[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: 21CFR809.11]

[Page 96-97]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 809_IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--
Table of Contents
 
                           Subpart B_Labeling
 
Sec. 809.11  Exceptions or alternatives to labeling requirements for 
in vitro diagnostic products for human use held by the

Strategic National Stockpile.

    (a) The appropriate FDA Center Director may grant an exception or 
alternative to any provision listed in paragraph (f) of this section and 
not explicitly required by statute, for specified lots, batches, or 
other units of an in vitro diagnostic product for human use, if the 
Center Director determines that compliance with such labeling 
requirement could adversely affect the safety, effectiveness, or 
availability of such products that are or will be included in the 
Strategic National Stockpile.
    (b)(1)(i) A Strategic National Stockpile official or any entity that 
manufactures (including labeling, packing, relabeling, or repackaging), 
distributes, or stores an in vitro diagnostic product for human use that 
is or will be included in the Strategic National Stockpile may submit, 
with written concurrence from a Strategic National Stockpile official, a 
written request for an exception or alternative described in paragraph 
(a) of this section to the Center Director.
    (ii) The Center Director may grant an exception or alternative 
described in paragraph (a) of this section on his or her own initiative.
    (2) A written request for an exception or alternative described in 
paragraph (a) of this section must:
    (i) Identify the specified lots, batches, or other units of an in 
vitro diagnostic product for human use that would be subject to the 
exception or alternative;
    (ii) Identify the labeling provision(s) listed in paragraph (f) of 
this section that are the subject of the exception or alternative 
request;
    (iii) Explain why compliance with such labeling provision(s) could 
adversely affect the safety, effectiveness, or availability of the 
specified lots, batches, or other units of the in vitro diagnostic 
product for human use that are or will be held in the Strategic National 
Stockpile;
    (iv) Describe any proposed safeguards or conditions that will be 
implemented so that the labeling of the product includes appropriate 
information necessary for the safe and effective use of the product, 
given the anticipated circumstances of use of the product;
    (v) Provide a draft of the proposed labeling of the specified lots, 
batches, or other units of the in vitro diagnostic products for human 
use subject to the exception or alternative; and
    (vi) Provide any other information requested by the Center Director 
in support of the request.
    (c) The Center Director must respond in writing to all requests 
under this

[[Page 97]]

section. The Center Director may impose appropriate conditions or 
safeguards when granting such an exception or alternative under this 
section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director to ensure that the labeling of the product subject to the 
exception or alternative includes the information necessary for the safe 
and effective use of the product, given the anticipated circumstances of 
use.
    (e) If the Center Director grants a request for an exception or 
alternative to the labeling requirements under this section:
    (1) The Center Director may determine that the submission and grant 
of a written request under this section satisfies the provisions 
relating to premarket notification submissions under Sec. 807.81(a)(3) 
of this chapter.
    (2)(i) For a Premarket Approval Application (PMA)-approved in vitro 
diagnostic product for human use, the submission and grant of a written 
request under this section satisfies the provisions relating to 
submission of PMA supplements under Sec. 814.39 of this chapter; 
however,
    (ii) The grant of the request must be identified in a periodic 
report under Sec. 814.84 of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this part, to the extent 
that the requirements in these provisions are not explicitly required by 
statute:
    (1) Sec. 809.10(a)(1) through (a)(6) and (a)(9);
    (2) Sec. 809.10(b);
    (3) Sec. 809.10(c)(2);
    (4) Sec. 809.10(d)(1)(i) through (d)(1)(v), (d)(1)(viii), and 
(d)(2); and
    (5) Sec. 809.10(e)(1)(i) through (e)(1)(vi) and (e)(1)(ix) through 
(e)(1)(xi).

[72 FR 73601, Dec. 28, 2007]