Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices 11961 

Dated: March 16, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–6031 Filed 3–19–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0641] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary Hazard 

Analysis and Critical Control Point 

Manuals for Operators and Regulators 

of Retail and Food Service 

Establishments 

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 20, 

2009. 

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, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0578. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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 Hazard Analysis and Critical 

Control Point Manuals for Operators 

and Regulators of Retail and Food 

Service Establishments—(OMB Control 

Number 0910–0578—Extension) 

The Operator’s Manual contains 

information and recommendations for 

operators of retail and foodservice 

establishments who wish to develop 

and implement a voluntary food safety 

management system based on Hazard 

Analysis and Critical Control Point 

(HACCP) principles. Operators may 

decide to incorporate some or all of the 

principles presented in the manual into 

their existing food safety management 

systems. The recordkeeping practices 

discussed in the manual are voluntary 

and may include documenting certain 

activities, such as monitoring and 

verification, which the operator may or 

may not deem necessary to ensure food 

safety. The manual includes optional 

worksheets to assist operators in 

developing and validating a voluntary 

food safety management system. 

The Regulator’s Manual contains 

recommendations for State, local, and 

tribal regulators on conducting riskbased inspections of retail and 

foodservice establishments, including 

recommendations about recordkeeping 

practices that can assist operators in 

preventing foodborne illness. These 

recommendations may lead to voluntary 

actions by operators based on 

consultation with regulators. For 

example, an operator may develop a risk 

control plan as an intervention strategy 

for controlling specific out-of-control 

foodborne illness risk factors identified 

during an inspection. Further, the 

manual contains recommendations to 

assist regulators when evaluating 

voluntary food safety management 

systems in retail and foodservice 

establishments. Such evaluations 

typically consist of the following two 

components: (1) Validation (assessing 

whether the establishment’s voluntary 

food safety management system is 

adequate to control food safety hazards) 

and (2) verification (assessing whether 

the establishment is following its 

voluntary food safety management 

system). The manual includes a sample 

entitled ‘‘Verification Inspection 

Checklist’’ to assist regulators when 

conducting verification inspections of 

establishments with voluntary food 

safety management systems. 

Types of operator records discussed 

in the manuals and listed in the 

following burden estimates include: (1) 

Food safety management systems (plans 

that delineate the formal procedures to 

follow to control all food safety hazards 

in an operation); (2) risk control plans 

(HACCP-based, goal-oriented plans for 

achieving active managerial control over 

specific out-of-control foodborne illness 

risk factors); (3) hazard analysis (written 

assessment of the significant food safety 

hazards associated with foods prepared 

in the establishment); (4) prerequisite 

programs (written policies or 

procedures, including but not limited 

to, standard operating procedures, 

training protocols, and buyer 

specifications that address maintenance 

of basic operational and sanitation 

conditions); (5) monitoring (records 

showing the observations or 

measurements that are made to help 

determine if critical limits are being met 

and maintained); (6) corrective action 

(records indicating the activities that are 

completed whenever a critical limit is 

not met); (7) ongoing verification 

(records showing the procedures that 

are followed to ensure that monitoring 

and other functions of the food safety 

management system are being 

implemented properly); and (8) 

validation (records indicating that 

scientific and technical information is 

collected and evaluated to determine if 

the food safety management system, 

when properly implemented, effectively 

controls the hazards). 

All recommendations in both manuals 

are voluntary. For simplicity and to 

avoid duplicate estimates for operator 

recordkeeping practices that are 

discussed in both manuals, the burden 

for all collection of information 

recommendations for retail and 

foodservice operators are estimated 

together in table 1 of this document, 

regardless of the manual in which they 

appear. Collection of information 

recommendations for regulators in the 

Regulator’s Manual are listed separately 

in table 2 of this document. 

Description of Respondents: The 

likely respondents to this collection of 

information are operators and regulators 

of retail and foodservice establishments. 

In the Federal Register of December 

19, 2008 (73 FR 77721), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

11962 Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR OPERATORS1

Types of Records No. of 

Recordkeepers 

Annual Frequency 

of Recordkeeping 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

Prerequisite Program Records 100,0002 365 36,500,000 0 .1 3,650,000 

Monitoring Records 100,0002 365 36,500,000 0 .3 10,950,000 

Corrective Action Records 100,0002 365 36,500,000 0 .1 3,650,000 

Ongoing Verification Records (includes calibration records) 100,0002 365 36,500,000 0 .1 3,650,000 

Validation Records 50,0002 1 50,000 4 200,000 

Annual Burden3: 22,100,000 

Risk Control Plan 50,000 1 50,000 2 100,000 

Monitoring Records 100,000 90 9,000,000 0 .3 2,700,000 

Corrective Action Records 100,000 90 9,000,000 0 .1 900,000 

Ongoing Verification Records (includes calibration records) 100,000 90 9,000,000 0 .1 900,000 

Annual Burden4 4,600,000 

Total Annual Burden for Operators 26,700,000 

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

2Annual burden. 

3Burden for developing and implementing a food safety management system based on the Operator’s Manual. 

4Annual burden for developing and implementing a risk control plan based on the Regulator’s Manual. 

The burden for these activities may 

vary among retail and foodservice 

operators depending on the type and 

number of products involved, the 

complexity of an establishment’s 

operation, the nature of the equipment 

or instruments required to monitor 

critical control points, and the extent to 

which an operator uses the Operator’s 

Manual and/or the Regulator’s Manual. 

The estimate does not include 

collections of information that are a 

usual and customary part of an 

operator’s normal activities. FDA has 

established as a goal to have 50,000 

(0.05 percent) of the approximately 1 

million U.S. retail and foodservice 

operators implement the 

recommendations outlined in the 2 

manuals. This target figure is used in 

calculating the burden in tables 1 and 2 

of this document because the agency 

lacks data on how to base an estimate 

of how many retail and foodservice 

establishments are likely to use one or 

more of the manuals to voluntarily 

implement a comprehensive food safety 

management system based on HACCP 

principles or a risk control plan for outof-control processes identified during an 

inspection. FDA’s estimate of the total 

number of retail and foodservice 

establishments is based on numbers 

obtained from the two major trade 

organizations representing these 

industries, the Food Marketing Institute, 

and the National Restaurant 

Association, respectively. 

The hour burden estimates in table 1 

of this document for operators who 

follow the HACCP-based 

recommendations in the Operator’s 

Manual are based on the estimated 

average annual information collection 

burden for mandatory HACCP rules, 

including seafood HACCP (60 FR 65096 

at 65178; December 18, 1995) and juice 

HACCP (66 FR 6138 at 6202; January 19, 

2001). FDA estimates that once the 

system is in place, the annual frequency 

of records is based on 365 operating 

days per year. Assuming there is one 

recordkeeper per shift of operation, the 

agency estimates that two recordkeepers 

per day would be needed to conduct 

monitoring, corrective action, 

recordkeeping, and verification outlined 

in the system. The agency further 

estimates that validation will be 

conducted once per year, based on 

menu or food list changes, changes in 

distributors, or changes in food 

preparation processes used. The 

validation will require a total of 4 labor 

hours. 

The second set of estimates in table 1 

of this document shows the annual 

burden for developing and 

implementing a risk control plan to 

control specific out-of-control foodborne 

illness risk factors identified during an 

inspection by a State, local, or tribal 

regulatory authority. If an operator 

decides to use a risk control plan as 

recommended in the Regulator’s 

Manual, one person from the 

establishment is needed to work with 

the regulator to develop the written 

plan. FDA estimates that two 

recordkeepers per day (one 

recordkeeper for each shift) would be 

needed to conduct monitoring, 

corrective action, recordkeeping, and 

verification outlined in the risk control 

plan. The estimated duration of 

implementation for a risk control plan is 

90 days, which is the minimum 

recommended time to achieve long-term 

behavior change. 

Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices 11963 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR REGULATORS1

Types of Records No. of 

Recordkeepers 

Annual Frequency 

of Recordkeeping 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

Voluntary Food Safety Management 

System Evaluation (includes validation, verification, and completion of verification inspection 

checklist) 50,000 1 50,000 16 800,000 

Total Annual Burden for Regulators 800,000 

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

It is difficult to predict the number of 

State, local, and tribal regulatory 

jurisdictions that will use the 

Regulator’s Manual. But, FDA 

anticipates that retail and foodservice 

establishments which voluntarily 

develop and implement a food safety 

management system based on the 

Operator’s Manual will request their 

regulatory authorities to conduct an 

evaluation of their system. The 

estimates in table 2 of this document for 

the annual burden to State, local, and 

tribal regulators that follow the 

recommendations in the Regulator’s 

Manual were calculated based on the 

usual time needed for one person to 

evaluate a voluntarily-implemented 

food safety management system and 

record the findings. The number of 

times an inspector may be asked by an 

operator to evaluate a voluntarilyimplemented system is not expected to 

exceed once per year. 

Dated: March 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6168 Filed 3–19–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0136] 

Draft Guidance for Industry on 

Community-Acquired Bacterial 

Pneumonia: Developing Drugs for 

Treatment; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Community-Acquired 

Bacterial Pneumonia: Developing Drugs 

for Treatment.’’ This draft guidance 

informs industry of FDA’s current 

thinking regarding the overall 

development program and clinical trial 

designs for drugs to support an 

indication for treatment of communityacquired bacterial pneumonia (CABP). 

This draft guidance does not address the 

development of drugs for other purposes 

or populations, such as treatment of 

patients with hospital-acquired 

pneumonia or ventilator-associated 

pneumonia. This draft guidance revises 

the draft guidance for industry entitled 

‘‘Community-Acquired PneumoniaDeveloping Antimicrobial Drugs for 

Treatment’’ published July 1998. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by June 18, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance 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.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Sumathi Nambiar, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6232, 

Silver Spring, MD 20993–0002, 

301–796–1400; or 

Edward Cox, Center for Drug 

Evaluation and Research, 10903 

New Hampshire Ave., Bldg. 22, rm. 

6212, Silver Spring, MD 20993– 

0002, 301–796–1300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Community-Acquired Bacterial 

Pneumonia: Developing Drugs for 

Treatment.’’ Since FDA published the 

draft guidance on the development of 

antimicrobial drugs for the treatment of 

community-acquired pneumonia in 

1998, there have been public 

discussions regarding clinical trial 

designs to study CABP, including an 

FDA–Infectious Disease Society of 

America (IDSA) workshop and a 

meeting of the Anti-Infective Drugs 

Advisory Committee. These discussions 

have focused on clinical trial designs for 

CABP and other important issues such 

as the following: 

• Noninferiority versus superiority 

design 

• Justification of an appropriate 

noninferiority margin 

• Classification of severity of illness 

• Classification of CABP based on 

hospitalization (inpatient versus 

outpatient) 

• Enrollment criteria 

• Application of appropriate 

diagnostic criteria, including 

microbiologic diagnosis 

• Use of appropriate definitions of 

clinical outcomes, including mortality 

• Timing of outcome assessments 

• Use of prior antibacterial drugs 

Important changes from the 1998 draft 

guidance that are based on these 

discussions have been incorporated into 

this revised draft guidance. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the development of antibacterial 

drugs for CABP including appropriate 

clinical trial designs to evaluate drugs 

for the treatment of CABP. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach