I 
114TH CONGRESS 
1ST SESSION H. R. 4061 
To amend the Federal Food, Drug, and Cosmetic Act to strengthen require-
ments related to nutrient information on food labels, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 18, 2015 
Mr. PALLONE (for himself and Ms. DELAURO) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
strengthen requirements related to nutrient information 
on food labels, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Food Labeling Modernization Act of 2015’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Additional requirements for front-of-packaging (FOP) labeling for proc-
essed foods. 
Sec. 3. Claims for conventional foods. 
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Sec. 4. Use of specific terms. 
Sec. 5. Modernization of the Nutrition Facts Panel. 
Sec. 6. Ingredient labels. 
Sec. 7. Caffeine content on information panel. 
Sec. 8. Food allergen labeling for sesame. 
Sec. 9. Information about major food allergens in nonprepackaged foods. 
Sec. 10. Submission and availability of food label information. 
Sec. 11. Definitions. 
Sec. 12. Effective date; regulations. 
SEC. 2. ADDITIONAL REQUIREMENTS FOR FRONT-OF-PACK-
AGING (FOP) LABELING FOR PROCESSED 
FOODS. 
(a) SUMMARY
NUTRITION
LABELING
INFORMA-
TION.— 
(1) IN GENERAL.—Section 403 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343) is 
amended by adding at the end the following new 
paragraph: 
‘‘(z)(1) Except as provided in subparagraphs (3), (4), 
and (5) of paragraph (q), if it is food (other than a dietary 
supplement) intended for human consumption and is of-
fered for sale and otherwise required to bear nutrition la-
beling, unless its principal display panel bears summary 
nutrition information that reflects the overall nutritional 
value of the food or specified ingredients, as specified in 
accordance with regulations of the Secretary, and does not 
contain any summary nutritional information which is in 
addition to or inconsistent with the information required 
under this subparagraph.’’. 
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(2) PRINCIPLES FOR IMPLEMENTING REGULA-
TIONS.—In promulgating regulations regarding the 
summary nutrition information required under the 
amendment made by paragraph (1), the Secretary of 
Health and Human Services shall take into account 
published reports of the Institute of Medicine of the 
National Academy of Sciences regarding such infor-
mation and base regulations on the following prin-
ciples: 
(A) There should be a single simple, stand-
ard symbol system that displays calorie infor-
mation related to a common serving size, and 
information related to nutrients strongly associ-
ated with public health concerns. 
(B) Consumers should be able to quickly 
and easily comprehend the meaning of the sym-
bol system as an indicator of a product’s con-
tribution to a healthy diet. 
(C) The information should appear on all 
products that are required to bear nutrition la-
beling. 
(D) The information should— 
(i) appear in a consistent location on 
the principal display panels across prod-
ucts; 
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(ii) have a prominent design that vis-
ually contrasts with existing packaging de-
sign; and 
(iii) be sufficiently large to be easily 
legible. 
(E) The nutrition information should be 
consistent with the Nutrition Facts Panel and 
with the recommendations of the Dietary 
Guidelines of Americans. 
(F) The information should aim to facili-
tate consumer selection of healthy product op-
tions, including among nutritionally at-risk sub-
populations. 
(G) The Secretary should periodically 
evaluate the front-of-package information to as-
sess its ability to help facilitate consumer selec-
tion of healthy product options and the extent 
to which manufacturers are offering healthier 
products as a result of the disclosure. 
(H) The implementation of the information 
disclosure should be accompanied by appro-
priate consumer education and promotion cam-
paigns determined by the Secretary. 
(b) PERCENTAGE OF WHEAT AND GRAINS IN GRAIN- 
BASED PRODUCTS.—Section 403(z) of the Federal Food, 
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Drug, and Cosmetic Act (21 U.S.C. 343(z)), as added by 
subsection (a)(1), is further amended by adding at the end 
the following new subparagraph: 
‘‘(2) If, in the case of food other than a dietary sup-
plement, the principal display panel bears— 
‘‘(A) the phrase ‘made with whole grain’, the 
term ‘multigrain’, or similar descriptive phrases, 
terms, or representations with respect to whole grain 
content, unless the amount of whole grains, ex-
pressed as a percentage of total grains, is conspicu-
ously disclosed in immediate proximity to such de-
scriptive phrase, term, or representation; or 
‘‘(B) the terms ‘wheat’ or ‘whole wheat’ on 
breads, pasta, crackers, or similar wheat-based prod-
ucts, unless the percentage of whole wheat by weight 
contained in the food is conspicuously declared in 
immediate proximity to that term or there is a con-
spicuous declaration that the food ‘contains no whole 
wheat’ in immediate proximity to that term.’’. 
(c) SWEETENERS, COLORING, AND FLAVORING.— 
Section 403(z) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343(z)), as amended, is further amended 
by adding at the end the following new subparagraph: 
‘‘(3) If, in the case of food other than a dietary sup-
plement, it bears or contains any added artificial or nat-
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ural coloring, any added artificial or natural non-caloric 
sweetener, or any added artificial or natural flavoring, un-
less such fact is prominently stated on the principal dis-
play panel of a package or container of the food.’’. 
(d) CONFORMING AMENDMENT.—The second sen-
tence of section 403(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(k)) is amended by striking 
‘‘and (i)’’ and inserting ‘‘, (i), and (z)’’. 
(e) CONSTRUCTION.—Nothing in this section shall be 
construed as affecting any requirement in regulation in 
effect as of the date of the enactment of this Act with 
respect to matters that are required to be stated on the 
principal display panel of a package or container of food 
that is not required by an amendment made by this section 
or as restricting the authority of the Secretary of Health 
and Human Services to require additional information be 
disclosed on such a principal display panel. 
SEC. 3. CLAIMS FOR CONVENTIONAL FOODS. 
(a) HEALTH-RELATED CLAIMS.— 
(1) REGULATIONS AND GUIDANCE.—Not later 
than three years after the date of enactment of this 
Act, the Secretary of Health and Human Services 
shall— 
(A) promulgate a final rule clarifying the 
application of section 403(r) of the Federal 
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Food, Drug, and Cosmetic Act (21 U.S.C. 
343(r)) with respect to the mechanisms by 
which a nutrient in food (other than a dietary 
supplement) is intended to affect the structure 
or any function of the human body, or charac-
terize the documented mechanism by which a 
nutrient in such food acts to maintain such 
structure or function; and 
(B) issue guidance clarifying the applica-
tion of such section 403(r) with respect to the 
substantiation of claims pursuant to a request 
under section 403(r)(7) of such Act, as added 
by paragraph (2). 
(2) 
SUBSTANTIATION
OF
CLAIM.—Section 
403(r) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 343(r)) is amended— 
(A) by redesignating subparagraph (7) as 
subparagraph (8); and 
(B) by inserting after subparagraph (6) 
the following: 
‘‘(7) If the Secretary requests that a claim 
under subparagraph (1)(B) for food (other than a 
dietary supplement) be substantiated, then not later 
than 90 days after the date on which the Secretary 
makes such request, the manufacturer shall provide 
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to the Secretary all documentation in the manufac-
turer’s possession relating to the claim.’’. 
(b) TRANS FATS.—Section 403(r)(2)(A) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
343(r)(2)(A)) is amended— 
(1) in subclause (iii)— 
(A) in the matter before item (I), by strik-
ing ‘‘fat or saturated fat’’ and inserting ‘‘fat, 
saturated fat, or trans fats’’; and 
(B) in item (II), by striking ‘‘fat or satu-
rated fat’’ and inserting ‘‘fat, saturated fat, or 
trans fats’’; 
(2) in subclause (iv), by striking ‘‘saturated 
fat’’ and inserting ‘‘saturated fat or trans fats’’ each 
place it appears; 
(3) by redesignating subclauses (v) and (vi) as 
subclauses (vi) and (vii), respectively; and 
(4) by inserting after subclause (iv) the fol-
lowing new subclause: 
‘‘(v) may not be made with respect to the level 
of trans fats in the food unless the food contains less 
than one gram of saturated fat per serving or, if the 
food contains more than one gram of saturated fat 
per serving, unless the label or labeling of the food 
discloses the level of saturated fat in the food in im-
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mediate proximity to such claim and with appro-
priate prominence which shall be no less than one- 
half the size of the claim with respect to the level 
of trans fats,’’. 
(c) ADDED SUGARS.—Not more than 3 years after 
the date of enactment of this Act, the Secretary of Health 
and Human Services shall promulgate a final rule revising 
section 101.14 of title 21, Code of Federal Regulations, 
to include a disqualifying nutrient level for added sugars. 
SEC. 4. USE OF SPECIFIC TERMS. 
(a) USE OF THE TERM ‘‘NATURAL’’.— 
(1) IN
GENERAL.—Not later than two years 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall promul-
gate a final rule— 
(A) relating to use of the term ‘‘natural’’ 
on the labeling of food (other than a dietary 
supplement); and 
(B) including provisions to specifically ad-
dress the use of such term on the principal dis-
play panel and the information panel. 
(2) DEFINITION.—The rule promulgated pursu-
ant to paragraph (1) shall define the term ‘‘nat-
ural’’— 
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(A) to exclude, at a minimum, the use of 
any artificial food or ingredient (including any 
artificial flavor or added color) or any synthetic 
substance; and 
(B) based on data, including data on con-
sumers’ understanding of the term as used in 
connection with food. 
(3) PROCESS.—In promulgating the rule re-
quired by paragraph (1), the Secretary of Health 
and Human Services shall— 
(A) conduct consumer surveys and studies 
and issue a timely call for relevant public sub-
missions regarding relevant consumer research, 
including with respect to consumer under-
standing of the term ‘‘natural’’ in relation to 
the term ‘‘organic’’; and 
(B) fully consider the results of such sur-
veys and studies, as well as such public submis-
sions. 
(b) USE OF TERM ‘‘HEALTHY’’.— 
(1) ADDED SUGARS AND WHOLE GRAINS.—The 
Secretary of Health and Human Services shall revise 
the regulations under the Federal Food, Drug, and 
Cosmetic Act relating to the use of the term 
‘‘healthy’’ on the labeling of a food (other than a di-
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etary supplement) to take into account the extent to 
which such food contains added sugars or whole 
grains. 
(2) REQUIREMENTS.—In making the revisions 
to regulations required by paragraph (1)— 
(A) in the case of a food (other than a die-
tary supplement) that contains grains, the Sec-
retary shall not consider the food to be 
‘‘healthy’’ unless at least half of those grains, 
by weight, are whole grains; and 
(B) the Secretary shall not allow a food to 
be labeled ‘‘healthy’’ if the food contains more 
than 10 percent of the daily value of added 
sugar per serving as determined by the Sec-
retary under section 403(q)(1)(F)(i) of the Fed-
eral Food, Drug, and Cosmetic Act, as added 
by section 5(c) of this Act. 
SEC. 5. MODERNIZATION OF THE NUTRITION FACTS PANEL. 
(a) DISCLOSURE OF CALORIE INFORMATION.—Sec-
tion 403(q)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343(q)(1)) is amended— 
(1) by striking the period at the end of clause 
(E) and inserting a comma; 
(2) by inserting after clause (E) the following 
new clause: 
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‘‘(F) in the case of food other than a die-
tary supplement— 
‘‘(i) the percent of recommended daily 
calories that are provided by one serving of 
the product, based on a recommended daily 
consumption of calories determined by the 
Secretary to be appropriate for members of 
the general population; and 
‘‘(ii) at the discretion of the Sec-
retary, the percent of recommended daily 
calories that are provided by one serving of 
the product— 
‘‘(I) for members of any sub-
population identified by the Secretary; 
and 
‘‘(II) based on a recommended 
daily consumption of calories deter-
mined by the Secretary to be appro-
priate for members of such subpopula-
tion.’’; and 
(3) by adding, after the flush text following 
clause (F), as added by paragraph (2), the following: 
‘‘The information required under clause (C)(i) shall, 
in the case of food other than a dietary supplement, 
appear in a typeface and design which is more 
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prominent and conspicuous than that used for other 
information required under this subparagraph.’’. 
(b) SERVING SIZE.—Section 403(q)(1)(A)(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(q)(1)(A)(i)) is amended by inserting ‘‘, or, in the case 
of a food (other than a dietary supplement) that is pack-
aged in an amount that could reasonably be consumed in 
a single-eating occasion, which is an amount equal to the 
amount of food contained in the package’’ before ‘‘, or’’. 
(c) DISCLOSURE
OF INFORMATION RELATING
TO 
SUGAR ON NUTRITION FACT PANEL.— 
(1) IN
GENERAL.—Section 403(q)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(q)(1)), as amended by subsection (a), is amend-
ed— 
(A) in subparagraph (D), by striking ‘‘sug-
ars’’ and inserting ‘‘sugars (and, in the case of 
food other than a dietary supplement, total sug-
ars, and of that, added sugars, disclosed in 
teaspoons as well as grams)’’; and 
(B) by inserting after clause (F) the fol-
lowing new clause: 
‘‘(G) in the case of food other than a die-
tary supplement— 
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‘‘(i) the percent of added sugars rec-
ommended for daily consumption that are 
provided by one serving of the product, 
based on a recommended daily consump-
tion of calories determined by the Sec-
retary to be appropriate for members of 
the general population; and 
‘‘(ii) at the discretion of the Sec-
retary, the percent of added sugars rec-
ommended for daily consumption that are 
provided by one serving of the product— 
‘‘(I) for members of any sub-
population identified by the Secretary; 
and 
‘‘(II) based on a recommended 
daily consumption of calories deter-
mined by the Secretary to be appro-
priate for members of such subpopula-
tion.’’. 
SEC. 6. INGREDIENT LABELS. 
(a) FORMAT OF INGREDIENT LABELS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall include requirements for the 
format of the information required under section 
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403(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 343(i))— 
(A) for the purpose of improving the read-
ability of such information on the label of the 
food (other than a dietary supplement); and 
(B) that are, as determined by the Sec-
retary, necessary to assist consumers in main-
taining healthy dietary practices. 
(2) FORMAT REQUIREMENTS.—The format re-
quirements referred to in paragraph (1) shall include 
requirements for upper- and lower-case characters, 
serif and noncondensed font types, high-contrast be-
tween text and background, and bullet points be-
tween adjacent ingredients with appropriate exemp-
tions for small packages or other considerations. 
(b) CHARACTERIZING INGREDIENTS
IN NAME
OR 
PRIMARY DISPLAY PANEL.— 
(1) IN GENERAL.—Section 403 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343) is 
amended by adding at the end the following new 
paragraph: 
‘‘(aa) If the name or primary display panel of the 
food (other than a dietary supplement) refers to any char-
acterizing ingredient or component of the food, unless— 
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‘‘(1) the characterizing ingredient or component 
is a predominant ingredient in the food; or 
‘‘(2) the primary display panel of the food in-
cludes, in letters not less than one-half the height of 
the letters used in the name of the food, the percent-
age of the characterizing ingredient or component 
contained in each serving of the food.’’. 
(2) ENFORCEMENT
OF
CHARACTERIZING
IN-
GREDIENTS.—Not later than 2 years after the date 
of enactment of this Act and every 2 years there-
after, the Secretary of Health and Human Services 
shall submit a report to the Congress on the Sec-
retary’s enforcement of— 
(A) section 403(aa) of the Federal Food, 
Drug, and Cosmetic, as added by paragraph 
(1); and 
(B) regulations of the Food and Drug Ad-
ministration on characterizing ingredients and 
components including section 102.5 of title 21, 
Code of Federal Regulations (and any successor 
regulations). 
SEC. 7. CAFFEINE CONTENT ON INFORMATION PANEL. 
Section 403(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343(i)) is amended— 
(1) by striking ‘‘and (2)’’ and inserting ‘‘(2)’’; 
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(2) by striking ‘‘and if the food purports’’ and 
inserting ‘‘, (3) if the food purports’’; and 
(3) by inserting ‘‘, and (4) if the food is food 
other than a dietary supplement and contains at 
least 10 milligrams of caffeine from all sources per 
serving, a statement (with appropriate prominence 
near the statement of ingredients required by this 
paragraph) of the number of milligrams of caffeine 
contained in one serving of the food and the size of 
such serving’’ after ‘‘vegetable juice contained in the 
food’’. 
SEC. 8. FOOD ALLERGEN LABELING FOR SESAME. 
(a) DEFINITION OF MAJOR FOOD ALLERGEN.—Sec-
tion 201(qq)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(qq)(1)) is amended by striking ‘‘and 
soybeans’’ and inserting ‘‘soybeans, and sesame’’. 
(b) REGULATION.—Not later than 3 years after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall promulgate a final regulation under 
section 403(w) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343(x)) determining the manner in which 
sesame must be disclosed. 
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SEC. 9. INFORMATION ABOUT MAJOR FOOD ALLERGENS IN 
NONPREPACKAGED FOODS. 
(a) IN GENERAL.—Section 403(w) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343(w)) is 
amended— 
(1) in subparagraph (1)(A), by striking ‘‘is 
printed immediately after or is adjacent to the list 
of ingredients (in a type size no smaller than the 
type size used in the list of ingredients) required 
under subsections (g) and (i)’’ and inserting ‘‘is 
printed as specified in subparagraph (8)’’; 
(2) in subparagraph (1)(B), by striking ‘‘in the 
list of ingredients required under subsections (g) 
and (i)’’ and inserting ‘‘as so printed’’; 
(3) in subparagraph (3), by striking ‘‘The infor-
mation’’ and inserting ‘‘Subject to subparagraph 
(8)(B), the information’’; and 
(4) by adding at the end the following: 
‘‘(8) The information required by subparagraph (1) 
to be conveyed to the consumer shall be— 
‘‘(A) printed immediately after or adjacent to 
the list of ingredients (in a type size no smaller than 
the type size used in the list of ingredients) required 
under subsections (g) and (i); or 
‘‘(B) in the case of a nonpackaged food being 
offered for sale at retail, and not subject to the re-
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quirements of subsections (g) and (i), placed on a 
sign adjacent to the food (in a type size no smaller 
than the name of the food item).’’. 
(b) APPLICABILITY.—The amendments made by sub-
section (a) apply beginning on the date that is 3 years 
after the date of enactment of this Act. 
SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL 
INFORMATION. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by inserting after section 403C of such Act (21 U.S.C. 
343–3) the following: 
‘‘SEC. 403D. SUBMISSION AND AVAILABILITY OF FOOD 
LABEL INFORMATION. 
‘‘(a) SUBMISSIONS.— 
‘‘(1) REQUIREMENT.—The Secretary shall re-
quire the manufacturer or importer of any food that 
is introduced or delivered for introduction into inter-
state commerce in package form to submit to the 
Secretary all information to be included in the label 
of the food, including— 
‘‘(A) the nutrition facts panel; 
‘‘(B) ingredients; 
‘‘(C) any natural or artificial flavoring; 
‘‘(D) an image of the primary display 
panel; 
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‘‘(E) allergy warnings or information; 
‘‘(F) claims under section 403(r)(1)(A) 
(popularly referred to as ‘nutrient-content 
claims’); 
‘‘(G) claims under section 403(r)(1)(B) 
(popularly 
referred 
to 
as 
‘health-related 
claims’); and 
‘‘(H) other relevant information as deter-
mined by the Secretary. 
‘‘(2) UPDATES.—The Secretary shall require 
the manufacturer or importer of food to update or 
supplement the information submitted under para-
graph (1) with respect to the food in order to keep 
the information up-to-date and complete. 
‘‘(3) CIVIL PENALTY.—Whoever knowingly vio-
lates paragraph (1) with respect to any food shall be 
liable to the United States for a civil penalty in an 
amount not to exceed $10,000 for each day on which 
such violation continues with respect to such food. 
‘‘(b) PUBLIC DATABASE.—The Secretary shall estab-
lish and maintain a public database containing the infor-
mation submitted under this section that— 
‘‘(1) is available to the public through the 
website of the Food and Drug Administration; and 
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‘‘(2) is for a public database of searchable, sort-
able information.’’. 
SEC. 11. DEFINITIONS. 
(a) DEFINITIONS APPLICABLE IN THIS ACT.—In this 
Act, the terms ‘‘food’’ and ‘‘dietary supplement’’ have the 
meanings given to such terms in section 201 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 321). 
(b) DEFINITIONS APPLICABLE
IN
THE FEDERAL 
FOOD, DRUG, AND COSMETIC ACT.—Section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 
is amended by adding at the end the following: 
‘‘(ss) The term ‘artificial’, with respect to food or any 
ingredient of food, means— 
‘‘(1) food or an ingredient that is synthetically 
produced but has the same chemical structure as a 
naturally occurring food or ingredient; 
‘‘(2) food or an ingredient that has undergone 
chemical changes through the introduction of syn-
thetic chemicals or processing aids (such as corn 
syrup, high-fructose corn syrup, high-maltose corn 
syrup, maltodextrin, chemically modified starch, and 
cocoa processed with alkali), excluding— 
‘‘(A) food or an ingredient that has under-
gone traditional processes used to make food 
edible, to preserve food, or to make food safe 
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for human consumption (such as smoking, 
roasting, freezing, drying, and fermenting proc-
esses); or 
‘‘(B) food or ingredient that has undergone 
traditional physical processes that do not fun-
damentally alter the raw product or which only 
separate a whole intact food into component 
parts (such as grinding grains, separating eggs 
into albumen and yolk, or pressing fruits to 
produce juice); or 
‘‘(3) any food or ingredient that the Secretary 
specifies by regulation to be artificial for purposes of 
this Act. 
‘‘(tt) The term ‘synthetic’, with respect to a sub-
stance, means a substance that is formulated or manufac-
tured by a chemical process or by a process that chemi-
cally changes a substance extracted from a naturally oc-
curring plant, animal, or mineral source, except that such 
term does not apply to a substance created by naturally 
occurring biological processes.’’. 
SEC. 12. EFFECTIVE DATE; REGULATIONS. 
(a) EFFECTIVE DATE.—The amendments made by— 
(1) sections 3, 4, 5, 6, 7, 10, and 11(b) shall 
take effect on the date that is 2 years after the date 
of enactment of this Act; and 
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(2) sections 2 and 9 shall take effect on the 
date that is 3 years after such date of enactment. 
(b) REGULATIONS.— 
(1) PROPOSED REGULATIONS.—The Secretary 
of Health and Human Services shall propose regula-
tions— 
(A) not later than 1 year after the date of 
enactment of this Act, to implement the amend-
ments made by sections 3, 4, 5, 6, 7, 9, 10, and 
11(b); and 
(B) not later than 2 years after such date 
of enactment, to implement the amendments 
made by section 2. 
(2) FINAL
REGULATIONS.—The Secretary of 
Health and Human Services shall promulgate final 
regulations— 
(A) not later than 2 years after such date 
of enactment, to implement the amendments 
made by sections 3, 4, 5, 6, 7, 9, 10, and 11(b); 
and 
(B) not later than 3 years after such date 
of enactment to implement the amendments 
made by section 2. 
(3) DEADLINE.—If the Secretary of Health and 
Human Services does not issue a final regulation by 
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the deadline specified in subparagraph (A) or (B) of 
paragraph (2), the corresponding proposed regula-
tion under subparagraph (A) or (B) of paragraph 
(1) shall become final on the respective deadline. 
Æ 
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