0338 21cfr601 14 2007

§ 601.14

21 CFR Ch. I (4–1–06 Edition)
(2) Changes to the most recent revision
date of the labeling as specified in
§ 201.57(a)(15) of this chapter.

(g) Failure to comply. In addition to
other remedies available in law and
regulations, in the event of repeated
failure of the applicant to comply with
this section, FDA may require that the
applicant submit a supplement for any
proposed change and obtain approval of
the supplement by FDA prior to distribution of the product made using
the change.
(h) Administrative review. Under § 10.75
of this chapter, an applicant may request internal FDA review of FDA employee decisions under this section.

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§ 601.12 Changes to an approved application.

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(f) * * *
(1) * * * An applicant cannot use paragraph
(f)(2) of this section to make any change to
the information required in § 201.57(a) of this
chapter. An applicant may report the minor
changes to the information specified in paragraph (f)(3)(i)(D) of this section in an annual
report. * * *
(2) * * *
(i) An applicant shall submit, at the time
such change is made, a supplement for any
change in the package insert, package label,
or container label, except for changes to the
package insert required in § 201.57(a) of this
chapter (which must be made pursuant to
paragraph (f)(1) of this section), to accomplish any of the following:

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§ 601.15 Foreign establishments and
products: samples for each importation.
Random samples of each importation, obtained by the District Director
of Customs and forwarded to the Director, Center for Biologics Evaluation
and Research or the Director, Center
for Drug Evaluation and Research (see
mailing addresses in § 600.2 of this chapter) must be at least two final containers of each lot of product. A copy
of the associated documents which describe and identify the shipment must
accompany the shipment for forwarding with the samples to the Director, Center for Biologics Evaluation
and Research or the Director, Center
for Drug Evaluation and Research (see
mailing addresses in § 600.2). For shipments of 20 or less final containers,

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[68 FR 69020, Dec. 11, 2003]

(f) * * *
(3) * * *
(i) * * *
(D) A change to the information required
in § 201.57(a) of this chapter as follows:
(1) Removal of a listed section(s) specified
in § 201.57(a)(5) of this chapter; and

VerDate Aug<31>2005

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(a) General. Electronic format submissions must be in a form that FDA
can process, review, and archive. FDA
will periodically issue guidance on how
to provide the electronic submission
(e.g., method of transmission, media,
file formats, preparation and organization of files.)
(b) Labeling. The content of labeling
required under § 201.100(d)(3) of this
chapter (commonly referred to as the
package insert or professional labeling), including all text, tables, and figures, must be submitted to the agency
in electronic format as described in
paragraph (a) of this section. This requirement is in addition to the provisions of §§ 601.2(a) and 601.12(f) that require applicants to submit specimens
of the labels, enclosures, and containers, or to submit other final printed labeling. Submissions under this
paragraph must be made in accordance
with part 11 of this chapter except for
the requirements of § 11.10(a), (c)
through (h), and (k), and the corresponding requirements of § 11.30.

EFFECTIVE DATE NOTE: At 71 FR 3997, Jan.
24, 2006, § 601.12 was amended by adding two
sentences after the second sentence and before the third sentence in paragraph (f)(1);
revising the introductory text of paragraph
(f)(2)(i); removing from paragraph (f)(3)(i)(B)
the word ‘‘and’’; removing from paragraph
(f)(3)(i)(C) the phrase ‘‘Medication Guide.’’
and adding in its place the phrase ‘‘Medication Guide; and’’; and adding paragraph
(f)(3)(i)(D), effective June 30, 2006. For the
convenience of the user, the additions and
revisions follow:

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§ 601.14 Regulatory submissions
electronic format.

[62 FR 39901, July 24, 1997, as amended at 63
FR 66399, Dec. 1, 1998. Redesignated at 65 FR
59718, Oct. 6, 2000, and amended at 69 FR
18766, Apr. 8, 2004; 70 FR 14983, Mar. 24, 2005]

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