[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.25]

[Page 78-79]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS--Table of Contents
 
                     Subpart B--Exemption Procedures
 
Sec. 808.25  Procedures for processing an application.

    (a) Upon receipt of an application for an exemption from preemption 
submitted in accordance with Sec. 808.20, the Commissioner shall notify 
the State or political subdivision of the date of such receipt.
    (b) If the Commissioner finds that an application does not meet the 
requirements of Sec. 808.20, he shall notify the State or political 
subdivision of the deficiencies in the application and of the 
opportunity to correct such deficiencies. A deficient application may be 
corrected at any time.
    (c) After receipt of an application meeting the requirements of 
Sec. 808.20, the Commissioner shall review such application and 
determine whether to grant or deny an exemption from preemption for each 
requirement which is the subject of the application. The Commissioner 
shall then issue in the Federal Register a proposed regulation either to 
grant or to deny an exemption from preemption. The Commissioner shall 
also issue in the Federal Register a notice of opportunity to request an 
oral hearing before the Commissioner or the Commissioner's designee.
    (d) A request for an oral hearing may be made by the State or 
political subdivision or any other interested person. Such request shall 
be submitted to the Dockets Management Branch within the period of time 
prescribed in the notice and shall include an explanation of why an oral 
hearing, rather than submission of written comments only, is essential 
to the presentation of views on the application for exemption from 
preemption and the proposed regulation.
    (e) If a timely request for an oral hearing is made, the 
Commissioner shall review such a request and may grant a legislative-
type informal oral hearing pursuant to part 15 of this chapter by 
publishing in the Federal Register a notice of the hearing in accordance 
with Sec. 15.20 of this chapter. The scope of the oral hearing shall be 
limited to matters relevant to the application for exemption from 
preemption and the proposed regulation. Oral or written presentations at 
the oral hearing which are not relevant to the application shall be 
excluded from the administrative record of the hearing.
    (f) If a request for hearing is not timely made or a notice of 
appearance is not filed pursuant to Sec. 15.21 of this

[[Page 79]]

chapter, the Commissioner shall consider all written comments submitted 
and publish a final rule in accordance with paragraph (g) of this 
section.
    (g)(1) The Commissioner shall review all written comments submitted 
on the proposed rule and the administrative record of the oral hearing, 
if an oral hearing has been granted, and shall publish in the Federal 
Register a final rule in subpart C of this part identifying any 
requirement in the application for which exemption from preemption is 
granted, or conditionally granted, and any requirement in the 
application for which exemption from preemption is not granted.
    (2) The Commissioner may issue a regulation granting or 
conditionally granting an application for an exemption from preemption 
for any requirement if the Commissioner makes either of the following 
findings:
    (i) The requirement is more stringent than a requirement applicable 
to the device under the act;
    (ii) The requirement is required by compelling local conditions, and 
compliance with the requirement would not cause the device to be in 
violation of any requirement applicable to the device under the act.
    (3) The Commissioner may not grant an application for an exemption 
from preemption for any requirement with respect to a device if the 
Commissioner determines that the granting of an exemption would not be 
in the best interest of public health, taking into account the potential 
burden on interstate commerce.
    (h) An advisory opinion pursuant to Sec. 808.5 or a regulation 
pursuant to paragraph (g) of this section constitutes final agency 
action.