[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.155]

[Page 733]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS--Table of Contents
 
                 Subpart D_Current Good Tissue Practice
 
Sec. 1271.155  Exemptions and alternatives.

    (a) General. You may request an exemption from or alternative to any 
requirement in subpart C or D of this part.
    (b) Request for exemption or alternative. Submit your request under 
this section to the Director of the appropriate Center (the Director), 
e.g., the Center for Biologics Evaluation and Research or the Center for 
Devices and Radiological Health. The request must be accompanied by 
supporting documentation, including all relevant valid scientific data, 
and must contain either:
    (1) Information justifying the requested exemption from the 
requirement, or
    (2) A description of a proposed alternative method of meeting the 
requirement.
    (c) Criteria for granting an exemption or alternative. The Director 
may grant an exemption or alternative if he or she finds that such 
action is consistent with the goals of protecting the public health and/
or preventing the introduction, transmission, or spread of communicable 
diseases and that:
    (1) The information submitted justifies an exemption; or
    (2) The proposed alternative satisfies the purpose of the 
requirement.
    (d) Form of request. You must ordinarily make your request for an 
exemption or alternative in writing (hard copy or electronically). 
However, if circumstances make it difficult (e.g., there is inadequate 
time) to submit your request in writing, you may make the request 
orally, and the Director may orally grant an exemption or alternative. 
You must follow your oral request with an immediate written request, to 
which the Director will respond in writing.
    (e) Operation under exemption or alternative. You must not begin 
operating under the terms of a requested exemption or alternative until 
the exemption or alternative has been granted. You may apply for an 
extension of an exemption or alternative beyond its expiration date, if 
any.
    (f) Documentation. If you operate under the terms of an exemption or 
alternative, you must maintain documentation of:
    (1) FDA's grant of the exemption or alternative, and
    (2) The date on which you began operating under the terms of the 
exemption or alternative.
    (g) Issuance of an exemption or alternative by the Director. In a 
public health emergency, the Director may issue an exemption from, or 
alternative to, any requirement in part 1271. The Director may issue an 
exemption or alternative under this section if the exemption or 
alternative is necessary to assure that certain HCT/Ps will be available 
in a specified location to respond to an unanticipated immediate need 
for those HCT/Ps.