
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360ee]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
              Part B--Drugs for Rare Diseases or Conditions
 
Sec. 360ee. Grants and contracts for development of drugs for 
        rare diseases and conditions
        

(a) Authority of Secretary

    The Secretary may make grants to and enter into contracts with 
public and private entities and individuals to assist in (1) defraying 
the costs of qualified testing expenses incurred in connection with the 
development of drugs for rare diseases and conditions, (2) defraying the 
costs of developing medical devices for rare diseases or conditions, and 
(3) defraying the costs of developing medical foods for rare diseases or 
conditions.

(b) Definitions

    For purposes of subsection (a) of this section:
        (1) The term ``qualified testing'' means--
            (A) human clinical testing--
                (i) which is carried out under an exemption for a drug 
            for a rare disease or condition under section 355(i) of this 
            title (or regulations issued under such section); and
                (ii) which occurs after the date such drug is designated 
            under section 360bb of this title and before the date on 
            which an application with respect to such drug is submitted 
            under section 355(b) of this title or under section 262 of 
            title 42; and

            (B) preclinical testing involving a drug for a rare disease 
        or condition which occurs after the date such drug is designated 
        under section 360bb of this title and before the date on which 
        an application with respect to such drug is submitted under 
        section 355(b) of this title or under section 262 of title 42.

        (2) The term ``rare disease or condition'' means (1) in the case 
    of a drug, any disease or condition which (A) affects less than 
    200,000 persons in the United States, or (B) affects more than 
    200,000 in the United States and for which there is no reasonable 
    expectation that the cost of developing and making available in the 
    United States a drug for such disease or condition will be recovered 
    from sales in the United States of such drug, (2) in the case of a 
    medical device, any disease or condition that occurs so infrequently 
    in the United States that there is no reasonable expectation that a 
    medical device for such disease or condition will be developed 
    without assistance under subsection (a) of this section, and (3) in 
    the case of a medical food, any disease or condition that occurs so 
    infrequently in the United States that there is no reasonable 
    expectation that a medical food for such disease or condition will 
    be developed without assistance under subsection (a) of this 
    section. Determinations under the preceding sentence with respect to 
    any drug shall be made on the basis of the facts and circumstances 
    as of the date the request for designation of the drug under section 
    360bb of this title is made.
        (3) The term ``medical food'' means a food which is formulated 
    to be consumed or administered enterally under the supervision of a 
    physician and which is intended for the specific dietary management 
    of a disease or condition for which distinctive nutritional 
    requirements, based on recognized scientific principles, are 
    established by medical evaluation.

(c) Authorization of appropriations

    For grants and contracts under subsection (a) of this section there 
are authorized to be appropriated $10,000,000 for fiscal year 1988, 
$12,000,000 for fiscal year 1989,\1\ $14,000,000 for fiscal year 1990.
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    \1\ So in original. Probably should be followed by ``and''.
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(Pub. L. 97-414, Sec. 5, Jan. 4, 1983, 96 Stat. 2056; Pub. L. 98-551, 
Sec. 4(b), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, Sec. 5, Aug. 15, 
1985, 99 Stat. 391; Pub. L. 100-290, Sec. 3(a)-(c), Apr. 18, 1988, 102 
Stat. 90, 91; Pub. L. 105-115, title I, Sec. 125(b)(2)(N), Nov. 21, 
1997, 111 Stat. 2326.)

                          Codification

    Section was enacted as part of the Orphan Drug Act, and not as part 
of the Federal Food, Drug, and Cosmetic Act which comprises this 
chapter.


                               Amendments

    1997--Subsec. (b)(1)(A)(ii), (B). Pub. L. 105-115 struck out ``or 
357'' after ``355(b)''.
    1988--Subsec. (a). Pub. L. 100-290, Sec. 3(a)(1), (b)(1), inserted 
``(1)'' after ``assist in'' and added cls. (2) and (3).
    Subsec. (b)(2). Pub. L. 100-290, Sec. 3(a)(2), (b)(2), inserted 
``(1) in the case of a drug,'' after ``means'', added cls. (2) and (3), 
and substituted ``under section 360bb of this title'' for ``under this 
subsection'' in last sentence.
    Subsec. (b)(3). Pub. L. 100-290, Sec. 3(b)(3), added par. (3).
    Subsec. (c). Pub. L. 100-290, Sec. 3(c), amended subsec. (c) 
generally. Prior to amendment, subsec. (c) read as follows: ``For grants 
and contracts under subsection (a) of this section there are authorized 
to be appropriated $4,000,000 for fiscal year 1986, $4,000,000 for 
fiscal year 1987, and $4,000,000 for fiscal year 1988.''
    1985--Subsec. (a). Pub. L. 99-91, Sec. 5(a)(1), struck out 
``clinical'' before ``testing''.
    Subsec. (b)(1). Pub. L. 99-91, Sec. 5(a)(2), substituted provisions 
defining ``qualified testing'' for provisions defining ``qualified 
clinical testing''.
    Subsec. (c). Pub. L. 99-91, Sec. 5(b), substituted provisions 
authorizing appropriations for fiscal years 1986 to 1988, for provisions 
authorizing appropriations for fiscal years 1983 and the two succeeding 
fiscal years.
    1984--Subsec. (b)(2). Pub. L. 98-551 substituted ``which (A) affects 
less than 200,000 persons in the United States, or (B) affects more than 
200,000 in the United States and for which'' for ``which occurs so 
infrequently in the United States that''.


                    Effective Date of 1985 Amendment

    Amendment by Pub. L. 99-91 effective Oct. 1, 1985, see section 8(a) 
of Pub. L. 99-91, set out as a note under section 360aa of this title.

                  Section Referred to in Other Sections

    This section is referred to in section 343 of this title; title 42 
section 236.
