102 STAT. 3982

PUBLIC LAW 100-670—NOV. 16, 1988

21 USC 360b.
21 USC 360b.
21 USC 360b
note.
Public
information.

"(G) the application failed to contain the patent information
prescribed by subsection (b)(l);".
 (3)	The second sentence of section 512(d)(l) is amended by
striking out "(H)" and inserting in lieu thereof "(G)".
 (4)	The first sentence of section 512(e)(l) is amended by re-
designating subparagraphs (D) and (E) as subparagraphs (E) and
(F), respectively, and by inserting after subparagraph (C) the
following:
"(D) the patent information prescribed by subsection (c)(3) was
not filed within 30 days after the receipt of written notice from
the Secretary specifying the failure to file such information;".
SEC. 103. REGULATIONS.
 (a)	general rule.—The Secretary of Health and Human Services
shall promulgate, in accordance with the notice and comment
requirements of section 553 of title 5, United States Code, such
regulations as may be necessary for the administration of section
512 of the Federal Food, Drug, and Cosmetic Act, as amended by
sections 101 through 103 of this title, within one year of the date of
enactment of this Act.
 (b)	transition.—During the period beginning 60 days after the
date of enactment of this Act and ending on the date regulations
promulgated under subsection (a) take effect, abbreviated new
animal drug applications may be submitted in accordance with the
provisions of section 314.55 and part 320 of title 21 of the Code of
Federal Regulations and shall be considered as suitable for any drug
which has been approved for safety and effectiveness under section
512(c) of the Federal Food, Drug, and Cosmetic Act before the date of
enactment of this Act. If any such provision of section 314.55 or part
320 is inconsistent with the requirements of section 512 of the
Federal Food, Drug, and Cosmetic Act (as amended by this title), the
Secretary shall  consider the  application  under  the  applicable
requirements of section 512 (as so amended).
SEC. 104. SAFETY AND EFFECTIVENESS DATA.
Section 512 (as amended by section 101(b) of this title) is amended
by adding at the end the following:
"(pXD Safety and effectiveness data and information which has
been submitted in an application filed under subsection (b)(l) for a
drug and which has not previously been disclosed to the public shall
be made available to the public, upon request, unless extraordinary
circumstances are shown—
"(A) if no work is being or will be undertaken to have the
application approved,
'(B) if the Secretary has determined that the application is
not approvable and all legal appeals have been exhausted,
"(C) if approval of the application under subsection (c) is
withdrawn and all legal appeals have been exhausted,
"(D) if the Secretary has determined that such drug is not a
new drug, or
"(E) upon the effective date of the approval of the first
application filed under subsection (b)(2) which refers to such
drug or upon the date upon which the approval of an applica-
tion filed under subsection (b)(2) which refers to such drug could
(( be made effective if such an application had been filed.
"(2) Any request for data and information pursuant to paragraph
(1) shall include a verified statement by the person making the