67978 Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

UCEDD: Interview with Peer Researchers and Colleagues ........................... 100 1 0.75 75 

UCEDD: Interview with Recipients of Community Services or Members of 

Organizations/Agencies that are Trained to Provide Community Services 100 1 0.75 75 

UCEDD: Self-administered Form ..................................................................... 20 1 8 160 

P&A: Executive Director Interview ................................................................... 20 1 4 80 

P&A: Staff Interview ......................................................................................... 60 1 0.75 45 

P&A: Board of Directors (Commissioners)-Chair and Members ..................... 60 1 0.75 45 

P&A: Group Interview with Policymakers and Collaborators .......................... 160 1 2 320 

P&A: Interview with Recipient of Community Education ................................. 100 1 0.75 75 

P&A: Interview with Clients ............................................................................. 100 1 0.75 75 

P&A: Self-administered Form .......................................................................... 20 1 8 160 

UCEDD: Interview with Director ...................................................................... 20 1 4 80 

DD Council: Group Interview with Recipients of Self-Advocacy and Leadership Education and Training ........................................................................ 100 1 0.75 75 

DD Council: Group Interview with Recipients of Education and Training to 

Improve Community Capacity ...................................................................... 100 1 0.75 75 

DD Council: Self-administered Form ............................................................... 20 1 8 160 

Estimated Total Annual Burden Hours: .................................................... ........................ ........................ ........................ 4,135 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 

202–395–7285, E-mail: 

OIRA_SUBMISSION

@OMB.EOP.GOV., Attn: Desk Officer 

for the Administration for Children 

and Families. 

Dated: November 1, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–27855 Filed 11–3–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0564] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Restaurant Menu 

Labeling: Registration for Small 

Chains 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 information collection provisions of 

FDA’s program of voluntary registration 

under the Patient Protection and 

Affordable Care Act of 2010 (Affordable 

Care Act). 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 3, 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: 

I. Background 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 67979 

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 Labeling: Registration 

for Small Chains Under Section 4205 of 

the Patient Protection and Affordable 

Care Act of 2010—(OMB Control 

Number 0910–0664)—Extension 

On March 23, 2010, the President 

signed into law the Affordable Care Act 

(Pub. L. 111–148). Section 4205 of the 

legislation, which principally amends 

sections 403 (21 U.S.C. 343) and 403A 

(21 U.S.C. 343–1) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

requires chain restaurants and similar 

retail food establishments (SRFE) with 

20 or more locations, as well as 

operators of 20 or more vending 

machines, to disclose certain nutrition 

information on 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 in restaurants and calorie 

declarations for food in vending 

machines that are not ‘‘identical to’’ the 

section 4205 requirements. 

In addition to restaurant menu and 

vending machine labeling, section 4205 

of the Affordable Care Act provides that 

persons or firms not subject to the 

disclosure of nutrition information 

required by this legislation, such as 

restaurants with fewer than 20 locations 

or vending machine operators with 

fewer than 20 vending machines, may 

elect to be subject to the requirements 

provided in section 4205 by registering 

biannually with FDA. As required by 

section 4205, FDA published a notice in 

the Federal Register of July 23, 2010 (75 

FR 43182) (the July 23, 2010, notice) to 

explain how retail food establishments 

and vending machine operators not 

otherwise subject to the provisions of 

section 4205 may voluntarily elect to 

become subject to them. The 

information collection requirements of 

FDA’s program of voluntary registration 

under section 4205 of the Affordable 

Care Act were approved under the 

emergency processing provisions of the 

PRA and assigned OMB control number 

0910–0664. 

Voluntary registration allows 

companies with outlets or machines 

regulated by local or State calorie 

labeling requirements to opt instead for 

the requirements of section 4205 of the 

Affordable Care Act. The information 

provided to FDA will help Federal, 

State or local officials to determine 

which jurisdiction’s requirements apply 

to the firm. 

Description of Respondents: 

Respondents to this collection of 

information include retail food 

establishments and vending machine 

operators with fewer than 20 outlets or 

machines. 

FDA’s July 23, 2010, notice requires 

that retail food establishments and 

vending machine operators register with 

FDA using the Agency’s Form FDA 3757 

available at http://www.fda.gov/ 

menulabeling. FDA prefers that the 

information be submitted by e-mail by 

typing complete information into the 

form (PDF), saving it on the registrant’s 

computer, and sending it by e-mail to 

http:// 

menulawregistration@fda.hhs.gov. If email is not available, the registrant can 

either fill in the form (PDF) and print it 

out (or print out the blank PDF and fill 

in the information by hand or 

typewriter), and send it to FDA either by 

faxing the completed form to 301–436– 

2804 or mailing it to the Center for Food 

Safety and Applied Nutrition, 

Compliance Information Branch (HFS– 

681), 5600 Fishers Lane, Rockville, MD 

20857. 

Information FDA requires on the 

registration form for restaurants and 

similar retail food establishments 

includes the following: 

• The name, address, phone number, 

e-mail address, and contact information 

for the authorized official; 

• The name, address, and e-mail 

address of each restaurant or similar 

retail food establishment being 

registered, as well as the name and 

contact information for an official 

onsite, such as the owner or manager, 

for each specific restaurant or similar 

retail food establishment; 

• All trade names the restaurant or 

similar retail food establishment uses; 

• Preferred mailing address (if 

different from location address for each 

establishment) for purposes of receiving 

correspondence; and 

• Certification that the information 

submitted is true and accurate, that the 

person or firm submitting it is 

authorized to do so, and that each 

registered restaurant or similar retail 

food establishment will be subject to the 

requirements of section 4205. 

Information FDA requires on the 

registration form for vending machine 

operators includes the following: 

• The name, address, phone number, 

e-mail address, and contact information 

for the vending machine operator; 

• The address of each vending 

machine owned or operated by the 

vending machine operator, and the 

name and contact information, 

including e-mail address, of the location 

in which each vending machine is 

located; 

• Preferred mailing address (if 

different from location address), for 

purposes of receiving correspondence; 

and 

• Certification that the information 

submitted is true and accurate, that the 

person or firm submitting it is 

authorized to do so, and that each 

registered restaurant or similar retail 

food establishment will be subject to the 

requirements of section 4205 of the 

Affordable Care Act. 

In addition to the initial registration, 

the authorized official must register 

every other year with FDA, and the 

registration will automatically expire if 

not renewed. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response 

(average) 

Total hours 

Restaurant initial ................................................................ 103 1 103 2 206 

Grocery initial ..................................................................... 167 1 167 2 334 

C-store initial ...................................................................... 11 1 11 2 22 

Other SRFE initial .............................................................. 81 1 81 2 162 


jlentini on DSKJ8SOYB1PROD with NOTICES
67980 Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Type of respondent Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response 

(average) 

Total hours 

Total initial hours ........................................................ ........................ ........................ ........................ .......................... 724 

New registrations ............................................................... 7 1 7 1 7 

Re-registrations .................................................................. 355 1 355 0 .25 89 

Total recurring hours .................................................. ........................ ........................ ........................ .......................... 96 

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

FDA estimates the reporting burden of 

this information collection to be 724 

hours in the first year and 96 hours each 

year thereafter. The registration burden 

will be an ongoing, semiannual 

reporting of firm contact and location 

information to FDA. FDA bases its per 

respondent burden on the PRA analysis 

for section 415 of the FD&C Act (21 

U.S.C. 350d) as laid out for the proposed 

rule entitled ‘‘Registration of Food 

Facilities Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002’’ (68 FR 5378, 

February 3, 2003) (Ref. 1). FDA 

estimates that the initial collection of 

the information, and presentation of it 

in a format that will meet the Agency’s 

registration regulations, will require a 

burden of approximately 2 hours per 

registration for the first year because the 

registration system will not be fully 

automated. 

FDA estimates that renewal 

registrations after the first year will 

require substantially less time because 

firms are expected to be able to affirm 

or edit the existing information in an 

online account in a way similar to other 

FDA firm registration systems. 

Therefore, FDA estimates that reregistration will take 0.25 hours for each 

registrant. Because there will be entry 

and exit from this set of firms, there will 

also be new registrations once the 

system is fully operational. FDA 

estimates that initial registration under 

the fully operational system will take 1 

hour. 

The pool of potential registrants will 

be restaurants and SRFEs with outlets in 

jurisdictions that have their own menu 

labeling regulations and that are not 

explicitly regulated under section 4205 

of the Affordable Care Act. Of the 

existing State and local regulations, the 

minimum number of outlets for which 

any of them currently apply is 15, and 

section 4205 applies explicitly to firms 

with 20 or more outlets. Therefore, only 

firms with between 15 and 19 outlets, 

inclusive, have any explicit incentive to 

register. However, chains with fewer 

outlets may choose to register, either 

because they are growing quickly, or 

because they are concerned about 

possible regulation, therefore, for the 

purposes of this analysis we include 

chains with between 10 and 19 outlets, 

inclusive. The primary source of 

potential registrants will be restaurant 

and specialty food chains, but there are 

significant numbers of convenience 

stores and grocery stores that prepare 

food onsite and have a partial function 

as a take-away, or quick-service, 

restaurant. In addition, small chains of 

similar retail food establishments that 

operate in retail, hotel, corporate, 

educational, military or entertainment 

settings may want to register. 

Because the statute preempts State 

and local regulations on vending 

machine labeling, no vending machine 

operators will have an incentive to 

register. Therefore, FDA estimates that 

zero vending machine operators will 

register with FDA under section 4205 of 

the Affordable Care Act. 

According to The NPD Group’s Spring 

2010 ReCount report, there were 

579,416 sole purpose eating and 

drinking establishments in the United 

States in the winter of 2010 (Ref. 2). Of 

these, 40 percent will be explicitly 

subject to FDA rulemaking for the 

Affordable Care Act because they are 

part of chains with 20 or more outlets 

(Ref. 2). Of the remaining 350,000 

outlets, only those that would be subject 

to local or State rules concerning menu 

labeling would have any incentive to 

register. Approximately 7.5 percent of 

restaurant outlets are in States or 

localities with currently operational 

menu labeling regulation, principally 

New York City, Oregon, Philadelphia, 

and some New York State counties (Ref. 

3). NPD’s Spring 2010 ReCount report 

shows a total of 20,000 outlets are part 

of chains with between 10 and 19 

establishments. If outlets are evenly 

distributed geographically, then 1,500 

outlets and 103 restaurant firms may 

have an incentive to register with FDA. 

The hourly burden for restaurant chains 

is 206 hours (= 100 chains × 1 

responses/chain/year × 2 hours/ 

response). 

From the U.S. Census County 

Business Patterns data, FDA estimates 

that there are approximately 62,000 

grocery stores in 2010. Of these, 

approximately 6,500 are ‘‘independents’’ 

which means that they are part of chains 

with fewer than 11 outlets (Ref. 4), and 

35,000 are known to belong to chains 

with more than 20 outlets (Ref. 5). We 

round the remaining 20,523 outlets up 

to 21,000 to account for those outlets in 

chains with 10 or 11 establishments. 

County Business Patterns show that 11.5 

percent of all grocery stores are in 

jurisdictions that have relevant menu 

labeling regulations. Taking 11.5 

percent of 21,000 yields approximately 

2,400 stores run by 167 firms. The 

hourly burden for grocery chains is 334 

hours (= 167 chains × 1 responses/ 

chain/year × 2 hours/response). 

According to Stagnito Media, there 

are 144,000 convenience store outlets in 

the United States (Ref. 6). Of these, 

64,000 are defined as very small ‘‘mom 

and pop’’ locations. Approximately 

60,000 outlets are controlled by 1 of the 

top 100 chains, each having at least 65 

outlets (Ref. 7). Of the remaining 20,000, 

FDA estimates that half fall in the 10 to 

19 outlet range. From County Business 

Patterns (Ref. 3), 1.6 percent of all 

convenience store outlets are in a 

jurisdiction with a local or State menu 

labeling regulation that does not 

explicitly exempt convenience stores. 

FDA estimates that approximately 160 

convenience store outlets from 11 firms 

may have an incentive to register under 

this notice. The hourly burden for 

convenience store chains is 22 hours 

(= 11 chains × 1 responses/chain/year 

× 2 hours/response). 

Additional covered establishments, 

such as those in operating in lodging, 

corporate, entertainment, and 

educational settings are often provided 

by very large firms with many hundreds 

or thousands of outlets, and will thus be 

explicitly covered by section 4205 of the 

Affordable Care Act rather than by the 

registration provisions. FDA estimates 

that an additional 81 firms, controlling 

approximately 1,200 outlets may have 

an incentive to register. The hourly 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 67981 

burden for these additional chains is 

162 hours (= 81 chains × 1 responses/ 

chain/year × 2 hours/response). 

If all of these restaurant and similar 

retail food establishment chains choose 

to register with FDA, then FDA 

estimates the number of firms 

registering in the first year would be 

approximately 362 firms. At two hours 

per registration, the total initial hourly 

burden will then be 724 hours (= 362 

firms × 2 hours/firm). 

FDA estimates that the rate of growth 

for chains entering the 10 to 19 outlet 

segment will match the rate of growth 

out of this segment, so that the number 

of registrants will remain constant. 

County Business Patterns data shows an 

average growth rate in the number of 

establishments to be 2 percent per year 

over the 8 years from 1999 to 2007 for 

restaurants (Ref. 3). If the restaurant 

growth rate for outlets of approximately 

2 percent per year applies to these 

chains, then new registrants will 

amount to approximately 7 per year, 

with the remaining 355 registrants only 

renewing their registration. The yearly 

burden for registration is estimated to be 

1 hour per new registrant. Thus, the 

total hour burden will be 7 hours (7 

firms × 1 hour/firm). The yearly burden 

for renewing registration is estimated to 

be 0.25 hour per continuing registrant. 

Thus, the total hour burden will be 89 

hours (355 firms × 0.25 hour/firm = 

88.75, rounded to 89). This yields a 

recurring hourly burden of 96 hours per 

year (7 hours + 89 hours). 

II. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Food and Drug Administration, 

‘‘Registration of Food Facilities Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002,’’ 68 FR 5378, 

February 3, 2003. 

2. The NPD Group, ‘‘Chains System 

Size Trend Report for U.S. FDA,’’ 

ReCount, Spring 2010. 

3. U.S. Census Bureau, 2007, County 

Business Patterns, http:// 

www.census.gov/econ/cbp/index.html, 

2007, version date September 22, 2009. 

4. Moran, M., J. McTaggart, and D. 

Chanil, ‘‘Looking Up, Cautiously,’’ 

Progressive Grocer 89(3): 20–52, 2010. 

5. Food Marketing Institute, Top U.S. 

Supermarket & Grocery Chains (by 2007 

grocery sales), http://www.fmi.org, 2008. 

6. Stagnito Media, ‘‘Directory of 

Convenience Stores: FAQ,’’ http:// 

www.conveniencestores.com/faq.html, 

accessed June 1, 2010. 

7. Longo, D. ‘‘Convenience Store 

News: Hot Top 100,’’ Convenience Store 

News, 45(10), pp. 27–32, August 10, 

2009. 

Dated: October 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27854 Filed 11–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0543] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Importer’s Entry 

Notice 

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 

revision 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 revision of an approved Office of 

Management and Budget (OMB) 

collection of information for FDA’s 

Importer’s Entry Notice. This revision 

reflects additional burden recognized as 

a result of including tobacco products to 

the list of FDA-regulated products under 

the Family Smoking Prevention and 

Tobacco Control Act (the Tobacco 

Control Act). 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 3, 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: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.Capezutto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from 

OMB for each collection of information 

they conduct or sponsor. ‘‘Collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed revision 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. 

Information Request Regarding 

Importer’s Entry Notice—(OMB Control 

Number 0910–0046)—Revision 

On June 22, 2009, the President 

signed the Tobacco Control Act (Pub. L. 

111–31) into law. The Tobacco Control 

Act amended the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) by adding 

a new chapter granting FDA important 

new authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 


jlentini on DSKJ8SOYB1PROD with NOTICES