
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360bbb-1]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
        Part E--General Provisions Relating to Drugs and Devices
 
Sec. 360bbb-1. Dispute resolution

    If, regarding an obligation concerning drugs or devices under this 
Act or section 351 of the Public Health Service Act [42 U.S.C. 262], 
there is a scientific controversy between the Secretary and a person who 
is a sponsor, applicant, or manufacturer and no specific provision of 
the Act involved, including a regulation promulgated under such Act, 
provides a right of review of the matter in controversy, the Secretary 
shall, by regulation, establish a procedure under which such sponsor, 
applicant, or manufacturer may request a review of such controversy, 
including a review by an appropriate scientific advisory panel described 
in section 355(n) of this title or an advisory committee described in 
section 360e(g)(2)(B) of this title. Any such review shall take place in 
a timely manner. The Secretary shall promulgate such regulations within 
1 year after November 21, 1997.

(June 25, 1938, ch. 675, Sec. 562, as added Pub. L. 105-115, title IV, 
Sec. 404, Nov. 21, 1997, 111 Stat. 2368.)

                       References in Text

    This Act, referred to in text, is the Federal Food, Drug, and 
Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, 
which is classified generally to this chapter. For complete 
classification of this Act to the Code, see section 301 of this title 
and Tables.


                             Effective Date

    Section effective 90 days after Nov. 21, 1997, except as otherwise 
provided, see section 501 of Pub. L. 105-115, set out as an Effective 
Date of 1997 Amendment note under section 321 of this title.

                  Section Referred to in Other Sections

    This section is referred to in section 360l of this title.
