[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.91]

[Page 123-124]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 314_APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--
Table of Contents
 
                         Subpart B_Applications
 
Sec. 314.91  Obtaining a reduction in the discontinuance notification period.

    (a) What is the discontinuance notification period? The 
discontinuance notification period is the 6-month period required under 
Sec. 314.81(b)(3)(iii)(a). The discontinuance notification period 
begins when an applicant who is the sole manufacturer of certain 
products notifies FDA that it will discontinue manufacturing the 
product. The discontinuance notification period ends when manufacturing 
ceases.
    (b) When can FDA reduce the discontinuance notification period? FDA 
can reduce the 6-month discontinuance notification period when it finds 
good cause exists for the reduction. FDA may find good cause exists 
based on information certified by an applicant in a request for a 
reduction of the discontinuance notification period. In limited 
circumstances, FDA may find good cause exists based on information 
already known to the agency. These circumstances can include the 
withdrawal of the drug from the market based upon formal FDA regulatory 
action (e.g., under the procedures described in Sec. 314.150 for the 
publication of a notice of opportunity for a hearing describing the 
basis for the proposed withdrawal of a drug from the market) or 
resulting from the applicant's consultations with the agency.
    (c) How can an applicant request a reduction in the discontinuance 
notification period? (1) The applicant must certify in a written request 
that, in its opinion and to the best of its knowledge, good

[[Page 124]]

cause exists for the reduction. The applicant must submit the following 
certification:
    The undersigned certifies that good cause exists for a reduction in 
the 6-month notification period required in Sec. 314.81(b)(3)(iii)(a) 
for discontinuing the manufacture of (name of the drug product). The 
following circumstances establish good cause (one or more of the 
circumstances in paragraph (d) of this section).
    (2) The certification must be signed by the applicant or the 
applicant's attorney, agent (representative), or other authorized 
official. If the person signing the certification does not reside or 
have a place of business within the United States, the certification 
must contain the name and address of, and must also be signed by, an 
attorney, agent, or other authorized official who resides or maintains a 
place of business within the United States.
    (3) For drugs regulated by the Center for Drug Evaluation and 
Research (CDER) or the Center for Biologics Evaluation and Research 
(CBER), one copy of the certification must be submitted to the Drug 
Shortage Coordinator at the address of the Director of CDER, one copy to 
the CDER Drug Registration and Listing Team, Division of Compliance Risk 
Management and Surveillance in CDER, and one copy to either the director 
of the review division in CDER responsible for reviewing the 
application, or the director of the office in CBER responsible for 
reviewing the application.
    (d) What circumstances and information can establish good cause for 
a reduction in the discontinuance notification period? (1) A public 
health problem may result from continuation of manufacturing for the 6-
month period. This certification must include a detailed description of 
the potential threat to the public health.
    (2) A biomaterials shortage prevents the continuation of the 
manufacturing for the 6-month period. This certification must include a 
detailed description of the steps taken by the applicant in an attempt 
to secure an adequate supply of biomaterials to enable manufacturing to 
continue for the 6-month period and an explanation of why the 
biomaterials could not be secured.
    (3) A liability problem may exist for the manufacturer if the 
manufacturing is continued for the 6-month period. This certification 
must include a detailed description of the potential liability problem.
    (4) Continuation of the manufacturing for the 6-month period may 
cause substantial economic hardship for the manufacturer. This 
certification must include a detailed description of the financial 
impact of continuing to manufacture the drug product over the 6-month 
period.
    (5) The manufacturer has filed for bankruptcy under chapter 7 or 11 
of title 11, United States Code (11 U.S.C. 701 et seq. and 1101 et 
seq.). This certification must be accompanied by documentation of the 
filing or proof that the filing occurred.
    (6) The manufacturer can continue distribution of the drug product 
to satisfy existing market need for 6 months. This certification must 
include a detailed description of the manufacturer's processes to ensure 
such distribution for the 6-month period.
    (7) Other good cause exists for the reduction. This certification 
must include a detailed description of the need for a reduction.

[72 FR 58999, Oct. 18, 2007]