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
67982 Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 

protect the public health generally and 

to reduce tobacco use by minors. 

Section 801 of the FD&C Act, as 

amended by the Tobacco Control Act, 

charges the Secretary of Health and 

Human Services (HHS), through the 

FDA, with the responsibility of assuring 

foreign origin FDA regulated foods, 

drugs, cosmetics, medical devices, 

radiological health, and tobacco 

products offered for import into the 

United States meet the same 

requirements of the FD&C Act as do 

domestic products, and for preventing 

products from entering the country if 

they are not in compliance. The 

discharge of this responsibility involves 

close coordination and cooperation 

between FDA (headquarters and field 

inspectional personnel) and the U.S. 

Customs Service (USCS), as the USCS is 

responsible for enforcing the revenue 

laws covering the very same products. 

This collection of information was 

approved by OMB on August 10, 2009, 

and received an expiration date of 

August 31, 2012 (ICR Reference Number 

200905–0910–006). However, because 

tobacco products had only recently been 

added to FDA’s listing of regulated 

products when this collection of 

information was approved, the 

approved collection did not reflect 

information regarding tobacco products 

offered for import into and for 

prevention from them from entering the 

United States if they did not meet the 

same requirements of the Act as 

domestic products. The revision to this 

collection of information expands the 

universe of respondents being regulated 

under the FD&C Act, as amended, to 

include importers of tobacco products. 

In the most recent OMB approval of 

this information collection package, 

FDA noted that in order to make an 

admissibility decision for each entry, 

the Agency needed four additional 

pieces of information that were not 

available from USCS’s system. These 

data elements were the FDA Product 

Code, FDA country of production, 

manufacturer/shipper, and ultimate 

consignee. It was the ‘‘automated’’ 

collection of these four data elements 

for which OMB approval was being 

requested. When this package was sent 

to OMB for approval, FDA construed 

this request as an extension of the prior 

approval of collection of this data via a 

different media, i.e., paper. FDA noted 

that there were additional data elements 

which filers could provide to FDA along 

with other entry-related information. 

Doing so could result in their receiving 

an FDA admissibility decision more 

expeditiously, e.g., the quantity, value, 

and Affirmation(s) of Compliance with 

Qualifier(s). 

At each U.S. port of entry (seaport, 

landport, and airport) where foreignorigin FDA-regulated products are 

offered for import, FDA is notified, 

through Custom’s Automated 

Commercial System (ACS) by the 

importer (or his agent) of the arrival of 

each entry. Following such notification, 

FDA reviews relevant data to ensure the 

imported product meets the standards 

as are required for domestic products, 

makes an admissibility decision, and 

informs the importer and USCS of its 

decision. A single entry frequently 

contains multiple lines of different 

products. FDA may authorize products 

listed on specific lines to enter the 

United States unimpeded, while other 

products in the same entry are to be 

held pending further FDA review/ 

action. 

An important feature developed and 

programmed into FDA’s automated 

system is that all entry data passes 

through a screening criteria module, 

which makes the initial screening 

decision on every entry of foreign-origin 

FDA-regulated product. Almost 

instantaneously after the entry is filed, 

the filer receives FDA’s admissibility 

decision covering each entry line, i.e., 

‘‘May Proceed’’ or ‘‘FDA Review.’’ 

Examples of FDA’s need to further 

review an entry may result from some 

products originating from a specific 

country or manufacturer known to have 

a history of problems, FDA having no 

previous knowledge of the foreign 

manufacturer and/or product, or a 

product import alert may have been 

issued, etc. The system assists FDA 

entry reviewers by notifying them of 

information, such as the issuance of 

import alerts, thus averting the chance 

that such information will be missed in 

their review. 

Since the inception of the interface 

with ACS, FDA’s electronic screening 

criteria program is applied nationwide. 

This eliminates problems such as ‘‘port 

shopping,’’ e.g., attempts to intentionally 

slip products through one FDA port 

when refused by another, or filing 

entries at a port known to receive a high 

volume of entries. Every electronically 

submitted entry line of foreign-origin 

FDA-regulated product undergoes 

automated screening. The screening 

criteria can be set to be as specific or as 

broad as applicable; changes are 

immediately effective. This capability is 

of tremendous value in protecting the 

public in the event there is a need to 

immediately halt a specific product 

from entering the United States. 

FDA estimates the revised reporting 

burden for this collection of information 

is as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA imported products Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Non-Tobacco (approved by OMB 09/01/2009) ................... 3,406 1,089 3,709,134 .14 519,279 

Tobacco (new estimated burden) ........................................ 200 68 13,600 .14 1,904 

Total .............................................................................. 3,606 ........................ 3,722,734 .28 521,183 

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


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices 67983 

Dated: October 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27850 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–0190] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Infant Formula Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Infant Formula Requirements’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Johnny Vilela, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7651, e-mail: 

Juanmanuel.Vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 10, 2010 (75 

FR 48350), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0256. The 

approval expires on October 31, 2013. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: October 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27849 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–2009–N–0098] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Evaluation of Potential Data Sources 

for the Sentinel Initiative 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Evaluation of Potential Data Sources for 

the Sentinel Initiative’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

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.capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 4, 2009 

(74 FR 45858), the agency announced 

that the proposed information collection 

had been submitted to OMB for review 

and clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0657. The 

approval expires on February 28, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: October 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–27848 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–0536] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request, Guidance for 

Industry on Pharmacogenomic Data 

Submissions; Extension 

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 resulting 

from recommendations to sponsors 

submitting or holding investigational 

new drug applications (INDs), new drug 

applications (NDAs), or biologic 

licensing applications (BLAs) on what 

pharmacogenomic data should be 

submitted to the agency during the drug 

development process. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 

301–796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES