study room use to: Library means the National Library

(1) Persons engaged in "special sciof Medicine, established by section 465

entific projects" under section 473 of of the Act (42 U.S.C. 286).

the Act (42 U.S.C. 286b-4). Regional Medical Library mean (2) Health-sciences professionals, and medical library established or man (3) The general public.


84.5 Use of materials from the collec- has first exhausted its own colle tions.

resources, those of other local liba (a) Unrestricted materials. Except as

in the geographic area, and those a otherwise provided in this section, ma

Regional Medical Library netwozi terials from the collections are gen

cluding Regional and Resource i erally available to any interested per

ies) before making a request for al son only in facilities provided by the

(4) Loans to health-sciences, Library for this purpose. The Director

sionals. The Director may make 1 may prescribe additional reasonable

of materials directly to health-scie rules to assure the most effective use

professionals. An individual wisti of the Library's resources by health

loan of library materials must a sciences professionals and to protect

to the satisfaction of the Director the collections from misuse or damage.

the individual is geographically The rules must be consistent with the

lated, in terms of distance or arail regulations in this part and applicable

transportation, from medical Department regulations and policies on

erature resources likely to contain nondiscrimination. Materials in the

desired material. collections are available upon each re- (Approved by the Office of Management quest which assures, to the Director's Budget under control number 0925 OZ) satisfaction, that the materials will be safeguarded from misuse, damage, loss,

$ 4.6 Reference, bibliographic, N or misappropriation, and will be re

duction, and consultation servis turned promptly after use or upon re- (a) General. To the extent resou quest of the Library.

permit, the Library will make ai (b) Restricted materials (1) Historical able, upon request, reference, bit collection. Materials from the historical graphic, reproduction, and consu collection are available only as the Di- tion services. Priority will be gives rector may permit to assure their max- requests from health-sciences pro imum preservation and protection. sionals for services not reasona Copies of these materials may be made available through local or regional available in the form of microfilm and braries. other copies, for which reasonable fees (b) Specialized bibliographic servi may be charged.

The Director may provide bibli (2) Gifts. Materials in the collections raphies on individually selected m are available only in accordance with cal or scientific topics upon requ any limitations imposed as a condition where it is consistent with the of the acquisition of those materials, brary's purpose. The Director may pi whether the acquisition was by gift or lish and make available for general d purchase.

tribution by the Library, bibliograp) (c) Loans—(1) General. Requests for searches determined to be of gene loans of materials must assure the Li- interest. The Library may also produ brary that (i) the materials will be and distribute a limited number of bi safeguarded from misuse, damage, loss, liographies on topics of general int or misappropriation and (ii) the mate- est to public or nonprofit health-rela rials will be returned promptly after ed professional societies, research use or upon request of the Library. The ganizations, and other group usel Library may provide copies in lieu of These bibliographies may be produa original materials, which need not be on a regularly recurring or intermi returned unless otherwise stated at the tent basis under contract between ti time of the loan.

Library and public or nonprofit age (2) Loans of audiovisual materials. cies, when determined in each case Audiovisual materials are available for the Director to be necessary to assu loan under the same general terms as more effective distribution of the bil printed materials.

liographic information. (3) Loans to other libraries. Upon re- (c) Information retrieval system com quest materials or copies are available puter tapes. To the extent Library n for use through libraries of public or sources permit and in order to furthe private agencies or institutions. The the Library's purpose, the Direct requesting library must assure that it may make available upon reques


cies, organizations, and institu- SOURCE: 45 FR 76000, Nov. 17, 1980, unless 3 copies of all or part of the Li- otherwise noted. y's magnetic tapes.

EDITORIAL NOTE: Nomenclature changes to

part 5 appear at 57 FR 2480, Jan. 22, 1992. Fees. ne Director may charge reasonable

85.1 Purpose. for any service provided by the Li- These regulations establish criteria y under this part, in accordance and procedures for the designation of 2 a schedule available at the Li- geographic areas, population groups, ry upon request, which are designed medical facilities, and other public farecover all or a portion of the cost cilities, in the States, as health ihe Library of providing the service. professional(s) shortage areas. 3 Publication of the Library and in- 85.2 Definitions. formation about the Library.

Act means the Public Health Service ists of bibliographies, Library publi- Act, as amended. ions sold by the Government Print- Health professional(s) shortage area : Office, necessary application forms, means any of the following which the 1 other information concerning the Secretary determines has a shortage of ganization, operation, functions, and health professional(s): (1) An urban or 'vices of the Library, are available rural area (which need not conform to im the National Library of Medicine, the geographic boundaries of a politithesda, Maryland 20894.

cal subdivision and which is a rational

area for the delivery of health servART 5-DESIGNATION OF HEALTH

ices); (2) a population group; or (3) a PROFESSIONAL(S) SHORTAGE

public or nonprofit private medical fa

cility. AREAS

Health service area means a health service area whose boundaries have

been designated by the Secretary, 1 Purpose.

under section 1511 of the Act, for pur2 Definitions.

poses of health planning activities. 3 Procedures for designation of health

Health systems agency or HSA means professional(s) shortage areas.

the health systems agency designated, 4 Notification and publication of designa

under section 1515 of the Act, to carry tions and withdrawals.

out health planning activities for a APPENDIX A TO PART 5 CRITERIA FOR DES

specific health service area. IGNATION OF AREAS HAVING SHORTAGES OF

Medical facility means a facility for PRIMARY MEDICAL CARE PROFESSIONAL(S)


cludes: (1) A community health center, DENTAL PROFESSIONAL(8)

public health center, outpatient mediAPPENDIX CTO PART 5-CRITERIA FOR DES

cal facility, or community mental IGNATION OF AREAS HAVING SHORTAGES OF health center; (2) a hospital, State MENTAL HEALTH PROFESSIONALS

mental hospital, facility for long-term APPENDIX D TO PART 5 CRITERIA FOR DES- care, or rehabilitation facility; (3) a


Health service facility; (4) a facility for APPENDIX E TO PART 5—CRITERIA FOR DES

delivery of health services to inmates IGNATION OF AREAS HAVING SHORTAGES OF


tion (under section 323 of the Act) or a IGNATION OF AREAS HAVING SHORTAGES OF

State correctional institution; (5) a PHARMACY PROFESSIONAL(S)

Public Health Service medical facility APPENDIX G TO PART 5-CRITERIA FOR DES- (used in connection with the delivery


321, 322, 324, 325, or 326 of the Act); or AUTHORITY: Sec. 215 of the Public Health (6) any other Federal medical facility. Service Act, 58 Stat. 690 (42 U.S.C. 216): seo Metropolitan area means an area 332 of the Public Health Sarvice Act, 90 Stat which has been designated by the Of2270-2272 (42 U.S.C. 2546)

Dice of Management and Budget as a


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