Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Notices 60195

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Vessel Sanitation Program Operations

Manual—2000

AGENCY: Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services (HHS).

ACTION: Notice.

SUMMARY: This notice announces the

revision and implementation of the

Vessel Sanitation Program Operations

Manual—2000.

EFFECTIVE DATE: The revised Operations

Manual will become effective on

November 1, 2000.

FOR FURTHER INFORMATION CONTACT:

David Forney, Chief, Vessel Sanitation

Program, Division of Emergency and

Environmental Health Services (EEHS),

National Center for Environmental

Health (NCEH), Mailstop F–16, Centers

for Disease Control and Prevention

(CDC), Atlanta, Georgia 30333,

telephone (770) 488–7333, e-mail:

DForney@cdc.gov.

SUPPLEMENTARY INFORMATION:

Purpose and Background

The Vessel Sanitation Program (VSP)

is a cooperative activity between the

cruise ship industry and the Centers for

Disease Control and Prevention (CDC),

U.S. Department of Health and Human

Services. The purpose and goals of VSP

are to achieve and maintain a level of

sanitation that will lower the risk for

gastrointestinal disease outbreaks and

assist the passenger cruise line industry

in its effort to provide a healthy

environment for passengers and crew.

Comments

CDC announced their intention to

revise the Vessel Sanitation Operations

Manual, August 1989 in the Federal

Register, Volume 62, Thursday, August

23, 1997, page 44475. A subsequent

request to solicit topic-specific

information for incorporation into a

revised operations manual was

published in the Federal Register on

July 9, 1998 (63 FR 37128). Input and

public comments were requested and

received from the cruise ship industry,

private sanitation consultants, other

Federal agencies, and other interested

parties and were discussed in detail at

a public meeting held in Fort

Lauderdale, Florida, on April 14–16,

1999.

Based on comments received, VSP

staff redrafted the manual and that

revised draft was discussed at a public

meeting held in Fort Lauderdale,

Florida, on October 5–7, 1999. The

current document incorporates the

input and comments received from the

cruise ship industry, private sanitation

consultants, and other interested parties

who attended both public meetings, and

who submitted comments in writing.

The final draft of the VSP Operations

Manual—2000 was also presented to

attendees at the VSP annual public

meeting held in Ft. Lauderdale, Florida,

on March 28, 2000. Major input to this

document was also provided by the

International Council of Cruise Lines,

which represents the 17 largest

passenger cruise lines that call on major

ports in the United States and abroad.

Implementation and Transition for the

VSP Operations Manual—2000

The VSP Operations Manual—2000

will become effective on November 1,

2000. At that time, VSP environmental

health officers will begin using the new

manual and inspection report when

they conduct their routine operational

inspections.

For a period of one year, or two

routine inspections, whichever comes

first, VSP staff will document all

deficiencies not in compliance with the

2000 manual; however, points will not

be deducted for those new and more

stringent provisions contained in the

2000 manual that were not in the 1989

manual. During the phase-in period,

these deficiencies will only be ‘‘starred’’

so corrective actions can be made

accordingly. For example, the new cold

holding temperature for potentially

hazardous foods is 5°C (41°F) and the

old temperature is 7.5°C (45°F). Food

found to be labeled between these

temperatures during the first year, or

two routine inspections, will be

documented and ‘‘starred’’ on the

inspection report without points being

deducted.

Applicability

The VSP Operations Manual—2000

will be applicable to all passenger cruise

vessels with international itineraries

calling on U.S. ports.

Availability

Final copies of the VSP Operations

Manual—2000 are available in pdf

format on the VSP Web site at http://

www.cdc.gov/nceh/vsp or by contacting

Dorothy Johnson, Program Management

Assistant at the Vessel Sanitation

Program, National Center for

Environmental Health, Centers for

Disease Control and Prevention (CDC),

Mailstop F–16, 4770 Buford Highway,

N.E., Atlanta GA 30341–3274, or by emailing her at DJJohnson@cdc.gov.

Requests may also be sent to

vsp@cdc.gov.

Dated: October 3, 2000.

Thena M. Durham,

Director, Executive Secretariat, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 00–25906 Filed 10–6–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1521]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Food Labeling

Regulations

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

information collection provisions in

FDA’s food labeling regulations.

DATES: Submit written or electronic

comments on the collection of

information by December 11, 2000.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (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:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

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

60196 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Notices

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

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Food Labeling Regulations (21 CFR

Parts 101, 102, 104, and 105)

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

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

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Notices 60197

§ 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.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Sections and Parts No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Total Capital,

Operating, and

Maintenance

Costs

101.3, 101.22 and 102 and

104 17,000 1.03 17,500 0.5 8,750 0

101.4, 101.22, 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), 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

60198 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN—Continued

21 CFR Sections and Parts No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Total Capital,

Operating, and

Maintenance

Costs

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)(i) 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 0.5 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

101.100(d) 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 985,000 $16,800,000

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Sections and Parts No. of

Recordkeepers

Annual

Frequency per

Recordkeepers

Total Annual

Records

Hours per

Record Total Hours

Total Capital,

Operating, and

Maintenance

Costs

101.12(e) 25 1 25 1 25 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

101.22(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

Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Notices 60199

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: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25810 Filed 10–6–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

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

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: The Health Education

Assistance Loan (HEAL)

Program: Regulatory Requirements—

(OMB No. 0915–0108)—Revision

This clearance request is for revision

of approval for the notification,

reporting and recordkeeping

requirements in the HEAL program to

insure that the lenders, holders and

schools participating in the HEAL

program follow sound management

procedures in the administration of

federally-insured student loans. While

the regulatory requirements are

approved under this OMB number,

some of the burden associated with the

regulations is cleared under the OMB

numbers for the HEAL forms used to

report required information (listed

below). The table listed at the end of

this notice contains the estimate of

burden for the remaining regulations.

Annual Response Burden for the

following regulations is cleared by OMB

when the reporting forms are cleared:

OMB Approval No. 0915–0034,

Lender’s Application, Borrower Status,

Loan Transfer, Contract for Loan

Insurance

Reporting

42 CFR 60.31(a), Lender annual

application.

42 CFR 60.38(a), Loan Reassignment.

Notification

42 CFR 60.12(c)(1), Borrower

deferment.

OMB Approval No. 0915–0036,

Lender’s Application for Insurance

Claim

Reporting

42 CFR 60.35(a)(2), Lender skiptracing activities.

42 CFR 60.40(a), Lender

documentation to litigate a default.

42 CFR 60.40(c)(i), (ii), and (iii),

Lender default claim.

42 CFR 60.40(c)(2), Lender death

claim.

42 CFR 60.40(c)(3), Lender disability

claim.

42 CFR 60.40(c)(4), Lender report of

student bankruptcy.

OMB Approval No. 0915–0043,

Repayment Schedule, Call Report

Notification

42 CFR 60.11(e), Establishment of

repayment terms-borrower.

42 CFR 60.11(f)(5), Borrower notice of

supplemental repayment agreement.

42 CFR 60.34(b)(1), Establishment of

repayment terms-lender.

OMB Approval No. 0915–0204,

Physicians Certification of Permanent

and Total Disability

Reporting

42 CFR 60.39(b)(2), Holder request to

Secretary to determine borrower

disability.

OMB Approval No. 0915–227,

Refinancing Application/Promissory

Note

42 CFR 60.33(e), Executed application

and note to borrower.

The estimate of burden for the

regulatory requirements of this

clearance are as follows:

REPORTING REQUIREMENTS

Number of respondents

Number of

transactions per

respondent

Total

transactions

Time per

response

(hours)

Total burden

hours

22 Lenders ................................................................................................. 7 161 0.7 116

200 Schools ............................................................................................... 7 139 0.2 23

Total Reporting ................................................................................... .......................... .......................... ........................ 139

NOTIFICATION REQUIREMENTS

Number of respondents

Number of

transactions per

respondent

Total transactions

Time per

response

(hours)

Total burden

hours

22 Lenders ................................................................................................. 11,271 247,958 0.2 46,293

200 Schools ............................................................................................... 30 5,956 0.3 1,988