Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 53743 

GOVERNMENT PRINTING OFFICE 

Depository Library Council to the 

Public Printer; Meeting 

The Depository Library Council to the 

Public Printer (DLC) will meet on 

Monday, October 19, 2009, through 

Wednesday, October 21, 2009, at 

Doubletree Hotel Crystal City, located at 

Arlington, Virginia. The sessions will 

take place from 8 a.m. to 5:30 p.m. on 

Monday through Tuesday, and 

Wednesday, 8 a.m. to 12 p.m. The 

meeting will be held at the Doubletree 

Hotel Crystal City, 300 Army Navy 

Drive, Arlington, Virginia. The purpose 

of this meeting is to discuss the Federal 

Depository Library Program. All 

sessions are open to the public. The 

sleeping rooms available at the 

Doubletree Hotel Crystal City will be at 

the Government rate of $229.00 (plus 

applicable state and local taxes, 

currently 10.25%) a night for a single or 

double for $249.00. The Doubletree 

Hotel Crystal City is in compliance with 

the requirements of Title III of the 

Americans With Disabilities Act and 

meets all Fire Safety Act regulations. 

Robert C. Tapella, 

Public Printer of the United States. 

[FR Doc. E9–25296 Filed 10–19–09; 8:45 am] 

BILLING CODE 1520–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0296] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food Labeling 

Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

19, 2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0381. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

JonnaLynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food Labeling Regulations—(OMB 

Control Number 0910–0381)—Extension 

FDA regulations require food 

producers to disclose to consumers and 

others specific information about 

themselves or their products on the 

label or labeling of their products. 

Related regulations require that food 

producers retain records establishing 

the basis for the information contained 

in the label or labeling of their products 

and provide those records to regulatory 

officials. Finally, certain regulations 

provide for the submission of food 

labeling petitions to FDA. FDA’s food 

labeling regulations under parts 101, 

102, 104, and 105 (21 CFR parts 101, 

102, 104, and 105) were issued under 

the authority of sections 4, 5, and 6 of 

the Fair Packaging and Labeling Act (the 

FPLA) (15 U.S.C. 1453, 1454, and 1455) 

and under sections 201, 301, 402, 403, 

409, 411, 701, and 721 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 321, 331, 342, 343, 348, 350, 

371, and 379e). Most of these 

regulations derive from section 403 of 

the act, which provides that a food 

product shall be deemed to be 

misbranded if, among other things, its 

label or labeling fails to bear certain 

required information concerning the 

food product, is false or misleading in 

any particular, or bears certain types of 

unauthorized claims. The disclosure 

requirements and other collections of 

information in the regulations in parts 

101, 102, 104, and 105 are necessary to 

ensure that food products produced or 

sold in the United States are in 

compliance with the labeling provisions 

of the act and the FPLA. 

Section 101.3 of FDA’s food labeling 

regulations requires that the label of a 

food product in packaged form bear a 

statement of identity (i.e., the name of 

the product), including, as appropriate, 

the form of the food or the name of the 

food imitated. Section 101.4 prescribes 

requirements for the declaration of 

ingredients on the label or labeling of 

food products in packaged form. Section 

101.5 requires that the label of a food 

product in packaged form specify the 

name and place of business of the 

manufacturer, packer, or distributor 

and, if the food producer is not the 

manufacturer of the food product, its 

connection with the food product. 

Section 101.9 requires that nutrition 

information be provided for all food 

products intended for human 

consumption and offered for sale, unless 

an exemption in § 101.9(j) applies to the 

product. Section 101.9(g)(9) also 

provides for the submission to FDA of 

requests for alternative approaches to 

nutrition labeling. Finally, § 101.9(j)(18) 

provides for the submission to FDA of 

notices from firms claiming the small 

business exemption from nutrition 

labeling. FDA has developed Form FDA 

3570 to assist small businesses in 

claiming the small business exemption 

from nutrition labeling. The form 

contains all the elements required by 

§ 101.9(j)(18). 

Section 101.10 requires that 

restaurants provide nutrition 

information, upon request, for any food 

or meal for which a nutrient content 

claim or health claim is made. Section 

101.12(b) provides the reference amount 

that is used for determining the serving 

sizes for specific products, including 

baking powder, baking soda, and pectin. 

Section 101.12(e) provides that a 

manufacturer that adjusts the reference 

amount customarily consumed (RACC) 

of an aerated food for the difference in 

density of the aerated food relative to 

the density of the appropriate 

nonaerated reference food must be 

prepared to show FDA detailed 

protocols and records of all data that 

were used to determine the densityadjusted RACC. Section 101.12(g) 

requires that the label or labeling of a 

food product disclose the serving size 

that is the basis for a claim made for the 

product if the serving size on which the 

claim is based differs from the RACC. 

Section 101.12(h) provides for the 

submission of petitions to FDA to 

request changes in the reference 

amounts defined by regulation. 

Section 101.13 requires that nutrition 

information be provided in accordance 

with § 101.9 for any food product for 

which a nutrient content claim is made. 

Under some circumstances, § 101.13 

also requires the disclosure of other 

types of information as a condition for 

the use of a nutrient content claim. For 

example, under § 101.13(j), if the claim 

compares the level of a nutrient in the 

food with the level of the same nutrient 

in another ‘‘reference’’ food, the claim 


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53744 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 

must also disclose the identity of the 

reference food, the amount of the 

nutrient in each food, and the 

percentage or fractional amount by 

which the amount of the nutrient in the 

labeled food differs from the amount of 

the nutrient in the reference food. It also 

requires that when this comparison is 

based on an average of food products, 

this information must be provided to 

consumers or regulatory officials upon 

request. Section 101.13(q)(5) requires 

that restaurants document and provide 

to appropriate regulatory officials, upon 

request, the basis for any nutrient 

content claims they have made for the 

foods they sell. 

Section 101.14(d)(2) and (d)(3) 

provides for the disclosure of nutrition 

information in accordance with § 101.9 

and, under some circumstances, certain 

other information as a condition for 

making a health claim for a food 

product. Section 101.15 provides that, if 

the label of a food product contains any 

representation in a foreign language, all 

words, statements, and other 

information required by or under 

authority of the act to appear on the 

label shall appear thereon in both the 

foreign language and in English. Section 

101.22 contains labeling requirements 

for the disclosure of spices, flavorings, 

colorings, and chemical preservatives in 

food products. Section 101.22(i)(4) sets 

forth reporting and recordkeeping 

requirements pertaining to certifications 

for flavors designated as containing no 

artificial flavor. Section 101.30 specifies 

the conditions under which a beverage 

that purports to contain any fruit or 

vegetable juice must declare the 

percentage of juice present in the 

beverage and the manner in which the 

declaration is to be made. Section 

102.33 specifies the common or usual 

name for beverages that contain fruit or 

vegetable juice. 

Section 101.36 requires that nutrition 

information be provided for dietary 

supplements offered for sale, unless an 

exemption in § 101.36(h) applies. 

Section 101.36(f)(2) cross-references the 

provisions in § 101.9(g)(9) for the 

submission to FDA of requests for 

alternative approaches to nutrition 

labeling. Also, § 101.36(h)(2) crossreferences the provisions in 

§ 101.9(j)(18) for the submission of small 

business exemption notices. As noted 

previously, FDA has developed Form 

FDA 3570 to assist small businesses in 

claiming the small business exemption 

from nutrition labeling. The form 

contains all the elements required by 

§ 101.36(h)(2). 

Section 101.36(e) permits the 

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. 

Section 101.42 requests that food 

retailers voluntarily provide nutrition 

information for raw fruits, vegetables, 

and fish at the point of purchase, and 

§ 101.45 contains guidelines for 

providing such information. Also, 

§ 101.45(c) provides for the submission 

of nutrient databases and proposed 

nutrition labeling values for raw fruit, 

vegetables, and fish to FDA for review 

and approval. 

Sections 101.54, 101.56, 101.60, 

101.61, and 101.62 specify information 

that must be disclosed as a condition for 

making particular nutrient content 

claims. Section 101.67 provides for the 

use of nutrient content claims for butter, 

and cross-references requirements in 

other regulations for ingredient 

declaration (§ 101.4) and disclosure of 

information concerning performance 

characteristics (§ 101.13(d)). Section 

101.69 provides for the submission of a 

petition requesting that FDA authorize a 

particular nutrient content claim by 

regulation. Section 101.70 provides for 

the submission of a petition requesting 

that FDA authorize a particular health 

claim by regulation. Section 

101.77(c)(2)(ii)(D) requires the 

disclosure of the amount of soluble fiber 

per serving in the nutrition labeling of 

a food bearing a health claim about the 

relationship between soluble fiber and a 

reduced risk of coronary heart disease. 

Section 101.79(c)(2)(iv) requires the 

disclosure of the amount of folate per 

serving in the nutrition labeling of a 

food bearing a health claim about the 

relationship between folate and a 

reduced risk of neural tube defects. 

Section 101.100(d) provides that any 

agreement that forms the basis for an 

exemption from the labeling 

requirements of section 403(c), (e), (g), 

(h), (i), (k), and (q) of the act be in 

writing and that a copy of the agreement 

be made available to FDA upon request. 

Section 101.100 also contains reporting 

and disclosure requirements as 

conditions for claiming certain labeling 

exemptions (e.g., § 101.100(h)). 

Section 101.105 specifies 

requirements for the declaration of the 

net quantity of contents on the label of 

a food in packaged form and prescribes 

conditions under which a food whose 

label does not accurately reflect the 

actual quantity of contents may be sold, 

with appropriate disclosures, to an 

institution operated by Federal, State, or 

local government. Section 101.108 

provides for the submission to FDA of 

a written proposal requesting a 

temporary exemption from certain 

requirements of §§ 101.9 and 105.66 for 

the purpose of conducting food labeling 

experiments with FDA’s authorization. 

Regulations in part 102 define the 

information that must be included as 

part of the statement of identity for 

particular foods and prescribe related 

labeling requirements for some of these 

foods. For example, § 102.22 requires 

that the name of a protein hydrolysate 

shall include the identity of the food 

source from which the protein was 

derived. 

Part 104, which pertains to nutritional 

quality guidelines for foods, crossreferences several labeling provisions in 

part 101 but contains no separate 

information collection requirements. 

Part 105 contains special labeling 

requirements for hypoallergenic foods, 

infant foods, and certain foods 

represented as useful in reducing or 

maintaining body weight. 

The disclosure and other information 

collection requirements in the 

previously mentioned regulations are 

placed primarily upon manufacturers, 

packers, and distributors of food 

products. Because of the existence of 

exemptions and exceptions, not all of 

the requirements apply to all food 

producers or to all of their products. 

Some of the regulations affect food 

retailers, such as supermarkets and 

restaurants. 

The purpose of the food labeling 

requirements is to allow consumers to 

be knowledgeable about the foods they 

purchase. Nutrition labeling provides 

information for use by consumers in 

selecting a nutritious diet. Other 

information enables a consumer to 

comparison shop. Ingredient 

information also enables consumers to 

avoid substances to which they may be 

sensitive. Petitions or other requests 

submitted to FDA provide the basis for 

the agency to permit new labeling 

statements or to grant exemptions from 

certain labeling requirements. 

Recordkeeping requirements enable 

FDA to monitor the basis upon which 

certain label statements are made for 

food products and whether those 

statements are in compliance with the 

requirements of the act or the FPLA. 

In the Federal Register of July 15, 

2009 (74 FR 34353), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 53745 

TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

of Disclosure 

Total Annual 

Disclosures 

Hours per 

Disclosures Total Hours 

101.3, 101.22, 102 and 104 25,000 1.03 25,750 .5 12,875 

101.4, 101.22, 101.100, 102, 104 

and 105 25,000 1.03 25,750 1 25,750 

101.5 25,000 1.03 25,750 0.25 6,438 

101.9, 101.13(n), 101.14(d)(3), 

101.62, and 104 25,000 1.03 25,750 4 103,000 

101.9(g)(9 and 101.36(f)(2) 12 1 12 4 48 

101.10 300,000 1.5 450,000 0.25 112,500 

101.12(b) 29 2.3 67 1 67 

101.12(e) 25 1 25 1 25 

101.12(g) 5,000 1 5,000 1 5,000 

101.12(h) 5 1 5 80 400 

101.13(d)(1) and 101.67 200 1 200 1 200 

101.13(j)(2), 101.13(k), 101.54, 

101.56, 101.60, 101.61, and 

101.62 5,000 1 5,000 1 5,000 

101.13(q)(5) 300,000 1.5 450,000 0.75 337,500 

101.14(d)(2) 300,000 1.5 450,000 0.75 337,500 

101.15 160 10 1,600 8 12,800 

101.22(i)(4) 25 1 25 1 25 

101.30 and 102.33 1,500 5 7,500 1 7,500 

101.36 300 40 12,000 4 48,000 

101.36(e) 125 13 1,625 0.25 406 

101.42 and 101.45 1,000 1 1,000 0.5 500 

101.45(c) 5 4 20 4 80 

101.69 3 1 3 25 75 

101.70 5 1 5 80 400 

101.79(c)(2)(i)(D) 1,000 1 1,000 0.25 250 

101.79(c)(2)(iv) 100 1 100 0.25 25 

101.100(d) 1,000 1 1,000 1 1,000 

101.105 and 101.100(h) 25,000 1.03 25,750 0.5 12,875 

101.108 1 1 1 40 40 

Total 1,110,279 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

101.12(e) 25 1 25 1 25 

101.13(q)(5) 300,000 1.5 450,000 0.75 337,500 


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53746 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

101.14(d)(2) 300,000 1.5 450,000 0.75 337,500 

101.22(i)(4) 25 1 25 1 25 

101.100(d)(2) 1,000 1 1,000 1 1,000 

101.105(t) 100 1 100 1 100 

Total 676,150 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED REPORTING BURDEN1

21 CFR Section/ 

Form No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

101.9(j)(18) and 101.36(h)(2)/ 

Form FDA 3570 10,000 1 10,000 8 80,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The estimated annual reporting and 

recordkeeping burdens are based on 

agency communications with industry 

and FDA’s knowledge of and experience 

with food labeling and the submission 

of petitions and requests to the agency. 

Where an agency regulation implements 

an information collection requirement 

in the act or the FPLA, only any 

additional burden attributable to the 

regulation has been included in FDA’s 

burden estimate. 

No burden has been estimated for 

those requirements where the 

information to be disclosed is 

information that has been supplied by 

FDA. Also, no burden has been 

estimated for information that is 

disclosed to third parties as a usual and 

customary part of a food producer’s 

normal business activities. Under 5 CFR 

1320.3(c)(2), the public disclosure of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of disclosure to the public 

is not a collection of information. Under 

5 CFR 1320.3(b)(2), the time, effort, and 

financial resources necessary to comply 

with a collection of information are 

excluded from the burden estimate if 

the reporting, recordkeeping, or 

disclosure activities needed to comply 

are usual and customary because they 

would occur in the normal course of 

activities. 

In this request for extension of OMB 

approval under the PRA, FDA is 

combining the burden hours associated 

with OMB control numbers 0910–0395 

(collection entitled ‘‘Food Labeling: 

Nutrition Labeling of Dietary 

Supplements on a ‘Per Day’ Basis’’) and 

0910–0515 (collection entitled ‘‘Food 

Labeling: Trans Fatty Acids in Nutrition 

Labeling’’) with the burden hours 

approved under OMB control number 

0910–0381 (collection entitled ‘‘Food 

Labeling Regulations’’). 

Dated: October 9, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25102 Filed 10–19–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0501] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Third Party 

Disclosure and Recordkeeping 

Requirements for Reportable Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection provisions of 

FDA’s third party disclosure and 

recordkeeping requirements for 

reportable food. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 21, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794, 

Jonnalynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 


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