Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 65491 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1—ESTIMATE OF ONE-TIME REPORTING BURDEN1

Activity Number of 

respondents 

Annual 

frequency 

per response 

Total 

average 

annual 

responses 

Hours per response Total hours 

Providing negative response to request for dissolvable 

tobacco product documents ........................................... 110 1 110 0 .50 55 

Submission of dissolvable tobacco products ..................... 10 1 10 230 2,300 

Total ............................................................................ 120 ........................ 120 .......................... 2,355 

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

These burden estimates were derived 

by taking into consideration FDA’s 

experience with document production, 

experience with submissions pertaining 

to other tobacco product-related 

information collections, and comments 

received in response to other tobacco 

product-related information collections. 

FDA is limiting the burden on 

respondents by only requesting 

documents on specific topics that will 

have utility for FDA. FDA is requesting 

the final version of documents or the 

most recent draft in the absence of a 

final document. Also, publically 

available published abstracts, editorials, 

letters, and manuscripts are not being 

requested, although FDA would 

appreciate a list of such publications. 

Information responsive to this section 

904(b) information request that has been 

previously provided to FDA under the 

FD&C Act or other letter requests does 

not have to be resubmitted as long as the 

document is fully referenced. FDA 

believes that the number of documents 

being requested in this information 

collection will be limited due to the 

estimated small number of respondents 

and the relatively shorter amount of 

time these tobacco products have been 

in existence compared to other tobacco 

products. 

FDA estimates that there are 

approximately 120 tobacco product 

manufacturers who may be affected by 

this collection of information. Of the 

total number of manufacturers, FDA 

estimates that most manufacturers (110) 

will not have documents which will be 

responsive to this section 904(b) request 

and that they will only need to send a 

letter notifying the FDA’s Center for 

Tobacco Products that they have no 

documents to report. FDA anticipates it 

should take no longer than 30 minutes 

to draft such a response and send to 

FDA. The total one-time hourly burden 

to submit this letter to FDA is estimated 

to be 55 hours (30 minutes × 110 

manufacturers). 

FDA estimates that there are 

approximately 10 tobacco product 

manufacturers who may have 

documents meeting the criteria of this 

information collection request. Because 

the volume of responsive documents 

each of these respondents may have will 

likely vary, the corresponding time 

burden for each respondent to satisfy 

this information collection request will 

also vary. Therefore, FDA estimates that 

these 10 respondents will average 

approximately 230 hours each to satisfy 

the requirements of this section 904(b) 

request. The total one-time hourly 

burden to locate and send documents 

meeting the requirements of this request 

is estimated to be 2,300 hours (230 

hours × 10 manufacturers). The total 

one-time hourly burden for this 

collection of information is 2,355 hours 

(55 hours + 2,300 hours). 

Dated: October 19, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26830 Filed 10–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0411] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guide To Minimize 

Microbial Food Safety Hazards of 

Fresh-Cut Fruits and Vegetables 

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 November 

24, 2010. 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0609. 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. 

Guide To Minimize Microbial Food 

Safety Hazards of Fresh-Cut Fruits and 

Vegetables—(OMB Control Number 

0910–0609)—Extension 

Fresh-cut fruits and vegetables are 

fruits and vegetables that have been 

processed by peeling, slicing, chopping, 

shredding, coring, trimming, or 

mashing, with or without washing or 

other treatment, prior to being packaged 

for consumption. The methods by 

which produce is grown, harvested, and 

processed may contribute to its 

contamination with pathogens and, 

consequently, the role of the produce in 

transmitting foodborne illness. Factors 

such as the high degree of handling and 

mixing of the product, the release of 

cellular fluids during cutting or 

mashing, the high moisture content of 

the product, the absence of a step lethal 


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65492 Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 

to pathogens, and the potential for 

temperature abuse in the processing, 

storage, transport, and retail display all 

enhance the potential for pathogens to 

survive and grow in fresh-cut produce. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) prohibits the 

distribution of adulterated food in 

interstate commerce (21 U.S.C. 331 and 

342). In response to the increased 

consumption of fresh-cut fruits and 

vegetables and the potential for 

foodborne illness associated with these 

products, FDA recognizes the need for 

guidance specific to the processing of 

fresh-cut fruits and vegetables. The 

guidance document entitled ‘‘Guide to 

Minimize Microbial Food Safety 

Hazards of Fresh-cut Fruits and 

Vegetables,’’ which is available at: 

http://www.fda.gov/FoodGuidances, 

provides FDA’s recommendations to 

fresh-cut produce processors about how 

to avoid contamination of their product 

with pathogens. The guidance is in 

addition to the current good 

manufacturing practices (cGMPs) 

provided in part 110 of FDA’s 

regulations (21 CFR part 110). The 

guidance is intended to assist fresh-cut 

produce processors in minimizing 

microbial food safety hazards common 

to the processing of most fresh-cut fruits 

and vegetables sold to consumers and 

retail establishments in a ready-to-eat 

form. Accordingly, FDA encourages 

fresh-cut produce processors to adopt 

the general recommendations in the 

guidance and to tailor practices to their 

individual operations. 

The guidance provides information 

and recommended procedures designed 

to help fresh-cut produce processors 

minimize microbial food safety hazards. 

The recommended procedures 

contained in the guidance are voluntary. 

Both FDA and fresh-cut produce 

processors will use and benefit from the 

information collected. 

Two general recommendations in the 

guidance are for operators to develop 

and implement both a written Standard 

Operating Procedures (SOPs) plan and a 

Sanitary Standard Operation Procedures 

(SSOPs) plan. SOPs and SSOPs are 

important components to properly 

implemented and monitored cGMPs 

that are required for processed food 

operations under part 110. Other 

recommended programs that require 

documentation and recordkeeping are 

recall and traceback programs. In the 

event of a food safety concern, 

processors who adopt these 

recommended programs will be 

prepared to recall products from the 

market place or be able to trace back 

fresh produce, which might be 

implicated in a foodborne illness 

outbreak, to its source. Fresh-cut 

produce processors are also asked to 

consider the application of Hazards 

Analysis and Critical Control Point 

(HACCP) principles or comparable 

preventive control programs to the 

processing of fruits and vegetables. 

FDA, other Federal and State food 

agencies, industry, and food 

establishments have found such 

preventive control programs, when 

properly designed and maintained by 

the establishment’s personnel, to be 

valuable in managing the safety of food 

products. 

FDA’s fresh-cut guidance represents 

the agency’s recommendations to 

industry based on the current state of 

science. Following the 

recommendations set forth in the freshcut guidance is the choice of each 

individual fresh-cut operation, plant, or 

processor. FDA estimates the burden of 

the guidance on industry by assuming 

that those in the fresh-cut industry who 

do not currently follow the 

recommendations put forth in the 

guidance will find it of value to do so. 

Therefore, the estimates of the burden 

associated with the issuance of the 

guidance represent the upper bound 

estimate of burden; the burden if every 

fresh-cut plant, processor, or operation 

that does not follow the 

recommendations of the guidance 

should choose to do so. 

In the Federal Register of August 11, 

2010 (75 FR 48692), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received . 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity No. of recordkeepers 

Annual frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

SOP and SSOP: Maintenance ............................................ 122 3,315 404,430 0.067 27,097 

Traceback development ....................................................... 10 1 10 20 200 

Traceback maintenance ....................................................... 290 1 290 40 11,600 

Preventive control program comparable to a HACCP system: System development ................................................ 10 1 10 100 1,000 

Preventive control program comparable to a HACCP system: System implementation ............................................ 145 510 73,950 0.067 4,955 

Preventive control program comparable to a HACCP system: Implementation review ............................................. 145 4 580 4 2,320 

Annual burden hours .................................................... ........................ ........................ ........................ ........................ 47,172 

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

Industry Profile 

Estimates of the paperwork burden to 

the fresh-cut industry are based on 

information received from a fresh-cut 

processor who has developed and 

maintained these programs and 

information from a fresh-cut produce 

industry trade association. Because of 

the small number of fresh-cut 

processors, the agency is able to 

extrapolate data from industry programs 

to calculate the total estimated upper 

bound burdens (see table 1 of this 

document). 

The burden to industry of developing 

and maintaining the activities 

recommended in FDA’s fresh-cut 

guidance will vary considerably among 

fresh-cut processors, depending on the 

type and number of products involved, 

the sophistication of the equipment or 

instruments (e.g., those that 

automatically monitor and record food 

safety controls), and the type of controls 

monitored under any individual 

preventive control program, such as 

critical control points (CCPs) monitored 

under a HACCP program. 

In 2007, FDA estimated that there 

were 250 fresh-cut plants in operation 

in the United States, and that 

approximately 10 new firms enter the 

fresh-cut industry each year (72 FR 


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Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 65493 

11364, at 11366, March 13, 2007). Using 

these figures, we estimate that in 2010 

there are 280 fresh-cut plants in 

operation and that approximately 10 

new firms will enter the fresh-cut 

industry each year, over the next 3 

years. Many of the existing firms in the 

fresh-cut industry already make use of 

cGMP-related, recall, HACCP, and other 

activities. FDA estimates that the 

burden of the fresh-cut guidance will 

fall on both existing and new firms 

entering the industry who may follow 

the recommendations in the guidance. 

SOPs and SSOPs 

Two general recommendations in the 

guidance are for operators to develop 

and implement both a written SOPs 

plan and a written SSOPs plan. SOPs 

describe in writing the performance of 

the day-to-day operations of a 

processing plant. Examples of activities 

that would fall under SOPs would be 

developing written specifications for 

agricultural inputs, ingredients, and 

packaging materials; production steps 

for the processing and packaging 

operations; instructions for packaging 

and storage activities; and procedures 

for equipment maintenance, calibration, 

and replacement and facility 

maintenance and upkeep; and 

maintaining SOP records on product 

processing and distribution activities. 

SSOPs provide written instructions or 

procedures for sanitary practices 

developed for each specific sanitation 

activity in and around the facility. 

Sanitation activities include procedures 

for cleaning equipment, food-contact 

surfaces, and plant facilities; chemical 

use and storage; cleaning equipment 

maintenance, use, and storage; pest 

control; and maintaining SSOP records 

for the activities. From communication 

with the fresh-cut industry, we know 

that existing fresh-cut processors 

already have developed SOPs and 

SSOPs. We therefore consider the 

development of SOPs and SSOPs to be 

‘‘usual and customary’’ for 

manufacturers and processors in the 

fresh-cut industry (see 5 CFR 

1320.3(b)(2)). Thus, we do not calculate 

this burden for existing firms or new 

firms entering this industry. 

FDA recommends that facilities not 

only develop but also maintain SOPs 

and SSOPs. Implementation and 

maintenance of SOPs and SSOPs 

include maintaining daily records for 

each of the firm’s operational days for 

the following activities: Inspection of 

incoming ingredients, such as the fresh 

produce and packaging material; facility 

and production sanitation inspections; 

equipment maintenance, sanitation, and 

visual safety inspections; equipment 

calibration, e.g., checking pH meters; 

facility and premises pest control 

audits; temperature controls during 

processing and in storage areas; and 

audits of ingredients, food contact 

surfaces, and equipment for 

microbiological contamination. Of the 

280 fresh-cut processors, we estimate 

that well over half have SOP and SSOP 

maintenance programs in place. 

Therefore, for purposes of estimating the 

annual recordkeeping burden for SOP 

and SSOP maintenance programs, the 

agency assumed that 40 percent of the 

existing processors, or 112 firms, and 

the 10 new firms do not have SOP and 

SSOP maintenance programs in place. 

FDA estimates the recordkeeping 

burden for SOP and SSOP maintenance 

programs by assuming that these 122 

firms will choose to implement such a 

maintenance strategy as a result of the 

recommendations in the fresh-cut 

guidance document. 

A typical fresh-cut processing plant 

operates about 255 days per year. For an 

8-hour shift, assuming the ingredients 

are received twice during that time, 

under the recommendations in the 

guidance, there would be about 13 

records kept (2 for inspecting incoming 

ingredients; 2 for inspecting the facility 

and production areas once every 4 

hours; 3 records for equipment 

(maintenance, sanitation, and visual 

inspections for defects); 1 for calibrating 

equipment; 2 temperature recording 

audits (1 time for each of the 2 

processing runs); and 3 microbiological 

audits (ingredients, food contact 

surfaces, and equipment)). Therefore, 

the annual frequency of recordkeeping 

for SOPs and SSOPs is calculated to be 

3,315 times (255 × 13) per year per firm; 

122 firms will be performing these 

activities to generate a total 404,430 

records (3,315 × 122) annually, 

assuming all firms choose to follow the 

recommendations on keeping records. 

The total time to record observations 

for SOP and SSOP maintenance is 

estimated to take 4 minutes or 0.067 

hours per record, and the number of 

records maintained is 404,430. 

Therefore, the total annual burden in 

hours for 122 processors to maintain 

their SOP and SSOP records is 

approximately 27,097 hours (404,430 × 

0.067). The maintenance burden for 

these 122 firms, along with the annual 

maintenance burden of audits or testing, 

is estimated in row 1 of table 1 of this 

document. Again, these figures assume 

that all firms choose to follow the 

recommendations on recording 

observations. 

Recall and Traceback 

We recommend that fresh-cut 

processors establish and maintain 

written traceback procedures to respond 

to food safety hazard problems when 

they arise and establish and maintain a 

written contingency plan for use in 

initiating and effecting a recall. In order 

to facilitate tracebacks and recalls, we 

recommend that processors establish a 

program that documents and tracks 

fresh-cut products back to the source of 

their raw ingredients, and keep records 

of product identity and specifications, 

the product in inventory, and where, 

when, to whom, and how much of the 

product is shipped. 

Traceback programs are used for those 

times when a food safety problem has 

been identified or a product has been 

implicated in a foodborne illness 

outbreak. The burden to develop a 

traceback program is a one-time activity 

estimated to take approximately 20 

hours. In 2007, we previously estimated 

that firms in the industry would choose 

to begin a traceback program after the 

guidance was made available and 

estimated that the 250 existing fresh-cut 

firms and the 10 new businesses 

expected to enter the industry annually 

from 2007 to 2010 would spend 5,200 

hours (250 × 20) on this activity. 

Accordingly, we only need to estimate 

the burden of this one-time activity on 

the 10 new businesses expected to enter 

the industry annually in the next 3 

years. We estimate that the 10 new firms 

will spend 20 hours each preparing a 

traceback program, for a total of 200 

hours (10 × 20). The burden estimate of 

developing a traceback program is 

shown in row 2 of table 1 of this 

document. 

Traceback program adjustments or 

revisions may, or may not, be needed 

annually. Firms may test their traceback 

programs yearly to see if adjustments 

are needed to maintain traceback 

capabilities. Evaluating and updating 

traceback programs is estimated to take 

40 hours to complete. The annual 

burden of maintaining a traceback 

program is estimated for the 280 

existing firms in the industry plus the 

10 firms new to the industry that may 

decide to implement this type of 

program. Assuming that each firm 

completes this exercise once a year, the 

total maintenance burden of traceback 

programs is 11,600 hours yearly (290 × 

40). This burden estimate is shown in 

row 3 of table 1 of this document. 

The fresh-cut guidance refers to 

previously approved collections of 

information found in FDA regulations. 

The recommendations in this document 

regarding establishing and maintaining 


emcdonald on DSK2BSOYB1PROD with NOTICES
65494 Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 

a recall plan, as provided in 21 CFR 

7.59, have been approved under OMB 

control number 0910–0249. Therefore, 

FDA is not calculating a new paperwork 

burden for recall plans. 

Preventative Control Program 

When properly designed and 

maintained by the establishment’s 

personnel, a preventive control program 

is a valuable program for managing the 

safety of food products. A common 

preventive control program used by the 

fresh-cut industry is a HACCP system. A 

HACCP system allows managers to 

assess the inherent risks and identify 

hazards attributable to a product or a 

process, and then determine the 

necessary steps to control the hazards. 

Monitoring and verification steps, 

which include recordkeeping, are 

included in the HACCP system to 

ensure that potential risks are 

controlled. We use HACCP as an 

example of a preventive control program 

that a firm may choose based on the 

recommendations in the guidance to 

estimate the burden of developing, 

implementing, and reviewing a 

preventive control program. 

FDA estimated the paperwork burden 

of developing and implementing a 

HACCP plan based on a plan with two 

CCPs. The number of CCPs may vary 

depending on how the processor 

chooses to identify the CCPs for a 

particular operation. Developing a 

HACCP plan is a one-time activity that 

is estimated to take 100 hours based on 

a trained HACCP team working on the 

plan full time. The HACCP team 

identifies the CCPs and measures 

needed to control them, and then 

identifies the approach needed to verify 

the effectiveness of the controls. During 

this plan development period, the firm 

chooses the records to be kept and 

information and observations to be 

recorded. This is a one-time process 

during the first year. 

In 2007, we previously estimated that, 

of the estimated 250 fresh-cut 

processors, approximately 50 percent of 

the firms already have HACCP plans in 

place. We therefore assumed that the 

remaining fresh-cut processors (125 

existing firms plus the 10 new firms), 

would voluntarily develop a HACCP 

plan, and estimated that 135 processors 

would spend 13,500 hours (135 × 100) 

to develop their individual HACCP 

plans. Accordingly, we only need to 

estimate the burden of this one-time 

activity on the 10 new businesses 

expected to enter the industry annually 

in the next 3 years. We estimate that the 

10 new firms will spend 100 hours each 

to develop their individual HACCP 

plans, for a total of 1,000 hours (10 × 

100). This burden estimate is shown in 

row 4 of table 1 of this document. 

After the HACCP plan is developed, 

the frequency for recordkeeping for 

implementing or maintaining daily 

records is estimated to be 510 records 

per year. (This is based on a firm 

choosing to maintain daily records for 2 

CCPs for one 8-hour shift per day for 

each of the estimated 255 operational 

days per year.) The total time to record 

observations for the CCPs was estimated 

to take 4 minutes or 0.067 hours per 

record. Therefore, the total annual 

records kept by 145 firms (the 135 firms 

plus the 10 new businesses expected to 

enter the industry) is 73,950 (510 × 145), 

and the total hours required are 4,955 

(73,950 records × 0.067 hours per record 

= 4,954.65, rounded to 4,955). This 

annual burden is shown in row 5 of 

table 1 of this document. 

After the HACCP plan has been 

developed and implemented, we 

recommend that the plan is reviewed 

regularly to ensure that it is working 

properly. Fresh-cut processors are 

estimated to review their HACCP plans 

four times per year (once per quarter). 

Assuming that it takes each of the 145 

firms 4 hours per review each quarter, 

the total burden of this activity, for 

firms that choose to review their plans 

annually, is 2,320 (145 × 4 × 4) hours 

per year. This annual burden is shown 

in row 6 of table 1 of this document. 

Dated: October 18, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26829 Filed 10–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Award of Three Single-Source 

Expansion Supplements to The 

University of Colorado Health Sciences 

Center in Aurora, CO, The University of 

Massachusetts (Institute for 

Community Inclusion) in Boston, MA, 

and The University of Minnesota (The 

Research and Training Center) in 

Minneapolis, MN 

AGENCY: Administration on 

Developmental Disabilities, ACF, HHS. 

ACTION: Notice. 

CFDA Number: 93.631. 

Statutory Authority: This award will 

be made pursuant to Section 161 of the 

Developmental Disabilities Assistance 

and Bill of Rights Act of 2000 (42 U.S.C. 

15081–15083). 

Amount of Award: $200,000 per 

award. 

Project Period: 9/30/2010–9/29/2012. 

SUMMARY: This notice announces that 

the Administration for Children and 

Families (ACF), Administration on 

Developmental Disabilities (ADD) has 

awarded three single-source expansion 

supplements for data collection, 

analyses, and reporting. 

The following projects will be funded: 

The University of Colorado Health 

Sciences Center, Aurora, CO. This 

cooperative agreement will allow for 

data collection, analysis and reporting 

on spending and services for 

individuals with intellectual and 

developmental disabilities, including 

disaggregation of data related to specific 

demographic groups. The project will 

analyze and report on trends in 

utilization of and spending for 

institutional services and home and 

community-based services. Project staff 

will also participate in collaborative 

efforts with ADD and other data 

collection projects to review and report 

on unmet needs in data collection, 

analyses, and reporting activities that 

would promote the self-determination, 

independence, productivity, and 

integration and inclusion of people with 

intellectual and developmental 

disabilities in all facets of community 

life. 

The University of Massachusetts 

(Institute for Community Inclusion), 

Boston, MA. This cooperative agreement 

will provide for data collection and 

analyses related to the effectiveness of 

State agencies in promoting community 

integrated employment for individuals 

with intellectual and developmental 

disabilities. The project will collect 

data, analyze, and report on the 

employment and economic status of 

individuals with intellectual and 

developmental disabilities including 

disaggregation of data related to specific 

demographic groups. The project will 

also make recommendations related to 

the standardization of data and 

reporting of employment outcomes. 

Project staff will also participate in 

collaborative efforts with ADD and other 

data collection projects to review and 

report on unmet needs in data 

collection, analyses, and reporting 

activities that would promote the selfdetermination, independence, 

productivity, and integration and 

inclusion of people with intellectual 

and developmental disabilities in all 

facets of community life. 

The University of Minnesota (The 

Research and Training Center), 

Minneapolis, MN. This cooperative 

agreement will provide for data 

collection, analyses, and reporting of 


emcdonald on DSK2BSOYB1PROD with NOTICES