2396 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of survey Number of 

respondents 

Annual 

frequency 

per response 

Hours per 

response Total hours 

Mail, telephone, web-based ............................................................................. 20,000 1 0.25 5,000 

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

Dated: January 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–532 Filed 1–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0016] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Recordkeeping 

and Records Access Requirements for 

Food Facilities 

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 of 

FDA’s recordkeeping and records access 

requirements for food facilities. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 14, 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 

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. 

Recordkeeping and Records Access 

Requirements for Food Facilities—21 

CFR 1.337, 1.345, and 1.352 (OMB 

Control Number 0910–0560)—Extension 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) added section 414 of the Federal 

Food, Drug, and Cosmetic Act (the FD 

& C Act) (21 U.S.C. 350c), which 

requires that persons who manufacture, 

process, pack, hold, receive, distribute, 

transport, or import food in the United 

States establish and maintain records 

identifying the immediate previous 

sources and immediate subsequent 

recipients of food. Sections 1.326 to 

1.363 (21 CFR 1.326 to 1.363) of FDA’s 

regulations set forth the requirements 

for recordkeeping and records access. 

The requirement to establish and 

maintain records improves FDA’s ability 

to respond to, and further contain, 

threats of serious adverse health 

consequences or death to humans or 

animals from accidental or deliberate 

contamination of food. 

Description of respondents: Persons 

that manufacture, process, pack, hold, 

receive, distribute, transport, or import 

food in the United States are required to 

establish and maintain records, 

including persons that engage in both 

interstate and intrastate commerce. 

FDA’s regulations require that records 

for nontransporters include the name 

and full contact information of sources, 

recipients, and transporters, an adequate 

description of the food, including the 

quantity and packaging, and the receipt 

and shipping dates (§§ 1.337 and 1.345). 

Required records for transporters 

include the names of consignor and 

consignee, points of origin and 

destination, date of shipment, number 

of packages, description of freight, route 

of movement and name of each carrier 

participating in the transportation, and 

transfer points through which shipment 

moved (§ 1.352). Existing records may 

be used if they contain all of the 

required information and are retained 

for the required time period. 

FDA estimates the burden of this 

collection of information as follows: 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 2397 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

1.337, 1.345, and 1.352 (Records maintenance) ............ 379,493 1 379,493 13.228 5,020,000 

1.337, 1.345, and 1.352 (Learning for new firms) ........... 18,975 1 18,975 4.790 90,890 

Total .......................................................................... 5,110,890 

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

This estimate is based on FDA’s 

estimate of the number of facilities 

affected by the final rule entitled 

‘‘Establishment and Maintenance of 

Records Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002,’’ published in 

the Federal Register of December 9, 

2004 (69 FR 71562 at 71630). With 

regard to records maintenance, FDA 

estimates that approximately 379,493 

facilities will spend 13.228 hours 

collecting, recording, and checking for 

accuracy the limited amount of 

additional information required by the 

regulations, for a total of 5,020,000 

hours annually. In addition, FDA 

estimates that new firms entering the 

affected businesses will incur a burden 

from learning the regulatory 

requirements and understanding the 

records required for compliance. In this 

regard, the Agency estimates the 

number of new firms entering the 

affected businesses to be 5 percent (5%) 

of 379,493, or 18,975 firms. Thus, FDA 

estimates that approximately 18,975 

facilities will spend 4.790 hours 

learning about the recordkeeping and 

records access requirements, for a total 

of 90,890 hours annually. Therefore, the 

total annual recordkeeping burden is 

estimated to be 5,110,890 hours. 

Dated: January 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–592 Filed 1–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Menthol Report Subcommittee of the 

Tobacco Products Scientific Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Menthol Report 

Subcommittee of the Tobacco Products 

Scientific Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on February 11, 2011, from 9 a.m. 

to 5 p.m. 

Location: Center for Tobacco 

Products, 9200 Corporate Blvd, 

Rockville, MD, 20850. The telephone 

number is 1–877–287–1373. 

Contact Person: Caryn Cohen, Office 

of Science, Center for Tobacco Products, 

Food and Drug Administration, 9200 

Corporate Blvd, Rockville, MD 20850, 

1–877–287–1373 (choose Option 4), email: TPSAC@fda.hhs.gov or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On February 11, 2011, the 

subcommittee will receive presentations 

and discuss the timelines and structure 

of the Tobacco Products Scientific 

Advisory Committee’s required report to 

the Secretary of Health and Human 

Services regarding the impact of use of 

menthol in cigarettes on the public 

health. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before January 28, 2011. 

Oral presentations from the public will 

be scheduled between approximately 11 

a.m. and 12 noon on February 11, 2011. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 20, 2011. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

January 21, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Caryn Cohen 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 


srobinson on DSKHWCL6B1PROD with NOTICES