Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39093

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

21 CFR Section No. of Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.110 200 120 24,000 0.25 6,000

226.115 200 120 24,000 1.00 24,000

Total burden hours 150,000

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

The estimate of the times required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

manufacturing sites, number of Type A

medicated articles being manufactured,

etc.) are derived from agency records

and experience.

Dated: July 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19312 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0546]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

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 August 20,

1998.

ADDRESSES: Submit written comments

on the proposed 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: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. 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 section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following collection of

information to OMB for review and

clearance.

Food Labeling Regulations (21 CFR

Parts 101, 102, 104, and 105)

FDA regulations in parts 101, 102,

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

104, and 105) require food producers to

disclose to consumers and others

specific information about themselves

or their products on the label or labeling

of their products. Certain of these

regulations also 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 submissions of information

to FDA in the form of petitions or

notices. These regulations were issued

under the authority of sections 4, 5, and

6 of the Fair Packaging and Labeling Act

(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 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 sold in the

United States are in compliance with

the labeling provisions of the act and

the FPLA. One purpose of this

submission to OMB under the PRA is to

consolidate all of the information

collection provisions in these

regulations into one submission to OMB

for its review and approval.

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

the 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) 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(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 the provisions of § 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
39094 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices

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 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. 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 flavors. 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 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

information 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 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 in the nutrition

label 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 a 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 §§ 101.109 and 105.66

for the purpose of conducting food

labeling experiments with FDA

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 a notice published in the Federal

Register of March 23, 1998 (63 FR

13862), FDA invited comments on the

information collection provisions

contained in its food labeling

regulations in parts 101, 102, 104, and

105. FDA received no comments in

response to that notice.

FDA estimates the burden of this

collection of information as follows:
Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39095

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Total Annual

Responses

Hours per

Response Total Hours

Total Operating,

Capital or Maintenance Costs

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

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

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

101.9, 101.13(n), 101.14(d)(3), 101.62, and part

104 17,000 17,500 4 70,000 $1,000,000

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

101.9(j)(18) and 101.36(h)(2) 8,600 8,600 8 68,800 0

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

101.12(e) 25 25 1 25 0

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

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

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

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

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

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

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

101.15 160 1,600 8 12,800 0

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

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

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

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

101.45(c) 5 20 4 80 0

101.69 3 3 25 75 0

101.70 3 3 80 240 $400,000

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

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

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

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

101.108 0 0 40 0 0

Total Burden Hours 985,603 16,800,000

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Respondents

Total Annual

Records

Hours per

Response Total Hours

Total Operating,

Capital or Maintenance Costs

101.12(e) 25 25 1 25 0

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

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

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

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

101.105(t) 100 100 1 100 0

Total Burden Hours 597,400 0

These estimates are based on FDA’s

‘‘Regulatory Impact Analysis of the

Final Rules to Amend the Food Labeling

Regulations,’’ 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 that 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(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: July 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19313 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F