106 STAT. 4500

PUBLIC LAW 102-571—OCT. 29, 1992

21 USC 379g
note.

Dietary
Supplement
Act of 1992.

21 USC 301
note.

21 USC 343
note.

(C) by indenting, and aligning the margins of, subpara-
grapha (A) and (B) of paragraph (2) (as so designated
by subparagraph (A)) so as to align with the subparagraphs
of paragraph (1).

(17) Section 10(c)(2XA) of the Nutrition Labeling and Edu-
cation Act of 1990 (21 U.S.C. 343 note) (as amended by section
1 of the Act entitled "An Act to make Technical Amendments
to the Nutrition Information and Labeling Act, and for other
purposes", approved August 17, 1991 (Public Law 102-108;
105 Stat. 549) is amended by striking "706" and inserting
"721".

SEC. 108. ANIMAL DRUG USER FEE STUDY.

(a) STUDY.—The Secretary, in consultation with manufacturers
of animal drug products and other interested persons, shall under-
take a study to evaluate whether, and under what conditions,
to impose user fees to supplement appropriated funds in order
to improve the process of reviewing applications (including abbre-
viated and supplemental applications) for new animal drugs under
section 512 of the Federal Food, Drug, and Cosmetic Act. The
study shall include—

(1) an assessment of the overall review process for animal
drugs at the Center for Veterinary Medicine, including the
number of applications received, and the average times for
interim and final decisions on each type of application,

(2) the current allocation of funds to the animal drug
review process,

(3) recommendations for goals for decision making times
on applications submitted to the Center for Veterinary Medicine
and for additional resources required to meet the goals, and

(4) recommendations for supplementing the resources for
the animal drug review process through user fees.

(b) COMPLETION.—The results of the study required by sub-
section (a) shall be presented no later than January 4, 1994, to
the Committee on Energy and Commerce of the House of Represent-
atives and the Committee on Labor and Human Resources of the
Senate.

TITLE II—DIETARY SUPPLEMENTS

SEC. 201. SHORT TITLE.

This title may be cited as the "Dietary Supplement Act of
1992".

SEC. 202. PROHIBITION.

(a) IN GENERAL.—

(1) PROHIBITION ON IMPLEMENTATION.—Notwithstanding
any other provision of law and except as provided in subsection

(b) and in the amendment made by paragraph (2XA), the Sec-
retary of Health and Human Services may not implement the
Nutrition Labeling and Education Act of 1990 (Public Law
101-535; 104 Stat. 2353), or any amendment made by such
Act, earlier than December 15, 1993, with respect to dietary
supplements of vitamins, minerals, herbs, or other similar
nutritional substances.

(2) FEDERAL REGULATORY ACTION.—