178 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)) prior to the date of enactment of this Act; 
(3) the status of public and private insurance 
coverage of devices granted an exemption under 
paragraph (2) of such section 520(m) and costs to 
patients of such devices; 
(4) the impact that paragraph (4) of such sec-
tion 520(m) has had on access to and insurance cov-
erage of devices granted an exemption under para-
graph (2) of such section 520(m); and 
(5) the effect of the amendments made by sub-
section (a) on patients described in such section 
520(m). 
Subtitle G—Records and Reports 
on Devices 
SEC. 761. UNIQUE DEVICE IDENTIFICATION SYSTEM REGU-
LATIONS. 
Not later than 120 days after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall promulgate the regulations required by section 
519(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360i(f)). 
SEC. 762. EFFECTIVE DEVICE SENTINEL PROGRAM. 
(a) INCLUSION OF DEVICES IN POSTMARKET RISK 
IDENTIFICATION AND ANALYSIS SYSTEM.—Section 519 
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(21 U.S.C. 360i) is amended by adding at the end the 
following: 
‘‘(h) INCLUSION OF DEVICES IN POSTMARKET RISK 
IDENTIFICATION AND ANALYSIS SYSTEM.— 
‘‘(1) IN GENERAL.—The Secretary shall amend 
the procedures established and maintained under 
clauses (i), (ii), (iii), and (v) of section 505(k)(3)(C) 
in order to expand the postmarket risk identification 
and analysis system established under such section 
to include and apply to devices. 
‘‘(2) DATA.—In expanding the system as de-
scribed in paragraph (1), the Secretary shall use rel-
evant data with respect to devices cleared under sec-
tion 510(k) or approved under section 515, which 
may include claims data, patient survey data, and 
standardized analytic files that allow for the pooling 
and analysis of data from disparate data environ-
ments. 
‘‘(3) STAKEHOLDER INPUT.—To help ensure ef-
fective implementation of the system as described in 
paragraph (1) with respect to devices, the Secretary 
shall engage outside stakeholders in development of 
the system, and gather information from outside 
stakeholders regarding the content of an effective 
sentinel program, through a public hearing, advisory 
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committee meeting, maintenance of a public docket, 
or other similar public measures. 
‘‘(4) VOLUNTARY
SURVEYS.—Chapter 35 of 
title 44, United States Code, shall not apply to the 
collection of voluntary information from health care 
providers, such as voluntary surveys or question-
naires, initiated by the Secretary for purposes of 
postmarket risk identification, mitigation, and anal-
ysis for devices.’’. 
(b) AMENDMENTS TO POSTMARKET RISK IDENTI-
FICATION
AND
ANALYSIS
SYSTEM.—Section 
505(k)(3)(C)(i) (21 U.S.C. 355(k)(3)(C)(i)) is amended— 
(1) by striking subclause (II); 
(2) by redesignating subclauses (III) through 
(VI) as subclauses (II) through (V), respectively; 
and 
(3) in item (bb) of subclause (II), as so redesig-
nated, by striking ‘‘pharmaceutical purchase data 
and health insurance claims data’’ and inserting 
‘‘medical device utilization data, health insurance 
claims data, and procedure and device registries’’. 
Subtitle H—Miscellaneous 
SEC. 771. CUSTOM DEVICES. 
Section 520(b) (21 U.S.C. 360j) is amended to read 
as follows: 
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‘‘(b) CUSTOM DEVICES.— 
‘‘(1) IN GENERAL.—The requirements of sec-
tions 514 and 515 shall not apply to a device that— 
‘‘(A) is created or modified in order to 
comply with the order of an individual physician 
or dentist (or any other specially qualified per-
son designated under regulations promulgated 
by the Secretary after an opportunity for an 
oral hearing); 
‘‘(B) in order to comply with an order de-
scribed in subparagraph (A), necessarily devi-
ates from an otherwise applicable performance 
standard under section 514 or requirement 
under section 515; 
‘‘(C) is not generally available in the 
United States in finished form through labeling 
or advertising by the manufacturer, importer, 
or distributor for commercial distribution; 
‘‘(D) is designed to treat a unique pathol-
ogy or physiological condition that no other de-
vice is domestically available to treat; 
‘‘(E)(i) is intended to meet the special 
needs of such physician or dentist (or other spe-
cially qualified person so designated) in the 
course of the professional practice of such phy-
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sician or dentist (or other specially qualified 
person so designated); or 
‘‘(ii) is intended for use by an individual 
patient named in such order of such physician 
or dentist (or other specially qualified person so 
designated); 
‘‘(F) is assembled from components or 
manufactured and finished on a case-by-case 
basis to accommodate the unique needs of indi-
viduals described in clause (i) or (ii) of subpara-
graph (E); and 
‘‘(G) may have common, standardized de-
sign characteristics, chemical and material com-
positions, and manufacturing processes as com-
mercially distributed devices. 
‘‘(2) LIMITATIONS.—Paragraph (1) shall apply 
to a device only if— 
‘‘(A) such device is for the purpose of 
treating a sufficiently rare condition, such that 
conducting clinical investigations on such device 
would be impractical; and 
‘‘(B) production of such device under para-
graph (1) is limited to no more than 5 units per 
year of a particular device type, provided that 
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such replication otherwise complies with this 
section. 
‘‘(3) GUIDANCE.—Not later than 2 years after 
the date of enactment of this section, the Secretary 
shall issue final guidance on replication of multiple 
devices described in paragraph (2)(B). 
‘‘(4) NOTIFICATION TO THE SECRETARY.—The 
manufacturer of such device created or modified as 
described in paragraph (1) shall notify the Secretary 
on an annual basis, in a manner prescribed by the 
Secretary, of the manufacture of such device.’’. 
SEC. 772. PEDIATRIC DEVICE REAUTHORIZATION. 
(a) FINAL RULE RELATING TO TRACKING OF PEDI-
ATRIC USES OF DEVICES.—The Secretary of Health and 
Human Services shall issue— 
(1) a proposed rule implementing section 
515A(a)(2) of the Federal Food, Drug and Cosmetic 
Act (21 U.S.C. 360e–1(a)(2)) not later than Decem-
ber 31, 2012; and 
(2) a final rule implementing such section not 
later than December 31, 2013. 
(b) DEMONSTRATION GRANTS TO IMPROVE PEDI-
ATRIC DEVICE AVAILABILITY.—Section 305(e) of the Pe-
diatric Medical Device Safety and Improvement Act of 
2007 (Title III of Public Law 110–85) is amended by 
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striking ‘‘2008 through 2012’’ and inserting ‘‘2013 
through 2017’’. 
SEC. 773. REPORT ON REGULATION OF HEALTH INFORMA-
TION TECHNOLOGY. 
(a) REPORT.—Not later than 18 months after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services, in consultation with the Commis-
sioner of Food and Drugs, the National Coordinator for 
Health Information Technology, and the Chairman of the 
Federal Communications Commission, shall submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the appropriate committees of the 
Senate a report that contains— 
(1) a strategy for coordinating the regulation of 
health information technology in order to avoid regu-
latory duplication; and 
(2) recommendations on an appropriate regu-
latory framework for health information technology, 
including a risk-based framework. 
(b) DEFINITION.—In this section, the terms ‘‘health 
information technology’’ has the meaning given such term 
in section 3000(5) of the Public Health Service Act and 
includes technologies such as electronic health records, 
personal health records, mobile medical applications, com-
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puterized health care provider order entry systems, and 
clinical decision support. 
TITLE VIII—DRUG REGULATORY 
IMPROVEMENTS 
Subtitle A—Drug Supply Chain 
SEC. 801. REGISTRATION OF PRODUCERS OF DRUGS. 
(a) TIMING.—Section 510 (21 U.S.C. 360) is amend-
ed— 
(1) in subsection (b)(1), by striking ‘‘On or be-
fore’’ and inserting ‘‘During the period beginning on 
October 1 and ending on’’; and 
(2) in subsection (i)(1)(B)(i), by striking ‘‘on or 
before’’ and inserting ‘‘during the period beginning 
on October 1 and ending on’’. 
(b) ESTABLISHMENTS NOT DULY REGISTERED; MIS-
BRANDING.—Section 502(o) (21 U.S.C. 352(o)) is amend-
ed by striking ‘‘in any State’’. 
SEC. 802. INSPECTION OF DRUGS. 
Subsection (h) of section 510 (21 U.S.C. 360) is 
amended— 
(1) by striking ‘‘(h)’’ and inserting ‘‘(h)(1)’’; 
(2) by inserting ‘‘with respect to the manufac-
ture, preparation, propagation, compounding, or 
processing of a device’’ after ‘‘registered with the 
Secretary pursuant to this section’’; 
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(3) by striking ‘‘of a drug or drugs or’’; and 
(4) by adding at the end the following: 
‘‘(2) INSPECTIONS WITH RESPECT TO DRUG ESTAB-
LISHMENTS.—With respect to the manufacture, prepara-
tion, propagation, compounding, or processing of a drug: 
‘‘(A) IN GENERAL.—Every establishment that 
is required to be registered with the Secretary under 
this section shall be subject to inspection pursuant 
to section 704. 
‘‘(B) RISK-BASED SCHEDULE.—In the case of 
an establishment that is engaged in the manufac-
ture, preparation, propagation, compounding, or 
processing of a drug or drugs (referred to in this 
subsection as a ‘drug establishment’), the inspec-
tions required under subparagraph (A) shall be con-
ducted by officers or employees duly designated by 
the Secretary, on a risk-based schedule established 
by the Secretary. 
‘‘(C) RISK FACTORS.—In establishing the risk- 
based schedule under subparagraph (B), the Sec-
retary shall allocate resources to inspect establish-
ments according to the known safety risks of such 
establishments, based on the following factors: 
‘‘(i) The compliance history of the estab-
lishment. 
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‘‘(ii) The inspection frequency and history 
of the establishment, including whether it has 
been inspected pursuant to section 704 within 
the last four years. 
‘‘(iii) The record, history, and nature of re-
calls linked to the establishment. 
‘‘(iv) The inherent risk of the drug manu-
factured, prepared, propagated, compounded, or 
processed at the establishment. 
‘‘(v) Any other criteria deemed necessary 
and appropriate by the Secretary for purposes 
of allocating inspection resources. 
‘‘(D) EFFECT OF STATUS.—In determining the 
risk associated with an establishment for purposes of 
establishing a risk-based schedule under subpara-
graph (B), the Secretary shall not consider whether 
the drugs manufactured, prepared, propagated, com-
pounded, or processed by such establishment are 
drugs described in section 503(b)(1). 
‘‘(E) ANNUAL REPORT ON INSPECTIONS OF ES-
TABLISHMENTS.—Not later than February 1 of each 
year, the Secretary shall submit to Congress a re-
port that contains the following: 
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‘‘(i) The number of domestic and foreign 
establishments registered pursuant to this sec-
tion in the previous calendar year. 
‘‘(ii) The number of such registered domes-
tic and foreign establishments that the Sec-
retary inspected in the previous calendar year. 
‘‘(iii) The number of such registered estab-
lishments that list one or more drugs approved 
pursuant to an application filed under section 
505(j). 
‘‘(iv) The number of such registered estab-
lishments that list one or more drugs approved 
pursuant to an application filed under section 
505(b). 
‘‘(v) The number of registered establish-
ments that list both drug products approved 
pursuant to an application filed under section 
505(j) and drug products approved pursuant to 
an application filed under section 505(b). 
‘‘(vi) A description of how the Secretary 
implemented the risk-based schedule under sub-
paragraph (B) utilizing the factors under sub-
paragraph (C). 
‘‘(F) PUBLIC
AVAILABILITY
OF
ANNUAL
RE-
PORTS.—The Secretary shall make the report re-
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quired under subparagraph (E) available to the pub-
lic on the Internet Web site of the Food and Drug 
Administration.’’. 
SEC. 803. DRUG SUPPLY QUALITY AND SAFETY. 
Paragraph (a) of section 501 (21 U.S.C. 351) is 
amended by adding at the end the following: ‘‘For pur-
poses of subparagraph (2)(B), the term ‘current good 
manufacturing practice’ includes the implementation of 
oversight and controls over the manufacture of drugs to 
ensure quality, including managing the risk of and estab-
lishing the safety of raw materials, materials used in the 
manufacturing of drugs, and finished drug products.’’. 
SEC. 804. PROHIBITION AGAINST DELAYING, DENYING, LIM-
ITING, OR REFUSING INSPECTION. 
(a) IN GENERAL.—Section 501 (21 U.S.C. 351) is 
amended by adding at the end the following: 
‘‘(j) If it is a drug and it has been manufactured, 
processed, packed, or held in any factory, warehouse, or 
establishment and the owner, operator, or agent of such 
factory, warehouse, or establishment delays, denies, or 
limits an inspection, or refuses to permit entry or inspec-
tion.’’. 
(b) GUIDANCE.—Not later than 1 year after the date 
of enactment of this section, the Secretary of Health and 
Human Services shall issue guidance that defines the cir-
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cumstances that would constitute delaying, denying, or 
limiting inspection, or refusing to permit entry or inspec-
tion, for purposes of section 501(j) of the Federal Food, 
Drug, and Cosmetic Act (as added by subsection (a)). 
SEC. 805. DESTRUCTION OF ADULTERATED, MISBRANDED, 
OR COUNTERFEIT DRUGS OFFERED FOR IM-
PORT. 
(a) IN GENERAL.—The sixth sentence of section 
801(a) (21 U.S.C. 381(a)) is amended by inserting before 
the period at the end the following: ‘‘, except that the Sec-
retary of Health and Human Services, in consultation with 
the Secretary of Homeland Security, may cause the de-
struction, without the opportunity for export, of any drug 
refused admission that has reasonable probability of caus-
ing serious adverse health consequences or death, as deter-
mined by the Secretary of Health and Human Services, 
or that is valued at an amount that is $2,000 or less (or 
such higher amount as the Secretary of Homeland Secu-
rity may set by regulation pursuant to section 1498 of 
title 19, United States Code)’’. 
(b) NOTICE.—Section 801(a) (21 U.S.C. 381(a)), as 
amended by subsection (a), is further amended by insert-
ing after the sixth sentence the following: ‘‘The Secretary 
of Health and Human Services shall issue regulations pro-
viding for notice and an opportunity for a hearing on the 
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destruction of a drug under the previous sentence. For a 
drug with a value less than and or equal to $2,000 (or, 
as described in the sixth sentence of this subsection, such 
higher amount as the Secretary of Homeland Security 
may set by regulation pursuant to section 1498 of title 
19, United States Code) the regulations under the pre-
vious sentence shall provide for prompt notice and an op-
portunity for a hearing for the owner or consignee before 
or after the destruction has occurred. For a drug with a 
value greater than $2,000 (or, as described in the sixth 
sentence of this subsection, such higher amount as the 
Secretary of Homeland Security may set by regulation 
pursuant to section 1498 of title 19, United States Code) 
that has reasonable probability of causing serious adverse 
health consequences or death as determined by the Sec-
retary of Health and Human Services, the regulations 
under the seventh sentence of this subsection shall provide 
for notice and an opportunity for a hearing to the owner 
or consignee before the destruction occurs.’’. 
(c) RESTITUTION.—In the regulations described in 
the seventh sentence of section 801(a) of the Federal 
Food, Drug, and Cosmetic Act (as added by subsection 
(b)), the Secretary of Health and Human Services shall 
establish an administrative process whereby an owner or 
consignee of a drug destroyed without an opportunity for 
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a hearing on destruction may obtain restitution for the 
value of the drug destroyed under the sixth sentence of 
such section upon demonstration that such drug was 
wrongfully destroyed. 
(d) CONFORMING AMENDMENT.—The first sentence 
of section 801(a) (21 U.S.C. 381(a)) is amended by insert-
ing ‘‘, except as otherwise described in the sixth and sev-
enth sentences of this subsection,’’ after ‘‘giving notice 
thereof’’. 
SEC. 806. ADMINISTRATIVE DETENTION. 
(a) IN
GENERAL.—Section 304(g) (21 U.S.C. 
335a(g)) is amended— 
(1) in paragraph (1), by inserting ‘‘, drug,’’ 
after ‘‘device’’, each place it appears; 
(2) in paragraph (2)(A), by inserting ‘‘, drug,’’ 
after ‘‘(B), a device’’; and 
(3) in paragraph (2)(B), by inserting ‘‘or drug’’ 
after ‘‘device’’ each place it appears. 
(b) REGULATION.—Not later than 2 years after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall promulgate regulations to im-
plement administrative detention authority with respect to 
drugs, as authorized by the amendments made by sub-
section (a). Before promulgating such regulations, the 
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Secretary shall consult with stakeholders, including manu-
facturers of drugs. 
(c) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall not take effect until the Secretary has 
issued a final regulation under subsection (b). 
SEC. 807. ENHANCED CRIMINAL PENALTY FOR COUNTER-
FEIT DRUGS. 
(a) IN
GENERAL.—Section 303(a) (21 U.S.C. 
333(a)) is amended by adding at the end the following: 
‘‘(3) Notwithstanding paragraph (2), any person who 
engages in any conduct described in section 301(i)(2) 
knowing or having reason to know that the conduct con-
cerns the rendering of a drug as a counterfeit drug, or 
who engages in conduct described in section 301(i)(3) 
knowing or having reason to know that the conduct will 
cause a drug to be a counterfeit drug or knowing or having 
reason to know that a drug held, sold, or dispensed is a 
counterfeit drug, shall be fined in accordance with title 
18, United States Code, or imprisoned not more than 20 
years, or both, except that if the use of the counterfeit 
drug by a consumer is the proximate cause of the death 
of the consumer, the term of imprisonment shall be any 
term of years or for life.’’. 
(b) CONFORMING AMENDMENT.—Section 201(g)(2) 
(21 U.S.C. 321(g)(2)) is amended by adding at the end 
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later than 5 years after the approval of the applica-
ble rare pediatric disease product application. Such 
report shall provide the following information, with 
respect to each of the first 4 years after approval of 
such product: 
‘‘(A) The estimated population in the 
United States suffering from the rare pediatric 
disease. 
‘‘(B) The estimated demand in the United 
States for such rare pediatric disease product. 
‘‘(C) The actual amount of such rare pedi-
atric disease product distributed in the United 
States. 
‘‘(f) NOTICE AND REPORT.— 
‘‘(1) NOTICE OF ISSUANCE OF VOUCHER AND 
APPROVAL
OF
PRODUCTS
UNDER
VOUCHER.—The 
Secretary shall publish a notice in the Federal Reg-
ister and on the Web site of the Food and Drug Ad-
ministration not later than 30 days after the occur-
rence of each of the following: 
‘‘(A) The Secretary issues a priority review 
voucher under this section. 
‘‘(B) The Secretary approves a drug pur-
suant to an application submitted under section 
505(b) of this Act or section 351(a) of the Pub-
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