
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: 21USC360bb]

 
                        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. 360bb. Designation of drugs for rare diseases or conditions


(a) Request by sponsor; preconditions; ``rare disease or condition'' 
        defined

    (1) The manufacturer or the sponsor of a drug may request the 
Secretary to designate the drug as a drug for a rare disease or 
condition. A request for designation of a drug shall be made before the 
submission of an application under section 355(b) of this title for the 
drug, or the submission of an application for licensing of the drug 
under section 262 of title 42. If the Secretary finds that a drug for 
which a request is submitted under this subsection is being or will be 
investigated for a rare disease or condition and--
        (A) if an application for such drug is approved under section 
    355 of this title, or
        (B) if a license for such drug is issued under section 262 of 
    title 42,

the approval, certification, or license would be for use for such 
disease or condition, the Secretary shall designate the drug as a drug 
for such disease or condition. A request for a designation of a drug 
under this subsection shall contain the consent of the applicant to 
notice being given by the Secretary under subsection (b) of this section 
respecting the designation of the drug.
    (2) For purposes of paragraph (1), the term ``rare disease or 
condition'' means 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. 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 this subsection is made.

(b) Notification of discontinuance of drug or application as condition

    A designation of a drug under subsection (a) of this section shall 
be subject to the condition that--
        (1) if an application was approved for the drug under section 
    355(b) of this title or a license was issued for the drug under 
    section 262 of title 42, the manufacturer of the drug will notify 
    the Secretary of any discontinuance of the production of the drug at 
    least one year before discontinuance, and
        (2) if an application has not been approved for the drug under 
    section 355(b) of this title or a license has not been issued for 
    the drug under section 262 of title 42 and if preclinical 
    investigations or investigations under section 355(i) of this title 
    are being conducted with the drug, the manufacturer or sponsor of 
    the drug will notify the Secretary of any decision to discontinue 
    active pursuit of approval of an application under section 355(b) of 
    this title or approval of a license under section 262 of title 42.

(c) Notice to public

    Notice respecting the designation of a drug under subsection (a) of 
this section shall be made available to the public.

(d) Regulations

    The Secretary shall by regulation promulgate procedures for the 
implementation of subsection (a) of this section.

(June 25, 1938, ch. 675, Sec. 526, as added Pub. L. 97-414, Sec. 2(a), 
Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-551, Sec. 4(a), Oct. 30, 
1984, 98 Stat. 2817; Pub. L. 99-91, Sec. 3(a)(2), Aug. 15, 1985, 99 
Stat. 387; Pub. L. 100-290, Sec. 2, Apr. 18, 1988, 102 Stat. 90; Pub. L. 
105-115, title I, Sec. 125(b)(2)(H), (I), Nov. 21, 1997, 111 Stat. 
2326.)


                               Amendments

    1997--Subsec. (a)(1). Pub. L. 105-115, Sec. 125(b)(2)(H), struck out 
``the submission of an application for certification of the drug under 
section 357 of this title,'' before ``or the submission of an 
application for licensing of the drug'' in introductory provisions, 
inserted ``or'' at end of subpar. (A), redesignated subpar. (C) as (B), 
and struck out former subpar. (B) which read as follows: ``if a 
certification for such drug is issued under section 357 of this title, 
or''.
    Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(I)(i), struck out 
``, a certificate was issued for the drug under section 357 of this 
title,'' before ``or a license was issued''.
    Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(I)(ii), struck out 
``, a certificate has not been issued for the drug under section 357 of 
this title,'' before ``or a license has not been issued'' and ``, 
approval of an application for certification under section 357 of this 
title,'' before ``or approval of a license''.
    1988--Subsec. (a)(1). Pub. L. 100-290, Sec. 2(a), inserted after 
first sentence ``A request for designation of a drug shall be made 
before the submission of an application under section 355(b) of this 
title for the drug, the submission of an application for certification 
of the drug under section 357 of this title, or the submission of an 
application for licensing of the drug under section 262 of title 42.''
    Subsecs. (b) to (d). Pub. L. 100-290, Sec. 2(b), added subsec. (b) 
and redesignated former subsecs. (b) and (c) as (c) and (d), 
respectively.
    1985--Subsec. (a)(1). Pub. L. 99-91 struck out ``or'' at end of 
subpar. (A), struck out subpar. (B) and substituted subpars. (B) and 
(C), and inserted ``, certification,'' after ``approval''.
    1984--Subsec. (a)(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 Aug. 15, 1985, see section 8(b) 
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 sections 355a, 360cc, 360dd, 360ee, 
379h of this title; title 26 section 45C; title 42 sections 236, 1395l.
