
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-2]

 
                        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-2. Classification of products


(a) Request

    A person who submits an application or submission (including a 
petition, notification, and any other similar form of request) under 
this chapter for a product, may submit a request to the Secretary 
respecting the classification of the product as a drug, biological 
product, device, or a combination product subject to section 353(g) of 
this title or respecting the component of the Food and Drug 
Administration that will regulate the product. In submitting the 
request, the person shall recommend a classification for the product, or 
a component to regulate the product, as appropriate.

(b) Statement

    Not later than 60 days after the receipt of the request described in 
subsection (a) of this section, the Secretary shall determine the 
classification of the product under subsection (a) of this section, or 
the component of the Food and Drug Administration that will regulate the 
product, and shall provide to the person a written statement that 
identifies such classification or such component, and the reasons for 
such determination. The Secretary may not modify such statement except 
with the written consent of the person, or for public health reasons 
based on scientific evidence.

(c) Inaction of Secretary

    If the Secretary does not provide the statement within the 60-day 
period described in subsection (b) of this section, the recommendation 
made by the person under subsection (a) of this section shall be 
considered to be a final determination by the Secretary of such 
classification of the product, or the component of the Food and Drug 
Administration that will regulate the product, as applicable, and may 
not be modified by the Secretary except with the written consent of the 
person, or for public health reasons based on scientific evidence.

(June 25, 1938, ch. 675, Sec. 563, as added Pub. L. 105-115, title IV, 
Sec. 416, Nov. 21, 1997, 111 Stat. 2378.)


                             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.
