[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.22]
[Page 319-321]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 60 PATENT TERM RESTORATION--Table of Contents
Subpart C Regulatory Review Period Determinations
Sec. 60.22 Regulatory review period determinations.
In determining a product's regulatory review period, which consists
of the sum of the lengths of a testing phase and an approval phase, FDA
will review the information in each application using the following
definitions of the testing phase and the approval phase for that class
of products.
(a) For human drugs:
(1) The testing phase begins on the date an exemption under section
505(i) of the Act becomes effective (or the date an exemption under
former section 507(d) of the Act became effective) for the approved
human drug product and ends on the date a marketing application under
section 351 of the Public Health Service Act or section 505 of the act
is initially submitted to FDA (or was initially submitted to FDA under
former section 507 of the Act), and
(2) The approval phase begins on the date a marketing application
under section 351 of the Public Health Service Act or section 505(b) of
the Act is initially submitted to FDA (or was initially submitted under
former section 507 of the Act) and ends on the date the application is
approved.
[[Page 320]]
(b) For food and color additives:
(1) The testing phase begins on the date a major health or
environmental effects test is begun and ends on the date a petition
relying on the test and requesting the issuance of a regulation for use
of the additive under section 409 or 721 of the Act is initially
submitted to FDA.
(2) The approval phase begins on the date a petition requesting the
issuance of a regulation for use of the additive under section 409 or
721 of the Act is initially submitted to FDA and ends upon whichever of
the following occurs last:
(i) The regulation for the additive becomes effective; or
(ii) Objections filed against the regulation that result in a stay
of effectiveness are resolved and commercial marketing is permitted; or
(iii) Proceedings resulting from objections to the regulation, after
commercial marketing has been permitted and later stayed pending
resolution of the proceedings, are finally resolved and commercial
marketing is permitted.
(c) For medical devices:
(1) The testing phase begins on the date a clinical investigation on
humans is begun and ends on the date an application for premarket
approval of the device or a notice of completion of a product
development protocol is initially submitted under section 515 of the
Act. For purposes of this part, a clinical investigation is considered
to begin on whichever of the following dates applies:
(i) If an investigational device exemption (IDE) under section
520(g) of the Act is required, the effective date of the exemption.
(ii) If an IDE is not required, but institutional review board (IRB)
approval under section 520(g)(3) of the Act is required, the IRB
approval date.
(iii) If neither an IDE nor IRB approval is required, the date on
which the device is first used with human subjects as part of a clinical
investigation to be filed with FDA to secure premarket approval of the
device.
(2) The approval phase either:
(i) Begins on the date an application for premarket approval of the
device is initially submitted under section 515 of the Act and ends on
the date the application is approved; or
(ii) Begins on the date a notice of completion of a product
development protocol is initially submitted under section 515 of the Act
and ends on the date the protocol is declared to be completed.
(d) For animal drugs:
(1) The testing phase begins on the date a major health or
environmental effects test is begun or the date on which the agency
acknowledges the filing of a notice of claimed investigational exemption
for a new animal drug, whichever is earlier, and ends on the date a
marketing application under section 512 of the Act is initially
submitted to FDA.
(2) The approval phase begins on the date a marketing application
under section 512 of the Act is initially submitted to FDA and ends on
the date the application is approved.
(e) For purposes of this section, a ``major health or environmental
effects test'' may be any test which:
(1) Is reasonably related to the evaluation of the product's health
or environmental effects, or both:
(2) Produces data necessary for marketing approval; and
(3) Is conducted over a period of no less than 6 months duration,
excluding time required to analyze or evaluate test results.
(f) For purposes of determining the regulatory review period for any
product, a marketing application, a notice of completion of a product
development protocol, or a petition is initially submitted on the date
it contains sufficient information to allow FDA to commence review of
the application. A marketing application, a notice of completion of a
product development protocol, or a petition is approved on the date FDA
sends the applicant a letter informing it of the approval or, by order
declares a product development protocol to be completed, or, in the case
of food and color additives, on the effective date of the final rule
listing the additive for use as published in the Federal Register or, in
the case of a new animal drug in a Category II Type A medicated article,
on the date of publication in the Federal Register of the notice of
approval pursuant to
[[Page 321]]
section 512(i) of the Act. For purposes of this section, the regulatory
review period for an animal drug shall mean either the regulatory review
period relating the drug's approval for use in nonfood-producing animals
or the regulatory review period relating to the drug's approval for use
in food-producing animals, whichever is applicable.
[53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56262, Nov. 27, 1992; 64
FR 400, Jan. 5, 1999]
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