[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.44]

[Page 205-206]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 20--PUBLIC INFORMATION--Table of Contents
 
                     Subpart C--Procedures and Fees
 
Sec. 20.44  Presubmission review of request for confidentiality of voluntarily submitted data or information.

    (a) Any person who is considering submission of data or information 
voluntarily to the Food and Drug Administration may forward to the 
Director of the Center involved, or to the Associate Commissioner for 
Regulatory Affairs, a request for presubmission review of the records 
involved to determine whether the Food and Drug Administration will or 
will not make part or all of them available for public disclosure upon 
request if they are submitted. Any such request shall state why the data 
or information involved fall within an exemption from public disclosure 
set out in subpart D of this part and shall enclose the records 
involved.
    (b) Pending a determination upon such request, the records involved 
shall be held confidentially and separately by the Food and Drug 
Administration and shall not be received as part of Food and Drug 
Administration files.
    (c) Pursuant to such a request, the Food and Drug Administration 
shall make a determination whether part or all of the records involved 
will be made available for public disclosure upon request if they are 
submitted. A determination of confidentiality will be made only if it is 
concluded that the data or information involved fall within an exemption 
from public disclosure set out in subpart D of this part and are 
relevant to and important for agency activity.
    (d) After a determination is made pursuant to this section, the Food 
and Drug Administration shall receive as part of its files the records 
for which a request for confidentiality has been granted and shall so 
mark or designate those records. The person requesting the presubmission 
review shall have the option of submitting or withdrawing the records 
for which a request for confidentiality has been denied. No copy or 
summary of records withdrawn pursuant to this section, or any 
correspondence or memoranda or records relating thereto, shall be 
retained in Food and Drug Administration files.
    (e) A determination of confidentiality pursuant to this section is 
subject to the limitations established in subpart E of this part except 
that the data or information involved shall not be subject to 
discretionary release pursuant to Sec. 20.82. Such a determination of 
confidentiality by the Food and Drug Administration means that the Food 
and Drug Administration will not make the data or information involved 
available for public disclosure unless ordered to do so by a court.

[[Page 206]]

    (f) A determination based upon a presubmission review pursuant to 
this section shall be made in writing and shall be signed only by the 
Associate Commissioner for Public Affairs.
    (g) Data and information that may be required to be submitted to the 
Food and Drug Administration but that are submitted voluntarily instead 
are not subject to the provisions of this section and will be handled as 
if they had been required to be submitted.
    (h) No request under this section shall be accepted if the status of 
the records involved is already determined by Sec. 20.111 or by any 
other regulation published or cross-referenced in this part.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 
FR 8995, Mar. 6, 1985]