tions of laboratories for compliance with this 
section and section 353; and 
‘‘(B) during an inspection under subpara-
graph (A), may require a test-offering entity to 
provide evidence of clinical validity for any 
claim made for a DTC DNA test offered or 
marketed by that entity. 
‘‘(3) PROPRIETARY OR CONFIDENTIAL INFOR-
MATION.—The Secretary shall establish procedures 
to protect any proprietary or confidential informa-
tion concerning an LDT or DTC DNA test that may 
be disclosed during an inspection under this sub-
section. 
‘‘(k) DELEGATION.—The Secretary shall administer 
this section solely through the Centers for Medicare & 
Medicaid Services. The Administrator may— 
‘‘(1) pursuant to agreement, designate a non-
governmental organization that has qualifications 
and expertise in the evaluation of laboratory testing 
and in evaluating the analytical and clinical validity 
of laboratory tests to assist in the review of pre-
market notifications and test registry data bank in-
formation and in the performance of inspections au-
thorized under subsection (j); and 
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‘‘(2) subject to the provisions of section 353(e), 
designate an accreditation organization to assist in 
the review of premarket notifications and test reg-
istry data bank information and in the performance 
of inspections authorized under subsection (j). 
‘‘(l) FEDERAL TRADE COMMISSION.—Nothing in this 
section shall be construed to limit regulation of advertising 
under the Federal Trade Commission Act.’’. 
SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
(a) DEVICE DEFINITION.—Section 201(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(h)) is amended by adding at the end the following: 
‘‘The term ‘device’ does not include a laboratory-developed 
test or a direct-to-consumer DNA test as defined in sec-
tion 353A of the Public Health Service Act.’’. 
(b) REGISTRATION EXCLUSION.—Section 510(g) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360(g)) is amended— 
(1) by redesignating paragraphs (4) and (5) as 
(5) and (6), respectively; and 
(2) by inserting after paragraph (3) the fol-
lowing: 
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‘‘(4) clinical laboratories certified under section 
353 of the Public Health Service Act insofar as such 
laboratories— 
‘‘(A) use devices to perform laboratory 
tests; or 
‘‘(B) create and perform laboratory-devel-
oped tests as defined in section 353A of such 
Act;’’. 
SEC. 4. FEES. 
Section 353(m) of the Public Health Service Act (42 
U.S.C. 263a(m)) is amended— 
(1) in paragraph (2), by adding at the end the 
following sentence: ‘‘In the case of a laboratory or 
test-offering entity that is required to submit infor-
mation under section 353A(b)(2)(A), the Secretary 
shall also require the payment of fees for reviews of 
premarket notifications and supplemental notifica-
tions submitted pursuant to subparagraph (A), (B), 
or (C) of section 353A(c)(2), registration of test-of-
fering entities under section 353A(d), and inspec-
tions conducted pursuant to section 353A(j).’’; 
(2) in paragraph (3)(B)— 
(A) by striking ‘‘inspections and pro-
ficiency testing described in paragraph (2)’’ and 
inserting ‘‘inspections and proficiency testing 
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described in the first sentence of paragraph 
(2)’’; and 
(B) by striking the period at the end and 
inserting ‘‘, review of premarket notifications 
and supplemental notifications submitted pursu-
ant to subparagraph (A), (B), or (C) of section 
353A(c)(2), registration of test-offering entities 
under section 353A(d), and inspections con-
ducted pursuant to section 353A(j)’’; and 
(3) by adding at the end the following new 
paragraph: 
‘‘(4) FISCAL REPORT.—By December 31, 2011, 
and by the end of each calendar year thereafter, the 
Secretary shall prepare and submit to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report 
on the amount of fees collected during the preceding 
fiscal year under this subsection and the amount of 
fees collected under this subsection available to sup-
port activities under this section and section 353A. 
Before increasing the amount of any fee required by 
this subsection, the Secretary shall include in a re-
port under this paragraph an explanation of the 
need for such an increase, including the likely reve-
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nues and expenses expected to be incurred. The ef-
fective date of any such increase shall not be sooner 
than the date that is 120 days after the submission 
of the report containing such explanation.’’. 
Æ 
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