232 
‘‘(I) the scope and format of the 
data to be submitted under subsection 
(d); 
‘‘(II) best practices with respect 
to de-identification of data, as appro-
priate; 
‘‘(III) the appropriate uses of 
data by authorized users, including 
developing standards for the approval 
of requests by organizations to access 
and use the data; and 
‘‘(IV) the appropriate formats 
and methods for making reports and 
analyses based on the database to the 
public; 
‘‘(iii) conduct an annual review of 
whether data was used according to the 
appropriate uses as described in clause 
(ii)(II), and advise the designated entities 
on using the data for authorized purposes; 
‘‘(iv) report, as appropriate, to the 
Secretary and Congress on the operation of 
the database and opportunities to better 
achieve the objectives of this section; 
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‘‘(v) establish additional restrictions 
on researchers who receive compensation 
from 
entities 
described 
in 
subsection 
(e)(2)(B)(ii), in order to protect propri-
etary financial information; and 
‘‘(vi) establish objectives for research 
and public reporting. 
‘‘(4) STATE REQUIREMENTS.—A State may re-
quire health insurance issuers and other payers to 
submit claims data to the database established 
under this section, provided that such data is sub-
mitted to the entities awarded contracts under this 
section in a form and manner established by the 
Secretary, and pursuant to subsection (d)(4)(B). 
‘‘(5) SANCTIONS.—The Secretary shall take ap-
propriate action to sanction users who attempt to re- 
identify data accessed pursuant to paragraph 
(1)(D). 
‘‘(c) CONTRACT REQUIREMENTS.— 
‘‘(1) COMPETITIVE
PROCEDURES.—The Sec-
retary shall enter into the contract under subsection 
(a) using full and open competition procedures pur-
suant to chapter 33 of title 41, United States Code. 
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‘‘(2) ELIGIBLE
ENTITIES.—To be eligible to 
enter into a contract described in subsection (a), an 
entity shall— 
‘‘(A) be a private nonprofit entity governed 
by a board that includes representatives of the 
academic research community and individuals 
with expertise in employer-sponsored insurance, 
research using health care claims data and ac-
tuarial analysis; 
‘‘(B) conduct its business in an open and 
transparent manner that provides the oppor-
tunity for public comment on its activities; and 
‘‘(C) agree to comply with any require-
ments imposed under the rulemaking described 
in subsection (d)(4)(A). 
‘‘(3) CONSIDERATIONS.—In awarding a con-
tract under subsection (a), the Secretary shall con-
sider an entity’s experience in— 
‘‘(A) health care claims data collection, ag-
gregation, quality assurance, analysis, and secu-
rity; 
‘‘(B) supporting academic research on 
health costs, spending, and utilization for and 
by privately insured patients; 
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‘‘(C) working with large health insurance 
issuers and third-party administrators to as-
semble a national claims database; 
‘‘(D) effectively collaborating with and en-
gaging stakeholders to develop reports; 
‘‘(E) meeting budgets and timelines, in-
cluding in connection with report generation; 
and 
‘‘(F) facilitating the creation of, or sup-
porting, State all-payer claims databases. 
‘‘(4) CONTRACT
TERM.—A contract awarded 
under this section shall be for a period of 5 years, 
and may be renewed after a subsequent competitive 
bidding process under this section. 
‘‘(5) TRANSITION OF CONTRACT.—If the Sec-
retary, following a competitive process at the end of 
the contract period, selects a new entity to maintain 
the database, all data shall be transferred to the new 
entity according to a schedule and process to be de-
termined by the Secretary. Upon termination of a 
contract, no entity may keep data held by the data-
base or disclose such data to any entity other than 
the entity so designated by the Secretary. The Sec-
retary shall include enforcement terms in any con-
tract with an organization chosen under this section, 
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to ensure the timely transfer of all data, and any as-
sociated code or algorithms, to a new entity in the 
event of contract termination. 
‘‘(d) RECEIVING HEALTH INFORMATION.— 
‘‘(1) REQUIREMENTS.— 
‘‘(A) IN
GENERAL.—The Secretary of 
Labor shall ensure that the applicable self-in-
sured group health plan, through its third-party 
administrator, pharmacy benefit manager, or 
other entity designated by the group health 
plan, as applicable, electronically submits all 
claims data with respect to the plan, pursuant 
to subparagraph (B). 
‘‘(B) SCOPE OF INFORMATION AND FOR-
MAT OF SUBMISSION.—An entity awarded the 
contract under subsection (a), in consultation 
with the Committee described in subsection 
(b)(3), and pursuant to the privacy and security 
requirements of subsection (b)(2), shall— 
‘‘(i) specify the data elements required 
to be submitted under subparagraph (A), 
which shall include all data related to 
transactions described in subparagraphs 
(A) and (E) of section 1173(a)(2) of the 
Social Security Act, including all data ele-
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ments normally present in such trans-
actions when adjudicated, and enrollment 
information; 
‘‘(ii) specify the form and manner for 
such submissions, and the historical period 
to be included in the initial submission; 
and 
‘‘(iii) offer an automated submission 
option to minimize administrative burdens 
for entities required to submit data. 
‘‘(C) DE-IDENTIFICATION
OF
DATA.—An 
entity awarded the contract under subsection 
(a) shall— 
‘‘(i) establish a process under which 
data is de-identified consistent with the de- 
identification requirements under section 
164.514 of title 45, Code of Federal Regu-
lations (or any successor regulations), 
while retaining the ability to link data lon-
gitudinally for the purposes of research on 
cost and quality, and the ability to com-
plete risk adjustment and geographic anal-
ysis; 
‘‘(ii) ensure that any third-party sub-
contractors who perform the de-identifica-
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238 
tion process described in clause (i) retain 
only the minimum necessary information 
to perform such a process, and adhere to 
effective security and encryption practices 
in data storage and transmission; 
‘‘(iii) store claims and other data col-
lected under this subsection only in de- 
identified form, in accordance with section 
164.514 of title 45, Code of Federal Regu-
lations (or any successor regulations); and 
‘‘(iv) ensure that individually identifi-
able data is encrypted, in accordance with 
guidance issued by the Secretary under 
section 13402(h)(2) of the HITECH Act. 
‘‘(2) 
APPLICABLE
SELF-INSURED
GROUP 
HEALTH PLAN.—For purposes of paragraph (1), a 
self-insured group health plan is an applicable self- 
insured group health plan if such plan is self-admin-
istered, or is administered by a third-party plan ad-
ministrator that meets 1 or both of the following cri-
teria: 
‘‘(A) Administers health, medical, or phar-
macy benefits for more than 50,000 enrollees. 
‘‘(B) Is one of the 5 largest administrators 
or issuers of self-insured group health plans in 
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a State in which such administrator operates, 
as measured by the aggregate number of enroll-
ees in plans administered by such administrator 
in such State, as determined by the Secretary. 
‘‘(3) THIRD-PARTY
ADMINISTRATORS.—In the 
case of a third-party administrator that is required 
under this subsection to submit claims data with re-
spect to an applicable self-insured group health plan, 
such administrator shall submit claims data with re-
spect to all self-insured group health plans that the 
administrator administers, including such plans that 
are not applicable self-insured group health plans, as 
described in paragraph (2). 
‘‘(4) RECEIVING OTHER INFORMATION.— 
‘‘(A) MEDICARE
DATA.—The Secretary, 
through rulemaking, shall ensure that the data 
made available to such entity is available to 
qualified entities under section 1874(e) of the 
Social Security Act is made available to each 
entity awarded a contract under subsection (a). 
‘‘(B) STATE DATA.—An entity awarded a 
contract under subsection (a) shall collect data 
from State all payer claims databases that seek 
access to the database established under this 
section. 
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‘‘(5) AVAILABILITY
OF
DATA.—An entity re-
quired to submit data under this subsection may not 
place any restrictions on the use of such data by au-
thorized users. 
‘‘(e) USES OF INFORMATION.— 
‘‘(1) IN GENERAL.—An entity awarded a con-
tract under subsection (a) shall make the database 
available to users who are authorized under this sub-
section, at cost, and reports and analyses based on 
the data available to the public with no charge. 
‘‘(2) AUTHORIZATION OF USERS.— 
‘‘(A) IN GENERAL.—An entity may request 
authorization by an entity awarded a contract 
under subsection (a) for access to the database 
in accordance with this paragraph. 
‘‘(B) APPLICATION.—An entity desiring 
authorization under this paragraph shall submit 
to an entity awarded a contract an application 
for such access, which shall include— 
‘‘(i) in the case of an entity requesting 
access for research purposes— 
‘‘(I) a description of the uses and 
methodologies for evaluating health 
system performance using such data; 
and 
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‘‘(II) documentation of approval 
of the research by an institutional re-
view board, if applicable for a par-
ticular plan of research; or 
‘‘(ii) in the case of an entity such as 
an employer, health insurance issuer, 
third-party administrator, or health care 
provider, requesting access for the purpose 
of quality improvement or cost-contain-
ment, a description of the intended uses 
for such data. 
‘‘(C) REQUIREMENTS.— 
‘‘(i) RESEARCH.—Upon approval of 
an application for research purposes under 
subparagraph (B)(i), the authorized user 
shall enter into a data use and confiden-
tiality agreement with an entity awarded a 
contract under subsection (a), which shall 
include a prohibition on attempts to re-
identify and disclose individually identifi-
able health information and proprietary fi-
nancial information. 
‘‘(ii) QUALITY
IMPROVEMENT
AND 
COST-CONTAINMENT.—In consultation with 
the Committee described in subsection 
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242 
(b)(3), the Secretary shall, through rule-
making, establish the form and manner in 
which authorized users described in sub-
paragraph (B)(ii) may access data. Data 
provided to such authorized users shall be 
provided in a form and manner such that 
users may not obtain individually identifi-
able price information with respect to di-
rect competitors. Upon approval, such au-
thorized user shall enter into a data use 
and confidentiality agreement with the en-
tity. 
‘‘(iii) CUSTOMIZED
REPORTS.—Em-
ployers and employer organizations may 
request customized reports from an entity 
awarded a contract under subsection (a), 
at cost, subject to the requirements of this 
section with respect to privacy, security, 
and proprietary financial information. 
‘‘(iv) NON-CUSTOMIZED
REPORTS.— 
An entity awarded a contract under sub-
section (a), in consultation with the Com-
mittee, shall make available to all author-
ized users aggregate data sets, free of 
charge. 
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‘‘(f) FUNDING.— 
‘‘(1) INITIAL FUNDING.—There are authorized 
to be appropriated, and there are appropriated, out 
of monies in the Treasury not otherwise appro-
priated, $20,000,000 for fiscal year 2020, for the 
implementation of the initial contract and establish-
ment of the database under this section. 
‘‘(2) ONGOING
FUNDING.—There are author-
ized to be appropriated $15,000,000 for each of fis-
cal years 2021 through 2025, for purposes of car-
rying out this section (other than the grant program 
under subsection (h)). 
‘‘(g) ANNUAL REPORT.— 
‘‘(1) SUBMISSION.—On each of the dates de-
scribed in paragraph (2), an entity receiving a con-
tract under subsection (a) shall submit to Congress, 
the Secretary of Health and Human Services, and 
the Secretary of Labor and publish online for access 
by the general public, a report containing a descrip-
tion of— 
‘‘(A) trends in the price, utilization, and 
total spending on health care services, including 
a geographic analysis of differences in such 
trends; 
‘‘(B) limitations in the data set; 
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‘‘(C) progress towards the objectives of 
this section; and 
‘‘(D) the performance by the entity of the 
duties required under such contract. 
‘‘(2) DATES
DESCRIBED.—The reports de-
scribed in paragraph (1) shall be submitted— 
‘‘(A) not later than 3 years after the date 
of enactment of the Fair Care Act of 2020; 
‘‘(B) the later of 1 year after the date that 
is 3 years after such date of enactment or 
March 1 of the year after the date that is 3 
years after such date of enactment; and 
‘‘(C) March 1 of each year thereafter. 
‘‘(3) PUBLIC
REPORTS
AND
RESEARCH.—An 
entity receiving a contract under subsection (a) 
shall, in coordination with authorized users, make 
analyses and research available to the public on an 
ongoing basis to promote the objectives of this sec-
tion. 
‘‘(h) GRANTS TO STATES.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the Secretary of Labor, may award grants 
to States for the purpose of establishing and main-
taining State all-payer claims databases that im-
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prove transparency of data in order to meet the 
goals of subsection (a)(1). 
‘‘(2) REQUIREMENT.—To be eligible to receive 
the funding under paragraph (1), a State shall sub-
mit data to the database as described in subsection 
(b)(1)(C), using the format described in subsection 
(d)(1). 
‘‘(3) FUNDING.—There is authorized to be ap-
propriated $100,000,000 for the period of fiscal 
years 2020 through 2029 for the purpose of award-
ing grants to States under this subsection. 
‘‘(i) EXEMPTION FROM PUBLIC DISCLOSURE.— 
‘‘(1) IN
GENERAL.—Claims data provided to 
the database, and the database itself shall not be 
considered public records and shall be exempt from 
public disclosure requirements. 
‘‘(2) RESTRICTIONS
ON
USES
FOR
CERTAIN 
PROCEEDINGS.—Data disclosed to authorized users 
shall not be subject to discovery or admission as 
public information, or evidence in judicial or admin-
istrative proceedings without consent of the affected 
parties. 
‘‘(j) DEFINITIONS.— 
‘‘(1) INDIVIDUALLY IDENTIFIABLE HEALTH IN-
FORMATION.—The term ‘individually identifiable 
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health information’ has the meaning given such term 
in section 1171(6) of the Social Security Act. 
‘‘(2) PROPRIETARY FINANCIAL INFORMATION.— 
The term ‘proprietary financial information’ means 
data that would disclose the terms of a specific con-
tract between an individual health care provider or 
facility and a specific group health plan, Medicaid 
managed care organization or other managed care 
entity, or health insurance issuer offering group or 
individual coverage. 
‘‘(k) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to affect or modify enforcement 
of the privacy, security, or breach notification rules pro-
mulgated under section 264(c) of the Health Insurance 
Portability and Accountability Act of 1996 (or successor 
regulations).’’. 
(b) GAO REPORT.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study on— 
(A) the performance of the entity awarded 
a contract under section 2795(a) of the Public 
Health Service Act, as added by subsection (a), 
under such contract; 
(B) the privacy and security of the infor-
mation reported to the entity; and 
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(C) the costs incurred by such entity in 
performing such duties. 
(2) REPORTS.—Not later than 2 years after the 
effective date of the first contract entered into under 
section 2795(a) of the Public Health Service Act, as 
added by subsection (a), and again not later than 4 
years after such effective date, the Comptroller Gen-
eral of the United States shall submit to Congress 
a report containing the results of the study con-
ducted under paragraph (1), together with rec-
ommendations for such legislation and administra-
tive action as the Comptroller General determines 
appropriate. 
SEC. 324. PROTECTING PATIENTS AND IMPROVING THE AC-
CURACY OF PROVIDER DIRECTORY INFOR-
MATION. 
(a) IN GENERAL.—Subpart II of part A of title 
XXVII of the Public Health Service Act (42 U.S.C. 
300gg–11 et seq.), as amended by the preceding sections, 
is further amended by adding at the end the following: 
‘‘SEC. 2729C. PROTECTING PATIENTS AND IMPROVING THE 
ACCURACY OF PROVIDER DIRECTORY INFOR-
MATION. 
‘‘(a) NETWORK STATUS OF PROVIDERS.— 
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‘‘(1) IN GENERAL.—Beginning on the date that 
is one year after the date of enactment of this sec-
tion, a group health plan or a health insurance 
issuer offering group or individual health insurance 
coverage shall— 
‘‘(A) establish business processes to ensure 
that all enrollees in such plan or coverage re-
ceive proof of a health care provider’s network 
status, based on what a plan or issuer knows or 
could reasonably know— 
‘‘(i) through a written electronic com-
munication from the plan or issuer to the 
enrollee, as soon as practicable and not 
later than 1 business day after a telephone 
inquiry is made by such enrollee for such 
information; 
‘‘(ii) through an oral confirmation, 
documented by such issuer or coverage, 
and kept in the enrollee’s file for a min-
imum of 2 years; and 
‘‘(iii) in real-time through an online 
health care provider directory search tool 
maintained by the plan or issuer; and 
‘‘(B) include in any print directory a dis-
closure that the information included in the di-
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rectory is accurate as of the date of the last 
data update and that enrollees or prospective 
enrollees should consult the group health plan 
or issuer’s electronic provider directory on its 
website or call a specified customer service tele-
phone number to obtain the most current pro-
vider directory information. 
‘‘(2) GROUP HEALTH PLAN AND HEALTH IN-
SURANCE ISSUER BUSINESS PROCESSES.—Beginning 
on the date that is one year after the date of enact-
ment of the Fair Care Act of 2020, a group health 
plan or a health insurance issuer offering group or 
individual health insurance coverage shall establish 
business processes to— 
‘‘(A) verify and update, at least once every 
90 days, the provider directory information for 
all providers included in the online health care 
provider directory search tool described in para-
graph (1)(A)(iii); and 
‘‘(B) remove any provider from such online 
directory search tool if such provider has not 
verified the directory information within the 
previous 6 months or the plan or issuer has 
been unable to verify the provider’s network 
participation. 
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‘‘(b) COST-SHARING LIMITATIONS.— 
‘‘(1) IN GENERAL.—A group health plan or a 
health insurance issuer offering group or individual 
health insurance coverage shall not apply, and shall 
ensure that no provider applies cost-sharing to an 
enrollee for treatment or services provided by a 
health care provider in excess of the normal cost- 
sharing applied for in-network care (including any 
balance bill issued by the health care provider in-
volved), if such enrollee, or health care provider re-
ferring such enrollee, demonstrates (based on the 
electronic, written information described in sub-
section (a)(1)(A)(i), the oral confirmation described 
in subsection (a)(1)(A)(ii), or a copy of the online 
provider 
directory 
described 
in 
subsection 
(a)(1)(A)(iii) on the date the enrollee attempted to 
obtain the provider’s network status) that the en-
rollee relied on the information described in sub-
section (a)(1), if the provider’s network status or di-
rectory information on such directory was incorrect 
at the time the treatment or services involved was 
provided. 
‘‘(2) REFUNDS
TO
ENROLLEES.—If a health 
care provider submits a bill to an enrollee in viola-
tion of paragraph (1), and the enrollee pays such 
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bill, the provider shall reimburse the enrollee for the 
full amount paid by the enrollee in excess of the in- 
network cost-sharing amount for the treatment or 
services involved, plus interest, at an interest rate 
determined by the Secretary. 
‘‘(c) PROVIDER BUSINESS PROCESSES.—A health 
care provider shall have in place business processes to en-
sure the timely provision of provider directory information 
to a group health plan or a health insurance issuer offer-
ing group or individual health insurance coverage to sup-
port compliance by such plans or issuers with subsection 
(a)(1). Such providers shall submit provider directory in-
formation to a plan or issuers, at a minimum— 
‘‘(1) when the provider begins a network agree-
ment with a plan or with an issuer with respect to 
certain coverage; 
‘‘(2) when the provider terminates a network 
agreement with a plan or with an issuer with respect 
to certain coverage; 
‘‘(3) when there are material changes to the 
content of provider directory information described 
in subsection (a)(1); and 
‘‘(4) every 90 days throughout the duration of 
the network agreement with a plan or issuer. 
‘‘(d) ENFORCEMENT.— 
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‘‘(1) IN GENERAL.—Subject to paragraph (2), a 
health care provider that violates a requirement 
under subsection (c) or takes actions that prevent a 
group health plan or health insurance issuer from 
complying with subsection (a)(1) or (b) shall be sub-
ject to a civil monetary penalty of not more than 
$10,000 for each act constituting such violation. 
‘‘(2) SAFE HARBOR.—The Secretary may waive 
the penalty described under paragraph (1) with re-
spect to a health care provider that unknowingly vio-
lates subsection (b)(1) with respect to an enrollee if 
such provider rescinds the bill involved and, if appli-
cable, reimburses the enrollee within 30 days of the 
date on which the provider billed the enrollee in vio-
lation of such subsection. 
‘‘(3) PROCEDURE.—The provisions of section 
1128A of the Social Security Act, other than sub-
sections (a) and (b) and the first sentence of sub-
section (c)(1) of such section, shall apply to civil 
money penalties under this subsection in the same 
manner as such provisions apply to a penalty or pro-
ceeding under section 1128A of the Social Security 
Act. 
‘‘(e) SAVINGS CLAUSE.—Nothing in this section shall 
prohibit a provider from requiring in the terms of a con-
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tract, or contract termination, with a group health plan 
or health insurance issuer— 
‘‘(1) that the plan or issuer remove, at the time 
of termination of such contract, the provider from a 
directory of the plan or issuer described in sub-
section (a)(1); or 
‘‘(2) that the plan or issuer bear financial re-
sponsibility, including under subsection (b), for pro-
viding inaccurate network status information to an 
enrollee. 
‘‘(f) DEFINITION.—For purposes of this section, the 
term ‘provider directory information’ includes the names, 
addresses, specialty, and telephone numbers of individual 
health care providers, and the names, addresses, and tele-
phone numbers of each medical group, clinic, or facility 
contracted to participate in any of the networks of the 
group health plan or health insurance coverage involved. 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to preempt any provision of State 
law relating to health care provider directories or network 
adequacy.’’. 
(b) EFFECTIVE DATE.—Section 2729C of the Public 
Health Service Act, as added by subsection (a), shall take 
effect with respect to plan years beginning on or after the 
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date that is 18 months after the date of enactment of this 
Act. 
SEC. 325. ENSURING ENROLLEE ACCESS TO COST-SHARING 
INFORMATION. 
(a) IN GENERAL.—Subpart II of part A of title 
XXVII of the Public Health Service Act (42 U.S.C. 
300gg–11 et seq.), as amended by the preceding sections, 
is further amended by adding at the end the following: 
‘‘SEC. 2729F. PROVISION OF COST-SHARING INFORMATION. 
‘‘(a) PROVIDER DISCLOSURES.—A provider that is 
in-network with respect to a group health plan or a health 
insurance issuer offering group or individual health insur-
ance coverage shall provide to an enrollee in the plan or 
coverage who submits a request for the information de-
scribed in paragraph (1) or (2), together with accurate 
and complete information about the enrollee’s coverage 
under the applicable plan or coverage— 
‘‘(1) as soon as practicable and not later than 
2 business days after the enrollee requests such in-
formation, a good faith estimate of the expected en-
rollee cost-sharing for the provision of a particular 
health care service (including any service that is rea-
sonably expected to be provided in conjunction with 
such specific service); and 
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‘‘(2) as soon as practicable and not later than 
2 business days after an enrollee requests such in-
formation, the contact information for any ancillary 
providers for a scheduled health care service. 
‘‘(b) INSURER DISCLOSURES.—A group health plan 
or a health insurance issuer offering group or individual 
health insurance coverage shall provide an enrollee in the 
plan or coverage with a good faith estimate of the enroll-
ee’s cost-sharing (including deductibles, copayments, and 
coinsurance) for which the enrollee would be responsible 
for paying with respect to a specific health care service 
(including any service that is reasonably expected to be 
provided in conjunction with such specific service), as soon 
as practicable and not later than 2 business days after 
a request for such information by an enrollee. 
‘‘(c) ENFORCEMENT.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), a 
health care provider that violates a requirement 
under subsection (a) shall be subject to a civil mone-
tary penalty of not more than $10,000 for each act 
constituting such violation. 
‘‘(2) PROCEDURE.—The provisions of section 
1128A of the Social Security Act, other than sub-
sections (a) and (b) and the first sentence of sub-
section (c)(1) of such section, shall apply to civil 
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money penalties under this subsection in the same 
manner as such provisions apply to a penalty or pro-
ceeding under section 1128A of the Social Security 
Act.’’. 
(b) EFFECTIVE DATE.—Section 2729G of the Public 
Health Service Act, as added by subsection (a), shall apply 
with respect to plan years beginning on or after the date 
that is 18 months after the date of enactment of this Act. 
SEC. 326. ACCESS OF INDIVIDUALS TO PROTECTED HEALTH 
INFORMATION. 
The provisions of section 164.524 of title 45, Code 
of Federal Regulations, as in effect on the day before the 
date of the enactment of this Act, shall have the force and 
effect of law. 
SEC. 327. TIMELY BILLS FOR PATIENTS. 
(a) IN GENERAL.— 
(1) AMENDMENT.—Part P of title III of the 
Public Health Service Act (42 U.S.C. 280g et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 399V–7. TIMELY BILLS FOR PATIENTS. 
‘‘(a) IN GENERAL.—The Secretary shall require— 
‘‘(1) health care facilities, or in the case of 
practitioners providing services outside of such a fa-
cility, practitioners, to provide to patients a list of 
services rendered during the visit to such facility or 
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practitioner, and, in the case of a facility, the name 
of the provider for each such service, upon discharge 
or end of the visit or by postal or electronic commu-
nication as soon as practicable and not later than 5 
calendar days after discharge or date of visit; and 
‘‘(2) health care facilities and practitioners to 
furnish all adjudicated bills to the patient as soon as 
practicable, but not later than 45 calendar days 
after discharge or date of visit. 
‘‘(b) PAYMENT AFTER BILLING.—No patient may be 
required to pay a bill for health care services any earlier 
than 35 days after the postmark date of a bill for such 
services. 
‘‘(c) EFFECT OF VIOLATION.— 
‘‘(1) NOTIFICATION
AND
REFUND
REQUIRE-
MENTS.— 
‘‘(A) PROVIDER
LISTS.—If a facility or 
practitioner fails to provide a patient a list as 
required under subsection (a)(1), such facility 
or practitioner shall report such failure to the 
Secretary. 
‘‘(B) BILLING.—If a facility or practitioner 
bills a patient after the 45-calendar-day period 
described in subsection (a)(2), such facility or 
practitioner shall— 
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‘‘(i) report such bill to the Secretary; 
and 
‘‘(ii) refund the patient for the full 
amount paid in response to such bill with 
interest, at a rate determined by the Sec-
retary. 
‘‘(2) CIVIL MONETARY PENALTIES.— 
‘‘(A) IN
GENERAL.—The Secretary may 
impose civil monetary penalties of up to 
$10,000 a day on any facility or practitioner 
that— 
‘‘(i) fails to provide a list required 
under subsection (a)(1) more than 10 
times, beginning on the date of such tenth 
failure; 
‘‘(ii) submits more than 10 bills out-
side of the period described in subsection 
(a)(2), beginning on the date on which 
such facility or practitioner sends the tenth 
such bill; 
‘‘(iii) fails to report to the Secretary 
any failure to provide lists as required 
under paragraph (1)(A), beginning on the 
date that is 45 calendar days after dis-
charge or visit; or 
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‘‘(iv) fails to send any bill as required 
under subsection (a)(2), beginning on the 
date that is 45 calendar days after the 
date of discharge or visit, as applicable. 
‘‘(B) PROCEDURE.—The provisions of sec-
tion 1128A of the Social Security Act, other 
than subsections (a) and (b) and the first sen-
tence of subsection (c)(1) of such section, shall 
apply to civil money penalties under this sub-
section in the same manner as such provisions 
apply to a penalty or proceeding under section 
1128A of the Social Security Act. 
‘‘(3) SAFE HARBOR.—The Secretary may ex-
empt a practitioner or facility from the penalties 
under paragraph (2)(A) or extend the period of time 
specified under subsection (a)(2) for compliance with 
such subsection if a practitioner or facility— 
‘‘(A) makes a good-faith attempt to send a 
bill within 30 days but is unable to do so be-
cause of an incorrect address; or 
‘‘(B) 
experiences 
extenuating 
cir-
cumstances (as defined by the Secretary), such 
as a hurricane or cyberattack, that may reason-
ably delay delivery of a timely bill.’’. 
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(2) RULEMAKING.—Not later than 1 year after 
the date of enactment of this Act, the Secretary 
shall promulgate final regulations to define the term 
‘‘extenuating circumstance’’ for purposes of section 
399V–7(c)(3)(B) of the Public Health Service Act, 
as added by paragraph (1). 
(b) GROUP HEALTH PLAN AND HEALTH INSURANCE 
ISSUER REQUIREMENTS.—Subpart II of part A of title 
XXVII of the Public Health Service Act (42 U.S.C. 
300gg–11), as amended by the preceding sections, is fur-
ther amended by adding at the end the following: 
‘‘SEC. 2729D. TIMELY BILLS FOR PATIENTS. 
‘‘(a) IN GENERAL.—A group health plan or health 
insurance issuer offering group or individual health insur-
ance coverage shall have in place business practices with 
respect to in-network facilities and practitioners to ensure 
that claims are adjudicated in order to facilitate facility 
and practitioner compliance with the requirements under 
section 399V–7(a). 
‘‘(b) CLARIFICATION.—Nothing in subsection (a) pro-
hibits a provider and a group health plan or health insur-
ance issuer from establishing in a contract the timeline 
for submission by either party to the other party of billing 
information, adjudication, sending of remittance informa-
tion, or any other coordination required between the pro-
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vider and the plan or issuer necessary for meeting the 
deadline described in section 399V–7(a)(2).’’. 
(c) EFFECTIVE DATE.—The amendments made by 
subsections (a) and (b) shall take effect 6 months after 
the date of enactment of this Act. 
SEC. 328. ADVISORY GROUP ON REDUCING BURDEN OF 
HOSPITAL ADMINISTRATIVE REQUIREMENTS. 
(a) IN GENERAL.—Not later than January 1, 2021, 
the Secretary of Health and Human Services shall convene 
an advisory group to provide, in accordance with this sec-
tion, recommendations on ways the Federal Government 
could reduce the burden of administrative requirements on 
hospitals. 
(b) RECOMMENDATIONS.—Not later than January 1, 
2022, the advisory board convened under this section 
shall— 
(1) submit to the Secretary of Health and 
Human Services recommendations described under 
subsection (a) for executive action and any rec-
ommendations for State actions for potential consid-
eration in making grants under section 2(c) to 
States; and 
(2) submit to Congress recommendations de-
scribed under subsection (a) for legislative proposals. 
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(c) MEMBERSHIP.—The advisory board under this 
section shall consist of the following members: 
(1) Three representatives of companies that 
have— 
(A) geographically distributed workforces; 
(B) at least 10,000 employees; and 
(C) no more than 10 percent of such em-
ployees in any single State. 
(2) Three representatives of health insurance 
issuers and health plans, consisting of— 
(A) one representative of for-profit health 
insurance issuers and health plans with at least 
20,000,000 enrollees in the employer-sponsored 
market; 
(B) one representative of non-profit health 
insurance issuers and health plans operating in 
at least 5 States; and 
(C) one representative of non-profit health 
insurance issuers and health plans operating in 
a rural State (as defined by the Census Bu-
reau). 
(3) Seven public policy experts in the field of 
hospital consolidation. 
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263 
SEC. 329. DATA REPORTING TO IMPROVE THE TRANS-
PARENCY REGARDING HOW 340B HOSPITAL 
COVERED ENTITIES PROVIDE CARE FOR PA-
TIENTS. 
Section 340B of the Public Health Service Act (42 
U.S.C. 256b) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(f) DATA REPORTING TO IMPROVE THE TRANS-
PARENCY REGARDING HOW HOSPITAL COVERED ENTI-
TIES PROVIDE CARE FOR PATIENTS.— 
‘‘(1) IN GENERAL.—Beginning on the date that 
is 14 months after the date of the enactment of this 
subsection, and annually thereafter, subject to sub-
paragraph (C), a covered entity described in sub-
paragraph (L) or (M) of subsection (a)(4), unless 
otherwise indicated, shall report on the following, 
with respect to the previous year, in such a manner 
and form as specified by the Secretary: 
‘‘(A) The following information: 
‘‘(i) With respect to such covered enti-
ty and with respect to each child site of 
such entity (as referenced in paragraph 
(11)), the number and percentage of indi-
viduals who are dispensed or administered 
drugs that are subject to an agreement 
under this section, organized by form of 
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health insurance coverage of such individ-
uals (including at least by the Medicare 
program under title XVIII of the Social 
Security Act, the Medicaid program under 
title XIX of such Act, health insurance 
coverage offered in the individual or group 
market or a group health plan (as such 
terms are defined in section 2791), and 
uninsured). 
‘‘(ii) With respect to each such child 
site of such entity, the total costs incurred 
at each such site and the cost incurred at 
each such site for charity care as defined 
in line 23 of worksheet S–10 to the Medi-
care cost report or in any successor form. 
‘‘(B) The aggregate amount of gross reim-
bursement received by each such covered entity 
(including child sites of such entity) described 
in such subparagraph (L) or (M) for all drugs 
purchased that are subject to an agreement 
under this section and the entity’s aggregate 
acquisition cost for such drugs. 
‘‘(C) In the case of covered entity de-
scribed in subparagraph (L) of subsection 
(a)(4), at the time of application and recertifi-
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cation (and at least annually thereafter), the 
contract that is the basis for eligibility under 
the requirement under clause (i) of such sub-
paragraph and any modifications to such con-
tract for purposes of review by the Secretary. 
‘‘(D) With respect to such covered entity 
and with respect to each child site of such enti-
ty, the name of all third-party vendors or other 
similar entities that the covered entity contracts 
with to provide services associated with the pro-
gram under this section. 
‘‘(2) AVAILABILITY OF INFORMATION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
make data reported by covered entities under 
subparagraphs (A), (C), and (D) of paragraph 
(1) available on the public website of the De-
partment of Health and Human Services in an 
electronic and searchable format, which may in-
clude the 340B Office of Pharmacy Affairs In-
formation System or a successor to such sys-
tem. 
‘‘(B) 
FORMAT.—Data 
made 
available 
under subparagraph (A) shall be made available 
in a manner that shows each category of data 
reported both in the aggregate and identified by 
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covered entities described in subparagraphs (L) 
and (M) of subsection (a)(4) and child sites of 
such covered entities. In carrying out this para-
graph, with respect to data reported pursuant 
to paragraph (1)(C), the Secretary shall ensure 
that any proprietary information shall be re-
dacted from contracts submitted pursuant to 
such paragraph (1)(C) before posting such 
data. 
‘‘(3) INTERIM FINAL REGULATIONS.—The Sec-
retary shall issue interim final regulations no later 
than the date that is 6 months after the date of the 
enactment of this subsection, to carry out this sub-
section and shall finalize such regulations prior to 
the end of the moratorium period to which sub-
section (a)(11) applies. 
‘‘(4) REPORTS TO CONGRESS.— 
‘‘(A) OIG REPORT.—Not later than 2 
years after the date of the enactment of this 
subsection, the Office of the Inspector General 
shall submit to Congress a final report on the 
level of charity care provided by covered entities 
described in subparagraphs (L) and (M) of sub-
section (a)(4) and separately by child sites of 
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such covered entities, as reported in paragraph 
(1)(A). 
‘‘(B) GAO REPORTS.— 
‘‘(i) INITIAL REPORT.—Not later than 
1 year after the date of the enactment of 
this subsection, the Comptroller General of 
the United States shall submit to Congress 
a report— 
‘‘(I) analyzing the State and local 
government contracts intended to sat-
isfy the requirement under subsection 
(a)(4)(L)(i) for a covered entity to 
qualify as an entity described in sub-
paragraph (L) of subsection (a)(4); 
‘‘(II) assessing the amount of 
care such contracts obligate such enti-
ty to provide to low-income individuals 
ineligible for Medicare under title 
XVIII of the Social Security Act and 
Medicaid under title XIX of such Act; 
and 
‘‘(III) analyzing how these con-
tracts define low-income individuals 
and whether the Secretary reviews 
such determinations. 
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‘‘(ii) 
SUBSEQUENT
REPORT.—Not 
later than 2 years after the date of the en-
actment of this subsection, the Comptroller 
General of the United States shall submit 
to Congress a final report on the informa-
tion collected under paragraph (1)(B) re-
garding the difference between the aggre-
gate gross reimbursement and aggregate 
acquisition costs received by each such cov-
ered entity (including child sites of such 
entity) for drugs subject to an agreement 
under this section.’’. 
SEC. 330. REQUIRING 340B DRUG DISCOUNT PROGRAM RE-
PORTS BY DSH HOSPITAL COVERED ENTITIES 
ON LOW-INCOME UTILIZATION RATE OF OUT-
PATIENT HOSPITAL SERVICES. 
(a) IN GENERAL.—Section 340B(d)(2) of the Public 
Health Service Act (42 U.S.C. 256b(d)(2)) is amended— 
(1) in subparagraph (B)(i), by inserting before 
the period at the end the following: ‘‘, including, 
with respect to such updates made on or after Janu-
ary 1, 2021, by requiring covered entities described 
in subsection (a)(4)(L) to submit (and to so regu-
larly update) information described in subparagraph 
(C)’’; and 
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(2) by adding at the end the following new sub-
paragraph: 
‘‘(C) INFORMATION ON LOW-INCOME UTI-
LIZATION
RATE
OF
OUTPATIENT
HOSPITAL 
SERVICES.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (B)(i), the information de-
scribed in this subparagraph, with respect 
to a covered entity described in subsection 
(a)(4)(L) and an update under such sub-
paragraph (B)(i), is— 
‘‘(I) the low-income outpatient 
utilization rate of such covered entity 
for the most recent fiscal year; and 
‘‘(II) the low-income outpatient 
utilization rate of off-site outpatient 
facilities, clinics, eligible off-site loca-
tions, and associated sites of such en-
tity identified as child sites of such 
entity pursuant to the identification 
system under subparagraph (B)(iv) 
for the most recent fiscal year. 
‘‘(ii) LOW-INCOME OUTPATIENT UTI-
LIZATION
RATE
DEFINED.—In this sub-
paragraph, the term ‘low-income outpatient 
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utilization rate’ has the meaning given the 
term ‘low-income utilization rate’ under 
paragraph (3) of section 1923(b) of the 
Social Security Act, except that— 
‘‘(I) clauses (i) and (ii) of sub-
paragraph (A) of such paragraph 
shall be applied as if— 
‘‘(aa) each reference to ‘pa-
tient services’ were a reference to 
‘patient services furnished on an 
outpatient basis’; and 
‘‘(bb) for purposes of clause 
(i)(II) of this subparagraph, each 
reference to ‘hospital’ were a ref-
erence to ‘off-site outpatient fa-
cilities, clinics, eligible off-site lo-
cations, and associated sites of 
the hospital that are identified as 
child sites of the hospital pursu-
ant to the identification system 
under section 340B(d)(2)(B)(iv) 
of the Public Health Service Act’; 
and 
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271 
‘‘(II) clauses (i) and (ii) of sub-
paragraph (B) of such paragraph 
shall be applied as if— 
‘‘(aa) each reference to ‘in-
patient hospital services’ were a 
reference to ‘outpatient hospital 
services’; and 
‘‘(bb) for purposes of clause 
(i)(II) each reference to ‘hos-
pital’s charges’ were a reference 
to ‘charges of the off-site out-
patient facilities, clinics, eligible 
off-site locations, and associated 
sites of the hospital that are 
identified as child sites of the 
hospital pursuant to the identi-
fication system under section 
340B(d)(2)(B)(iv) of the Public 
Health Service Act’.’’. 
(b) ANNUAL REPORTS.—Not later than January 1, 
2021, and annually thereafter, the Administrator of the 
Health Resources and Services Administration shall sub-
mit to Congress a report on information submitted by cov-
ered entities for the previous year pursuant to the amend-
ments made by subsection (a). 
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SEC. 331. EMPLOYER BENEFITS REPORTS. 
(a) IN GENERAL.—Subject to subsection (b), for each 
plan year beginning on or after January 1, 2021, a group 
health plan and a health insurance issuer offering group 
health insurance coverage shall provide to each individual 
enrolled in such plan or such coverage for such plan year 
a notification containing the following: 
(1) The amount the sponsor of such group 
health plan expended with respect to such individual 
under such plan for such plan year (or, in the case 
of a health insurance issuer offering group health in-
surance coverage, the amount the employer of such 
individual contributed for such coverage for such in-
dividual for such plan year). 
(2) The amount the sponsor of such group 
health plan expended with respect to such individual 
under such plan for each previous plan year (or, in 
the case of a health insurance issuer offering group 
health insurance coverage, the amount the employer 
of such individual contributed for such coverage for 
such individual for each previous plan year), if appli-
cable. 
(b) LIMITATION.—Subsection (a) shall not apply to 
a group health plan, or a health insurance issuer offering 
group health insurance coverage, for a plan year if, for 
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‘‘SEC. 2797. GROUP HEALTH PLAN REPORTING. 
‘‘(a) IN GENERAL.—A group health plan or health 
insurance issuer offering group or individual health insur-
ance coverage shall submit to the Secretary, not later than 
March 1 of each year, the following information with re-
spect to the health plan in the previous plan year: 
‘‘(1) The beginning and end dates of the plan 
year. 
‘‘(2) The number of enrollees. 
‘‘(3) Each State in which the plan is offered. 
‘‘(4) The 50 brand prescription drugs most fre-
quently dispensed by pharmacies for claims paid by 
the issuer, and the total number of paid claims for 
each such drug. 
‘‘(5) The 50 most costly prescription drugs with 
respect to the plan by total annual spending, and the 
annual amount spent by the plan for each such 
drug. 
‘‘(6) The 50 prescription drugs with the great-
est increase in plan expenditures over the plan year 
preceding the plan year that is the subject of the re-
port, and, for each such drug, the change in 
amounts expended by the plan in each such plan 
year. 
‘‘(7) Total spending on health care services by 
such group health plan, broken down by— 
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‘‘(A) the type of costs, including— 
‘‘(i) hospital costs; 
‘‘(ii) health care provider and clinical 
service costs; 
‘‘(iii) costs for prescription drugs; and 
‘‘(iv) other medical costs; and 
‘‘(B) spending on prescription drugs by— 
‘‘(i) the health plan; and 
‘‘(ii) the enrollees. 
‘‘(8) The average monthly premium— 
‘‘(A) paid by employers on behalf of enroll-
ees; and 
‘‘(B) paid by enrollees. 
‘‘(9) Any impact on premiums by rebates, fees, 
and any other remuneration paid by drug manufac-
turers to the plan or its administrators or service 
providers, with respect to prescription drugs pre-
scribed to enrollees in the plan, including— 
‘‘(A) the amounts so paid for each thera-
peutic class of drugs; and 
‘‘(B) the amounts so paid for each of the 
25 drugs that yielded the highest amount of re-
bates and other remuneration under the plan 
from drug manufacturers during the plan year. 
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‘‘(10) Any reduction in premiums and out-of- 
pocket costs associated with rebates, fees, or other 
remuneration described in paragraph (9). 
‘‘(b) REPORT.—Not later than 18 months after the 
date on which the first report is required under subsection 
(a) and biannually thereafter, the Secretary, acting 
through the Assistant Secretary of Planning and Evalua-
tion and in coordination with the Inspector General of the 
Department of Health and Human Services, shall make 
available on the internet website of the Department of 
Health and Human Services a report on prescription drug 
reimbursements under group health plans, prescription 
drug pricing trends, and the role of prescription drug costs 
in contributing to premium increases or decreases under 
such plans, aggregated in such a way as no drug or plan 
specific information will be made public. 
‘‘(c) PRIVACY PROTECTIONS.—No confidential or 
trade secret information submitted to the Secretary under 
subsection (a) shall be included in the report under sub-
section (b).’’. 
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SEC. 333. GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
ON 
PROFIT- 
AND 
REVENUE-SHARING 
IN 
HEALTH CARE. 
(a) STUDY.—Not later than 1 year after the date of 
enactment of this Act, the Comptroller General of the 
United States shall conduct a study to— 
(1) describe what is known about profit- and 
revenue-sharing relationships in the commercial 
health care markets, including those relationships 
that— 
(A) involve one or more— 
(i) physician groups that practice 
within a hospital included in the profit- or 
revenue-sharing relationship, or refer pa-
tients to such hospital; 
(ii) laboratory, radiology, or pharmacy 
services that are delivered to privately in-
sured patients of such hospital; 
(iii) surgical services; 
(iv) hospitals or group purchasing or-
ganizations; or 
(v) rehabilitation or physical therapy 
facilities or services; and 
(B) include revenue- or profit-sharing 
whether through a joint venture, management 
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or professional services agreement, or other 
form of gain-sharing contract; 
(2) describe Federal oversight of such relation-
ships, including authorities of the Department of 
Health and Human Services and the Federal Trade 
Commission to review such relationships and their 
potential to increase costs for patients, and identify 
limitations in such oversight; and 
(3) as appropriate, make recommendations to 
improve Federal oversight of such relationships. 
(b) REPORT.—Not later than 1 year after the date 
of enactment of this Act, the Comptroller General of the 
United States shall prepare and submit a report on the 
study conducted under subsection (a) to the Committee 
on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Education and Labor and Com-
mittee on Energy and Commerce of the House of Rep-
resentatives. 
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Subtitle C—Prescription Drug 
Competition and Innovation 
SEC. 341. EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW FOR GENERIC COMPLEX DRUG PROD-
UCTS. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 524B. EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW FOR GENERIC COMPLEX DRUG PROD-
UCTS. 
‘‘(a) ESTABLISHMENT OF PROGRAM.—The Secretary 
shall establish a program to expedite the development of, 
and provide priority review under section 505(j) for, ge-
neric complex drug products. 
‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a 
generic complex drug product may request that the Sec-
retary designate such product for expedited development 
and priority review under this section. 
‘‘(c) 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 prod-
uct that is the subject of the request meets the cri-
teria under subsection (e) to be considered a generic 
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complex drug product. If the Secretary determines 
that the product meets the criteria, the Secretary 
shall designate the product for expedited develop-
ment and priority review. 
‘‘(2) REVIEW.—Review of a request under sub-
section (b) shall be undertaken by a team that is 
composed 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 (e) no 
longer applying because of the subsequent clearance 
or approval of any other product. 
‘‘(d) EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW GUIDANCE.— 
‘‘(1) CONTENT.—Not later than December 31, 
2021, the Secretary shall issue guidance on the im-
plementation of this section. Such guidance shall— 
‘‘(A) set forth the process by which a per-
son may seek a designation under subsection 
(c); 
‘‘(B) provide a template for requests under 
subsection (b); 
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‘‘(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 expedite the development 
and review of products designated under this 
section. 
‘‘(2) PROCESS.—Prior to finalizing the guid-
ance under paragraph (1), the Secretary shall seek 
public comment on a draft version of that guidance. 
‘‘(e) GENERIC
COMPLEX
DRUG
PRODUCT
DE-
FINED.—In this section, the term ‘generic complex drug 
product’ means a product that represents a complex ther-
apy that consists of or includes a drug for approval under 
section 505(j) and that— 
‘‘(1)(A) contains complex active ingredients 
(such as peptides, polymeric compounds, complex 
mixtures of active ingredients, and naturally sourced 
ingredients); 
‘‘(B) is composed of complex formulations (such 
as liposomes or colloids); 
‘‘(C) requires a complex route of delivery (such 
as locally acting drugs such as dermatological prod-
ucts and complex ophthalmological products and otic 
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dosage forms that are formulated as suspensions, 
emulsions, or gels); or 
‘‘(D) involves a complex dosage form (such as 
transdermals, metered dose inhalers, or extended re-
lease injectables); 
‘‘(2) presents as a complex drug-device com-
bination product (such as auto injectors or metered 
dose inhalers); or 
‘‘(3) is a product that would benefit from early 
scientific engagement due to complexity or uncer-
tainty concerning the approval pathway under sec-
tion 505(j).’’. 
SEC. 342. PREVENTING BLOCKING OF GENERIC DRUGS. 
(a) IN GENERAL.—Section 505(j)(5)(B)(iv)(I) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(5)(B)(iv)(I)) is amended— 
(1) by striking ‘‘180 days after the date’’ and 
inserting ‘‘180 days after the earlier of the fol-
lowing: 
‘‘(aa) The date’’; and 
(2) by adding at the end the following: 
‘‘(bb) The date on which all of the fol-
lowing conditions are first met, provided 
no application submitted by any first appli-
cant is approved on or before such date: 
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‘‘(AA) An application for the 
drug submitted by an applicant other 
than a first applicant has received 
tentative approval and could receive 
approval, if no first applicant were eli-
gible for 180-day exclusivity under 
this clause, and such applicant has 
not entered into an agreement that 
would prevent commercial marketing 
upon approval and has submitted a 
notification to the Secretary docu-
menting that it has not entered into 
an agreement that would prevent com-
mercial marketing. 
‘‘(BB) Thirty-three months have 
passed since the date of submission of 
an application for the drug by one 
first applicant, if there is only one 
first applicant, or, in the case of more 
than one first applicant, 33 months 
have passed since the date of submis-
sion of all such applications. 
‘‘(CC) Approval of an application 
for the drug submitted by at least one 
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first applicant would not be precluded 
under clause (iii).’’. 
(b) INFORMATION.—Not later than 60 days of the 
date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this subsection as the 
‘‘Secretary’’) shall publish, as appropriate and available, 
information sufficient to allow applicants to assess wheth-
er the conditions described in subitems (AA) through (CC) 
of section 505(j)(5)(B)(iv)(I)(bb) of the Federal Food, 
Drug, and Cosmetic Act (as amended by subsection (a)) 
have been or will be satisfied for all applications where 
the exclusivity period under (iv)(I) of section 505(j)(5)(B) 
of the Federal Food, Drug, and Cosmetic Act (as so 
amended) has not expired, and shall provide updates to 
reflect the most recent information available to the Sec-
retary. 
SEC. 343. ENSURING TIMELY ACCESS TO GENERICS. 
Section 505(q) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(q)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)(i), by inserting ‘‘, 
10.31,’’ after ‘‘10.30’’; 
(B) in subparagraph (E)— 
(i) by striking ‘‘application and’’ and 
inserting ‘‘application or’’; 
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(ii) by striking ‘‘If the Secretary’’ and 
inserting the following: 
‘‘(i) IN GENERAL.—If the Secretary’’; 
and 
(iii) by striking the second sentence 
and inserting the following: 
‘‘(ii) PRIMARY
PURPOSE
OF
DELAY-
ING.— 
‘‘(I) IN
GENERAL.—In deter-
mining whether a petition was sub-
mitted with the primary purpose of 
delaying an application, the Secretary 
may consider the following factors: 
‘‘(aa) Whether the petition 
was submitted in accordance with 
paragraph (2)(B), based on when 
the petitioner knew or reasonably 
should have known the relevant 
information relied upon to form 
the basis of such petition. 
‘‘(bb) Whether the petitioner 
has submitted multiple or serial 
petitions or supplements to peti-
tions raising issues that reason-
ably could have been known to 
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the petitioner at the time of sub-
mission of the earlier petition or 
petitions. 
‘‘(cc) Whether the petition 
was submitted close in time to a 
known, first date upon which an 
application 
under 
subsection 
(b)(2) or (j) of this section or 
section 351(k) of the Public 
Health Service Act could be ap-
proved. 
‘‘(dd) Whether the petition 
was submitted without relevant 
data or information in support of 
the scientific positions forming 
the basis of such petition. 
‘‘(ee) Whether the petition 
raises the same or substantially 
similar issues as a prior petition 
to which the Secretary has re-
sponded substantively already, in-
cluding if the subsequent submis-
sion follows such response from 
the Secretary closely in time. 
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‘‘(ff) Whether the petition 
requests changing the applicable 
standards that other applicants 
are required to meet, including 
requesting testing, data, or label-
ing standards that are more on-
erous or rigorous than the stand-
ards the Secretary has deter-
mined to be applicable to the list-
ed drug, reference product, or pe-
titioner’s version of the same 
drug. 
‘‘(gg) The petitioner’s record 
of submitting petitions to the 
Food and Drug Administration 
that have been determined by the 
Secretary to have been submitted 
with the primary purpose of 
delay. 
‘‘(hh) Other relevant and 
appropriate factors, which the 
Secretary shall describe in guid-
ance. 
‘‘(II) GUIDANCE.—The Secretary 
may issue or update guidance, as ap-
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propriate, to describe factors the Sec-
retary considers in accordance with 
subclause (II).’’; 
(C) by adding at the end the following: 
‘‘(iii) REFERRAL
TO
THE
FEDERAL 
TRADE COMMISSION.—The Secretary shall 
establish procedures for referring to the 
Federal Trade Commission any petition or 
supplement to a petition that the Secretary 
determines was submitted with the primary 
purpose of delaying approval of an applica-
tion. Such procedures shall include notifi-
cation to the petitioner by the Secretary.’’; 
(D) by striking subparagraph (F); 
(E) by redesignating subparagraphs (G) 
through (I) as subparagraphs (F) through (H), 
respectively; and 
(F) in subparagraph (H), as so redesig-
nated, by striking ‘‘submission of this petition’’ 
and inserting ‘‘submission of this document’’; 
(2) in paragraph (2)— 
(A) by redesignating subparagraphs (A) 
through (C) as subparagraphs (C) through (E), 
respectively; 
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(B) by inserting before subparagraph (C), 
as so redesignated, the following: 
‘‘(A) IN GENERAL.—A person shall submit 
a petition to the Secretary under paragraph (1) 
before filing a civil action in which the person 
seeks to set aside, delay, rescind, withdraw, or 
prevent submission, review, or approval of an 
application submitted under subsection (b)(2) 
or (j) of this section or section 351(k) of the 
Public Health Service Act. Such petition and 
any supplement to such a petition shall describe 
all information and arguments that form the 
basis of the relief requested in any civil action 
described in the previous sentence. 
‘‘(B) TIMELY SUBMISSION OF CITIZEN PE-
TITION.—A petition and any supplement to a 
petition shall be submitted within 60 days after 
the person knew, or reasonably should have 
known, the information that forms the basis of 
the request made in the petition or supple-
ment.’’; 
(C) in subparagraph (C), as so redesig-
nated— 
(i) in the heading, by striking ‘‘WITH-
IN 150 DAYS’’; 
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(ii) in clause (i), by striking ‘‘during 
the 150-day period referred to in para-
graph (1)(F),’’; and 
(iii) by amending clause (ii) to read as 
follows: 
‘‘(ii) on or after the date that is 151 
days after the date of submission of the 
petition, the Secretary approves or has ap-
proved the application that is the subject 
of the petition without having made such a 
final decision.’’; 
(D) by amending subparagraph (D), as so 
redesignated, to read as follows: 
‘‘(D) DISMISSAL
OF
CERTAIN
CIVIL
AC-
TIONS.— 
‘‘(i) PETITION.—If a person files a 
civil action against the Secretary in which 
a person seeks to set aside, delay, rescind, 
withdraw, or prevent submission, review, or 
approval of an application submitted under 
subsection (b)(2) or (j) of this section or 
section 351(k) of the Public Health Service 
Act without complying with the require-
ments of subparagraph (A), the court shall 
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dismiss without prejudice the action for 
failure to exhaust administrative remedies. 
‘‘(ii) TIMELINESS.—If a person files a 
civil action against the Secretary in which 
a person seeks to set aside, delay, rescind, 
withdraw, or prevent submission, review, or 
approval of an application submitted under 
subsection (b)(2) or (j) of this section or 
section 351(k) of the Public Health Service 
Act without complying with the require-
ments of subparagraph (B), the court shall 
dismiss with prejudice the action for fail-
ure to timely file a petition. 
‘‘(iii) FINAL RESPONSE.—If a civil ac-
tion is filed against the Secretary with re-
spect to any issue raised in a petition time-
ly filed under paragraph (1) in which the 
petitioner requests that the Secretary take 
any form of action that could, if taken, set 
aside, delay, rescind, withdraw, or prevent 
submission, review, or approval of an appli-
cation submitted under subsection (b)(2) 
or (j) of this section or section 351(k) of 
the Public Health Service Act before the 
Secretary has taken final agency action on 
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the petition within the meaning of sub-
paragraph (C), the court shall dismiss 
without prejudice the action for failure to 
exhaust administrative remedies.’’; and 
(E) in clause (iii) of subparagraph (E), as 
so redesignated, by striking ‘‘as defined under 
subparagraph (2)(A)’’ and inserting ‘‘within the 
meaning of subparagraph (C)’’; and 
(3) in paragraph (4)— 
(A) by striking ‘‘EXCEPTIONS’’ and all that 
follows through ‘‘This subsection does’’ and in-
serting ‘‘EXCEPTIONS.—This subsection does’’; 
(B) by striking subparagraph (B); and 
(C) by redesignating clauses (i) and (ii) as 
subparagraphs (A) and (B), respectively, and 
adjusting the margins accordingly. 
SEC. 344. PREEMPTION OF STATE BARRIERS TO THE SUB-
STITUTION OF BIOSIMILAR PRODUCTS. 
No State, or any political subdivision thereof, may, 
under any circumstances, prohibit a pharmacy or phar-
macist from dispensing, in place of a biological reference 
product, any biosimilar that the Food and Drug Adminis-
tration has designated as an interchangeable product for 
that biological reference product. 
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SEC. 345. INCREASING PHARMACEUTICAL OPTIONS TO 
TREAT AN UNMET MEDICAL NEED. 
Subsection (b) of section 506 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356) is amended by 
adding at the end the following: 
‘‘(4) UNMET MEDICAL NEED.—For purposes of 
paragraph (1), a drug shall be deemed to address an 
unmet medical need for a disease or condition if 
fewer than 3 available drugs exist for the treatment 
of such disease or condition.’’. 
SEC. 346. PROVISIONAL APPROVAL OF NEW HUMAN DRUGS. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by adding at the end of the following: 
‘‘SEC. 524B. PROVISIONAL APPROVAL OF NEW HUMAN 
DRUGS. 
‘‘(a) PRIORITY REVIEW AND EVALUATION OF APPLI-
CATIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a priority review system to evaluate applications 
submitted under this pathway for provisional ap-
proval within 90 days of receipt of a completed ap-
plication. 
‘‘(2) 
REVIEW
OF
APPLICATIONS
DURING 
EPIDEMICS AND PANDEMICS.—In the case of an epi-
demic or pandemic, including with respect to 
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COVID–19, the Secretary shall accept and review 
various portions of an application submitted under 
the pathway under this section for provisional ap-
proval on a rolling basis, and the review of any part 
of an application so submitted shall be completed 
not later than 3 weeks after submission. 
‘‘(3) OTHER
DESIGNATIONS.—If a drug sub-
mitted for review under the pathway under this sec-
tion is eligible for a special designation by the Sec-
retary under this Act, including as a drug for a rare 
disease or condition under section 526, all benefits 
of such other designation shall be available for use 
under provisional approval, including any tax credits 
and waiving of fees under chapter VII. 
‘‘(b) ELIGIBILITY.—A drug may be eligible for provi-
sional approval under this section if the Secretary deter-
mines that the drug is intended for the treatment, preven-
tion, or medical diagnosis of— 
‘‘(1) a serious or life-threatening disease or con-
dition for which there is a reasonable likelihood that 
premature death will occur without early medical 
intervention for an individual contracting or being 
diagnosed with such disease or condition; 
‘‘(2) a disease or condition that poses a threat 
of epidemic or pandemic; or 
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‘‘(3) a disease or condition associated with mor-
bidity that has a substantial impact on day-to-day 
functioning. 
‘‘(c) STANDARD OF REVIEW FOR APPROVAL.— 
‘‘(1) REQUIREMENTS.—An application for pro-
visional approval under this section may be approved 
only if the Secretary determines that— 
‘‘(A) there is substantial evidence of safety 
for the drug, such that there is evidence con-
sisting of adequate and well-controlled inves-
tigations, including clinical investigations, by 
experts qualified by scientific training and expe-
rience to evaluate the safety of the drug in-
volved, on the basis of which it could fairly and 
responsibly be concluded that the drug will have 
the effect it purports or is represented to have 
under the conditions of use prescribed, rec-
ommended, or suggested in the labeling or pro-
posed labeling; and 
‘‘(B) there is relevant early evidence based 
on adequate and well-controlled investigations, 
including early-stage clinical investigations, to 
establish that— 
‘‘(i) the drug provides a positive 
therapeutic outcome; and 
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‘‘(ii) the outcome of the drug is con-
sistent with or greater than currently mar-
keted on-label therapies, with equal or 
fewer side effects, if there are currently 
marketed on-label therapies. 
‘‘(2) PROTOCOLS.—The Secretary shall promul-
gate rules that establish the appropriate protocols 
for a sponsor of an application for provisional ap-
proval under this section and the Commissioner to 
follow to enable rolling, real-time, mid-trial submis-
sion while preserving the integrity of the ongoing 
trial and without penalizing the sponsor for making 
use of this pathway. 
‘‘(3) REAL WORLD EVIDENCE.—The Secretary 
shall allow the use of real world evidence (as defined 
in section 505F(b)), including real world data used 
to generate real world evidence, to support an appli-
cation for provisional approval under this section, 
and to fulfill the follow-up requirements and support 
applications for full approval as described under sec-
tion 505 or section 351 of the Public Health Service 
Act, as applicable. 
‘‘(4) USE OF SCIENTIFICALLY SUBSTANTIATED 
SURROGATES.— 
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‘‘(A) IN GENERAL.—The sponsor of an ap-
plication for provisional approval under this sec-
tion may use scientifically substantiated surro-
gates to support such application. 
‘‘(B) DEFINITION.—In subparagraph (A), 
the term ‘scientifically substantiated surrogates’ 
means surrogate endpoints to predict clinical 
benefit other than such endpoints previously 
validated by the Secretary, based on— 
‘‘(i) epidemiologic, therapeutic, patho-
physiologic, or other evidence; or 
‘‘(ii) an effect on a clinical endpoint 
other than survival or irreversible mor-
bidity of interest. 
‘‘(d) TRANSPARENCY
AND PATIENT MONITORING 
REQUIREMENTS.— 
‘‘(1) REGISTRIES.— 
‘‘(A) IN GENERAL.—The sponsor of a drug 
provisionally approved under this section shall 
require that all patients who use such drug par-
ticipate in an observational registry and consent 
to the sponsor’s collection, and submission to 
the registry, of data related to the patient’s use 
of such drug until such drug receives full ap-
proval under section 505 or section 351 of the 
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Public Health Service Act, or the provisional 
approval is rescinded. 
‘‘(B) REQUIREMENTS FOR REGISTRIES.— 
An observational registry described in subpara-
graph (A) may be run by a third party, such as 
a government, for profit, or non-profit organiza-
tion, and shall track all patients who use the 
provisionally approved drug. 
‘‘(C) ACCESSIBILITY.—An observational 
registry described in subparagraph (A) shall be 
easily accessible for— 
‘‘(i) all patients who are participating 
in any registry related to a provisionally 
approved drug that allows for easy, unre-
stricted (or transparent) access for such 
patients to their patient data and related 
information regarding their usage of the 
provisionally approved drug; and 
‘‘(ii) approved researchers and med-
ical professionals who may access data 
maintained in the registry, which access 
shall be for public health research and only 
in a de-identified, aggregated manner. 
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‘‘(2) 
FUNDING.—An 
observational 
registry 
under this subsection shall be maintained, as appli-
cable— 
‘‘(A) by the sponsor of the drug provision-
ally approved under this section that is the sub-
ject of the registry; 
‘‘(B) by a third party, such as a govern-
ment, for profit, or nonprofit organization; or 
‘‘(C) the Federal Government, in the case 
of any drug so approved that is intended to 
treat a disease or condition associated with an 
epidemic or pandemic. 
‘‘(3) SPONSOR REQUIREMENTS.— 
‘‘(A) IN GENERAL.—For any drug applica-
tion provisionally approved under this section, 
the Secretary shall notify the sponsor of the 
exact data such sponsor is required to submit 
to an observational registry. 
‘‘(B) ANNUAL REVIEW OF THE REGISTRY; 
PENALTIES.—The Secretary shall conduct an 
annual review of observational registries estab-
lished under this subsection. If, at such an an-
nual review, less than 90 percent of patients are 
participating in an observational registry with 
respect to a drug approved under this section, 
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the Secretary shall issue to the sponsor of such 
drug a civil monetary penalty of not more than 
$100,000. If a violation of this section is not 
corrected within the 30-day period following no-
tification, the sponsor shall, in addition to any 
penalty under this subparagraph be subject to 
a civil monetary penalty of not more than 
$10,000 for each day of the violation after such 
period until the violation is corrected. If appli-
cation patient participation in an observational 
registry is not at or above 90 percent within 6 
months of issuance of such penalty, the provi-
sional approval shall be withdrawn. 
‘‘(4) ANNUAL
REPORT
TO
CONGRESS.—The 
Secretary shall submit an annual report to Congress 
on all drugs granted provisional approval under this 
section. Such report shall include— 
‘‘(A) the number of patients treated with 
each such drug, and the number of patients 
tracked in an observational registry with re-
spect to each such drug; 
‘‘(B) a discussion of the minimum amount 
of data required in the registries, including pa-
tient treatments and uses, length of use, side 
effects encountered, relevant biomarkers or sci-
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entifically substantiated surrogates, scan re-
sults, cause of death and how long the patient 
lived, and adverse drug effects; 
‘‘(C) a list of all such drugs for which an 
application for full approval under section 505 
of this Act or section 351 of the Public Health 
Service Act, or an application for an extension 
of provisional approval under this section, has 
been submitted; and 
‘‘(D) a list of all applications denied provi-
sional approval under this section, together with 
an explanation for the decisions to deny each 
such application. 
‘‘(e) WITHDRAWAL OF PROVISIONAL APPROVAL.— 
‘‘(1) IN GENERAL.—The Secretary shall with-
draw provisional approval under this section if there 
are a significant number of patients who experience 
serious adverse effects, compared to the other cur-
rently marketed on-label therapies that are available 
for the applicable disease or condition. 
‘‘(2) EFFECT
OF
WITHDRAWAL.—If a provi-
sional approval is withdrawn under this subsection, 
the sponsor may not make the drug available to any 
new patients, but may be allowed to continue to 
make such drug available to patients who started 
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taking the drug prior to the date of withdrawal, for 
as long a period as dictated by patient need, as de-
termined by the Secretary. 
‘‘(f) TRANSPARENCY.—Any scientific, medical, aca-
demic, or health care journal publishing an article explain-
ing, releasing, conveying or announcing research findings 
which were funded by the Department of Health and 
Human Services shall be prohibited from publishing such 
research unless— 
‘‘(1) such article conveying research findings is 
made publicly available on the journal’s internet 
website without a paywall or charge not later than 
3 months after the date on which such article was 
first provided to subscribers of such journal (or first 
made available for purchase); and 
‘‘(2) the article’s author or researcher or au-
thor’s institution (or, in the case of multiple authors, 
researchers, or institutions, all such authors, re-
searchers, or institutions) received less than 30 per-
cent of funding for such research from the Depart-
ment of Health and Human Services throughout the 
period of time the research was conducted. 
‘‘(g) INFORMED CONSENT.—Prior to receiving a drug 
provisionally approved under this section, the sponsor of 
the drug shall receive from each patient, or the patient’s 
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representative, informed consent, through a signed in-
formed consent form, acknowledging that such patient un-
derstands that the drug did not undergo the usual process 
for full approval of a drug by the Food and Drug Adminis-
tration, and that such patient is willing to accept the risks 
involved in taking such drug. 
‘‘(h) POSTMARKET CONTROLS AND LABELING.— 
‘‘(1) FDA 
ANNUAL
REVIEW
OF
REGISTRY 
DATA.—The Secretary shall annually review the data 
made available through the observational registries 
under subsection (d) and make a determination re-
garding whether the side effect profile of any drug 
approved under this pathway does not support the 
benefit provided, or the data shows the benefit is 
less than the benefits offered through other, fully 
approved drugs. 
‘‘(2) LABELING.—The sponsor of the provision-
ally approved drug shall ensure that all labeling and 
promotional materials for the drug bear the state-
ment ‘provisionally approved by the FDA pending a 
full demonstration of effectiveness under application 
number llllll’ (specifying the application 
number assigned by the Secretary in place of the 
blank). All promotional, educational and marketing 
materials for provisionally approved products shall 
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be reviewed and approved by the Secretary before 
such materials are distributed. 
‘‘(3) 
RESCISSION
OF
PROVISIONAL
AP-
PROVAL.—If the Secretary determines that the side 
effect profile of any drug included in such observa-
tional registries does not support the benefit pro-
vided by such drug, or that the data shows that the 
benefit is less than the benefits offered through 
other, fully approved drugs, the Secretary shall re-
scind such provisional approval. 
‘‘(i) DURATION
OF PROVISIONAL APPROVAL; RE-
QUIREMENT TO BRING DRUG TO MARKET.— 
‘‘(1) DURATION; RENEWALS.—The period of 
provisional approval for a drug approved under this 
section is effective for a 2-year period. The sponsor 
may request renewal for provisional approval status 
for up to 3 subsequent 2-year periods by the Sec-
retary. Provisional approval status with respect to a 
drug shall not exceed a total of 6 years from the ini-
tial date the sponsor was awarded provisional ap-
proval status. 
‘‘(2) MARKETING REQUIREMENT.—If any drug 
that receives provisional approval status under this 
section is not brought to market within 180 days of 
the approval, such approval shall be rescinded. 
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‘‘(j) LIMITATION ON LIABILITY.—With respect to any 
claim under State law alleging that a drug sold or other-
wise made available pursuant to a grant of provisional ap-
proval under this section is unsafe or ineffective, no liabil-
ity in a cause of action shall lie against a sponsor or manu-
facturer, unless the relevant conduct constitutes reckless 
or willful misconduct, gross negligence, or an intentional 
tort under any applicable State law. 
‘‘(k) APPLYING FOR FULL APPROVAL.— 
‘‘(1) IN GENERAL.—Except as provided under 
paragraph (2), the sponsor of a drug granted provi-
sional approval pursuant to this section may, at any 
point, submit an application for full approval of such 
drug under section 505 of this Act or section 351 
of the Public Health Service Act, as applicable. 
‘‘(2) EFFECT OF RECESSION ON APPROVAL AND 
AUTOMATIC APPROVAL.— 
‘‘(A) IN GENERAL.—The sponsor of a drug 
granted provisional approval pursuant to this 
section that has been rescinded under sub-
section (h)(3), may submit an application for 
full approval of such drug under section 505 of 
this Act or section 351 of the Public Health 
Service Act at any time. 
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‘‘(B) AUTOMATIC
APPROVAL.—Such full 
approval may be awarded at any time for any 
drug granted provisional approval pursuant to 
this section if the sponsor of the drug estab-
lishes a 15 percent improvement in an impor-
tant endpoint, including surrogate endpoints 
not validated by the Food and Drug Adminis-
tration, compared to a standard drug. 
‘‘(3) REAL-TIME EPIDEMIC AND PANDEMIC VAC-
CINE APPROVAL.— 
‘‘(A) IN GENERAL.—In the case of a vac-
cine developed in response to an epidemic or 
pandemic, including COVID–19, the Secretary 
shall share data information regarding the ap-
proval of the vaccine with the Advisory Com-
mittee on Immunization Practices of the Cen-
ters for Disease Control and Prevention as the 
review nears completion. 
‘‘(B) EVALUATION.—Any vaccine that has 
been approved by the Secretary for an epidemic 
or pandemic-related disease, including COVID– 
19, shall be evaluated by the Advisory Com-
mittee on Immunization Practices of the Cen-
ters for Disease Control and Prevention not 
later than 1 week after the date of submission 
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to the Advisory Committee by the Secretary of 
the vaccine. 
‘‘(l) PATIENT ADVOCATE GENERAL.—Not later than 
6 months after the date of enactment of the Promising 
Pathway Act, the Secretary shall establish within the Of-
fice of the Commissioner, the position of Patient Advocate 
General, who shall provide assistance to patients and their 
families who use drugs under evaluation in this pathway 
or drugs reviewed or approved under section 505 or sec-
tion 351 of the Public Health Service Act. Such assistance 
shall include providing bi-informational communication 
about maintaining patient health, delivery of proper in-
formed consent, participating in clinical investigations, 
completing required documentation in order to participate 
in the applicable programs, and providing other informa-
tion.’’. 
(b) CONFORMING AMENDMENT.—Section 505(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(a)) is amended by inserting ‘‘, or there is in effect 
a provisional approval under section 524B with respect to 
such drug’’ before the period. 
(c) REIMBURSEMENT.— 
(1) 
PRIVATE
HEALTH
INSURERS.—Section 
2719A of the Public Health Service Act (42 U.S.C. 
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300gg–19a) is amended by adding at the end the 
following: 
‘‘(e) TREATMENT
OF CERTAIN DRUGS.—A group 
health plan or health insurance issuer of group or indi-
vidual health insurance coverage shall not deny coverage 
of any drug provisionally approved under section 524B of 
the Federal Food, Drug, and Cosmetic Act on the basis 
of such drug being experimental. In determining coverage 
under the applicable plan or coverage, a group health plan 
or health insurance issuer shall treat a drug provisionally 
approved under such section in the same manner as such 
plan or coverage would treat a drug approved under sec-
tion 505 of the Federal Food, Drug, and Cosmetic Act 
or section 351 of this Act. Nothing in this subsection shall 
be construed to require a group health plan or health in-
surance issuer to cover any specific drug provisionally ap-
proved under such section 524B.’’. 
(2) FEDERAL HEALTH CARE PROGRAMS.—The 
requirement under subsection (e) of section 2719A 
of the Public Health Service Act (as added by para-
graph (1)) shall apply with respect to coverage de-
terminations under a Federal health care program 
(as defined in section 1128B(f) of the Social Secu-
rity Act (42 U.S.C. 1320a–7b(f))) in the same man-
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ner such requirement applies under such subsection 
(e). 
(3) 
CONFORMING
AMENDMENT.—Section 
1927(k)(2)(A)(i) of the Social Security Act (42 
U.S.C. 1396r–8(k)(2)(A)(i)) is amended— 
(A) by striking ‘‘or which’’ and inserting ‘‘, 
which’’; and 
(B) by inserting ‘‘, or which is provision-
ally approved under section 524B of such Act’’ 
before the semicolon. 
SEC. 347. CONSOLIDATING EXCLUSIVITY PERIODS FOR 
DRUGS TREATING RARE DISEASES AND CON-
DITIONS. 
(a) IN GENERAL.—Subsection (a) of section 527 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended to read as follows: 
‘‘(a) EXCLUSIVITY.— 
‘‘(1) IN GENERAL.—Except as provided in sub-
section (b), if the Secretary approves an application 
filed pursuant to section 505, or issues a license 
under section 351 of the Public Health Service Act, 
for a drug designated under section 526 for a rare 
disease or condition, the Secretary may not approve 
an application filed pursuant to section 505, or issue 
a license under section 351 of the Public Health 
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Service Act, for the same drug for the same disease 
or condition for a person who is not the holder of 
such approved application or of such license until 
the expiration of the exclusivity period described in 
paragraph (2). 
‘‘(2) EXCLUSIVITY
PERIOD
DESCRIBED.—The 
exclusivity period described in this paragraph, with 
respect to a drug designated under section 526 for 
a rare disease or condition, is— 
‘‘(A) a single 7-year period of exclusivity 
with respect to the first designation of such 
drug under such section for that rare disease or 
condition; or 
‘‘(B) in the case of a drug that has pre-
viously received a period of exclusivity under 
paragraph (1), a single 3-year period of exclu-
sivity with respect to any subsequent designa-
tion of such drug under such section for any 
other rare disease or condition. 
‘‘(3) LIMITATION.—In the case of a drug that 
has received two periods of exclusivity pursuant to 
paragraph (1), no additional exclusivity period under 
this section is available with respect to such drug, 
regardless of whether such drug has been designated 
under section 526 for a rare disease or condition 
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that is distinct from the rare disease or condition for 
which such exclusivity periods were granted.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 505(j)(5)(B)(iv)(II)(dd)(AA) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended by striking ‘‘7-year period’’ and 
inserting ‘‘exclusivity period’’. 
(2) Section 505A(b)(1)(A)(ii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is 
amended by striking ‘‘rather than seven years;’’ and 
inserting ‘‘, or three years and six months, rather 
than seven years or three years, respectively;’’. 
(3) Section 505A(c)(1)(A)(ii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is 
amended by striking ‘‘rather than seven years;’’ and 
inserting ‘‘, or three years and six months, rather 
than seven years or three years, respectively;’’. 
(4) Section 505E(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360cc) is amended by 
striking ‘‘7-year period’’ and inserting ‘‘exclusivity 
periods’’. 
(5) Section 527(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360cc) is amended by 
striking ‘‘the 7-year period’’ and inserting ‘‘any ex-
clusivity period’’. 
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(6) Section 351(m)(2)(B) of the Public Health 
Service Act (42 U.S.C. 262) is amended by striking 
‘‘rather than 7 years’’ and inserting ‘‘or 3 years and 
6 months, rather than 7 years or 3 years, respec-
tively’’. 
(7) Section 351(m)(3)(B) of the Public Health 
Service Act (42 U.S.C. 262) is amended by striking 
‘‘rather than 7 years’’ and inserting ‘‘or 3 years and 
6 months, rather than 7 years or 3 years, respec-
tively’’. 
SEC. 348. EXCLUSIVITY PERIOD FOR BRAND NAME BIO-
LOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 351(k)(7)(A) of the Pub-
lic Health Service Act (42 U.S.C. 262(k)(7)(A)) is amend-
ed by striking ‘‘12 years’’ and inserting ‘‘5 years’’. 
(b) CONFORMING CHANGES.—Paragraphs (2)(A) and 
(3)(A) of section 351(m) of the Public Health Service Act 
(42 U.S.C. 262(m)) is amended by striking ‘‘12 years’’ 
each place it appears and inserting ‘‘5 years’’. 
(c) APPLICABILITY.—This Act and the amendments 
made by this Act apply only with respect to a biological 
product for which the reference product (as such term is 
used in section 351 of the Public Health Service Act (42 
U.S.C. 262)) is licensed under subsection (a) of such sec-
tion on or after the date of enactment of this Act. 
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SEC. 349. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS. 
Section 351(k)(7) of the Public Health Service Act 
(42 U.S.C. 262(k)(7)) is amended by adding at the end 
the following: 
‘‘(D) DEEMED LICENSES.— 
‘‘(i) NO
ADDITIONAL
EXCLUSIVITY 
THROUGH DEEMING.—An approved appli-
cation that is deemed to be a license for a 
biological product under this section pursu-
ant to section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act of 
2009 shall not be treated as having been 
first licensed under subsection (a) for pur-
poses of subparagraphs (A) and (B). 
‘‘(ii) APPLICATION
OF
LIMITATIONS 
ON EXCLUSIVITY.—Subparagraph (C) shall 
apply with respect to a reference product 
referred to in such subparagraph that was 
the subject of an approved application that 
was deemed to be a license pursuant to 
section 7002(e)(4) of the Biologics Price 
Competition and Innovation Act of 2009. 
‘‘(iii) 
APPLICABILITY.—The 
exclu-
sivity periods described in section 527, sec-
tion 
505A(b)(1)(A)(ii), 
and 
section 
505A(c)(1)(A)(ii) of the Federal Food, 
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Drug, and Cosmetic Act shall continue to 
apply to a biological product after an ap-
proved application for the biological prod-
uct is deemed to be a license for the bio-
logical product under subsection (a) pursu-
ant to section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act of 
2009.’’. 
SEC. 350. STREAMLINING THE TRANSITION OF BIOLOGICAL 
PRODUCTS. 
Section 7002(e)(4) of the Biologics Price Competition 
and Innovation Act of 2009 (Public Law 111–148) is 
amended by adding at the end the following: ‘‘With respect 
to an application for a biological product submitted under 
section 505(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(b)) with a filing date that is not later 
than September 23, 2019, and that does not receive final 
approval on or before March 23, 2020, such application 
shall be deemed to be withdrawn and the Secretary shall 
refund the fee paid under section 736(a)(1)(B) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(a)(1)(B)). Notwithstanding any such withdrawal of 
the drug application, the Secretary shall consider any pre-
viously conducted scientific review and accelerate review 
of any such subsequent application with respect to such 
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315 
biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262). The Secretary shall provide 
additional assistance to the sponsor or manufacturer of 
such application.’’. 
SEC. 351. REGULATION OF MANUFACTURER-SPONSORED 
COPAY CONTRIBUTIONS. 
Notwithstanding any other provision of law, the Sec-
retary of Health and Human Services may establish a 
mechanism to regulate drug manufacturers’ financial con-
tributions to patient out-of-pocket costs, such as drug co- 
pays. 
SEC. 352. ANTITRUST EXEMPTION FOR PRIVATE HEALTH 
INSURER ISSUERS TO NEGOTIATE WHOLE-
SALE ACQUISITION PRICES OF PRESCRIP-
TION DRUGS PURCHASED FROM DRUG MANU-
FACTURERS. 
(a) EXEMPTION.—It shall not be a violation of the 
antitrust laws for one or more private health insurer 
issuers or their designated agents to jointly negotiate 
wholesale acquisition prices of a prescription drug with a 
manufacturer of a prescription drug with regards to the 
reimbursement policies of the insurers of the manufactur-
er’s drugs so long as no one single wholesale acquisition 
price is jointly determined between the insurance issuers 
or their designated agents. 
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(b) DEFINITIONS.—For purposes of this section: 
(1) ANTITRUST
LAWS.—The term ‘‘antitrust 
laws’’ has the meaning given it in subsection (a) of 
the 1st section of the Clayton Act (15 U.S.C. 12(a)), 
except that such term includes section 5 of the Fed-
eral Trade Commission Act (15 U.S.C. 45) to the 
extent such section 5 applies to unfair methods of 
competition. 
(2) HEALTH
INSURANCE
ISSUER.—The term 
‘‘health insurance issuer’’ means an insurance com-
pany, insurance service, or insurance organization 
(including a health maintenance organization, as de-
fined in subparagraph (C)) which is licensed to en-
gage in the business of insurance in a State and 
which is subject to State law which regulates insur-
ance (within the meaning of section 514(b)(2) of the 
Employee Retirement Income Security Act of 1974 
(29 U.S.C. 1144(b)(2))). Such term does not include 
a group health plan. 
(3) HEALTH MAINTENANCE ORGANIZATION.— 
The 
term 
‘‘health 
maintenance 
organization’’ 
means— 
(A) a Federally qualified health mainte-
nance organization (as defined in section 
300e(a) of title 42 of the United States Code), 
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(B) an organization recognized under State 
law as a health maintenance organization, or 
(C) a similar organization regulated under 
State law for solvency in the same manner and 
to the same extent as such a health mainte-
nance organization. 
(4) MANUFACTURER.—The term ‘‘manufac-
turer’’ means anyone who is engaged in manufac-
turing, preparing, propagating, compounding, proc-
essing, packaging, repackaging, or labeling of a pre-
scription drug. 
(5) PRESCRIPTION DRUG.—The term ‘‘prescrip-
tion drug’’ means any human drug required by Fed-
eral law or regulation to be dispensed only by a pre-
scription, including finished dosage forms and active 
ingredients subject to section 503(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)). 
(c) EFFECTIVE DATE.—This section shall take effect 
on the date of the enactment of this Act but shall not 
apply with respect to conduct that occurs before such date. 
SEC. 353. BIOLOGICAL PRODUCT INNOVATION. 
Section 351(j) of the Public Health Service Act (42 
U.S.C. 262(j)) is amended— 
(1) by striking ‘‘except that a product’’ and in-
serting ‘‘except that— 
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‘‘(1) a product’’; 
(2) by striking ‘‘Act.’’ and inserting ‘‘Act; and’’; 
and 
(3) by adding at the end the following: 
‘‘(2) no requirement under such Act regarding 
an official compendium (as defined in section 201(j) 
of such Act), or other reference in such Act to an 
official compendium (as so defined), shall apply with 
respect to a biological product subject to regulation 
under this section.’’. 
SEC. 354. CLARIFYING THE MEANING OF NEW CHEMICAL 
ENTITY. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended— 
(1) in section 505 (21 U.S.C. 355)— 
(A) in subsection (c)(3)(E), by striking 
‘‘active ingredient (including any ester or salt of 
the active ingredient)’’ each place it appears 
and inserting ‘‘active moiety (as defined by the 
Secretary in section 314.3 of title 21, Code of 
Federal Regulations (or any successor regula-
tions))’’; 
(B) in subsection (j)(5)(F), by striking 
‘‘active ingredient (including any ester or salt of 
the active ingredient)’’ each place it appears 
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and inserting ‘‘active moiety (as defined by the 
Secretary in section 314.3 of title 21, Code of 
Federal Regulations (or any successor regula-
tions))’’; 
(C) in subsection (l)(2)(A)— 
(i) by amending clause (i) to read as 
follows: 
‘‘(i) not later than 30 days after the date 
of approval of such applications— 
‘‘(I) for a drug, no active moiety (as 
defined by the Secretary in section 314.3 
of title 21, Code of Federal Regulations (or 
any successor regulations)) of which has 
been approved in any other application 
under this section; or 
‘‘(II) for a biological product, no ac-
tive ingredient of which has been approved 
in any other application under section 351 
of the Public Health Service Act; and’’; 
and 
(ii) in clause (ii), by inserting ‘‘or bio-
logical product’’ before the period; 
(D) by amending subsection (s) to read as 
follows: 
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‘‘(s) REFERRAL
TO ADVISORY COMMITTEE.—The 
Secretary shall— 
‘‘(1) refer a drug or biological product to a 
Food and Drug Administration advisory committee 
for review at a meeting of such advisory committee 
prior to the approval of such drug or biological if it 
is— 
‘‘(A) a drug, no active moiety (as defined 
by the Secretary in section 314.3 of title 21, 
Code of Federal Regulations (or any successor 
regulations)) of which has been approved in any 
other application under this section; or 
‘‘(B) a biological product, no active ingre-
dient of which has been approved in any other 
application under section 351 of the Public 
Health Service Act; or 
‘‘(2) if the Secretary does not refer a drug or 
biological product described in paragraph (1) to a 
Food and Drug Administration advisory committee 
prior to such approval, provide in the action letter 
on the application for the drug or biological product 
a summary of the reasons why the Secretary did not 
refer the drug or biological product to an advisory 
committee prior to approval.’’; and 
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(E) in subsection (u)(1), in the matter pre-
ceding subparagraph (A)— 
(i) by striking ‘‘active ingredient (in-
cluding any ester or salt of the active in-
gredient)’’ and inserting ‘‘active moiety (as 
defined by the Secretary in section 314.3 
of title 21, Code of Federal Regulations (or 
any successor regulations))’’; and 
(ii) by striking ‘‘same active ingre-
dient’’ and inserting ‘‘same active moiety’’; 
(2) 
in 
section 
512(c)(2)(F) 
(21 
U.S.C. 
360b(c)(2)(F)), by striking ‘‘active ingredient (in-
cluding any ester or salt of the active ingredient)’’ 
each place it appears and inserting ‘‘active moiety 
(as defined by the Secretary in section 314.3 of title 
21, Code of Federal Regulations (or any successor 
regulations))’’; 
(3) 
in 
section 
524(a)(4) 
(21 
U.S.C. 
360n(a)(4)), by amending subparagraph (C) to read 
as follows: 
‘‘(C) is for— 
‘‘(i) a human drug, no active moiety 
(as defined by the Secretary in section 
314.3 of title 21, Code of Federal Regula-
tions (or any successor regulations)) of 
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which has been approved in any other ap-
plication under section 505(b)(1); or 
‘‘(ii) a biological product, no active in-
gredient of which has been approved in any 
other application under section 351 of the 
Public Health Service Act.’’; 
(4) 
in 
section 
529(a)(4) 
(21 
U.S.C. 
360ff(a)(4)), by striking subparagraphs (A) and (B) 
and inserting the following: 
‘‘(A) is for a drug or biological product 
that is for the prevention or treatment of a rare 
pediatric disease; 
‘‘(B)(i) is for such a drug— 
‘‘(I) that contains no active moiety (as 
defined by the Secretary in section 314.3 
of title 21, Code of Federal Regulations (or 
any successor regulations)) that has been 
previously approved in any other applica-
tion under subsection (b)(1), (b)(2), or (j) 
of section 505; and 
‘‘(II) that is the subject of an applica-
tion submitted under section 505(b)(1); or 
‘‘(ii) or is for such a biological product— 
‘‘(I) that contains no active ingredient 
that has been previously approved in any 
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other application under section 351(a) or 
351(k) of the Public Health Service Act; 
and 
‘‘(II) that is the subject of an applica-
tion submitted under section 351(a) of the 
Public Health Service Act;’’; and 
(5) in section 565A(a)(4) (21 U.S.C. 360bbb– 
4a(a)(4)), by amending subparagraph (D) to read as 
follows: 
‘‘(D) is for— 
‘‘(i) a human drug, no active moiety 
(as defined by the Secretary in section 
314.3 of title 21, Code of Federal Regula-
tions (or any successor regulations)) of 
which has been approved in any other ap-
plication under section 505(b)(1); or 
‘‘(ii) a biological product, no active in-
gredient of which has been approved in any 
other application under section 351 of the 
Public Health Service Act.’’. 
(b) TECHNICAL CORRECTIONS.—Chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended— 
(1) in section 505 (21 U.S.C. 355)— 
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(A) in subsection (c)(3)(E), by repealing 
clause (i); and 
(B) in subsection (j)(5)(F), by repealing 
clause (i); and 
(2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 
355a(c)(1)(A)(i)), by striking ‘‘(c)(3)(D)’’ and in-
serting ‘‘(c)(3)(E)’’. 
SEC. 355. PROMPT APPROVAL OF DRUGS RELATED TO 
SAFETY INFORMATION. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the 
following: 
‘‘(z) PROMPT APPROVAL OF DRUGS WHEN SAFETY 
INFORMATION IS ADDED TO LABELING.— 
‘‘(1) GENERAL RULE.—A drug for which an ap-
plication has been submitted or approved under sub-
section (b)(2) or (j) shall not be considered ineligible 
for approval under this section or misbranded under 
section 502 on the basis that the labeling of the 
drug omits safety information, including contra-
indications, warnings, precautions, dosing, adminis-
tration, or other information pertaining to safety, 
when the omitted safety information is protected by 
exclusivity under clause (iii) or (iv) of subsection 
(j)(5)(F), clause (iii) or (iv) of subsection (c)(3)(E), 
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or section 527(a), or by an extension of such exclu-
sivity under section 505A or 505E. 
‘‘(2) LABELING.—Notwithstanding clauses (iii) 
and (iv) of subsection (j)(5)(F), clauses (iii) and (iv) 
of subsection (c)(3)(E), or section 527, the Sec-
retary shall require that the labeling of a drug ap-
proved pursuant to an application submitted under 
subsection (b)(2) or (j) that omits safety information 
described in paragraph (1) include a statement of 
any appropriate safety information that the Sec-
retary considers necessary to assure safe use. 
‘‘(3) AVAILABILITY
AND
SCOPE
OF
EXCLU-
SIVITY.—This subsection does not affect— 
‘‘(A) the availability or scope of exclusivity 
or an extension of exclusivity described in sub-
paragraph (A) or (B) of section 505A(o)(3); 
‘‘(B) the question of the eligibility for ap-
proval under this section of any application de-
scribed in subsection (b)(2) or (j) that omits 
any other aspect of labeling protected by exclu-
sivity under— 
‘‘(i) clause (iii) or (iv) of subsection 
(j)(5)(F); 
‘‘(ii) clause (iii) or (iv) of subsection 
(c)(3)(E); or 
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‘‘(iii) section 527(a); or 
‘‘(C) except as expressly provided in para-
graphs (1) and (2), the operation of this section 
or section 527.’’. 
SEC. 356. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGI-
CAL PRODUCTS. 
Section 351(k)(2)(A)(iii) of the Public Health Service 
Act (42 U.S.C. 262(k)(2)(A)(iii)) is amended— 
(1) in subclause (I), by striking ‘‘; and’’ and in-
serting a semicolon; 
(2) in subclause (II), by striking the period and 
inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(III) may include information to 
show that the conditions of use pre-
scribed, recommended, or suggested in 
the labeling proposed for the biological 
product have been previously approved 
for the reference product.’’. 
SEC. 357. EDUCATION ON BIOLOGICAL PRODUCTS. 
Subpart 1 of part F of title III of the Public Health 
Service Act (42 U.S.C. 262 et seq.) is amended by adding 
at the end the following: 
‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 
‘‘(a) INTERNET WEBSITE.— 
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‘‘(1) IN GENERAL.—The Secretary may main-
tain and operate an internet website to provide edu-
cational materials for health care providers, patients, 
and caregivers, regarding the meaning of the terms, 
and the standards for review and licensing of, bio-
logical products, including biosimilar biological prod-
ucts and interchangeable biosimilar biological prod-
ucts. 
‘‘(2) CONTENT.—Educational materials pro-
vided under paragraph (1) may include— 
‘‘(A) explanations of key statutory and 
regulatory terms, including ‘biosimilar’ and 
‘interchangeable’, and clarification regarding 
the use of interchangeable biosimilar biological 
products; 
‘‘(B) information related to development 
programs for biological products, including bio-
similar biological products and interchangeable 
biosimilar biological products and relevant clin-
ical considerations for prescribers, which may 
include, as appropriate and applicable, informa-
tion related to the comparability of such biologi-
cal products; 
‘‘(C) an explanation of the process for re-
porting adverse events for biological products, 
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including biosimilar biological products and 
interchangeable biosimilar biological products; 
and 
‘‘(D) an explanation of the relationship be-
tween biosimilar biological products and inter-
changeable biosimilar biological products li-
censed under section 351(k) and reference 
products (as defined in section 351(i)), includ-
ing the standards for review and licensing of 
each such type of biological product. 
‘‘(3) FORMAT.—The educational materials pro-
vided under paragraph (1) may be— 
‘‘(A) in formats such as webinars, con-
tinuing medical education modules, videos, fact 
sheets, infographics, stakeholder toolkits, or 
other formats as appropriate and applicable; 
and 
‘‘(B) tailored for the unique needs of 
health care providers, patients, caregivers, and 
other audiences, as the Secretary determines 
appropriate. 
‘‘(4) OTHER INFORMATION.—In addition to the 
information described in paragraph (2), the Sec-
retary shall continue to publish the following infor-
mation: 
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‘‘(A) The action package of each biological 
product licensed under subsection (a) or (k). 
‘‘(B) The summary review of each biologi-
cal product licensed under subsection (a) or (k). 
‘‘(5) CONFIDENTIAL AND TRADE SECRET IN-
FORMATION.—This subsection does not authorize 
the disclosure of any trade secret, confidential com-
mercial or financial information, or other matter de-
scribed in section 552(b) of title 5. 
‘‘(b) CONTINUING EDUCATION.—The Secretary shall 
advance education and awareness among health care pro-
viders regarding biological products, including biosimilar 
biological products and interchangeable biosimilar biologi-
cal products, as appropriate, including by developing or 
improving continuing medical education programs that ad-
vance the education of such providers on the prescribing 
of, and relevant clinical considerations with respect to, bio-
logical products, including biosimilar biological products 
and interchangeable biosimilar biological products.’’. 
SEC. 358. CONGRESSIONAL REVIEW OF THE FOOD AND 
DRUG ADMINISTRATION RULEMAKING. 
(a) CONGRESSIONAL REVIEW.—Part I of title 5, 
United States Code, is amended by adding at the end the 
following: 
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‘‘CHAPTER 10—CONGRESSIONAL REVIEW 
OF FOOD AND DRUG ADMINISTRATION 
RULEMAKING 
‘‘Sec. 
‘‘920. Applicability. 
‘‘921. Congressional review. 
‘‘922. Congressional approval procedure for major rules. 
‘‘923. Congressional disapproval procedure for nonmajor rules. 
‘‘924. Definitions. 
‘‘925. Judicial review. 
‘‘926. Exemption for monetary policy. 
‘‘927. Effective date of certain rules. 
‘‘928. Regulatory cut-go requirement. 
‘‘929. Review of rules currently in effect. 
‘‘§ 920. Applicability 
‘‘This chapter applies in lieu of chapter 8 with respect 
to the Food and Drug Administration. 
‘‘§ 921. Congressional review 
‘‘(a)(1)(A) Before a rule may take effect, the Food 
and Drug Administration shall satisfy the requirements 
of section 928 and shall publish in the Federal Register 
a list of information on which the rule is based, including 
data, scientific and economic studies, and cost-benefit 
analyses, and identify how the public can access such in-
formation online, and shall submit to each House of the 
Congress and to the Comptroller General a report con-
taining— 
‘‘(i) a copy of the rule; 
‘‘(ii) a concise general statement relating to the 
rule; 
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‘‘(iii) a classification of the rule as a major or 
nonmajor rule, including an explanation of the clas-
sification specifically addressing each criteria for a 
major rule contained within sections 924(2)(A), 
924(2)(B), and 924(2)(C); 
‘‘(iv) a list of any other related regulatory ac-
tions intended to implement the same statutory pro-
vision or regulatory objective as well as the indi-
vidual and aggregate economic effects of those ac-
tions; and 
‘‘(v) the proposed effective date of the rule. 
‘‘(B) On the date of the submission of the report 
under subparagraph (A), the Food and Drug Administra-
tion shall submit to the Comptroller General and make 
available to each House of Congress— 
‘‘(i) a complete copy of the cost-benefit analysis 
of the rule, if any, including an analysis of any jobs 
added or lost, differentiating between public and pri-
vate sector jobs; 
‘‘(ii) the Food and Drug Administration’s ac-
tions pursuant to sections 603, 604, 605, 607, and 
609 of this title; 
‘‘(iii) the Food and Drug Administration’s ac-
tions pursuant to sections 202, 203, 204, and 205 
of the Unfunded Mandates Reform Act of 1995; and 
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‘‘(iv) any other relevant information or require-
ments under any other Act and any relevant Execu-
tive orders. 
‘‘(C) Upon receipt of a report submitted under sub-
paragraph (A), each House shall provide copies of the re-
port to the chairman and ranking member of each stand-
ing committee with jurisdiction under the rules of the 
House of Representatives or the Senate to report a bill 
to amend the provision of law under which the rule is 
issued. 
‘‘(2)(A) The Comptroller General shall provide a re-
port on each major rule to the committees of jurisdiction 
by the end of 15 calendar days after the submission or 
publication date. The report of the Comptroller General 
shall include an assessment of the Food and Drug Admin-
istration’s compliance with procedural steps required by 
paragraph (1)(B) and an assessment of whether the major 
rule imposes any new limits or mandates on private-sector 
activity. 
‘‘(B) The Food and Drug Administration shall co-
operate with the Comptroller General by providing infor-
mation relevant to the Comptroller General’s report under 
subparagraph (A). 
‘‘(3) A major rule relating to a report submitted 
under paragraph (1) shall take effect upon enactment of 
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a joint resolution of approval described in section 922 or 
as provided for in the rule following enactment of a joint 
resolution of approval described in section 922, whichever 
is later. 
‘‘(4) A nonmajor rule shall take effect as provided 
by section 923 after submission to Congress under para-
graph (1). 
‘‘(5) If a joint resolution of approval relating to a 
major rule is not enacted within the period provided in 
subsection (b)(2), then a joint resolution of approval relat-
ing to the same rule may not be considered under this 
chapter in the same Congress by either the House of Rep-
resentatives or the Senate. 
‘‘(b)(1) A major rule shall not take effect unless the 
Congress enacts a joint resolution of approval described 
under section 922. 
‘‘(2) If a joint resolution described in subsection (a) 
is not enacted into law by the end of 70 session days or 
legislative days, as applicable, beginning on the date on 
which the report referred to in section 921(a)(1)(A) is re-
ceived by Congress (excluding days either House of Con-
gress is adjourned for more than 3 days during a session 
of Congress), then the rule described in that resolution 
shall be deemed not to be approved and such rule shall 
not take effect. 
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‘‘(c)(1) Notwithstanding any other provision of this 
section (except subject to paragraph (3)), a major rule 
may take effect for one 90-calendar-day period if the 
President makes a determination under paragraph (2) and 
submits written notice of such determination to the Con-
gress. 
‘‘(2) Paragraph (1) applies to a determination made 
by the President by Executive order that the major rule 
should take effect because such rule is— 
‘‘(A) necessary because of an imminent threat 
to health or safety or other emergency; 
‘‘(B) necessary for the enforcement of criminal 
laws; 
‘‘(C) necessary for national security; or 
‘‘(D) issued pursuant to any statute imple-
menting an international trade agreement. 
‘‘(3) An exercise by the President of the authority 
under this subsection shall have no effect on the proce-
dures under section 922. 
‘‘(d)(1) In addition to the opportunity for review oth-
erwise provided under this chapter, in the case of any rule 
for which a report was submitted in accordance with sub-
section (a)(1)(A) during the period beginning on the date 
occurring— 
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‘‘(A) in the case of the Senate, 60 session days; 
or 
‘‘(B) in the case of the House of Representa-
tives, 60 legislative days, 
before the date the Congress is scheduled to adjourn a 
session of Congress through the date on which the same 
or succeeding Congress first convenes its next session, sec-
tions 922 and 923 shall apply to such rule in the suc-
ceeding session of Congress. 
‘‘(2)(A) In applying sections 922 and 923 for pur-
poses of such additional review, a rule described under 
paragraph (1) shall be treated as though— 
‘‘(i) such rule were published in the Federal 
Register on— 
‘‘(I) in the case of the Senate, the 15th 
session day; or 
‘‘(II) in the case of the House of Rep-
resentatives, the 15th legislative day, 
after the succeeding session of Congress first con-
venes; and 
‘‘(ii) a report on such rule were submitted to 
Congress under subsection (a)(1) on such date. 
‘‘(B) Nothing in this paragraph shall be construed 
to affect the requirement under subsection (a)(1) that a 
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report shall be submitted to Congress before a rule can 
take effect. 
‘‘(3) A rule described under paragraph (1) shall take 
effect as otherwise provided by law (including other sub-
sections of this section). 
‘‘§ 922. Congressional approval procedure for major 
rules 
‘‘(a)(1) For purposes of this section, the term ‘joint 
resolution’ means only a joint resolution addressing a re-
port classifying a rule as major pursuant to section 
921(a)(1)(A)(iii) that— 
‘‘(A) bears no preamble; 
‘‘(B) bears the following title (with blanks filled 
as appropriate): ‘Approving the rule submitted by 
lll relating to lll.’; 
‘‘(C) includes after its resolving clause only the 
following (with blanks filled as appropriate): ‘That 
Congress approves the rule submitted by lll re-
lating to lll.’; and 
‘‘(D) is introduced pursuant to paragraph (2). 
‘‘(2) After a House of Congress receives a report 
classifying a rule as major pursuant to section 
921(a)(1)(A)(iii), the majority leader of that House (or 
his or her respective designee) shall introduce (by request, 
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if appropriate) a joint resolution described in paragraph 
(1)— 
‘‘(A) in the case of the House of Representa-
tives, within 3 legislative days; and 
‘‘(B) in the case of the Senate, within 3 session 
days. 
‘‘(3) A joint resolution described in paragraph (1) 
shall not be subject to amendment at any stage of pro-
ceeding. 
‘‘(b) A joint resolution described in subsection (a) 
shall be referred in each House of Congress to the commit-
tees having jurisdiction over the provision of law under 
which the rule is issued. 
‘‘(c) In the Senate, if the committee or committees 
to which a joint resolution described in subsection (a) has 
been referred have not reported it at the end of 15 session 
days after its introduction, such committee or committees 
shall be automatically discharged from further consider-
ation of the resolution and it shall be placed on the cal-
endar. A vote on final passage of the resolution shall be 
taken on or before the close of the 15th session day after 
the resolution is reported by the committee or committees 
to which it was referred, or after such committee or com-
mittees have been discharged from further consideration 
of the resolution. 
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‘‘(d)(1) In the Senate, when the committee or com-
mittees to which a joint resolution is referred have re-
ported, or when a committee or committees are discharged 
(under subsection (c)) from further consideration of a 
joint resolution described in subsection (a), it is at any 
time thereafter in order (even though a previous motion 
to the same effect has been disagreed to) for a motion 
to proceed to the consideration of the joint resolution, and 
all points of order against the joint resolution (and against 
consideration of the joint resolution) are waived. The mo-
tion is not subject to amendment, or to a motion to post-
pone, or to a motion to proceed to the consideration of 
other business. A motion to reconsider the vote by which 
the motion is agreed to or disagreed to shall not be in 
order. If a motion to proceed to the consideration of the 
joint resolution is agreed to, the joint resolution shall re-
main the unfinished business of the Senate until disposed 
of. 
‘‘(2) In the Senate, debate on the joint resolution, 
and on all debatable motions and appeals in connection 
therewith, shall be limited to not more than 2 hours, which 
shall be divided equally between those favoring and those 
opposing the joint resolution. A motion to further limit 
debate is in order and not debatable. An amendment to, 
or a motion to postpone, or a motion to proceed to the 
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consideration of other business, or a motion to recommit 
the joint resolution is not in order. 
‘‘(3) In the Senate, immediately following the conclu-
sion of the debate on a joint resolution described in sub-
section (a), and a single quorum call at the conclusion of 
the debate if requested in accordance with the rules of the 
Senate, the vote on final passage of the joint resolution 
shall occur. 
‘‘(4) Appeals from the decisions of the Chair relating 
to the application of the rules of the Senate to the proce-
dure relating to a joint resolution described in subsection 
(a) shall be decided without debate. 
‘‘(e) In the House of Representatives, if any com-
mittee to which a joint resolution described in subsection 
(a) has been referred has not reported it to the House 
at the end of 15 legislative days after its introduction, 
such committee shall be discharged from further consider-
ation of the joint resolution, and it shall be placed on the 
appropriate calendar. On the second and fourth Thursdays 
of each month it shall be in order at any time for the 
Speaker to recognize a Member who favors passage of a 
joint resolution that has appeared on the calendar for at 
least 5 legislative days to call up that joint resolution for 
immediate consideration in the House without intervention 
of any point of order. When so called up a joint resolution 
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shall be considered as read and shall be debatable for 1 
hour equally divided and controlled by the proponent and 
an opponent, and the previous question shall be considered 
as ordered to its passage without intervening motion. It 
shall not be in order to reconsider the vote on passage. 
If a vote on final passage of the joint resolution has not 
been taken by the third Thursday on which the Speaker 
may recognize a Member under this subsection, such vote 
shall be taken on that day. 
‘‘(f)(1) If, before passing a joint resolution described 
in subsection (a), one House receives from the other a 
joint resolution having the same text, then— 
‘‘(A) the joint resolution of the other House 
shall not be referred to a committee; and 
‘‘(B) the procedure in the receiving House shall 
be the same as if no joint resolution had been re-
ceived from the other House until the vote on pas-
sage, when the joint resolution received from the 
other House shall supplant the joint resolution of 
the receiving House. 
‘‘(2) This subsection shall not apply to the House of 
Representatives if the joint resolution received from the 
Senate is a revenue measure. 
‘‘(g) If either House has not taken a vote on final 
passage of the joint resolution by the last day of the period 
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341 
described in section 921(b)(2), then such vote shall be 
taken on that day. 
‘‘(h) This section and section 923 are enacted by 
Congress— 
‘‘(1) as an exercise of the rulemaking power of 
the Senate and House of Representatives, respec-
tively, and as such is deemed to be part of the rules 
of each House, respectively, but applicable only with 
respect to the procedure to be followed in that 
House in the case of a joint resolution described in 
subsection (a) and superseding other rules only 
where explicitly so; and 
‘‘(2) with full recognition of the Constitutional 
right of either House to change the rules (so far as 
they relate to the procedure of that House) at any 
time, in the same manner and to the same extent as 
in the case of any other rule of that House. 
‘‘§ 923. 
Congressional 
disapproval 
procedure 
for 
nonmajor rules 
‘‘(a) For purposes of this section, the term ‘joint res-
olution’ means only a joint resolution introduced in the 
period beginning on the date on which the report referred 
to in section 921(a)(1)(A) is received by Congress and 
ending 60 days thereafter (excluding days either House 
of Congress is adjourned for more than 3 days during a 
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342 
session of Congress), the matter after the resolving clause 
of which is as follows: ‘That Congress disapproves the 
nonmajor rule submitted by the lll relating to 
lll, and such rule shall have no force or effect.’ (The 
blank spaces being appropriately filled in). 
‘‘(b) A joint resolution described in subsection (a) 
shall be referred to the committees in each House of Con-
gress with jurisdiction. 
‘‘(c) In the Senate, if the committee to which is re-
ferred a joint resolution described in subsection (a) has 
not reported such joint resolution (or an identical joint 
resolution) at the end of 15 session days after the date 
of introduction of the joint resolution, such committee may 
be discharged from further consideration of such joint res-
olution upon a petition supported in writing by 30 Mem-
bers of the Senate, and such joint resolution shall be 
placed on the calendar. 
‘‘(d)(1) In the Senate, when the committee to which 
a joint resolution is referred has reported, or when a com-
mittee is discharged (under subsection (c)) from further 
consideration of a joint resolution described in subsection 
(a), it is at any time thereafter in order (even though a 
previous motion to the same effect has been disagreed to) 
for a motion to proceed to the consideration of the joint 
resolution, and all points of order against the joint resolu-
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tion (and against consideration of the joint resolution) are 
waived. The motion is not subject to amendment, or to 
a motion to postpone, or to a motion to proceed to the 
consideration of other business. A motion to reconsider the 
vote by which the motion is agreed to or disagreed to shall 
not be in order. If a motion to proceed to the consideration 
of the joint resolution is agreed to, the joint resolution 
shall remain the unfinished business of the Senate until 
disposed of. 
‘‘(2) In the Senate, debate on the joint resolution, 
and on all debatable motions and appeals in connection 
therewith, shall be limited to not more than 10 hours, 
which shall be divided equally between those favoring and 
those opposing the joint resolution. A motion to further 
limit debate is in order and not debatable. An amendment 
to, or a motion to postpone, or a motion to proceed to 
the consideration of other business, or a motion to recom-
mit the joint resolution is not in order. 
‘‘(3) In the Senate, immediately following the conclu-
sion of the debate on a joint resolution described in sub-
section (a), and a single quorum call at the conclusion of 
the debate if requested in accordance with the rules of the 
Senate, the vote on final passage of the joint resolution 
shall occur. 
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344 
‘‘(4) Appeals from the decisions of the Chair relating 
to the application of the rules of the Senate to the proce-
dure relating to a joint resolution described in subsection 
(a) shall be decided without debate. 
‘‘(e) In the Senate, the procedure specified in sub-
section (c) or (d) shall not apply to the consideration of 
a joint resolution respecting a nonmajor rule— 
‘‘(1) after the expiration of the 60 session days 
beginning with the applicable submission or publica-
tion date; or 
‘‘(2) if the report under section 921(a)(1)(A) 
was submitted during the period referred to in sec-
tion 921(d)(1), after the expiration of the 60 session 
days beginning on the 15th session day after the 
succeeding session of Congress first convenes. 
‘‘(f) If, before the passage by one House of a joint 
resolution of that House described in subsection (a), that 
House receives from the other House a joint resolution 
described in subsection (a), then the following procedures 
shall apply: 
‘‘(1) The joint resolution of the other House 
shall not be referred to a committee. 
‘‘(2) With respect to a joint resolution described 
in subsection (a) of the House receiving the joint 
resolution— 
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‘‘(A) the procedure in that House shall be 
the same as if no joint resolution had been re-
ceived from the other House; but 
‘‘(B) the vote on final passage shall be on 
the joint resolution of the other House. 
‘‘§ 924. Definitions 
‘‘For purposes of this chapter: 
‘‘(1) The term ‘major rule’ means any rule of 
the Food and Drug Administration, including an in-
terim final rule, that the Administrator of the Office 
of Information and Regulatory Affairs of the Office 
of Management and Budget finds has resulted in or 
is likely to result in— 
‘‘(A) an annual cost on the economy of 
$100,000,000 or more, adjusted annually for 
inflation; 
‘‘(B) a major increase in costs or prices for 
consumers, 
individual 
industries, 
Federal, 
State, or local government agencies, or geo-
graphic regions; or 
‘‘(C) significant adverse effects on competi-
tion, employment, investment, productivity, in-
novation, or on the ability of United States- 
based enterprises to compete with foreign-based 
enterprises in domestic and export markets. 
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346 
‘‘(2) The term ‘nonmajor rule’ means any rule 
of the Food and Drug Administration that is not a 
major rule. 
‘‘(3) The term ‘rule’ has the meaning given 
such term in section 551, except that such term does 
not include— 
‘‘(A) any rule of particular applicability; 
‘‘(B) any rule relating to agency manage-
ment or personnel; or 
‘‘(C) any rule of agency organization, pro-
cedure, or practice that does not substantially 
affect the rights or obligations of non-agency 
parties. 
‘‘(4) The term ‘submission date or publication 
date’, except as otherwise provided in this chapter, 
means— 
‘‘(A) in the case of a major rule, the date 
on which the Congress receives the report sub-
mitted under section 921(a)(1); and 
‘‘(B) in the case of a nonmajor rule, the 
later of— 
‘‘(i) the date on which the Congress 
receives the report submitted under section 
921(a)(1); and 
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‘‘(ii) the date on which the nonmajor 
rule is published in the Federal Register, if 
so published. 
‘‘§ 925. Judicial review 
‘‘(a) No determination, finding, action, or omission 
under this chapter shall be subject to judicial review. 
‘‘(b) Notwithstanding subsection (a), a court may de-
termine whether the Food and Drug Administration has 
completed the necessary requirements under this chapter 
for a rule to take effect. 
‘‘(c) The enactment of a joint resolution of approval 
under section 922 shall not be interpreted to serve as a 
grant or modification of statutory authority by Congress 
for the promulgation of a rule, shall not extinguish or af-
fect any claim, whether substantive or procedural, against 
any alleged defect in a rule, and shall not form part of 
the record before the court in any judicial proceeding con-
cerning a rule except for purposes of determining whether 
or not the rule is in effect. 
‘‘§ 926. Exemption for monetary policy 
‘‘Nothing in this chapter shall apply to rules that con-
cern monetary policy proposed or implemented by the 
Board of Governors of the Federal Reserve System or the 
Federal Open Market Committee. 
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348 
‘‘§ 927. Effective date of certain rules 
‘‘Notwithstanding section 921, any rule other than a 
major rule which the Food and Drug Administration for 
good cause finds (and incorporates the finding and a brief 
statement of reasons therefore in the rule issued) that no-
tice and public procedure thereon are impracticable, un-
necessary, or contrary to the public interest, shall take ef-
fect at such time as the Food and Drug Administration 
determines. 
‘‘§ 928. Regulatory cut-go requirement 
‘‘In making any new rule, the Food and Drug Admin-
istration shall identify a rule or rules that may be amend-
ed or repealed to completely offset any annual costs of 
the new rule to the United States economy. Before the 
new rule may take effect, the Food and Drug Administra-
tion shall make each such repeal or amendment. In mak-
ing such an amendment or repeal, the Food and Drug Ad-
ministration shall comply with the requirements of sub-
chapter II of chapter 5, but the Food and Drug Adminis-
tration may consolidate proceedings under subchapter II 
(of chapter 5) with proceedings on the new rule. 
‘‘§ 929. Review of rules currently in effect 
‘‘(a) ANNUAL REVIEW.—Beginning on the date that 
is 6 months after the date of enactment of this section 
and annually thereafter for the 9 years following, the Food 
and Drug Administration shall designate not less than 10 
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349 
percent of eligible rules made by the Food and Drug Ad-
ministration for review, and shall submit a report includ-
ing each such eligible rule in the same manner as a report 
under section 921(a)(1). Section 921, section 922, and 
section 923 shall apply to each such rule, subject to sub-
section (c) of this section. No eligible rule previously des-
ignated may be designated again. 
‘‘(b) SUNSET
FOR
ELIGIBLE
RULES
NOT
EX-
TENDED.—Beginning after the date that is 10 years after 
the date of enactment of this section, if Congress has not 
enacted a joint resolution of approval for that eligible rule, 
that eligible rule shall not continue in effect. 
‘‘(c) CONSOLIDATION; SEVERABILITY.—In applying 
sections 921, 922, and 923 to eligible rules under this sec-
tion, the following shall apply: 
‘‘(1) The words ‘take effect’ shall be read as 
‘continue in effect’. 
‘‘(2) Except as provided in paragraph (3), a 
single joint resolution of approval shall apply to all 
eligible rules in a report designated for a year, and 
the matter after the resolving clause of that joint 
resolution is as follows: ‘That Congress approves the 
rules submitted by the ll for the year ll.’ (The 
blank spaces being appropriately filled in). 
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350 
‘‘(3) It shall be in order to consider any amend-
ment that provides for specific conditions on which 
the approval of a particular eligible rule included in 
the joint resolution is contingent. 
‘‘(4) A member of either House may move that 
a separate joint resolution be required for a specified 
rule. 
‘‘(d) DEFINITION.—In this section, the term ‘eligible 
rule’ means a rule that is in effect as of the date of enact-
ment of this section.’’. 
(b) BUDGETARY EFFECTS OF RULES SUBJECT TO 
SECTION 922 OF TITLE 5, UNITED STATES CODE.—Sec-
tion 257(b)(2) of the Balanced Budget and Emergency 
Deficit Control Act of 1985 is amended by adding at the 
end the following new subparagraph: 
‘‘(E) BUDGETARY
EFFECTS
OF
RULES 
SUBJECT TO SECTION 922 OF TITLE 5, UNITED 
STATES CODE.—Any rules subject to the con-
gressional approval procedure set forth in sec-
tion 922 of chapter 8 of title 5, United States 
Code, affecting budget authority, outlays, or re-
ceipts shall be assumed to be effective unless it 
is not approved in accordance with such sec-
tion.’’. 
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351 
(c) GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
OF RULES.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study to deter-
mine, as of the date of the enactment of this Act— 
(A) how many rules (as such term is de-
fined in section 924 of title 5, United States 
Code) of the Food and Drug Administration 
were in effect; 
(B) how many major rules (as such term 
is defined in section 924 of title 5, United 
States Code) of the Food and Drug Administra-
tion were in effect; and 
(C) the total estimated economic cost im-
posed by all such rules. 
(2) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Comptroller 
General of the United States shall submit a report 
to Congress that contains the findings of the study 
conducted under paragraph (1). 
(d) EFFECTIVE DATE.—Subsections (a) and (b), and 
the amendments made by such sections, shall take effect 
beginning on the date that is 1 year after the date of en-
actment of this Act. 
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352 
SEC. 359. GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
OF RULES. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study to determine, as of 
the date of the enactment of this Act— 
(1) how many rules (as such term is defined in 
section 804 of title 5, United States Code) were in 
effect; 
(2) how many major rules (as such term is de-
fined in section 804 of title 5, United States Code) 
were in effect; and 
(3) the total estimated economic cost imposed 
by all such rules. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Comptroller General of 
the United States shall submit a report to Congress that 
contains the findings of the study conducted under sub-
section (a). 
Subtitle D—Prescription Drug and 
Pharmacy 
Benefit 
Manager 
Transparency 
SEC. 361. PATENT DISCLOSURE REQUIREMENTS. 
(a) IN GENERAL.—Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the 
end the following: 
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‘‘(o) ADDITIONAL REQUIREMENTS WITH RESPECT 
TO PATENTS.— 
‘‘(1) APPROVED APPLICATION HOLDER LISTING 
REQUIREMENTS.— 
‘‘(A) IN GENERAL.—Beginning on the date 
of enactment of this subsection, within 30 days 
of approval of an application under subsection 
(a) or (k), the holder of such approved applica-
tion shall submit to the Secretary a list of each 
patent required to be disclosed (as described in 
paragraph (3)). 
‘‘(B) 
PREVIOUSLY
APPROVED
OR
LI-
CENSED BIOLOGICAL PRODUCTS.— 
‘‘(i) PRODUCTS
APPROVED
UNDER 
SECTION
351
OF
THE
PHSA.—Not later 
than 30 days after the date of enactment 
of the Fair Care Act of 2020, the holder 
of a biological product license that was ap-
proved under subsection (a) or (k) before 
the date of enactment of such Act shall 
submit to the Secretary a list of each pat-
ent required to be disclosed (as described 
in paragraph (3)). 
‘‘(ii) PRODUCTS
APPROVED
UNDER 
SECTION 505 OF THE FFDCA.—Not later 
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354 
than 30 days after March 23, 2021, the 
holder of an approved application for a bio-
logical product under section 505 of the 
Federal Food, Drug, and Cosmetic Act 
that is deemed to be a license for the bio-
logical product under this section on 
March 23, 2021, shall submit a list of each 
patent required to be disclosed (as de-
scribed in paragraph (3)). 
‘‘(C) UPDATES.—The holder of a biological 
product license approved under subsection (a) 
or (k) shall submit to the Secretary a list that 
includes— 
‘‘(i) any patent first required to be 
disclosed (as described in paragraph (3)) 
after the submission under subparagraph 
(A) or (B), as applicable, within 30 days of 
the earlier of— 
‘‘(I) the date of issuance of such 
patent by the United States Patent 
and Trademark Office; or 
‘‘(II) the date of approval of a 
supplemental application for the bio-
logical product; and 
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