11364 Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 

For Further Information Contact: Christine 

Morrison, Ph.D., Scientific Review 

Administrator, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE., 

Mailstop D72, Atlanta, GA 30333, Telephone 

404.639.3098. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–4533 Filed 3–12–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): The National 

Center for Chronic Disease Prevention 

and Health Promotion (NCCDPHP) 

Arthritis Program Programmatic 

Review 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting. 

Time and Date: 8 a.m.–5 p.m., April 24, 

2007 (Closed). 

Place: Renaissance Hotel, 590 W. Peachtree 

Street NW., Atlanta, GA 30308, telephone 

404–881–6000. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of the NCCDPHP Arthritis 

Program. 

For Further Information Contact: Lee Ann 

B. Ramsey, Designated Federal Official, 

Division of Adult and Community Health, 

CDC, 4770 Buford Hwy. NE., Mailstop K51, 

Atlanta, GA 30341, Telephone 770–488–

6036. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 2, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–4537 Filed 3–12–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Annual Meeting 

The National Center for 

Environmental Health (NCEH) of the 

Centers for Disease Control and 

Prevention (CDC) Vessel Sanitation 

Program (VSP) announces the following 

meeting: 

Name: Vessel Sanitation Program: Current 

Program Status and Experience to Date with 

Program Operations. 

Time and Date: 9 a.m. to 4 p.m., April 17, 

2007. 

Location: Auditorium, Port Everglades 

Administration Building, 1850 Eller Drive, 

Ft. Lauderdale, Florida 33316. 

Status: Open to the public, limited by the 

space available. The meeting room 

accommodates approximately 100 people. 

Meeting Objectives: CDC staff, cruise ship 

industry representatives, private sanitation 

consultants, and other interested parties will 

meet to discuss the current status of the 

Vessel Sanitation Program and experience to 

date. 

Topics to be discussed include but are not 

limited to the following: 

• 2006 Program Review, 

• Updates to the Vessel Sanitation Program 

Operations Manual 2005, 

• Updates to the Vessel Sanitation Program 

Construction Guidelines 2005, and 

• Updates on cruise ship outbreaks and 

Norovirus. 

The official record of this meeting will 

remain open for a period of 15 days following 

the meeting (through May 1, 2007) so that 

additional materials or comments may be 

submitted and made part of the record of the 

meeting. 

Advanced registration is encouraged. 

Please provide the following information: 

Name, title, company name, mailing address, 

telephone number, facsimile number, and email address to Lisa Beaumier at 770–488–

7138, FAX 770–488–4127, or 

lbeaumier@cdc.gov. 

If you need additional information, please 

contact Lisa Beaumier (see contact 

information above). 

Dated: March 5, 2007. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E7–4530 Filed 3–12–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0079] 

Draft Final Guidance for Industry: 

Guide to Minimize Food Safety 

Hazards for Fresh-Cut Fruits and 

Vegetables; Availability; Agency 

Information Collection Activities; 

Submission for Office of Management 

and Budget Review; Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft final guidance 

document entitled ‘‘Guidance for 

Industry: Guide to Minimize Microbial 

Food Safety Hazards of Fresh-Cut Fruits 

and Vegetables’’ (the draft final fresh-cut 

guidance). This document complements 

FDA’s Current Good Manufacturing 

Practice (CGMP) requirements for foods 

by providing specific guidance on the 

processing of fresh-cut produce. The 

draft final fresh-cut guidance and the 

CGMP regulations are intended to assist 

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. 

FDA also 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: Submit written or electronic 

comments on the guidance at any time. 

Fax written comments on the collection 

of information by April 12, 2007. 

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: 

202–395–6974. Submit written requests 

for single copies of the draft final 

guidance entitled: ‘‘Guidance for 

Industry: Guide to Minimize Microbial 

Food Safety Hazards for Fresh-Cut 

Fruits and Vegetables’’ to the Center for 

Food Safety and Applied Nutrition, 

Office of Plant and Dairy Foods (HFS–

306), 5100 Paint Branch Pkwy., College 

Park, MD 20740, 301–436–1400 or FAX: 

301–436–2651. Include a self-addressed 

adhesive label to assist that office in 

processing your request. 

Submit written comments on the draft 

final guidance, identified with Docket 


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 11365 

No. 2006D–0079, to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. A 

copy of the draft final guidance is 

available for public examination in the 

Division of Dockets Management, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852, between 9 a.m. and 4 p.m., 

Monday through Friday. Persons with 

access to the Internet may obtain the 

draft final guidance at http:// 

www.cfsan.fda.gov/~dms/ 

guidance.html. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the information 

collection: Jonna Capezzuto, Office 

of the Chief Information Officer 

(HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

4659. 

With regard to the draft final 

guidance document: Amy Green, 

Center for Food Safety and Applied 

Nutrition (HFS–306), Food and 

Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 

20740, 301–436–2025 or FAX: 301–

436–2651, e-mail: 

amy.green@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Fresh-cut fruits and vegetables are 

minimally processed fruits and 

vegetables that have been altered in 

form by peeling, slicing, chopping, 

shredding, coring, or trimming, with or 

without washing or other treatment, 

prior to being packaged for use by the 

consumer or a retail establishment. 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 chopping, the high moisture 

content of the product, the absence of a 

step lethal 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 freshcut produce. 

With this notice, FDA is announcing 

the availability of the draft final freshcut guidance. The draft final fresh-cut 

guidance is intended to assist processors 

in minimizing microbial food safety 

hazards common to the processing of 

most fresh-cut fruits and vegetables sold 

to consumers in a ready-to-eat form. The 

draft final guidance was revised based 

on public comments. This draft final 

guidance represents FDA’s current 

thinking on the microbiological hazards 

presented by most fresh-cut fruits and 

vegetables and the recommended 

control measures for such hazards in the 

processing of such produce. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. You may use an 

alternative approach if such approach 

satisfies the requirements of the 

applicable statutes and regulations. If 

you want to discuss an alternative 

approach, contact the FDA staff 

responsible for implementing this 

guidance (see FOR FURTHER INFORMATION

CONTACT). 

II. Paperwork Reduction Act of 1995 

This draft final guidance contains 

information collection provisions that 

are subject to review by the OMB under 

the PRA (44 U.S.C 3501–3520). Under 

the PRA, 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 

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 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, in the Federal Register of 

March 6, 2006 (71 FR 11209), FDA gave 

interested persons 60 days to comment 

on the information collection provisions 

in the draft guidance. FDA received a 

number of comments on the draft 

guidance but received no comments 

regarding the information collection 

provisions. 

After publishing the 60-day notice 

requesting public comment, section 

3507 of the PRA (44 U.S.C. 3507) 

requires Federal agencies to submit the 

proposed collection to OMB for review 

and clearance. In compliance with 44 

U.S.C. 3507, FDA has submitted the 

following proposed collection of 

information to OMB for review and 

clearance. FDA will not finalize this 

guidance unless and until OMB 

approves the collection of information. 

If the collection is approved, FDA will 

publish a notice in the Federal Register 

announcing that the guidance is final 

and providing an OMB control number. 

Draft Final Guidance for Industry: 

Guide to Minimize Food Safety Hazards 

for Fresh-Cut Fruits and Vegetables 

Description: The Federal Food, Drug, 

and Cosmetic Act (the 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. 

Accordingly, FDA encourages fresh-cut 

produce processors to adopt the general 

recommendations in the guidance and 

to tailor practices to their individual 

operations. 

FDA’s draft final fresh-cut guidance 

represents the agency’s 

recommendations to industry based on 

the current state of science. Following 

the recommendations set forth in the 

fresh-cut guidance is the choice of each 

individual fresh-cut operation, plant, or 

processor. FDA estimates the burden of 

this 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 this 

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. 

A. Industry Profile 

Estimates of the paperwork burden to 

the fresh-cut industry that may result 

from the publication of FDA’s draft final 

fresh-cut guidance are based on 

information from FDA’s relationship 

with a fresh-cut processor who has 

developed and maintained these 

programs and information from a freshcut produce industry trade association. 

Because of the small number of freshcut processors, the agency is able to 

extrapolate data from industry programs 

to calculate the total estimated upper 

bound burdens that may result from the 

issuance of this draft final fresh-cut 

guidance (see table 1 of this document). 

The burden to industry of developing 

and maintaining the activities 

recommended in FDA’s draft final freshcut 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 


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11366 Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 

controls monitored under any 

individual preventive control program, 

such as critical control points (CCPs) 

monitored under a hazard analysis and 

critical control point (HACCP) program. 

Currently, the fresh-cut trade 

association estimates that there are 250 

fresh-cut plants in operation in the 

United States. While most of the recent 

growth in the fresh-cut industry has 

been due to mergers between already 

existing firms, there are approximately 

50 fresh-cut plants that did not exist in 

2001. This implies that about 10 new 

firms are entering the fresh-cut industry 

each year. 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 this draft final fresh-cut 

guidance will fall on both existing and 

new firms entering the industry who 

may follow the recommendations in the 

guidance. 

B. SOPs and SSOPs 

Two general recommendations in this 

draft final guidance are for operators to 

develop and implement both a written 

standard operating procedures (SOPs) 

plan and a written sanitary standard 

operation procedures (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 250 fresh-cut processors, the 

fresh-cut trade association estimates 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 100 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 110 

firms will choose to implement such a 

maintenance strategy as a result of the 

recommendations in this draft final 

fresh-cut guidance document, when 

finalized. 

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 draft 

final 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); one 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 x 13) 

per year per firm; 110 firms will be 

performing these activities to generate a 

total 364,650 records (3,315 x 110) 

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 364,650. 

Therefore, the total annual burden in 

hours for 110 processors to maintain 

their SOP and SSOP records is 

approximately 24,432 hours. The 

maintenance burden for these 110 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. 

C. 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. Firms in the industry may choose 

to begin a traceback program after this 

guidance is made available. The total 

annual estimated burden for this 

activity for the 250 existing fresh cut 

firms and the 10 new businesses 

expected to enter the industry annually 

is 5,200 hours. 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 250 

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 10,400 hours yearly. This 

burden estimate is shown in row 3 of 

table 1 of this document. 


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 11367 

This draft final fresh-cut guidance 

refers to previously approved 

collections of information found in FDA 

regulations. The recommendations in 

this document regarding establishing 

and maintaining 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. 

D. 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 draft final 

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. Of the estimated 

250 fresh-cut processors, the fresh-cut 

industry estimates that approximately 

50 percent of the firms already have 

HACCP plans in place. Therefore, 

assuming that the remaining fresh-cut 

processors voluntarily decide to develop 

a HACCP plan, 125 existing firms plus 

the 10 new firms, will develop a HACCP 

plan. 

Developing a HACCP plan is a onetime 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. Therefore, the total 

time for 135 processors to develop their 

individual HACCP plans is 

approximately 13,500 hours. This onetime burden 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 the 135 firms choosing 

to implement the HACCP plan is 68,850, 

and the ‘‘Total Hours’’ required are 

4,613. 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 135 

firms 4 hours per review each quarter, 

the total burden of this activity, for 

firms that choose to review their plans 

annually, is 2,160 hours per year. This 

annual burden is shown in row 6 of 

table 1 of this document. 

FDA estimates the burden of the 

collection of information described in 

the previous paragraphs as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Activity No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

SOP and SSOP: Maintenance 110 3,315 364,650 0.067 24,432 

Traceback Development2 260 1 260 20 5,200 

Traceback Maintenance 260 1 260 40 10,400 

Preventive control program comparable to a HACCP system: 

System development2 135 1 135 100 13,500 

Preventive control program comparable to a HACCP system: 

System implementation 135 510 68,850 0.067 4,613 

Preventive control program comparable to a HACCP system: 

Implementation review 135 4 540 4 2,160 

One-time burden hours 18,700 

Annual burden hours 41,605 

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

2First year activity. 

Summing the ‘‘Total Hours’’ column, 

the estimated one-time recordkeeping 

burden for firms that choose to follow 

the recommendations is 18,700 hours; 

the annual burden for firms, existing 

and new, is estimated to be 41,605 

hours. 

III. Comments 

Interested persons may submit written 

or electronic comments to the Division 


cprice-sewell on PROD1PC66 with NOTICES
11368 Federal Register / Vol. 72, No. 48 / Tuesday, March 13, 2007 / Notices 

of Dockets Management (see ADDRESSES) 

regarding this guidance document at 

any time. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. The draft final guidance and 

received comments may be seen in the 

office above between 9 a.m. and 4 p.m., 

Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft final guidance 

document at http://www.cfsan.fda.gov/ 

~dms/guidance.html. 

Dated: March 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4446 Filed 3–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0073] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Control of 

Communicable Diseases; Restrictions 

on African Rodents, Prairie Dogs, and 

Certain Other Animals 

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 requirements 

establishing restrictions on the import, 

capture, transport, sale, barter, 

exchange, distribution, and release of 

African rodents, prairie dogs, and 

certain other animals. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 14, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. 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 the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857,301–827–

4659. 

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. 

Control of Communicable Diseases; 

African Rodents and Other Animals 

That May Carry the Monkeypox 

Virus—21 CFR 1240.63 (OMB Control 

Number 0910–0519)—Extension 

Under 21 CFR 1240.63(a)(2)(ii), an 

individual must submit a written 

request to seek permission to capture, 

offer to capture, transport, offer to 

transport, sell, barter, or exchange, offer 

to sell, barter, or exchange, distribute, 

offer to distribute, and/or release into 

the environment any of the following 

animals: 

• Prairie dogs (Cynomys sp.), 

• African Tree squirrels (Heliosciurus 

sp.), 

• Rope squirrels (Funisciurus sp.), 

• African Dormice (Graphiurus sp.), 

• Gambian giant pouched rats 

(Cricetomys sp.), 

• Brush-tailed porcupines (Atherurus 

sp.), 

• Striped mice (Hybomys sp.), or 

• Any other animal so prohibited by 

order of the Commissioner of Food and 

Drugs (the Commissioner) because of 

that animal’s potential to transmit the 

monkeypox virus. 

The request cannot seek written 

permission to sell, barter, or exchange, 

or offer to sell, barter, or exchange, as 

a pet, the animals listed previously or 

any animal covered by an order by the 

Commissioner. 

The request must state the reasons 

why an exemption is needed, describe 

the animals involved, and explain why 

an exemption will not result in the 

spread of monkeypox within the United 

States. 

Our estimates are based on our 

current experience with the interim 

final rule. To estimate the number of 

respondents, we examined the number 

of requests we have received in fiscal 

year 2006. There were 122 requests, 

submitted by 65 individuals, in that 

time, and this figure represents a minor 

increase over the previous estimate of 

120 annual responses. (See 69 FR 7752 

(February 19, 2004).) As we cannot 

determine whether the latest data 

indicates a trend towards more requests 

or is an anomaly, we have elected to 

increase our estimate to 122 requests. 

We also have revised the estimated 

number of respondents to 65 (compared 

to 120 in our previous estimate) and, as 

a result, adjusted the annual frequency 

per response to 1.88 (which represents 

122 responses/65 respondents; the 

actual result is 1.8769, which we have 

rounded up to 1.88). 

Furthermore, consistent with our 

earlier Paperwork Reduction Act 

submission, we will estimate that each 

respondent will need 4 hours to 

complete its request for an exemption. 

Therefore, the total reporting burden 

under 21 CFR 1240.63(a)(2)(ii)(A) and 

(B) will be 488 hours (122 responses x 

4 hours per response = 488 hours). 

FDA estimates the burden of this 

collection of information as follows: 


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