Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 17131 

also be asked to provide 

recommendations to the Secretary 

regarding how to improve Head Start 

and other early childhood programs by 

enhancing the use of research-informed 

practices in early childhood. Finally, 

the Committee will be asked to provide 

recommendations on the overall Head 

Start research agenda, including—but 

not limited to—how the Head Start 

Impact Study fits within this agenda. 

The Committee will provide advice 

regarding future research efforts to 

inform HHS about how to guide the 

development and implementation of 

best practices in Head Start and other 

early childhood programs around the 

country. 

DATES: The meeting will be held on 

April 12th and April 13th, 2011, from 

8:30 a.m. to 5 p.m. 

ADDRESSES: Hyatt Arlington, 1325 

Wilson Boulevard, Arlington, VA 22209, 

Phone: 703–525–1234. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Brooks, Office of Planning, 

Research, and Evaluation, e-mail 

jennifer.brooks@acf.hhs.gov or call (202) 

205–8212. 

Agenda: The committee will review 

information on the federal Head Start 

program and the children and families 

it serves, hear information about the 

early Head Start program, and learn 

about the latest research in the area of 

quality teaching and learning. 

Procedure: Interested persons may 

present data, information or views, in 

writing, on issues pending before the 

Committee. Written submissions may be 

made to the contact person on or before 

April 1, 2011. All written materials 

provided to the contact person will be 

shared with the Committee members. 

ACF welcomes the attendance of the 

public at this advisory committee 

meeting 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 Jennifer 

Brooks at least seven days in advance of 

the meeting. Information about the 

committee and this meeting can be 

found at the committee Web site, 

http://www.acf.hhs.gov/programs/opre/ 

hs/advisory_com/. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Robert Sargis, 

Reports Clearance Officer, Administration for 

Children and Families. 

[FR Doc. 2011–7170 Filed 3–25–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0016] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 27, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0560. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

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 

through 1.363 of FDA’s regulations (21 

CFR 1.326 through 1.363) 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 non-transporters 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. 

In the Federal Register of January 13, 

2011 (76 FR 2396), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. FDA received one letter 

containing multiple comments in 

response to the notice. 

(Comment 1) One comment was 

generally supportive of the necessity of 

the information collection and its 

practical utility. 

(Response) FDA agrees. As discussed 

previously in this document, 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. 

(Comment 2) Another comment stated 

that accurate recordkeeping is integral 

to the effective and timely tracing of 

food products through the supply chain 

and, to support effective product 

tracing, suggested that industry should 

determine the Critical Tracking Events 

(CTEs) and the Key Data Elements 

(KDEs) necessary for product tracing; 

FDA should encourage the adoption of 

standard ways to express this 


Emcdonald on DSK2BSOYB1PROD with NOTICES
17132 Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 

information as well as the adoption of 

electronic recordkeeping and electronic 

submission of data to the agency; and, 

review of product tracing procedures 

should be part of standard audits. 

(Response) FDA agrees that 

recordkeeping is key to effective 

product tracing. However, to the extent 

that the comments suggest changes to 

the requirements of the recordkeeping 

regulations in sections 1.326 through 

1.363, such requests are outside the 

scope of the four collection of 

information topics on which the notice 

solicits comments. Such changes to the 

current recordkeeping requirements can 

only be accomplished by notice and 

comment rulemaking. 

FDA estimates the burden of this 

collection of information as follows: 

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 of 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 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: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7188 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0017] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary National 

Retail Food Regulatory Program 

Standards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by April 27, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0621. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Voluntary National Retail Food 

Regulatory Program Standards—(OMB 

Control Number 0910–0621)—Extension 

The Program Standards define nine 

essential elements of an effective 

regulatory program for retail food 

establishments, establish basic quality 

control criteria for each element, and 

provide a means of recognition for those 

state, local, and tribal regulatory 

programs that meet the Program 

Standards. The program elements 

addressed by the Program Standards are 

as follows: (1) Regulatory foundation, 

(2) trained regulatory staff, (3) 

inspection program based on Hazard 

Analysis and Critical Control Point 

(HACCP) principles, (4) uniform 

inspection program, (5) foodborne 

illness and food defense preparedness 

and response, (6) compliance and 

enforcement, (7) industry and 

community relations, (8) program 

support and resources, and (9) program 

assessment. Each standard includes a 

list of records needed to document 

compliance with the standard (referred 

to in the Program Standards document 

as ‘‘quality records’’) and has one or 

more corresponding appendices that 

contain forms and worksheets to 

facilitate the collection of information 

needed to assess the retail food 

regulatory program against that 

standard. The respondents are State, 

local and tribal government Agencies. 

Regulatory Agencies may use existing, 

available records or may choose to 

develop and use alternate forms and 

worksheets that capture the same 

information. 

In the course of their normal 

activities, state, local, and tribal 


Emcdonald on DSK2BSOYB1PROD with NOTICES