[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.75]

[Page 104]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
              Subpart B--General Administrative Procedures
 
Sec. 10.75  Internal agency review of decisions.

    (a) A decision of an FDA employee, other than the Commissioner, on a 
matter, is subject to review by the employee's supervisor under the 
following circumstances:
    (1) At the request of the employee.
    (2) On the initiative of the supervisor.
    (3) At the request of an interested person outside the agency.
    (4) As required by delegations of authority.
    (b)(1) The review will be made by consultation between the employee 
and the supervisor or by review of the administrative file on the 
matter, or both. The review will ordinarily follow the established 
agency channels of supervision or review for that matter.
    (2) A sponsor, applicant, or manufacturer of a drug or device 
regulated under the act or the Public Health Service Act (42 U.S.C. 
262), may request review of a scientific controversy by an appropriate 
scientific advisory panel as described in section 505(n) of the act, or 
an advisory committee as described in section 515(g)(2)(B) of the act. 
The reason(s) for any denial of a request for such review shall be 
briefly set forth in writing to the requester. Persons who receive a 
Center denial of their request under this section may submit a request 
for review of the denial. The request should be sent to the Chief 
Mediator and Ombudsman.
    (c) An interested person outside the agency may request internal 
agency review of a decision through the established agency channels of 
supervision or review. Personal review of these matters by center 
directors or the office of the Commissioner will occur for any of the 
following purposes:
    (1) To resolve an issue that cannot be resolved at lower levels 
within the agency (e.g., between two parts of a center or other 
component of the agency, between two centers or other components of the 
agency, or between the agency and an interested person outside the 
agency).
    (2) To review policy matters requiring the attention of center or 
agency management.
    (3) In unusual situations requiring an immediate review in the 
public interest.
    (4) As required by delegations of authority.
    (d) Internal agency review of a decision must be based on the 
information in the administrative file. If an interested person presents 
new information not in the file, the matter will be returned to the 
appropriate lower level in the agency for reevaluation based on the new 
information.

[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 63 
FR 63982, Nov. 18, 1998]