[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.6]
[Page 334-335]
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.
[[Page 335]]
(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. 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]
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