Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 47803 

Date: September 9, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–22374 Filed 9–16–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–09BH] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Assessing the Safety Culture of 

Underground Coal Mining—New— 

National Institute for Occupational 

Safety and Health, (NIOSH), Centers for 

Disease Control and Prevention, (CDC). 

Background and Brief Description 

NIOSH, under Public Law 91–596, 

(Section 20–22, Occupational Safety and 

Health Act of 1970) has the 

responsibility to conduct research 

relating to innovative methods, 

techniques, and approaches dealing 

with occupational safety and health 

problems. 

This research relates to occupational 

safety and health problems in the coal 

mining industry. In recent years, coal 

mining safety has attained national 

attention due to highly publicized 

disasters. Despite these threats to 

worker safety and health, the U.S. relies 

on coal mining to meet its electricity 

needs. For this reason, the coal mining 

industry must continue to find ways to 

protect its workers while maintaining 

productivity. One way to do so is 

through improving the safety culture at 

coal mines. In order to achieve this 

culture, operators, employees, the 

inspectorate, etc. must share a 

fundamental commitment to it as a 

value. This type of culture is known in 

other industries as a ‘‘safety culture.’’ 

Safety culture can be defined as the 

characteristics of the work environment, 

such as the norms, rules, and common 

understandings that influence 

employees’ perceptions of the 

importance that the organization places 

on safety. 

NIOSH proposes an assessment of the 

current safety culture of underground 

coal mining in order to identify 

recommendations for promoting and 

ensuring the existence of a positive 

safety culture across the industry. A 

total of 6 underground coal mines will 

be studied for this assessment in an 

attempt to study mines of different 

characteristics. It is hoped that a small, 

a medium and a large unionized as well 

as non-unionized mines will participate. 

Data will be collected one time at each 

mine; this is not a longitudinal study. 

The assessment includes the collection 

of data using several diagnostic tools: (a) 

Functional analysis, (b) structured 

interviews, (c) behavioral observations, 

and (d) surveys. 

It is estimated that across the 6 mines 

approximately 900 respondents will be 

surveyed. Similarly the number of 

interviews will be based upon the 

number of individuals in the mine 

population. An exact number of 

participants is unavailable at this time 

because not all mine sites have been 

selected. 

The use of multiple methods to assess 

safety culture is a key aspect to the 

methodology. After all of the 

information has been gathered, a variety 

of statistical and qualitative analyses are 

conducted on the data to obtain 

conclusions with respect to the mine’s 

safety culture. The results from these 

analyses will be presented in a report 

describing the status of the behaviors 

important to safety culture at that mine. 

This project will provide 

recommendations for the enactment of 

new safety practices or the enhancement 

of existing safety practices across the 

underground coal mining industry. This 

final report will present a generalized 

model of a positive safety culture for 

underground coal mines that can be 

applied at individual mines. In 

addition, all study measures and 

procedures will be available for mines 

to use in the future to evaluate their 

own safety cultures. There is no cost to 

respondents other than their time. The 

total estimated annualized burden hours 

are 480. 

ESTIMATED ANNUALIZED BURDEN HOURS

Phase Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Year one Survey ............................................. Mine Employees ............................................. 500 1 20/60 

Year one Interviews ........................................ Mine Employees ............................................. 100 1 1 

Year two Survey ............................................. Mine Employees ............................................. 400 1 20/60 

Year two Interviews ........................................ Mine Employees ............................................. 80 1 1 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
47804 Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 

Date: September 9, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–22373 Filed 9–16–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0408] 

Draft Guidance for Industry on 

Microbiological Data for Systemic 

Antibacterial Drug Products— 

Development, Analysis, and 

Presentation; 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 ‘‘Microbiological Data 

for Systemic Antibacterial Drug 

Products—Development, Analysis, and 

Presentation.’’ The draft guidance 

informs industry of FDA’s current 

thinking regarding the types of 

microbiological studies, assessments, 

and clinical trials needed to support an 

investigational new drug application 

(IND) and a new drug application (NDA) 

for a systemic antibacterial drug 

product. Recommendations in this 

guidance cover microbiological 

considerations in the three major areas 

of conducting general nonclinical 

studies; conducting animal and human 

studies and clinical trials; and 

establishing and updating in vitro 

susceptibility test methods, quality 

control (QC) parameters, and 

interpretive criteria. This guidance also 

recommends the content and format for 

presentation of microbiological data for 

antibacterial drug products in the 

Microbiology subsection of labeling. 

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 December 16, 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: Fred 

Marsik, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 6108, Silver Spring, 

MD 20993–0002, 301–796–7956; or 

Edward Cox, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 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 

‘‘Microbiological Data for Systemic 

Antibacterial Drug Products— 

Development, Analysis, and 

Presentation.’’ This guidance provides 

recommendations on the type of 

information to provide in submissions 

to the clinical microbiology section of 

INDs and NDAs for systemic 

antibacterial drug products. The in vitro 

microbiological data and in vivo animal 

studies (e.g., spectrum of activity in 

vitro and in appropriate animal models 

of human disease) support the 

justification of testing in humans. 

Sponsors usually submit data from 

nonclinical investigations to provide 

proof of concept of clinical activity 

before commencing human phase 2 

studies and clinical trials and to aid in 

the development of provisional 

interpretive criteria for use in phase 3 

clinical trials. Microbiological data 

submitted to an NDA will be used to 

substantiate the microbiological 

information contained in the labeling. 

Specific topics discussed in the 

guidance include validating in vitro 

susceptibility testing methods; 

mechanism of action studies; 

mechanism of resistance studies; use of 

animal models; clinical trial protocols; 

establishment of QC parameters and 

interpretive criteria; submission and 

placement of microbiology information 

in the NDA submission; format and 

content of the Microbiology subsection 

of the labeling; and revision of existing 

susceptibility testing methods, QC 

parameters, or interpretive criteria. 

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 microbiological data for systemic 

antibacterial drug products. 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 

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 found in FDA regulations. 

These collections of information 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). 

(1) The draft guidance provides 

recommendations on the type of 

information to include in submissions 

of the clinical microbiology section of 

INDs and NDAs for systemic 

antibacterial drug products. The 

microbiology section of an NDA is 

required under 21 CFR 314.50(d)(4) and 

this information collection is approved 

under OMB Control Number 0910–0001. 

For INDs, this information is required 

under 21 CFR 312.23(a) and approved 

under OMB Control Number 0910–0014. 

(2) The draft guidance also 

recommends the types of data that 

should be submitted in a labeling 

supplement to update the microbiology 

information in approved labeling if an 

application holder chooses to update 

this information without relying on a 

standard recognized by FDA. The 

submission of labeling supplements is 

required under 21 CFR 314.70(b)(2)(v) 

and 201.56(a)(2) and this information 

collection is approved under OMB 

Control Numbers 0910–0001 and 0910– 

0572, respectively. 

(3) Appendix A of the draft guidance 

describes the content of the 

Microbiology subsection of labeling. 

This labeling is covered under 21 CFR 

201.57(c)(13)(i) and the information 

collection is approved under OMB 

Control Number 0910–0572. 

(4) The draft guidance also references 

the guidance for industry entitled 

‘‘Updating Labeling for Susceptibility 

Test Information in Systemic 

Antibacterial Drug Products and 

Antimicrobial Susceptibility Testing 

Devices’’ for updating labeling 

information. The information collection 

in this guidance has been approved 

under OMB Control Number 0910–0638. 


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