Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Notices 68361 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

List of Ingredients Added to Tobacco 

in the Manufacture of Cigarette 

Products—Extension—Office on 

Smoking and Health, National Center 

for Chronic Disease Prevention and 

Health Promotion (NCCDPHP), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

Cigarette smoking is the leading 

preventable cause of premature death 

and disability in the United States. Each 

year, more than 440,000 premature 

deaths occur as the result of diseases 

related to cigarette smoking. The 

Centers for Disease Control and 

Prevention (CDC), Office on Smoking 

and Health (OSH) has the primary 

responsibility for the Department of 

Health and Human Services (HHS) 

smoking and health program. HHS’s 

overall goal is to reduce death and 

disability resulting from cigarette 

smoking and other forms of tobacco use 

through programs of information, 

education and research. 

The Comprehensive Smoking 

Education Act of 1984 (CSEA, 15 U.S.C. 

1336 or Public Law 98–474) requires 

each person who manufactures, 

packages, or imports cigarettes to 

provide the Secretary of Health and 

Human Services (HHS) with a list of 

ingredients added to tobacco in the 

manufacture of cigarettes. The 

legislation also authorizes HHS to 

undertake research, and to report to the 

Congress (as deemed appropriate) 

discussing the health effects of these 

ingredients. 

HHS has delegated responsibility for 

implementing the CSEA’s ingredient 

reporting requirements to CDC’s Office 

on Smoking and Health (OSH). OSH has 

collected ingredient reports on cigarette 

products since 1986. Respondents are 

commercial cigarette manufacturers, 

packagers, or importers, or their 

designated representatives. Respondents 

are not required to submit specific 

forms, however, they are required to 

submit a list of all ingredients used in 

their products. CDC requires the 

ingredient report to be submitted by 

chemical name and Chemical Abstract 

Service (CAS) Registration Number, 

consistent with accepted reporting 

practices for other companies currently 

required to report ingredients added to 

other consumer products. Typically, 

respondents submit a summary report to 

CDC with the ingredient information for 

multiple products, or a statement that 

there are no changes to their previously 

submitted ingredient report. 

Ingredient reports for new products 

are due at the time of first importation. 

Thereafter, ingredient reports are due 

annually on March 31. Information is 

submitted to OSH by mailing a written 

report on the respondent’s letterhead, by 

CD, three-inch floppy disk, or thumb 

drive. Electronic mail submissions are 

not accepted. Upon receipt and 

verification of the annual ingredient 

report, OSH issues a Certificate of 

Compliance to the respondent. 

There are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents No. of 

respondents 

No. of responses per 

respondent 

Average burden per response 

(in hours) 

Total burden 

hours 

Cigarette Manufacturers, Packagers, and Importers ....................................... 143 1 6.5 930 

Dated: November 1, 2010. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–27983 Filed 11–4–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0567] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Restaurant Menu 

and Vending Machine Labeling: 

Recordkeeping and Mandatory Third 

Party Disclosure Under Section 4205 of 

the Patient Protection and Affordable 

Care Act of 2010 

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 recordkeeping and mandatory third 

party disclosure provisions of Section 

4205 of the Patient Protection and 

Affordable Care Act of 2010 (ACA). 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 4, 2011. 

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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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 

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68362 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Notices 

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 these topics: (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. 

Restaurant Menu and Vending Machine 

Labeling: Recordkeeping and Mandatory 

Third Party Disclosure Under Section 

4205 of the Patient Protection and 

Affordable Care Act of 2010—(OMB 

Control Number 0910–0665)—Revision 

On March 23, 2010, the President 

signed into law the ACA (Pub. L. 111– 

148). Section 4205 of the legislation, 

which principally amends sections 403 

and 403A of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 343 and 

343–1), requires chain restaurants and 

similar retail food establishments 

(SRFE) with 20 or more locations doing 

business under the same name and 

offering for sale substantially the same 

menu items (hereinafter ‘‘chain retail 

food establishments’’), as well as 

operators of 20 or more vending 

machines (hereinafter ‘‘chain vending 

machine operators’’), to disclose certain 

nutrition information for certain food 

items offered for sale so that consumers 

can make more informed choices about 

the food they purchase. Section 4205 

preempts State and local governments 

from establishing menu labeling 

requirements for chain retail food 

establishments and vending machine 

nutrition labeling requirements that are 

not ‘‘identical to’’ the section 4205 

requirements. 

Section 4205 became effective on the 

date the law was signed, March 23, 

2010. The provisions that went into 

immediate effect are as follows: 

For chain retail food establishments: 

• Disclosing the number of calories in 

each standard menu item on menus and 

menu boards, 

• Making additional written nutrition 

information available to consumers 

upon request, 

• Providing a statement on menus 

and menu boards about the availability 

of the written nutrition information, and 

• Providing calorie information (per 

serving or per food item) for self-service 

items and food on display, in a sign 

adjacent to each food item. 

For chain vending machine operators: 

• Providing a sign in close proximity 

to each article of food (or the selection 

button) that discloses the number of 

calories contained in the article, unless 

a prospective purchaser is able to 

examine the Nutrition Facts Panel 

before purchasing the article, or visible 

nutrition information is otherwise 

provided at the point of purchase. 

Section 4205 of the legislation 

requires recordkeeping—for the calorie 

analysis—and a third party disclosure— 

for the menu and vending machine 

labeling. 

In the Federal Register of August 25, 

2010 (75 FR 52427), FDA published a 

notice of availability of the guidance 

document entitled ‘‘Guidance for 

Industry: Questions and Answers 

Regarding the Effect of Section 4205 of 

the Patient Protection and Affordable 

Care Act of 2010 on State and Local 

Menu and Vending Machine Labeling 

Laws.’’ The guidance is intended to 

clarify section 4205’s effect on State and 

local menu and vending machine 

labeling laws, and to ensure that 

industry and State and local government 

understand the immediate effects of the 

law. Persons with access to the Internet 

may obtain the guidance at the 

following Web site: http:// 

www.cfsan.fda.gov/∼dms/ 

guidance.html. In addition, the 

information collection requirements 

were approved under the emergency 

processing provisions of the PRA and 

assigned OMB control number 0910– 

0665. 

Menu and vending machine labeling 

will be used by consumers to assess the 

calorie content of their purchases. The 

purpose of the disclosure is to allow 

consumers to choose foods that are 

appropriate for their energy needs. 

Because consumers do not observe the 

preparation of food prepared by 

restaurants or similar retail food 

establishments, and because many of 

these foods were exempted from 

nutrition labeling requirements under 

the National Labeling Education Act 

(NLEA), consumers were not able to 

ascertain the calorie content of this 

food, and therefore could not make 

informed decisions about how that food 

fits their calorie requirements without 

the disclosure. The calorie information 

will be collected and recorded by the 

chain retail food establishments and 

chain vending machine operators that 

are required to disclose calorie 

information to their customers. The 

covered entities will use the records to 

ensure that calorie information that they 

disclose is accurate. 

Description of Respondents: 

Respondents to this collection of 

information include chain retail food 

establishments and chain vending 

machine operators. 

FDA estimates the burden of this 

collection of information as follows. The 

burden is described in the following 

paragraphs in two parts: A 

recordkeeping burden associated with 

discovering and recording the calorie 

count for each menu/vending item; and 

the third party disclosure burden 

associated with communicating that 

information to the consumer. The 

estimates are also separated for retail 

food service and vending operators. 

FDA estimates a total of 1,388,010 

initial burden hours. This number has 

been divided by three in tables 1 and 2 

of this document in order to avoid 

double counting in the Regulatory 

Information Service Center (RISC) and 

Office of Information and Regulatory 

Affairs (OIRA) Consolidated Information 

System to yield 141,222 initial hours for 

recordkeeping and 312,448 initial hours 

for third party disclosure, for a sum of 

462,670 initial hours. FDA estimates a 

total of 14,068,808 recurring hours, with 

nearly all of these for vending machine 

operators, including 31,408 recurring 

hours for recordkeeping and 14,037,400 

recurring hours for third party 

disclosure. 

Recordkeeping Burdens for Chain 

Retail Food Establishments 

The time burden for calorie analysis 

on chain retail food establishments is 

the time necessary for creating a record, 

managing the contracts for analysis, and 

communicating the results of the 

analysis to the outlets. FDA estimates 

the hourly burden of calorie analysis on 

these firms to be 4 hours per menu item. 

FDA estimates that there are 

approximately 1,069 restaurant chains, 

with 231,000 outlets, will be required to 

disclose calorie information. On 

average, we estimate that a chain has 

117 items on its menu, and that 48 

percent of chain restaurants, or 516, do 

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Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Notices 68363 

not already have calorie information. 

The hourly burden for restaurant chains 

is 241,488 hours (= 516 chains × 117 

items/chain × 4 hours/item). 

FDA estimates that there are 570 

covered grocery and convenience store 

chains with an average of 40 standard 

menu items per chain. The hourly 

burden for grocery store chains is 91,200 

hours (= 570 chains × 40 items/chain × 

4 hours/item). 

FDA estimates that there are 420 other 

chains that will be covered by the 

proposed rule. With 40 menu items on 

average, the number of hours required to 

deal with calorie analysis at these other 

chains is 67,200 hours (= 420 chains × 

40 items/chain × 4 hours/item). 

FDA has estimated that each of the 

1,506 covered chains, on average, 

introduces new items or reformulates 

existing items 4 times per year. The 

recurring hourly burden of 

recordkeeping for new items, as 

displayed in the sixth row of table 1 of 

this document, is 24,096 hours (= 1,506 

chains × 4 items/chain × 4 hours/item). 

FDA estimates that 30 chains will 

become newly covered under the 

requirements of the proposed rule each 

year. With an average number of menu 

items of 60 per chain, this would result 

in approximately 7,200 hours (= 30 

chains × 60 items/chain × 4 hours/item). 

This amount is displayed in the seventh 

row of table 1 of this document. 

The final column of table 1of this 

document gives the estimated capital 

costs associated with calorie and 

nutrition analysis. These are the costs of 

acquiring nutrition analyses. FDA has 

estimated that the average cost of a full 

analysis is $269 per menu item. These 

costs are calculated by multiplying this 

per item cost by the number of items in 

column three multiplied by the number 

of recordkeepers in column two. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN: CALORIE ANALYSIS AND RECORDING 1

Type of respondent Number of 

recordkeepers 

Annual frequency per 

recordkeeper 

Total annual 

records 

Hours per 

record Total hours Total capital costs 

Restaurant Chains ................................... 516 117 60,372 4 241,488 $16.2 million 

Grocery and Convenience Store Chains 570 40 22,800 4 91,200 $6.1 million 

Other Chains ........................................... 420 40 16,800 4 67,200 $4.5 million 

Vending Operators .................................. 600 20 12,000 2 24,000 $0,000 

Total Initial Hours ............................. 423,888 $26.9 million 

New/Reformulated Items ......................... 1,506 4 6,024 4 24,096 $1.6 million 

New Chains ............................................. 30 60 1,800 4 7,200 $0.5 million 

New Vendors ........................................... 3 20 60 2 120 $4,000 

Total Recurring Hours ...................... 31,416 

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

Third Party Disclosure Burdens for 

Chain Retail Food Establishments 

The third party reporting burden for 

chain retail food establishments is the 

time necessary to display calorie 

information on menus, menu boards, 

displayed food and other required 

locations. In practice, this is the time 

necessary to change out redesigned 

menu boards, FDA estimates 2 hours of 

time per menu board change. 

FDA estimates that limited service 

restaurant chains have an average of 

three menu boards or displays per 

establishment. With 135,705 outlets 

having these displays, the total hourly 

burden estimated for third party 

disclosure at restaurants is 814,230 

hours (= 135,705 outlets × 3 displays/ 

outlet × 2 hours/display). 

For grocery and convenience store 

chains, FDA estimates an average of 

1 major menu board or display per 

establishment. With 41,945 outlets, the 

total hourly burden is 83,890 hours (= 

41,945 outlets × 1 displays/outlet × 2 

hours/display). 

For other covered chains, FDA 

estimates 33,114 covered outlets, each 

with an average of one major display or 

menu board. At 4 hours per disclosure, 

FDA estimates an hourly burden of 

66,228 hours (= 33,114 outlets × 1 

displays/outlet × 2 hours/display). 

The most inexpensive technology 

available to vending machine operators 

for disclosing calorie content is using 

stickers. Because these do not require 

any initial investment and because they 

are not durable, all burden and costs 

will be on a recurring basis. 

Recurring Disclosure Burdens for Chain 

Retail Food Establishments 

FDA estimates that the annual 

number of newly covered chains will be 

30. At 20 establishments per chain, 

there will be 600 establishments at 

newly covered chains each year that 

will need to disclose calorie content. 

Taking an average number of displays 

equal to 2, the total hourly burden for 

disclosure due to newly covered chains 

is 2,400 hours (= 600 outlets × 2 

displays/outlet × 2 hours/display). 

The final column of table 2 of this 

document gives the estimated capital 

costs associated with third party 

disclosure. These are the costs of 

acquiring new menu boards or displays. 

FDA has estimated that the average cost 

of menu board to be $550. These costs 

are calculated by multiplying this per 

menu board cost by the frequency of 

disclosures in column three multiplied 

by the number of respondents in 

column two. 

TABLE 2—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN: CALORIE CONTENT 1

Type of respondent Number of 

respondents 

Annual 

frequency per 

disclosure 

Total annual 

disclosures 

Hours per 

disclosure Total hours 

Restaurants .............................................................. 135,705 3 407,115 2 814,230 

Grocery and Convenience Store Chains ................. 41,945 1 41,945 2 83,890 

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68364 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Notices 

TABLE 2—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN: CALORIE CONTENT 1—Continued 

Type of respondent Number of 

respondents 

Annual 

frequency per 

disclosure 

Total annual 

disclosures 

Hours per 

disclosure Total hours 

Other Chains ............................................................ 33,114 1 33,114 2 66,228 

Total Initial Hours ....................................................................................................................................................................... 964,348 

New SRFE Outlets ................................................... 600 2 1,200 2 2,400 

Vending (Ongoing) ................................................... 5,000 56,000 280,000,000 0 .05 14,000,000 

Vending (Growth) ..................................................... 5,000 140 700,000 0 .05 35,000 

Total Recurring Hours ................................................................................................................................................................ 14,037,400 

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

Burdens for Chain Vending Machine 

Operators 

Because almost all vending machines 

sell food that is previously 

manufactured and packaged, calorie 

analysis and production of calorie 

analysis displays will be most 

efficiently done at the manufacturer 

level instead of the operator level. 

Furthermore, most vended foods are 

subject to NLEA, which means that 

calorie content is already collected. A 

likely scenario for response to vending 

machine labeling is that food 

manufacturers include a set of calorie 

label stickers in each case of product. 

This would be efficient both because 

most manufacturers will already have 

the calorie information available, and 

because economies of scale exist for the 

manufacturer. In this case, vending 

machine operators will not need to keep 

a record of calorie content. Instead, the 

burden for most operators will be 

limited to that of administering records 

and passing the existing information on 

to consumers. 

FDA estimates that there are 

approximately 300,000 beverage 

machines that sell unpackaged 

products. The manufacturer of the 

ingredients to these foods (hot coffee 

drinks and sodas) would not necessarily 

have calorie information if the products 

were not subject to NLEA in some form. 

There are likely a limited number of 

manufacturers of the inputs to the 

beverage machines. For the purposes of 

this document, FDA estimates that there 

are 10 manufacturers serving these 

machines, and 20 drinks per 

manufacturer, so that approximately 200 

drinks would need to have calorie 

analysis. The cost of this calorie 

analysis will be included in the capital 

costs in the following paragraphs. FDA 

estimates that the recordkeeping burden 

for these firms is half that for 

restaurants, or two hours per item. If 

there are 600 firms using beverage 

dispensers, then the hourly burden for 

recordkeeping is 24,000 hours (= 600 

firms × 20 items/firm × 2 hours/item). 

FDA believes that the set of items sold 

in these dispensary machines is 

approximately constant. If there is .5 

percent growth in the number of firms, 

then approximately three new firms will 

become covered in this market in a 

given year. The burden associated with 

these three firms would be 120 hours (= 

3 firms × 20 items/firm × 2 hours/item). 

This amount is given in eighth row of 

table 1 of this document. 

The third party reporting for chain 

vending machine operators is the time 

necessary to install calorie displays on 

their vending machines. Because there 

is wide variation in the kinds of vending 

machines used—in materials, display, 

mechanism—there will likely be a 

variety of solutions. On the high end, a 

calorie display that is integrated with 

the graphics on the machine may cost 

several hundred dollars or more. On the 

low end, a set of calorie stickers affixed 

to the front of the machine would cost 

at most a few dollars per machine. 

Given the low margins in the vending 

machine industry, and given that nearly 

all of the regulated operators will be 

small businesses, FDA believes that 

almost all operators will, at least 

initially, choose the sticker option. In 

the long run, the manufacturers of 

vending machines, and the larger 

vending machine operators, such as the 

soft drink companies, may use the more 

integrated, and thus expensive, solution. 

FDA tentatively estimates a recurring 

hourly burden of 1 hour per machine, 2 

times per year to install the displays. If 

there are an average of 20 items per 

machine, then the burden per response 

is .05 hours (= 1 hours/machine/20 

items/machine).This will be the time 

necessary to decide where to put the 

displays on the machine, and to sort, 

remove and affix calorie stickers. FDA 

expects the stickers to have a relatively 

short life, and the mix of product in a 

machine to change over time. 

FDA estimates approximately 7 

million machines are serviced by 5,000 

operators, for an average number of 

machines per operator of 1,400 

machines. If each machine has 20 items, 

then the average number of responses 

per operator is 28,000. Given that 

stickers will likely need to be replaced 

twice per year on average, this number 

of responses doubles, to 56,000 

responses per operator. The total 

recurring hours needed for third party 

display is then 14 million hours (= 5000 

firms × 1,400 machines/firm x 20 

displays/machine × .05 hours/display × 

2). This amount is recurring in every 

year, and is given in row 7 of table 2 of 

this document. 

If growth in the vending machine 

industry is .5 percent, then each of the 

5,000 respondents will have an average 

of 7 additional machines that would 

need to report calorie content each year. 

With an average number of items per 

machine of 20, the number of 

disclosures per respondent is 140. At 

.05 hours per response, the hours 

needed to disclose calorie content on 

new machines is 35,000 hours per year 

(= 5000 firms × 7 machines/firm × 20 

items/machine × .05 hours/item). This 

amount is displayed in row 8 of table 2 

of this document. 

Dated: November 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28014 Filed 11–4–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0275] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Full-Field Digital Mammography 

System; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

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