SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Manufacturing API, 
Drugs, and Excipients in America Act’’ or the ‘‘MADE 
in America Act’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—HEALTH PROVISIONS 
Sec. 101. Report to Congress on barriers to domestic manufacturing of medical 
products. 
Sec. 102. Enhance intra-agency coordination and public health assessment with 
regard to compliance activities. 
Sec. 103. Reporting of mutual recognition agreements for inspections and re-
view activities. 
Sec. 104. Enhancing transparency of drug facility inspection timelines. 
Sec. 105. Advanced manufacturing technologies program. 
TITLE II—TAX INCENTIVES TO INCREASE DOMESTIC 
PHARMACEUTICAL AND MEDICAL DEVICE PRODUCTION 
Sec. 201. Credit for pharmaceutical and medical device production activities in 
distressed zones. 
TITLE I—HEALTH PROVISIONS 
SEC. 101. REPORT TO CONGRESS ON BARRIERS TO DOMES-
TIC MANUFACTURING OF MEDICAL PROD-
UCTS. 
(a) REPORT.—Not later than 6 months after the date 
of enactment of this Act, the Secretary of Health and 
Human Services, the Secretary of the Treasury, the Sec-
retary of Commerce, and the United States Trade Rep-
resentative (collectively referred to in this section as the 
‘‘Secretaries’’) shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the 
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Committee on Energy and Commerce of the House of 
Representatives a report on barriers to domestic manufac-
turing of active pharmaceutical ingredients, finished drug 
products, and devices that are imported from outside of 
the United States. 
(b) CONTENTS.—Such report shall— 
(1) identify factors that limit or otherwise dis-
courage the domestic manufacturing of active phar-
maceutical ingredients, drugs, and devices that are 
currently imported from outside of the United 
States, including any Federal, State, local, or Tribal 
laws that hinder domestic manufacturing opportuni-
ties; and 
(2) recommend specific strategies to overcome 
the challenges identified under paragraph (1), in-
cluding strategies— 
(A) to develop effective incentives for do-
mestic manufacturing; and 
(B) to make changes to laws or regulations 
that hinder domestic manufacturing opportuni-
ties. 
(c) CONSULTATION.—In preparing the report under 
subsection (a), the Secretaries shall consult with— 
(1) the Food and Drug Administration, the 
Centers for Medicare & Medicaid Services, the De-
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partment of Defense, the Department of State, the 
Department of Veterans Affairs, the Department of 
Justice, and any other Federal agencies as appro-
priate; and 
(2) relevant stakeholders, including drug, de-
vice, and active pharmaceutical ingredient manufac-
turers, and other entities, as appropriate. 
(d) DEFINITION.—In this section, the term ‘‘active 
pharmaceutical ingredient’’ has the meaning given to such 
term in section 207.1 of title 21, Code of Federal Regula-
tions (or any successor regulations). 
(e) PUBLICATION.—The Secretary shall make the re-
port under subsection (a) available on the public website 
of the Department of Health and Human Services. 
SEC. 102. ENHANCE INTRA-AGENCY COORDINATION AND 
PUBLIC HEALTH ASSESSMENT WITH REGARD 
TO COMPLIANCE ACTIVITIES. 
(a) COORDINATION.—Section 506D of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is 
amended by adding at the end the following: 
‘‘(g) COORDINATION.—The Secretary shall ensure 
timely and effective internal coordination and alignment 
among the field investigators of the Food and Drug Ad-
ministration and the staff of the Center for Drug Evalua-
tion and Research’s Office of Compliance and Drug Short-
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age Program regarding the reviews of reports shared pur-
suant to section 704(b)(2), and any feedback or corrective 
or preventive actions in response to such reports.’’. 
(b) REPORTING.—Section 506C–1(a)(2) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 356c– 
1(a)(2)) is amended to read as follows: 
‘‘(2)(A) describes the communication between 
the field investigators of the Food and Drug Admin-
istration and the staff of the Center for Drug Eval-
uation and Research’s Office of Compliance and 
Drug Shortage Program, including the Food and 
Drug Administration’s procedures for enabling and 
ensuring such communication; 
‘‘(B) provides the number of reports described 
in section 704(b)(2) that were required to be sent to 
the appropriate offices of the Food and Drug Ad-
ministration with expertise regarding drug shortage 
and the number of such reports that were sent; and 
‘‘(C) describes the adoption and utilization of 
the approach described in section 506D(g);’’. 
(c) APPLICABILITY.— 
(1) SUBSECTION (a).—The amendment made 
by subsection (a) shall apply beginning on the date 
of enactment of this Act. 
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(2) SUBSECTION (b).—The amendment made 
by subsection (b) shall apply beginning on the date 
that is 1 year after the date of enactment of this 
Act. 
SEC. 103. REPORTING OF MUTUAL RECOGNITION AGREE-
MENTS FOR INSPECTIONS AND REVIEW AC-
TIVITIES. 
(a) IN GENERAL.—Not later than the end of calendar 
year 2020, and annually thereafter, the Secretary of 
Health and Human Services (referred to in this section 
as the ‘‘Secretary’’) shall publish a report on the public 
website of the Food and Drug Administration on the utili-
zation of agreements entered into pursuant to section 809 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384e) or otherwise entered into by the Secretary to recog-
nize inspections between drug regulatory authorities 
across countries and international regions with analogous 
review criteria to the Food and Drug Administration, such 
as the Pharmaceutical Inspection Co-Operation Scheme, 
the Mutual Recognition Agreement with the European 
Union, and the Australia-Canada-Singapore-Switzerland 
Consortium, in the previous fiscal year. 
(b) CONTENT.—The report under subsection (a) shall 
include each of the following: 
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(1) FDA INSPECTION
CATEGORY.—The term 
‘‘FDA inspection category’’ means the following in-
spection categories: 
(A) Inspections to support approvals of 
changes to the manufacturing process of drugs 
approved under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
or section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
(B) Good manufacturing practice surveil-
lance inspections. 
(C) For-cause inspections. 
(2) REGION OF INTEREST.—The term ‘‘region 
of interest’’ means China, India, the European 
Union, and any other geographic region as the Sec-
retary determines appropriate. 
SEC. 104. ENHANCING TRANSPARENCY OF DRUG FACILITY 
INSPECTION TIMELINES. 
Section 902 of the FDA Reauthorization Act of 2017 
(21 U.S.C. 355 note) is amended to read as follows: 
‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 
‘‘Not later than March 1 of each year, the Secretary 
of Health and Human Services shall post on the public 
website of the Food and Drug Administration information 
related to inspections of facilities, including inspections 
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that are necessary for approval of a drug under subsection 
(c) or (j) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355), approval of a device under 
section 515 of such Act (21 U.S.C. 360e), or clearance 
of a device under section 510(k) of such Act (21 U.S.C. 
360(k)) that were conducted during the previous calendar 
year. Such information shall include the following: 
‘‘(1) The median time following a request from 
staff of the Food and Drug Administration review-
ing an application or report to the beginning of the 
inspection, including— 
‘‘(A) the median time for drugs described 
in section 505(j)(11)(A)(i) of the Federal Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355(j)(11)(A)(i)); 
‘‘(B) the median time for drugs described 
in section 506C(a) of such Act (21 U.S.C. 
356c(a)) only; and 
‘‘(C) the median time for drugs on the 
drug shortage list in effect under section 506E 
of such Act (21 U.S.C. 356f). 
‘‘(2) The median time from the issuance of a 
report pursuant to section 704(b) of such Act (21 
U.S.C. 374(b)) to the sending of a warning letter, 
issuance of an import alert, or holding of a regu-
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latory meeting for inspections for which the Sec-
retary concluded that regulatory or enforcement ac-
tion was indicated, including the median time for 
each category of drugs listed in subparagraphs (A) 
through (C) of paragraph (1). 
‘‘(3) The median time from the sending of a 
warning letter, issuance of an import alert, or hold-
ing of a regulatory meeting to resolution of the ac-
tions indicated to address the conditions or practices 
observed during an inspection. 
‘‘(4) The number of facilities that were unable 
to implement requested corrective or preventive ac-
tions following a report pursuant to such section 
704(b), resulting in a withhold recommendation, in-
cluding the number of such times for each category 
of drugs listed in subparagraphs (A) through (C) of 
paragraph (1).’’. 
SEC. 105. ADVANCED MANUFACTURING TECHNOLOGIES 
PROGRAM. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
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‘‘SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES 
PROGRAM. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of the Manufacturing API, Drugs, and 
Excipients in America Act, the Secretary shall continue 
in effect the programs to facilitate the development and 
review of an application under subsection (b) or (j) of sec-
tion 505 of this Act or subsection (a) or (k) of section 
351 of the Public Health Service Act for a drug or biologi-
cal product that is manufactured using one of more ad-
vanced manufacturing technologies that have been des-
ignated in accordance with subsection (b). 
‘‘(b) DESIGNATION.—The Secretary shall designate a 
method of manufacturing or development of a drug or bio-
logical product as an advanced manufacturing technology 
under this section if it incorporates a novel technology or 
uses an established technique or technology in a novel way 
that— 
‘‘(1) enhances drug quality; or 
‘‘(2) improves the flexibility, robustness, or effi-
ciency of the manufacturing process to— 
‘‘(A) prevent or resolve a drug shortage; 
‘‘(B) reduce premarket development time; 
or 
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‘‘(C) increase the supply of drugs described 
in paragraph (1) or (2) of section 506C(a) for 
national emergencies. 
‘‘(c) CONSULTATION.—If the Secretary designates a 
method of manufacturing as an advanced manufacturing 
technology under this section, the Secretary shall take ac-
tions to expedite the development and implementation of 
such method of manufacture for purposes of approval of 
an application under subsection (c) or (j) of section 505 
of this Act or subsection (a) or (k) of section 351 of the 
Public Health Service Act, which may include, as appro-
priate, holding meetings between the sponsor of the appli-
cation and appropriate Food and Drug Administration 
staff throughout the development of the drug of biological 
product using such advanced manufacturing technology. 
‘‘(d) EVALUATION
OF
AN ADVANCED MANUFAC-
TURING TECHNOLOGY.— 
‘‘(1) PACKAGE.—A person who seeks designa-
tion of an advanced manufacturing technology under 
this section shall submit to the Secretary a package 
of scientific evidence supporting the implementation 
of the advanced manufacturing technology in a par-
ticular context-of-use. The Secretary shall assist 
with the development of such package by— 
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‘‘(A) providing timely advice to, and inter-
active communication with, the sponsor regard-
ing the development of the technology; and 
‘‘(B) involving senior managers and experi-
enced staff of the Food and Drug Administra-
tion, as appropriate, in a collaborative, cross- 
disciplinary review of the method of manufac-
turing. 
‘‘(2) EVALUATION.—Within 90 days of receiv-
ing a package under paragraph (1), the Secretary 
shall determine whether a designated advanced man-
ufacturing technology is validated for the proposed 
context of use based on the scientific merit the sup-
porting evidence provided by the sponsor. 
‘‘(3) EFFECT
OF
DESIGNATION.—Upon des-
ignation of an advanced manufacturing technology, 
the holder of the advanced manufacturing technology 
designation, or a person the advanced manufac-
turing technology designation holder authorizes, may 
rely upon the advanced manufacturing technology 
for use across multiple manufacturing or product 
lines within the same context-of-use without having 
to re-submit data to the Secretary validating the un-
derlying technology. 
‘‘(e) IMPLEMENTATION AND REPORTING.— 
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TITLE II—TAX INCENTIVES TO 
INCREASE DOMESTIC PHAR-
MACEUTICAL AND MEDICAL 
DEVICE PRODUCTION 
SEC. 201. CREDIT FOR PHARMACEUTICAL AND MEDICAL 
DEVICE PRODUCTION ACTIVITIES IN DIS-
TRESSED ZONES. 
(a) IN GENERAL.—Subpart D of part IV of sub-
chapter A of chapter 1 of the Internal Revenue Code of 
1986 is amended by adding at the end the following new 
section: 
‘‘SEC. 45U. DISTRESSED ZONE PHARMACEUTICAL AND MED-
ICAL DEVICE PRODUCTION CREDIT. 
‘‘(a) IN GENERAL.—For purposes of section 38, the 
distressed zone pharmaceutical and medical device produc-
tion credit for the taxable year shall be an amount equal 
to the applicable percentage of the qualified production ac-
tivity expenditures of the taxpayer for the taxable year. 
‘‘(b) APPLICABLE PERCENTAGE.—For purposes of 
this section— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), the term ‘applicable percentage’ means 
25 percent. 
‘‘(2) INCREASED AMOUNT WHERE EMPLOYEES 
RESIDE IN DISTRESSED ZONE.—In the case of any 
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qualified pharmaceutical or medical device produc-
tion business a substantial portion of the employees 
of which reside in a distressed zone, the applicable 
percentage shall be 30 percent. 
‘‘(c) QUALIFIED PRODUCTION ACTIVITY EXPENDI-
TURES.—For purposes of this section— 
‘‘(1) IN GENERAL.—The term ‘qualified produc-
tion activity expenditures’ means— 
‘‘(A) wages paid or incurred to an em-
ployee of the taxpayer for services performed by 
such employee in the conduct of a qualified 
pharmaceutical or diagnostic medical device 
production business in a distressed zone (but 
only if the employee’s principal place of employ-
ment is in a distressed zone), and 
‘‘(B) qualified pharmaceutical or medical 
device production expenditures. 
‘‘(2) QUALIFIED PHARMACEUTICAL OR MEDICAL 
DEVICE PRODUCTION BUSINESS.— 
‘‘(A) IN
GENERAL.—The term ‘qualified 
pharmaceutical or medical device production 
business’ means the trade or business of pro-
ducing qualified pharmaceuticals in commercial 
quantities. 
‘‘(B) QUALIFIED PHARMACEUTICALS.— 
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‘‘(i) IN GENERAL.—The term ‘quali-
fied 
pharmaceuticals’ 
means 
pharma-
ceuticals, active pharmaceutical ingredi-
ents, excipients, medical diagnostic devices, 
or personal protective equipment. 
‘‘(ii) PHARMACEUTICAL.—The term 
‘pharmaceuticals’— 
‘‘(I) means any drug (as defined 
in section 201 of the Federal Food, 
Drug, and Cosmetic Act), and 
‘‘(II) includes a biological prod-
uct (as defined in section 351 of the 
Public Health Service Act). 
‘‘(iii) ACTIVE
PHARMACEUTICAL
IN-
GREDIENT.—The term ‘active pharma-
ceutical ingredients’ has the meaning given 
to such term in section 207.1 of title 21, 
Code of Federal Regulations (or any suc-
cessor regulations). 
‘‘(iv) EXCIPIENT.—The term ‘excip-
ient’— 
‘‘(I) means any inactive ingre-
dient that is intentionally added to a 
pharmaceutical that is not intended to 
exert therapeutic effects at the in-
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tended dosage, other than by acting to 
improve product delivery, and 
‘‘(II) includes any such filler, ex-
tenders, diluent, wetting agent, sol-
vent, emulsifier, preservative, flavor, 
absorption enhancer, sustained release 
matrix, and coloring agent. 
‘‘(v) MEDICAL DIAGNOSTIC DEVICE.— 
The term ‘medical diagnostic device’ means 
any device (as defined in section 201(h) of 
the Federal Food, Drug, and Cosmetic 
Act) intended for use in the diagnosis of 
disease or other conditions. 
‘‘(vi) PERSONAL PROTECTIVE EQUIP-
MENT.—The 
term 
‘personal 
protective 
equipment’ means— 
‘‘(I) any device (as defined in 
section 201(h) of the Federal Food, 
Drug, and Cosmetic Act) that is a 
face mask, filtering facepiece res-
pirator, face shield, surgical mask, 
gown, other apparel, or glove that is 
intended for a medical purpose, and 
‘‘(II) any particulate filtering air 
purifying respiratory protective device 
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that is approved by the National In-
stitute for Occupational Safety and 
Health under part 84 of title 42, Code 
of Federal Regulations (or successor 
regulations). 
‘‘(3) CERTAIN HEALTH PLAN EXPENSES TREAT-
ED AS WAGES.— 
‘‘(A) IN
GENERAL.—The term ‘wages’ 
shall include so much of the eligible employer’s 
qualified health plan expenses as are properly 
allocable to such wages. 
‘‘(B) 
QUALIFIED
HEALTH
PLAN
EX-
PENSES.—For purposes of this paragraph, the 
term ‘qualified health plan expenses’ means 
amounts paid or incurred by the eligible em-
ployer to provide and maintain a group health 
plan (as defined in section 5000(b)(1)), but 
only to the extent that such amounts are ex-
cluded from the gross income of employees by 
reason of section 106(a) of such Code. 
‘‘(C) ALLOCATION RULES.—For purposes 
of this paragraph, qualified health plan ex-
penses shall be allocated to qualified wages in 
such manner as the Secretary may prescribe. 
Except as otherwise provided by the Secretary, 
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such allocation shall be treated as properly 
made if made on the basis of being pro rata 
among employees and pro rata on the basis of 
periods of coverage (relative to the periods to 
which such wages relate). 
‘‘(4) QUALIFIED PHARMACEUTICAL OR MEDICAL 
DEVICE PRODUCTION EXPENDITURES.— 
‘‘(A) DEFINITION.—The term ‘qualified 
pharmaceutical or medical device production ex-
penditures’ means amount paid or incurred 
(whether or not chargeable to capital account) 
for qualified property used in the conduct of a 
qualified pharmaceutical or medical device pro-
duction business in a distressed zone (but only 
if the primary use of such property is in a dis-
tressed zone). 
‘‘(B) QUALIFIED PROPERTY.— 
‘‘(i) IN GENERAL.—The term ‘quali-
fied property’ means any tangible personal 
property (other than a building or its 
structural components) used in the conduct 
of a qualified pharmaceutical or medical 
device production business in a distressed 
zone (but only if the primary use of such 
property is in a distressed zone). 
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‘‘(ii) EXCEPTION.—Such term shall 
not include any property described in sec-
tion 50(b) (determined as if the United 
States included Puerto Rico). 
‘‘(d) DISTRESSED ZONE.—For purposes of this sec-
tion, the term ‘distressed zone’ means a population census 
tract which— 
‘‘(1) has been designated as a qualified oppor-
tunity zone under section 1400Z–1, and 
‘‘(2) has a poverty rate in excess of 30 percent 
for the calendar year prior to the calendar year that 
includes the date of enactment of this section. 
‘‘(e) SPECIAL RULES.— 
‘‘(1) APPLICATION TO UNITED STATES SHARE-
HOLDERS
OF
CONTROLLED
FOREIGN
CORPORA-
TIONS.— 
‘‘(A) IN GENERAL.—In the case of a do-
mestic corporation that is a United States 
shareholder of a qualified controlled foreign cor-
poration, the credit under subsection (a) (deter-
mined without regard to this paragraph) shall 
be increased by an amount equal to 30 percent 
of the corporation’s pro rata share (determined 
under rules similar to the rules of section 
951(a)(2)) of qualified production activity ex-
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penditures of such controlled foreign corpora-
tion for the taxable year of the qualified con-
trolled foreign corporation ending with or with-
in the taxable year of the domestic corporation. 
‘‘(B) QUALIFIED CORPORATION.—For pur-
poses of subparagraph (A), the term ‘qualified 
controlled foreign corporation’ means, for any 
taxable year, a controlled foreign corporation 
which does not have gross income that is effec-
tively connected with the conduct of a trade or 
business within the United States for such tax-
able year. 
‘‘(2) REDUCTION IN BASIS.—If a credit is de-
termined under this section with respect to any 
property by reason of any qualified production activ-
ity expenditures described in subsection (b)(1)(B), 
the basis of such property shall be reduced by the 
amount of the credit so determined. 
‘‘(3) COORDINATION WITH OTHER CREDITS.— 
Any qualified production activity expenditures taken 
into account in determining the amount of the credit 
under subsection (a) shall not be taken into account 
in determining a credit under any other provision of 
this chapter. 
‘‘(f) RECAPTURE.— 
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‘‘(1) IN GENERAL.—If, during any taxable year, 
property 
take 
into 
account 
under 
subsection 
(c)(1)(B) is disposed of, or otherwise ceases to be 
used by the taxpayer in the active trade or business 
of producing qualified pharmaceuticals in commer-
cial quantities, before the close of the recapture pe-
riod, then the tax under this chapter for such tax-
able year shall be increased by the recapture per-
centage of the aggregate decrease in the credits al-
lowed under section 38 for all prior taxable years 
which would have resulted solely from reducing to 
zero any credit determined under this section with 
respect to such property. 
‘‘(2) RECAPTURE PERCENTAGE.—For purposes 
of subparagraph (A), the recapture percentage shall 
be determined in the same manner as under section 
50(a)(1)(B). 
‘‘(3) APPLICATION TO UNITED STATES SHARE-
HOLDERS.—In the case of any taxpayer to whom a 
credit is allowed by reason of subsection (e)(1), 
paragraph (1) shall be applied by substituting ‘the 
controlled foreign corporation with respect to which 
the taxpayer is a United States shareholder’ for ‘the 
taxpayer’. 
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‘‘(4) APPLICATION
OF
OTHER
RULES.—For 
purposes of this paragraph, rules similar to the rules 
of paragraphs (3), (4), and (5) (other than subpara-
graph (A) thereof) of section 50(a)(1) shall apply.’’. 
(b) CREDIT ALLOWED AGAINST ALTERNATIVE MIN-
IMUM TAX.—Section 38(c)(4)(B) of such Code is amended 
by redesignating clauses (x), (xi), and (xii) as clauses (xi), 
(xii), and (xiii), respectively, and by inserting after clause 
(ix) the following new clause: 
‘‘(x) the credit determined under sec-
tion 45U,’’. 
(c) CREDIT ALLOWED AGAINST BASE EROSION 
ANTI-ABUSE
TAX.—Section 59A(b)(1)(B)(ii) of such 
Code is amended by striking ‘‘plus’’ at the end of sub-
clause (I), by redesignating subclause (II) as subclause 
(III), and by inserting after subclause (I) (as so amended) 
the following new subclause: 
‘‘(II) the credit allowed under 
section 38 for the taxable year which 
is properly allocable to the distressed 
zone pharmaceutical and medical de-
vice 
production 
credit 
determined 
under section 45U(a), plus’’. 
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(d) DENIAL OF DEDUCTION.—Section 280C of such 
Code is amended by adding at the end the following new 
subsection: 
‘‘(i) DISTRESSED
ZONE
PHARMACEUTICAL
AND 
MEDICAL DEVICE PRODUCTION CREDIT.—No deduction 
shall be allowed for that portion of the qualified produc-
tion activity expenditures (as defined in section 45U(b)) 
otherwise allowable as a deduction for the taxable year 
which is equal to the amount of the distressed zone phar-
maceutical and medical device production credit deter-
mined for such taxable year under section 45U(a).’’. 
(e) PART OF GENERAL BUSINESS CREDIT.—Section 
38(b) of such Code is amended by striking ‘‘plus’’ at the 
end of paragraph (32), by striking the period at the end 
of paragraph (33) and inserting ‘‘, plus’’, and by adding 
at the end the following new paragraph: 
‘‘(34) the distressed zone pharmaceutical and 
medical device production credit determined under 
section 45U(a).’’. 
(f) CLERICAL AMENDMENT.—The table of sections 
for subpart D of part IV of subchapter A of chapter 1 
is amended by adding at the end the following new item: 
‘‘Sec. 45U. Distressed zone pharmaceutical and medical device production cred-
it.’’. 
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(g) EFFECTIVE DATE.—The amendments made by 
this section shall apply to amounts paid or incurred after 
the date of the enactment of this Act. 
Æ 
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