[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR99.3]



[Page 444-445]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 99_DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED 

DRUGS, BIOLOGICS, AND DEVICES--Table of Contents

 

                      Subpart A_General Information

 

Sec.  99.3  Definitions.



    (a) Agency or FDA means the Food and Drug Administration.

    (b) For purposes of this part, a clinical investigation is an 

investigation in humans that tests a specific clinical hypothesis.

    (c) Group health plan means an employee welfare benefit plan (as 

defined in section 3(1) of the Employee Retirement Income Security Act 

of 1974 (29 U.S.C. 1002(1))) to the extent that the plan provides 

medical care (as defined in paragraphs (c)(1) through (c)(3) of this 

section and including items and services paid for as medical care) to 

employees or their dependents (as defined under the terms of the plan) 

directly or through insurance, reimbursement, or otherwise. For purposes 

of this part, the term medical care means:

    (1) Amounts paid for the diagnosis, cure, mitigation, treatment, or 

prevention of disease, or amounts paid for the purpose of affecting any 

structure or function of the body;

    (2) Amounts paid for transportation primarily for and essential to 

medical care referred to in paragraph (c)(1) of this section; and

    (3) Amounts paid for insurance covering medical care referred to in 

paragraphs (c)(1) and (c)(2) of this section.

    (d) Health care practitioner means a physician or other individual 

who is a health care provider and licensed under State law to prescribe 

drugs or devices.

    (e) Health insurance issuer means an insurance company, insurance 

service, or insurance organization (including a health maintenance 

organization, as defined in paragraph (e)(2) of this section) which is 

licensed to engage in the business of insurance in a State and which is 

subject to State law which regulates insurance (within the meaning of 

section 514(b)(2) of the Employee Retirement Income Security Act of 1974 

(29 U.S.C. 1144(b)(2))).

    (1) Such term does not include a group health plan.

    (2) For purposes of this part, the term health maintenance 

organization means:

    (i) A Federally qualified health maintenance organization (as 

defined in section 1301(a) of the Public Health Service Act (42 U.S.C. 

300e(a)));

    (ii) An organization recognized under State law as a health 

maintenance organization; or

    (iii) A similar organization regulated under State law for solvency 

in the same manner and to the same extent as such a health maintenance 

organization.

    (f) Manufacturer means a person who manufactures a drug or device or 

who is licensed by such person to distribute or market the drug or 

device. For purposes of this part, the term may also include the sponsor 

of the approved, licensed, or cleared drug or device.

    (g) New use means a use that is not included in the approved 

labeling of an approved drug or device, or a use that is not included in 

the statement of intended use for a cleared device.



[[Page 445]]



    (h) Pharmacy benefit manager means a person or entity that has, as 

its principal focus, the implementation of one or more device and/or 

prescription drug benefit programs.

    (i) A reference publication is a publication that:

    (1) Has not been written, edited, excerpted, or published 

specifically for, or at the request of, a drug or device manufacturer;

    (2) Has not been edited or significantly influenced by such a 

manufacturer;

    (3) Is not solely distributed through such a manufacturer, but is 

generally available in bookstores or other distribution channels where 

medical textbooks are sold;

    (4) Does not focus on any particular drug or device of a 

manufacturer that disseminates information under this part and does not 

have a primary focus on new uses of drugs or devices that are marketed 

or are under investigation by a manufacturer supporting the 

dissemination of information; and

    (5) Does not present materials that are false or misleading.

    (j) Scientific or medical journal means a scientific or medical 

publication:

    (1) That is published by an organization that has an editorial 

board, that uses experts who have demonstrated expertise in the subject 

of an article under review by the organization and who are independent 

of the organization, to review and objectively select, reject, or 

provide comments about proposed articles, and that has a publicly stated 

policy, to which the organization adheres, of full disclosure of any 

conflict of interest or biases for all authors or contributors involved 

with the journal or organization;

    (2) Whose articles are peer-reviewed and published in accordance 

with the regular peer-review procedures of the organization;

    (3) That is generally recognized to be of national scope and 

reputation;

    (4) That is indexed in the Index Medicus of the National Library of 

Medicine of the National Institutes of Health; and

    (5) That is not in the form of a special supplement that has been 

funded in whole or in part by one or more manufacturers.

    (k) Supplemental application means:

    (1) For drugs, a supplement to support a new use to an approved new 

drug application;

    (2) For biologics, a supplement to an approved license application;

    (3) For devices that are the subject of a cleared 510(k) submission 

and devices that are exempt from the 510(k) process, a new 510(k) 

submission to support a new use or, for devices that are the subject of 

an approved premarket approval application, a supplement to support a 

new use to an approved premarket approval application.