Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Rules and Regulations 74785 

(B) Addition of an intended use; 

(C) If it is a prescription drug, any 

mailing or promotional piece used after 

the drug is placed on the market is 

labeling requiring a supplemental 

application, unless: 

(1) The parts of the labeling 

furnishing directions, warnings, and 

information for use of the drug are the 

same in language and emphasis as 

labeling approved or permitted; and 

(2) Any other parts of the labeling are 

consistent with and not contrary to such 

approved or permitted labeling. 

(3) Prescription drug labeling not 

requiring an approved supplemental 

application is submitted in accordance 

with § 514.80(b)(5)(ii). 

(D) Any other changes in labeling, 

except ones described in paragraph 

(c)(3) of this section. 

(ii) The applicant must obtain 

approval of the supplement from FDA 

prior to distribution of the drug. The 

supplement must contain the following: 

(A) A completed Form FDA 356V; 

(B) A detailed description of the 

proposed change; 

(C) The drug(s) involved; 

(D) The data derived from studies in 

support of the change; and 

(E) Any other information as directed 

by FDA. 

(3) Labeling changes to be placed into 

effect prior to receipt of a written notice 

of approval of a supplemental 

application. (i) Labeling changes of the 

following kinds that increase the 

assurance of drug safety proposed in 

supplemental applications must be 

placed into effect immediately: 

(A) The addition to package labeling, 

promotional labeling, or prescription 

drug advertising of additional warning, 

contraindication, adverse reaction, and 

precaution information; 

(B) The deletion from package 

labeling, promotional labeling, or drug 

advertising of false, misleading, or 

unsupported intended uses or claims for 

effectiveness; and 

(C) Any other changes as directed by 

FDA. 

(ii) Labeling changes (for example, 

design and style) that do not decrease 

safety of drug use proposed in 

supplemental applications may be 

placed into effect prior to written notice 

of approval from FDA of a supplemental 

application. 

(iii) A supplement submitted under 

paragraph (c)(3) of this section must 

include the following information: 

(A) A full explanation of the basis for 

the changes, the date on which such 

changes are being effected, and plainly 

marked on the mailing cover and on the 

supplement, ‘‘Supplement—Labeling 

Changes Being Effected’’; 

(B) Two sets of printed copies of any 

revised labeling to be placed in use, 

identified with the new animal drug 

application number; and 

(C) A statement by the applicant that 

all promotional labeling and all drug 

advertising will promptly be revised 

consistent with the changes made in the 

labeling on or within the new animal 

drug package no later than upon 

approval of the supplemental 

application. 

(iv) If the supplemental application is 

not approved and the drug is being 

distributed with the proposed labeling, 

FDA may initiate an enforcement action 

because the drug is misbranded under 

section 502 of the act and/or adulterated 

under section 501 of the act. In addition, 

under section 512(e) of the act, FDA 

may, after due notice and opportunity 

for a hearing, issue an order 

withdrawing approval of the 

application. 

(4) Changes providing for additional 

distributors to be reported under 

Records and reports concerning 

experience with approved new animal 

drugs (§ 514.80). Supplemental 

applications as described under 

paragraph (c)(2) of this section will not 

be required for an additional distributor 

to distribute a drug that is the subject of 

an approved new animal drug 

application or abbreviated new animal 

drug application if the conditions 

described under § 514.80(b)(5)(iii) are 

met. 

(d) Patent information. The applicant 

must comply with the patent 

information requirements under section 

512(c)(3) of the act. 

(e) Claimed exclusivity. If an 

applicant claims exclusivity under 

section 512(c)(2)(F) of the act upon 

approval of a supplemental application 

for a change in its previously approved 

drug, the applicant must include such a 

statement. 

(f) Good laboratory practice for 

nonclinical laboratory studies. A 

supplemental application that contains 

nonclinical laboratory studies must 

include, with respect to each 

nonclinical study, either a statement 

that the study was conducted in 

compliance with the requirements set 

forth in part 58 of this chapter, or, if the 

study was not conducted in compliance 

with such regulations, a brief statement 

of the reason for the noncompliance. 

■ 7. Section 514.106 is amended by 

removing paragraphs (b)(1)(xiv), and 

revising paragraphs (b)(1)(vi) and 

(b)(1)(xiii) to read as follows: 

§ 514.106 Approval of supplemental 

applications. 

* * * * * 

(b) * * * 

(1) * * * 

(vi) A change in promotional material 

for a prescription new animal drug not 

exempted by § 514.8(c)(2)(i)(C)(1) 

through (c)(2)(i)(C)(3). 

* * * * * 

(xiii) A change permitted in advance 

of approval as described under 

§ 514.8(b)(3). 

* * * * * 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 8. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.5 [Amended] 

■ 9. Section 558.5 is amended in 

paragraph (j) by removing ‘‘514.8(d) and 

(e)’’ and by adding in its place 

‘‘514.8(c)(3)’’. 

Dated: September 1, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–21133 Filed 12–12–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. 1998P–0043] (formerly Docket 

No. 98P–0043) 

Food Labeling: Nutrition Labeling of 

Dietary Supplements on a ‘‘Per Day’’

Basis 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

nutrition labeling regulations for dietary 

supplements to provide that the 

quantitative amount and the percent of 

Daily Value of a dietary ingredient may 

be voluntarily presented on a ‘‘per day’’

basis in addition to the required ‘‘per 

serving’’ basis when a recommendation 

is made on the label that the dietary 

supplement be consumed more than 

once per day. This final rule responds 

to a citizen petition requesting that FDA 

amend our dietary supplement nutrition 

labeling regulations to include this 

provision. FDA is taking this action to 

give manufacturers of dietary 

supplements the option to present 

nutrition information on a ‘‘per day’’

basis to consumers. 


hsrobinson on PROD1PC76 with RULES
74786 Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Rules and Regulations 

DATES: The regulation is effective 

December 13, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Carole L. Adler, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740–

3835, 301–436–2371. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 12, 

1999 (64 FR 1765), FDA published a 

proposed rule entitled ‘‘Food Labeling: 

Nutrition Labeling of Dietary 

Supplements on a ‘Per Day’ Basis’’ (the 

proposed rule). The proposed rule was 

published in response to a citizen 

petition submitted by the Nutrilite 

Division of the Amway Corporation (the 

petitioner) (filed January 23, 1998, 

Docket No. 98P–0043/CP1). In the 

citizen petition, the petitioner requested 

that we amend our nutrition labeling 

regulations for dietary supplements to 

permit the option of listing the 

quantitative amount and percent of 

Daily Value of dietary ingredients on a 

‘‘per day’’ basis in addition to the 

required ‘‘per serving’’ basis when the 

label of the product recommends or 

instructs that the dietary supplement be 

consumed more than once per day. The 

proposed rule described the petitioner’s 

request for ‘‘per day’’ labeling, including 

the petitioner’s proposed language for 

amending § 101.36 (21 CFR 101.36) (64 

FR 1765 at 1766 through 1767). 

In the proposed rule, FDA explained 

the relevant background and history of 

§ 101.36, which governs the nutrition 

labeling of dietary supplements (64 FR 

1765 at 1766). Among other statutory 

provisions, § 101.36 implements section 

403(q)(5)(F)(ii) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 343(q)(5)(F)(ii)), which was 

added by the Dietary Supplement 

Health and Education Act of 1994 

(DSHEA). Section 403(q)(5)(F)(ii) states 

that the listing of dietary ingredients in 

dietary supplement nutrition labeling 

must include the quantity of each such 

ingredient (or of a proprietary blend of 

such ingredients) ‘‘per serving.’’

In response to DSHEA, in its 

December 28, 1995, proposal entitled 

‘‘Food Labeling; Statement of Identity, 

Nutrition Labeling and Ingredient 

Labeling of Dietary Supplements’’ (the 

December 28, 1995, proposed rule), FDA 

proposed that quantitative nutrition 

information for a dietary supplement be 

listed on a ‘‘per serving’’ basis (60 FR 

67194 at 67198 and 67201). This 

requirement remained unchanged in the 

September 23, 1997, final rule (62 FR 

49826 at 49830) entitled ‘‘Food 

Labeling; Statement of Identity, 

Nutrition Labeling and Ingredient 

Labeling of Dietary Supplements; 

Compliance Policy Guide Revocation’’

(the September 23, 1997, final rule). The 

September 23, 1997, final rule 

established requirements for the 

nutrition labeling and ingredient 

labeling of dietary supplements. These 

regulations state, in relevant part, that, 

for ‘‘(b)(2)-dietary ingredients’’ (i.e., 

dietary ingredients that have a 

Reference Daily Intake (RDI) or a Daily 

Reference Value (DRV) as established in 

§ 101.9(c) (21 CFR 101.9(c))) and their 

subcomponents (see § 101.36(b)(2)), the 

declaration of nutrition information on 

the label and in the labeling of dietary 

supplements must include the 

quantitative amount and percent of 

Daily Value of each dietary ingredient 

‘‘per serving’’ (§ 101.36(b)(2)(ii) through 

(b)(2)(iii)). For ‘‘other dietary 

ingredients’’ (i.e., dietary ingredients for 

which RDIs and DRVs have not been 

established (see § 101.36(b)(3)), FDA’s 

regulations require a declaration of the 

quantitative amount of each dietary 

ingredient ‘‘per serving’’ and a symbol 

(e.g., an asterisk) in the column under 

the heading ‘‘% Daily Value,’’ or 

following the quantitative amount when 

such a heading is not used, that refers 

to the same symbol placed at the bottom 

of the Supplement Facts label and 

followed by the statement ‘‘Daily Value 

not established’’ (§ 101.36(b)(3)(ii) and 

(b)(3)(iv)). 

At the manufacturer’s option, 

nutrition labeling for a dietary 

supplement (i.e., the Supplement Facts 

label) may also include the quantitative 

amount and percent of Daily Value of 

each dietary ingredient on a ‘‘per unit’’

basis in addition to the required ‘‘per 

serving’’ basis (§ 101.36(b)(2)(iv)). The 

petitioner requested that § 101.36 be 

amended to include a provision that the 

quantitative amount and percent of 

Daily Value of a dietary ingredient may 

also be listed on a ‘‘per day’’ basis in 

addition to the required ‘‘per serving’’

basis when a recommendation is made 

on the label that the dietary supplement 

be consumed more than once per day. 

In response to the petitioner’s request, 

we proposed to amend § 101.36 by 

adding new paragraph (e)(9) to permit 

quantitative information by weight (or 

volume, if permitted) to be declared on 

a ‘‘per day’’ basis in addition to the 

required ‘‘per serving’’ basis. 

Accordingly, we proposed to remove 

§ 101.36(b)(2)(iv), which provides for 

the optional listing of quantitative 

information on a ‘‘per unit’’ basis, and 

to include this provision with the new 

provision for the optional listing of 

quantitative information on a ‘‘per day’’

basis in new § 101.36(e)(9). These 

labeling provisions would apply to all 

dietary ingredients (i.e., paragraph (b)(2) 

and other dietary ingredients). We 

further proposed to redesignate existing 

paragraphs (e)(9), (e)(10), and (e)(11) of 

§ 101.36 as (e)(10), (e)(11), and (e)(12), 

respectively, and, accordingly, in 

redesignated paragraph (e)(12), to 

change the reference to paragraph 

(e)(10) to (e)(11). Finally, we proposed 

to provide an example in new 

§ 101.36(e)(11)(viii) of a suggested 

format for a Supplement Facts label 

providing information on a ‘‘per 

serving’’ and ‘‘per day’’ basis. Interested 

persons were given until March 29, 

1999, to comment on the proposed rule. 

II. Summary of Comments and the 

Agency’s Responses 

FDA received six letters, each 

containing one or more comments, in 

response to the proposed rule. 

Comments were received from industry 

(including the petitioner), trade 

associations, and a consumer advocacy 

group. All comments supported the 

proposed rule with two comments 

requesting additional changes. The 

latter comments and the agency’s 

responses are discussed in the following 

paragraphs. Two other comments raised 

issues regarding the ‘‘Analysis of 

Impacts’’ of the proposed regulation; 

they are discussed in the ‘‘Analysis of 

Impacts’’ section of this document. 

• Two comments responding to the 

proposed rule’s inclusion of a sample 

Supplement Facts label for ‘‘per 

serving’’ and ‘‘per day’’ information 

recommended additional options for the 

required format. One comment 

requested that manufacturers have the 

option of providing a statement such as 

‘‘Recommended Servings Per Day 3 

Caplets (multiply per caplet amounts by 

3 for per day amount)’’ below the 

‘‘Serving Size’’ declaration. The 

comment requested that we permit firms 

to provide the ‘‘per day’’ information 

either in this format or in the proposed 

rule’s column format. The comment 

stated that the requested optional format 

gives consumers instructions for 

calculating the total amount of a dietary 

supplement and its dietary ingredients 

consumed per day and that most 

consumers are able to do this simple 

calculation. Also, the comment noted 

that the requested optional format 

would enable companies to optimize the 

type size on dietary supplement labels 

to improve label readability. The 

comment explained that using a column 

format to provide ‘‘per day’’ information 

would increase the Supplement Facts 

label by about 30 percent and that such 

an increase may drive the choice of type 


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Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Rules and Regulations 74787 

1This comment referred to proposed paragraph 

§ 101.36(e)(9)(vii) for the sample label. However, 

because there was no § 101.36(e)(9)(vii) in the 

proposed rule, we presume that the comment 

intended to refer to the sample label in paragraph 

§ 101.36(e)(11)(viii) of the proposed rule. 

2This comment referred to the non-continuous 

nature of the heavy bar below the listing of 

§ 101.36(b)(3) dietary ingredients (i.e., ‘‘other 

dietary ingredients’’) in the proposed sample label. 

However, because the sample label in the proposed 

rule did not include other dietary ingredients, we 

presume that the comment intended to inquire 

about the non-continuous heavy bar below the 

listing of (b)(2)-dietary ingredients. 

size to the minimum allowed, rather 

than larger type. The comment 

contended that use of the minimum 

type size to offset the additional space 

consumed by a larger Supplement Facts 

label is not necessarily in the public 

interest. 

The other comment requested that we 

allow a statement such as 

‘‘Recommended: Three (3) servings per 

day’’ immediately following the 

‘‘Serving Size’’ declaration in the 

Supplement Facts panel when nutrition 

information is presented on a ‘‘per day’’

basis. The comment’s sample label 

provided this statement in conjunction 

with the column format. The comment 

stated that the recommendation of a 

day’s consumption in the Supplement 

Facts label is not confusing and allows 

for easy readability by the consumer so 

that the consumer understands the 

concept of total daily consumption in 

one place on the label. 

We have considered the comments 

requesting that the agency allow these 

additional optional statements about 

servings ‘‘per day’’ recommended 

elsewhere on the label in the 

Supplement Facts label of a dietary 

supplement. We believe that permitting 

a parenthetical statement as part of the 

‘‘Serving Size’’ declaration in lieu of an 

additional column would promote 

larger print and would improve the 

readability of the Supplement Facts 

label in some circumstances. We also 

agree with the comment that permitting 

manufacturers to include a parenthetical 

declaration of the servings per day 

recommended elsewhere on the label 

after the listed serving size on the 

Supplement Facts panel would be 

useful, and would not be confusing, to 

consumers. Accordingly, we are 

permitting both types of parenthetical 

statements with slight modifications. 

We disagree with some of the 

language proposed by both comments. 

Both comments proposed language for 

the optional parenthetical statements, 

and both proposals included the word 

‘‘recommended.’’ We are not providing 

for use of the word ‘‘recommended’’ in 

new § 101.36(e)(9) because we believe 

that the word may cause confusion 

among consumers if used in the context 

of the Supplement Facts label. The 

purpose of the Supplement Facts label 

is to set out the factual nutritional 

information for the serving size of the 

product. To assure that the relevant 

nutritional information is set out, 

section 403(q)(5)(F) of the act prescribes 

information that must be included on 

the label of the dietary supplement. 

FDA’s nutrition labeling regulations for 

dietary supplements prescribe both the 

information in a Supplement Facts label 

and its presentation, including the 

format (§ 101.36(b)), the percent of Daily 

Value of certain dietary ingredients 

(§§ 101.9(c) and 101.36(b)(2)), the order 

in which certain dietary ingredients are 

presented (§ 101.36(b)(2)(i)(B)), the 

manner in which amounts are to be 

expressed (§ 101.36(b)(2)(ii)), and the 

manner in which dietary ingredients are 

to be listed, even if no RDI or DRV has 

been established (§ 101.36(d)). 

Introducing the term ‘‘recommended’’

into the Supplement Facts label could 

suggest to consumers that the 

recommendation for the number of 

servings per day comes from some 

independent source, such as an expert 

body. FDA believes that permitting the 

same information to be conveyed 

without use of the word 

‘‘recommended’’ would achieve the 

same result sought by the comments 

without leading to the potential 

confusion stemming from use of the 

word ‘‘recommended’’ in the context of 

the Supplement Facts label. Moreover, 

manufacturers and distributors remain 

free to use the term ‘‘recommended’’

elsewhere on the label of their dietary 

supplements, so long as use of the term 

is not false or misleading (e.g, if it 

suggests that the recommendation 

comes from a source other than the 

manufacturer or distributor when, in 

fact, it does not) or does not otherwise 

misbrand the dietary supplement under 

section 403 of the act. 

New § 101.36(e)(9) will now permit a 

parenthetical statement in the 

Supplement Facts label that provides 

directions for calculating the ‘‘per day’’

amount when there is a manufacturer’s 

(or distributor’s, if the distributor labels 

the product) recommendation or 

directions for use in other parts of the 

label that the dietary supplement be 

consumed more than once per day. A 

manufacturer may use such a 

parenthetical statement as an alternative 

to the column format for ‘‘per day’’

information described in the proposed 

rule and permitted in new 

§ 101.36(e)(9). For example, a 

manufacturer could provide a statement 

such as ‘‘Serving Size: 1 Caplet 

(Multiply amounts by 3 for total daily 

amount).’’ We are also incorporating a 

provision for a parenthetical declaration 

of the servings per day recommended 

elsewhere on the label into new 

§ 101.36(e)(9). The regulation will now 

permit such a simple statement 

following the ‘‘Serving Size’’

declaration. FDA believes that a simple 

declaration of the servings per day 

recommended on other parts of the 

label, such as ‘‘Total daily amount: 3 

caplets per day,’’ on the Supplement 

Facts label would provide clarity for the 

consumer when interpreting the column 

format, which provides the same 

information in a different way (e.g., ‘‘Per 

Day (3 Caplets)’’). 

• One comment asked if continuous 

bars and lines would be acceptable in 

place of the non-continuous bars and 

lines shown in the sample Supplement 

Facts label in the proposed rule.1

Specifically, concerning the sample 

Supplement Facts label, this comment 

was referring to (1) the non-continuous 

heavy bar below the ‘‘Serving Size’’

declaration, (2) the non-continuous light 

bar below the ‘‘Per Serving’’ (‘‘Per 

Caplet’’ in the proposed sample label) 

and ‘‘Per Day’’ headings, (3) the noncontinuous hairlines between the listed 

dietary ingredients, and (4) the noncontinuous heavy bar below the listing 

of the (b)(2)-dietary ingredients.2

The non-continuous lines and bars 

provided in the proposed sample 

Supplement Facts label are a means of 

helping consumers distinguish each 

column. However, the agency would 

like to clarify that the sample labels 

presented in § 101.36(e)(10) (now 

§ 101.36(e)(11)) are included for the 

purpose of illustration. The noncontinuous lines and bars used in the 

sample Supplement Facts labels are one 

acceptable way to comply with the 

regulations, but not the only way. As 

long as the presentation otherwise 

complies with § 101.36, deviations from 

the sample Supplement Facts labels in 

new § 101.36(e)(11) would not violate 

the regulation. We believe that a 

Supplement Facts label using 

continuous bars and lines to separate 

multiple pairs of quantitative amounts 

and percents of Daily Value for dietary 

ingredients would be acceptable when 

the information is clearly identified by 

appropriate column headings. 

To clarify the proposed provisions for 

‘‘per day’’ and ‘‘per unit’’ information, 

and to make the codified language read 

more clearly and to conform to plain 

language principles, we are making a 

number of additional changes to the 

proposed codified language of new 

§ 101.36(e)(9), both in response to 


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74788 Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Rules and Regulations 

comments, and after our own review of 

the proposal. We are providing the 

codified language in two paragraphs: 

§ 101.36(e)(9)(i) and § 101.36(e)(9)(ii). 

The first two sentences, which pertain 

to ‘‘per unit’’ information are included 

in § 101.36(e)(9)(i). The remainder of the 

codified section, which pertains to ‘‘per 

day’’ information is included in 

§ 101.36(e)(9)(ii). In the first sentence of 

the codified section, after ‘‘Daily 

Value,’’ we are adding ‘‘of each dietary 

ingredient’’ and replacing the last clause 

of this sentence (i.e., ‘‘as required in 

paragraph (b)(2)(ii) and (b)(2)(iii) of this 

section’’) with the following: ‘‘required 

by paragraphs (b)(2)(ii) and (b)(2)(iii) of 

this section for (b)(2)-dietary ingredients 

and (b)(3)(ii) and (b)(3)(iv) of this 

section for other dietary ingredients.’’

After the first sentence, we are adding 

the following (second) sentence: ‘‘If ‘per 

unit’ information is provided, it must be 

presented in additional columns to the 

right of the ‘per serving’ information 

and be clearly identified by appropriate 

headings.’’ The second sentence in the 

proposed codified language is now the 

third sentence in this final rule (the first 

sentence of § 101.36(e)(9)(ii)), and 

incorporates changes as follows: (1) We 

are adding ‘‘by weight (or volume, if 

permitted)’’ following the words ‘‘total 

quantitative amount’’ and (2) following 

‘‘Daily Value,’’ we are adding ‘‘of each 

dietary ingredient may be presented on 

a ‘per day’ basis in addition to the ‘per 

serving’ basis required by paragraphs 

(b)(2)(ii) and (b)(2)(iii) of this section for 

(b)(2)-dietary ingredients and (b)(3)(ii) 

and (b)(3)(iv) of this section for other 

dietary ingredients,’’ to be consistent 

with the first sentence for ‘‘per unit’’

information and to avoid potential 

confusion. 

In addition, to clarify the proposed 

provisions for ‘‘per day’’ information, 

we are adding the following sentences 

to § 101.36(e)(9)(ii)): 

If ‘‘per day’’ information is provided, it 

must be presented in additional columns to 

the right of the ‘‘per serving’’ information and 

be clearly identified by appropriate headings 

and/or be presented in a parenthetical 

statement as part of the ‘‘Serving Size’’

declaration. A sample illustration for ‘‘per 

day’’ information in a column format is 

provided in paragraph (e)(11)(viii) of this 

section. As illustrated, the additional ‘‘Per 

Day’’ column heading is followed 

parenthetically by the number of servings 

recommended per day in other parts of the 

label (e.g., ‘‘Per Day (3 Caplets)’’). When the 

parenthetical statement format following the 

‘‘Serving Size’’ declaration is used as an 

alternative to the column format, the 

statement must provide no more than simple 

instructions regarding how to calculate the 

‘‘per day’’ amount for the number of servings 

per day recommended in other parts of the 

label (e.g., ‘‘Serving Size: 1 Caplet (Multiply 

amounts by 3 for total daily amount)’’). When 

the parenthetical statement format following 

the ‘‘Serving Size’’ declaration is used in 

addition to the column format, the statement 

must provide no more than a simple 

declaration of the number of servings 

recommended in other parts of the label (e.g., 

‘‘Serving Size: 1 Caplet (Total daily amount: 

3 caplets per day)’’). 

We are also changing the word 

‘‘shall’’ to ‘‘must’’ in the second 

sentence of new § 101.36(e)(12). This 

change is meant to make the codified 

language read more clearly and conform 

to plain language principles. 

In sum, we are finalizing the proposed 

rule as follows: We are removing 

§ 101.36(b)(2)(iv), which provides for 

the optional listing of quantitative 

information on a ‘‘per unit’’ basis, and 

including this provision in a new 

§ 101.36(e)(9). We are, therefore, 

continuing to provide for the optional 

presentation of the quantitative amount 

by weight (or volume, if permitted) and 

the percent of Daily Value on a ‘‘per 

unit’’ basis, in addition to the required 

‘‘per serving’’ basis. We are also adding 

a new provision in the new 

§ 101.36(e)(9) to provide for the optional 

presentation of the quantitative amount 

by weight (or volume, if permitted) and 

the percent of Daily Value on a ‘‘per 

day’’ basis, in addition to the required 

‘‘per serving’’ basis, when the label 

recommends consumption of the dietary 

supplement more than once per day. 

As proposed, we are also 

redesignating existing paragraphs (e)(9), 

(e)(10), and (e)(11) of § 101.36 as (e)(10), 

(e)(11), and (e)(12), respectively, and 

accordingly, in redesignated paragraph 

(e)(12) changing the reference to 

paragraph (e)(10) to the newly 

redesignated paragraph (e)(11). Lastly, 

in new § 101.36(e)(11)(viii), we are 

providing a sample label for the purpose 

of illustrating a column format for a 

Supplement Facts label providing 

information on a ‘‘per serving’’ and ‘‘per 

day’’ basis. 

III. Legal Authority 

In response to a citizen petition, FDA 

is amending its food labeling regulations 

for dietary supplements to provide that 

the quantitative amount and percent of 

Daily Value of a dietary ingredient may 

be voluntarily presented on a ‘‘per day’’

basis in addition to the required ‘‘per 

serving’’ basis when a recommendation 

is made on the label that the dietary 

supplement be consumed more than 

once per day. FDA has authority to take 

this action under sections 201(n), 

403(a)(1) and (q)(5)(F), and 701(a) of the 

act (21 U.S.C. 321(n), 343(a)(1) and 

(q)(5)(F), 371(a)). 

By delegation from the Secretary of 

Health and Human Services (the 

Secretary), FDA has authority under 

section 701(a) of the act to issue 

regulations for the efficient enforcement 

of the act. Further, section 403(q)(5)(F) 

provides that a dietary supplement 

product must comply with the 

requirements of sections 403(q)(1) and 

(q)(2) in a manner which is appropriate 

for the product and which is specified 

in regulations of the Secretary (and by 

delegation, FDA). Sections 403(q)(1) and 

(q)(2) require that if a food, which 

includes a dietary supplement, is 

intended for human consumption and is 

offered for sale, its label or labeling 

must bear certain nutrition information. 

For dietary supplements, this includes 

nutrition information ‘‘per serving’’

about dietary ingredients that are 

present in significant amounts (21 

U.S.C. 343(q)(5)(F)(i)). Under these two 

sections, FDA has authority to permit 

the voluntary presentation of ‘‘per day’’

nutrition information on a dietary 

supplement label and provide 

requirements for such labeling. 

This final rule will give dietary 

supplement manufacturers the option to 

present nutrition information of dietary 

supplements on a ‘‘per day’’ basis to 

consumers. When manufacturers choose 

to include ‘‘per day’’ information on a 

dietary supplement label, in addition to 

the required ‘‘per serving’’ information, 

consumers will have more information 

about the daily intake of dietary 

ingredients from a dietary supplement 

that is recommended by the 

manufacturer to be consumed more than 

once per day. When provided, ‘‘per 

day’’ information about a dietary 

supplement can assist consumers in 

making dietary choices about total 

consumption of dietary ingredients. 

IV. Analysis of Impacts 

A. Benefit-Cost Analysis 

FDA has examined the impacts of this 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action as defined 

by the Executive order. 

1. The Need for This Regulation 

Current regulations do not permit the 

voluntary declaration of potentially 


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useful information on the labels of 

dietary supplements. Consumers may 

want information on the amount of 

nutrition provided by dietary 

supplements on a ‘‘per day’’ basis. 

Without this rule, manufacturers are 

precluded from providing consumers 

with that information in the 

Supplement Facts label of their dietary 

supplements. 

2. Options 

There are primarily four regulatory 

options available to us. 

a. Option 1.—Take no new regulatory 

action. This option would result in no 

change to the current situation. This 

option is the baseline for comparison of 

options and entails no costs or benefits. 

b. Option 2.—Take the regulatory 

actions as described in the proposed 

rule. We proposed allowing the 

nutrition labeling of dietary 

supplements to declare the quantitative 

amount and the percent of Daily Value 

of a dietary ingredient on a ‘‘per day’’

basis in addition to the required ‘‘per 

serving’’ basis when the label 

recommends that the dietary 

supplement be consumed more than 

once per day as long as the information 

was provided in a column format. 

The proposed rule would have caused 

costs and benefits only to the extent that 

firms elected to take advantage of the 

option of presenting information on a 

‘‘per day’’ basis. No firm would have 

borne the cost of changing labels unless 

it believed that the claim would have 

resulted in increased profits by virtue of 

increased sales of its products or an 

increased willingness by consumers to 

pay more for the product. Interested 

consumers would have benefited from 

the additional ‘‘per day’’ information. 

In response to the proposal, we 

received one comment that agreed with 

our analysis and stated that ‘‘[t]he 

agency accurately notes that the cost 

impact of this change is 

inconsequential.’’ However, the 

comment went on to say that, ‘‘FDA 

should seek ways to balance the 

potentially conflicting public health 

needs of the presentation of all of the 

needed and required information and 

the limited label space of dietary 

supplement product labels. * * * The 

use of a column format would increase 

the Supplement Facts box by about 

30%, thereby potentially driving the 

choice of type size to the minimum 

required to offset the additional space 

consumed by a larger Supplement Facts 

box. This is not necessarily in the public 

interest.’’

We still believe that finalizing the 

proposed rule would have been of 

greater benefit to producers and 

consumers than continuing to preclude 

the provision of this information in the 

Supplement Facts label. However, that 

benefit would have been mitigated by 

the potential cost to consumers of 

having to read the Supplement Facts 

label in a smaller type size. 

c. Option 3.—Take the regulatory 

actions described in this final rule. In 

this final rule, we are allowing the 

nutrition labeling of dietary 

supplements to declare the quantitative 

amount and the percent of Daily Value 

of a dietary ingredient on a ‘‘per day’’

basis in addition to the required ‘‘per 

serving’’ basis when the label 

recommends that the dietary 

supplement be consumed more than 

once per day. Based on comments 

(described in section II of this 

document) we are also permitting this 

information to be provided in 

parenthetical notations as an alternative 

to the column format described in the 

proposed rule, as detailed in section II 

of this document. These regulatory 

actions provide producers of dietary 

supplements the option to present 

nutrition information on a ‘‘per day’’

basis in the Supplement Facts label with 

greater flexibility than in the proposed 

rule. 

As under Option 2, the final rule will 

cause costs and benefits only to the 

extent that firms elect to take advantage 

of the option of presenting information 

on a ‘‘per day’’ basis. No firm will bear 

the cost of changing labels unless it 

believes that the claim will result in 

increased profits by virtue of increased 

sales of its products or an increased 

willingness by consumers to pay more 

for the product. 

However, this final rule is an 

improvement over the proposed rule. It 

gives producers of dietary supplements 

greater flexibility in how they provide 

consumers with the ‘‘per day’’

information. This potentially decreases 

the costs to them (in comparison to 

Option 2) by not requiring the 

information to be provided in a column 

format and thereby reducing the 

potential need for extensive label 

redesigns. 

The increased flexibility and 

decreased cost to producers of providing 

the information increases the likelihood 

(compared to Option 2) that producers 

will voluntarily provide consumers with 

‘‘per day’’ information. It also reduces 

the likelihood (compared to Option 2) 

that the new ‘‘per day’’ information and 

all of the other information in the 

Supplement Facts label would be 

provided in smaller and less legible 

type. 

Therefore, we conclude that this final 

rule will improve social welfare 

compared with Options 1 and 2. 

d. Option 4.—Require ‘‘per day’’

labeling of dietary supplements. In 

response to the proposed rule, one 

comment stated that we should monitor 

the costs for manufacturers who use the 

voluntary ‘‘per day’’ labeling and, if the 

costs are minimal, ‘‘consider making per 

day labeling mandatory in some future 

regulation.’’ The comment stated the 

belief ‘‘that the informational benefits of 

the rule for consumers, both at the time 

of purchase and of consumption, may be 

significant enough to warrant a 

mandatory rule.’’

We are not precluding that action in 

the future. There are at least 62,500 

dietary supplement labels for products 

sold in the United States. Requiring that 

all labels be changed could impose 

significant costs on the industry. For 

example, if we were to require ‘‘per 

day’’ labeling within 2 years of the 

publication of this final rule, it could 

cost between as little as $40 million and 

as much as $100 million, based on data 

in our labeling cost model. Such 

significant costs would warrant 

evidence of at least similarly sized 

benefits to consumers from information 

on ‘‘per day’’ nutritional information. 

We currently do not have enough 

information on the benefit to consumers 

of ‘‘per day’’ labeling to justify 

mandatory ‘‘per day‘‘ labeling for all 

dietary supplements. Therefore, we 

have no evidence that this option is 

superior for social welfare than this 

final rule (Option 3). 

B. Small Entity Analysis 

The Regulatory Flexibility Act (5 

U.S.C. 601–612) requires agencies to 

analyze regulatory options that would 

minimize any significant impact of a 

rule on small entities. Because this final 

rule allows voluntary ‘‘per day’’ labeling 

of dietary supplements, the agency 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Because ‘‘per day’’ labeling will be 

permitted and not required, a firm, 

including any small firm, would change 

its labeling and incur costs only if the 

expected benefits to it (e.g., increased 

sales) exceed the expected costs. 

Therefore, under the Regulatory 

Flexibility Act, no further analysis is 

required. 

C. Unfunded Mandates 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 


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74790 Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Rules and Regulations 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $122 

million, using the most current (2005) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

V. Federalism Analysis 

We have analyzed this rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule has a 

preemptive effect on State law. Section 

4(a) of the Executive order requires 

agencies to ‘‘construe * * * a Federal 

Statute to preempt State law only where 

the statute contains an express 

preemption provision, or there is some 

other clear evidence that Congress 

intended preemption of State law, or 

where the exercise of State authority 

conflicts with the exercise of Federal 

authority under the Federal statute.’’

Section 403A of the act (21 U.S.C. 343–

1) is an express preemption provision. 

Section 403A(a)(4) of the act provides 

that: ‘‘* * * no State or political 

subdivision of a State may directly or 

indirectly establish under any authority 

or continue in effect as to any food in 

interstate commerce—* * * (4) any 

requirement for nutrition labeling of 

food that is not identical to the 

requirement of section 403(q) * * *.’’

Before the effective date of this rule, 

this provision operated to preempt 

States from permitting ‘‘per day’’

nutrition labeling on dietary 

supplements because no such 

requirements had been authorized by 

FDA under section 403(q) of the act. 

Once this rule becomes effective, States 

will be preempted from imposing any 

requirements about ‘‘per day’’ nutrition 

labeling for dietary supplements that are 

not identical to those permitted by this 

rule. This preemptive effect is 

consistent with what Congress set forth 

in section 403A of the act. Section 

403A(a)(4) of the act displaces both 

State and legislative requirements and 

State common law duties (Medtronic v. 

Lohr, 518 U.S. 470, 503 (1996) (Breyer, 

J., concurring in part and concurring in 

the judgment); id. at 510 (O’Connor, J., 

joined by Rehnquist, C.J., Scalia, J., and 

Thomas, J., concurring in part and 

dissenting in part); Cippollone v. Liggett 

Group, Inc., 505 U.S. 504, 521 (1992) 

(plurality op.); id. at 548–49 (Scalia, J., 

joined by Thomas, J., concurring in part 

in the judgment and dissenting in part)). 

FDA believes that the preemptive 

effect of the final rule is consistent with 

Executive Order 13132. Section 4(e) of 

the Executive order provides that, 

‘‘when an agency proposes to act 

through adjudication or rulemaking to 

preempt State law, the agency shall 

provide all affected State and local 

officials notice and an opportunity for 

appropriate participation in the 

proceedings.’’ FDA provided the States 

with an opportunity for appropriate 

participation in this rulemaking when it 

sought input from all stakeholders 

through publication of the proposed 

rule in the Federal Register on January 

12, 1999 (64 FR 1765). FDA received no 

comments from any States on the 

proposed rulemaking. 

In conclusion, FDA believes that it 

has complied with all of the applicable 

requirements of Executive Order 13132, 

and has determined that the preemptive 

effects of this final rule are consistent 

with the Executive order. 

VI. The Paperwork Reduction Act of 

1995 

This final rule contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). A description of these provisions 

with an estimate of the annual reporting 

burden is given in the following 

paragraphs. Included in the estimate is 

the time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

each collection of information. 

Title: Food Labeling: Nutrition 

Labeling of Dietary Supplements on a 

‘‘Per Day’’ Basis. 

Description: Section 403(q)(5)(F) of 

the act provides that dietary 

supplements must bear nutrition 

labeling in a manner that is appropriate 

for the product and that is specified in 

regulations issued by FDA. We issued 

regulations establishing the 

requirements for nutrition labeling of 

dietary supplements in § 101.36 in the 

September 23, 1997, final rule. We are 

now amending our nutrition labeling 

regulations for dietary supplements to 

permit voluntary declaration of the 

quantitative amount and the percent of 

Daily Value of a dietary ingredient on a 

‘‘per day’’ basis in addition to the 

required ‘‘per serving’’ basis, if a dietary 

supplement label recommends that the 

dietary supplement be consumed more 

than once per day. These provisions 

respond to a citizen petition submitted 

by a manufacturer and marketer of 

dietary supplements. This rule will 

provide the option to present nutrition 

information on a ‘‘per day’’ basis to 

consumers. 

Description of Respondents: Suppliers 

of dietary supplements. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response 

Total Annual 

Hours 

Total 

Operating Cost 

101.36(e) 125 13 1,625 0.25 406 $151,000 

1There are no capital or maintenance costs associated with this collection. 

The agency estimated in the March 

13, 2003, proposed rule entitled 

‘‘Current Good Manufacturing Practice 

in Manufacturing, Packing, or Holding 

Dietary Ingredients and Dietary 

Supplements’’ that there were about 

1,250 manufacturers and relabelers of 

dietary supplements (68 FR 12157 at 

12223). Based on data in our labeling 

cost model each producer has, on 

average, roughly 50 products. We 

assume that only 10 percent, or 125, of 

the dietary supplement suppliers would 

revise the labels of their products to 

incorporate ‘‘per day’’ information for 

their products. We also assume that 

‘‘per day’’ information would generally 

be placed on, at most, 25 percent, or, at 

most, 13 of a firm’s estimated 50 

products, although this number would 

vary by firm based on the types of 

products that it produces. The agency 

also believes that the burden associated 

with providing nutrition information on 

a ‘‘per day’’ basis for dietary 

supplements would be a one-time 

burden for the small number of firms 

that decide voluntarily to add this 

additional information to the labels of 

their products, separate from any other 

label changes for their products. We 

estimate that at least 90 percent of firms 

would coordinate adding ‘‘per day’’


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information with other changes to their 

labels. In this case, the voluntary cost of 

transmitting ‘‘per day’’ information to 

consumers would be subsumed almost 

entirely in the cost of these other 

voluntary or required labeling changes. 

The incremental cost for these 113 firms 

would be approximately $50 (64 FR 

1765 at 1768) per label for 1,469 labels, 

or about $73,000 total. For the 

remaining 12 firms that would not 

coordinate adding ‘‘per day’’

information with other labeling changes, 

we estimate that the cost would be 

approximately $500 per label (64 FR 

1765 at 1768 through 1769) for 156 

labels, or $78,000 total. The estimated 

total operating costs in table 1 of this 

document are, therefore, $151,000. 

Respondents are already required to list 

the quantitative amount and percent of 

Daily Value of dietary ingredients ‘‘per 

serving’’ as part of the nutrition 

information for dietary supplements. 

The ‘‘per day’’ information is generated 

by simple extrapolation from the ‘‘per 

serving’’ information. 

Individuals and organizations may 

submit comments on these burden 

estimates or on any other aspect of these 

information collection provisions, 

including suggestions for reducing the 

burden, and should direct them to the 

Office of Nutritional Products, Labeling, 

and Dietary Supplements (HFS–800), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740–3835. 

The information collection provisions 

in the proposed rule were approved 

under OMB control number 0910–0395. 

This approval was discontinued in 

November 2004, but is now reinstated 

and expires on October 31, 2009. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. 

VII. Environmental Impact 

We have carefully considered the 

potential environmental effects of this 

action. FDA has determined under 21 

CFR 25.30(k) that this action is of a type 

that does not have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. No new information or 

comments have been received that 

would affect this determination. 

List of Subjects in 21 CFR Part 101 

Food labeling, Nutrition, Reporting 

and recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 101 is 

amended as follows: 

PART 101—FOOD LABELING 

■ 1. The authority citation for 21 CFR 

part 101 continues to read as follows: 

Authority: 15 U.S.C. 1453, 1454, 1455; 21 

U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 

243, 264, 271. 

■ 2. Section 101.36 is amended by 

removing paragraph (b)(2)(iv); by 

redesignating paragraphs (e)(9), (e)(10), 

and (e)(11) as paragraphs (e)(10), (e)(11), 

and (e)(12), respectively; by adding new 

paragraphs (e)(9)(i) and (e)(9)(ii); by 

adding new paragraph (e)(11)(viii) to 

newly redesignated paragraph (e)(11); 

and by revising newly redesignated 

paragraph (e)(12) to read as follows (The 

graphic to newly redesignated (e)(12) 

remains unchanged.): 

§ 101.36 Nutrition labeling of dietary 

supplements. 

* * * * * 

(e) * * * 

(9)(i) The quantitative amount by 

weight (or volume, if permitted) and the 

percent of Daily Value of each dietary 

ingredient may be presented on a ‘‘per 

unit’’ basis in addition to the ‘‘per 

serving’’ basis required by paragraphs 

(b)(2)(ii) and (b)(2)(iii) of this section for 

(b)(2)-dietary ingredients and (b)(3)(ii) 

and (b)(3)(iv) of this section for other 

dietary ingredients. If ‘‘per unit’’

information is provided, it must be 

presented in additional columns to the 

right of the ‘‘per serving’’ information 

and be clearly identified by appropriate 

headings. 

(ii) Alternatively, if a 

recommendation is made in other parts 

of the label that a dietary supplement be 

consumed more than once per day, the 

total quantitative amount by weight (or 

volume, if permitted) and the percent of 

Daily Value of each dietary ingredient 

may be presented on a ‘‘per day’’ basis 

in addition to the ‘‘per serving’’ basis 

required by paragraphs (b)(2)(ii) and 

(b)(2)(iii) of this section for (b)(2)-dietary 

ingredients and (b)(3)(ii) and (b)(3)(iv) of 

this section for other dietary 

ingredients. If ‘‘per day’’ information is 

provided, it must be presented in 

additional columns to the right of the 

‘‘per serving’’ information and be clearly 

identified by appropriate headings and/ 

or be presented in a parenthetical 

statement as part of the ‘‘Serving Size’’

declaration. A sample illustration for 

‘‘per day’’ information in a column 

format is provided in paragraph 

(e)(11)(viii) of this section. As 

illustrated, the additional ‘‘Per Day’’

column heading is followed 

parenthetically by the number of 

servings recommended per day in other 

parts of the label (e.g., ‘‘Per Day (3 

Caplets)’’). When the parenthetical 

statement format following the ‘‘Serving 

Size’’ declaration is used as an 

alternative to the column format, the 

statement must provide no more than 

simple instructions regarding how to 

calculate the ‘‘per day’’ amount for the 

number of servings per day 

recommended in other parts of the label 

(e.g., ‘‘Serving Size: 1 Caplet (Multiply 

amounts by 3 for total daily amount)’’). 

When the parenthetical statement 

format following the ‘‘Serving Size’’

declaration is used in addition to the 

column format, the statement must 

provide no more than a simple 

declaration of the number of servings 

recommended in other parts of the label 

(e.g., ‘‘Serving Size: 1 Caplet (Total daily 

amount: 3 caplets per day)’’). 

* * * * * 

(11) * * * 

(viii) Dietary supplement illustrating 

‘‘per serving’’ and ‘‘per day’’

information: 


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74792 Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Rules and Regulations 

(12) If space is not adequate to list the 

required information as shown in the 

sample labels in paragraph (e)(11) of 

this section, the list may be split and 

continued to the right as long as the 

headings are repeated. The list to the 

right must be set off by a line that 

distinguishes it and sets it apart from 

the dietary ingredients and percent of 

Daily Value information given to the 

left. The following sample label 

illustrates this display: 

* * * * * 

Dated: November 30, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–9657 Filed 12–12–06; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 51, 96, and 97 

[EPA–HQ–OAR–2004–0076; FRL–8254–7] 

RIN 2060–AM99 

Clean Air Interstate Rule (CAIR) and 

Federal Implementation Plans for 

CAIR; Corrections 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; correcting 

amendments. 

SUMMARY: In this rule, EPA is making 

minor corrections to the Clean Air 

Interstate Rule (CAIR) and the Federal 

Implementation Plans (FIPs) for the 

CAIR to clarify text that may potentially 

be misleading. This corrections rule 

does not change any of CAIR or CAIR 

FIPs rule requirements or substantively 

change the rules in any way. 

DATES: Effective Date: These correcting 

amendments are effective on December 

13, 2006. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2004–0076. 

Documents related to the CAIR are 

available in the rulemaking docket 

under Docket ID No. EPA–HQ–OAR–

2003–0053; documents related to the 

CAIR FIPs are available in the 

rulemaking docket under Docket ID No. 

EPA–HQ–OAR–2004–0076. All 

documents in the dockets are listed on 

the http://www.regulations.gov Web 

site. Although listed in the indexes, 

some information is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the EPA Docket Center (Air Docket), 

EPA/DC, EPA West, Room B102, 1301 

Constitution Ave., NW., Washington, 

DC. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744. 

Note: The EPA Docket Center suffered 

damage due to flooding during the last week 

of June 2006. The Docket Center is 

continuing to operate. However, during the 

cleanup, there will be temporary changes to 

Docket Center telephone numbers, addresses, 

and hours of operation for people who wish 

to visit the Public Reading Room to view 

documents. Consult EPA’s Federal Register 

notice at 71 FR 38147 (July 5, 2006) or the 

EPA Web site at http://www.epa.gov/ 

epahome/dockets.htm for current 

information on docket status, locations and 

telephone numbers. 

FOR FURTHER INFORMATION CONTACT: 

Carla Oldham, U.S. EPA, Office of Air 

Quality Planning and Standards, Air 

Quality Policy Division, C539–04, 

Research Triangle Park, NC 27711; 

telephone number (919) 541–3347, email address: oldham.carla@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On May 12, 2005, EPA published the 

Clean Air Interstate Rule (CAIR) in a 

final rule entitled, ‘‘Rule to Reduce 

Interstate Transport of Fine Particulate 

Matter and Ozone (Clean Air Interstate 

Rule); Revisions to Acid Rain Program; 

Revisions to NOX SIP Call’’ (70 FR 

25162). On April 28, 2006, EPA 

published Federal Implementation 

Plans for the CAIR as part of a final rule 

entitled, ‘‘Rulemaking on Section 126 

Petition From North Carolina to Reduce 

Interstate Transport of Fine Particulate 

Matter and Ozone; Federal 

Implementation Plans To Reduce 

Interstate Transport of Fine Particulate 

Matter and Ozone; Revisions to the 

Clean Air Interstate Rule; Revisions to 

the Acid Rain Program’’ (71 FR 25328). 

The CAIR requires States to reduce 

emissions of nitrogen oxides and sulfur 

dioxide that contribute significantly to 

nonattainment and maintenance 

problems in downwind States with 

respect to the national ambient air 

quality standards for fine particulate 

matter (PM2.5) and 8-hour ozone. The 

CAIR FIPs ensure that the emissions 

reductions required by the CAIR are 

achieved on schedule. As the control 

strategy for the FIPs, EPA adopted the 

model cap-and-trade programs for 

power plants that EPA provided in the 

CAIR as a control option for States, with 

minor changes to account for Federal, 

rather than State, implementation. The 

EPA will withdraw the FIP for any State 

once that State’s own State 

implementation plan for meeting the 

CAIR requirements is fully approved. 

For a detailed description of the CAIR 

and CAIR FIPs, please see the 

rulemaking actions which are available 

on EPA’s Web site at http:// 

www.epa.gov/cair and in the Federal 

Register at and 70 FR 25162; May 12, 

2005 and 71 FR 25328; April 28, 2006. 


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