‘‘(i) widespread or otherwise significant
abuse of such drug or class in the United
States or any region of the United States poses
a serious threat to public health or safety,
‘‘(ii) there exists a well-documented and re-
liable method for toxicological urinalysis of such
drug or class and for establishing cutoff levels
applicable to such drug or class,
‘‘(iii) such test methods and cutoff levels
provide specificity and protection of the inter-
ests of test subjects equal to or greater than
that provided with respect to the drugs or class-
es for which test methods and cutoff levels have
been previously prescribed by the Secretary,
and
‘‘(iv) at least one laboratory certified under
section 571 has an interest in providing toxi-
cological urinalysis for the drug or class de-
scribed in the petition or comment and is com-
petent to do so.
A petitioner or commenter shall also furnish to the
Secretary such additional explanatory and support-
ing data as the Secretary may require.
‘‘(2)(A) Commencing 90 days following publica-
tion in the Federal Register of the request for public
comment described in paragraph (1)(B), and every
24 months thereafter, the Secretary shall review all
petitions received and pending under paragraph
(1)(A) and all comments received and pending under
paragraph (1)(B), together with additional explana-
tory and supporting data submitted by petitioners
and commenters and shall, with respect to each drug
or class of drugs which is the subject of a petition
or comment, determine whether the petitioner or
commenter has made the demonstration required by
paragraph (1)(C) and whether other facts, cir-
cumstances, or considerations outweigh the need to
prescribe test methods and cutoff levels for such
drug or class.
‘‘(B)(i) If the Secretary determines under sub-
paragraph (A) that a petitioner or commenter has
made the demonstration required by paragraph
(1)(C) and that no other facts, circumstances, or
considerations outweigh the need to prescribe test
methods and cutoff levels for such drug or class, the
Secretary shall by order issue a regulation prescrib-
ing test methods and cutoff levels for such drug or
class.
‘‘(ii) If the Secretary determines that a peti-
tioner has failed to make the demonstration required
by paragraph (1)(C) and that other facts, cir-
cumstances, or considerations outweigh the need to
prescribe test methods and cutoff levels as requested
in the petition, the Secretary shall by order deny the
petition and within 30 days thereafter notify the pe-
titioner of such order and of the reasons for such ac-
tion.
‘‘(C) The order required by subparagraph (B)
shall be issued within 90 days after review by the
Secretary commences under paragraph (2)(A), ex-
cept that the Secretary may (prior to such 90th
day), by written notice to a petitioner in the case of
a petition or publication in the Federal Register in
the case of a comment, extend such 90-day period
to such time (not more than 180 days after com-
mencement of such review) as the Secretary deems
necessary to permit appropriate study and investiga-
tion.
‘‘(d) AMATEUR ATHLETICS.—In issuing regulations
under subsection (a), the Secretary shall take into consid-
eration any special factors or circumstances applicable to
the testing of participants in—
‘‘(1) organized interscholastic or intercollegiate
athletic competition, or
‘‘(2) organized athletic competition conducted
under the auspices of or sanctioned by the United
States Olympic Committee or any member thereof,
that warrant separate or different treatment of such test-
ing under the regulations.
‘‘(e) REVISION.—The Secretary shall, in accordance
with section 553 of title 5, United States Code, revise the
regulations issued under subsection (a) as necessary to re-
flect improvements in drug testing methods for the pur-
pose of ensuring the full reliability and accuracy of drug
testing, the accurate reporting of results, and the integrity
and efficacy of drug testing programs.
‘‘SEC. 573. SPECIMEN COLLECTION PROCEDURES.
‘‘(a) IN GENERAL.—Not later than 1 year after the
date of enactment of this part, the Secretary shall issue
model specimen collection procedures for the guidance of
drug testing programs other than those conducted by Fed-
eral agencies under Executive Order 12564. Such model
procedures shall include provisions for designation of a
collection site, security, personnel access, and privacy in
the collection process, and precautions to ensure the integ-
rity and identity of specimens. In issuing such model pro-
cedures, the Secretary may recommend alternatives to ad-
dress appropriate particularized needs or circumstances,
including those applicable to athletic competition, and may
provide technical assistance to drug testing programs
adopting or considering adoption of such model proce-
dures.
‘‘(b) SAVINGS PROVISION.—Subsection (a) shall not
be construed to affect the applicability of the specimen col-
lection procedures in subpart B of the HHS guidelines to
drug testing programs conducted by Federal agencies
under Executive Order 12564.
‘‘SEC. 574. PROHIBITIONS.
‘‘(a) CERTIFICATION REQUIREMENT.—(1) No person
may perform any toxicological urinalysis in connection
with any drug testing program unless that person is a lab-
oratory which is certified under the certification program
established under section 571.
‘‘(2) It shall be unlawful for any laboratory certified
to perform toxicological urinalysis under the certification
program established under section 571 to perform toxi-
cological urinalyses in connection with any drug testing
program for any drug or drug class other than those listed
in section 571(c)(3)(A) unless—
‘‘(A) in a case where such other drug or drug
class is one for which the Secretary has prescribed
test methods and cutoff levels under section
572(b)(2) or 572(c), such laboratory is certified by
‘‘(5) the term ‘false positive result’ means a re-
port in connection with any toxicological urinalysis
of the presence of a drug in a urine specimen in
which that drug is not in fact present at or above
the cutoff level for that drug established by the
Secretary,
‘‘(6) the term ‘medical review officer’ has the
meaning given such term in subpart A of the HHS
guidelines,
‘‘(7) the term ‘person’ includes the Federal
Government, a State or local government, or any
agency of such a government,
‘‘(8) the term ‘performance testing’ means test-
ing of a laboratory’s ability—
‘‘(A) to identify correctly whether a urine
specimen contains a quantity of a drug, and
‘‘(B) in the case of a spiked specimen, to
identify correctly the amount of any drug in
that specimen within qualitative threshold levels
and quantitative ranges established by the regu-
lations issued under section 572,
‘‘(9) the term ‘spiked specimen’ means a urine
specimen into which a quantity of a drug or drugs
has intentionally been placed for use in performance
testing,