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Draft Guidance for Industry on 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availability of a draft guidance for 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 This draft guidance 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This draft guidance does not address the 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 

11964 Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices 

satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control no. 0910–0014; the 

collections of information in 21 CFR 

part 314 have been approved under 

OMB control no. 0910–0001; and the 

collections of information referred to in 

the guidance ‘‘Establishment and 

Operation of Clinical Trial Data 

Monitoring Committees’’ have been 

approved under OMB control no. 0910– 

0581. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: March 13, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6145 Filed 3–19–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Nursing Research, Special Emphasis Panel, 

NINR Loan Repayment Program Review 

(L30/L40). 

Date: April 16, 2009. 

Time: 10 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892. (Telephone 

Conference Call). 

Contact Person: Yujing Liu, PhD, MD, 

Chief, Office of Review, Division of 

Extramural Activities, National Institute of 

Nursing Research, National Institutes of 

Health, 6701 Democracy Blvd., Ste 710, 

Bethesda, MD 20892. (301) 451–5152. 

yujing_liu@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: March 10, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–5995 Filed 3–19–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

New Agency Information Collection 

Activity Under OMB Review: Security 

Program Training Feedback for 

Hazardous Materials Motor Carriers & 

Shippers 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: 30 Day Notice. 

SUMMARY: This notice announces that 

the Transportation Security 

Administration (TSA) has forwarded the 

new Information Collection Request 

(ICR) abstracted below to the Office of 

Management and Budget (OMB) for 

review and approval under the 

Paperwork Reduction Act. The ICR 

describes the nature of the information 

collection and its expected burden. TSA 

published a Federal Register notice, 

with a 60-day comment period soliciting 

comments, of the following collection of 

information on November 20, 2008, 73 

FR 70359. TSA will provide a voluntary 

security-related training course to the 

Hazardous Materials (Hazmat) motor 

carrier and shipper industry, to include 

an evaluation for respondents to 

complete. TSA will use this data to 

measure the program’s effectiveness at 

achieving its goal of heightened security 

awareness levels throughout the hazmat 

motor carrier and shipper industry. 

DATES: Send your comments by April 

20, 2009. A comment to OMB is most 

effective if OMB receives it within 30 

days of publication. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

the proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget. Comments should be addressed 

to Desk Officer, Department of 

Homeland Security/TSA, and sent via 

electronic mail to 

oira_submission@omb.eop.gov or faxed 

to (202) 395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Ginger LeMay, Office of Information 

Technology, TSA–11, Transportation 

Security Administration, 601 South 

12th Street, Arlington, VA 20598–6011; 

telephone (571) 227–3616; e-mail 

ginger.lemay@dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a valid OMB control 

number. The ICR documentation is 

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

Therefore, in preparation for OMB 

review and approval of the following 

information collection, TSA is soliciting 

comments to— 

(1) Evaluate whether the proposed 

information requirement is necessary for 

the proper performance of the functions 

of the agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including using 

appropriate automated, electronic, 

mechanical, or other technological