220 
of this Act or section 351 of the Public Health 
Service Act, as applicable, for each such drug, 
not later than 1 year after establishment of the 
Interpretive Criteria Website described in sub-
section (b)(1), shall remove susceptibility test in-
terpretive criteria, if any, and related informa-
tion from the approved drug labeling and replace 
it with a reference to the Interpretive Criteria 
Website. 
‘‘(B) LABELING
CHANGES.—The labeling 
changes required by this section shall be consid-
ered a minor change under section 314.70 of title 
21, Code of Federal Regulations (or any suc-
cessor regulations) that may be implemented 
through documentation in the next applicable 
annual report. 
‘‘(2) DRUGS MARKETED SUBSEQUENT TO ESTAB-
LISHMENT OF INTERPRETIVE CRITERIA WEBSITE.— 
With respect to antimicrobial drugs approved on or 
after the date of the establishment of the Interpretive 
Criteria Website described in subsection (b)(1), the la-
beling for such a drug shall include, in lieu of suscep-
tibility test interpretive criteria and related informa-
tion, a reference to such Website.
221 
‘‘(e) SPECIAL CONDITION FOR MARKETING OF ANTI-
MICROBIAL SUSCEPTIBILITY TESTING DEVICES.— 
‘‘(1) IN
GENERAL.—Notwithstanding sections 
501, 502, 505, 510, 513, and 515, if the conditions 
specified in paragraph (2) are met (in addition to 
other applicable provisions under this chapter) with 
respect to an antimicrobial susceptibility testing de-
vice described in subsection (f)(1), the Secretary may 
authorize the marketing of such device for a use de-
scribed in such subsection. 
‘‘(2) 
CONDITIONS
APPLICABLE
TO
ANTI-
MICROBIAL SUSCEPTIBILITY TESTING DEVICES.—The 
conditions specified in this paragraph are the fol-
lowing: 
‘‘(A) The device is used to make a deter-
mination of susceptibility using susceptibility 
test interpretive criteria that are— 
‘‘(i) included in a standard recognized 
by the Secretary under subsection (c); or 
‘‘(ii) otherwise listed on the Interpre-
tive Criteria Website under subsection 
(b)(2). 
‘‘(B) The labeling of such device includes 
statements conveying—
222 
‘‘(i) that the device provides informa-
tion about the in vitro susceptibility of bac-
teria, fungi, or other microorganisms, as 
applicable to antimicrobial drugs; 
‘‘(ii) that— 
‘‘(I) the safety and efficacy of such 
drugs in treating clinical infections 
due to such bacteria, fungi, or other 
microorganisms, as applicable, may or 
may not have been established in ade-
quate and well-controlled clinical trials 
in order for the device to report the 
susceptibility of such bacteria, fungi, 
or other microorganisms, as applicable, 
to such drugs; and 
‘‘(II) the clinical significance of 
such 
susceptibility 
information 
in 
those instances is unknown; 
‘‘(iii) that the approved labeling for 
drugs tested using such a device provides 
the uses for which the Secretary has ap-
proved such drugs; and 
‘‘(iv) any other information the Sec-
retary determines appropriate to adequately 
convey the meaning of the data supporting
223 
the recognition or listing of susceptibility 
test interpretive criteria standards or sus-
ceptibility test interpretive criteria de-
scribed in subparagraph (A). 
‘‘(C) The antimicrobial susceptibility test-
ing device meets all other requirements to be 
cleared under section 510(k), classified under sec-
tion 513(f)(2), or approved under section 515. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) The term ‘antimicrobial susceptibility test-
ing device’ means a device that utilizes susceptibility 
test interpretive criteria to determine and report the 
in vitro susceptibility of certain microorganisms to a 
drug (or drugs). 
‘‘(2) The term ‘qualified infectious disease prod-
uct’ means a qualified infectious disease product des-
ignated under section 505E(d). 
‘‘(3) The term ‘susceptibility test interpretive cri-
teria’ means— 
‘‘(A) one or more specific numerical values 
which characterize the susceptibility of bacteria 
or other microorganisms to the drug tested; and 
‘‘(B) related categorizations of such suscep-
tibility, including categorization of the drug as
224 
susceptible, intermediate, resistant, or such other 
term as the Secretary determines appropriate. 
‘‘(4)(A) The term ‘antimicrobial drug’ means, 
subject to subparagraph (B), a systemic antibacterial 
or antifungal drug that— 
‘‘(i) is intended for human use in the treat-
ment of a disease or condition caused by a bac-
terium or fungus; 
‘‘(ii) may include a qualified infectious dis-
ease product designated under section 505E(d); 
and 
‘‘(iii) is subject to section 503(b)(1). 
‘‘(B) If provided by the Secretary through regu-
lations, such term may include— 
‘‘(i) drugs other than systemic antibacterial 
and antifungal drugs; and 
‘‘(ii) biological products (as such term is de-
fined in section 351 of the Public Health Service 
Act) to the extent such products exhibit anti-
microbial activity. 
‘‘(5) The term ‘interpretive criteria standard’ 
means a compilation of susceptibility test interpretive 
criteria developed by a standard development organi-
zation that meets the criteria set forth in subsection 
(b)(2)(A)(i).
225 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to— 
‘‘(1) alter the standards of evidence under sub-
section (c) or (d) of section 505 (including the sub-
stantial evidence standard under section 505(d)) or 
under section 351 of the Public Health Service Act (as 
applicable); or 
‘‘(2) with respect to clearing devices under sec-
tion 
510(k), 
classifying 
devices 
under 
section 
513(f)(2), or approving devices under section 515— 
‘‘(A) apply with respect to any drug, device, 
or biological product, in any context other than 
an antimicrobial drug and an antimicrobial sus-
ceptibility testing device that uses susceptibility 
test interpretive criteria to characterize and re-
port the susceptibility of certain bacteria, fungi, 
or other microorganisms, as applicable, to such 
drug to reflect patient morbidity and mortality 
in accordance with this section; or 
‘‘(B) unless specifically stated, have any ef-
fect on authorities provided under other sections 
of this Act, including any regulations issued 
under such sections.’’. 
(b) CONFORMING AMENDMENTS.—
226 
(1) REPEAL OF PRIOR RELATED AUTHORITY.— 
Section 1111 of the Food and Drug Administration 
Amendments Act of 2007 (42 U.S.C. 247d–5a), relat-
ing to identification of clinically susceptible con-
centrations of antimicrobials, is repealed. 
(2) ADDITION TO CATEGORIES OF MISBRANDED 
DRUGS.—Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding 
at the end the following: 
‘‘(dd) If it is an antimicrobial drug, as defined in sec-
tion 511A(f), and its labeling fails to conform with the re-
quirements under section 511A(d).’’. 
(3) RECOGNITION
OF
INTERPRETIVE
CRITERIA 
STANDARD
AS
DEVICE
STANDARD.—Section 
514(c)(1)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360d(c)(1)(A)) is amended by insert-
ing after ‘‘the Secretary shall, by publication in the 
Federal Register’’ the following: ‘‘(or, with respect to 
a susceptibility test interpretive criteria standard 
under section 511A, by posting on the Interpretive 
Criteria Website in accordance with such section)’’. 
(c) REPORT TO CONGRESS.—Not later than 2 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
227 
and the Committee on Energy and Commerce of the House 
of Representatives a report on the progress made in imple-
menting section 511A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360a), as added by subsection (a). 
(d) REQUESTS FOR UPDATES TO INTERPRETIVE CRI-
TERIA WEBSITE.—Chapter 35 of title 44, United States 
Code, shall not apply to the collection of information from 
interested parties regarding updating the lists established 
under section 511A(b) of the Federal Food, Drug, and Cos-
metic Act and posted on the Interpretive Criteria Website 
established under section 511A(c) of such Act. 
Subtitle F—Medical Device 
Innovations 
SEC. 3051. BREAKTHROUGH DEVICES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 
by inserting after section 515B, as added by section 
3034(b), the following: 
‘‘SEC. 515C. BREAKTHROUGH DEVICES. 
‘‘(a) PURPOSE.—The purpose of this section is to en-
courage the Secretary, and provide the Secretary with suffi-
cient authority, to apply efficient and flexible approaches 
to expedite the development of, and prioritize the Food and 
Drug Administration’s review of, devices that represent 
breakthrough technologies.
228 
‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary 
shall establish a program to expedite the development of, 
and provide for the priority review for, devices, as deter-
mined by the Secretary— 
‘‘(1) that provide for more effective treatment or 
diagnosis of life-threatening or irreversibly debili-
tating human disease or conditions; and 
‘‘(2)(A) that represent breakthrough technologies; 
‘‘(B) for which no approved or cleared alter-
natives exist; 
‘‘(C) that offer significant advantages over exist-
ing approved or cleared alternatives, including the 
potential, compared to existing approved alternatives, 
to reduce or eliminate the need for hospitalization, 
improve patient quality of life, facilitate patients’ 
ability to manage their own care (such as through 
self-directed personal assistance), or establish long- 
term clinical efficiencies; or 
‘‘(D) the availability of which is in the best in-
terest of patients. 
‘‘(c) REQUEST FOR DESIGNATION.—A sponsor of a de-
vice may request that the Secretary designate such device 
for expedited development and priority review under this 
section. Any such request for designation may be made at 
any time prior to the submission of an application under
229 
section 515(c), a notification under section 510(k), or a pe-
tition for classification under section 513(f)(2). 
‘‘(d) DESIGNATION PROCESS.— 
‘‘(1) IN GENERAL.—Not later than 60 calendar 
days after the receipt of a request under subsection 
(c), the Secretary shall determine whether the device 
that is the subject of the request meets the criteria de-
scribed in subsection (b). If the Secretary determines 
that the device meets the criteria, the Secretary shall 
designate the device for expedited development and 
priority review. 
‘‘(2) REVIEW.—Review of a request under sub-
section (c) shall be undertaken by a team that is com-
posed of experienced staff and senior managers of the 
Food and Drug Administration. 
‘‘(3) WITHDRAWAL.—The Secretary may not 
withdraw a designation granted under this section on 
the basis of the criteria under subsection (b) no longer 
applying because of the subsequent clearance or ap-
proval of another device that— 
‘‘(A) was designated under this section; or 
‘‘(B) was given priority review under sec-
tion 515(d)(5), as in effect prior to the date of 
enactment of the 21st Century Cures Act.
230 
‘‘(e) EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW.— 
‘‘(1) ACTIONS.—For purposes of expediting the 
development and review of devices designated under 
subsection (d) the Secretary shall— 
‘‘(A) assign a team of staff, including a 
team leader with appropriate subject matter ex-
pertise and experience, for each device for which 
a request is submitted under subsection (c); 
‘‘(B) provide for oversight of the team by 
senior agency personnel to facilitate the efficient 
development of the device and the efficient review 
of any submission described in subsection (c) for 
the device; 
‘‘(C) adopt an efficient process for timely 
dispute resolution; 
‘‘(D) provide for interactive and timely 
communication with the sponsor of the device 
during the development program and review 
process; 
‘‘(E) expedite the Secretary’s review of 
manufacturing and quality systems compliance, 
as applicable; 
‘‘(F) disclose to the sponsor, not less than 5 
business days in advance, the topics of any con-
231 
sultation the Secretary intends to undertake with 
external experts or an advisory committee con-
cerning the sponsor’s device and provide the 
sponsor the opportunity to recommend such ex-
ternal experts; 
‘‘(G) provide for advisory committee input, 
as the Secretary determines appropriate (includ-
ing in response to the request of the sponsor) for 
applications submitted under section 515(c); and 
‘‘(H) assign staff to be available within a 
reasonable time to address questions by institu-
tional review committees concerning the condi-
tions and clinical testing requirements applica-
ble to the investigational use of the device pursu-
ant to an exemption under section 520(g). 
‘‘(2) ADDITIONAL ACTIONS.—In addition to the 
actions described in paragraph (1), for purposes of 
expediting the development and review of devices des-
ignated under subsection (d), the Secretary, in col-
laboration with the device sponsor, may, as appro-
priate— 
‘‘(A) coordinate with the sponsor regarding 
early agreement on a data development plan;
233 
and at which the director documents the 
substantial scientific issue. 
‘‘(f) PRIORITY REVIEW GUIDANCE.— 
‘‘(1) CONTENT.—Not later than 1 year after the 
date of enactment of the 21st Century Cures Act, the 
Secretary shall issue guidance on the implementation 
of this section. Such guidance shall— 
‘‘(A) set forth the process by which a person 
may seek a designation under subsection (d); 
‘‘(B) provide a template for requests under 
subsection (c); 
‘‘(C) identify the criteria the Secretary will 
use in evaluating a request for designation under 
this section; and 
‘‘(D) identify the criteria and processes the 
Secretary will use to assign a team of staff, in-
cluding team leaders, to review devices des-
ignated for expedited development and priority 
review, including any training required for such 
personnel to ensure effective and efficient review. 
‘‘(2) PROCESS.—Prior to finalizing the guidance 
under paragraph (1), the Secretary shall seek public 
comment on a proposed guidance. 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to affect—
234 
‘‘(1) the criteria and standards for evaluating an 
application pursuant to section 515(c), a report and 
request for classification under section 513(f)(2), or a 
report under section 510(k), including the recognition 
of valid scientific evidence as described in section 
513(a)(3)(B) and consideration and application of 
the least burdensome means of evaluating device effec-
tiveness or demonstrating substantial equivalence be-
tween devices with differing technological characteris-
tics, as applicable; 
‘‘(2) the authority of the Secretary with respect 
to clinical holds under section 520(g)(8)(A); 
‘‘(3) the authority of the Secretary to act on an 
application pursuant to section 515(d) before comple-
tion of an establishment inspection, as the Secretary 
determines appropriate; or 
‘‘(4) the authority of the Secretary with respect 
to postmarket surveillance under sections 519(h) and 
522.’’. 
(b) DOCUMENTATION AND REVIEW OF SIGNIFICANT 
DECISIONS.—Section 517A(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is 
amended by inserting ‘‘a request for designation under sec-
tion 515C,’’ after ‘‘application under section 515,’’. 
(c) TERMINATION OF PREVIOUS PROGRAM.—
235 
(1) IN GENERAL.—Section 515(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)) is 
amended— 
(A) by striking paragraph (5); and 
(B) by redesignating paragraph (6) as 
paragraph (5). 
(2) CONFORMING AMENDMENT.—Section 737(5) 
of the Federal Food, Drug, and Cosmetics Act (21 
U.S.C. 379i(5)) is amended by striking ‘‘515(d)(6)’’ 
and inserting ‘‘515(d)(5)’’. 
(d) REPORT.—On January 1, 2019, the Secretary of 
Health and Human Services shall issue a report to the 
Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce 
of the House of Representatives— 
(1) on the program under section 515C of the 
Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a), in bringing safe and effective devices 
included in such program to patients as soon as pos-
sible; and 
(2) that includes recommendations, if any, to 
strengthen the program to better meet patient device 
needs in a manner as timely as possible.
236 
SEC. 3052. HUMANITARIAN DEVICE EXEMPTION. 
(a) IN GENERAL.—Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amend-
ed— 
(1) in paragraph (1) by striking ‘‘fewer than 
4,000’’ and inserting ‘‘not more than 8,000’’; 
(2) in paragraph (2)(A) by striking ‘‘fewer than 
4,000’’ and inserting ‘‘not more than 8,000’’; and 
(3) in paragraph (6)(A)(ii), by striking ‘‘4,000’’ 
and inserting ‘‘8,000’’. 
(b) GUIDANCE DOCUMENT ON PROBABLE BENEFIT.— 
Not later than 18 months after the date of enactment of 
this Act, the Secretary of Health and Human Services, act-
ing through the Commissioner of Food and Drugs, shall 
publish a draft guidance that defines the criteria for estab-
lishing ‘‘probable benefit’’ as that term is used in section 
520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j(m)(2)(C)). 
SEC. 3053. RECOGNITION OF STANDARDS. 
(a) IN GENERAL.—Section 514(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360d(c)) is amended— 
(1) in paragraph (1), by inserting after subpara-
graph (B) the following new subparagraphs: 
‘‘(C)(i) Any person may submit a request for recogni-
tion under subparagraph (A) of all or part of an appro-
237 
priate standard established by a nationally or internation-
ally recognized standard organization. 
‘‘(ii) Not later than 60 calendar days after the Sec-
retary receives such a request, the Secretary shall— 
‘‘(I) make a determination to recognize all, part, 
or none of the standard that is the subject of the re-
quest; and 
‘‘(II) issue to the person who submitted such re-
quest a response in writing that states the Secretary’s 
rationale for that determination, including the sci-
entific, technical, regulatory, or other basis for such 
determination. 
‘‘(iii) The Secretary shall make a response issued 
under clause (ii)(II) publicly available, in such a manner 
as the Secretary determines appropriate. 
‘‘(iv) The Secretary shall take such actions as may be 
necessary to implement all or part of a standard recognized 
under clause (ii)(I), in accordance with subparagraph (A). 
‘‘(D) The Secretary shall make publicly available, in 
such manner as the Secretary determines appropriate, the 
rationale for recognition under subparagraph (A) of all, 
part, or none of a standard, including the scientific, tech-
nical, regulatory, or other basis for the decision regarding 
such recognition.’’; and 
(2) by adding at the end the following:
238 
‘‘(4) The Secretary shall provide to all employees of 
the Food and Drug Administration who review premarket 
submissions for devices periodic training on the concept and 
use of recognized standards for purposes of meeting a pre-
market submission requirement or other applicable require-
ment under this Act, including standards relevant to an 
employee’s area of device review.’’. 
(b) GUIDANCE.—The Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall review and update, if necessary, previously 
published guidance and standard operating procedures 
identifying the principles for recognizing standards, and for 
withdrawing the recognition of standards, under section 
514(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360d(c)), taking into account the experience with 
and reliance on a standard by foreign regulatory authori-
ties and the device industry, and whether recognition of a 
standard will promote harmonization among regulatory 
authorities in the regulation of devices. 
SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES. 
(a) CLASS I DEVICES.—Section 510(l) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amend-
ed—
239 
(1) by striking ‘‘A report under subsection (k)’’ 
and inserting ‘‘(1) A report under subsection (k)’’; 
and 
(2) by adding at the end the following new para-
graph: 
‘‘(2) Not later than 120 calendar days after the date 
of enactment of the 21st Century Cures Act and at least 
once every 5 years thereafter, as the Secretary determines 
appropriate, the Secretary shall identify, through publica-
tion in the Federal Register, any type of class I device that 
the Secretary determines no longer requires a report under 
subsection (k) to provide reasonable assurance of safety and 
effectiveness. Upon such publication— 
‘‘(A) each type of class I device so identified shall 
be exempt from the requirement for a report under 
subsection (k); and 
‘‘(B) the classification regulation applicable to 
each such type of device shall be deemed amended to 
incorporate such exemption.’’. 
(b) CLASS II DEVICES.—Section 510(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) is 
amended— 
(1) by striking ‘‘(m)(1)’’ and all that follows 
through ‘‘by the Secretary.’’ and inserting the fol-
lowing:
241 
(B) by striking ‘‘30-day period’’ and insert-
ing ‘‘60-calendar-day period’’; and 
(C) by adding at the end the following new 
paragraph: 
‘‘(3) Upon the publication of the final list under para-
graph (1)(B)— 
‘‘(A) each type of class II device so listed shall 
be exempt from the requirement for a report under 
subsection (k); and 
‘‘(B) the classification regulation applicable to 
each such type of device shall be deemed amended to 
incorporate such exemption.’’. 
SEC. 3055. CLASSIFICATION PANELS. 
(a) CLASSIFICATION PANELS.—Paragraph (5) of sec-
tion 513(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360c(b)) is amended— 
(1) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; 
and 
(2) by adding at the end the following: 
‘‘(B) When a device is specifically the subject of review 
by a classification panel, the Secretary shall— 
‘‘(i) ensure that adequate expertise is represented 
on the classification panel to assess—
242 
‘‘(I) the disease or condition which the de-
vice is intended to cure, treat, mitigate, prevent, 
or diagnose; and 
‘‘(II) the technology of the device; and 
‘‘(ii) provide an opportunity for the person 
whose device is specifically the subject of panel review 
to provide recommendations on the expertise needed 
among the voting members of the panel. 
‘‘(C) For purposes of subparagraph (B)(i), the term 
‘adequate expertise’ means that the membership of the clas-
sification panel includes— 
‘‘(i) two or more voting members, with a spe-
cialty or other expertise clinically relevant to the de-
vice under review; and 
‘‘(ii) at least one voting member who is knowl-
edgeable about the technology of the device. 
‘‘(D) The Secretary shall provide an annual oppor-
tunity for patients, representatives of patients, and spon-
sors of medical device submissions to provide recommenda-
tions for individuals with appropriate expertise to fill vot-
ing member positions on classification panels.’’. 
(b) PANEL REVIEW PROCESS.—Section 513(b)(6) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c(b)(6)) is amended—
243 
(1) in subparagraph (A)(iii), by inserting before 
the period at the end ‘‘, including, subject to the dis-
cretion of the panel chairperson, by designating a 
representative who will be provided a time during the 
panel meeting to address the panel for the purpose of 
correcting misstatements of fact or providing clari-
fying information, and permitting the person or rep-
resentative to call on experts within the person’s orga-
nization to address such specific issues in the time 
provided’’; and 
(2) by striking subparagraph (B) and inserting 
the following new subparagraph: 
‘‘(B)(i) Any meeting of a classification panel with re-
spect to the review of a device shall— 
‘‘(I) provide adequate time for initial presen-
tations by the person whose device is specifically the 
subject of such review and by the Secretary; and 
‘‘(II) encourage free and open participation by 
all interested persons. 
‘‘(ii) Following the initial presentations described in 
clause (i), the panel may— 
‘‘(I) pose questions to a designated representative 
described in subparagraph (A)(iii); and 
‘‘(II) consider the responses to such questions in 
the panel’s review of the device.’’.
244 
SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY. 
Section 520 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j) is amended— 
(1) in subsection (g)(3)— 
(A) in subparagraph (A)(i)— 
(i) by striking ‘‘local’’; and 
(ii) by striking ‘‘which has been’’; and 
(B) in subparagraph (B), by striking ‘‘a 
local institutional’’ and inserting ‘‘an institu-
tional’’; and 
(2) in subsection (m)(4)— 
(A) by striking subparagraph (A) and in-
serting the following: 
‘‘(A) in facilities in which clinical testing of de-
vices is supervised by an institutional review com-
mittee established in accordance with the regulations 
of the Secretary; and’’; 
(B) in subparagraph (B), by striking ‘‘a 
local institutional’’ and inserting ‘‘an institu-
tional’’; and 
(C) in the matter following subparagraph 
(B), by striking ‘‘local’’. 
SEC. 3057. CLIA WAIVER IMPROVEMENTS. 
(a) DRAFT REVISED GUIDANCE.—Not later than 1 
year after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, acting through the
245 
Commissioner of Food and Drugs, shall publish a draft 
guidance that— 
(1) revises ‘‘Section V. Demonstrating Insignifi-
cant Risk of an Erroneous Result – Accuracy’’ of the 
guidance entitled ‘‘Recommendations for Clinical 
Laboratory 
Improvement 
Amendments 
of 
1988 
(CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices’’ and dated January 30, 
2008; and 
(2) includes the appropriate use of comparable 
performance between a waived user and a moderately 
complex laboratory user to demonstrate accuracy. 
(b) FINAL REVISED GUIDANCE.—The Secretary of 
Health and Human Services, acting through the Commis-
sioner of Food and Drugs, shall finalize the draft guidance 
published under subsection (a) not later than 1 year after 
the comment period for such draft guidance closes. 
SEC. 3058. LEAST BURDENSOME DEVICE REVIEW. 
(a) IN GENERAL.—Section 513 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 
adding at the end the following: 
‘‘(j) TRAINING AND OVERSIGHT OF LEAST BURDEN-
SOME REQUIREMENTS.— 
‘‘(1) The Secretary shall—
246 
‘‘(A) ensure that each employee of the Food 
and Drug Administration who is involved in the 
review of premarket submissions, including su-
pervisors, receives training regarding the mean-
ing and implementation of the least burdensome 
requirements under subsections (a)(3)(D) and 
(i)(1)(D) of this section and section 515(c)(5); 
and 
‘‘(B) periodically assess the implementation 
of the least burdensome requirements, including 
the employee training under subparagraph (A), 
to ensure that the least burdensome requirements 
are fully and consistently applied. 
‘‘(2) Not later than 18 months after the date of 
enactment of the 21st Century Cures Act, the ombuds-
man for any organizational unit of the Food and 
Drug Administration responsible for the premarket 
review of devices shall— 
‘‘(A) conduct an audit of the training de-
scribed in paragraph (1)(A), including the effec-
tiveness of such training in implementing the 
least burdensome requirements; 
‘‘(B) include in such audit interviews of 
persons who are representatives of the device in-
dustry regarding their experiences in the device
247 
premarket review process, including with respect 
to the application of least burdensome concepts 
to premarket review and decisionmaking; 
‘‘(C) include in such audit a list of the 
measurement tools the Secretary uses to assess 
the implementation of the least burdensome re-
quirements, including under paragraph (1)(B) 
and section 517A(a)(3), and may also provide 
feedback on the effectiveness of such tools in the 
implementation of the least burdensome require-
ments; 
‘‘(D) summarize the findings of such audit 
in a final audit report; and 
‘‘(E) within 30 calendar days of completion 
of such final audit report, make such final audit 
report available— 
‘‘(i) to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate 
and the Committee on Energy and Com-
merce of the House of Representatives; and 
‘‘(ii) on the Internet website of the 
Food and Drug Administration.’’. 
(b) PREMARKET APPLICATIONS.—Section 515(c) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) 
is amended by adding at the end the following:
248 
‘‘(5)(A) In requesting additional information with re-
spect to an application under this section, the Secretary 
shall consider the least burdensome appropriate means nec-
essary to demonstrate a reasonable assurance of device safe-
ty and effectiveness. 
‘‘(B) For purposes of subparagraph (A), the term ‘nec-
essary’ means the minimum required information that 
would support a determination by the Secretary that an 
application provides a reasonable assurance of the safety 
and effectiveness of the device. 
‘‘(C) For purposes of this paragraph, the Secretary 
shall consider the role of postmarket information in deter-
mining the least burdensome means of demonstrating a rea-
sonable assurance of device safety and effectiveness. 
‘‘(D) Nothing in this paragraph alters the standards 
for premarket approval of a device.’’. 
(c) RATIONALE FOR SIGNIFICANT DECISIONS REGARD-
ING DEVICES.—Section 517A(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360g–1(a)) is amended by 
adding at the end the following: 
‘‘(3) APPLICATION OF LEAST BURDENSOME RE-
QUIREMENTS.—The substantive summary required 
under this subsection shall include a brief statement 
regarding how the least burdensome requirements 
were considered and applied consistent with section
249 
513(i)(1)(D), 
section 
513(a)(3)(D), 
and 
section 
515(c)(5), as applicable.’’. 
SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION 
DATA REQUIREMENT. 
(a) IN GENERAL.—Section 510 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360) is amended by 
adding at the end the following: 
‘‘(q) REUSABLE MEDICAL DEVICES.— 
‘‘(1) IN
GENERAL.—Not later than 180 days 
after the date of enactment of the 21st Century Cures 
Act, the Secretary shall identify and publish a list of 
reusable device types for which reports under sub-
section (k) are required to include— 
‘‘(A) instructions for use, which have been 
validated in a manner specified by the Sec-
retary; and 
‘‘(B) validation data, the types of which 
shall be specified by the Secretary; 
regarding cleaning, disinfection, and sterilization, 
and for which a substantial equivalence determina-
tion may be based. 
‘‘(2) REVISION OF LIST.—The Secretary shall re-
vise the list under paragraph (2), as the Secretary de-
termines appropriate, with notice in the Federal Reg-
ister.
250 
‘‘(3) CONTENT OF REPORTS.—Reports under sub-
section (k) that are submitted after the publication of 
the list described in paragraph (1), for devices or 
types of devices included on such list, shall include 
such instructions for use and validation data.’’. 
(b) DEVICE MODIFICATIONS.—The Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall issue final guidance regarding when 
a premarket notification under section 510(k) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is re-
quired to be submitted for a modification or change to a 
legally marketed device. Such final guidance shall be issued 
not later than 1 year after the date on which the comment 
period closes for the draft guidance on such subject. 
SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION. 
(a) IN GENERAL.—Section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by 
adding at the end the following: 
‘‘(o) REGULATION OF MEDICAL AND CERTAIN DECI-
SIONS SUPPORT SOFTWARE.— 
‘‘(1) The term device, as defined in section 
201(h), shall not include a software function that is 
intended— 
‘‘(A) for administrative support of a health 
care facility, including the processing and main-
251 
tenance of financial records, claims or billing in-
formation, appointment schedules, business ana-
lytics, information about patient populations, 
admissions, practice and inventory management, 
analysis of historical claims data to predict fu-
ture utilization or cost-effectiveness, determina-
tion of health benefit eligibility, population 
health management, and laboratory workflow; 
‘‘(B) for maintaining or encouraging a 
healthy lifestyle and is unrelated to the diag-
nosis, cure, mitigation, prevention, or treatment 
of a disease or condition; 
‘‘(C) to serve as electronic patient records, 
including patient-provided information, to the 
extent that such records are intended to transfer, 
store, convert formats, or display the equivalent 
of a paper medical chart, so long as— 
‘‘(i) such records were created, stored, 
transferred, or reviewed by health care pro-
fessionals, or by individuals working under 
supervision of such professionals; 
‘‘(ii) such records are part of health in-
formation technology that is certified under 
section 3001(c)(5) of the Public Health 
Service Act; and
252 
‘‘(iii) such function is not intended to 
interpret or analyze patient records, includ-
ing medical image data, for the purpose of 
the diagnosis, cure, mitigation, prevention, 
or treatment of a disease or condition; 
‘‘(D) for transferring, storing, converting 
formats, or displaying clinical laboratory test or 
other device data and results, findings by a 
health care professional with respect to such data 
and results, general information about such find-
ings, and general background information about 
such laboratory test or other device, unless such 
function is intended to interpret or analyze clin-
ical laboratory test or other device data, results, 
and findings; or 
‘‘(E) unless the function is intended to ac-
quire, process, or analyze a medical image or a 
signal from an in vitro diagnostic device or a 
pattern or signal from a signal acquisition sys-
tem, for the purpose of— 
‘‘(i) displaying, analyzing, or printing 
medical information about a patient or 
other medical information (such as peer-re-
viewed clinical studies and clinical practice 
guidelines);
253 
‘‘(ii) supporting or providing rec-
ommendations to a health care professional 
about prevention, diagnosis, or treatment of 
a disease or condition; and 
‘‘(iii) enabling such health care profes-
sional to independently review the basis for 
such recommendations that such software 
presents so that it is not the intent that 
such health care professional rely primarily 
on any of such recommendations to make a 
clinical diagnosis or treatment decision re-
garding an individual patient. 
‘‘(2) In the case of a product with multiple func-
tions that contains— 
‘‘(A) at least one software function that 
meets the criteria under paragraph (1) or that 
otherwise does not meet the definition of device 
under section 201(h); and 
‘‘(B) at least one function that does not 
meet the criteria under paragraph (1) and that 
otherwise meets the definition of a device under 
section 201(h), 
the Secretary shall not regulate the software function 
of such product described in subparagraph (A) as a 
device. Notwithstanding the preceding sentence, when
254 
assessing the safety and effectiveness of the device 
function or functions of such product described in 
subparagraph (B), the Secretary may assess the im-
pact that the software function or functions described 
in subparagraph (A) have on such device function or 
functions. 
‘‘(3)(A) Notwithstanding paragraph (1), a soft-
ware function described in subparagraph (C), (D), or 
(E) of paragraph (1) shall not be excluded from the 
definition of device under section 201(h) if— 
‘‘(i) the Secretary makes a finding that use 
of such software function would be reasonably 
likely to have serious adverse health con-
sequences; and 
‘‘(ii) the software function has been identi-
fied in a final order issued by the Secretary 
under subparagraph (B). 
‘‘(B) Subparagraph (A) shall apply only if the 
Secretary— 
‘‘(i) publishes a notification and proposed 
order in the Federal Register; 
‘‘(ii) includes in such notification the Sec-
retary’s finding, including the rationale and 
identification of the evidence on which such find-
255 
ing was based, as described in subparagraph 
(A)(i); and 
‘‘(iii) provides for a period of not less than 
30 calendar days for public comment before 
issuing a final order or withdrawing such pro-
posed order. 
‘‘(C) In making a finding under subparagraph 
(A)(i) with respect to a software function, the Sec-
retary shall consider— 
‘‘(i) the likelihood and severity of patient 
harm if the software function were to not per-
form as intended; 
‘‘(ii) the extent to which the software func-
tion is intended to support the clinical judgment 
of a health care professional; 
‘‘(iii) whether there is a reasonable oppor-
tunity for a health care professional to review 
the basis of the information or treatment rec-
ommendation provided by the software function; 
and 
‘‘(iv) the intended user and user environ-
ment, such as whether a health care professional 
will use a software function of a type described 
in subparagraph (E) of paragraph (1).
256 
‘‘(4) Nothing in this subsection shall be construed 
as limiting the authority of the Secretary to— 
‘‘(A) exercise enforcement discretion as to 
any device subject to regulation under this Act; 
‘‘(B) regulate software used in the manufac-
ture and transfusion of blood and blood compo-
nents to assist in the prevention of disease in hu-
mans; or 
‘‘(C) regulate software as a device under 
this Act if such software meets the criteria under 
section 513(a)(1)(C).’’. 
(b) REPORTS.—The Secretary of Health and Human 
Services (referred to in this subsection as the ‘‘Secretary’’), 
after consultation with agencies and offices of the Depart-
ment of Health and Human Services involved in health in-
formation technology, shall publish a report, not later than 
2 years after the date of enactment of this Act and every 
2 years thereafter, that— 
(1) includes input from outside experts, such as 
representatives of patients, consumers, health care 
providers, startup companies, health plans or other 
third-party payers, venture capital investors, infor-
mation technology vendors, health information tech-
nology vendors, small businesses, purchasers, employ-
257 
ers, and other stakeholders with relevant expertise, as 
determined by the Secretary; 
(2) examines information available to the Sec-
retary on any risks and benefits to health associated 
with software functions described in section 520(o)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j) (as amended by subsection (a)); and 
(3) summarizes findings regarding the impact of 
such software functions on patient safety, including 
best practices to promote safety, education, and com-
petency related to such functions. 
(c) 
CLASSIFICATION
OF
ACCESSORIES.—Section 
513(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c(b)) is amended by adding at the end the fol-
lowing: 
‘‘(9) The Secretary shall classify an accessory under 
this section based on the intended use of the accessory, not-
withstanding the classification of any other device with 
which such accessory is intended to be used.’’. 
(d) CONFORMING AMENDMENT.—Section 201(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) 
is amended by adding at the end the following: ‘‘The term 
‘device’ does not include software functions excluded pursu-
ant to section 520(o).’’.
258 
Subtitle G—Improving Scientific 
Expertise and Outreach at FDA 
SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RE-
SEARCH AND BIOMEDICAL PRODUCT ASSESS-
MENT SERVICE. 
(a) HIRING
AND RETENTION AUTHORITY.—Section 
228 of the Public Health Service Act (42 U.S.C. 237) is 
amended— 
(1) in the section heading, by inserting ‘‘AND 
BIOMEDICAL PRODUCT ASSESSMENT’’ after ‘‘RE-
SEARCH’’; 
(2) in subsection (a)— 
(A) in paragraph (1), by striking ‘‘Silvio O. 
Conte Senior Biomedical Research Service, not 
to exceed 500 members’’ and inserting ‘‘Silvio O. 
Conte Senior Biomedical Research and Bio-
medical Product Assessment Service (in this sec-
tion referred to as the ‘Service’), not to exceed 
2,000 members, the purpose of which is to recruit 
and retain outstanding and qualified scientific 
and technical experts in the fields of biomedical 
research, clinical research evaluation, and bio-
medical product assessment’’; 
(B) by amending paragraph (2) to read as 
follows:
259 
‘‘(2) The authority established in paragraph (1) may 
not be construed to require the Secretary to reduce the num-
ber of employees serving under any other employment sys-
tem in order to offset the number of members serving in 
the Service.’’; and 
(C) by adding at the end the following: 
‘‘(3) The Secretary shall assign experts under this sec-
tion to agencies within the Department of Health and 
Human Services taking into account the need for the exper-
tise of such expert.’’; 
(3) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘or clinical research evaluation’’ and 
inserting ‘‘, clinical research evaluation, or bio-
medical product assessment’’; and 
(B) in paragraph (1), by inserting ‘‘or a 
doctoral or master’s level degree in engineering, 
bioinformatics, or a related or emerging field,’’ 
after the comma; 
(4) in subsection (d)(2), by striking ‘‘and shall 
not exceed the rate payable for level I of the Executive 
Schedule unless approved by the President under sec-
tion 5377(d)(2) of title 5, United States Code’’ and 
inserting ‘‘and shall not exceed the amount of annual
260 
compensation (excluding expenses) specified in section 
102 of title 3, United States Code’’; 
(5) by striking subsection (e); and 
(6) by redesignating subsections (f) and (g) as 
subsections (e) and (f), respectively. 
(b) GAO STUDY.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study of the effec-
tiveness of the amendments to section 228 of the Pub-
lic Health Service Act (42 U.S.C. 237) made by sub-
section (a) and the impact of such amendments, if 
any, on all agencies or departments of the Depart-
ment of Health and Human Services, and, not later 
than 4 years after the date of enactment of this Act, 
shall submit a report based on such study to the Com-
mittee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Com-
merce of the House of Representatives. 
(2) CONTENT
OF
STUDY
AND
REPORT.—The 
study and report under paragraph (1) shall include 
an examination of the extent to which recruitment 
and retention of outstanding and qualified scientific, 
medical, or technical experts in the fields of bio-
medical research, clinical research evaluation, and 
biomedical product assessment have improved or oth-
261 
erwise have been affected by the amendments to sec-
tion 228 of the Public Health Service Act (42 U.S.C. 
237) made by subsection (a), including by deter-
mining, during the period between the date of enact-
ment of this Act and the completion of the study— 
(A) the total number of members recruited 
and retained under the Senior Biomedical Re-
search and Biomedical Product Assessment Serv-
ice under such section 228, and the effect of in-
creasing the number of members eligible for such 
Service; 
(B) the number of members of such Senior 
Biomedical Research and Biomedical Product 
Assessment Service hired with a doctoral level 
degree in biomedicine or a related field, and the 
number of such members hired with a doctoral or 
master’s 
level 
degree 
in 
engineering, 
bioinformatics, or a related or emerging field; 
and 
(C) the number of Senior Biomedical Re-
search and Biomedical Product Assessment Serv-
ice members that have been hired by each agency 
or department of the Department of Health and 
Human Services, and how such Department as-
262 
signs such members to each agency or depart-
ment. 
SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECH-
NICAL, AND PROFESSIONAL PERSONNEL. 
(a) IN GENERAL.—The Federal Food, Drug, and Cos-
metic Act is amended by inserting after section 714 (21 
U.S.C. 379d–3) the following: 
‘‘SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECH-
NICAL, AND PROFESSIONAL PERSONNEL. 
‘‘(a) IN GENERAL.—The Secretary may, notwith-
standing title 5, United States Code, governing appoint-
ments in the competitive service, appoint outstanding and 
qualified candidates to scientific, technical, or professional 
positions that support the development, review, and regula-
tion of medical products. Such positions shall be within the 
competitive service. 
‘‘(b) COMPENSATION.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of law, including any requirement with re-
spect to General Schedule pay rates under subchapter 
III of chapter 53 of title 5, United States Code, and 
consistent with the requirements of paragraph (2), the 
Commissioner of Food and Drugs may determine and 
set—
263 
‘‘(A) the annual rate of pay of any indi-
vidual appointed under subsection (a); and 
‘‘(B) for purposes of retaining qualified em-
ployees, the annual rate of pay for any qualified 
scientific, technical, or professional personnel ap-
pointed to a position described in subsection (a) 
before the date of enactment of the 21st Century 
Cures Act. 
‘‘(2) LIMITATION.—The annual rate of pay es-
tablished pursuant to paragraph (1) may not exceed 
the amount of annual compensation (excluding ex-
penses) specified in section 102 of title 3, United 
States Code. 
‘‘(3) PUBLIC AVAILABILITY.—The annual rate of 
pay provided to an individual in accordance with 
this section shall be publicly available information. 
‘‘(c) RULE OF CONSTRUCTION.—The authorities under 
this section shall not be construed to affect the authority 
provided under section 714. 
‘‘(d) REPORT ON WORKFORCE PLANNING.— 
‘‘(1) IN GENERAL.—Not later than 18 months 
after the date of enactment of the 21st Century Cures 
Act, the Secretary shall submit a report on workforce 
planning to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee
264 
on Energy and Commerce of the House of Representa-
tives that examines the extent to which the Food and 
Drug Administration has a critical need for qualified 
individuals for scientific, technical, or professional 
positions, including— 
‘‘(A) an analysis of the workforce needs at 
the Food and Drug Administration and the Sec-
retary’s strategic plan for addressing such needs, 
including through use of the authority under this 
section; and 
‘‘(B) a recruitment and retention plan for 
hiring qualified scientific, technical, and profes-
sional candidates, which may include the use 
of— 
‘‘(i) recruitment through nongovern-
mental recruitment or placement agencies; 
‘‘(ii) recruitment through academic in-
stitutions; 
‘‘(iii) recruitment or hiring bonuses, if 
applicable; 
‘‘(iv) recruitment using targeted direct 
hiring authorities; and 
‘‘(v) retention of qualified scientific, 
technical, and professional employees using
265 
the authority under this section, or other 
applicable authorities of the Secretary. 
‘‘(2) RECOMMENDATIONS.—The report under 
paragraph (1) may include the recommendations of 
the Commissioner of Food and Drugs that would help 
the Food and Drug Administration to better recruit 
and retain qualified individuals for scientific, tech-
nical, or professional positions at the agency.’’. 
(b) GAO STUDY AND REPORT.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study of the ability 
of the Food and Drug Administration to hire, train, 
and retain qualified scientific, technical, and profes-
sional staff, not including contractors, necessary to 
fulfill the mission of the Food and Drug Administra-
tion to protect and promote public health. Not later 
than January 1, 2022, the Comptroller General shall 
submit a report on such study to the Committee on 
Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the 
House of Representatives. 
(2) CONTENTS
OF
STUDY.—The Comptroller 
General shall include in the study and report under 
paragraph (1)—
266 
(A) information about the progress of the 
Food and Drug Administration in recruiting 
and retaining qualified scientific, technical, and 
professional staff outstanding in the field of bio-
medical research, clinical research evaluation, 
and biomedical product assessment; 
(B) the extent to which critical staffing 
needs exist at the Food and Drug Administra-
tion, and barriers to hiring, training, and re-
taining qualified staff, if any; 
(C) an examination of the recruitment and 
retention strategies of the Food and Drug Ad-
ministration, including examining any strategic 
workforce plan, focused on improving scientific, 
technical, and professional staff recruitment and 
retention; and 
(D) recommendations for potential improve-
ments that would address staffing needs of the 
Food and Drug Administration. 
SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINIS-
TRATION INTERCENTER INSTITUTES. 
(a) IN GENERAL.—Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended 
by adding at the end the following:
267 
‘‘SEC. 1014. FOOD AND DRUG ADMINISTRATION INTER-
CENTER INSTITUTES. 
‘‘(a) IN GENERAL.—The Secretary shall establish one 
or more Intercenter Institutes within the Food and Drug 
Administration (referred to in this section as an ‘Institute’) 
for a major disease area or areas. With respect to the major 
disease area of focus of an Institute, such Institute shall 
develop and implement processes for coordination of activi-
ties, as applicable to such major disease area or areas, 
among the Center for Drug Evaluation and Research, the 
Center for Biologics Evaluation and Research, and the Cen-
ter for Devices and Radiological Health (for the purposes 
of this section, referred to as the ‘Centers’). Such activities 
may include— 
‘‘(1) coordination of staff from the Centers with 
diverse product expertise in the diagnosis, cure, miti-
gation, treatment, or prevention of the specific dis-
eases relevant to the major disease area of focus of the 
Institute; 
‘‘(2) streamlining, where appropriate, the review 
of medical products to diagnose, cure, mitigate, treat, 
or prevent the specific diseases relevant to the major 
disease area of focus of the Institute, applying rel-
evant standards under sections 505, 510(k), 513(f)(2), 
and 515 of this Act and section 351 of the Public 
Health Service Act, and other applicable authorities;
268 
‘‘(3) promotion of scientific programs within the 
Centers related to the major disease area of focus of 
the Institute; 
‘‘(4) development of programs and enhancement 
of strategies to recruit, train, and provide continuing 
education opportunities for the personnel of the Cen-
ters with expertise related to the major disease area 
of focus of the Institute; 
‘‘(5) enhancement of the interactions of the Cen-
ters with patients, sponsors, and the external bio-
medical community regarding the major disease area 
of focus of the Institute; and 
‘‘(6) facilitation of the collaborative relationships 
of the Centers with other agencies within the Depart-
ment of Health and Human Services regarding the 
major disease area of focus of the Institute. 
‘‘(b) PUBLIC PROCESS.—The Secretary shall provide 
a period for public comment during the time that each In-
stitute is being implemented. 
‘‘(c) TIMING.—The Secretary shall establish at least 
one Institute under subsection (a) before the date that is 
1 year after the date of enactment of the 21st Century Cures 
Act. 
‘‘(d) TERMINATION OF INSTITUTES.—The Secretary 
may terminate any Institute established pursuant to this
269 
section if the Secretary determines such Institute is no 
longer benefitting the public health. Not less than 60 days 
prior to so terminating an Institute, the Secretary shall 
provide public notice, including the rationale for such ter-
mination.’’. 
(b) TECHNICAL AMENDMENTS.—Chapter X of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) 
is amended— 
(1) by redesignating section 1012 as section 
1013; and 
(2) by redesignating the second section 1011 
(with respect to improving the training of State, 
local, territorial, and tribal food safety officials), as 
added by section 209(a) of the FDA Food Safety Mod-
ernization Act (Public Law 111–353), as section 
1012. 
SEC. 3074. SCIENTIFIC ENGAGEMENT. 
(a) IN GENERAL.—Scientific meetings that are at-
tended by scientific or medical personnel, or other profes-
sionals, of the Department of Health and Human Services 
for whom attendance at such meeting is directly related to 
their professional duties and the mission of the Depart-
ment— 
(1) shall not be considered conferences for the 
purposes of complying with Federal reporting require-
270 
ments contained in annual appropriations Acts or in 
this section; and 
(2) shall not be considered conferences for pur-
poses of a restriction contained in an annual appro-
priations Act, based on Office of Management and 
Budget Memorandum M-12-12 or any other regula-
tion restricting travel to such meeting. 
(b) LIMITATION.—Nothing in this section shall be con-
strued to exempt travel for scientific meetings from Federal 
regulations relating to travel. 
(c) REPORTS.—Not later than 90 days after the end 
of the fiscal year, each operating division of the Department 
of Health and Human Services shall prepare, and post on 
an Internet website of the operating division, an annual 
report on scientific meeting attendance and related travel 
spending for each fiscal year. Such report shall include— 
(1) general information concerning the scientific 
meeting activities involved; 
(2) information concerning the total amount ex-
pended for such meetings; 
(3) a description of all such meetings that were 
attended by scientific or medical personnel, or other 
professionals, of each such operating division where 
the total amount expended by the operating division
271 
associated with each such meeting were in excess of 
$30,000, including— 
(A) the total amount of meeting expenses 
incurred by the operating division for such meet-
ing; 
(B) the location of such meeting; 
(C) the date of such meeting; 
(D) a brief explanation on how such meet-
ing advanced the mission of the operating divi-
sion; and 
(E) the total number of individuals whose 
travel expenses or other scientific meeting ex-
penses were paid by the operating division; and 
(4) with respect to any such meeting where the 
total expenses to the operating division exceeded 
$150,000, a description of the exceptional cir-
cumstances that necessitated the expenditure of such 
amounts. 
SEC. 3075. DRUG SURVEILLANCE. 
(a) NEW DRUGS.—Section 505(k)(5) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)(5)), as 
amended by section 2074, is further amended— 
(1) in subparagraph (A), by striking ‘‘, bi-weekly 
screening’’ and inserting ‘‘screenings’’;
272 
(2) in subparagraph (B), as redesignated by sec-
tion 2074(1)(C), by striking the period at the end and 
inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(C) make available on the Internet website of 
the Food and Drug Administration— 
‘‘(i) guidelines, developed with input from 
experts qualified by scientific training and expe-
rience to evaluate the safety and effectiveness of 
drugs, that detail best practices for drug safety 
surveillance using the Adverse Event Reporting 
System; and 
‘‘(ii) criteria for public posting of adverse 
event signals.’’. 
(b) FAERS REVISION.—Section 505(r)(2)(D) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(r)(2)(D)) is amended by striking ‘‘, by 18 months’’ and 
all that follows through the semicolon at the end of the sub-
paragraph and inserting ‘‘and making publicly available 
on the Internet website established under paragraph (1) best 
practices for drug safety surveillance activities for drugs 
approved under this section or section 351 of the Public 
Health Service Act;’’.
273 
(c) RISK EVALUATION
AND MITIGATION STRATE-
GIES.—Section 505–1(f)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1(f)(5)) is amended— 
(1) in the matter preceding subparagraph (A), 
by inserting ‘‘or other advisory committee’’ after ‘‘(or 
successor committee)’’; and 
(2) in subparagraph (B), by striking ‘‘at least 
annually,’’ and inserting ‘‘periodically’’. 
SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD 
AND DRUG ADMINISTRATION. 
(a) BOARD OF DIRECTORS.— 
(1) 
COMPOSITION
AND
SIZE.—Section 
770(d)(1)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379dd(d)(1)(C)) is amended— 
(A) by redesignating clause (ii) as clause 
(iii); 
(B) by inserting after clause (i) the fol-
lowing: 
‘‘(ii) 
ADDITIONAL
MEMBERS.—The 
Board, through amendments to the bylaws 
of the Foundation, may provide that the 
number of voting members of the Board 
shall be a number (to be specified in such 
amendment) greater than 14. Any Board 
positions that are established by any such
274 
amendment shall be appointed (by majority 
vote) by the individuals who, as of the date 
of such amendment, are voting members of 
the Board and persons so appointed may 
represent any of the categories specified in 
subclauses (I) through (V) of clause (i), so 
long as no more than 30 percent of the total 
voting members of the Board (including 
members whose positions are established by 
such amendment) are representatives of the 
general pharmaceutical, device, food, cos-
metic, and biotechnology industries.’’; and 
(C) in clause (iii)(I), as redesignated by 
subparagraph (A), by striking ‘‘The ex officio 
members shall ensure’’ and inserting ‘‘The ex 
officio members, acting pursuant to clause (i), 
and the Board, acting pursuant to clause (ii), 
shall ensure’’. 
(2) FEDERAL EMPLOYEES ALLOWED TO SERVE 
ON BOARD.—Clause (iii)(II) of section 770(d)(1)(C) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379dd(d)(1)(C)), 
as 
redesignated 
by 
paragraph 
(1)(A), is amended by adding at the end the fol-
lowing: ‘‘For purposes of this section, the term ‘em-
ployee of the Federal Government’ does not include a
275 
special Government employee, as that term is defined 
in section 202(a) of title 18, United States Code.’’. 
(3) STAGGERED TERMS.—Subparagraph (A) of 
section 770(d)(3) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379dd(d)(3)) is amended to read 
as follows: 
‘‘(A) TERM.—The term of office of each 
member of the Board appointed under para-
graph (1)(C)(i), and the term of office of any 
member of the Board whose position is estab-
lished pursuant to paragraph (1)(C)(ii), shall be 
4 years, except that— 
‘‘(i) the terms of offices for the members 
of the Board initially appointed under 
paragraph (1)(C)(i) shall expire on a stag-
gered basis as determined by the ex officio 
members; and 
‘‘(ii) the terms of office for the persons 
initially appointed to positions established 
pursuant to paragraph (1)(C)(ii) may be 
made to expire on a staggered basis, as de-
termined by the individuals who, as of the 
date of the amendment establishing such po-
sitions, are members of the Board.’’.
276 
(b) EXECUTIVE DIRECTOR COMPENSATION.—Section 
770(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379dd(g)(2)) is amended by striking ‘‘but shall not 
be greater than the compensation of the Commissioner’’. 
(c) SEPARATION OF FUNDS.—Section 770(m) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379dd(m)) is amended by striking ‘‘are held in separate 
accounts from funds received from entities under subsection 
(i)’’ and inserting ‘‘are managed as individual pro-
grammatic funds under subsection (i), according to best ac-
counting practices’’. 
Subtitle H—Medical 
Countermeasures Innovation 
SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES. 
Section 319F–2 of the Public Health Service Act (42 
U.S.C. 247d–6b) is amended— 
(1) in subsection (a), by adding at the end the 
following: 
‘‘(3) UTILIZATION GUIDELINES.—The Secretary 
shall ensure timely and accurate recommended utili-
zation guidelines for qualified countermeasures (as 
defined in section 319F–1), qualified pandemic and 
epidemic products (as defined in section 319F–3), 
and security countermeasures (as defined in sub-
277 
section (c)), including for such products in the stock-
pile.’’; and 
(2) in subsection (g)— 
(A) by amending paragraph (4) to read as 
follows: 
‘‘(4) REPORT
ON
SECURITY
COUNTERMEASURE 
PROCUREMENT.—Not later than March 1 of each year 
in which the Secretary determines that the amount of 
funds available for procurement of security counter-
measures is less than $1,500,000,000, the Secretary 
shall submit to the Committee on Appropriations and 
the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Appro-
priations and the Committee on Energy and Com-
merce of the House of Representatives a report detail-
ing the amount of such funds available for procure-
ment and the impact such amount of funding will 
have— 
‘‘(A) in meeting the security countermeasure 
needs identified under this section; and 
‘‘(B) on the annual Public Health Emer-
gency Medical Countermeasures Enterprise and 
Strategy Implementation Plan (pursuant to sec-
tion 2811(d)).’’.
278 
SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY. 
(a) IN GENERAL.—Section 319F–2(g) of the Public 
Health Service Act (42 U.S.C. 247d–6b(g)) is amended by 
adding at the end the following: 
‘‘(5) CLARIFICATION ON CONTRACTING AUTHOR-
ITY.—The Secretary, acting through the Director of 
the Biomedical Advanced Research and Development 
Authority, shall carry out the programs funded by the 
special reserve fund (for the procurement of security 
countermeasures under subsection (c) and for car-
rying out section 319L), including the execution of 
procurement contracts, grants, and cooperative agree-
ments pursuant to this section and section 319L.’’. 
(b) BARDA CONTRACTING
AUTHORITY.—Section 
319L(c)(3) of the Public Health Service Act (42 U.S.C. 
247d–7c) is amended by inserting ‘‘, including the execution 
of procurement contracts, grants, and cooperative agree-
ments pursuant to this section’’ before the period. 
SEC. 3083. COUNTERMEASURE BUDGET PLAN. 
Section 2811(b)(7) of the Public Health Service Act 
(42 U.S.C. 300hh–10(b)(7)) is amended— 
(1) in the matter preceding subparagraph (A), 
by striking the first sentence and inserting ‘‘Develop, 
and update not later than March 1 of each year, a 
coordinated 5-year budget plan based on the medical 
countermeasure priorities described in subsection (d),
279 
including with respect to chemical, biological, radio-
logical, and nuclear agent or agents that may present 
a threat to the Nation, including such agents that are 
novel or emerging infectious diseases, and the cor-
responding efforts to develop qualified counter-
measures (as defined in section 319F–1), security 
countermeasures (as defined in section 319F–2), and 
qualified pandemic or epidemic products (as defined 
in section 319F–3) for each such threat.’’; 
(2) in subparagraph (C), by striking ‘‘; and’’ 
and inserting a semicolon; 
(3) in subparagraph (D), by striking ‘‘to the ap-
propriate committees of Congress upon request.’’ and 
inserting ‘‘, not later than March 15 of each year, to 
the Committee on Appropriations and the Committee 
on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Appropriations and the 
Committee on Energy and Commerce of the House of 
Representatives; and’’; and 
(4) by adding at the end the following: 
‘‘(E) not later than March 15 of each year, 
be made publicly available in a manner that 
does not compromise national security.’’.
280 
SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION. 
Section 319L(c)(4) of the Public Health Service Act 
(42 U.S.C. 247d–7e(c)(4)) is amended by adding at the end 
the following: 
‘‘(E) MEDICAL COUNTERMEASURES INNOVA-
TION PARTNER.— 
‘‘(i) IN
GENERAL.—To support the 
purposes described in paragraph (2), the 
Secretary, acting through the Director of 
BARDA, may enter into an agreement (in-
cluding through the use of grants, contracts, 
cooperative agreements, or other trans-
actions as described in paragraph (5)) with 
an independent, nonprofit entity to— 
‘‘(I) foster and accelerate the de-
velopment and innovation of medical 
countermeasures and technologies that 
may assist advanced research and the 
development 
of 
qualified 
counter-
measures and qualified pandemic or 
epidemic products, including through 
the use of strategic venture capital 
practices and methods; 
‘‘(II) promote the development of 
new and promising technologies that
281 
address urgent medical countermeasure 
needs, as identified by the Secretary; 
‘‘(III) 
address 
unmet 
public 
health needs that are directly related to 
medical countermeasure requirements, 
such 
as 
novel 
antimicrobials 
for 
multidrug resistant organisms and 
multiuse 
platform 
technologies 
for 
diagnostics, prophylaxis, vaccines, and 
therapeutics; and 
‘‘(IV) provide expert consultation 
and advice to foster viable medical 
countermeasure innovators, including 
helping 
qualified 
countermeasure 
innovators navigate unique industry 
challenges with respect to developing 
chemical, biological, radiological, and 
nuclear countermeasure products. 
‘‘(ii) ELIGIBILITY.— 
‘‘(I) IN GENERAL.—To be eligible 
to enter into an agreement under 
clause (i) an entity shall— 
‘‘(aa) be an independent, 
nonprofit entity;
282 
‘‘(bb) have a demonstrated 
record of being able to create link-
ages between innovators and in-
vestors and leverage such partner-
ships and resources for the pur-
pose of addressing identified stra-
tegic needs of the Federal Govern-
ment; 
‘‘(cc) have experience in pro-
moting novel technology innova-
tion; 
‘‘(dd) be problem-driven and 
solution-focused 
based 
on 
the 
needs, requirements, and problems 
identified by the Secretary under 
clause (iv); 
‘‘(ee) demonstrate the ability, 
or the potential ability, to pro-
mote the development of medical 
countermeasure products; 
‘‘(ff) demonstrate expertise, 
or the capacity to develop or ac-
quire expertise, related to tech-
nical and regulatory consider-
283 
ations with respect to medical 
countermeasures; and 
‘‘(gg) not be within the De-
partment of Health and Human 
Services. 
‘‘(II) 
PARTNERING
EXPERI-
ENCE.—In selecting an entity with 
which to enter into an agreement 
under clause (i), the Secretary shall 
place a high value on the demonstrated 
experience of the entity in partnering 
with the Federal Government to meet 
identified strategic needs. 
‘‘(iii) NOT
AGENCY.—An entity that 
enters into an agreement under clause (i) 
shall not be deemed to be a Federal agency 
for any purpose, including for any purpose 
under title 5, United States Code. 
‘‘(iv) DIRECTION.—Pursuant to an 
agreement entered into under this subpara-
graph, the Secretary, acting through the Di-
rector of BARDA, shall provide direction to 
the entity that enters into an agreement 
under clause (i). As part of this agreement 
the Director of BARDA shall—
284 
‘‘(I) communicate the medical 
countermeasure needs, requirements, 
and problems to be addressed by the 
entity under the agreement; 
‘‘(II) develop a description of 
work to be performed by the entity 
under the agreement; 
‘‘(III) provide technical feedback 
and appropriate oversight over work 
carried out by the entity under the 
agreement, including subsequent devel-
opment and partnerships consistent 
with the needs and requirements set 
forth in this subparagraph; 
‘‘(IV) ensure fair consideration of 
products developed under the agree-
ment in order to maintain competition 
to the maximum practical extent, as 
applicable and appropriate under ap-
plicable provisions of this section; and 
‘‘(V) ensure, as a condition of the 
agreement that the entity— 
‘‘(aa) has in place a com-
prehensive set of policies that
374 
access, exchange, or use of electronic health infor-
mation; or 
‘‘(ii) if conducted by a health care provider, 
such provider knows that such practice is unrea-
sonable and is likely to interfere with, prevent, 
or materially discourage access, exchange, or use 
of electronic health information. 
‘‘(2) PRACTICES DESCRIBED.—The information 
blocking practices described in paragraph (1) may in-
clude— 
‘‘(A) practices that restrict authorized ac-
cess, exchange, or use under applicable State or 
Federal law of such information for treatment 
and other permitted purposes under such appli-
cable law, including transitions between certified 
health information technologies; 
‘‘(B) implementing health information tech-
nology in nonstandard ways that are likely to 
substantially increase the complexity or burden 
of accessing, exchanging, or using electronic 
health information; and 
‘‘(C) implementing health information tech-
nology in ways that are likely to— 
‘‘(i) restrict the access, exchange, or use 
of electronic health information with respect