[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.6]

[Page 339-340]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 71--COLOR ADDITIVE PETITIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 71.6  Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice.

    (a) Extension of time for studying petitions. If the Commissioner 
determines that additional time is needed to study and investigate the 
petition, he shall by written notice to the petitioner extend the 90-day 
period for not more than 180 days after the filing of the petition.
    (b) Substantive amendments. After a petition has been filed, the 
petitioner may submit additional information or data in support thereof. 
In such cases, if the Commissioner determines that the additional 
information or data amounts to a substantive amendment, the petition as 
amended will be given a new filing date, and the time limitation will 
begin to run anew. If nonclinical laboratory studies are involved, 
additional information and data submitted in support of filed petitions 
shall include, with respect to each nonclinical laboratory study 
contained in the petition, either a statement that the study was 
conducted in compliance with the requirements set forth in part 58 of 
this chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance. If 
clinical investigations involving human subjects are involved, 
additional information or data submitted in support of filed petitions 
shall include statements regarding each such clinical investigation from 
which the information or data are derived, that it either was conducted 
in compliance with the requirements for institutional review set forth 
in part 56 of this chapter, or was not subject to such requirements in 
accordance with Sec. 56.104 or Sec. 56.105, and that it was conducted in 
compliance with the requirements for informed consent set forth in part 
50 of this chapter.
    (c) Withdrawal of petitions without prejudice. (1) In some cases the 
Commissioner may notify the petitioner that the petition, while 
technically complete, is inadequate to justify the establishment of a 
regulation or the regulation requested by petitioner.

[[Page 340]]

This may be due to the fact that the data are not sufficiently clear or 
complete. In such cases, the petitioner may withdraw the petition 
pending its clarification or the obtaining of additional data. This 
withdrawal will be without prejudice to a future filing. Upon refiling, 
the time limitation will begin to run anew from the date of refiling.
    (2) At any time before the order provided for in Sec. 71.20 has been 
forwarded to the Federal Register for publication the petitioner may 
withdraw the petition without prejudice to a future filing. Upon 
refiling, the time limitation will begin to run anew.

[42 FR 15636, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 
46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985]