6620 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Notices

American Academy of Pediatrics,

physicians can play an important role in

educating parents about ways to

promote their child’s sexual health. The

total annual burden for this project is

300 hours.

Respondents Number of

respondents

Number of

responses

Average

hour burden

per response

Pediatricians ............................................................................................................................................ 900 1 20/60

Dated: January 16, 2001.

Nancy E. Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 01–1763 Filed 1–19–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1283]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Food

Labeling Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by February

21, 2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

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—21 CFR

Parts 101, 102, 104, and 105 (OMB

Control No. 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 in 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 of 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.

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 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

must also disclose the identity of the

reference food, the amount of the

nutrient in each food, and the

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Notices 6621

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 served foods, 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 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 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.

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

data bases 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 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.

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 above

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 October 10,

2000 (65 FR 60195), the agency

requested comments on the proposed

collection of information. The agency

received several comments, none of

which were relevant to the PRA.

FDA estimates the burden of this

collection of information as follows:

6622 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Sections and Parts No. of Respondents

Annual

Frequency

per Response

Total Annual ResponsesHours

Per ResponseTotal Hours

Total Capital,

Operating, and

Maintenance

Costs

101.3 and 101.22, and 102 and 104 17,000 1.03 17,500 0.5 8,750 0

101.4, 101.22, and 101.100, and 102, 104, and 105 17,000 1.03 17,500 1 17,500 0

101.5 17,000 1.03 17,500 0.25 4,375 0

101.9, 101.13(n), 101.14(d)(3), and 101.62, and 104 17,000 1.03 17,500 4 70,000 $1,000,000

101.9(g)(9) and 101.36(f)(2) 12 1 12 4 48 0

101.9(j)(18) and 101.36(h)(2) 10,000 1 10,000 8 80,000 0

101.10 265,000 1.5 397,500 0.25 99,375 0

101.12(b) 29 2.3 66 1 66 $39,600

101.12(e) 25 1 25 1 25 0

101.12(g) 5,000 1 5,000 1 5,000 0

101.12(h) 5 1 5 80 400 $400,000

101.13(d)(1) and 101.67 200 1 200 1 200 0

101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61,

and 101.62 2,500 1 2,500 1 2,500 0

101.13(q)(5) 265,000 1.5 397,500 0.75 298,125 0

101.14(d)2 265,000 1.5 397,500 0.75 298,125 0

101.15 160 10 1,600 8 12,800 0

101.22(i)(4) 25 1 25 1 25 0

101.30 and 102.33 1,500 3.3 5,000 1 5,000 0

101.36 300 40 12,000 4 48,000 $15,000,000

101.42 and 101.45 72,270 1 72,270 0.50 36,135 0

101.45(c) 5 4 20 4 80 0

101.69 3 1 3 25 75 0

101.70 3 1 3 80 240 $400,000

101.77(c)(2)(ii)(D) 1,000 1 1,000 0.25 250 0

101.79(c)(2)(iv) 100 1 100 0.25 25 0

101.1002 1,000 1 1,000 1 1,000 0

101.105 and 101.100(h) 17,000 1.03 17,500 0.5 8,750 0

101.108 0 0 0 40 0 0

Total 996,8691 $16,800,000

1Due to a clerical error, the total that appeared in table 1 in the Federal Register of Tuesday, October 10, 2000 (65 FR 60195), was incorrect.

Table 1 of this document contains the correct estimates. 2Sections 101.14(d)(2) and 101.100(d) were incorrectly cited in table 1 in the Federal Register of Tuesday, October 10, 2000 (65 FR 60195).

Table 1 of this document contains the correct citations.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of Recordkeepers

Annual Frequency per

Recordkeepers

Total Annual

Records

Hours per

Record Total Hours Total Capital, Operating, andMaintenance Costs

101.12(e) 25 1 25 1 25 0

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Notices 6623

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued

21 CFR Section No. of Recordkeepers

Annual Frequency per

Recordkeepers

Total Annual

Records

Hours per

Record Total Hours Total Capital, Operating, andMaintenance Costs

101.13(q)(5) 265,000 1.5 397,500 0.75 298,125 0

101.14(d)(2) 265,000 1.5 397,500 0.75 298,125 0

101.22(i)(4) 25 1 25 1 25 0

101.100(d)(2) 1,000 1 1,000 1 1,000 0

101.105(t) 100 1 100 1 100 0

Total 597,400 0

These estimates are based on the

document entitled ‘‘Regulatory Impact

Analysis of the Final Rules to Amend

the Food Labeling Regulations,’’ which

is the agency’s most recent

comprehensive review of food labeling

costs that published in the Federal

Register of January 6, 1993 (58 FR

2927); 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.

Dated: January 12, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–1567 Filed 1–19–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1571]

Enrofloxacin for Poultry; Opportunity

for Hearing; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration’s (FDA’s) Center for

Veterinary Medicine (CVM), is revising

a notice of opportunity for hearing

(NOOH) that published in the Federal

Register on October 31, 2000 (65 FR

64954). After publishing the NOOH,

CVM determined that some estimates of

numbers of human campylobacteriosis

cases and fluoroquinolone-resistant

Campylobacter cases provided by a risk

assessment used as a reference in the

NOOH were incorrect. CVM has revised

the risk assessment and is revising the

estimates that were provided in the

NOOH. This notice also extends the

deadline for the sponsor to submit data

and analysis upon which a request for

a hearing relies. Other interested

persons may submit comments on the

NOOH before the deadline.

DATES: Submit all written data and

analysis upon which a request for a

hearing relies and other written

comments by February 21, 2001.

ADDRESSES: Data and analysis and other

comments are to be identified with

Docket No. 00N–1571 and must be

submitted to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

The revised risk assessment entitled

‘‘The Human Health Impact of

Fluoroquinolone Resistant

Campylobacter Attributed to the

Consumption of Chicken, Revised:

January 5, 2001’’ (hereafter referred to as

Ref. 2a) is available electronically at

http://www.fda.gov/cvm/antimicrobial/

antimicrobial.html and in this docket.

FOR FURTHER INFORMATION CONTACT:

Linda Tollefson, Center for Veterinary

Medicine (HFV–200), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–2950.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 31,

2000 (65 FR 64954), CVM published an

NOOH proposing withdrawal of the

approval of a new animal drug

application (NADA) for the use of the

fluoroquinolone enrofloxacin in poultry.

The NOOH included estimates that were

taken from Ref. 2 of the October 31,

2000, NOOH, the risk assessment

entitled ‘‘Human Health Impact of

Fluoroquinolone Resistant

Campylobacter Attributed to the

Consumption of Chicken, October 18,

2000.’’ After publication of the NOOH,

CVM determined that two of the cell

references in the risk assessment were

mislabeled and as a result, the model

outputs were incorrect. CVM has

revised the risk assessment to correct

the cell references. Because CVM

needed to make these corrections to the

risk assessment, it has also incorporated

the final FoodNet data for 1999 into the

risk assessment and has made other

related changes. CVM is revising the

NOOH to reflect the changes in the risk

assessment and to add the revised risk

assessment Ref. 2a to the list of

references in the NOOH. CVM does not

believe that these revisions in any way

alter the underlying basis of the NOOH.

The following section describes the

location and revisions to the October 31,

2000, NOOH.

II. Revisions

Based on the revisions to the risk

assessment, CVM is revising the

estimates in the October 31, 2000,

NOOH for the mean estimate of cases of

campylobacteriosis; the mean estimate

of the domestically-acquired