[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.45]

[Page 72-73]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
                    Subpart C_Administrative Actions
 
Sec. 312.45  Inactive status.

    (a) If no subjects are entered into clinical studies for a period of 
2 years or more under an IND, or if all investigations under an IND 
remain on clinical hold for 1 year or more, the IND may be placed by FDA 
on inactive status. This action may be taken by FDA either on request of 
the sponsor or on FDA's own initiative. If FDA seeks to act on its own 
initiative under this section, it shall first notify the sponsor in 
writing of the proposed inactive status. Upon receipt of such 
notification, the sponsor shall have 30 days to respond as to why the 
IND should continue to remain active.
    (b) If an IND is placed on inactive status, all investigators shall 
be so notified and all stocks of the drug shall be returned or otherwise 
disposed of in accordance with Sec. 312.59.
    (c) A sponsor is not required to submit annual reports to an IND on 
inactive status. An inactive IND is, however, still in effect for 
purposes of the public disclosure of data and information under Sec. 
312.130.
    (d) A sponsor who intends to resume clinical investigation under an 
IND placed on inactive status shall submit a protocol amendment under 
Sec. 312.30 containing the proposed general investigational plan for 
the coming year and appropriate protocols. If the protocol

[[Page 73]]

amendment relies on information previously submitted, the plan shall 
reference such information. Additional information supporting the 
proposed investigation, if any, shall be submitted in an information 
amendment. Notwithstanding the provisions of Sec. 312.30, clinical 
investigations under an IND on inactive status may only resume (1) 30 
days after FDA receives the protocol amendment, unless FDA notifies the 
sponsor that the investigations described in the amendment are subject 
to a clinical hold under Sec. 312.42, or (2) on earlier notification by 
FDA that the clinical investigations described in the protocol amendment 
may begin.
    (e) An IND that remains on inactive status for 5 years or more may 
be terminated under Sec. 312.44.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 
FR 9586, Mar. 4, 2002]