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COVID–19: Provided, That the maximum reimbursement 
authorized by this section shall be reduced by the amount 
of credit a contractor is allowed pursuant to division G of 
Public Law 116–127 and any applicable credits a con-
tractor is allowed under this Act. 
SEC. 3611. TECHNICAL CORRECTIONS. 
(1) Section 110(a)(3) of the Family and Medical 
Leave Act of 1993 (as added by the Emergency and 
Medical Leave Expansion Act) is amended by strik-
ing ‘‘553(d)(A)’’ and inserting ‘‘553(d)(3)’’. 
(2) Section 5111 of the Emergency Paid Sick 
Leave Act (division E of the Families First 
Coronavirus Response Act) is amended by striking 
‘‘553(d)(A)’’ and inserting ‘‘553(d)(3)’’. 
(3) Section 110(c) of the Family and Medical 
Leave Act of 1993 (as added by the Emergency and 
Medical Leave Expansion Act) is amended by strik-
ing ‘‘subsection (a)(2)(A)(iii)’’ and inserting ‘‘sub-
section (a)(2)(A)’’. 
(4) Section 3104 of the Emergency Family and 
Medical Leave Expansion Act (division C of the Fam-
ilies First Coronavirus Response Act) is amended— 
(A) by striking ‘‘110(a)(B)’’ and inserting 
‘‘section 110(a)(1)(B) of the Family and Medical 
Leave Act of 1993’’; and
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(B) by striking ‘‘section 107(a) for a viola-
tion of section 102(a)(1)(F) if the employer does 
not meet the definition of employer set forth in 
Section 101(4)(A)(i)’’ and inserting ‘‘section 
107(a) of such Act for a violation of section 
102(a)(1)(F) of such Act if the employer does not 
meet the definition of employer set forth in sec-
tion 101(4)(A)(i) of such Act’’. 
(5) Section 5110(1) of the Emergency Paid Sick 
Leave Act (division E of the Families First 
Coronavirus Response Act) is amended— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘terms’’ and inserting ‘‘term’’; 
and 
(B) in subparagraph (A)(i), by striking 
‘‘paragraph (5)(A)’’ and inserting ‘‘paragraph 
(2)(A)’’. 
(6) Section 5110(2)(B)(ii) of the Emergency 
Paid Sick Leave Act (division E of the Families First 
Coronavirus Response Act) is amended by striking 
‘‘clause (i)(IV)’’ and inserting ‘‘clause (i)(III)’’. 
(7) Section 110(a)(3) of the Family and Medical 
Leave Act of 1993 (as added by the Emergency and 
Medical Leave Expansion Act) is amended—
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† HR 748 EAS 
(A) by striking ‘‘and’’ after the semicolon at 
the end of subparagraph (A); 
(B) by striking the period at end of sub-
paragraph (B) and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(C) as necessary to carry out the purposes 
of this Act, including to ensure consistency be-
tween this Act and Division E and Division G 
of the Families First Coronavirus Response 
Act.’’. 
(8) Section 5104(1) of the Emergency Paid Sick 
Leave Act (division E of the Families First 
Coronavirus Response Act) is amended by striking 
‘‘and’’ after the semicolon and inserting ‘‘or’’. 
(9) Section 5105 of the Emergency Paid Sick 
Leave Act (division E of the Families First 
Coronavirus Response Act) is amended by adding at 
the end the following: 
‘‘(c) INVESTIGATIONS AND COLLECTION OF DATA.— 
The Secretary of Labor or his designee may investigate and 
gather data to ensure compliance with this Act in the same 
manner as authorized by sections 9 and 11 of the Fair 
Labor Standards Act of 1938 (29 U.S.C. 209; 211).’’.
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Subtitle D—Finance Committee 
SEC. 3701. EXEMPTION FOR TELEHEALTH SERVICES. 
(a) IN GENERAL.—Paragraph (2) of section 223(c) of 
the Internal Revenue Code of 1986 is amended by adding 
at the end the following new subparagraph: 
‘‘(E) SAFE HARBOR FOR ABSENCE OF DE-
DUCTIBLE
FOR
TELEHEALTH.—In the case of 
plan years beginning on or before December 31, 
2021, a plan shall not fail to be treated as a high 
deductible health plan by reason of failing to 
have a deductible for telehealth and other remote 
care services.’’. 
(b) CERTAIN COVERAGE DISREGARDED.—Clause (ii) 
of section 223(c)(1)(B) of the Internal Revenue Code of 1986 
is amended by striking ‘‘or long-term care’’ and inserting 
‘‘long-term care, or (in the case of plan years beginning 
on or before December 31, 2021) telehealth and other remote 
care’’. 
(c) EFFECTIVE DATE.—The amendments made by this 
section shall take effect on the date of the enactment of this 
Act.
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SEC. 3702. INCLUSION OF CERTAIN OVER-THE-COUNTER 
MEDICAL PRODUCTS AS QUALIFIED MEDICAL 
EXPENSES. 
(a) HSAS.—Section 223(d)(2) of the Internal Revenue 
Code of 1986 is amended— 
(1) by striking the last sentence of subparagraph 
(A) and inserting the following: ‘‘For purposes of this 
subparagraph, amounts paid for menstrual care prod-
ucts shall be treated as paid for medical care.’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(D) MENSTRUAL
CARE
PRODUCT.—For 
purposes of this paragraph, the term ‘menstrual 
care product’ means a tampon, pad, liner, cup, 
sponge, or similar product used by individuals 
with respect to menstruation or other genital- 
tract secretions.’’. 
(b) ARCHER MSAS.—Section 220(d)(2)(A) of such 
Code is amended by striking the last sentence and inserting 
the following: ‘‘For purposes of this subparagraph, amounts 
paid for menstrual care products (as defined in section 
223(d)(2)(D)) shall be treated as paid for medical care.’’. 
(c) HEALTH FLEXIBLE SPENDING ARRANGEMENTS 
AND HEALTH REIMBURSEMENT ARRANGEMENTS.—Section 
106 of such Code is amended by striking subsection (f) and 
inserting the following new subsection:
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‘‘(f) REIMBURSEMENTS FOR MENSTRUAL CARE PROD-
UCTS.—For purposes of this section and section 105, ex-
penses incurred for menstrual care products (as defined in 
section 223(d)(2)(D)) shall be treated as incurred for med-
ical care.’’. 
(d) EFFECTIVE DATES.— 
(1) DISTRIBUTIONS FROM SAVINGS ACCOUNTS.— 
The amendment made by subsections (a) and (b) shall 
apply to amounts paid after December 31, 2019. 
(2) REIMBURSEMENTS.—The amendment made 
by subsection (c) shall apply to expenses incurred 
after December 31, 2019. 
SEC. 3703. INCREASING MEDICARE TELEHEALTH FLEXIBILI-
TIES DURING EMERGENCY PERIOD. 
Section 1135 of the Social Security Act (42 U.S.C. 
1320b–5) is amended— 
(1) in subsection (b)(8), by striking ‘‘to an indi-
vidual by a qualified provider (as defined in sub-
section (g)(3))’’ and all that follows through the pe-
riod and inserting ‘‘, the requirements of section 
1834(m).’’; and 
(2) in subsection (g), by striking paragraph (3).
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SEC. 3704. ENHANCING MEDICARE TELEHEALTH SERVICES 
FOR FEDERALLY QUALIFIED HEALTH CEN-
TERS AND RURAL HEALTH CLINICS DURING 
EMERGENCY PERIOD. 
Section 1834(m) of the Social Security Act (42 U.S.C. 
1395m(m)) is amended— 
(1) in the first sentence of paragraph (1), by 
striking ‘‘The Secretary’’ and inserting ‘‘Subject to 
paragraph (8), the Secretary’’; 
(2) in paragraph (2)(A), by striking ‘‘The Sec-
retary’’ and inserting ‘‘Subject to paragraph (8), the 
Secretary’’; 
(3) in paragraph (4)— 
(A) in subparagraph (A), by striking ‘‘The 
term’’ and inserting ‘‘Subject to paragraph (8), 
the term’’; and 
(B) in subparagraph (F)(i), by striking 
‘‘The term’’ and inserting ‘‘Subject to paragraph 
(8), the term’’; and 
(4) by adding at the end the following new para-
graph: 
‘‘(8) ENHANCING
TELEHEALTH
SERVICES
FOR 
FEDERALLY QUALIFIED HEALTH CENTERS AND RURAL 
HEALTH CLINICS DURING EMERGENCY PERIOD.— 
‘‘(A) IN GENERAL.—During the emergency 
period described in section 1135(g)(1)(B)—
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‘‘(i) the Secretary shall pay for tele-
health services that are furnished via a tele-
communications system by a Federally 
qualified health center or a rural health 
clinic to an eligible telehealth individual en-
rolled under this part notwithstanding that 
the Federally qualified health center or 
rural clinic providing the telehealth service 
is not at the same location as the bene-
ficiary; 
‘‘(ii) the amount of payment to a Fed-
erally qualified health center or rural health 
clinic that serves as a distant site for such 
a telehealth service shall be determined 
under subparagraph (B); and 
‘‘(iii) for purposes of this subsection— 
‘‘(I) the term ‘distant site’ in-
cludes a Federally qualified health cen-
ter or rural health clinic that furnishes 
a telehealth service to an eligible tele-
health individual; and 
‘‘(II) the term ‘telehealth services’ 
includes a rural health clinic service or 
Federally qualified health center serv-
ice that is furnished using telehealth to
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† HR 748 EAS 
the extent that payment codes cor-
responding to services identified by the 
Secretary under clause (i) or (ii) of 
paragraph (4)(F) are listed on the cor-
responding claim for such rural health 
clinic service or Federally qualified 
health center service. 
‘‘(B) SPECIAL PAYMENT RULE.— 
‘‘(i) IN GENERAL.—The Secretary shall 
develop and implement payment methods 
that apply under this subsection to a Feder-
ally qualified health center or rural health 
clinic that serves as a distant site that fur-
nishes a telehealth service to an eligible tele-
health individual during such emergency 
period. Such payment methods shall be 
based on payment rates that are similar to 
the national average payment rates for com-
parable telehealth services under the physi-
cian fee schedule under section 1848. Not-
withstanding any other provision of law, 
the Secretary may implement such payment 
methods through program instruction or 
otherwise.
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‘‘(ii) EXCLUSION FROM FQHC PPS CAL-
CULATION
AND
RHC
AIR
CALCULATION.— 
Costs associated with telehealth services 
shall not be used to determine the amount 
of payment for Federally qualified health 
center services under the prospective pay-
ment system under section 1834(o) or for 
rural health clinic services under the meth-
odology for all-inclusive rates (established 
by 
the 
Secretary) 
under 
section 
1833(a)(3).’’. 
SEC. 3705. TEMPORARY WAIVER OF REQUIREMENT FOR 
FACE-TO-FACE VISITS BETWEEN HOME DIALY-
SIS PATIENTS AND PHYSICIANS. 
Section 1881(b)(3)(B) of the Social Security Act (42 
U.S.C. 1395rr(b)(3)(B)) is amended— 
(1) in clause (i), by striking ‘‘clause (ii)’’ and 
inserting ‘‘clauses (ii) and (iii)’’; 
(2) in clause (ii), in the matter preceding sub-
clause (I), by striking ‘‘Clause (i)’’ and inserting 
‘‘Except as provided in clause (iii), clause (i)’’; and 
(3) by adding at the end the following new 
clause: 
‘‘(iii) The Secretary may waive the 
provisions of clause (ii) during the emer-
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† HR 748 EAS 
gency 
period 
described 
in 
section 
1135(g)(1)(B).’’. 
SEC. 3706. USE OF TELEHEALTH TO CONDUCT FACE-TO- 
FACE ENCOUNTER PRIOR TO RECERTIFI-
CATION OF ELIGIBILITY FOR HOSPICE CARE 
DURING EMERGENCY PERIOD. 
Section 1814(a)(7)(D)(i) of the Social Security Act (42 
U.S.C. 1395f(a)(7(D)(i)) is amended— 
(1) by striking ‘‘a hospice’’ and inserting ‘‘(I) 
subject to subclause (II), a hospice’’; and 
(2) by inserting after subclause (I), as added by 
paragraph (1), the following new subclause: 
‘‘(II) during the emergency period de-
scribed in section 1135(g)(1)(B), a hospice 
physician or nurse practitioner may con-
duct a face-to-face encounter required under 
this clause via telehealth, as determined ap-
propriate by the Secretary; and’’. 
SEC. 3707. ENCOURAGING USE OF TELECOMMUNICATIONS 
SYSTEMS FOR HOME HEALTH SERVICES FUR-
NISHED DURING EMERGENCY PERIOD. 
With respect to home health services (as defined in sec-
tion 1861(m) of the Social Security Act (42 U.S.C. 
1395x(m)) that are furnished during the emergency period 
described in section 1135(g)(1)(B) of such Act (42 U.S.C.
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† HR 748 EAS 
1320b–5(g)(1)(B)), the Secretary of Health and Human 
Services shall consider ways to encourage the use of tele-
communications systems, including for remote patient mon-
itoring as described in section 409.46(e) of title 42, Code 
of Federal Regulations (or any successor regulations) and 
other communications or monitoring services, consistent 
with the plan of care for the individual, including by clari-
fying guidance and conducting outreach, as appropriate. 
SEC. 3708. IMPROVING CARE PLANNING FOR MEDICARE 
HOME HEALTH SERVICES. 
(a) PART A PROVISIONS.—Section 1814(a) of the So-
cial Security Act (42 U.S.C. 1395f(a)) is amended— 
(1) in paragraph (2)— 
(A) in the matter preceding subparagraph 
(A), by inserting ‘‘, a nurse practitioner or clin-
ical nurse specialist (as such terms are defined 
in section 1861(aa)(5)) who is working in ac-
cordance with State law, or a physician assist-
ant (as defined in section 1861(aa)(5)) who is 
working in accordance with State law, who is’’ 
after ‘‘in the case of services described in sub-
paragraph (C), a physician’’; and 
(B) in subparagraph (C)— 
(i) by inserting ‘‘, a nurse practitioner, 
a clinical nurse specialist, or a physician
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† HR 748 EAS 
assistant (as the case may be)’’ after ‘‘phy-
sician’’ the first 2 times it appears; and 
(ii) by striking ‘‘, and, in the case of 
a certification made by a physician’’ and 
all that follows through ‘‘face-to-face en-
counter’’ and inserting ‘‘, and, in the case 
of a certification made by a physician after 
January 1, 2010, or by a nurse practi-
tioner, clinical nurse specialist, or physi-
cian assistant (as the case may be) after a 
date specified by the Secretary (but in no 
case later than the date that is 6 months 
after the date of the enactment of the 
CARES Act), prior to making such certifi-
cation a physician, nurse practitioner, clin-
ical nurse specialist, or physician assistant 
must document that a physician, nurse 
practitioner, clinical nurse specialist, cer-
tified nurse-midwife (as defined in section 
1861(gg)) as authorized by State law, or 
physician assistant has had a face-to-face 
encounter’’; 
(2) in the third sentence— 
(A) by striking ‘‘physician certification’’ 
and inserting ‘‘certification’’;
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† HR 748 EAS 
(B) by inserting ‘‘(or in the case of regula-
tions to implement the amendments made by sec-
tion 3708 of the CARES Act, the Secretary shall 
prescribe regulations, which shall become effective 
no later than 6 months after the date of the en-
actment of such Act)’’ after ‘‘1981’’; and 
(C) by striking ‘‘a physician who’’ and in-
serting ‘‘a physician, nurse practitioner, clinical 
nurse specialist, or physician assistant who’’; 
(3) in the fourth sentence, by inserting ‘‘, nurse 
practitioner, clinical nurse specialist, or physician 
assistant’’ after ‘‘physician’’; and 
(4) in the fifth sentence— 
(A) by inserting ‘‘or no later than 6 months 
after the date of the enactment of the CARES 
Act for purposes of documentation for certifi-
cation and recertification made under paragraph 
(2) by a nurse practitioner, clinical nurse spe-
cialist, or physician assistant,’’ after ‘‘January 
1, 2019’’; and 
(B) by inserting ‘‘, nurse practitioner, clin-
ical nurse specialist, or physician assistant’’ 
after ‘‘of the physician’’. 
(b) PART B PROVISIONS.—Section 1835(a) of the So-
cial Security Act (42 U.S.C. 1395n(a)) is amended—
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† HR 748 EAS 
(1) in paragraph (2)— 
(A) in the matter preceding subparagraph 
(A), by inserting ‘‘, a nurse practitioner or clin-
ical nurse specialist (as those terms are defined 
in section 1861(aa)(5)) who is working in ac-
cordance with State law, or a physician assist-
ant (as defined in section 1861(aa)(5)) who is 
working in accordance with State law, who is’’ 
after ‘‘in the case of services described in sub-
paragraph (A), a physician’’; and 
(B) in subparagraph (A)— 
(i) in each of clauses (ii) and (iii) of 
subparagraph (A) by inserting ‘‘, a nurse 
practitioner, a clinical nurse specialist, or a 
physician assistant (as the case may be)’’ 
after ‘‘physician’’; and 
(ii) in clause (iv), by striking ‘‘after 
January 1, 2010’’ and all that follows 
through ‘‘face-to-face encounter’’ and insert-
ing ‘‘made by a physician after January 1, 
2010, or by a nurse practitioner, clinical 
nurse specialist, or physician assistant (as 
the case may be) after a date specified by 
the Secretary (but in no case later than the 
date that is 6 months after the date of the
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† HR 748 EAS 
enactment of the CARES Act), prior to 
making such certification a physician, 
nurse practitioner, clinical nurse specialist, 
or physician assistant must document that 
a physician, nurse practitioner, clinical 
nurse specialist, certified nurse-midwife (as 
defined in section 1861(gg)) as authorized 
by State law, or physician assistant has 
had a face-to-face encounter’’; 
(2) in the third sentence, by inserting ‘‘, nurse 
practitioner, clinical nurse specialist, or physician 
assistant (as the case may be)’’ after physician; 
(3) in the fourth sentence— 
(A) by striking ‘‘physician certification’’ 
and inserting ‘‘certification’’; 
(B) by inserting ‘‘(or in the case of regula-
tions to implement the amendments made by sec-
tion 3708 of the CARES Act the Secretary shall 
prescribe regulations which shall become effective 
no later than 6 months after the enactment of 
such Act)’’ after ‘‘1981’’; and 
(C) by striking ‘‘a physician who’’ and in-
serting ‘‘a physician, nurse practitioner, clinical 
nurse specialist, or physician assistant who’’;
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† HR 748 EAS 
(4) in the fifth sentence, by inserting ‘‘, nurse 
practitioner, clinical nurse specialist, or physician 
assistant’’ after ‘‘physician’’; and 
(5) in the sixth sentence— 
(A) by inserting ‘‘or no later than 6 months 
after the date of the enactment of the CARES 
Act for purposes of documentation for certifi-
cation and recertification made under paragraph 
(2) by a nurse practitioner, clinical nurse spe-
cialist, or physician assistant,’’ after ‘‘January 
1, 2019’’; and 
(B) by inserting ‘‘, nurse practitioner, clin-
ical nurse specialist, or physician assistant’’ 
after ‘‘of the physician’’. 
(c) DEFINITION PROVISIONS.— 
(1) HOME HEALTH SERVICES.—Section 1861(m) 
of the Social Security Act (42 U.S.C. 1395x(m)) is 
amended— 
(A) in the matter preceding paragraph 
(1)— 
(i) by inserting ‘‘, a nurse practitioner 
or a clinical nurse specialist (as those terms 
are defined in subsection (aa)(5)), or a phy-
sician assistant (as defined in subsection
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† HR 748 EAS 
(aa)(5))’’ after ‘‘physician’’ the first place it 
appears; and 
(ii) by inserting ‘‘, a nurse practi-
tioner, a clinical nurse specialist, or a phy-
sician assistant’’ after ‘‘physician’’ the sec-
ond place it appears; and 
(B) in paragraph (3), by inserting ‘‘, a 
nurse practitioner, a clinical nurse specialist, or 
a physician assistant’’ after ‘‘physician’’. 
(2) HOME HEALTH AGENCY.—Section 1861(o)(2) 
of the Social Security Act (42 U.S.C. 1395x(o)(2)) is 
amended— 
(A) by inserting ‘‘, nurse practitioners or 
clinical nurse specialists (as those terms are de-
fined in subsection (aa)(5)), certified nurse-mid-
wives (as defined in subsection (gg)), or physi-
cian 
assistants 
(as 
defined 
in 
subsection 
(aa)(5))’’ after ‘‘physicians’’; and 
(B) by inserting ‘‘, nurse practitioner, clin-
ical nurse specialist, certified nurse-midwife, 
physician assistant,’’ after ‘‘physician’’. 
(3) COVERED
OSTEOPOROSIS
DRUG.—Section 
1861(kk)(1) of the Social Security Act (42 U.S.C. 
1395x(kk)(1)) is amended by inserting ‘‘, nurse prac-
titioner or clinical nurse specialist (as those terms are
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† HR 748 EAS 
defined in subsection (aa)(5)), certified nurse-midwife 
(as defined in subsection (gg)), or physician assistant 
(as defined in subsection (aa)(5))’’ after ‘‘attending 
physician’’. 
(d) HOME HEALTH PROSPECTIVE PAYMENT SYSTEM 
PROVISIONS.—Section 1895 of the Social Security Act (42 
U.S.C. 1395fff) is amended— 
(1) in subsection (c)(1)— 
(A) by striking ‘‘(provided under section 
1842(r))’’; and 
(B) by inserting ‘‘the nurse practitioner or 
clinical nurse specialist (as those terms are de-
fined in section 1861(aa)(5)), or the physician 
assistant (as defined in section 1861(aa)(5))’’ 
after ‘‘physician’’; and 
(2) in subsection (e)— 
(A) in paragraph (1)(A), by inserting ‘‘a 
nurse practitioner or clinical nurse specialist, or 
a physician assistant’’ after ‘‘physician’’; and 
(B) in paragraph (2)— 
(i) in the heading, by striking ‘‘PHYSI-
CIAN CERTIFICATION’’ and inserting ‘‘RULE 
OF
CONSTRUCTION
REGARDING
REQUIRE-
MENT FOR CERTIFICATION’’; and 
(ii) by striking ‘‘physician’’.
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† HR 748 EAS 
(e) APPLICATION
TO MEDICAID.—The amendments 
made under this section shall apply under title XIX of the 
Social Security Act in the same manner and to the same 
extent as such requirements apply under title XVIII of such 
Act or regulations promulgated thereunder. 
(f) EFFECTIVE DATE.—The Secretary of Health and 
Human Services shall prescribe regulations to apply the 
amendments made by this section to items and services fur-
nished, which shall become effective no later than 6 months 
after the date of the enactment of this legislation. The Sec-
retary shall promulgate an interim final rule if necessary, 
to comply with the required effective date. 
SEC. 3709. ADJUSTMENT OF SEQUESTRATION. 
(a) TEMPORARY SUSPENSION OF MEDICARE SEQUES-
TRATION.—During the period beginning on May 1, 2020 
and ending on December 31, 2020, the Medicare programs 
under title XVIII of the Social Security Act (42 U.S.C. 
1395 et seq.) shall be exempt from reduction under any se-
questration order issued before, on, or after the date of en-
actment of this Act. 
(b) EXTENSION OF DIRECT SPENDING REDUCTIONS 
THROUGH FISCAL YEAR 2030.—Section 251A(6) of the 
Balanced Budget and Emergency Deficit Control Act of 
1985 (2 U.S.C. 901a(6)) is amended—
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† HR 748 EAS 
(1) in subparagraph (B), in the matter pre-
ceding clause (i), by striking ‘‘through 2029’’ and in-
serting ‘‘through 2030’’; and 
(2) in subparagraph (C), in the matter preceding 
clause (i), by striking ‘‘fiscal year 2029’’ and insert-
ing ‘‘fiscal year 2030’’. 
SEC. 3710. MEDICARE HOSPITAL INPATIENT PROSPECTIVE 
PAYMENT SYSTEM ADD-ON PAYMENT FOR 
COVID–19 PATIENTS DURING EMERGENCY PE-
RIOD. 
(a) IN GENERAL.—Section 1886(d)(4)(C) of the Social 
Security Act (42 U.S.C. 1395ww(d)(4)(C)) is amended by 
adding at the end the following new clause: 
‘‘(iv)(I) For discharges occurring during the emer-
gency period described in section 1135(g)(1)(B), in the case 
of a discharge of an individual diagnosed with COVID– 
19, the Secretary shall increase the weighting factor that 
would otherwise apply to the diagnosis-related group to 
which the discharge is assigned by 20 percent. The Sec-
retary shall identify a discharge of such an individual 
through the use of diagnosis codes, condition codes, or other 
such means as may be necessary. 
‘‘(II) Any adjustment under subclause (I) shall not be 
taken into account in applying budget neutrality under 
clause (iii)
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† HR 748 EAS 
‘‘(III) In the case of a State for which the Secretary 
has waived all or part of this section under the authority 
of section 1115A, nothing in this section shall preclude such 
State from implementing an adjustment similar to the ad-
justment under subclause (I).’’. 
(b) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary may implement the amend-
ment made by subsection (a) by program instruction or oth-
erwise. 
SEC. 3711. INCREASING ACCESS TO POST-ACUTE CARE DUR-
ING EMERGENCY PERIOD. 
(a) WAIVER OF IRF 3-HOUR RULE.—With respect to 
inpatient rehabilitation services furnished by a rehabilita-
tion facility described in section 1886(j)(1) of the Social 
Security Act (42 U.S.C. 1395ww(j)(1)) during the emer-
gency period described in section 1135(g)(1)(B) of the So-
cial Security Act (42 U.S.C. 1320b–5(g)(1)(B)), the Sec-
retary of Health and Human Services shall waive section 
412.622(a)(3)(ii) of title 42, Code of Federal Regulations 
(or any successor regulations), relating to the requirement 
that patients of an inpatient rehabilitation facility receive 
at least 15 hours of therapy per week. 
(b) WAIVER OF SITE-NEUTRAL PAYMENT RATE PROVI-
SIONS FOR LONG-TERM CARE HOSPITALS.—With respect to 
inpatient hospital services furnished by a long-term care
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† HR 748 EAS 
hospital described in section 1886(d)(1)(B)(iv) of the Social 
Security Act (42 U.S.C. 1395ww(d)(1)(B)(iv)) during the 
emergency period described in section 1135(g)(1)(B) of the 
Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), the Sec-
retary of Health and Human Services shall waive the fol-
lowing provisions of section 1886(m)(6) of such Act (42 
U.S.C. 1395ww(m)(6)): 
(1) LTCH 50-PERCENT
RULE.—Subparagraph 
(C)(ii) of such section, relating to the payment adjust-
ment for long-term care hospitals that do not have a 
discharge payment percentage for the period that is at 
least 50 percent. 
(2) SITE-NEUTRAL IPPS PAYMENT RATE.—Sub-
paragraph (A)(i) of such section, relating to the ap-
plication of the site-neutral payment rate (and pay-
ment shall be made to a long-term care hospital with-
out regard to such section) for a discharge if the ad-
mission occurs during such emergency period and is 
in response to the public health emergency described 
in such section 1135(g)(1)(B).
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† HR 748 EAS 
SEC. 3712. REVISING PAYMENT RATES FOR DURABLE MED-
ICAL EQUIPMENT UNDER THE MEDICARE 
PROGRAM THROUGH DURATION OF EMER-
GENCY PERIOD. 
(a) RURAL AND NONCONTIGUOUS AREAS.—The Sec-
retary of Health and Human Services shall implement sec-
tion 414.210(g)(9)(iii) of title 42, Code of Federal Regula-
tions (or any successor regulation), to apply the transition 
rule described in such section to all applicable items and 
services furnished in rural areas and noncontiguous areas 
(as such terms are defined for purposes of such section) as 
planned through December 31, 2020, and through the dura-
tion of the emergency period described in section 
1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b– 
5(g)(1)(B)), if longer. 
(b) AREAS OTHER THAN RURAL AND NONCONTIGUOUS 
AREAS.—With respect to items and services furnished on 
or after the date that is 30 days after the date of the enact-
ment of this Act, the Secretary of Health and Human Serv-
ices shall apply section 414.210(g)(9)(iv) of title 42, Code 
of Federal Regulations (or any successor regulation), as if 
the reference to ‘‘dates of service from June 1, 2018 through 
December 31, 2020, based on the fee schedule amount for 
the area is equal to 100 percent of the adjusted payment 
amount established under this section’’ were instead a ref-
erence to ‘‘dates of service from March 6, 2020, through the
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remainder of the duration of the emergency period described 
in section 1135(g)(1)(B) of the Social Security Act (42 
U.S.C. 1320b–5(g)(1)(B)), based on the fee schedule amount 
for the area is equal to 75 percent of the adjusted payment 
amount established under this section and 25 percent of the 
unadjusted fee schedule amount’’. 
SEC. 3713. COVERAGE OF THE COVID–19 VACCINE UNDER 
PART B OF THE MEDICARE PROGRAM WITH-
OUT ANY COST-SHARING. 
(a) MEDICAL AND OTHER HEALTH SERVICES.—Sec-
tion 1861(s)(10)(A) of the Social Security Act (42 U.S.C. 
1395x(s)(10)(A)) is amended by inserting ‘‘, and COVID– 
19 vaccine and its administration’’ after ‘‘influenza vaccine 
and its administration’’. 
(b) PART B DEDUCTIBLE.—The first sentence of sec-
tion 1833(b) of the Social Security Act (42 U.S.C. 1395l(b)) 
is amended— 
(1) in paragraph (10), by striking ‘‘and’’ at the 
end; and 
(2) in paragraph (11), by striking the period at 
the end and inserting ‘‘, and (12) such deductible 
shall not apply with respect a COVID–19 vaccine and 
its 
administration 
described 
in 
section 
1861(s)(10)(A).’’.
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(c) MEDICARE ADVANTAGE.—Section 1852(a)(1)(B) of 
the Social Security Act (42 U.S.C. 1395w–22(a)(1)(B)) is 
amended— 
(1) in clause (iv)— 
(A) by redesignating subclause (VI) as sub-
clause (VII); and 
(B) by inserting after subclause (V) the fol-
lowing new subclause: 
‘‘(VI) A COVID–19 vaccine and 
its administration described in section 
1861(s)(10)(A).’’; and 
(2) in clause (v), by striking ‘‘subclauses (IV) 
and (V)’’ inserting ‘‘subclauses (IV), (V), and (VI)’’. 
(d) EFFECTIVE DATE.—The amendments made by this 
section shall take effect on the date of enactment of this Act 
and shall apply with respect to a COVID–19 vaccine begin-
ning on the date that such vaccine is licensed under section 
351 of the Public Health Service Act (42 U.S.C. 262). 
(e) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary may implement the provi-
sions of, and the amendments made by, this section by pro-
gram instruction or otherwise.
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SEC. 3714. REQUIRING MEDICARE PRESCRIPTION DRUG 
PLANS AND MA–PD PLANS TO ALLOW DURING 
THE 
COVID–19 
EMERGENCY 
PERIOD 
FOR 
FILLS AND REFILLS OF COVERED PART D 
DRUGS FOR UP TO A 3-MONTH SUPPLY. 
(a) IN GENERAL.—Section 1860D–4(b) of the Social 
Security Act (42 U.S.C. 1395w–104(b)) is amended by add-
ing at the end the following new paragraph: 
‘‘(4) ENSURING ACCESS DURING COVID–19 PUB-
LIC HEALTH EMERGENCY PERIOD.— 
‘‘(A) IN GENERAL.—During the emergency 
period described in section 1135(g)(1)(B), subject 
to subparagraph (B), a prescription drug plan 
or MA–PD plan shall, notwithstanding any cost 
and utilization management, medication therapy 
management, or other such programs under this 
part, permit a part D eligible individual en-
rolled in such plan to obtain in a single fill or 
refill, at the option of such individual, the total 
day supply (not to exceed a 90-day supply) pre-
scribed for such individual for a covered part D 
drug. 
‘‘(B) SAFETY
EDIT
EXCEPTION.—A pre-
scription drug plan or MA–PD plan may not 
permit a part D eligible individual to obtain a
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single fill or refill inconsistent with an applica-
ble safety edit.’’. 
(b) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary of Health and Human Serv-
ices may implement the amendment made by this section 
by program instruction or otherwise. 
SEC. 3715. PROVIDING HOME AND COMMUNITY-BASED 
SERVICES IN ACUTE CARE HOSPITALS. 
Section 1902(h) of the Social Security Act (42 U.S.C. 
1396a(h)) is amended— 
(1) by inserting ‘‘(1)’’ after ‘‘(h)’’; 
(2) by inserting ‘‘, home and community-based 
services provided under subsection (c), (d), or (i) of 
section 1915 or under a waiver or demonstration 
project under section 1115, self-directed personal as-
sistance services provided pursuant to a written plan 
of care under section 1915(j), and home and commu-
nity-based attendant services and supports under sec-
tion 1915(k)’’ before the period; and 
(3) by adding at the end the following: 
‘‘(2) Nothing in this title, title XVIII, or title XI shall 
be construed as prohibiting receipt of any care or services 
specified in paragraph (1) in an acute care hospital that 
are—
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‘‘(A) identified in an individual’s person-cen-
tered service plan (or comparable plan of care); 
‘‘(B) provided to meet needs of the individual 
that are not met through the provision of hospital 
services; 
‘‘(C) not a substitute for services that the hos-
pital is obligated to provide through its conditions of 
participation or under Federal or State law, or under 
another applicable requirement; and 
‘‘(D) designed to ensure smooth transitions be-
tween acute care settings and home and community- 
based settings, and to preserve the individual’s func-
tional abilities.’’. 
SEC. 3716. CLARIFICATION REGARDING UNINSURED INDI-
VIDUALS. 
Subsection (ss) of section 1902 of the Social Security 
Act (42 U.S.C. 1396a), as added by section 6004(a)(3)(C) 
of the Families First Coronavirus Response Act, is amend-
ed— 
(1) in paragraph (1), by inserting ‘‘(excluding 
subclause (VIII) of such subsection if the individual 
is a resident of a State which does not furnish med-
ical assistance to individuals described in such sub-
clause)’’ before the semicolon; and
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(2) in paragraph (2), by inserting ‘‘, except that 
individuals who are eligible for medical assistance 
under 
subsection 
(a)(10)(A)(ii)(XII), 
subsection 
(a)(10)(A)(ii)(XVIII), subsection (a)(10)(A)(ii)(XXI), 
or subsection (a)(10)(C) (but only to the extent such 
an individual is considered to not have minimum es-
sential coverage under section 5000A(f)(1) of the In-
ternal Revenue Code of 1986), or who are described 
in subsection (l)(1)(A) and are eligible for medical as-
sistance only because of subsection (a)(10)(A)(i)(IV) 
or (a)(10)(A)(ii)(IX) and whose eligibility for such 
assistance is limited by the State under clause (VII) 
in the matter following subsection (a)(10)(G), shall 
not be treated as enrolled in a Federal health care 
program for purposes of this paragraph’’ before the 
period at the end. 
SEC. 3717. CLARIFICATION REGARDING COVERAGE OF 
COVID–19 TESTING PRODUCTS. 
Subparagraph (B) of section 1905(a)(3) of the Social 
Security Act (42 U.S.C. 1396d(a)(3)), as added by section 
6004(a)(1)(C) of the Families First Coronavirus Response 
Act (Public Law 116–127), is amended by striking ‘‘that 
are approved, cleared, or authorized under section 510(k), 
513, 515 or 564 of the Federal Food, Drug, and Cosmetic 
Act’’.
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SEC. 3718. AMENDMENTS RELATING TO REPORTING RE-
QUIREMENTS WITH RESPECT TO CLINICAL DI-
AGNOSTIC LABORATORY TESTS. 
(a) REVISED REPORTING PERIOD FOR REPORTING OF 
PRIVATE SECTOR PAYMENT RATES FOR ESTABLISHMENT 
OF MEDICARE PAYMENT RATES.—Section 1834A(a)(1)(B) 
of the Social Security Act (42 U.S.C. 1395m–1(a)(1)(B)) 
is amended— 
(1) in clause (i), by striking ‘‘December 31, 
2020’’ and inserting ‘‘December 31, 2021’’; and 
(2) in clause (ii)— 
(A) by striking ‘‘January 1, 2021’’ and in-
serting ‘‘January 1, 2022’’; and 
(B) by striking ‘‘March 31, 2021’’ and in-
serting ‘‘March 31, 2022’’. 
(b) REVISED PHASE-IN OF REDUCTIONS FROM PRI-
VATE
PAYOR
RATE
IMPLEMENTATION.—Section 
1834A(b)(3) of the Social Security Act (42 U.S.C. 1395m– 
1(b)(3)) is amended— 
(1) in subparagraph (A), by striking ‘‘through 
2023’’ and inserting ‘‘through 2024’’; and 
(2) in subparagraph (B)— 
(A) in clause (i), by striking ‘‘and’’ at the 
end; 
(B) by redesignating clause (ii) as clause 
(iii);
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(C) by inserting after clause (i) the fol-
lowing new clause: 
‘‘(ii) for 2021, 0 percent; and’’; and 
(D) in clause (iii), as redesignated by sub-
paragraph (B), by striking ‘‘2021 through 2023’’ 
and inserting ‘‘2022 through 2024’’. 
SEC. 3719. EXPANSION OF THE MEDICARE HOSPITAL AC-
CELERATED 
PAYMENT 
PROGRAM 
DURING 
THE COVID–19 PUBLIC HEALTH EMERGENCY. 
Section 1815 of the Social Security Act (42 U.S.C. 
1395g) is amended— 
(1) in subsection (e)(3), by striking ‘‘In the case’’ 
and inserting ‘‘Subject to subsection (f), in the case’’; 
and 
(2) by adding at the end the following new sub-
section: 
‘‘(f)(1) During the emergency period described in sec-
tion 1135(g)(1)(B), the Secretary shall expand the program 
under subsection (e)(3) pursuant to paragraph (2). 
‘‘(2) In expanding the program under subsection 
(e)(3), the following shall apply: 
‘‘(A)(i) In addition to the hospitals described in 
subsection (e)(3), the following hospitals shall be eligi-
ble to participate in the program:
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‘‘(I) Hospitals described in clause (iii) of 
section 1886(d)(1)(B). 
‘‘(II) Hospitals described in clause (v) of 
such section. 
‘‘(III) Critical access hospitals (as defined 
in section 1861(mm)(1)). 
‘‘(ii) Subject to appropriate safeguards against 
fraud, waste, and abuse, upon a request of a hospital 
described in clause (i), the Secretary shall provide ac-
celerated payments under the program to such hos-
pital. 
‘‘(B) Upon the request of the hospital, the Sec-
retary may do any of the following: 
‘‘(i) Make accelerated payments on a peri-
odic or lump sum basis. 
‘‘(ii) Increase the amount of payment that 
would otherwise be made to hospitals under the 
program up to 100 percent (or, in the case of 
critical access hospitals, up to 125 percent). 
‘‘(iii) Extend the period that accelerated 
payments cover so that it covers up to a 6-month 
period. 
‘‘(C) Upon the request of the hospital, the Sec-
retary shall do the following:
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‘‘(i) Provide up to 120 days before claims 
are offset to recoup the accelerated payment. 
‘‘(ii) Allow not less than 12 months from 
the date of the first accelerated payment before 
requiring that the outstanding balance be paid 
in full. 
‘‘(3) Nothing in this subsection shall preclude the Sec-
retary from carrying out the provisions described in clauses 
(i), (ii), and (iii) of paragraph (2)(B) and clauses (i) and 
(ii) of paragraph (2)(C) under the program under sub-
section (e)(3) after the period for which this subsection ap-
plies. 
‘‘(4) Notwithstanding any other provision of law, the 
Secretary may implement the provisions of this subsection 
by program instruction or otherwise.’’. 
SEC. 3720. DELAYING REQUIREMENTS FOR ENHANCED 
FMAP TO ENABLE STATE LEGISLATION NEC-
ESSARY FOR COMPLIANCE. 
Section 6008 of the Families First Coronavirus Re-
sponse Act is amended by adding at the end the following 
new subsection: 
‘‘(d) DELAY IN APPLICATION OF PREMIUM REQUIRE-
MENT.—During the 30 day period beginning on the date 
of enactment of this Act, a State shall not be ineligible for 
the increase to the Federal medical assistance percentage
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† HR 748 EAS 
of the State described in subsection (a) on the basis that 
the State imposes a premium that violates the requirement 
of subsection (b)(2) if such premium was in effect on the 
date of enactment of this Act.’’. 
Subtitle E—Health and Human 
Services Extenders 
PART I—MEDICARE PROVISIONS 
SEC. 3801. EXTENSION OF THE WORK GEOGRAPHIC INDEX 
FLOOR UNDER THE MEDICARE PROGRAM. 
Section 1848(e)(1)(E) of the Social Security Act (42 
U.S.C. 1395w–4(e)(1)(E)) is amended by striking ‘‘May 23, 
2020’’ and inserting ‘‘December 1, 2020’’. 
SEC. 3802. EXTENSION OF FUNDING FOR QUALITY MEAS-
URE ENDORSEMENT, INPUT, AND SELECTION. 
(a) IN GENERAL.—Section 1890(d)(2) of the Social Se-
curity Act (42 U.S.C. 1395aaa(d)(2)) is amended— 
(1) in the first sentence, by striking ‘‘and 
$4,830,000 for the period beginning on October 1, 
2019, and ending on May 22, 2020’’ and inserting 
‘‘$20,000,000 for fiscal year 2020, and for the period 
beginning on October 1, 2020, and ending on Novem-
ber 30, 2020, the amount equal to the pro rata por-
tion of the amount appropriated for such period for 
fiscal year 2020’’; and
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† HR 748 EAS 
(2) in the third sentence, by striking ‘‘and 2019 
and for the period beginning on October 1, 2019, and 
ending on May 22, 2020’’ and inserting ‘‘, 2019, and 
2020, and for the period beginning on October 1, 
2020, and ending on November 30, 2020,’’. 
(b) EFFECTIVE DATE.—The amendments made by sub-
section (a) shall take effect as if included in the enactment 
of the Further Consolidated Appropriations Act, 2020 (Pub-
lic Law 116–94). 
SEC. 3803. EXTENSION OF FUNDING OUTREACH AND AS-
SISTANCE FOR LOW-INCOME PROGRAMS. 
(a) FUNDING EXTENSIONS.— 
(1) ADDITIONAL FUNDING FOR STATE HEALTH 
INSURANCE PROGRAMS.—Subsection (a)(1)(B) of sec-
tion 119 of the Medicare Improvements for Patients 
and Providers Act of 2008 (42 U.S.C. 1395b–3 note), 
as amended by section 3306 of the Patient Protection 
and Affordable Care Act (Public Law 111–148), sec-
tion 610 of the American Taxpayer Relief Act of 2012 
(Public Law 112–240), section 1110 of the Pathway 
for SGR Reform Act of 2013 (Public Law 113–67), 
section 110 of the Protecting Access to Medicare Act 
of 2014 (Public Law 113–93), section 208 of the 
Medicare Access and CHIP Reauthorization Act of 
2015 (Public Law 114–10), section 50207 of division
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† HR 748 EAS 
E of the Bipartisan Budget Act of 2018 (Public Law 
115–123), section 1402 of division B of the Con-
tinuing Appropriations Act, 2020, and Health Ex-
tenders Act of 2019 (Public Law 116–59), section 
1402 of division B of the Further Continuing Appro-
priations Act, 2020, and Further Health Extenders 
Act of 2019 (Public Law 116–69), and section 103 of 
division N of the Further Consolidated Appropria-
tions Act, 2020 (Public Law 116–94) is amended by 
striking clauses (x) through (xii) and inserting the 
following new clauses: 
‘‘(x) 
for 
fiscal 
year 
2020, 
of 
$13,000,000; and 
‘‘(xi) for the period beginning on Octo-
ber 1, 2020, and ending on November 30, 
2020, the amount equal to the pro rata por-
tion of the amount appropriated for such 
period for fiscal year 2020.’’. 
(2) ADDITIONAL FUNDING FOR AREA AGENCIES 
ON AGING.—Subsection (b)(1)(B) of such section 119, 
as so amended, is amended by striking clauses (x) 
through (xii) and inserting the following new clauses: 
‘‘(x) for fiscal year 2020, of $7,500,000; 
and
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† HR 748 EAS 
‘‘(xi) for the period beginning on Octo-
ber 1, 2020, and ending on November 30, 
2020, the amount equal to the pro rata por-
tion of the amount appropriated for such 
period for fiscal year 2020.’’. 
(3) ADDITIONAL FUNDING FOR AGING AND DIS-
ABILITY
RESOURCE
CENTERS.—Subsection (c)(1)(B) 
of such section 119, as so amended, is amended by 
striking clauses (x) through (xii) and inserting the 
following new clauses: 
‘‘(x) for fiscal year 2020, of $5,000,000; 
and 
‘‘(xi) for the period beginning on Octo-
ber 1, 2020, and ending on November 30, 
2020, the amount equal to the pro rata por-
tion of the amount appropriated for such 
period for fiscal year 2020.’’. 
(4) ADDITIONAL FUNDING FOR CONTRACT WITH 
THE
NATIONAL
CENTER
FOR
BENEFITS
AND
OUT-
REACH ENROLLMENT.—Subsection (d)(2) of such sec-
tion 119, as so amended, is amended by striking 
clauses (x) through (xii) and inserting the following 
new clauses: 
‘‘(x) 
for 
fiscal 
year 
2020, 
of 
$12,000,000; and
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‘‘(xi) for the period beginning on Octo-
ber 1, 2020, and ending on November 30, 
2020, the amount equal to the pro rata por-
tion of the amount appropriated for such 
period for fiscal year 2020.’’. 
(b) EFFECTIVE DATE.—The amendments made by sub-
section (a) shall take effect as if included in the enactment 
of the Further Consolidated Appropriations Act, 2020 (Pub-
lic Law 116–94). 
PART II—MEDICAID PROVISIONS 
SEC. 3811. EXTENSION OF THE MONEY FOLLOWS THE PER-
SON REBALANCING DEMONSTRATION PRO-
GRAM. 
Section 6071(h) of the Deficit Reduction Act of 2005 
(42 U.S.C. 1396a note) is amended— 
(1) in paragraph (1), by striking subparagraph 
(G) and inserting the following: 
‘‘(G) subject to paragraph (3), $337,500,000 
for the period beginning on January 1, 2020, 
and ending on September 30, 2020; and 
‘‘(H) subject to paragraph (3), for the pe-
riod beginning on October 1, 2020, and ending 
on November 30, 2020, the amount equal to the 
pro rata portion of the amount appropriated for 
such period for fiscal year 2020.’’; and
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(2) in paragraph (3), by striking ‘‘and (G)’’ and 
inserting ‘‘, (G), and (H)’’. 
SEC. 3812. EXTENSION OF SPOUSAL IMPOVERISHMENT 
PROTECTIONS. 
(a) IN GENERAL.—Section 2404 of Public Law 111– 
148 (42 U.S.C. 1396r–5 note) is amended by striking ‘‘May 
22, 2020’’ and inserting ‘‘November 30, 2020’’. 
(b) RULE
OF CONSTRUCTION.—Nothing in section 
2404 of Public Law 111–148 (42 U.S.C. 1396r–5 note) or 
section 1902(a)(17) or 1924 of the Social Security Act (42 
U.S.C. 1396a(a)(17), 1396r–5) shall be construed as prohib-
iting a State from— 
(1) applying an income or resource disregard 
under a methodology authorized under section 
1902(r)(2) of such Act (42 U.S.C. 1396a(r)(2))— 
(A) to the income or resources of an indi-
vidual 
described 
in 
section 
1902(a)(10)(A)(ii)(VI) of such Act (42 U.S.C. 
1396a(a)(10)(A)(ii)(VI)) (including a disregard 
of the income or resources of such individual’s 
spouse); or 
(B) on the basis of an individual’s need for 
home and community-based services authorized 
under subsection (c), (d), (i), or (k) of section
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† HR 748 EAS 
1915 of such Act (42 U.S.C. 1396n) or under sec-
tion 1115 of such Act (42 U.S.C. 1315); or 
(2) disregarding an individual’s spousal income 
and assets under a plan amendment to provide med-
ical assistance for home and community-based serv-
ices for individuals by reason of being determined eli-
gible under section 1902(a)(10)(C) of such Act (42 
U.S.C. 1396a(a)(10)(C)) or by reason of section 
1902(f) of such Act (42 U.S.C. 1396a(f)) or otherwise 
on the basis of a reduction of income based on costs 
incurred for medical or other remedial care under 
which the State disregarded the income and assets of 
the individual’s spouse in determining the initial and 
ongoing financial eligibility of an individual for such 
services in place of the spousal impoverishment provi-
sions applied under section 1924 of such Act (42 
U.S.C. 1396r–5). 
SEC. 3813. DELAY OF DSH REDUCTIONS. 
Section 1923(f)(7)(A) of the Social Security Act (42 
U.S.C. 1396r–4(f)(7)(A)) is amended— 
(1) in clause (i), in the matter preceding sub-
clause (I), by striking ‘‘May 23, 2020, and ending 
September 30, 2020, and for each of fiscal years 
2021’’ and inserting ‘‘December 1, 2020, and ending
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† HR 748 EAS 
September 30, 2021, and for each of fiscal years 
2022’’; and 
(2) in clause (ii)— 
(A) in subclause (I), by striking ‘‘May 23, 
2020, and ending September 30, 2020’’ and in-
serting ‘‘December 1, 2020, and ending Sep-
tember 30, 2021’’; and 
(B) in subclause (II), by striking ‘‘2021’’ 
and inserting ‘‘2022’’. 
SEC. 3814. EXTENSION AND EXPANSION OF COMMUNITY 
MENTAL HEALTH SERVICES DEMONSTRATION 
PROGRAM. 
(a) IN GENERAL.—Section 223(d) of the Protecting 
Access to Medicare Act of 2014 (42 U.S.C. 1396a note) is 
amended— 
(1) in paragraph (3)— 
(A) by striking ‘‘Not more than’’ and insert-
ing ‘‘Subject to paragraph (8), not more than’’; 
and 
(B) by striking ‘‘May 22, 2020’’ and insert-
ing ‘‘November 30, 2020’’; and 
(2) by adding at the end the following new para-
graph: 
‘‘(8) ADDITIONAL PROGRAMS.—
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‘‘(A) IN
GENERAL.—Not later than 6 
months after the date of enactment of this para-
graph, in addition to the 8 States selected under 
paragraph (1), the Secretary shall select 2 States 
to participate in 2-year demonstration programs 
that meet the requirements of this subsection. 
‘‘(B) SELECTION OF STATES.— 
‘‘(i) IN
GENERAL.—Subject to clause 
(ii), in selecting States under this para-
graph, the Secretary— 
‘‘(I) shall select States that— 
‘‘(aa) were awarded plan-
ning grants under subsection (c); 
and 
‘‘(bb) applied to participate 
in the demonstration programs 
under this subsection under para-
graph (1) but, as of the date of en-
actment of this paragraph, were 
not selected to participate under 
paragraph (1); and 
‘‘(II) shall use the results of the 
Secretary’s evaluation of each State’s 
application under paragraph (1) to de-
termine which States to select, and
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† HR 748 EAS 
shall not require the submission of any 
additional application. 
‘‘(C) 
REQUIREMENTS
FOR
SELECTED 
STATES.—Prior to services being delivered under 
the demonstration authority in a State selected 
under this paragraph, the State shall— 
‘‘(i) submit a plan to monitor certified 
community behavioral health clinics under 
the demonstration program to ensure com-
pliance with certified community behavioral 
health criteria during the demonstration pe-
riod; and 
‘‘(ii) commit to collecting data, noti-
fying the Secretary of any planned changes 
that would deviate from the prospective 
payment system methodology outlined in 
the State’s demonstration application, and 
obtaining approval from the Secretary for 
any such change before implementing the 
change.’’. 
(b) LIMITATION.—Section 223(d)(5) of the Protecting 
Access to Medicare Act of 2014 (42 U.S.C. 1396a note) is 
amended— 
(1) in subparagraph (B), in the matter pre-
ceding clause (i), by striking ‘‘The Federal matching’’
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† HR 748 EAS 
and inserting ‘‘Subject to subparagraph (C)(iii), the 
Federal matching’’; and 
(2) in subparagraph (C), by adding at the end 
the following new clause: 
‘‘(iii) PAYMENTS
FOR
AMOUNTS
EX-
PENDED AFTER 2019.—The Federal match-
ing percentage applicable under subpara-
graph (B) to amounts expended by a State 
participating in the demonstration program 
under this subsection shall— 
‘‘(I) in the case of a State partici-
pating in the demonstration program 
as of January 1, 2020, apply to 
amounts expended by the State during 
the 8 fiscal quarter period (or any por-
tion of such period) that begins on 
January 1, 2020; and 
‘‘(II) in the case of a State se-
lected to participate in the demonstra-
tion program under paragraph (8), 
during first 8 fiscal quarter period (or 
any portion of such period) that the 
State participates in a demonstration 
program.’’.
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† HR 748 EAS 
(c) GAO STUDY AND REPORT ON THE COMMUNITY 
AND MENTAL HEALTH SERVICES DEMONSTRATION PRO-
GRAM.— 
(1) IN
GENERAL.—Not later than 18 months 
after the date of the enactment of this Act, the Comp-
troller General of the United States shall submit to 
the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Finance of 
the Senate a report on the community and mental 
health services demonstration program conducted 
under section 223 of the Protecting Access to Medicare 
Act of 2014 (42 U.S.C. 1396a note) (referred to in 
this subsection as the ‘‘demonstration program’’). 
(2) CONTENT OF REPORT.—The report required 
under paragraph (1) shall include the following infor-
mation: 
(A) Information on States’ experiences par-
ticipating in the demonstration program, includ-
ing the extent to which States— 
(i) measure the effects of access to cer-
tified community behavioral health clinics 
on patient health and cost of care, includ-
ing— 
(I) engagement in treatment for 
behavioral health conditions;
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† HR 748 EAS 
(II) relevant clinical outcomes, to 
the extent collected; 
(III) screening and treatment for 
comorbid medical conditions; and 
(IV) use of crisis stabilization, 
emergency department, and inpatient 
care. 
(B) Information on Federal efforts to evalu-
ate the demonstration program, including— 
(i) quality measures used to evaluate 
the program; 
(ii) assistance provided to States on 
data collection and reporting; 
(iii) assessments of the reliability and 
usefulness of State-submitted data; and 
(iv) the extent to which such efforts 
provide information on the relative quality, 
scope, and cost of services as compared with 
services not provided under the demonstra-
tion program, and in comparison to Med-
icaid beneficiaries with mental illness and 
substance use disorders not served under the 
demonstration program. 
(C) Recommendations for improvements to 
the following:
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(i) The reporting, accuracy, and vali-
dation of encounter data. 
(ii) Accuracy in payments to certified 
community behavioral health clinics under 
State plans or waivers under title XIX of 
the Social Security Act (42 U.S.C. 1396 et 
seq.). 
PART III—HUMAN SERVICES AND OTHER HEALTH 
PROGRAMS 
SEC. 3821. EXTENSION OF SEXUAL RISK AVOIDANCE EDU-
CATION PROGRAM. 
Section 510 of the Social Security Act (42 U.S.C. 710) 
is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), in the matter pre-
ceding subparagraph (A)— 
(i) by striking ‘‘and 2019 and for the 
period beginning October 1, 2019, and end-
ing May 22, 2020’’ and inserting ‘‘through 
2020 and for the period beginning October 
1, 2020, and ending November 30, 2020’’; 
and 
(ii) by striking ‘‘fiscal year 2020’’ and 
inserting ‘‘fiscal year 2021’’ 
(B) in paragraph (2)(A)—
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(i) by striking ‘‘and 2019 and for the 
period beginning October 1, 2019, and end-
ing May 22, 2020’’ and inserting ‘‘through 
2020 and for the period beginning October 
1, 2020, and ending November 30, 2020’’; 
and 
(ii) by striking ‘‘fiscal year 2020’’ and 
inserting ‘‘fiscal year 2021’’; and 
(2) in subsection (f)(1), by striking ‘‘and 2019 
and $48,287,671 for the period beginning October 1, 
2019, and ending May 22, 2020’’ and inserting 
‘‘through 2020, and for the period beginning on Octo-
ber 1, 2020, and ending on November 30, 2020, the 
amount equal to the pro rata portion of the amount 
appropriated for such period for fiscal year 2020’’. 
SEC. 3822. EXTENSION OF PERSONAL RESPONSIBILITY EDU-
CATION PROGRAM. 
Section 513 of the Social Security Act (42 U.S.C. 713) 
is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) in subparagraph (A), in the matter 
preceding clause (i), by striking ‘‘2019 and 
for the period beginning October 1, 2019, 
and ending May 22, 2020’’ and inserting
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† HR 748 EAS 
‘‘2020 and for the period beginning October 
1, 2020, and ending November 30, 2020’’; 
and 
(ii) in subparagraph (B)(i), by strik-
ing by striking ‘‘October 1, 2019, and end-
ing May 22, 2020’’ and inserting ‘‘October 
1, 2020, and ending November 30, 2020’’; 
(2) in paragraph (4)(A), by striking ‘‘2019’’ 
each place it appears and inserting ‘‘2020’’; and 
(3) in subsection (f), by striking ‘‘2019 and 
$48,287,671 for the period beginning October 1, 2019, 
and ending May 22, 2020’’ and inserting ‘‘2020, and 
for the period beginning on October 1, 2020, and end-
ing on November 30, 2020, the amount equal to the 
pro rata portion of the amount appropriated for such 
period for fiscal year 2020’’. 
SEC. 3823. EXTENSION OF DEMONSTRATION PROJECTS TO 
ADDRESS 
HEALTH 
PROFESSIONS 
WORK-
FORCE NEEDS. 
Activities authorized by section 2008 of the Social Se-
curity Act shall continue through November 30, 2020, in 
the manner authorized for fiscal year 2019, and out of any 
money in the Treasury of the United States not otherwise 
appropriated, there are hereby appropriated such sums as 
may be necessary for such purpose. Grants and payments
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† HR 748 EAS 
may be made pursuant to this authority through the date 
so specified at the pro rata portion of the total amount au-
thorized for such activities in fiscal year 2019. 
SEC. 3824. EXTENSION OF THE TEMPORARY ASSISTANCE 
FOR NEEDY FAMILIES PROGRAM AND RE-
LATED PROGRAMS. 
Activities authorized by part A of title IV and section 
1108(b) of the Social Security Act shall continue through 
November 30, 2020, in the manner authorized for fiscal year 
2019, and out of any money in the Treasury of the United 
States not otherwise appropriated, there are hereby appro-
priated such sums as may be necessary for such purpose. 
PART IV—PUBLIC HEALTH PROVISIONS 
SEC. 3831. EXTENSION FOR COMMUNITY HEALTH CENTERS, 
THE NATIONAL HEALTH SERVICE CORPS, AND 
TEACHING HEALTH CENTERS THAT OPERATE 
GME PROGRAMS. 
(a) 
COMMUNITY
HEALTH
CENTERS.—Section 
10503(b)(1)(F) of the Patient Protection and Affordable 
Care Act (42 U.S.C. 254b–2(b)(1)(F)) is amended by strik-
ing ‘‘and $2,575,342,466 for the period beginning on Octo-
ber 1, 2019, and ending on May 22, 2020’’ and inserting 
‘‘$4,000,000,000 for fiscal year 2020, and $668,493,151 for 
the period beginning on October 1, 2020, and ending on 
November 30, 2020’’.
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(b) NATIONAL HEALTH SERVICE CORPS.—Section 
10503(b)(2) of the Patient Protection and Affordable Care 
Act (42 U.S.C. 254b–2(b)(2)) is amended— 
(1) in subparagraph (F), by striking ‘‘and’’ at 
the end; and 
(2) by striking subparagraph (G) and inserting 
the following: 
‘‘(G) $310,000,000 for fiscal year 2020; and 
‘‘(H) $51,808,219 for the period beginning 
on October 1, 2020, and ending on November 30, 
2020.’’. 
(c) TEACHING HEALTH CENTERS THAT OPERATE 
GRADUATE
MEDICAL
EDUCATION
PROGRAMS.—Section 
340H(g)(1) of the Public Health Service Act (42 U.S.C. 
256h(g)(1)) is amended by striking ‘‘and 2019, and 
$81,445,205 for the period beginning on October 1, 2019, 
and ending on May 22, 2020’’ and inserting ‘‘through fiscal 
year 2020, and $21,141,096 for the period beginning on Oc-
tober 1, 2020, and ending on November 30, 2020’’. 
(d) APPLICATION OF PROVISIONS.—Amounts appro-
priated pursuant to the amendments made by this section 
for fiscal year 2020 and for the period beginning on October 
1, 2020, and ending on November 30, 2020, shall be subject 
to the requirements contained in Public Law 116–94 for 
funds for programs authorized under sections 330 through
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† HR 748 EAS 
340 of the Public Health Service Act (42 U.S.C. 254 
through 256). 
(e) CONFORMING AMENDMENT.—Paragraph (4) of sec-
tion 3014(h) of title 18, United States Code, as amended 
by section 401(e) of division N of Public Law 116–94, is 
amended by striking ‘‘section 401(d) of division N of the 
Further Consolidated Appropriations Act, 2020’’ and in-
serting ‘‘section 3831 of the CARES Act’’. 
SEC. 3832. DIABETES PROGRAMS. 
(a) TYPE I.—Section 330B(b)(2)(D) of the Public 
Health Service Act (42 U.S.C. 254c–2(b)(2)(D)) is amended 
by striking ‘‘and 2019, and $96,575,342 for the period be-
ginning on October 1, 2019, and ending on May 22, 2020’’ 
and inserting ‘‘through 2020, and $25,068,493 for the pe-
riod beginning on October 1, 2020, and ending on November 
30, 2020’’. 
(b) INDIANS.—Section 330C(c)(2)(D) of the Public 
Health Service Act (42 U.S.C. 254c–3(c)(2)(D)) is amended 
by striking ‘‘and 2019, and $96,575,342 for the period be-
ginning on October 1, 2019, and ending on May 22, 2020’’ 
and inserting ‘‘through 2020, and $25,068,493 for the pe-
riod beginning on October 1, 2020, and ending on November 
30, 2020’’.
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PART V—MISCELLANEOUS PROVISIONS 
SEC. 3841. PREVENTION OF DUPLICATE APPROPRIATIONS 
FOR FISCAL YEAR 2020. 
Expenditures made under any provision of law 
amended in this title pursuant to the amendments made 
by the Continuing Appropriations Act, 2020, and Health 
Extenders Act of 2019 (Public Law 116–59), the Further 
Continuing Appropriations Act, 2020, and Further Health 
Extenders Act of 2019 (Public Law 116–69), and the Fur-
ther Consolidated Appropriations Act, 2020 (Public Law 
116–94) for fiscal year 2020 shall be charged to the applica-
ble appropriation or authorization provided by the amend-
ments made by this title to such provision of law for such 
fiscal year. 
Subtitle F—Over-the-Counter Drugs 
PART I—OTC DRUG REVIEW 
SEC. 3851. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 505F of such Act (21 U.S.C. 355g) the following:
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† HR 748 EAS 
‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITHOUT 
AN APPROVED APPLICATION.—Nonprescription drugs mar-
keted without an approved drug application under section 
505, as of the date of the enactment of this section, shall 
be treated in accordance with this subsection. 
‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 
CATEGORY I DRUGS SUBJECT TO A TENTATIVE FINAL 
MONOGRAPH.—A drug is deemed to be generally rec-
ognized as safe and effective under section 201(p)(1), 
not a new drug under section 201(p), and not subject 
to section 503(b)(1), if— 
‘‘(A) the drug is— 
‘‘(i) in conformity with the require-
ments for nonprescription use of a final 
monograph issued under part 330 of title 
21, Code of Federal Regulations (except as 
provided in paragraph (2)), the general re-
quirements for nonprescription drugs, and 
conditions or requirements under sub-
sections (b), (c), and (k); and 
‘‘(ii) except as permitted by an order 
issued under subsection (b) or, in the case 
of a minor change in the drug, in con-
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formity with an order issued under sub-
section (c), in a dosage form that, imme-
diately prior to the date of the enactment of 
this section, has been used to a material ex-
tent and for a material time under section 
201(p)(2); or 
‘‘(B) the drug is— 
‘‘(i) classified in category I for safety 
and effectiveness under a tentative final 
monograph that is the most recently appli-
cable proposal or determination issued 
under part 330 of title 21, Code of Federal 
Regulations; 
‘‘(ii) in conformity with the proposed 
requirements for nonprescription use of such 
tentative final monograph, any applicable 
subsequent determination by the Secretary, 
the general requirements for nonprescription 
drugs, and conditions or requirements 
under subsections (b), (c), and (k); and 
‘‘(iii) except as permitted by an order 
issued under subsection (b) or, in the case 
of a minor change in the drug, in con-
formity with an order issued under sub-
section (c), in a dosage form that, imme-
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diately prior to the date of the enactment of 
this section, has been used to a material ex-
tent and for a material time under section 
201(p)(2). 
‘‘(2) TREATMENT OF SUNSCREEN DRUGS.—With 
respect to sunscreen drugs subject to this section, the 
applicable requirements in terms of conformity with 
a final monograph, for purposes of paragraph 
(1)(A)(i), shall be the requirements specified in part 
352 of title 21, Code of Federal Regulations, as pub-
lished on May 21, 1999, beginning on page 27687 of 
volume 64 of the Federal Register, except that the ap-
plicable requirements governing effectiveness and la-
beling shall be those specified in section 201.327 of 
title 21, Code of Federal Regulations. 
‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN-
TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS SUB-
JECT TO PROPOSED MONOGRAPH OR ADVANCE NOTICE 
OF PROPOSED RULEMAKING.—A drug that is not de-
scribed in paragraph (1), (2), or (4) is not required 
to be the subject of an application approved under 
section 505, and is not subject to section 503(b)(1), 
if— 
‘‘(A) the drug is—
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‘‘(i) classified in category III for safety 
or effectiveness in the preamble of a pro-
posed rule establishing a tentative final 
monograph that is the most recently appli-
cable proposal or determination for such 
drug issued under part 330 of title 21, Code 
of Federal Regulations; 
‘‘(ii) in conformity with— 
‘‘(I) the conditions of use, includ-
ing indication and dosage strength, if 
any, described for such category III 
drug in such preamble or in an appli-
cable subsequent proposed rule; 
‘‘(II) the proposed requirements 
for drugs classified in such tentative 
final monograph in category I in the 
most recently proposed rule estab-
lishing requirements related to such 
tentative final monograph and in any 
final rule establishing requirements 
that are applicable to the drug; and 
‘‘(III) the general requirements for 
nonprescription drugs and conditions 
or requirements under subsection (b) or 
(k); and
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‘‘(iii) in a dosage form that, imme-
diately prior to the date of the enactment of 
this section, had been used to a material ex-
tent and for a material time under section 
201(p)(2); or 
‘‘(B) the drug is— 
‘‘(i) classified in category I for safety 
and effectiveness under a proposed mono-
graph or advance notice of proposed rule-
making that is the most recently applicable 
proposal or determination for such drug 
issued under part 330 of title 21, Code of 
Federal Regulations; 
‘‘(ii) in conformity with the require-
ments for nonprescription use of such pro-
posed monograph or advance notice of pro-
posed rulemaking, any applicable subse-
quent determination by the Secretary, the 
general requirements for nonprescription 
drugs, and conditions or requirements 
under subsection (b) or (k); and 
‘‘(iii) in a dosage form that, imme-
diately prior to the date of the enactment of 
this section, has been used to a material ex-
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tent and for a material time under section 
201(p)(2). 
‘‘(4) 
CATEGORY
II
DRUGS
DEEMED
NEW 
DRUGS.—A drug that is classified in category II for 
safety or effectiveness under a tentative final mono-
graph or that is subject to a determination to be not 
generally recognized as safe and effective in a pro-
posed rule that is the most recently applicable pro-
posal issued under part 330 of title 21, Code of Fed-
eral Regulations, shall be deemed to be a new drug 
under section 201(p), misbranded under section 
502(ee), and subject to the requirement for an ap-
proved new drug application under section 505 begin-
ning on the day that is 180 calendar days after the 
date of the enactment of this section, unless, before 
such day, the Secretary determines that it is in the 
interest of public health to extend the period during 
which the drug may be marketed without such an ap-
proved new drug application. 
‘‘(5) DRUGS NOT GRASE DEEMED NEW DRUGS.— 
A drug that the Secretary has determined not to be 
generally recognized as safe and effective under sec-
tion 201(p)(1) under a final determination issued 
under part 330 of title 21, Code of Federal Regula-
tions, shall be deemed to be a new drug under section
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201(p), misbranded under section 502(ee), and subject 
to the requirement for an approved new drug applica-
tion under section 505. 
‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.—Ex-
cept as provided in subsection (m), a drug is deemed 
to be a new drug under section 201(p) and mis-
branded under section 502(ee) if the drug— 
‘‘(A) is not subject to section 503(b)(1); and 
‘‘(B) is not described in paragraph (1), (2), 
(3), (4), or (5), or subsection (b)(1)(B). 
‘‘(b) ADMINISTRATIVE ORDERS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) 
DETERMINATION.—The 
Secretary 
may, on the initiative of the Secretary or at the 
request of one or more requestors, issue an ad-
ministrative order determining whether there are 
conditions under which a specific drug, a class 
of drugs, or a combination of drugs, is deter-
mined to be— 
‘‘(i) not subject to section 503(b)(1); 
and 
‘‘(ii) generally recognized as safe and 
effective under section 201(p)(1). 
‘‘(B) EFFECT.—A drug or combination of 
drugs shall be deemed to not require approval
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† HR 748 EAS 
under section 505 if such drug or combination of 
drugs— 
‘‘(i) is determined by the Secretary to 
meet the conditions specified in clauses (i) 
and (ii) of subparagraph (A); 
‘‘(ii) is marketed in conformity with 
an administrative order under this sub-
section; 
‘‘(iii) meets the general requirements 
for nonprescription drugs; and 
‘‘(iv) meets the requirements under 
subsections (c) and (k). 
‘‘(C) STANDARD.—The Secretary shall find 
that a drug is not generally recognized as safe 
and effective under section 201(p)(1) if— 
‘‘(i) the evidence shows that the drug is 
not generally recognized as safe and effective 
under section 201(p)(1); or 
‘‘(ii) the evidence is inadequate to show 
that the drug is generally recognized as safe 
and effective under section 201(p)(1). 
‘‘(2) ADMINISTRATIVE
ORDERS
INITIATED
BY 
THE SECRETARY.—
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‘‘(A) IN GENERAL.—In issuing an adminis-
trative order under paragraph (1) upon the Sec-
retary’s initiative, the Secretary shall— 
‘‘(i) make reasonable efforts to notify 
informally, not later than 2 business days 
before the issuance of the proposed order, the 
sponsors of drugs who have a listing in ef-
fect under section 510(j) for the drugs or 
combination of drugs that will be subject to 
the administrative order; 
‘‘(ii) after any such reasonable efforts 
of notification— 
‘‘(I) issue a proposed administra-
tive order by publishing it on the 
website of the Food and Drug Adminis-
tration and include in such order the 
reasons for the issuance of such order; 
and 
‘‘(II) publish a notice of avail-
ability of such proposed order in the 
Federal Register; 
‘‘(iii) except as provided in subpara-
graph (B), provide for a public comment 
period with respect to such proposed order 
of not less than 45 calendar days; and
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† HR 748 EAS 
‘‘(iv) if, after completion of the pro-
ceedings specified in clauses (i) through 
(iii), the Secretary determines that it is ap-
propriate to issue a final administrative 
order— 
‘‘(I) issue the final administrative 
order, together with a detailed state-
ment of reasons, which order shall not 
take effect until the time for requesting 
judicial 
review 
under 
paragraph 
(3)(D)(ii) has expired; 
‘‘(II) publish a notice of such 
final administrative order in the Fed-
eral Register; 
‘‘(III) afford requestors of drugs 
that will be subject to such order the 
opportunity for formal dispute resolu-
tion up to the level of the Director of 
the Center for Drug Evaluation and 
Research, which initially must be re-
quested within 45 calendar days of the 
issuance of the order, and, for subse-
quent levels of appeal, within 30 cal-
endar days of the prior decision; and
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‘‘(IV) except with respect to drugs 
described in paragraph (3)(B), upon 
completion of the formal dispute reso-
lution procedure, inform the persons 
which sought such dispute resolution of 
their right to request a hearing. 
‘‘(B) EXCEPTIONS.—When issuing an ad-
ministrative order under paragraph (1) on the 
Secretary’s initiative proposing to determine 
that a drug described in subsection (a)(3) is not 
generally recognized as safe and effective under 
section 201(p)(1), the Secretary shall follow the 
procedures in subparagraph (A), except that— 
‘‘(i) the proposed order shall include 
notice of— 
‘‘(I) the general categories of data 
the Secretary has determined necessary 
to establish that the drug is generally 
recognized as safe and effective under 
section 201(p)(1); and 
‘‘(II) the format for submissions 
by interested persons; 
‘‘(ii) the Secretary shall provide for a 
public comment period of no less than 180 
calendar days with respect to such proposed
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† HR 748 EAS 
order, except when the Secretary determines, 
for good cause, that a shorter period is in 
the interest of public health; and 
‘‘(iii) any person who submits data in 
such comment period shall include a certifi-
cation that the person has submitted all evi-
dence created, obtained, or received by that 
person that is both within the categories of 
data identified in the proposed order and 
relevant to a determination as to whether 
the drug is generally recognized as safe and 
effective under section 201(p)(1). 
‘‘(3) HEARINGS; JUDICIAL REVIEW.— 
‘‘(A) IN
GENERAL.—Only a person who 
participated in each stage of formal dispute reso-
lution under subclause (III) of paragraph 
(2)(A)(iv) of an administrative order with re-
spect to a drug may request a hearing con-
cerning a final administrative order issued 
under such paragraph with respect to such drug. 
If a hearing is sought, such person must submit 
a request for a hearing, which shall be based sole-
ly on information in the administrative record, 
to the Secretary not later than 30 calendar days
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† HR 748 EAS 
after receiving notice of the final decision of the 
formal dispute resolution procedure. 
‘‘(B) NO
HEARING
REQUIRED
WITH
RE-
SPECT
TO
ORDERS
RELATING
TO
CERTAIN 
DRUGS.— 
‘‘(i) IN GENERAL.—The Secretary shall 
not be required to provide notice and an op-
portunity for a hearing pursuant to para-
graph (2)(A)(iv) if the final administrative 
order involved relates to a drug— 
‘‘(I) that is described in subsection 
(a)(3)(A); and 
‘‘(II) with respect to which no 
human or non-human data studies rel-
evant to the safety or effectiveness of 
such drug have been submitted to the 
administrative 
record 
since 
the 
issuance of the most recent tentative 
final monograph relating to such drug. 
‘‘(ii) HUMAN DATA STUDIES AND NON- 
HUMAN DATA DEFINED.—In this subpara-
graph: 
‘‘(I) The term ‘human data stud-
ies’ means clinical trials of safety or 
effectiveness (including actual use stud-
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† HR 748 EAS 
ies), pharmacokinetics studies, or bio-
availability studies. 
‘‘(II) The term ‘non-human data’ 
means data from testing other than 
with human subjects which provides 
information concerning safety or effec-
tiveness. 
‘‘(C) HEARING PROCEDURES.— 
‘‘(i) DENIAL OF REQUEST FOR HEAR-
ING.—If the Secretary determines that in-
formation submitted in a request for a hear-
ing under subparagraph (A) with respect to 
a final administrative order issued under 
paragraph (2)(A)(iv) does not identify the 
existence of a genuine and substantial ques-
tion of material fact, the Secretary may 
deny such request. In making such a deter-
mination, the Secretary may consider only 
information and data that are based on rel-
evant and reliable scientific principles and 
methodologies. 
‘‘(ii) SINGLE HEARING FOR MULTIPLE 
RELATED REQUESTS.—If more than one re-
quest for a hearing is submitted with re-
spect to the same administrative order
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† HR 748 EAS 
under subparagraph (A), the Secretary may 
direct that a single hearing be conducted in 
which all persons whose hearing requests 
were granted may participate. 
‘‘(iii) PRESIDING OFFICER.—The pre-
siding officer of a hearing requested under 
subparagraph (A) shall— 
‘‘(I) be designated by the Sec-
retary; 
‘‘(II) not be an employee of the 
Center for Drug Evaluation and Re-
search; and 
‘‘(III) not have been previously 
involved in the development of the ad-
ministrative order involved or pro-
ceedings relating to that administra-
tive order. 
‘‘(iv) RIGHTS OF PARTIES TO HEAR-
ING.—The parties to a hearing requested 
under subparagraph (A) shall have the right 
to present testimony, including testimony of 
expert witnesses, and to cross-examine wit-
nesses presented by other parties. Where ap-
propriate, the presiding officer may require 
that cross-examination by parties rep-
420 
† HR 748 EAS 
resenting substantially the same interests be 
consolidated to promote efficiency and avoid 
duplication. 
‘‘(v) FINAL DECISION.— 
‘‘(I) At the conclusion of a hear-
ing requested under subparagraph (A), 
the presiding officer of the hearing 
shall issue a decision containing find-
ings of fact and conclusions of law. The 
decision of the presiding officer shall be 
final. 
‘‘(II) The final decision may not 
take effect until the period under sub-
paragraph (D)(ii) for submitting a re-
quest for judicial review of such deci-
sion expires. 
‘‘(D) JUDICIAL REVIEW OF FINAL ADMINIS-
TRATIVE ORDER.— 
‘‘(i) IN GENERAL.—The procedures de-
scribed in section 505(h) shall apply with 
respect to judicial review of final adminis-
trative orders issued under this subsection 
in the same manner and to the same extent 
as such section applies to an order described 
in such section except that the judicial re-
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† HR 748 EAS 
view shall be taken by filing in an appro-
priate district court of the United States in 
lieu of the appellate courts specified in such 
section. 
‘‘(ii) PERIOD TO SUBMIT A REQUEST 
FOR JUDICIAL REVIEW.—A person eligible 
to request a hearing under this paragraph 
and seeking judicial review of a final ad-
ministrative order issued under this sub-
section shall file such request for judicial re-
view not later than 60 calendar days after 
the latest of— 
‘‘(I) the date on which notice of 
such order is published; 
‘‘(II) the date on which a hearing 
with respect to such order is denied 
under subparagraph (B) or (C)(i); 
‘‘(III) the date on which a final 
decision is made following a hearing 
under subparagraph (C)(v); or 
‘‘(IV) if no hearing is requested, 
the date on which the time for request-
ing a hearing expires.
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† HR 748 EAS 
‘‘(4) EXPEDITED PROCEDURE WITH RESPECT TO 
ADMINISTRATIVE
ORDERS
INITIATED
BY
THE
SEC-
RETARY.— 
‘‘(A) IMMINENT
HAZARD
TO
THE
PUBLIC 
HEALTH.— 
‘‘(i) IN GENERAL.—In the case of a de-
termination by the Secretary that a drug, 
class of drugs, or combination of drugs sub-
ject to this section poses an imminent haz-
ard to the public health, the Secretary, after 
first making reasonable efforts to notify, not 
later than 48 hours before issuance of such 
order under this subparagraph, sponsors 
who have a listing in effect under section 
510(j) for such drug or combination of 
drugs— 
‘‘(I) may issue an interim final 
administrative order for such drug, 
class of drugs, or combination of drugs 
under paragraph (1), together with a 
detailed statement of the reasons for 
such order; 
‘‘(II) shall publish in the Federal 
Register a notice of availability of any 
such order; and
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‘‘(III) shall provide for a public 
comment period of at least 45 calendar 
days with respect to such interim final 
order. 
‘‘(ii) NONDELEGATION.—The Secretary 
may not delegate the authority to issue an 
interim final administrative order under 
this subparagraph. 
‘‘(B) SAFETY LABELING CHANGES.— 
‘‘(i) IN GENERAL.—In the case of a de-
termination by the Secretary that a change 
in the labeling of a drug, class of drugs, or 
combination of drugs subject to this section 
is reasonably expected to mitigate a signifi-
cant or unreasonable risk of a serious ad-
verse event associated with use of the drug, 
the Secretary may— 
‘‘(I) make reasonable efforts to no-
tify informally, not later than 48 hours 
before the issuance of the interim final 
order, the sponsors of drugs who have 
a listing in effect under section 510(j) 
for such drug or combination of drugs; 
‘‘(II) after reasonable efforts of no-
tification, issue an interim final ad-
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† HR 748 EAS 
ministrative order in accordance with 
paragraph (1) to require such change, 
together with a detailed statement of 
the reasons for such order; 
‘‘(III) publish in the Federal Reg-
ister a notice of availability of such 
order; and 
‘‘(IV) provide for a public com-
ment period of at least 45 calendar 
days with respect to such interim final 
order. 
‘‘(ii) CONTENT
OF
ORDER.—An in-
terim final order issued under this subpara-
graph with respect to the labeling of a drug 
may provide for new warnings and other 
information required for safe use of the 
drug. 
‘‘(C) EFFECTIVE
DATE.—An order under 
subparagraph (A) or (B) shall take effect on a 
date specified by the Secretary. 
‘‘(D) FINAL ORDER.—After the completion 
of the proceedings in subparagraph (A) or (B), 
the Secretary shall— 
‘‘(i) issue a final order in accordance 
with paragraph (1);
425 
† HR 748 EAS 
‘‘(ii) publish a notice of availability of 
such final administrative order in the Fed-
eral Register; and 
‘‘(iii) afford sponsors of such drugs 
that will be subject to such an order the op-
portunity for formal dispute resolution up 
to the level of the Director of the Center for 
Drug Evaluation and Research, which must 
initially be within 45 calendar days of the 
issuance of the order, and for subsequent 
levels of appeal, within 30 calendar days of 
the prior decision. 
‘‘(E) HEARINGS.—A sponsor of a drug sub-
ject to a final order issued under subparagraph 
(D) and that participated in each stage of for-
mal dispute resolution under clause (iii) of such 
subparagraph may request a hearing on such 
order. The provisions of subparagraphs (A), (B), 
and (C) of paragraph (3), other than paragraph 
(3)(C)(v)(II), shall apply with respect to a hear-
ing on such order in the same manner and to the 
same extent as such provisions apply with re-
spect to a hearing on an administrative order 
issued under paragraph (2)(A)(iv). 
‘‘(F) TIMING.—
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‘‘(i) FINAL ORDER AND HEARING.—The 
Secretary shall— 
‘‘(I) not later than 6 months after 
the date on which the comment period 
closes under subparagraph (A) or (B), 
issue a final order in accordance with 
paragraph (1); and 
‘‘(II) not later than 12 months 
after the date on which such final 
order is issued, complete any hearing 
under subparagraph (E). 
‘‘(ii) 
DISPUTE
RESOLUTION
RE-
QUEST.—The Secretary shall specify in an 
interim final order issued under subpara-
graph (A) or (B) such shorter periods for 
requesting dispute resolution under sub-
paragraph (D)(iii) as are necessary to meet 
the requirements of this subparagraph. 
‘‘(G) JUDICIAL
REVIEW.—A final order 
issued pursuant to subparagraph (F) shall be 
subject to judicial review in accordance with 
paragraph (3)(D). 
‘‘(5) ADMINISTRATIVE ORDER INITIATED AT THE 
REQUEST OF A REQUESTOR.—
427 
† HR 748 EAS 
‘‘(A) IN GENERAL.—In issuing an adminis-
trative order under paragraph (1) at the request 
of a requestor with respect to certain drugs, 
classes of drugs, or combinations of drugs— 
‘‘(i) the Secretary shall, after receiving 
a request under this subparagraph, deter-
mine whether the request is sufficiently 
complete and formatted to permit a sub-
stantive review; 
‘‘(ii) if the Secretary determines that 
the request is sufficiently complete and for-
matted to permit a substantive review, the 
Secretary shall— 
‘‘(I) file the request; and 
‘‘(II) initiate proceedings with re-
spect to issuing an administrative 
order in accordance with paragraphs 
(2) and (3); and 
‘‘(iii) except as provided in paragraph 
(6), if the Secretary determines that a re-
quest does not meet the requirements for fil-
ing or is not sufficiently complete and for-
matted to permit a substantive review, the 
requestor may demand that the request be 
filed over protest, and the Secretary shall
428 
† HR 748 EAS 
initiate proceedings to review the request in 
accordance with paragraph (2)(A). 
‘‘(B) 
REQUEST
TO
INITIATE
PRO-
CEEDINGS.— 
‘‘(i) IN GENERAL.—A requestor seeking 
an administrative order under paragraph 
(1) with respect to certain drugs, classes of 
drugs, or combinations of drugs, shall sub-
mit to the Secretary a request to initiate 
proceedings for such order in the form and 
manner as specified by the Secretary. Such 
requestor may submit a request under this 
subparagraph for the issuance of an admin-
istrative order— 
‘‘(I) determining whether a drug 
is generally recognized as safe and ef-
fective under section 201(p)(1), exempt 
from section 503(b)(1), and not re-
quired to be the subject of an approved 
application under section 505; or 
‘‘(II) 
determining 
whether 
a 
change to a condition of use of a drug 
is generally recognized as safe and ef-
fective under section 201(p)(1), exempt 
from section 503(b)(1), and not re-
429 
† HR 748 EAS 
quired to be the subject of an approved 
application under section 505, if, ab-
sent such a changed condition of use, 
such drug is— 
‘‘(aa) generally recognized as 
safe and effective under section 
201(p)(1) in accordance with sub-
section (a)(1), (a)(2), or an order 
under this subsection; or 
‘‘(bb) subject to subsection 
(a)(3), but only if such requestor 
initiates such request in conjunc-
tion with a request for the Sec-
retary to determine whether such 
drug is generally recognized as 
safe and effective under section 
201(p)(1), which is filed by the 
Secretary 
under 
subparagraph 
(A)(ii). 
‘‘(ii) EXCEPTION.—The Secretary is 
not required to complete review of a request 
for a change described in clause (i)(II) if 
the Secretary determines that there is an 
inadequate basis to find the drug is gen-
erally recognized as safe and effective under
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† HR 748 EAS 
section 201(p)(1) under paragraph (1) and 
issues a final order announcing that deter-
mination. 
‘‘(iii) WITHDRAWAL.—The requestor 
may withdraw a request under this para-
graph, according to the procedures set forth 
pursuant to subsection (d)(2)(B). Notwith-
standing any other provision of this section, 
if such request is withdrawn, the Secretary 
may cease proceedings under this subpara-
graph. 
‘‘(C) EXCLUSIVITY.— 
‘‘(i) IN GENERAL.—A final adminis-
trative order issued in response to a request 
under this section shall have the effect of au-
thorizing solely the order requestor (or the 
licensees, assignees, or successors in interest 
of such requestor with respect to the subject 
of such order), for a period of 18 months 
following the effective date of such final 
order and beginning on the date the re-
questor may lawfully market such drugs 
pursuant to the order, to market drugs— 
‘‘(I) incorporating changes de-
scribed in clause (ii); and
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† HR 748 EAS 
‘‘(II) subject to the limitations 
under clause (iv). 
‘‘(ii) CHANGES DESCRIBED.—A change 
described in this clause is a change subject 
to an order specified in clause (i), which— 
‘‘(I) provides for a drug to con-
tain an active ingredient (including 
any ester or salt of the active ingre-
dient) not previously incorporated in a 
drug described in clause (iii); or 
‘‘(II) provides for a change in the 
conditions of use of a drug, for which 
new human data studies conducted or 
sponsored by the requestor (or for 
which the requestor has an exclusive 
right of reference) were essential to the 
issuance of such order. 
‘‘(iii) DRUGS DESCRIBED.—The drugs 
described in this clause are drugs— 
‘‘(I) specified in subsection (a)(1), 
(a)(2), or (a)(3); 
‘‘(II) subject to a final order 
issued under this section;
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† HR 748 EAS 
‘‘(III) subject to a final sunscreen 
order (as defined in section 586(2)(A)); 
or 
‘‘(IV) 
described 
in 
subsection 
(m)(1), other than drugs subject to an 
active enforcement action under chap-
ter III of this Act. 
‘‘(iv) LIMITATIONS ON EXCLUSIVITY.— 
‘‘(I) IN GENERAL.—Only one 18- 
month period under this subparagraph 
shall be granted, under each order de-
scribed in clause (i), with respect to 
changes (to the drug subject to such 
order) which are either— 
‘‘(aa) changes described in 
clause (ii)(I), relating to active 
ingredients; or 
‘‘(bb) changes described in 
clause (ii)(II), relating to condi-
tions of use. 
‘‘(II) 
NO
EXCLUSIVITY
AL-
LOWED.—No exclusivity shall apply to 
changes to a drug which are—
433 
† HR 748 EAS 
‘‘(aa) the subject of a Tier 2 
OTC monograph order request (as 
defined in section 744L); 
‘‘(bb) safety-related changes, 
as defined by the Secretary, or 
any other changes the Secretary 
considers necessary to assure safe 
use; or 
‘‘(cc) 
changes 
related 
to 
methods of testing safety or effi-
cacy. 
‘‘(v) NEW HUMAN DATA STUDIES DE-
FINED.—In this subparagraph, the term 
‘new human data studies’ means clinical 
trials of safety or effectiveness (including 
actual use studies), pharmacokinetics stud-
ies, or bioavailability studies, the results of 
which— 
‘‘(I) have not been relied on by the 
Secretary to support— 
‘‘(aa) a proposed or final de-
termination that a drug described 
in subclause (I), (II), or (III) of 
clause (iii) is generally recognized
434 
† HR 748 EAS 
as safe and effective under section 
201(p)(1); or 
‘‘(bb) approval of a drug that 
was approved under section 505; 
and 
‘‘(II) do not duplicate the results 
of another study that was relied on by 
the Secretary to support— 
‘‘(aa) a proposed or final de-
termination that a drug described 
in subclause (I), (II), or (III) of 
clause (iii) is generally recognized 
as safe and effective under section 
201(p)(1); or 
‘‘(bb) approval of a drug that 
was approved under section 505. 
‘‘(vi) NOTIFICATION
OF
DRUG
NOT 
AVAILABLE FOR SALE.—A requestor that is 
granted exclusivity with respect to a drug 
under this subparagraph shall notify the 
Secretary in writing within 1 year of the 
issuance of the final administrative order if 
the drug that is the subject of such order 
will not be available for sale within 1 year
435 
† HR 748 EAS 
of the date of issuance of such order. The re-
questor shall include with such notice the— 
‘‘(I) identity of the drug by estab-
lished name and by proprietary name, 
if any; 
‘‘(II) strength of the drug; 
‘‘(III) date on which the drug will 
be available for sale, if known; and 
‘‘(IV) reason for not marketing 
the drug after issuance of the order. 
‘‘(6) 
INFORMATION
REGARDING
SAFE
NON-
PRESCRIPTION MARKETING AND USE AS CONDITION 
FOR FILING A GENERALLY RECOGNIZED AS SAFE AND 
EFFECTIVE REQUEST.— 
‘‘(A) IN GENERAL.—In response to a request 
under this section that a drug described in sub-
paragraph (B) be generally recognized as safe 
and effective, the Secretary— 
‘‘(i) may file such request, if the re-
quest includes information specified under 
subparagraph (C) with respect to safe non-
prescription marketing and use of such 
drug; or 
‘‘(ii) if the request fails to include in-
formation specified under subparagraph
436 
† HR 748 EAS 
(C), shall refuse to file such request and re-
quire that nonprescription marketing of the 
drug be pursuant to a new drug application 
as described in subparagraph (D). 
‘‘(B) DRUG DESCRIBED.—A drug described 
in this subparagraph is a nonprescription drug 
which contains an active ingredient not pre-
viously incorporated in a drug— 
‘‘(i) specified in subsection (a)(1), 
(a)(2), or (a)(3); 
‘‘(ii) subject to a final order under this 
section; or 
‘‘(iii) subject to a final sunscreen order 
(as defined in section 586(2)(A)). 
‘‘(C) INFORMATION DEMONSTRATING PRIMA 
FACIE SAFE NONPRESCRIPTION MARKETING AND 
USE.—Information specified in this subpara-
graph, with respect to a request described in sub-
paragraph (A)(i), is— 
‘‘(i) information sufficient for a prima 
facie demonstration that the drug subject to 
such request has a verifiable history of being 
marketed and safely used by consumers in 
the United States as a nonprescription drug 
under comparable conditions of use;
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† HR 748 EAS 
‘‘(ii) if the drug has not been pre-
viously marketed in the United States as a 
nonprescription drug, information sufficient 
for a prima facie demonstration that the 
drug was marketed and safely used under 
comparable conditions of marketing and use 
in a country listed in section 802(b)(1)(A) 
or designated by the Secretary in accord-
ance with section 802(b)(1)(B)— 
‘‘(I) for such period as needed to 
provide reasonable assurances con-
cerning the safe nonprescription use of 
the drug; and 
‘‘(II) during such time was sub-
ject to sufficient monitoring by a regu-
latory body considered acceptable by 
the Secretary for such monitoring pur-
poses, including for adverse events as-
sociated with nonprescription use of 
the drug; or 
‘‘(iii) if the Secretary determines that 
information described in clause (i) or (ii) is 
not needed to provide a prima facie dem-
onstration that the drug can be safely mar-
keted and used as a nonprescription drug,
438 
† HR 748 EAS 
such other information the Secretary deter-
mines is sufficient for such purposes. 
‘‘(D) MARKETING PURSUANT TO NEW DRUG 
APPLICATION.—In the case of a request described 
in subparagraph (A)(ii), the drug subject to such 
request may be resubmitted for filing only if— 
‘‘(i) the drug is marketed as a non-
prescription drug, under conditions of use 
comparable to the conditions specified in 
the request, for such period as the Secretary 
determines appropriate (not to exceed 5 
consecutive years) pursuant to an applica-
tion approved under section 505; and 
‘‘(ii) during such period, 1,000,000 re-
tail packages of the drug, or an equivalent 
quantity as determined by the Secretary, 
were distributed for retail sale, as deter-
mined in such manner as the Secretary 
finds appropriate. 
‘‘(E) RULE
OF
APPLICATION.—Except in 
the case of a request involving a drug described 
in section 586(9), as in effect on January 1, 
2017, if the Secretary refuses to file a request 
under this paragraph, the requestor may not file
439 
† HR 748 EAS 
such request over protest under paragraph 
(5)(A)(iii). 
‘‘(7) 
PACKAGING.—An 
administrative 
order 
issued under paragraph (2), (4)(A), or (5) may in-
clude requirements for the packaging of a drug to en-
courage use in accordance with labeling. Such re-
quirements may include unit dose packaging, require-
ments for products intended for use by pediatric pop-
ulations, requirements to reduce risk of harm from 
unsupervised ingestion, and other appropriate re-
quirements. This paragraph does not authorize the 
Food and Drug Administration to require standards 
or testing procedures as described in part 1700 of title 
16, Code of Federal Regulations. 
‘‘(8) FINAL AND TENTATIVE FINAL MONOGRAPHS 
FOR CATEGORY I DRUGS DEEMED FINAL ADMINISTRA-
TIVE ORDERS.— 
‘‘(A) IN GENERAL.—A final monograph or 
tentative final monograph described in subpara-
graph (B) shall be deemed to be a final adminis-
trative order under this subsection and may be 
amended, revoked, or otherwise modified in ac-
cordance with the procedures of this subsection. 
‘‘(B) MONOGRAPHS DESCRIBED.—For pur-
poses of subparagraph (A), a final monograph or
440 
† HR 748 EAS 
tentative final monograph is described in this 
subparagraph if it— 
‘‘(i) establishes conditions of use for a 
drug described in paragraph (1) or (2) of 
subsection (a); and 
‘‘(ii) represents the most recently pro-
mulgated version of such conditions, includ-
ing as modified, in whole or in part, by 
any proposed or final rule. 
‘‘(C) DEEMED
ORDERS
INCLUDE
HARMO-
NIZING TECHNICAL AMENDMENTS.—The deemed 
establishment of a final administrative order 
under subparagraph (A) shall be construed to in-
clude any technical amendments to such order as 
the Secretary determines necessary to ensure that 
such order is appropriately harmonized, in 
terms of terminology or cross-references, with the 
applicable provisions of this Act (and regulations 
thereunder) and any other orders issued under 
this section. 
‘‘(c) PROCEDURE FOR MINOR CHANGES.— 
‘‘(1) IN GENERAL.—Minor changes in the dosage 
form of a drug that is described in paragraph (1) or 
(2) of subsection (a) or the subject of an order issued 
under subsection (b) may be made by a requestor
441 
† HR 748 EAS 
without the issuance of an order under subsection (b) 
if— 
‘‘(A) the requestor maintains such informa-
tion as is necessary to demonstrate that the 
change— 
‘‘(i) will not affect the safety or effec-
tiveness of the drug; and 
‘‘(ii) will not materially affect the ex-
tent of absorption or other exposure to the 
active ingredient in comparison to a suit-
able reference product; and 
‘‘(B) the change is in conformity with the 
requirements of an applicable administrative 
order issued by the Secretary under paragraph 
(3). 
‘‘(2) ADDITIONAL INFORMATION.— 
‘‘(A) ACCESS
TO
RECORDS.—A sponsor 
shall submit records requested by the Secretary 
relating to such a minor change under section 
704(a)(4), within 15 business days of receiving 
such a request, or such longer period as the Sec-
retary may provide. 
‘‘(B) INSUFFICIENT
INFORMATION.—If the 
Secretary determines that the information con-
tained in such records is not sufficient to dem-
442 
† HR 748 EAS 
onstrate that the change does not affect the safety 
or effectiveness of the drug or materially affect 
the extent of absorption or other exposure to the 
active ingredient, the Secretary— 
‘‘(i) may so inform the sponsor of the 
drug in writing; and 
‘‘(ii) if the Secretary so informs the 
sponsor, shall provide the sponsor of the 
drug with a reasonable opportunity to pro-
vide additional information. 
‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN-
FORMATION.—If the sponsor fails to provide such 
additional information within a time prescribed 
by the Secretary, or if the Secretary determines 
that such additional information does not dem-
onstrate that the change does not— 
‘‘(i) affect the safety or effectiveness of 
the drug; or 
‘‘(ii) materially affect the extent of ab-
sorption or other exposure to the active in-
gredient in comparison to a suitable ref-
erence product, 
the drug as modified is a new drug under section 
201(p) and shall be deemed to be misbranded 
under section 502(ee).
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† HR 748 EAS 
‘‘(3) DETERMINING WHETHER A CHANGE WILL 
AFFECT SAFETY OR EFFECTIVENESS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
issue one or more administrative orders speci-
fying requirements for determining whether a 
minor change made by a sponsor pursuant to 
this subsection will affect the safety or effective-
ness of a drug or materially affect the extent of 
absorption or other exposure to an active ingre-
dient in the drug in comparison to a suitable 
reference product, together with guidance for ap-
plying those orders to specific dosage forms. 
‘‘(B) STANDARD
PRACTICES.—The orders 
and guidance issued by the Secretary under sub-
paragraph (A) shall take into account relevant 
public standards and standard practices for 
evaluating the quality of drugs, and may take 
into account the special needs of populations, in-
cluding children. 
‘‘(d) CONFIDENTIALITY OF INFORMATION SUBMITTED 
TO THE SECRETARY.— 
‘‘(1) IN
GENERAL.—Subject to paragraph (2), 
any information, including reports of testing con-
ducted on the drug or drugs involved, that is sub-
mitted by a requestor in connection with proceedings
444 
† HR 748 EAS 
on an order under this section (including any minor 
change under subsection (c)) and is a trade secret or 
confidential information subject to section 552(b)(4) 
of title 5, United States Code, or section 1905 of title 
18, United States Code, shall not be disclosed to the 
public unless the requestor consents to that disclosure. 
‘‘(2) PUBLIC AVAILABILITY.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Secretary shall— 
‘‘(i) make any information submitted 
by a requestor in support of a request under 
subsection (b)(5)(A) available to the public 
not later than the date on which the pro-
posed order is issued; and 
‘‘(ii) make any information submitted 
by any other person with respect to an 
order requested (or initiated by the Sec-
retary) under subsection (b), available to 
the public upon such submission. 
‘‘(B) 
LIMITATIONS
ON
PUBLIC
AVAIL-
ABILITY.—Information described in subpara-
graph (A) shall not be made public if— 
‘‘(i) the information pertains to phar-
maceutical quality information, unless such 
information is necessary to establish stand-
445 
† HR 748 EAS 
ards under which a drug is generally recog-
nized as safe and effective under section 
201(p)(1); 
‘‘(ii) the information is submitted in a 
requestor-initiated request, but the requestor 
withdraws such request, in accordance with 
withdrawal procedures established by the 
Secretary, before the Secretary issues the 
proposed order; 
‘‘(iii) the Secretary requests and ob-
tains the information under subsection (c) 
and such information is not submitted in 
relation to an order under subsection (b); or 
‘‘(iv) the information is of the type 
contained in raw datasets. 
‘‘(e) UPDATES TO DRUG LISTING INFORMATION.—A 
sponsor who makes a change to a drug subject to this section 
shall submit updated drug listing information for the drug 
in accordance with section 510(j) within 30 calendar days 
of the date when the drug is first commercially marketed, 
except that a sponsor who was the order requestor with re-
spect to an order subject to subsection (b)(5)(C) (or a li-
censee, assignee, or successor in interest of such requestor) 
shall submit updated drug listing information on or before 
the date when the drug is first commercially marketed.
446 
† HR 748 EAS 
‘‘(f) APPROVALS UNDER SECTION 505.—The provi-
sions of this section shall not be construed to preclude a 
person from seeking or maintaining the approval of an ap-
plication for a drug under sections 505(b)(1), 505(b)(2), 
and 505(j). A determination under this section that a drug 
is not subject to section 503(b)(1), is generally recognized 
as safe and effective under section 201(p)(1), and is not 
a new drug under section 201(p) shall constitute a finding 
that the drug is safe and effective that may be relied upon 
for purposes of an application under section 505(b)(2), so 
that the applicant shall be required to submit for purposes 
of such application only information needed to support any 
modification of the drug that is not covered by such deter-
mination under this section. 
‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR-
DERS.—The Secretary shall establish, maintain, update (as 
determined necessary by the Secretary but no less frequently 
than annually), and make publicly available, with respect 
to orders issued under this section— 
‘‘(1) a repository of each final order and interim 
final order in effect, including the complete text of the 
order; and 
‘‘(2) a listing of all orders proposed and under 
development under subsection (b)(2), including—
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† HR 748 EAS 
‘‘(A) a brief description of each such order; 
and 
‘‘(B) the Secretary’s expectations, if re-
sources permit, for issuance of proposed orders 
over a 3-year period. 
‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE-
QUESTORS.—The Secretary shall establish procedures under 
which sponsors or requestors may meet with appropriate 
officials of the Food and Drug Administration to obtain 
advice on the studies and other information necessary to 
support submissions under this section and other matters 
relevant to the regulation of nonprescription drugs and the 
development of new nonprescription drugs under this sec-
tion. 
‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE-
QUESTORS.—The Secretary shall establish procedures to fa-
cilitate efficient participation by multiple sponsors or re-
questors in proceedings under this section, including provi-
sion for joint meetings with multiple sponsors or requestors 
or with organizations nominated by sponsors or requestors 
to represent their interests in a proceeding. 
‘‘(j) ELECTRONIC FORMAT.—All submissions under 
this section shall be in electronic format. 
‘‘(k) EFFECT ON EXISTING REGULATIONS GOVERNING 
NONPRESCRIPTION DRUGS.—
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† HR 748 EAS 
‘‘(1) REGULATIONS OF GENERAL APPLICABILITY 
TO NONPRESCRIPTION DRUGS.—Except as provided in 
this subsection, nothing in this section supersedes reg-
ulations establishing general requirements for non-
prescription drugs, including regulations of general 
applicability contained in parts 201, 250, and 330 of 
title 21, Code of Federal Regulations, or any successor 
regulations. The Secretary shall establish or modify 
such regulations by means of rulemaking in accord-
ance with section 553 of title 5, United States Code. 
‘‘(2) REGULATIONS
ESTABLISHING
REQUIRE-
MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 
‘‘(A) The provisions of section 310.545 of 
title 21, Code of Federal Regulations, as in effect 
on the day before the date of the enactment of 
this section, shall be deemed to be a final order 
under subsection (b). 
‘‘(B) Regulations in effect on the day before 
the date of the enactment of this section, estab-
lishing requirements for specific nonprescription 
drugs marketed pursuant to this section (includ-
ing such requirements in parts 201 and 250 of 
title 21, Code of Federal Regulations), shall be 
deemed to be final orders under subsection (b), 
only as they apply to drugs—
449 
† HR 748 EAS 
‘‘(i) subject to paragraph (1), (2), (3), 
or (4) of subsection (a); or 
‘‘(ii) otherwise subject to an order 
under this section. 
‘‘(3) WITHDRAWAL OF REGULATIONS.—The Sec-
retary shall withdraw regulations establishing final 
monographs and the procedures governing the over- 
the-counter drug review under part 330 and other rel-
evant parts of title 21, Code of Federal Regulations 
(as in effect on the day before the date of the enact-
ment of this section), or make technical changes to 
such regulations to ensure conformity with appro-
priate terminology and cross references. Notwith-
standing subchapter II of chapter 5 of title 5, United 
States Code, any such withdrawal or technical 
changes shall be made without public notice and com-
ment and shall be effective upon publication through 
notice in the Federal Register (or upon such date as 
specified in such notice). 
‘‘(l) GUIDANCE.—The Secretary shall issue guidance 
that specifies— 
‘‘(1) the procedures and principles for formal 
meetings between the Secretary and sponsors or re-
questors for drugs subject to this section;
450 
† HR 748 EAS 
‘‘(2) the format and content of data submissions 
to the Secretary under this section; 
‘‘(3) the format of electronic submissions to the 
Secretary under this section; 
‘‘(4) consolidated proceedings for appeal and the 
procedures for such proceedings where appropriate; 
and 
‘‘(5) for minor changes in drugs, recommenda-
tions on how to comply with the requirements in or-
ders issued under subsection (c)(3). 
‘‘(m) RULE OF CONSTRUCTION.— 
‘‘(1) IN GENERAL.—This section shall not affect 
the treatment or status of a nonprescription drug— 
‘‘(A) that is marketed without an applica-
tion approved under section 505 as of the date 
of the enactment of this section; 
‘‘(B) that is not subject to an order issued 
under this section; and 
‘‘(C) to which paragraph (1), (2), (3), (4), 
or (5) of subsection (a) do not apply. 
‘‘(2) TREATMENT
OF
PRODUCTS
PREVIOUSLY 
FOUND TO BE SUBJECT TO TIME AND EXTENT RE-
QUIREMENTS.— 
‘‘(A) Notwithstanding subsection (a), a drug 
described in subparagraph (B) may only be law-
451 
† HR 748 EAS 
fully marketed, without an application approved 
under section 505, pursuant to an order issued 
under this section. 
‘‘(B) A drug described in this subparagraph 
is a drug which, prior to the date of the enact-
ment of this section, the Secretary determined in 
a proposed or final rule to be ineligible for re-
view under the OTC drug review (as such phrase 
‘OTC drug review’ was used in section 330.14 of 
title 21, Code of Federal Regulations, as in effect 
on the day before the date of the enactment of 
this section). 
‘‘(3) PRESERVATION OF AUTHORITY.— 
‘‘(A) Nothing in paragraph (1) shall be con-
strued to preclude or limit the applicability of 
any provision of this Act other than this section. 
‘‘(B) Nothing in subsection (a) shall be con-
strued to prohibit the Secretary from issuing an 
order under this section finding a drug to be not 
generally recognized as safe and effective under 
section 201(p)(1), as the Secretary determines 
appropriate. 
‘‘(n) INVESTIGATIONAL NEW DRUGS.—A drug is not 
subject to this section if an exemption for investigational 
use under section 505(i) is in effect for such drug.
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‘‘(o) INAPPLICABILITY
OF PAPERWORK REDUCTION 
ACT.—Chapter 35 of title 44, United States Code, shall not 
apply to collections of information made under this section. 
‘‘(p) INAPPLICABILITY
OF NOTICE
AND COMMENT 
RULEMAKING AND OTHER REQUIREMENTS.—The require-
ments of subsection (b) shall apply with respect to orders 
issued under this section instead of the requirements of sub-
chapter II of chapter 5 of title 5, United States Code. 
‘‘(q) DEFINITIONS.—In this section: 
‘‘(1) The term ‘nonprescription drug’ refers to a 
drug not subject to the requirements of section 
503(b)(1). 
‘‘(2) The term ‘sponsor’ refers to any person 
marketing, manufacturing, or processing a drug 
that— 
‘‘(A) is listed pursuant to section 510(j); 
and 
‘‘(B) is or will be subject to an administra-
tive order under this section of the Food and 
Drug Administration. 
‘‘(3) The term ‘requestor’ refers to any person or 
group of persons marketing, manufacturing, proc-
essing, or developing a drug.’’. 
(b) GAO STUDY.—Not later than 4 years after the date 
of enactment of this Act, the Comptroller General of the
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United States shall submit a study to the Committee on 
Energy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pensions 
of the Senate addressing the effectiveness and overall impact 
of exclusivity under section 505G of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), and section 
586C of such Act (21 U.S.C. 360fff–3), including the impact 
of such exclusivity on consumer access. Such study shall in-
clude— 
(1) an analysis of the impact of exclusivity 
under such section 505G for nonprescription drug 
products, including— 
(A) the number of nonprescription drug 
products that were granted exclusivity and the 
indication for which the nonprescription drug 
products were determined to be generally recog-
nized as safe and effective; 
(B) whether the exclusivity for such drug 
products was granted for— 
(i) a new active ingredient (including 
any ester or salt of the active ingredient); or 
(ii) changes in the conditions of use of 
a drug, for which new human data studies 
conducted or sponsored by the requestor 
were essential;
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(C) whether, and to what extent, the exclu-
sivity impacted the requestor’s or sponsor’s deci-
sion to develop the drug product; 
(D) an analysis of the implementation of 
the exclusivity provision in such section 505G, 
including— 
(i) the resources used by the Food and 
Drug Administration; 
(ii) the impact of such provision on in-
novation, as well as research and develop-
ment in the nonprescription drug market; 
(iii) the impact of such provision on 
competition in the nonprescription drug 
market; 
(iv) the impact of such provision on 
consumer access to nonprescription drug 
products; 
(v) the impact of such provision on the 
prices of nonprescription drug products; 
and 
(vi) whether the administrative orders 
initiated by requestors under such section 
505G have been sufficient to encourage the 
development of nonprescription drug prod-
ucts that would likely not be otherwise de-
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veloped, or developed in as timely a man-
ner; and 
(E) whether the administrative orders initi-
ated by requestors under such section 505G have 
been sufficient incentive to encourage innovation 
in the nonprescription drug market; and 
(2) an analysis of the impact of exclusivity 
under such section 586C for sunscreen ingredients, in-
cluding— 
(A) the number of sunscreen ingredients 
that were granted exclusivity and the specific in-
gredient that was determined to be generally rec-
ognized as safe and effective; 
(B) whether, and to what extent, the exclu-
sivity impacted the requestor’s or sponsor’s deci-
sion to develop the sunscreen ingredient; 
(C) whether, and to what extent, the sun-
screen ingredient granted exclusivity had pre-
viously been available outside of the United 
States; 
(D) an analysis of the implementation of 
the exclusivity provision in such section 586C, 
including— 
(i) the resources used by the Food and 
Drug Administration;
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(ii) the impact of such provision on in-
novation, as well as research and develop-
ment in the sunscreen market; 
(iii) the impact of such provision on 
competition in the sunscreen market; 
(iv) the impact of such provision on 
consumer access to sunscreen products; 
(v) the impact of such provision on the 
prices of sunscreen products; and 
(vi) whether the administrative orders 
initiated by requestors under such section 
505G have been utilized by sunscreen ingre-
dient sponsors and whether such process has 
been sufficient to encourage the development 
of sunscreen ingredients that would likely 
not be otherwise developed, or developed in 
as timely a manner; and 
(E) whether the administrative orders initi-
ated by requestors under such section 586C have 
been sufficient incentive to encourage innovation 
in the sunscreen market. 
(c) CONFORMING AMENDMENT.—Section 751(d)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379r(d)(1)) is amended— 
(1) in the matter preceding subparagraph (A)—
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(A) by striking ‘‘final regulation promul-
gated’’ and inserting ‘‘final order under section 
505G’’; and 
(B) by striking ‘‘and not misbranded’’; and 
(2) in subparagraph (A), by striking ‘‘regulation 
in effect’’ and inserting ‘‘regulation or order in ef-
fect’’. 
SEC. 3852. MISBRANDING. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended by adding at the end the 
following: 
‘‘(ee) If it is a nonprescription drug that is subject to 
section 505G, is not the subject of an application approved 
under section 505, and does not comply with the require-
ments under section 505G. 
‘‘(ff) If it is a drug and it was manufactured, pre-
pared, propagated, compounded, or processed in a facility 
for which fees have not been paid as required by section 
744M.’’. 
SEC. 
3853. 
DRUGS 
EXCLUDED 
FROM 
THE 
OVER-THE- 
COUNTER DRUG REVIEW. 
(a) IN GENERAL.—Nothing in this Act (or the amend-
ments made by this Act) shall apply to any nonprescription 
drug (as defined in section 505G(q) of the Federal Food, 
Drug, and Cosmetic Act, as added by section 3851 of this
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subtitle) which was excluded by the Food and Drug Admin-
istration from the Over-the-Counter Drug Review in accord-
ance with the paragraph numbered 25 on page 9466 of vol-
ume 37 of the Federal Register, published on May 11, 1972. 
(b) RULE OF CONSTRUCTION.—Nothing in this section 
shall be construed to preclude or limit the applicability of 
any other provision of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.). 
SEC. 3854. TREATMENT OF SUNSCREEN INNOVATION ACT. 
(a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC-
TIVE INGREDIENTS.— 
(1) APPLICABILITY OF SECTION 505G FOR PEND-
ING SUBMISSIONS.— 
(A) IN
GENERAL.—A sponsor of a non-
prescription sunscreen active ingredient or com-
bination of nonprescription sunscreen active in-
gredients that, as of the date of enactment of this 
Act, is subject to a proposed sunscreen order 
under section 586C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360fff–3) may elect, 
by means of giving written notification to the 
Secretary of Health and Human Services within 
180 calendar days of the enactment of this Act, 
to transition into the review of such ingredient 
or combination of ingredients pursuant to the
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process set out in section 505G of the Federal 
Food, Drug, and Cosmetic Act, as added by sec-
tion 3851 of this subtitle. 
(B) ELECTION EXERCISED.—Upon receipt 
by the Secretary of Health and Human Services 
of a timely notification under subparagraph 
(A)— 
(i) the proposed sunscreen order in-
volved is deemed to be a request for an order 
under subsection (b) of section 505G of the 
Federal Food, Drug, and Cosmetic Act, as 
added by section 3851 of this subtitle; and 
(ii) such order is deemed to have been 
accepted 
for 
filing 
under 
subsection 
(b)(6)(A)(i) of such section 505G. 
(C) ELECTION NOT EXERCISED.—If a noti-
fication under subparagraph (A) is not received 
by the Secretary of Health and Human Services 
within 180 calendar days of the date of enact-
ment of this Act, the review of the proposed sun-
screen order described in subparagraph (A)— 
(i) shall continue under section 586C 
of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360fff–3); and
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(ii) shall not be eligible for review 
under section 505G, added by section 3851 
of this subtitle. 
(2) DEFINITIONS.—In this subsection, the terms 
‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen active in-
gredient’’, and ‘‘proposed sunscreen order’’ have the 
meanings given to those terms in section 586 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360fff). 
(b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 
(1) FINAL SUNSCREEN ORDERS.—Paragraph (3) 
of section 586C(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360fff–3(e)) is amended to 
read as follows: 
‘‘(3) RELATIONSHIP TO ORDERS UNDER SECTION 
505G.—A final sunscreen order shall be deemed to be 
a final order under section 505G.’’. 
(2) 
MEETINGS.—Paragraph 
(7) 
of 
section 
586C(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360fff–3(b)) is amended— 
(A) by striking ‘‘A sponsor may request’’ 
and inserting the following: 
‘‘(A) IN
GENERAL.—A sponsor may re-
quest’’; and 
(B) by adding at the end the following:
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‘‘(B) CONFIDENTIAL MEETINGS.—A sponsor 
may request one or more confidential meetings 
with respect to a proposed sunscreen order, in-
cluding a letter deemed to be a proposed sun-
screen order under paragraph (3), to discuss 
matters relating to data requirements to support 
a general recognition of safety and effectiveness 
involving confidential information and public 
information related to such proposed sunscreen 
order, as appropriate. The Secretary shall con-
vene a confidential meeting with such sponsor in 
a reasonable time period. If a sponsor requests 
more than one confidential meeting for the same 
proposed sunscreen order, the Secretary may 
refuse to grant an additional confidential meet-
ing request if the Secretary determines that such 
additional confidential meeting is not reasonably 
necessary for the sponsor to advance its proposed 
sunscreen order, or if the request for a confiden-
tial meeting fails to include sufficient informa-
tion upon which to base a substantive discussion. 
The Secretary shall publish a post-meeting sum-
mary of each confidential meeting under this 
subparagraph that does not disclose confidential 
commercial information or trade secrets. This
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subparagraph does not authorize the disclosure of 
confidential commercial information or trade se-
crets subject to 552(b)(4) of title 5, United States 
Code, or section 1905 of title 18, United States 
Code.’’. 
(3) EXCLUSIVITY.—Section 586C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3) is 
amended by adding at the end the following: 
‘‘(f) EXCLUSIVITY.— 
‘‘(1) IN GENERAL.—A final sunscreen order shall 
have the effect of authorizing solely the order requestor 
(or the licensees, assignees, or successors in interest of 
such requestor with respect to the subject of such re-
quest and listed under paragraph (5)) for a period of 
18 months, to market a sunscreen ingredient under 
this section incorporating changes described in para-
graph (2) subject to the limitations under paragraph 
(4), beginning on the date the requestor (or any li-
censees, assignees, or successors in interest of such re-
questor with respect to the subject of such request and 
listed under paragraph (5)) may lawfully market 
such sunscreen ingredient pursuant to the order. 
‘‘(2) CHANGES DESCRIBED.—A change described 
in this paragraph is a change subject to an order 
specified in paragraph (1) that permits a sunscreen
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to contain an active sunscreen ingredient not pre-
viously incorporated in a marketed sunscreen listed 
in paragraph (3). 
‘‘(3) MARKETED
SUNSCREEN.—The marketed 
sunscreen ingredients described in this paragraph are 
sunscreen ingredients— 
‘‘(A) marketed in accordance with a final 
monograph for sunscreen drug products set forth 
at part 352 of title 21, Code of Federal Regula-
tions (as published at 64 Fed. Reg. 27687); or 
‘‘(B) marketed in accordance with a final 
order issued under this section. 
‘‘(4) LIMITATIONS ON EXCLUSIVITY.—Only one 
18-month period may be granted per ingredient under 
paragraph (1). 
‘‘(5) LISTING
OF
LICENSEES, ASSIGNEES, OR 
SUCCESSORS IN INTEREST.—Requestors shall submit 
to the Secretary at the time when a drug subject to 
such request is introduced or delivered for introduc-
tion into interstate commerce, a list of licensees, as-
signees, or successors in interest under paragraph 
(1).’’. 
(4) SUNSET PROVISION.—Subchapter I of chap-
ter V of the Federal Food, Drug, and Cosmetic Act