[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.151]

[Page 147-148]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
   Subpart D--FDA Action on Applications and Abbreviated Applications
 
Sec. 314.151  Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.

    (a) Approval of an abbreviated new drug application approved under 
Sec. 314.105(d) may be withdrawn when the agency withdraws approval, 
under Sec. 314.150(a) or under this section, of the approved drug 
referred to in the abbreviated new drug application. If the agency 
proposed to withdraw approval of a listed drug under Sec. 314.150(a), 
the holder of an approved application for the listed drug has a right to 
notice and opportunity for hearing. The published notice of opportunity 
for hearing will identify all drug products approved under 
Sec. 314.105(d) whose applications are subject to withdrawal under this 
section if the listed drug is withdrawn, and will propose to withdraw 
such drugs. Holders of approved applications for the identified drug 
products will be provided notice and an opportunity to respond to the 
proposed withdrawal of their applications as described in paragraphs (b) 
and (c) of this section.
    (b)(1) The published notice of opportunity for hearing on the 
withdrawal of the listed drug will serve as notice to holders of 
identified abbreviated new drug applications of the grounds for the 
proposed withdrawal.
    (2) Holders of applications for drug products identified in the 
notice of opportunity for hearing may submit written comments on the 
notice of opportunity for hearing issued on the proposed withdrawal of 
the listed drug. If an abbreviated new drug application

[[Page 148]]

holder submits comments on the notice of opportunity for hearing and a 
hearing is granted, the abbreviated new drug application holder may 
participate in the hearing as a nonparty participant as provided for in 
Sec. 12.89 of this chapter.
    (3) Except as provided in paragraphs (c) and (d) of this section, 
the approval of an abbreviated new drug application for a drug product 
identified in the notice of opportunity for hearing on the withdrawal of 
a listed drug will be withdrawn when the agency has completed the 
withdrawal of approval of the listed drug.
    (c)(1) If the holder of an application for a drug identified in the 
notice of opportunity for hearing has submitted timely comments but does 
not have an opportunity to participate in a hearing because a hearing is 
not requested or is settled, the submitted comments will be considered 
by the agency, which will issue an initial decision. The initial 
decision will respond to the comments, and contain the agency's decision 
whether there are grounds to withdraw approval of the listed drug and of 
the abbreviated new drug applications on which timely comments were 
submitted. The initial decision will be sent to each abbreviated new 
drug application holder that has submitted comments.
    (2) Abbreviated new drug application holders to whom the initial 
decision was sent may, within 30 days of the issuance of the initial 
decision, submit written objections.
    (3) The agency may, at its discretion, hold a limited oral hearing 
to resolve dispositive factual issues that cannot be resolved on the 
basis of written submissions.
    (4) If there are no timely objections to the initial decision, it 
will become final at the expiration of 30 days.
    (5) If timely objections are submitted, they will be reviewed and 
responded to in a final decision.
    (6) The written comments received, the initial decision, the 
evidence relied on in the comments and in the initial decision, the 
objections to the initial decision, and, if a limited oral hearing has 
been held, the transcript of that hearing and any documents submitted 
therein, shall form the record upon which the agency shall make a final 
decision.
    (7) Except as provided in paragraph (d) of this section, any 
abbreviated new drug application whose holder submitted comments on the 
notice of opportunity for hearing shall be withdrawn upon the issuance 
of a final decision concluding that the listed drug should be withdrawn 
for grounds as described in Sec. 314.150(a). The final decision shall be 
in writing and shall constitute final agency action, reviewable in a 
judicial proceeding.
    (8) Documents in the record will be publicly available in accordance 
with Sec. 10.20(j) of this chapter. Documents available for examination 
or copying will be placed on public display in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, room. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857, promptly upon receipt in that office.
    (d) If the agency determines, based upon information submitted by 
the holder of an abbreviated new drug application, that the grounds for 
withdrawal of the listed drug are not applicable to a drug identified in 
the notice of opportunity for hearing, the final decision will state 
that the approval of the abbreviated new drug application for such drug 
is not withdrawn.

[57 FR 17994, Apr. 28, 1992]