515 or a substantial equivalence determination
under section 513(f)(1), and shall’’.
(c) IMPROVING INTERIM PMA REVIEW MEETINGS.—
Section 515(d)(3)(A) (21 U.S.C. 360e(d)(3)(A)) is
amended—
(1) in clause (i), by inserting at the end the fol-
lowing: ‘‘The term application, as used in this para-
graph, shall include any submission made under this
section, or regulations implementing this section,
which is subject to a 180 day review period.’’; and
(2) in clause (ii), by inserting at the end the
following: ‘‘The written identification of deficiencies
and the specific information that is required to cor-
rect such deficiencies shall be provided to the appli-
cant no later than 10 days prior to the meeting.’’.
SEC. 9. GUIDANCE.
(a) IN GENERAL.—Section 701(h)(1)(C) (21 U.S.C.
371(h)(1)(C)) is amended—
(1) by inserting ‘‘(i)’’ after ‘‘(C)’’; and
(2) by adding at the end the following:
‘‘(ii)(I) After a request for participation from individ-
uals or groups not employed or associated with Federal
or State governments to participate in the development of
specific guidance or policy documents, the Secretary shall
meet with such individuals or groups to obtain input into
the guidance development process when such persons or
groups have expertise germane to the subject matter of
potential guidance or policy documents and, in the opinion
of the Secretary, such persons or groups can provide infor-
mation that will enhance the Secretary’s public health as-
sessment of the impact of a potential guidance or policy
document.
‘‘(II) Any request under subclause (I) shall identify
the expertise, and relevance of such expertise, to the devel-
opment of a guidance or policy document, or the informa-
tion that would justify a meeting because of the expected
benefit to the public health resulting from such informa-
tion.
‘‘(III) Each meeting with an individual or group
under subclause (I) shall be promptly identified through
publication of the Secretary’s calendar.’’.
SEC. 10. MODULAR REVIEW.
Section 515(c) (21 U.S.C. 360e(c)), as amended by
section 4(b) of this Act, is further amended by adding at
the end the following:
‘‘(4)(A) Prior to the submission of an application
under this subsection, the Secretary shall accept and re-
view portions of such applications that applicants and the
Secretary agree are complete and ready for review.
‘‘(B) Each portion of a submission reviewed under
subparagraph (A) and found acceptable by the Secretary
shall not be further reviewed after receipt of an application
that satisfies the requirements of paragraph (1), unless
new information provides the Secretary cause to review
such accepted portion.
‘‘(C) Whenever the Secretary determines that a por-
tion of a submission under subparagraph (A) is unaccept-
able, the Secretary shall specifically identify, in writing,
the deficiency of such portion and describe in detail the
means by which it may be made acceptable.’’.
SEC. 11. REGISTRATION.
(a) IN
GENERAL.—Section 510(b) (21 U.S.C.
360(b)) is amended to read as follows:
‘‘(b)(1) Every second year after initially registering,
every person who owns or operates any establishment in
any State, territory, or foreign country engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug or drugs or a device or devices shall
register with the Secretary his name, place of business,
and such establishment.
‘‘(2) Every person who registers under this section
shall update such person’s registration information within
30 days of any change or event, when information about
such change or event is required by regulations promul-
gated by the Secretary.
‘‘(3) Initial registrations and registration updates
shall be submitted to the Secretary by electronic means,
unless the Secretary grants a request for waiver of this
requirement because use of electronic communications is
not reasonable for the regulated person requesting such
waiver.’’.
(b) CONFORMING AMENDMENT.—Section 510(d) (21
U.S.C. 360(d)) is amended by striking ‘‘immediately’’.
SEC. 12. ELECTRONIC LABELING.
Section 201(m) (21 U.S.C. 321(m)) is amended by
adding at the end the following: ‘‘For purposes of pro-
viding adequate directions for use, labeling may also in-
clude written, printed, or graphic matter which is dis-
played by electronic means and is intended as labeling by
the person responsible for labeling an article.’’.
Æ