0338 21cfr601 94 2007

§ 601.93

21 CFR Ch. I (4–1–05 Edition)

(6) Other evidence demonstrates that
the biological product is not shown to
be safe or effective under its conditions
of use.
(b) Notice of opportunity for a hearing.
The Director of the Center for Biologics Evaluation and Research or the
Director of the Center for Drug Evaluation and Research will give the applicant notice of an opportunity for a
hearing on the proposal to withdraw
the approval of an application approved
under this subpart. The notice, which
will ordinarily be a letter, will state
generally the reasons for the action
and the proposed grounds for the order.
(c) Submission of data and information.
(1) If the applicant fails to file a written request for a hearing within 15 days
of receipt of the notice, the applicant
waives the opportunity for a hearing.
(2) If the applicant files a timely request for a hearing, the agency will
publish a notice of hearing in the FEDERAL REGISTER in accordance with
§§ 12.32(e) and 15.20 of this chapter.
(3) An applicant who requests a hearing under this section must, within 30
days of receipt of the notice of opportunity for a hearing, submit the data
and information upon which the applicant intends to rely at the hearing.
(d) Separation of functions. Separation
of functions (as specified in § 10.55 of
this chapter) will not apply at any
point in withdrawal proceedings under
this section.
(e) Procedures for hearings. Hearings
held under this section will be conducted in accordance with the provisions of part 15 of this chapter, with
the following modifications:
(1) An advisory committee duly constituted under part 14 of this chapter
will be present at the hearing. The
committee will be asked to review the
issues involved and to provide advice
and recommendations to the Commissioner of Food and Drugs.
(2) The presiding officer, the advisory
committee members, up to three representatives of the applicant, and up to
three representatives of CBER may
question any person during or at the
conclusion of the person’s presentation. No other person attending the
hearing may question a person making
a presentation. The presiding officer
may, as a matter of discretion, permit

questions to be submitted to the presiding officer for response by a person
making a presentation.
(f) Judicial review. The Commissioner
of Food and Drugs’ decision constitutes
final agency action from which the applicant may petition for judicial review. Before requesting an order from a
court for a stay of action pending review, an applicant must first submit a
petition for a stay of action under
§ 10.35 of this chapter.
[67 FR 37996, May 31, 2002, as amended at 70
FR 14984, Mar. 24, 2005]

§ 601.93 Postmarketing safety reporting.
Biological products approved under
this subpart are subject to the postmarketing recordkeeping and safety
reporting applicable to all approved biological products.
§ 601.94 Promotional materials.
For biological products being considered for approval under this subpart,
unless otherwise informed by the agency, applicants must submit to the
agency for consideration during the
preapproval review period copies of all
promotional materials, including promotional labeling as well as advertisements, intended for dissemination or
publication within 120 days following
marketing approval. After 120 days following marketing approval, unless otherwise informed by the agency, the applicant must submit promotional materials at least 30 days prior to the intended time of initial dissemination of
the labeling or initial publication of
the advertisement.
§ 601.95 Termination of requirements.
If FDA determines after approval
under this subpart that the requirements established in §§ 601.91(b)(2),
601.92, and 601.93 are no longer necessary for the safe and effective use of
a biological product, FDA will so notify the applicant. Ordinarily, for biological
products
approved
under
§ 601.91, these requirements will no
longer apply when FDA determines
that the postmarketing study verifies
and describes the biological product’s
clinical benefit. For biological products approved under § 601.91, the restrictions would no longer apply when

46

VerDate Aug<04>2004

09:35 Apr 25, 2005

Jkt 205071

PO 00000

Frm 00056

Fmt 8010

Sfmt 8010

Y:\SGML\205071.XXX

205071