[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.68]

[Page 93-94]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610_GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                      Subpart G_Labeling Standards
 
Sec. 610.68  Exceptions or alternatives to labeling requirements for 

biological products 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 a biological product, if the Center Director determines 
that compliance with such labeling requirement could adversely affect 
the safety, effectiveness, or availability of such product that is 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 a biological product 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 the 
biological product 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 biological product that 
are or will be included 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 biological product 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 section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director so that the labeling of product subject to

[[Page 94]]

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 you are a sponsor receiving a grant of a request for an 
exception or alternative to the labeling requirements under this 
section:
    (1) You need not submit a supplement under Sec. 601.12(f)(1) 
through (f)(2) of this chapter; however,
    (2) You must report any grant of a request for an exception or 
alternative under this section as part of your annual report under Sec. 
601.12(f)(3) of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this chapter, to the extent 
that the requirements in these provisions are not explicitly required by 
statute:
    (1) Sec. 610.60;
    (2) Sec. 610.61(c) and (e) through (r);
    (3) Sec. 610.62;
    (4) Sec. 610.63;
    (5) Sec. 610.64;
    (6) Sec. 610.65; and
    (7) Sec. 312.6.

[72 FR 73600, Dec. 28, 2007]