199 
SEC. 2223. TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT. 
(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 IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT.— 
‘‘(1) TRAINING.—Each employee of the Food and 
Drug Administration who is involved in the review of 
premarket submissions under section 515 or section 
510(k), including supervisors, shall receive training 
regarding the meaning and implementation of the 
least burdensome appropriate means concept in the 
context of the use of that term in subsections 
(a)(3)(D) and (i)(1)(D) of this section and in section 
515(c)(5). 
‘‘(2) GUIDANCE DOCUMENTS.— 
‘‘(A) DRAFT
UPDATED
GUIDANCE.—Not 
later than 12 months after the date of enactment 
of the 21st Century Cures Act, the Secretary 
shall issue a draft guidance document updating 
the October 4, 2002, guidance document entitled 
‘The Least Burdensome Provision of the FDA 
Modernization Act of 1997: Concept and Prin-
ciples; Final Guidance for FDA and Industry’. 
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‘‘(B) MEETING OF STAKEHOLDERS.—In de-
veloping such draft guidance document, the Sec-
retary shall convene a meeting of stakeholders to 
ensure a full record to support the publication of 
such document. 
‘‘(3) OMBUDSMAN
AUDIT.—Not later than 18 
months after the date of issuance of final version of 
the draft guidance under paragraph (2), the ombuds-
man for the organizational unit of the Food and 
Drug Administration responsible for the premarket 
review of devices shall— 
‘‘(A) conduct, or have conducted, an audit 
of the training described in paragraph (1); and 
‘‘(B) include in such audit interviews with 
a representative sample of persons from industry 
regarding their experience in the device pre-
market review process.’’. 
(b) ADDITIONAL
INFORMATION
REGARDING
PRE-
MARKET APPLICATIONS.—Subsection (c) of section 515 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) 
is amended by adding at the end the following: 
‘‘(5)(A) Whenever the Secretary requests additional in-
formation from an applicant regarding an application 
under paragraph (1), the Secretary shall consider the least 
burdensome appropriate means necessary to demonstrate 
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device safety and effectiveness, and request information ac-
cordingly. 
‘‘(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) Nothing in this paragraph alters the standards 
for premarket approval of a device.’’. 
SEC. 2224. RECOGNITION OF STANDARDS. 
Section 514(c) of the Federal Food, Drug, and Cos-
metic 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-
priate standard established by a nationally or internation-
ally recognized standard organization. 
‘‘(ii) Not later than 60 days after the Secretary re-
ceives 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 
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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 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 (i)(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 part 
of a standard, including the scientific, technical, regulatory, 
or other basis for such recognition.’’; and 
(2) by adding at the end the following new para-
graphs: 
‘‘(4) TRAINING
ON
USE
OF
STANDARDS.—The 
Secretary shall provide to all employees of the Food 
and Drug Administration who review premarket sub-
missions for devices periodic training on the concept 
and use of recognized standards for purposes of meet-
ing a premarket submission requirement or other ap-
plicable requirement under this Act, including stand-
ards relevant to an employee’s area of device review. 
‘‘(5) GUIDANCE.— 
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‘‘(A) DRAFT
GUIDANCE.—The Secretary 
shall publish guidance identifying the principles 
for recognizing standards under this section. In 
publishing such guidance, the Secretary shall 
consider— 
‘‘(i) the experience with, and reliance 
on, a standard by other Federal regulatory 
authorities and the device industry; and 
‘‘(ii) whether recognition of a standard 
will promote harmonization among regu-
latory authorities in the regulation of de-
vices. 
‘‘(B) TIMING.—The Secretary shall pub-
lish— 
‘‘(i) draft guidance under subpara-
graph (A) not later than 12 months after 
the date of the enactment of the 21st Cen-
tury Cures Act; and 
‘‘(ii) final guidance not later than 12 
months after the close of the public comment 
period for the draft guidance under clause 
(i).’’. 
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204 
SEC. 2225. EASING REGULATORY BURDEN WITH RESPECT 
TO 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— 
(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 days after the date of the en-
actment of the 21st Century Cures Act, the Secretary shall 
identify, through publication in the Federal Register, any 
type of class I device that the Secretary determines no 
longer requires a report under subsection (k) to provide rea-
sonable 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— 
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(1) by striking paragraph (1) and inserting the 
following new paragraph: ‘‘(1) The Secretary shall— 
‘‘(A) not later than 60 days after the date of the 
enactment of the 21st Century Cures Act— 
‘‘(i) publish in the Federal Register a notice 
that contains a list of each type of class II device 
that the Secretary determines no longer requires 
a report under subsection (k) to provide reason-
able assurance of safety and effectiveness; and 
‘‘(ii) provide for a period of not less than 
60 days for public comment beginning on the 
date of the publication of such notice; and 
‘‘(B) not later than 180 days after the date of the 
enactment of 21st Century Cures Act, publish in the 
Federal Register a list representing the Secretary’s 
final determination with respect to the devices in-
cluded in the list published under subparagraph 
(A).’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘1 day after the date of the 
publication of a list under this subsection,’’ and 
inserting ‘‘1 day after the date of publication of 
the final list under paragraph (1)(B),’’; and 
(B) by striking ‘‘30-day period’’ and insert-
ing ‘‘60-day period’’; and 
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206 
(3) by adding at the end the following new para-
graph: 
‘‘(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. 2226. ADVISORY COMMITTEE PROCESS. 
(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— 
‘‘(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 
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‘‘(ii) as part of the process to ensure adequate ex-
pertise under clause (i), give due consideration to the 
recommendations of the person whose premarket sub-
mission is subject to panel review on the expertise 
needed among the voting members of the panel. 
‘‘(C) For review by a classification panel of a pre-
market submission for a device, the Secretary shall— 
‘‘(i) provide an opportunity for the person whose 
premarket submission is subject to panel review to 
provide recommendations on the expertise needed 
among the voting members of the panel; and 
‘‘(ii) give due consideration to such recommenda-
tions and ensure that adequate expertise is rep-
resented on advisory panels to assess— 
‘‘(I) the disease or condition for which the 
device is intended to cure, treat, mitigate, pre-
vent, or diagnose; and 
‘‘(II) the technology of the device. 
‘‘(D) For purposes of subparagraph (B)(ii), the term 
‘adequate expertise’ means, with respect to the membership 
of the classification panel reviewing a premarket submis-
sion, that such membership includes— 
‘‘(i) two or more voting members, with a spe-
cialty or other expertise clinically relevant to the de-
vice under review; and 
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208 
‘‘(ii) at least one voting member who is knowl-
edgeable about the technology of the device.’’. 
(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— 
(1) in subparagraph (A)(iii), by inserting before 
the period at the end ‘‘, including by designating a 
representative who will be provided a time during the 
panel meeting to address the panel individually (or 
accompanied by experts selected by such representa-
tive) for the purpose of correcting misstatements of 
fact or providing clarifying information, subject to 
the discretion of the panel chairperson’’; and 
(2) by striking subparagraph (B) and inserting 
the following new subparagraph: 
‘‘(B)(i) Any meeting of a classification panel for a de-
vice that is specifically the subject of review shall— 
‘‘(I) provide adequate time for initial presen-
tations by the person whose device is specifically the 
subject of a classification panel 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— 
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‘‘(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 that is specifically the 
subject of review by the panel.’’. 
SEC. 2227. HUMANITARIAN DEVICE EXEMPTION APPLICA-
TION. 
(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 document that defines the criteria 
for establishing ‘‘probable benefit’’ as that term is used in 
section 520(m)(2)(C) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(2)(C)). 
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SEC. 2228. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN 
VITRO DIAGNOSTICS. 
(a) DRAFT REVISED GUIDANCE.—Not later than 12 
months after the date of the enactment of this Act, the Sec-
retary of Health and Human Services 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 guidance on 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 shall finalize the draft guid-
ance published under subsection (a) not later than 12 
months after the comment period for such draft guidance 
closes. 
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Subtitle N—Sensible Oversight for 
Technology 
Which 
Advances 
Regulatory Efficiency 
SEC. 2241. HEALTH SOFTWARE. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
‘‘(ss)(1) The term ‘health software’ means software that 
does not, through use of an in vitro diagnostic device or 
signal acquisition system, acquire, process, or analyze an 
image or physiological signal, is not an accessory, is not 
an integral part of a device necessary to support the use 
of the device, is not used in the manufacture and trans-
fusion of blood and blood components to assist in the pre-
vention of disease in humans, and— 
‘‘(A) is intended for use for administrative or 
operational support or the processing and mainte-
nance of financial records; 
‘‘(B) is intended for use in clinical, laboratory, 
or administrative workflow and related recordkeeping; 
‘‘(C)(i) is intended for use solely in the transfer, 
aggregation, conversion (in accordance with a present 
specification), storage, management, retrieval, or 
transmission of data or information; 
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‘‘(ii) utilizes a connectivity software platform, 
electronic or electrical hardware, or a physical com-
munications infrastructure; and 
‘‘(iii) is not intended for use— 
‘‘(I) in active patient monitoring; or 
‘‘(II) in controlling or altering the functions 
or parameters of a device that is connected to 
such software; 
‘‘(D) is intended for use to organize and present 
information for health or wellness education or for 
use in maintaining a healthy lifestyle, including 
medication adherence and health management tools; 
‘‘(E) is intended for use to analyze information 
to provide general health information that does not 
include patient-specific recommended options to con-
sider in the prevention, diagnosis, treatment, cure, or 
mitigation of a particular disease or condition; or 
‘‘(F) is intended for use to analyze information 
to provide patient-specific recommended options to 
consider in the prevention, diagnosis, treatment, cure, 
or mitigation of a particular disease or condition. 
‘‘(2) The term ‘accessory’ means a product that— 
‘‘(A) is intended for use with one or more parent 
devices; 
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‘‘(B) is intended to support, supplement, or aug-
ment the performance of one or more parent devices; 
and 
‘‘(C) shall be classified by the Secretary— 
‘‘(i) according to its intended use; and 
‘‘(ii) independently of any classification of 
any parent device with which it is used.’’. 
SEC. 2242. APPLICABILITY AND INAPPLICABILITY OF REGU-
LATION. 
Subchapter A of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by 
section 2221(a), is further amended by adding at the end 
the following: 
‘‘SEC. 524C. HEALTH SOFTWARE. 
‘‘(a) INAPPLICABILITY OF REGULATION TO HEALTH 
SOFTWARE.—Except as provided in subsection (b), health 
software shall not be subject to regulation under this Act. 
‘‘(b) EXCEPTION.— 
‘‘(1) IN
GENERAL.—Subsection (a) shall not 
apply with respect to a software product— 
‘‘(A) of a type described in subparagraph 
(F) of section 201(ss)(1); and 
‘‘(B) that the Secretary determines poses a 
significant risk to patient safety. 
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‘‘(2) CONSIDERATIONS.—In making a deter-
mination under subparagraph (B) of paragraph (1) 
with respect to a product to which such paragraph 
applies, the Secretary shall consider the following: 
‘‘(A) The likelihood and severity of patient 
harm if the product were to not perform as in-
tended. 
‘‘(B) The extent to which the product is in-
tended to support the clinical judgment of a 
medical professional. 
‘‘(C) Whether there is a reasonable oppor-
tunity for a medical professional to review the 
basis of the information or treatment rec-
ommendation provided by the product. 
‘‘(D) The intended user and user environ-
ment, such as whether a medical professional 
will use a software product of a type described 
in subparagraph (F) of section 201(ss)(1). 
‘‘(c) DELEGATION.—The Secretary shall delegate pri-
mary jurisdiction for regulating a software product deter-
mined under subsection (b) to be subject to regulation under 
this Act to the center at the Food and Drug Administration 
charged with regulating devices. 
‘‘(d) REGULATION OF SOFTWARE.— 
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‘‘(1) IN GENERAL.—The Secretary shall review 
existing regulations and guidance regarding the regu-
lation of software under this Act. The Secretary may 
implement a new framework for the regulation of soft-
ware and shall, as appropriate, modify such regula-
tions and guidance or issue new regulations or guid-
ance. 
‘‘(2) ISSUANCE
BY
ORDER.—Notwithstanding 
subchapter II of chapter 5 of title 5, United States 
Code, the Secretary may modify or issue regulations 
for the regulation of software under this Act by ad-
ministrative order published in the Federal Register 
following the publication of a proposed order. 
‘‘(3) AREAS UNDER REVIEW.—The review of ex-
isting regulations and guidance under paragraph (1) 
may include review of the following areas: 
‘‘(A) Classification of software. 
‘‘(B) Standards for development of software. 
‘‘(C) 
Standards 
for 
validation 
and 
verification of software. 
‘‘(D) Review of software. 
‘‘(E) Modifications to software. 
‘‘(F) Manufacturing of software. 
‘‘(G) Quality systems for software. 
‘‘(H) Labeling requirements for software. 
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‘‘(I) Postmarketing requirements for report-
ing of adverse events. 
‘‘(4) PROCESS FOR ISSUING PROPOSED REGULA-
TIONS, ADMINISTRATIVE ORDER, AND GUIDANCE.—Not 
later than 18 months after the date of enactment of 
this section, the Secretary shall consult with external 
stakeholders (including patients, industry, health care 
providers, academia, and government) to gather input 
before issuing regulations, an administrative order, 
and guidance under this subsection. 
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as providing the Secretary with the 
authority to regulate under this Act any health software 
product of the type described in subparagraph (F) of section 
201(ss)(1) unless and until the Secretary has made a deter-
mination described in subsection (b)(1)(B) with respect to 
such product.’’. 
SEC. 2243. EXCLUSION FROM DEFINITION OF DEVICE. 
Section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended— 
(1) in subparagraph (2), by striking ‘‘or’’ after 
‘‘or other animals,’’; 
(2) in subparagraph (3), by striking ‘‘and’’ and 
inserting ‘‘or’’; and 
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(3) by inserting after subparagraph (3) the fol-
lowing: 
‘‘(4) not health software (other than software de-
termined to be a risk to patient safety under section 
524B(b)), and’’. 
Subtitle O—Streamlining Clinical 
Trials 
SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RE-
SEARCH; APPLICABILITY OF RULES. 
(a) IN GENERAL.—In order to simplify and facilitate 
compliance by researchers with applicable regulations for 
the protection of human subjects in research, the Secretary 
of Health and Human Services shall, to the extent possible 
and consistent with other statutory provisions, harmonize 
differences between the HHS Human Subject Regulations 
and the FDA Human Subject Regulations in accordance 
with subsection (b). 
(b) AVOIDING REGULATORY DUPLICATION AND UN-
NECESSARY DELAYS.— 
(1) IN GENERAL.—The Secretary shall— 
(A) make such modifications to the provi-
sions of the HHS Human Subject Regulations, 
the FDA Human Subject Regulations, and the 
vulnerable-populations rules as may be nec-
essary— 
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218 
(i) to reduce regulatory duplication 
and unnecessary delays; 
(ii) to modernize such provisions in the 
context of multisite and cooperative research 
projects; and 
(iii) to incorporate local consider-
ations, community values, and mechanisms 
to protect vulnerable populations; and 
(B) ensure that human subject research that 
is subject to the HHS Human Subject Regula-
tions or to the FDA Human Subject Regulations 
may— 
(i) use joint or shared review; 
(ii) rely upon the review of— 
(I) an independent institutional 
review board; or 
(II) an institutional review board 
of an entity other than the sponsor of 
the research; or 
(iii) use similar arrangements to avoid 
duplication of effort. 
(2) REGULATIONS
AND
GUIDANCE.—Not later 
than 36 months after the date of enactment of this 
Act, the Secretary, acting through the relevant agen-
cies and offices of the Department of Health and 
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Human Services, including the Office for Human Re-
search Protections and relevant agencies and offices of 
the Food and Drug Administration, shall issue such 
regulations and guidance and take such other actions 
as may be necessary to implement this section and 
help to facilitate the broader use of single, central, or 
lead institutional review boards. Such regulations 
and guidance shall clarify the requirements and poli-
cies relating to the following: 
(A) Arrangements to avoid duplication de-
scribed in paragraph (1)(A)(i), including— 
(i) delineating the roles of institutional 
review boards in multisite or cooperative, 
multisite studies where one or more local 
institutional review boards are relied upon, 
or similar arrangements are used; 
(ii) the risks and benefits to human 
subjects; 
(iii) standardizing the informed con-
sent and other processes and legal docu-
ments; and 
(iv) incorporating community values 
through the use of local institutional review 
boards while continuing to use central or 
lead institutional review boards. 
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220 
(B) Concerns about regulatory and legal li-
ability contributing to decisions by the sponsors 
of research to rely on local institutional review 
boards for multisite research. 
(3) CONSULTATION.—In issuing regulations or 
guidance under paragraph (2), the Secretary shall 
consult with stakeholders (including researchers, aca-
demic organizations, hospitals, institutional research 
boards, pharmaceutical, biotechnology and medical 
device developers, clinical research organizations, pa-
tient groups, and others). 
(c) TIMING.—The Secretary shall complete the harmo-
nization described in subsection (a) not later than 36 
months after the date of enactment of this Act. 
(d) PROGRESS REPORT.—Not later than 24 months 
after the date of enactment of this Act, the Secretary shall 
submit to Congress a report on the progress made toward 
completing such harmonization. 
(e) DRAFT NIH POLICY.—Not later than 12 months 
after the date of enactment of this Act, the Secretary, acting 
through the Director of the National Institutes of Health, 
shall finalize the draft policy entitled ‘‘Draft NIH Policy 
on Use of a Single Institutional Review Board for Multi- 
Site Research’’. 
(f) DEFINITIONS.— 
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(1) HUMAN
SUBJECT
REGULATIONS.—In this 
section: 
(A) FDA HUMAN SUBJECT REGULATIONS.— 
The term ‘‘FDA Human Subject Regulations’’ 
means the provisions of parts 50, 56, 312, and 
812 of title 21, Code of Federal Regulations (or 
any successor regulations). 
(B) 
HHS 
HUMAN
SUBJECT
REGULA-
TIONS.—The term ‘‘HHS Human Subject Regu-
lations’’ means the provisions of subpart A of 
part 46 of title 45, Code of Federal Regulations 
(or any successor regulations). 
(C) VULNERABLE-POPULATIONS
RULES.— 
The term ‘‘vulnerable-populations rules’’— 
(i) subject to clause (ii), means the 
provisions of subparts B through D of such 
part 46 (or any successor regulations); or 
(ii) as applicable to research that is 
subject to the FDA Human Subject Regula-
tions, means the provisions applicable to 
vulnerable populations under part 56 of 
such title 21 (or any successor regulations) 
and subpart D of part 50 of such title 21 
(or any successor regulations). 
(2) OTHER DEFINITIONS.—In this section: 
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(A) INSTITUTIONAL
REVIEW
BOARD.—The 
term ‘‘institutional review board’’ has the mean-
ing that applies to the term ‘‘institutional review 
board’’ under the HHS Human Subject Regula-
tions. 
(B) 
LEAD
INSTITUTIONAL
REVIEW 
BOARD.—The term ‘‘lead institutional review 
board’’ means an institutional review board that 
otherwise meets the requirements of the HHS 
Human Subject Regulations and enters into a 
written agreement with an institution, another 
institutional review board, a sponsor, or a prin-
cipal investigator to approve and oversee human 
subject research that is conducted at multiple lo-
cations. References to an institutional review 
board include an institutional review board that 
serves a single institution as well as a lead insti-
tutional review board. 
SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW 
BOARDS FOR REVIEW OF INVESTIGATIONAL 
DEVICE EXEMPTIONS AND HUMAN DEVICE 
EXEMPTIONS. 
(a) IN GENERAL.—Section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(j)) is amended— 
(1) in subsection (g)(3)— 
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(A) by striking ‘‘local’’ each place it ap-
pears; and 
(B) in subparagraph (A)(i), by striking 
‘‘which has been’’; and 
(2) in subsection (m)(4)— 
(A) by striking ‘‘local’’ each place it ap-
pears; and 
(B) by striking subparagraph (A) and in-
serting the following new subparagraph: 
‘‘(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) REGULATIONS.—Not later than 12 months after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall revise or issue such regulations 
or guidance as may be necessary to carry out the amend-
ments made by subsection (a). 
SEC. 2263. ALTERATION OR WAIVER OF INFORMED CON-
SENT FOR CLINICAL INVESTIGATIONS. 
(a) DEVICES.—Section 520(g)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amend-
ed— 
(1) in subparagraph (D), by striking ‘‘except 
where subject to such conditions as the Secretary may 
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prescribe, the investigator’’ and inserting the fol-
lowing: ‘‘except where, subject to such conditions as 
the Secretary may prescribe— 
‘‘(i) the proposed clinical testing poses no 
more than minimal risk to the human subject 
and includes appropriate safeguards to protect 
the rights, safety, and welfare of the human sub-
ject; or 
‘‘(ii) the investigator’’; and 
(2) in the matter following subparagraph (D), by 
striking ‘‘subparagraph (D)’’ and inserting ‘‘subpara-
graph (D)(ii)’’. 
(b) DRUGS.—Section 505(i)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended 
by striking ‘‘except where it is not feasible or it is contrary 
to the best interests of such human beings’’ and inserting 
‘‘except where it is not feasible, it is contrary to the best 
interests of such human beings, or the proposed clinical test-
ing poses no more than minimal risk to such human beings 
and includes appropriate safeguards as prescribed to pro-
tect the rights, safety, and welfare of such human beings’’. 
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Subtitle P—Improving Scientific 
Expertise and Outreach at FDA 
SEC. 2281. SILVIO O. CONTE SENIOR BIOMEDICAL RE-
SEARCH 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)(1), by striking ‘‘Silvio O. 
Conte Senior Biomedical Research Service, not to ex-
ceed 500 members’’ and inserting ‘‘Silvio O. Conte 
Senior Biomedical Research and Biomedical Product 
Assessment Service (in this section referred to as the 
‘Service’), the purpose of which is to recruit and re-
tain competitive and qualified scientific and technical 
experts outstanding in the field of biomedical re-
search, clinical research evaluation, and biomedical 
product assessment’’; 
(3) by amending subsection (a)(2) to read as fol-
lows: 
‘‘(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-
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226 
tem in order to offset the number of members serving in 
the Service.’’; 
(4) 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 
master’s 
level 
degree 
in 
engineering, 
bioinformatics, or a related or emerging field,’’ 
after the comma; 
(5) 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 rate payable for 
the President’’; 
(6) by striking subsection (e); and 
(7) by redesignating subsections (f) and (g) as 
subsections (e) and (f), respectively. 
(b) REPORT.—Not later than 3 years after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall submit, and publish on the website 
of the Department of Health and Human Services a report 
on the implementation of the amendments made by sub-
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227 
section (a), including whether the amendments have im-
proved the ability of the Food and Drug Administration 
to hire and retain qualified experts to fulfill obligations 
specified under user fee agreements. 
SEC. 2282. ENABLING FDA SCIENTIFIC ENGAGEMENT. 
It is the sense of Congress that the participation in, 
or sponsorship of, scientific conferences and meetings is es-
sential to the mission of the Food and Drug Administra-
tion. 
SEC. 2283. 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 
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228 
positions that are established by any such 
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-
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229 
ployee of the Federal Government’ does not include a 
‘special Government employee’, as that term is de-
fined 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 
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230 
date of the amendment establishing such po-
sitions, are members of the Board.’’. 
(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’’. 
SEC. 2284. COLLECTION OF CERTAIN VOLUNTARY INFORMA-
TION EXEMPTED FROM PAPERWORK REDUC-
TION ACT. 
Chapter VII of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 708 of such Act 
(21 U.S.C. 379) the following: 
‘‘SEC. 708A. COLLECTION OF CERTAIN VOLUNTARY INFOR-
MATION EXEMPTED FROM PAPERWORK RE-
DUCTION ACT. 
‘‘Chapter 35 of title 44, United States Code, shall not 
apply to the collection from patients, industry, academia, 
and other stakeholders, of voluntary information such as 
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231 
through voluntary surveys or questionnaires, initiated by 
the Secretary.’’. 
SEC. 2285. 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. ADDITIONAL HIRING AUTHORITY. 
‘‘(a) IN GENERAL.—The Secretary may, without re-
gard to the provisions of title 5, United States Code, gov-
erning appointments in the competitive service, appoint 
qualified candidates to scientific, technical, or professional 
positions within the following centers of the Food and Drug 
Administration: 
‘‘(1) The Center for Drug Evaluation and Re-
search. 
‘‘(2) The Center for Biologics Evaluation and 
Research. 
‘‘(3) The Center for Devices and Radiological 
Health. 
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 
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232 
III of chapter 53 of title 5, United States Code, and 
consistent with the requirements of paragraph (2), the 
Secretary may determine and fix— 
‘‘(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 highly 
qualified scientific, technical, or professional per-
sonnel appointed to a position at any of the cen-
ters listed under subsection (a) before the date of 
enactment of this section. 
‘‘(2) LIMITATION.—The annual rate of pay es-
tablished pursuant to paragraph (1) may not exceed 
the annual rate of pay of the President. 
‘‘(c) SUNSET.—The authority to appoint employees 
under this section shall terminate on September 30, 2022. 
‘‘(d) REPORT.— 
‘‘(1) IN GENERAL.—Not later than September 30, 
2021, the Secretary shall submit a report to Congress 
that examines the extent to which the authority to ap-
point and retain personnel under this section en-
hanced the Food and Drug Administration’s ability 
to meet the agency’s critical need for highly qualified 
individuals for scientific, technical, or professional 
positions. 
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233 
‘‘(2) RECOMMENDATIONS.—The report under 
paragraph (1) shall include the recommendations of 
the Secretary on— 
‘‘(A) whether the authority to appoint per-
sonnel under this section should be reauthorized; 
and 
‘‘(B) other personnel authorities that would 
help the Food and Drug Administration to better 
recruit and retain highly qualified individuals 
for scientific, technical, or professional positions 
in the agency’s medical product centers.’’. 
(b) RULE OF CONSTRUCTION.—The authority provided 
by section 714A of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a)) shall not be construed to 
affect the authority provided under section 714 of such Act. 
Subtitle Q—Exempting From 
Sequestration Certain User Fees 
SEC. 2301. EXEMPTING FROM SEQUESTRATION CERTAIN 
USER FEES OF FOOD AND DRUG ADMINISTRA-
TION. 
The Balanced Budget and Emergency Deficit Control 
Act of 1985 is amended— 
(1) 
in 
section 
255(g)(1)(A) 
(2 
U.S.C. 
905(g)(1)(A)), by inserting after the item relating to 
‘‘Financial Agent Services’’ the following new item: 
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‘‘Food and Drug Administration, Salaries 
and Expenses, but only the portion of appropria-
tions under such account corresponding to fees 
collected under sections 736, 738, 740, 741, 
744B, and 744H of the Federal Food, Drug, and 
Cosmetic Act (75–9911–0–1–554).’’; and 
(2) in section 256(h) (2 U.S.C. 906(h)), by add-
ing at the end the following new paragraph: 
‘‘(5) Notwithstanding any other provision of law, 
this subsection shall not apply with respect to the por-
tion of administrative expenses incurred by the Food 
and Drug Administration that are funded through 
fees collected under sections 736, 738, 740, 741, 744B, 
and 744H of the Federal Food, Drug, and Cosmetic 
Act.’’. 
TITLE III—DELIVERY 
Subtitle A—Interoperability 
SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH IN-
FORMATION TECHNOLOGY. 
(a) INTEROPERABILITY STANDARDS.— 
(1) IN GENERAL.—Subtitle A of title XXX of the 
Public Health Service Act (42 U.S.C. 300jj–11 et seq.) 
is amended by adding at the end the following new 
section: 
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235 
‘‘SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH IN-
FORMATION TECHNOLOGY. 
‘‘(a) INTEROPERABILITY.—In order for health infor-
mation technology to be considered interoperable, such tech-
nology must satisfy the following criteria: 
‘‘(1) SECURE TRANSFER.—The technology allows 
the secure transfer of the entirety of a patient’s data 
from any and all health information technology for 
authorized use under applicable law. 
‘‘(2) COMPLETE ACCESS TO HEALTH DATA.—The 
technology allows access to the entirety of a patient’s 
available data for authorized use under applicable 
law without special effort, as defined by recommenda-
tions for interoperability standards adopted under 
section 3004, by the requestor of such data unless such 
data is not disclosable under applicable law. 
‘‘(3) NO
INFORMATION
BLOCKING.—The tech-
nology is not configured, set up, or implemented to 
engage in information blocking, as defined in section 
3010A(f). 
‘‘(b) CATEGORIES
FOR INTEROPERABILITY STAND-
ARDS.—The categories described in this subsection, with re-
spect to standards for determining if health information 
technology is interoperable, consistent with the criteria de-
scribed in subsection (a), include the following categories 
of standards: 
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‘‘(1) Standards with respect to vocabulary and 
terminology. 
‘‘(2) Standards with respect to content and 
structure. 
‘‘(3) Standards with respect to transport of in-
formation. 
‘‘(4) Security standards. 
‘‘(5) Service standards.’’. 
(2) GUIDANCE.—Not later than January 1, 
2017, the Secretary of Health and Human Services, 
through the National Coordinator of the Office of the 
National Coordinator for Health Information Tech-
nology, shall issue guidance with respect to the imple-
mentation of section 3010 of the Public Health Serv-
ice Act, as added by paragraph (1), including with 
respect to defining and providing examples of author-
ized use of health information technology, as described 
in such section. 
(b) IMPROVEMENTS
TO
RECOMMENDATION
PROC-
ESS.— 
(1) HIT POLICY COMMITTEE TO INCORPORATE 
POLICIES
FOR
UPDATES
TO
INTEROPERABILITY 
STANDARDS.—Section 3002 of the Public Health 
Service Act (42 U.S.C. 300jj–12) is amended— 
(A) in subsection (a)— 
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237 
(i) by striking ‘‘National Coordinator’’ 
and inserting ‘‘Secretary, in consultation 
with the National Coordinator,’’; and 
(ii) by adding at the end the following 
new sentence: ‘‘The HIT Policy Committee 
is authorized only to provide policy and 
priority recommendations to the Secretary 
and not authorized to otherwise affect the 
development or modification of any stand-
ard, implementation specification, or cer-
tification criterion under this title.’’; and 
(B) in subsection (b)(2)— 
(i) in subparagraph (A), in the first 
sentence— 
(I) by striking ‘‘The HIT Policy 
Committee’’ and inserting ‘‘Subject to 
subparagraph (D), the HIT Policy 
Committee’’; and 
(II) by inserting ‘‘(including the 
areas in which modifications and ad-
ditions to interoperability standards 
under section 3010 are needed for the 
electronic exchange and use of health 
information for purposes of adoption of 
such 
modifications 
and 
additions 
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238 
under section 3004)’’ after ‘‘section 
3004’’. 
(ii) by adding at the end the following 
new subparagraph: 
‘‘(D) SPECIAL RULE RELATED TO INTER-
OPERABILITY.—Any recommendation made by 
the HIT Policy Committee on or after the date 
of the enactment of this subparagraph with re-
spect to interoperability of health information 
technology shall be consistent with the criteria 
described in subsection (a) of section 3010.’’. 
(2) SUNSET OF HIT STANDARDS COMMITTEE.— 
Section 3003 of the Public Health Service Act (42 
U.S.C. 300jj–13) is amended by adding at the end the 
following new subsection: 
‘‘(f) TERMINATION.—The HIT Standards Committee 
shall terminate on the date that is 90 days after the date 
of the enactment of this subsection.’’. 
(3) 
STANDARDS
DEVELOPMENT
ORGANIZA-
TIONS.—Title XXX of the Public Health Service Act 
is amended by inserting after section 3003 the fol-
lowing new section: 
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239 
‘‘SEC. 
3003A. 
RECOMMENDATIONS 
FOR 
STANDARDS 
THROUGH CONTRACTS WITH STANDARDS DE-
VELOPMENT ORGANIZATIONS. 
‘‘(a) CONTRACTS.— 
‘‘(1) IN
GENERAL.—For purposes of activities 
conducted under this title, the Secretary shall enter 
into contracts with health care standards development 
organizations accredited by the American National 
Standards Institute to carry out the duties described 
in subsection (b), as applicable. 
‘‘(2) TIMING FOR FIRST CONTRACT.—As soon as 
practicable after the date of the enactment of this sec-
tion, the Secretary shall enter into the first contract 
under paragraph (1). 
‘‘(3) PERIOD
OF
CONTRACT.—Each contract 
under paragraph (1) shall be for a period determined 
necessary by the Secretary, in consultation with the 
National Coordinator, to carry out the applicable du-
ties described in subsection (b). 
‘‘(4) APPROPRIATE
ORGANIZATIONS.—The Sec-
retary shall ensure the most appropriate organiza-
tions described in paragraph (1) are selected for each 
contract under such paragraph. 
‘‘(5) ALLOWANCE FOR VARIATIONS.—Standards 
developed pursuant to a contract under this sub-
section, and the methods to test such standards, shall 
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allow for variations on such standards as long as 
such variations are consistent with the standards so 
developed under this section. 
‘‘(b) DUTIES.— 
‘‘(1) INITIAL CONTRACT.—Under the initial con-
tract under subsection (a)(1), the standards develop-
ment organizations— 
‘‘(A) shall provide to the Secretary, in con-
sultation with the National Coordinator, for 
adoption under section 3004, recommendations, 
in accordance with section 3010, for interoper-
ability standards, and methods to test such 
standards, consistent with the criteria described 
in subsection (a) of such section and with respect 
to the categories described in subsection (b)(1) of 
such section; and 
‘‘(B) may provide to the Secretary rec-
ommendations described in paragraph (2). 
‘‘(2) SUBSEQUENT
CONTRACTS.—Under each 
subsequent contract, the organizations shall provide to 
the Secretary, in consultation with the National Coor-
dinator, for adoption under section 3004 rec-
ommendations for any standards (including inter-
operability standards and methods to test such stand-
ards), implementation specifications, and certifi-
VerDate Sep 11 2014 
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