152 
‘‘(1) 15 OR MORE DAYS IN ADVANCE.—As soon 
as practicable, but (except as provided in paragraph 
(2)) not later than 15 days prior to a meeting of an 
advisory committee to which a written determination 
as referred to in section 208(b)(1) of title 18, 
United States Code, or a written certification as re-
ferred to in section 208(b)(3) of such title, applies, 
the Secretary shall disclose (other than information 
exempted from disclosure under section 552 or sec-
tion 552a of title 5, United States Code (popularly 
known as the Freedom of Information Act and the 
Privacy Act of 1974, respectively)) on the Internet 
Website of the Food and Drug Administration— 
‘‘(A) the type, nature, and magnitude of 
the financial interests of the advisory committee 
member to which such determination or certifi-
cation applies; and 
‘‘(B) the reasons of the Secretary for such 
determination or certification, including, as ap-
propriate, the public health interest in having 
the expertise of the member with respect to the 
particular matter before the advisory com-
mittee. 
‘‘(2) LESS THAN 30 DAYS IN ADVANCE.—In the 
case of a financial interest that becomes known to 
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the Secretary less than 30 days prior to a meeting 
of an advisory committee to which a written deter-
mination as referred to in section 208(b)(1) of title 
18, United States Code, or a written certification as 
referred to in section 208(b)(3) of such title applies, 
the Secretary shall disclose (other than information 
exempted from disclosure under section 552 or 552a 
of title 5, United States Code) on the Internet 
Website of the Food and Drug Administration, the 
information described in subparagraphs (A), (B), 
and (C) of paragraph (1) as soon as practicable 
after the Secretary makes such determination or cer-
tification, but in no case later than the date of such 
meeting.’’; 
(2) in subsection (d), by striking ‘‘subsection 
(c)(3)’’ and inserting ‘‘subsection (c)’’; 
(3) by amending subsection (e) to read as fol-
lows: 
‘‘(e) ANNUAL REPORT.— 
‘‘(1) IN GENERAL.—Not later than February 1 
of each year, the Secretary shall submit to the Com-
mittee on Appropriations and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate, and the Committee on Appropriations and the 
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Committee on Energy and Commerce of the House 
of Representatives, a report that describes— 
‘‘(A) with respect to the fiscal year that 
ended on September 30 of the previous year, 
the number of persons nominated for participa-
tion at meetings for each advisory committee, 
the number of persons so nominated, and will-
ing to serve, the number of vacancies on each 
advisory committee, and the number of persons 
contacted for service as members on each advi-
sory committee meeting for each advisory com-
mittee who did not participate because of the 
potential for such participation to constitute a 
disqualifying financial interest under section 
208 of title 18, United States Code; 
‘‘(B) with respect to such year, the number 
of persons contacted for services as members 
for each advisory committee meeting for each 
advisory committee who did not participate be-
cause of reasons other than the potential for 
such participation to constitute a disqualifying 
financial interest under section 208 of title 18, 
United States Code; 
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‘‘(C) with respect to such year, the number 
of members attending meetings for each advi-
sory committee; and 
‘‘(D) with respect to such year, the aggre-
gate number of disclosures required under sub-
section (d) and the percentage of individuals to 
whom such disclosures did not apply who served 
on such committee. 
‘‘(2) PUBLIC AVAILABILITY.—Not later than 30 
days after submitting any report under paragraph 
(1) to the committees specified in such paragraph, 
the Secretary shall make each such report available 
to the public.’’; and 
(4) in subsection (f), by striking ‘‘shall review 
guidance’’ and all that follows through the end of 
the subsection and inserting the following: ‘‘shall— 
‘‘(1) review guidance of the Food and Drug Ad-
ministration with respect to advisory committees re-
garding disclosure of conflicts of interest and the ap-
plication of section 208 of title 18, United States 
Code; and 
‘‘(2) update such guidance as necessary to en-
sure that the Food and Drug Administration re-
ceives appropriate access to needed scientific exper-
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156 
tise, with due consideration of the requirements of 
such section 208.’’. 
(b) APPLICABILITY.—The amendments made by sub-
section (a) apply beginning on October 1, 2012. 
SEC. 603. ELECTRONIC SUBMISSION OF APPLICATIONS. 
Subchapter D of chapter VII (21 U.S.C. 379k et 
seq.) is amended by inserting after section 745 the fol-
lowing: 
‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 
‘‘(a) DRUGS AND BIOLOGICS.— 
‘‘(1) IN GENERAL.—Beginning no earlier than 
24 months after the issuance of a final guidance 
issued after public notice and opportunity for com-
ment, submissions under subsection (b), (i), or (j) of 
section 505 of this Act or subsection (a) or (k) of 
section 351 of the Public Health Service Act shall 
be submitted in such electronic format as specified 
by the Secretary in such guidance. 
‘‘(2) GUIDANCE CONTENTS.—In the guidance 
under paragraph (1), the Secretary may— 
‘‘(A) provide a timetable for establishment 
by the Secretary of further standards for elec-
tronic submission as required by such para-
graph; and 
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‘‘(B) set forth criteria for waivers of and 
exemptions from the requirements of this sub-
section. 
‘‘(3) EXCEPTION.—This subsection shall not 
apply to submissions described in section 561. 
‘‘(b) DEVICES.— 
‘‘(1) 
IN
GENERAL.—Beginning 
after 
the 
issuance of final guidance implementing this para-
graph, pre-submissions and submissions for devices 
under section 510(k), 513(f)(2)(A), 515(c), 515(d), 
515(f), 520(g), 520(m), or 564 of this Act or section 
351 of the Public Health Service Act, and any sup-
plements to such pre-submissions or submissions, 
shall include an electronic copy of such pre-submis-
sions or submissions. 
‘‘(2) GUIDANCE CONTENTS.—In the guidance 
under paragraph (1), the Secretary may— 
‘‘(A) provide standards for the electronic 
copy required under such paragraph; and 
‘‘(B) set forth criteria for waivers of and 
exemptions from the requirements of this sub-
section.’’. 
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158 
SEC. 604. NOTIFICATION OF FDA INTENT TO REGULATE 
LABORATORY-DEVELOPED TESTS. 
The Food and Drug Administration may not issue 
any draft or final guidance on the regulation of laboratory- 
developed tests under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) without, at least 60 
days prior to such issuance— 
(1) notifying the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate of the Administration’s intent to 
take such action; and 
(2) including in such notification the antici-
pated details of such action. 
TITLE VII—MEDICAL DEVICE 
REGULATORY IMPROVEMENTS 
Subtitle A—Premarket 
Predictability 
SEC. 701. INVESTIGATIONAL DEVICE EXEMPTIONS. 
Section 520(g) (21 U.S.C. 360j(g)) is amended— 
(1) in paragraph (2)(B)(ii), by inserting ‘‘safety 
or effectiveness’’ before ‘‘data obtained’’; and 
(2) in paragraph (4), by adding at the end the 
following: 
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‘‘(C) Consistent with paragraph (1), the Secretary 
shall not disapprove an application under this subsection 
because the Secretary determines that— 
‘‘(i) the investigation may not support a sub-
stantial equivalence or de novo classification deter-
mination or approval of the device; 
‘‘(ii) the investigation may not meet a require-
ment, including a data requirement, relating to the 
approval or clearance of a device; or 
‘‘(iii) an additional or different investigation 
may be necessary to support clearance or approval 
of the device.’’. 
SEC. 702. CLARIFICATION OF LEAST BURDENSOME STAND-
ARD. 
(a) PREMARKET APPROVAL.—Section 513(a)(3)(D) 
(21 U.S.C. 360c(a)(3)(D)) is amended— 
(1) by redesignating clause (iii) as clause (v); 
and 
(2) by inserting after clause (ii) the following: 
‘‘(iii) For purposes of clause (ii), the 
term ‘necessary’ means the minimum re-
quired information that would support a 
determination by the Secretary that an ap-
plication provides reasonable assurance of 
the effectiveness of the device. 
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‘‘(iv) Nothing in this subparagraph 
shall alter the criteria for evaluating an 
application for premarket approval of a de-
vice.’’. 
(b) PREMARKET NOTIFICATION UNDER SECTION 
510(k).—Section 513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) 
is amended— 
(1) by striking ‘‘(D) Whenever’’ and inserting 
‘‘(D)(i) Whenever’’; and 
(2) by adding at the end the following: 
‘‘(ii) For purposes of clause (i), the term ‘necessary’ 
means the minimum required information that would sup-
port a determination of substantial equivalence between 
a new device and a predicate device. 
‘‘(iii) Nothing in this subparagraph shall alter the 
standard for determining substantial equivalence between 
a new device and a predicate device.’’. 
SEC. 703. AGENCY DOCUMENTATION AND REVIEW OF SIG-
NIFICANT DECISIONS. 
Chapter V is amended by inserting after section 517 
(21 U.S.C. 360g) the following: 
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161 
‘‘SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF 
SIGNIFICANT 
DECISIONS 
REGARDING 
DE-
VICES. 
‘‘(a) DOCUMENTATION OF RATIONALE FOR SIGNIFI-
CANT DECISIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall com-
pletely document the scientific and regulatory ration-
ale for any significant decision of the Center for De-
vices and Radiological Health regarding submission 
or review of a report under section 510(k), an appli-
cation under section 515, or an application for an 
exemption under section 520(g), including docu-
mentation of significant controversies or differences 
of opinion and the resolution of such controversies 
or differences of opinion. 
‘‘(2) PROVISION
OF
DOCUMENTATION.—Upon 
request, the Secretary shall furnish such complete 
documentation to the person who is seeking to sub-
mit, or who has submitted, such report or applica-
tion. 
‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 
‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF 
SIGNIFICANT DECISION.—Any person may request a 
supervisory review of the significant decision de-
scribed in subsection (a)(1). Such review may be 
conducted at the next supervisory level or higher 
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162 
above the individual who made the significant deci-
sion. 
‘‘(2) SUBMISSION OF REQUEST.—A person re-
questing a supervisory review under paragraph (1) 
shall submit such request to the Secretary not later 
than 30 days after such decision and shall indicate 
in the request whether such person seeks an in-per-
son meeting or a teleconference review. 
‘‘(3) TIMEFRAME.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Secretary shall schedule 
an in-person or teleconference review, if so re-
quested, not later than 30 days after such re-
quest is made. The Secretary shall issue a deci-
sion to the person requesting a review under 
this subsection not later than 45 days after the 
request is made under paragraph (1), or, in the 
case of a person who requests an in-person 
meeting or teleconference, 30 days after such 
meeting or teleconference. 
‘‘(B) 
EXCEPTION.—Subparagraph 
(A) 
shall not apply in cases that are referred to ex-
perts outside of the Food and Drug Adminis-
tration.’’. 
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163 
SEC. 704. TRANSPARENCY IN CLEARANCE PROCESS. 
(a) PUBLICATION
OF DETAILED DECISION SUM-
MARIES.—Section 520(h) (21 U.S.C. 360j(h)) is amended 
by adding at the end the following: 
‘‘(5) Subject to subsection (c) and section 301(j), the 
Secretary shall regularly publish detailed decision sum-
maries for each clearance of a device under section 510(k) 
requiring clinical data.’’. 
(b) APPLICATION.—The requirement of section 
520(h)(5) of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a), applies only with respect to 
clearance of a device occurring after the date of the enact-
ment of this Act. 
SEC. 705. DEVICE MODIFICATIONS REQUIRING PREMARKET 
NOTIFICATION PRIOR TO MARKETING. 
Section 510(n) (21 U.S.C. 360(n)) is amended by— 
(1) striking ‘‘(n) The Secretary’’ and inserting 
‘‘(n)(1) The Secretary’’; and 
(2) by adding at the end the following: 
‘‘(2)(A) Not later than 18 months after the en-
actment of this paragraph, the Secretary shall sub-
mit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate a report regarding when a premarket notification 
under subsection (k) should be submitted for a 
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modification or change to a legally marketed device. 
The report shall include the Secretary’s interpreta-
tion of the following terms: ‘could significantly affect 
the safety or effectiveness of the device’, ‘a signifi-
cant change or modification in design, material, 
chemical composition, energy source, or manufac-
turing process,’, and ‘major change or modification 
in the intended use of the device’. The report also 
shall discuss possible processes for industry to use to 
determine whether a new submission under sub-
section (k) is required and shall analyze how to le-
verage existing quality system requirements to re-
duce premarket burden, facilitate continual device 
improvement. and provide reasonable assurance of 
safety and effectiveness of modified devices. In de-
veloping such report, the Secretary shall consider the 
input of interested stakeholders. 
‘‘(B) The Secretary shall withdraw the Food 
and Drug Administration draft guidance entitled 
‘Guidance for Industry and FDA Staff—510(k) De-
vice Modifications: Deciding When to Submit a 
510(k) for a Change to an Existing Device’, dated 
July 27, 2011, and shall not use this draft guidance 
as part of, or for the basis of, any premarket review 
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or any compliance or enforcement decisions or ac-
tions. The Secretary shall not issue— 
‘‘(i) any draft guidance or proposed regula-
tion that addresses when to submit a premarket 
notification submission for changes and modi-
fications made to a manufacturer’s previously 
cleared device before the receipt by the Com-
mittee on Energy and Commerce of the House 
of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the 
Senate of the report required in subparagraph 
(A); and 
‘‘(ii) any final guidance or regulation on 
that topic for one year after date of receipt of 
such report by the Committee on Energy and 
Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, 
and Pensions of the Senate. 
‘‘(C) The Food and Drug Administration guid-
ance entitled ‘Deciding When to Submit a 510(k) for 
a Change to an Existing Device’, dated January 10, 
1997, shall be in effect until the subsequent issuance 
of guidance or promulgation, if appropriate, of a 
regulation described in subparagraph (B), and the 
Secretary shall interpret such guidance in a manner 
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166 
that is consistent with the manner in which the Sec-
retary has interpreted such guidance since 1997.’’. 
Subtitle B—Patients Come First 
SEC. 711. ESTABLISHMENT OF SCHEDULE AND PROMULGA-
TION OF REGULATION. 
(a) ESTABLISHMENT OF SCHEDULE.—Not later than 
90 days after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall establish the 
schedule referred to in section 515(i)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)). 
(b) REGULATION.—Not later than one year after the 
date that the schedule is established under such section 
515(i)(3) (as required by subsection (a)) the Secretary 
shall issue a final regulation under section 515(b) of such 
Act for each device that the Secretary requires to remain 
in class III through a determination under section 
515(i)(2) of such Act. 
SEC. 712. PROGRAM TO IMPROVE THE DEVICE RECALL SYS-
TEM. 
Chapter V is amended by inserting after section 518 
(21 U.S.C. 360h) the following: 
‘‘SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL 
SYSTEM. 
‘‘(a) IN GENERAL.—The Secretary shall— 
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167 
‘‘(1) establish a program to routinely and sys-
tematically assess information relating to device re-
calls and use such information to proactively identify 
strategies for mitigating health risks presented by 
defective or unsafe devices; 
‘‘(2) clarify procedures for conducting device re-
call audit checks to improve the ability of investiga-
tors to perform those checks in a consistent manner; 
‘‘(3) develop detailed criteria for assessing 
whether a person performing a device recall has per-
formed an effective correction or action plan for the 
recall; and 
‘‘(4) document the basis for each termination 
by the Food and Drug Administration of a device re-
call. 
‘‘(b) ASSESSMENT CONTENT.—The program estab-
lished under subsection (a)(1) shall, at a minimum, iden-
tify— 
‘‘(1) trends in the number and types of device 
recalls; 
‘‘(2) devices that are most frequently the sub-
ject of a recall; and 
‘‘(3) underlying causes of device recalls. 
‘‘(c) DEFINITION.—In this section, the term ‘recall’ 
means— 
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‘‘(1) the removal from the market of a device 
pursuant to an order of the Secretary under sub-
section (b) or (e) of section 518; or 
‘‘(2) the correction or removal from the market 
of a device at the initiative of the manufacturer or 
importer of the device that is required to be reported 
to the Secretary under section 519(g).’’. 
Subtitle C—Novel Device 
Regulatory Relief 
SEC. 721. MODIFICATION OF DE NOVO APPLICATION PROC-
ESS. 
(a) IN GENERAL.—Section 513(f)(2) (21 U.S.C. 
360c(f)(2)) is amended— 
(1) by inserting ‘‘(i)’’ after ‘‘(2)(A)’’; 
(2) in subparagraph (A)(i), as so designated by 
paragraph (1), by striking ‘‘under the criteria set 
forth’’ and all that follows through the end of sub-
paragraph (A) and inserting a period; 
(3) by adding at the end of subparagraph (A) 
the following: 
‘‘(ii) In lieu of submitting a report under section 
510(k) and submitting a request for classification under 
clause (i) for a device, if a person determines there is no 
legally marketed device upon which to base a determina-
tion of substantial equivalence (as defined in subsection 
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169 
(i)), a person may submit a request under this clause for 
the Secretary to classify the device. 
‘‘(iii) Upon receipt of a request under clause (i) or 
(ii), the Secretary shall classify the device subject to the 
request under the criteria set forth in subparagraphs (A) 
through (C) of subsection (a)(1) within 120 days. 
‘‘(iv) Notwithstanding clause (iii), the Secretary may 
decline to undertake a classification of a device pursuant 
to a request under clause (ii) if the Secretary— 
‘‘(I) identifies a legally marketed device that 
would permit a substantial equivalence determina-
tion under paragraph (1) for the device; or 
‘‘(II) determines that the device submitted is 
not of low-moderate risk or special controls to miti-
gate the risks cannot be developed for the device. 
‘‘(v) The person submitting the request for classifica-
tion under this subparagraph may recommend to the Sec-
retary a classification for the device and shall, if recom-
mending classification in class II, include in the request 
an initial draft proposal for applicable special controls, as 
described in subsection (a)(1)(B), that are necessary, in 
conjunction with general controls, to provide reasonable 
assurance of safety and effectiveness and a description of 
how the special controls provide such assurance. Any such 
request shall describe the device and provide detailed in-
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170 
formation and reasons for the recommended classifica-
tion.’’; and 
(4) in subparagraph (B), by striking ‘‘Not later 
than 60 days after the date of the submission of the 
request under subparagraph (A), the Secretary’’ and 
inserting ‘‘The Secretary’’. 
(b) CONFORMING AMENDMENTS.—Section 513(f) of 
such Act (21 U.S.C. 360c(f)) is amended in paragraph 
(1)— 
(1) in subparagraph (A), by striking ‘‘, or’’ at 
the end and inserting a semicolon; 
(2) in subparagraph (B), by striking the period 
and inserting ‘‘; or’’; and 
(3) by inserting after subparagraph (B) the fol-
lowing: 
‘‘(C) the device is classified pursuant to a 
request submitted under paragraph (2).’’. 
Subtitle D—Keeping America Com-
petitive Through Harmonization 
SEC. 731. HARMONIZATION OF DEVICE PREMARKET RE-
VIEW, INSPECTION, AND LABELING SYMBOLS; 
REPORT. 
(a) IN GENERAL.—Paragraph (4) of section 803(c) 
(21 U.S.C. 383(c)) is amended to read as follows: 
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‘‘(4) With respect to devices, the Secretary may, 
when appropriate, enter into arrangements with nations 
regarding methods and approaches to harmonizing regu-
latory requirements for activities, including inspections 
and common international labeling symbols’’. 
(b) REPORT.—Not later than 3 years after the date 
of enactment of this Act, the Secretary of Health and 
Human Services shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives a report on the Food and Drug Adminis-
tration’s harmonization activities, itemizing methods and 
approaches that have been harmonized pursuant to section 
803(c)(4) of the Federal Food, Drug, and Cosmetic Act, 
as amended by subsection (a). 
SEC. 732. PARTICIPATION IN INTERNATIONAL FORA. 
Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) 
is amended— 
(1) by striking ‘‘(3)’’ and inserting ‘‘(3)(A)’’; 
and 
(2) by adding at the end the following: 
‘‘(B) In carrying out subparagraph (A), the Secretary 
may participate in appropriate fora, including the Inter-
national Medical Device Regulators Forum, and may— 
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‘‘(i) provide guidance to such fora on strategies, 
policies, directions, membership, and other activities 
of a forum as appropriate; 
‘‘(ii) to the extent appropriate, solicit, review, 
and consider comments from industry, academia, 
health care professionals, and patient groups regard-
ing the activities of such fora; and 
‘‘(iii) to the extent appropriate, inform the pub-
lic of the Secretary’s activities within such fora, and 
share with the public any documentation relating to 
a forum’s strategies, policies, and other activities of 
such fora.’’. 
Subtitle E—FDA Renewing Effi-
ciency From Outside Reviewer 
Management 
SEC. 741. REAUTHORIZATION OF THIRD PARTY REVIEW. 
(a) 
PERIODIC
REACCREDITATION.—Section 
523(b)(2) (21 U.S.C. 360m(b)(2)) is amended by adding 
at the end of the following: 
‘‘(E) PERIODIC REACCREDITATION.— 
‘‘(i) PERIOD.—Subject to suspension 
or withdrawal under subparagraph (B), 
any accreditation under this section shall 
be valid for a period of 3 years after its 
issuance. 
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‘‘(ii) RESPONSE TO REACCREDITATION 
REQUEST.—Upon the submission of a re-
quest by an accredited person for re-
accreditation under this section, the Sec-
retary shall approve or deny such request 
not later than 60 days after receipt of the 
request. 
‘‘(iii) CRITERIA.—Not later than 120 
days after the date of the enactment of 
this subparagraph, the Secretary shall es-
tablish and publish in the Federal Register 
criteria to reaccredit or deny reaccredita-
tion to persons under this section. The re-
accreditation of persons under this section 
shall specify the particular activities under 
subsection (a), and the devices, for which 
such persons are reaccredited.’’. 
(b) DURATION OF AUTHORITY.—Section 523(c) (21 
U.S.C. 360m(c)) is amended by striking ‘‘October 1, 
2012’’ and inserting ‘‘October 1, 2017’’. 
SEC. 742. REAUTHORIZATION OF THIRD PARTY INSPEC-
TION. 
Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amend-
ed by striking ‘‘October 1, 2012’’ and inserting ‘‘October 
1, 2017’’. 
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Subtitle F—Humanitarian Device 
Reform 
SEC. 751. EXPANDED ACCESS TO HUMANITARIAN USE DE-
VICES. 
(a) IN
GENERAL.—Section 520(m) (21 U.S.C. 
360j(m)) is amended— 
(1) in paragraph (6)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘subparagraph (D)’’ and in-
serting ‘‘subparagraph (C)’’; 
(ii) by striking clause (i) and inserting 
the following: 
‘‘(i) The device with respect to which the ex-
emption is granted— 
‘‘(I) is intended for the treatment or diag-
nosis of a disease or condition that occurs in 
pediatric patients or in a pediatric subpopula-
tion, and such device is labeled for use in pedi-
atric patients or in a pediatric subpopulation in 
which the disease or condition occurs; or 
‘‘(II) is intended for the treatment or diag-
nosis of a disease or condition that does not 
occur in pediatric patients or that occurs in pe-
diatric patients in such numbers that the devel-
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(3) in paragraph (8), by striking ‘‘of all devices 
described in paragraph (6)’’ and inserting ‘‘of all de-
vices described in paragraph (6)(A)(i)(I)’’. 
(b) APPLICABILITY TO EXISTING DEVICES.—A spon-
sor of a device for which an exemption was approved under 
paragraph (2) of section 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the 
date of enactment of this Act may seek a determination 
under subclause (I) or (II) of paragraph (6)(A)(i) of such 
section 520(m) (as amended by subsection (a)). If the Sec-
retary determines that such subclause (I) or (II) applies 
with respect to a device, then clauses (ii), (iii), and (iv) 
of subparagraph (A) and subparagraphs (B), (C), and (D) 
of paragraph (6) of such section 520(m) shall apply to 
such device. 
(c) REPORT.—Not later than January 1, 2017, the 
Comptroller General of the United States shall submit to 
Congress a report that evaluates and describes— 
(1) the effectiveness of the amendments made 
by subsection (a) in stimulating innovation with re-
spect to medical devices, including any favorable or 
adverse impact on pediatric device development; 
(2) the impact of such amendments on pediatric 
device approvals for devices that received a humani-
tarian use designation under section 520(m) of the 
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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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the following sentence: ‘‘The term ‘counterfeit drug’ shall 
not include a drug or placebo intended for use in a clinical 
trial that is intentionally labeled or marked to maintain 
proper blinding of the study.’’. 
SEC. 808. UNIQUE FACILITY IDENTIFICATION NUMBER. 
(a) DOMESTIC ESTABLISHMENTS.—Section 510 (21 
U.S.C. 360) is amended— 
(1) in subsection (b)(1), by striking ‘‘and all 
such establishments’’ and inserting ‘‘all such estab-
lishments, and the unique facility identifier of each 
such establishment’’; and 
(2) in subsection (c), by striking ‘‘and such es-
tablishment’’ and inserting ‘‘such establishment, and 
the unique facility identifier of such establishment’’. 
(b) FOREIGN ESTABLISHMENTS.—Subparagraph (A) 
of section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by 
inserting ‘‘the unique facility identifier of the establish-
ment,’’ after ‘‘the name and place of business of the estab-
lishment,’’. 
(c) GUIDANCE.—Section 510 (21 U.S.C. 360) is 
amended by adding at the end the following: 
‘‘(q) GUIDANCE ON SUBMISSION OF UNIQUE FACIL-
ITY IDENTIFIERS.— 
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‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this subsection, 
the Secretary shall, by guidance, specify— 
‘‘(A) the unique facility identifier system 
to be used to meet the requirements of— 
‘‘(i) 
subsections 
(b)(1), 
(c), 
and 
(i)(1)(A) of this section; and 
‘‘(ii) section 801(s) (relating to reg-
istration of commercial importers); and 
‘‘(B) the form, manner, and timing of sub-
missions of unique facility identifiers under the 
provisions specified in subparagraph (A). 
‘‘(2) CONSIDERATION.—In developing the guid-
ance under paragraph (1), the Secretary shall take 
into account the utilization of existing unique identi-
fication schemes and compatibility with customs 
automated systems.’’. 
(d) IMPORTATION.—Section 801(a) (21 U.S.C. 
381(a)) is amended by inserting ‘‘or (5) for an article that 
is a drug, the appropriate unique facility identifiers under 
subsection (s) (relating to commercial importers) and sec-
tion 510(i) (relating to foreign establishments), as speci-
fied by the Secretary, are not provided,’’ before ‘‘then such 
article shall be refused admission’’. 
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SEC. 809. DOCUMENTATION FOR ADMISSIBILITY OF IM-
PORTS. 
Section 801 (21 U.S.C. 381) is amended by adding 
at the end the following: 
‘‘(r) DOCUMENTATION.— 
‘‘(1) SUBMISSION.—The Secretary may require, 
in consultation with the Secretary of Homeland Se-
curity acting through U.S. Customs and Border Pro-
tection as determined appropriate by the Secretary, 
the submission of documentation or other informa-
tion for a drug that is imported or offered for im-
port into the United States. 
‘‘(2) REFUSAL
OF
ADMISSION.—A drug im-
ported or offered for import into the United States 
shall be refused admission unless all documentation 
and information the Secretary requires under this 
Act, the Public Health Service Act, or both, as ap-
propriate, for such article is submitted. 
‘‘(3) REGULATIONS.— 
‘‘(A) DOCUMENTS
AND
INFORMATION.— 
The Secretary shall issue a regulation to specify 
the documentation or other information that is 
described in paragraph (1). Such information 
may include— 
‘‘(i) information demonstrating the 
regulatory status of the drug, such as the 
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new drug application, abbreviated new 
drug application, or investigational new 
drug or Drug Master File number; 
‘‘(ii) facility information, such as 
proof of registration and the unique facility 
identifier; and 
‘‘(iii) indication of compliance with 
current good manufacturing practice, such 
as satisfactory testing results, certifi-
cations relating to satisfactory inspections, 
and compliance with the country of export 
regulations. 
‘‘(B) EXEMPTION.—The Secretary may, by 
regulation, exempt drugs imported for research 
purposes only and other types of drug imports 
from some or all of the requirements of this 
subsection. 
‘‘(4) EFFECTIVE DATE.—The final rule under 
paragraph (3)(A) shall take effect not less than 180 
days after the Secretary promulgates such final 
rule.’’. 
SEC. 810. REGISTRATION OF COMMERCIAL IMPORTERS. 
(a) PROHIBITIONS.—Section 301 (21 U.S.C. 331) is 
amended by adding at the end the following: 
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‘‘(aaa) The failure to register in accordance with sec-
tion 801(s).’’. 
(b) REGISTRATION.—Section 801 (21 U.S.C. 381), 
as amended by section 810, is further amended by adding 
at the end the following: 
‘‘(s) REGISTRATION OF COMMERCIAL IMPORTERS.— 
‘‘(1) REGISTRATION.—The Secretary shall re-
quire a commercial importer of drugs— 
‘‘(A) to be registered with the Secretary in 
a form and manner specified by the Secretary; 
and 
‘‘(B) consistent with the guidance under 
section 510(q), to submit, at the time of reg-
istration, a unique identifier for the principal 
place of business for which the importer is re-
quired to register under this subsection. 
‘‘(2) REGULATIONS.— 
‘‘(A) IN GENERAL.—The Secretary, in con-
sultation with the Secretary of Homeland Secu-
rity acting through U.S. Customs and Border 
Protection, shall promulgate regulations to es-
tablish good importer practices that specify the 
measures an importer shall take to ensure im-
ported drugs are in compliance with the re-
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quirements of this Act and the Public Health 
Service Act. 
‘‘(B) EXPEDITED
CLEARANCE
FOR
CER-
TAIN IMPORTERS.—In promulgating good im-
porter practice regulations under subparagraph 
(A), the Secretary may, as appropriate, take 
into account differences among importers and 
types of imports, and, based on the level of risk 
posed by the imported drug, provide for expe-
dited clearance for those importers that volun-
teer to participate in partnership programs for 
highly compliant companies. 
‘‘(3) DISCONTINUANCE
OF
REGISTRATION.— 
The Secretary shall discontinue the registration of 
any commercial importer of drugs that fails to com-
ply with the regulations promulgated under this sub-
section. 
‘‘(4) EXEMPTIONS.—The Secretary, by notice 
in the Federal Register, may establish exemptions 
from the requirements of this subsection.’’. 
(c) MISBRANDING.—Section 502(o) (21 U.S.C. 352) 
is amended by inserting ‘‘if it is a drug and was imported 
or offered for import by a commercial importer of drugs 
not duly registered under section 801(s),’’ after ‘‘not duly 
registered under section 510,’’. 
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(d) REGULATIONS.— 
(1) IN GENERAL.—Not later than 36 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, in consulta-
tion with the Secretary of Homeland Security acting 
through U.S. Customs and Border Protection, shall 
promulgate the regulations required to carry out sec-
tion 801(s) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (b). 
(2) EFFECTIVE DATE.—In establishing the ef-
fective date of the regulations under paragraph (1), 
the Secretary of Health and Human Services shall, 
in consultation with the Secretary of Homeland Se-
curity acting through U.S. Customs and Border Pro-
tection, as determined appropriate by the Secretary 
of Health and Human Services, provide a reasonable 
period of time for an importer of a drug to comply 
with good importer practices, taking into account 
differences among importers and types of imports, 
including based on the level of risk posed by the im-
ported product. 
SEC. 811. NOTIFICATION. 
(a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 
331), as amended by section 811, is further amended by 
adding at the end the following: 
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‘‘(bbb) The failure to notify the Secretary in violation 
of section 568.’’. 
(b) NOTIFICATION.—Subchapter E of chapter V (21 
U.S.C. 360bbb et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 568 NOTIFICATION. 
‘‘(a) NOTIFICATION TO SECRETARY.—With respect 
to a drug, the Secretary may require notification to the 
Secretary by a regulated person if the regulated person 
knows— 
‘‘(1) that the use of such drug in the United 
States may result in serious injury or death; 
‘‘(2) of a significant loss or known theft of such 
drug intended for use in the United States; or 
‘‘(3) that— 
‘‘(A) such drug has been or is being coun-
terfeited; and 
‘‘(B)(i) the counterfeit product is in com-
merce in the United States or could be reason-
ably expected to be introduced into commerce; 
or 
‘‘(ii) such drug has been or is being im-
ported into the United States or may reason-
ably be expected to be offered for import into 
the United States. 
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‘‘(b) 
MANNER
OF
NOTIFICATION.—Notification 
under this section shall be made in such manner and by 
such means as the Secretary may specify by regulation 
or guidance. 
‘‘(c) SAVINGS CLAUSE.—Nothing in this section shall 
be construed as limiting any other authority of the Sec-
retary to require notifications related to a drug under any 
other provision of this Act or the Public Health Service 
Act. 
‘‘(d) DEFINITION.—In this section, the term ‘regu-
lated person’ means— 
‘‘(1) a person who is required to register under 
section 510 or 801(s); 
‘‘(2) a wholesale distributor of a drug product; 
or 
‘‘(3) any other person that distributes drugs ex-
cept a person that distributes drugs exclusively for 
retail sale.’’. 
SEC. 812. EXCHANGE OF INFORMATION. 
Section 708 (21 U.S.C. 379) is amended— 
(1) by striking ‘‘The Secretary may provide’’ 
and inserting the following: 
‘‘(a) CONTRACTORS.—The Secretary may provide’’; 
and 
(2) by adding at the end the following: 
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‘‘(b) ABILITY TO RECEIVE
AND PROTECT CON-
FIDENTIAL INFORMATION.—Except pursuant to an order 
of a court of the United States, the Secretary shall not 
be required to disclose under section 552 of title 5, United 
States Code, or any other provision of law, any informa-
tion relating to drugs obtained from a Federal, State, or 
local government agency, or from a foreign government 
agency, if the agency has requested that the information 
be kept confidential. For purposes of section 552 of title 
5, United States Code, this subsection shall be considered 
a statute described in section 552(b)(3)(B). 
‘‘(c) AUTHORITY TO ENTER INTO MEMORANDA OF 
UNDERSTANDING FOR PURPOSES OF INFORMATION EX-
CHANGE.—The Secretary may enter into written agree-
ments regarding the exchange of information referenced 
in section 301(j) subject to the following criteria: 
‘‘(1) CERTIFICATION.—The Secretary may only 
enter into written agreements under this subsection 
with foreign governments that the Secretary has cer-
tified as having the authority and demonstrated abil-
ity to protect trade secret information from disclo-
sure. Responsibility for this certification shall not be 
delegated to any officer or employee other than the 
Commissioner of Food and Drugs. 
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203 
‘‘(2) 
WRITTEN
AGREEMENT.—The 
written 
agreement under this subsection shall include a com-
mitment by the foreign government to protect infor-
mation exchanged under this subsection from disclo-
sure unless and until the sponsor gives written per-
mission for disclosure or the Secretary makes a dec-
laration of a public health emergency pursuant to 
section 319 of the Public Health Service Act that is 
relevant to the information. 
‘‘(3) INFORMATION EXCHANGE.—The Secretary 
may provide to a foreign government that has been 
certified under paragraph (1), and that has executed 
a written agreement under paragraph (2), informa-
tion referenced in section 301(j) in the following cir-
cumstances: 
‘‘(A) Information concerning the inspection 
of a facility may be provided if— 
‘‘(i) the Secretary reasonably believes, 
or the written agreement described in 
paragraph (2) establishes, that the govern-
ment has authority to otherwise obtain 
such information; and 
‘‘(ii) the written agreement executed 
under paragraph (2) limits the recipient’s 
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204 
use of the information to the recipient’s 
civil regulatory purposes. 
‘‘(B) Information not described in sub-
paragraph (A) may be provided as part of an 
investigation, or to alert the foreign government 
to the potential need for an investigation, if the 
Secretary has reasonable grounds to believe 
that a drug has a reasonable probability of 
causing serious adverse health consequences or 
death. 
‘‘(d) NO LIMITATION ON AUTHORITY.—This section 
shall not affect the authority of the Secretary to provide 
or disclose information under any other provision of law.’’. 
SEC. 813. EXTRATERRITORIAL JURISDICTION. 
Chapter III (21 U.S.C. 331 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 
‘‘There is extraterritorial jurisdiction over any viola-
tion of this Act relating to any article regulated under this 
Act if such article was intended for import into the United 
States or if any act in furtherance of the violation was 
committed in the United States.’’. 
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SEC. 814. PROTECTION AGAINST INTENTIONAL ADULTERA-
TION. 
Section 303(b) (21 U.S.C. 333(b)) is amended by 
adding at the end the following: 
‘‘(7) Notwithstanding subsection (a)(2), any 
person that knowingly and intentionally engages in 
an activity that results in a drug becoming adulter-
ated under subsection (a)(1), (b), (c), or (d) of sec-
tion 501 and having a reasonable probability of 
causing serious adverse health consequences or 
death shall be imprisoned for not more than 20 
years or fined not more than $1,000,000, or both.’’. 
SEC. 815. RECORDS FOR INSPECTION. 
Section 704(a) (21 U.S.C. 374(a)) is amended by 
adding at the end the following: 
‘‘(4)(A) Any records or other information that the 
Secretary may inspect under this section from a person 
that owns or operates an establishment that is engaged 
in 
the 
manufacture, 
preparation, 
propagation, 
compounding, or processing of a drug shall, upon the re-
quest of the Secretary, be provided to the Secretary by 
such person, in advance of or in lieu of an inspection, with-
in a reasonable timeframe, within reasonable limits, and 
in a reasonable manner, and in either electronic or phys-
ical form, at the expense of such person. The Secretary’s 
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206 
request shall include a sufficient description of the records 
requested. 
‘‘(B) Upon receipt of the records requested under 
subparagraph (A), the Secretary shall provide to the per-
son confirmation of receipt. 
‘‘(C) Nothing in this paragraph supplants the author-
ity of the Secretary to conduct inspections otherwise per-
mitted under this Act in order to ensure compliance with 
this Act.’’. 
Subtitle B—Medical Gas Safety 
SEC. 821. REGULATION OF MEDICAL GASES. 
Chapter V (21 U.S.C. 351 et seq.) is amended by 
adding at the end the following: 
‘‘Subchapter G—Medical Gases 
‘‘SEC. 575. DEFINITIONS. 
‘‘In this subchapter: 
‘‘(1) The term ‘designated medical gas’ means 
any of the following: 
‘‘(A) Oxygen that meets the standards set 
forth in an official compendium. 
‘‘(B) Nitrogen that meets the standards 
set forth in an official compendium. 
‘‘(C) Nitrous oxide that meets the stand-
ards set forth in an official compendium. 
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‘‘(D) Carbon dioxide that meets the stand-
ards set forth in an official compendium. 
‘‘(E) Helium that meets the standards set 
forth in an official compendium. 
‘‘(F) Carbon monoxide that meets the 
standards set forth in an official compendium. 
‘‘(G) Medical air that meets the standards 
set forth in an official compendium. 
‘‘(H) Any other medical gas deemed appro-
priate by the Secretary, after taking into ac-
count any investigational new drug application 
or investigational new animal drug application 
for the same medical gas submitted in accord-
ance with regulations applicable to such appli-
cations in title 21 of the Code of Federal Regu-
lations, unless any period of exclusivity under 
section 
505(c)(3)(E)(ii) 
or 
section 
505(j)(5)(F)(ii), or the extension of any such 
period under section 505A, applicable to such 
medical gas has not expired. 
‘‘(2) The term ‘medical gas’ means a drug 
that— 
‘‘(A) is manufactured or stored in a lique-
fied, nonliquefied, or cryogenic state; and 
‘‘(B) is administered as a gas. 
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‘‘SEC. 576. REGULATION OF MEDICAL GASES. 
‘‘(a) CERTIFICATION
OF
DESIGNATED
MEDICAL 
GASES.— 
‘‘(1) SUBMISSION.—Beginning 180 days after 
the date of enactment of this section, any person 
may file with the Secretary a request for certifi-
cation of a medical gas as a designated medical gas. 
Any such request shall contain the following infor-
mation: 
‘‘(A) A description of the medical gas. 
‘‘(B) The name and address of the spon-
sor. 
‘‘(C) The name and address of the facility 
or facilities where the medical gas is or will be 
manufactured. 
‘‘(D) Any other information deemed appro-
priate by the Secretary to determine whether 
the medical gas is a designated medical gas. 
‘‘(2) GRANT OF CERTIFICATION.—The certifi-
cation requested under paragraph (1) is deemed to 
be granted unless, within 60 days of the filing of 
such request, the Secretary finds that— 
‘‘(A) the medical gas subject to the certifi-
cation is not a designated medical gas; 
‘‘(B) the request does not contain the in-
formation required under paragraph (1) or oth-
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209 
erwise lacks sufficient information to permit the 
Secretary to determine that the medical gas is 
a designated medical gas; or 
‘‘(C) denying the request is necessary to 
protect the public health. 
‘‘(3) EFFECT OF CERTIFICATION.— 
‘‘(A) IN GENERAL.— 
‘‘(i) APPROVED USES.—A designated 
medical gas for which a certification is 
granted under paragraph (2) is deemed, 
alone or in combination, as medically ap-
propriate, with another designated medical 
gas or gases for which a certification or 
certifications have been granted, to have in 
effect an approved application under sec-
tion 505 or 512, subject to all applicable 
post-approval requirements, for the fol-
lowing indications for use: 
‘‘(I) In the case of oxygen, the 
treatment or prevention of hypoxemia 
or hypoxia. 
‘‘(II) In the case of nitrogen, use 
in hypoxic challenge testing. 
‘‘(III) In the case of nitrous 
oxide, analgesia. 
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‘‘(IV) In the case of carbon diox-
ide, use in extracorporeal membrane 
oxygenation therapy or respiratory 
stimulation. 
‘‘(V) In the case of helium, the 
treatment of upper airway obstruction 
or increased airway resistance. 
‘‘(VI) In the case of medical air, 
to reduce the risk of hyperoxia. 
‘‘(VII) In the case of carbon 
monoxide, use in lung diffusion test-
ing. 
‘‘(VIII) Any other indication for 
use for a designated medical gas or 
combination of designated medical 
gases deemed appropriate by the Sec-
retary, unless any period of exclusivity 
under clause (iii) or (iv) of section 
505(c)(3)(E), clause (iii) or (iv) of 
section 505(j)(5)(F), or section 527, 
or the extension of any such period 
under section 505A, applicable to 
such indication for use for such gas or 
combination of gases has not expired. 
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‘‘(ii) LABELING.—The requirements 
of sections 503(b)(4) and 502(f) are 
deemed to have been met for a designated 
medical gas if the labeling on final use 
container for such medical gas bears— 
‘‘(I) the information required by 
section 503(b)(4); 
‘‘(II) a warning statement con-
cerning the use of the medical gas as 
determined by the Secretary by regu-
lation; and 
‘‘(III) appropriate directions and 
warnings concerning storage and han-
dling. 
‘‘(B) INAPPLICABILITY
OF
EXCLUSIVITY 
PROVISIONS.— 
‘‘(i) NO
EXCLUSIVITY
FOR
A
CER-
TIFIED
MEDICAL
GAS.—No designated 
medical gas deemed under subparagraph 
(A)(i) to have in effect an approved appli-
cation is eligible for any period of exclu-
sivity under section 505(c), 505(j), or 527, 
or the extension of any such period under 
section 505A, on the basis of such deemed 
approval. 
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‘‘(ii) EFFECT
ON
CERTIFICATION.— 
No period of exclusivity under section 
505(c), 505(j), or section 527, or the ex-
tension of any such period under section 
505A, with respect to an application for a 
drug product shall prohibit, limit, or other-
wise affect the submission, grant, or effect 
of a certification under this section, except 
as provided in subsection (a)(3)(A)(i)(VIII) 
and section 575(1)(H). 
‘‘(4) WITHDRAWAL, SUSPENSION, OR REVOCA-
TION OF APPROVAL.— 
‘‘(A) WITHDRAWAL, SUSPENSION
OF
AP-
PROVAL.—Nothing in this subchapter limits the 
Secretary’s authority to withdraw or suspend 
approval of a drug product, including a des-
ignated medical gas deemed under this section 
to have in effect an approved application under 
section 505 or section 512 of this Act. 
‘‘(B) REVOCATION
OF
CERTIFICATION.— 
The Secretary may revoke the grant of a certifi-
cation under paragraph (2) if the Secretary de-
termines that the request for certification con-
tains any material omission or falsification. 
‘‘(b) PRESCRIPTION REQUIREMENT.— 
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‘‘(1) IN GENERAL.—A designated medical gas 
shall be subject to the requirements of section 
503(b)(1) unless the Secretary exercises the author-
ity provided in section 503(b)(3) to remove such 
medical gas from the requirements of section 
503(b)(1), the gas is approved for use without a pre-
scription pursuant to an application under section 
505 or 512, or the use in question is authorized pur-
suant to another provision of this Act relating to use 
of medical products in emergencies. 
‘‘(2) OXYGEN.— 
‘‘(A) NO
PRESCRIPTION
REQUIRED
FOR 
CERTAIN
USES.—Notwithstanding paragraph 
(1), oxygen may be provided without a prescrip-
tion for the following uses: 
‘‘(i) For use in the event of depres-
surization or other environmental oxygen 
deficiency. 
‘‘(ii) For oxygen deficiency or for use 
in emergency resuscitation, when adminis-
tered by properly trained personnel. 
‘‘(B) LABELING.—For oxygen provided 
pursuant to subparagraph (A), the require-
ments of section 503(b)(4) shall be deemed to 
have been met if its labeling bears a warning 
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that the oxygen can be used for emergency use 
only and for all other medical applications a 
prescription is required. 
‘‘SEC. 577. INAPPLICABILITY OF DRUG FEES TO DES-
IGNATED MEDICAL GASES. 
‘‘A designated medical gas, alone or in combination 
with another designated gas or gases (as medically appro-
priate) deemed under section 576 to have in effect an ap-
proved application shall not be assessed fees under section 
736(a) on the basis of such deemed approval.’’. 
SEC. 822. CHANGES TO REGULATIONS. 
(a) REPORT.—Not later than 18 months after the 
date of the enactment of this Act, the Secretary, after ob-
taining input from medical gas manufacturers and any 
other interested members of the public, shall— 
(1) determine whether any changes to the Fed-
eral drug regulations are necessary for medical 
gases; and 
(2) submit to the Committee on Health, Edu-
cation, Labor and Pensions of the Senate and the 
Committee on Energy and Commerce of the House 
of Representatives a report regarding any such 
changes. 
(b) REGULATIONS.—If the Secretary determines 
under subsection (a) that changes to the Federal drug reg-
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215 
ulations are necessary for medical gases, the Secretary 
shall issue final regulations revising the Federal drug reg-
ulations with respect to medical gases not later than 48 
months after the date of the enactment of this Act. 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘Federal drug regulations’’ means 
regulations in title 21 of the Code of Federal Regu-
lations pertaining to drugs. 
(2) The term ‘‘medical gas’’ has the meaning 
given to such term in section 575 of the Federal 
Food, Drug, and Cosmetic Act, as added by section 
821 of this Act. 
(3) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
SEC. 823. RULES OF CONSTRUCTION. 
Nothing in this subtitle and the amendments made 
by this subtitle applies with respect to— 
(1) a drug that is approved prior to May 1, 
2012, pursuant to an application submitted under 
section 505 or 512 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355, 360b); 
(2) any gas listed in subparagraphs (A) through 
(G) of section 575(1) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 821 of this 
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Act, or any combination of any such gases, for an 
indication that— 
(A) is not included in, or is different from, 
those specified in subclauses (I) through (VII) 
of section 576(a)(3)(A)(i) of such Act; and 
(B) is approved on or after May 1, 2012, 
pursuant to an application submitted under 
Section 505 or 512; or 
(3) any designated medical gas added pursuant 
to subparagraph (H) of section 575(1) of such Act 
for an indication that— 
(A) is not included in, or is different from, 
those originally added pursuant to subpara-
graph (H) of section 575(1) and section 
576(a)(3)(A)(i)(VIII); and 
(B) is approved on or after May 1, 2012, 
pursuant to an application submitted under sec-
tion 505 or 512 of such Act. 
Subtitle C—Generating Antibiotic 
Incentives Now 
SEC. 831. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 505D 
(21 U.S.C. 355e) the following: 
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‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 
QUALIFIED INFECTIOUS DISEASE PRODUCTS. 
‘‘(a) EXTENSION.—If the Secretary approves an ap-
plication pursuant to section 505 for a drug that has been 
determined to be a qualified infectious disease product 
under subsection (d), then the four- and five-year periods 
described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of 
section 505, the three-year periods described in clauses 
(iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and 
(iv) of subsection (j)(5)(F) of section 505, or the seven 
year period described in section 527, as applicable, shall 
be extended by five years. 
‘‘(b) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 
extension under subsection (a) of a period shall be in addi-
tion to any extension of the period under section 505A 
with respect to the drug. 
‘‘(c) LIMITATIONS.—Subsection (a) does not apply to 
the approval of— 
‘‘(1) a supplement to an application under sec-
tion 505(b) for any qualified infectious disease prod-
uct for which an extension described in subsection 
(a) is in effect or has expired; 
‘‘(2) a subsequent application filed by the same 
sponsor or manufacturer of a qualified infectious 
disease product described in paragraph (1) (or a li-
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censor, predecessor in interest, or other related enti-
ty) for— 
‘‘(A) a change (not including a modifica-
tion to the active moiety of the qualified infec-
tious disease product) that results in a new in-
dication, route of administration, dosing sched-
ule, dosage form, delivery system, delivery de-
vice, or strength; or 
‘‘(B) a modification to the active moiety of 
the qualified infectious disease product that 
does not result in a change in safety or effec-
tiveness; or 
‘‘(3) a product that does not meet the definition 
of a qualified infectious disease product under sub-
section (f) based upon its approved uses. 
‘‘(d) DETERMINATION.—The manufacturer or spon-
sor of a drug may request that the Secretary designate 
a drug as a qualified infectious disease product at any 
time in the drug development process prior to the submis-
sion of an application under section 505(b) for the drug, 
but not later than 45 days before the submission of such 
application. The Secretary shall, not later than 30 days 
after the submission of such request, determine whether 
the drug is a qualified infectious disease product. 
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‘‘(e) REGULATIONS.—The Secretary shall promulgate 
regulations for carrying out this section. The Secretary 
shall promulgate the initial regulations for carrying out 
this section not later than 12 months after the date of 
the enactment of this section. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCT.—The term ‘qualified infectious disease prod-
uct’ means an antibacterial or antifungal drug for 
human use that treats or prevents an infection 
caused by a qualifying pathogen. 
‘‘(2) 
QUALIFYING
PATHOGEN.—The 
term 
‘qualifying pathogen’ means— 
‘‘(A) resistant gram-positive pathogens, in-
cluding 
methicillin-resistant 
Staphylococcus 
aureus (MRSA), vancomycin-resistant Staphy-
lococcus aureus (VRSA), and vancomycin-resist-
ant enterococcus (VRE); 
‘‘(B) multidrug resistant gram-negative 
bacteria, including Acinetobacter, Klebsiella, 
Pseudomonas, and E. coli species; 
‘‘(C) multi-drug resistant tuberculosis; or 
‘‘(D) any other infectious pathogen identi-
fied for purposes of this section by the Sec-
retary.’’. 
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(b) APPLICATION.—Section 505E of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a), applies only with respect to a drug that is first ap-
proved under section 505(c) of such Act (21 U.S.C. 
355(c)) on or after the date of the enactment of this Act. 
SEC. 832. STUDY ON INCENTIVES FOR QUALIFIED INFEC-
TIOUS DISEASE BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall— 
(1) conduct a study on the need for incentives 
to encourage research on and development and mar-
keting of qualified infectious disease biological prod-
ucts; and 
(2) not later than 1 year after the date of the 
enactment of this Act, submit a report to the Con-
gress on the results of such study, including any rec-
ommendations of the Comptroller General on appro-
priate incentives for addressing such need. 
(b) DEFINITIONS.—In this section: 
(1) The term ‘‘biological product’’ has the 
meaning given to such term in section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
(2) The term ‘‘qualified infectious disease bio-
logical product’’ means a biological product for 
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human use that treats or prevents an infection 
caused by a qualifying pathogen. 
(3) The term ‘‘qualifying pathogen’’ has the 
meaning given to such term in section 505E of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 831 of this Act. 
SEC. 833. CLINICAL TRIALS. 
(a) REVIEW AND REVISION OF GUIDELINES.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, and not later 
than 4 years thereafter, the Secretary shall— 
(A) review the guidance of the Food and 
Drug Administration for the conduct of clinical 
trials 
with 
respect 
to 
antibacterial 
and 
antifungal drugs; and 
(B) as appropriate, revise such guidance to 
reflect developments in scientific and medical 
information and technology and to ensure clar-
ity regarding the procedures and requirements 
for approval of an antibiotic and antifungal 
drug under chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et 
seq.). 
(2) ISSUES FOR REVIEW.—At a minimum, the 
review under paragraph (1) shall address the appro-
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222 
priate animal models of infection, in vitro tech-
niques, valid microbiological surrogate markers, the 
use of noninferiority versus superiority trials, and 
appropriate delta values for noninferiority trials. 
(3) RULE OF CONSTRUCTION.—Except to the 
extent to which the Secretary of Health and Human 
Services makes revisions under paragraph (1)(B), 
nothing in this section shall be construed to repeal 
or otherwise affect the guidance of the Food and 
Drug Administration. 
(b) RECOMMENDATIONS FOR INVESTIGATIONS.— 
(1) REQUEST.—The sponsor of a drug intended 
to be used to treat or prevent a qualifying pathogen 
may request that the Secretary provide written rec-
ommendations for nonclinical and clinical investiga-
tions which may be conducted with the drug before 
it may be approved for such use under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355). 
(2) RECOMMENDATIONS.—If the Secretary has 
reason to believe that a drug for which a request is 
made under this subsection is a qualified infectious 
disease product, the Secretary shall provide the per-
son making the request written recommendations for 
the nonclinical and clinical investigations which the 
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Secretary believes, on the basis of information avail-
able to the Secretary at the time of the request, 
would be necessary for approval under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) of such drug for the use described in 
paragraph (1). 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘drug’’ has the meaning given to 
such term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
(2) The term ‘‘qualified infectious disease prod-
uct’’ has the meaning given to such term in section 
505E of the Federal Food, Drug, and Cosmetic Act, 
as added by section 831 of this Act. 
(3) The term ‘‘qualifying pathogen’’ has the 
meaning given to such term in section 505E of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 831 of this Act. 
(4) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
SEC. 834. REASSESSMENT OF QUALIFIED INFECTIOUS DIS-
EASE PRODUCT INCENTIVES IN 5 YEARS. 
Not later than five years after the date of enactment 
of this Act, the Secretary of Health and Human Services 
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shall, in consultation with the Food and Drug Administra-
tion, Centers for Disease Control and Prevention and 
other appropriate agencies, submit to the Committee on 
Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report that contains the fol-
lowing: 
(1)(A) The number of initial designations of 
drugs as qualified infectious disease products under 
section 505E of the Federal Food, Drug, and Cos-
metic Act; 
(B) the number of qualified infectious disease 
products approved under this program; and 
(C) whether such products address the need for 
antibacterial and antifungal drugs to treat serious 
and life-threatening infections. 
(2) Recommendations— 
(A) based on the information in paragraph 
(1) and any other relevant data, on any changes 
that should be made to the list of pathogens 
that are defined as qualifying pathogens under 
section 505E(f)(2) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 831; and 
(B) on whether any additional program 
(such as the development of public-private col-
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laborations to advance antibacterial drug inno-
vation) or changes to the incentives under this 
subtitle may be needed to promote the develop-
ment of antibacterial drugs. 
(3) An examination of— 
(A) the adoption of programs to measure 
the use of antibacterial drugs in health care set-
tings; and 
(B) the implementation and effectiveness 
of antimicrobial stewardship protocols across all 
health care settings. 
(4) Any recommendations for ways to encour-
age further development and establishment of stew-
ardship programs. 
SEC. 
835. 
GUIDANCE 
ON 
PATHOGEN-FOCUSED 
ANTI-
BACTERIAL DRUG DEVELOPMENT. 
(a) DRAFT GUIDANCE.—Not later than June 30, 
2013, in order to facilitate the development of anti-
bacterial drugs for serious or life-threatening bacterial in-
fections, particularly in areas of unmet need, the Secretary 
of Health and Human Services shall publish draft guid-
ance that— 
(1) specifies how preclinical and clinical data 
can be utilized to inform an efficient and stream-
lined pathogen-focused antibacterial drug develop-
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ment program that meets the approval standards of 
the Food and Drug Administration; and 
(2) provides advice on approaches for the devel-
opment of antibacterial drugs that target a more 
limited spectrum of pathogens. 
(b) FINAL GUIDANCE.—Not later than December 31, 
2014, after notice and opportunity for public comment on 
the draft guidance under subsection (a), the Secretary of 
Health and Human Services shall publish final guidance 
consistent with this section. 
Subtitle D—Accelerated Approval 
SEC. 841. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 
OR LIFE-THREATENING DISEASES OR CONDI-
TIONS. 
(a) FINDINGS; SENSE OF CONGRESS.— 
(1) FINDINGS.—The Congress finds as follows: 
(A) The Food and Drug Administration 
(referred to in this subsection as the ‘‘FDA’’) 
serves a critical role in helping to assure that 
new medicines are safe and effective. Regu-
latory innovation is 1 element of the Nation’s 
strategy to address serious and life-threatening 
diseases or conditions by promoting investment 
in and development of innovative treatments for 
unmet medical needs. 
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(B) During the 2 decades following the es-
tablishment of the accelerated approval mecha-
nism, advances in medical sciences, including 
genomics, molecular biology, and bioinformatics, 
have provided an unprecedented understanding 
of the underlying biological mechanism and 
pathogenesis of disease. A new generation of 
modern, targeted medicines is under develop-
ment to treat serious and life-threatening dis-
eases, some applying drug development strate-
gies based on biomarkers or pharmacogenomics, 
predictive toxicology, clinical trial enrichment 
techniques, and novel clinical trial designs, such 
as adaptive clinical trials. 
(C) As a result of these remarkable sci-
entific and medical advances, the FDA should 
be encouraged to implement more broadly effec-
tive processes for the expedited development 
and review of innovative new medicines in-
tended to address unmet medical needs for seri-
ous or life-threatening diseases or conditions, 
including those for rare diseases or conditions, 
using a broad range of surrogate or clinical 
endpoints and modern scientific tools earlier in 
the drug development cycle when appropriate. 
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This may result in fewer, smaller, or shorter 
clinical trials for the intended patient popu-
lation or targeted subpopulation without com-
promising or altering the high standards of the 
FDA for the approval of drugs. 
(D) Patients benefit from expedited access 
to safe and effective innovative therapies to 
treat unmet medical needs for serious or life- 
threatening diseases or conditions. 
(E) For these reasons, the statutory au-
thority in effect on the day before the date of 
enactment of this Act governing expedited ap-
proval of drugs for serious or life-threatening 
diseases or conditions should be amended in 
order to enhance the authority of the FDA to 
consider appropriate scientific data, methods, 
and tools, and to expedite development and ac-
cess to novel treatments for patients with a 
broad range of serious or life-threatening dis-
eases or conditions. 
(2) SENSE OF CONGRESS.—It is the sense of 
the Congress that the FDA should apply the acceler-
ated approval and fast track provisions set forth in 
section 506 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356), as amended by this sec-
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229 
tion, to help expedite the development and avail-
ability to patients of treatments for serious or life- 
threatening diseases or conditions while maintaining 
safety and effectiveness standards for such treat-
ments. 
(b) EXPEDITED APPROVAL.—Section 506 (21 U.S.C. 
356) is amended to read as follows: 
‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 
OR LIFE-THREATENING DISEASES OR CONDI-
TIONS. 
‘‘(a) DESIGNATION
OF DRUG
AS
A FAST TRACK 
PRODUCT.— 
‘‘(1) IN GENERAL.—The Secretary shall, at the 
request of the sponsor of a new drug, facilitate the 
development and expedite the review of such drug if 
it is intended, whether alone or in combination with 
one or more other drugs, for the treatment of a seri-
ous or life-threatening disease or condition, and it 
demonstrates the potential to address unmet medical 
needs for such a disease or condition. (In this sec-
tion, such a drug is referred to as a ‘fast track prod-
uct’.) 
‘‘(2) REQUEST FOR DESIGNATION.—The spon-
sor of a new drug may request the Secretary to des-
ignate the drug as a fast track product. A request 
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for the designation may be made concurrently with, 
or at any time after, submission of an application 
for the investigation of the drug under section 505(i) 
of this Act or section 351(a)(3) of the Public Health 
Service Act. 
‘‘(3) DESIGNATION.—Within 60 calendar days 
after the receipt of a request under paragraph (2), 
the Secretary shall determine whether the drug that 
is the subject of the request meets the criteria de-
scribed in paragraph (1). If the Secretary finds that 
the drug meets the criteria, the Secretary shall des-
ignate the drug as a fast track product and shall 
take such actions as are appropriate to expedite the 
development and review of the application for ap-
proval of such product. 
‘‘(b) ACCELERATED APPROVAL OF A DRUG FOR A 
SERIOUS OR LIFE-THREATENING DISEASE OR CONDI-
TION, INCLUDING A FAST TRACK PRODUCT.— 
‘‘(1) IN GENERAL.—The Secretary may approve 
an application for approval of a product for a seri-
ous or life-threatening disease or condition, including 
a fast track product, under section 505(c) of this 
Act or section 351(a) of the Public Health Service 
Act upon making a determination that the product 
has an effect on— 
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‘‘(A) a surrogate endpoint that is reason-
ably likely to predict clinical benefit; or 
‘‘(B) a clinical endpoint that can be meas-
ured earlier than irreversible morbidity or mor-
tality, that is reasonably likely to predict an ef-
fect on irreversible morbidity or mortality or 
other clinical benefit, 
taking into account the severity or rarity of the dis-
ease or condition and the availability of alternative 
treatments. The evidence to support that an end-
point is reasonably likely to predict clinical benefit 
may include epidemiological, pathophysiologic, phar-
macologic, therapeutic or other evidence developed 
using, for example, biomarkers, or other scientific 
methods or tools. 
‘‘(2) LIMITATION.—Approval of a product 
under this subsection may, as determined by the 
Secretary, be subject to the following require-
ments— 
‘‘(A) that the sponsor conduct appropriate 
post-approval studies to verify and describe the 
predicted effect of the product on irreversible 
morbidity or mortality or other clinical benefit; 
and 
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‘‘(B) that the sponsor submit copies of all 
promotional materials related to the product, at 
least 30 days prior to dissemination of the ma-
terials— 
‘‘(i) during the preapproval review pe-
riod; and 
‘‘(ii) following approval, for a period 
that the Secretary determines to be appro-
priate. 
‘‘(3) 
EXPEDITED
WITHDRAWAL
OF
AP-
PROVAL.—The Secretary may withdraw approval of 
a product approved pursuant to this subsection 
using expedited procedures (as prescribed by the 
Secretary in regulations, which shall include an op-
portunity for an informal hearing) if— 
‘‘(A) the sponsor fails to conduct any re-
quired post-approval study of the product with 
due diligence; 
‘‘(B) a study required to verify and de-
scribe the predicted effect on irreversible mor-
bidity or mortality or other clinical benefit of 
the product fails to verify and describe such ef-
fect or benefit; 
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‘‘(C) other evidence demonstrates that the 
product is not safe or effective under the condi-
tions of use; or 
‘‘(D) the sponsor disseminates false or 
misleading promotional materials with respect 
to the product. 
‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR 
APPROVAL OF A FAST TRACK PRODUCT.— 
‘‘(1) IN
GENERAL.—If the Secretary deter-
mines, after preliminary evaluation of clinical data 
submitted by the sponsor, that a fast track product 
may be effective, the Secretary shall evaluate for fil-
ing, and may commence review of portions of, an ap-
plication for the approval of the product before the 
sponsor submits a complete application. The Sec-
retary shall commence such review only if the appli-
cant— 
‘‘(A) provides a schedule for submission of 
information necessary to make the application 
complete; and 
‘‘(B) pays any fee that may be required 
under section 736. 
‘‘(2) EXCEPTION.—Any time period for review 
of human drug applications that has been agreed to 
by the Secretary and that has been set forth in goals 
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identified in letters of the Secretary (relating to the 
use of fees collected under section 736 to expedite 
the drug development process and the review of 
human drug applications) shall not apply to an ap-
plication submitted under paragraph (1) until the 
date on which the application is complete. 
‘‘(d) AWARENESS EFFORTS.—The Secretary shall— 
‘‘(1) develop and disseminate to physicians, pa-
tient 
organizations, 
pharmaceutical 
and 
bio-
technology companies, and other appropriate persons 
a description of the provisions of this section appli-
cable to accelerated approval and fast track prod-
ucts; and 
‘‘(2) establish a program to encourage the de-
velopment of surrogate and clinical endpoints, in-
cluding biomarkers, and other scientific methods and 
tools that can assist the Secretary in determining 
whether the evidence submitted in an application is 
reasonably likely to predict clinical benefit for seri-
ous or life-threatening conditions for which there 
exist significant unmet medical needs.’’. 
SEC. 842. GUIDANCE; AMENDED REGULATIONS. 
(a) INITIAL GUIDANCE.—Not later than one year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services (in this subtitle referred to 
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as the ‘‘Secretary’’) shall issue draft guidance to imple-
ment the amendment made by section 841. 
(b) FINAL GUIDANCE.—Not later than one year after 
the issuance of draft guidance under subsection (a), after 
an opportunity for public comment, the Secretary shall— 
(1) issue final guidance to implement the 
amendment made by section 841; and 
(2) amend the regulations governing accelerated 
approval in parts 314 and 601 of title 21, Code of 
Federal Regulations, as necessary to conform such 
regulations with the amendments made by section 
841. 
(c) CONSIDERATIONS.—In developing the guidance 
under subsections (a) and (b)(1) and the amendments 
under subsection (b)(2), the Secretary shall consider— 
(1) issues arising under the accelerated ap-
proval and fast track processes under section 506 of 
the Federal Food, Drug, and Cosmetic Act (as 
amended by section 841) for drugs designated for a 
rare disease or condition under section 526 of the 
Federal, Food, Drug, and Cosmetic Act; and 
(2) how to incorporate novel approaches to the 
review of surrogate endpoints based on patho-
physiologic and pharmacologic evidence in such guid-
ance, especially in instances where the low preva-
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lence of a disease renders the existence or collection 
of other types of data unlikely or impractical. 
(d) NO DELAY
IN REVIEW
OR APPROVAL.—The 
issuance (or non-issuance) of guidance or conforming reg-
ulations implementing the amendments made by section 
841 shall not preclude the review of, or action on, a re-
quest for designation or an application for approval sub-
mitted pursuant to section 506 of the Federal Food, Drug, 
and Cosmetic Act, as amended by section 841. 
SEC. 843. INDEPENDENT REVIEW. 
(a) IN GENERAL.—The Secretary may, in conjunc-
tion with other planned reviews of the new drug review 
process, contract with an independent entity with expertise 
in assessing the quality and efficiency of biopharma-
ceutical development and regulatory review programs, to 
evaluate the Food and Drug Administration’s application 
of the processes described in section 506 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 
841, and the impact of such processes on the development 
and timely availability of innovative treatments for pa-
tients suffering from serious or life-threatening conditions. 
(b) CONSULTATION.—Any evaluation under sub-
section (a) shall include consultation with regulated indus-
tries, patient advocacy and disease research foundations, 
and relevant academic medical centers. 
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Subtitle E—Critical Path 
Reauthorization 
SEC. 851. REAUTHORIZATION OF THE CRITICAL PATH PUB-
LIC-PRIVATE PARTNERSHIPS. 
Subsection (f) of section 566 (21 U.S.C. 360bbb–5) 
is amended to read as follows: 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $6,000,000 for each of fiscal years 2013 through 
2017.’’. 
Subtitle F—Miscellaneous 
SEC. 861. REAUTHORIZATION OF PROVISION RELATING TO 
EXCLUSIVITY 
OF 
CERTAIN 
DRUGS 
CON-
TAINING SINGLE ENANTIOMERS. 
Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended 
by striking ‘‘2012’’ and inserting ‘‘2017’’. 
SEC. 862. EXTENSION OF PERIOD FOR FIRST APPLICANT TO 
OBTAIN 
TENTATIVE 
APPROVAL 
WITHOUT 
FORFEITING 180-DAY EXCLUSIVITY PERIOD. 
(a) EXTENSION OF PERIOD.— 
(1) IN
GENERAL.—Subclause (IV) of section 
505(j)(5)(D)(i) 
(21 
U.S.C. 
355(j)(5)(D)(i)) 
is 
amended to read as follows: 
‘‘(IV) FAILURE TO OBTAIN TEN-
TATIVE
APPROVAL.—The first appli-
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cant fails to obtain tentative approval 
of the application within 45 months 
after the date on which— 
‘‘(aa) the application is filed 
and initially contains a certifi-
cation described in paragraph 
(2)(A)(vii)(IV), or 
‘‘(bb) 
the 
application 
is 
amended to first contain such a 
certification, 
unless the failure is caused by a 
change in or a review of the require-
ments for approval of the application 
imposed after the date on which the 
application is so filed or amended.’’. 
(2) APPLICABILITY.— 
(A) IN GENERAL.—Subject to subsection 
(b), the amendment made by paragraph (1) ap-
plies— 
(i) only with respect to an application 
that is filed under section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) on or after the day that is 
30 months prior to the date of the enact-
ment of this Act; and 
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under paragraph (1), the Secretary shall determine 
whether— 
‘‘(A) the disease or condition that is the 
subject of such request is a rare pediatric dis-
ease; and 
‘‘(B) the application for the new drug is a 
rare pediatric disease product application. 
‘‘(e) MARKETING
OF RARE PEDIATRIC DISEASE 
PRODUCTS.— 
‘‘(1) IN GENERAL.—The Secretary shall deem a 
rare pediatric disease product application incomplete 
if such application does not contain a description of 
the plan of the sponsor of such application to mar-
ket the product in the United States. 
‘‘(2) REVOCATION.—The Secretary may revoke 
any priority review voucher awarded under sub-
section (b) if the rare pediatric disease product for 
which such voucher was awarded is not marketed in 
the United States within the 365 day period begin-
ning on the date of the approval of such drug under 
section 505 of this Act or section 351 of the Public 
Health Service Act. 
‘‘(3) POSTAPPROVAL
PRODUCTION
REPORT.— 
The sponsor of an approved rare pediatric disease 
product shall submit a report to the Secretary not 
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