Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices 49927

• Which audiences (e.g., doctors, 

local health officials, researchers, etc.) 

receive their information from which 

CDC platforms? 

• How often and with what purpose 

do they access CDC platforms? 

• How satisfied are subscribers of the 

platforms with the content and delivery 

of information? 

• Are there ways to enhance the 

platforms for the subscriber through 

improvements to current offerings or 

through new products / services? 

• Who are our most critical target 

audiences, i.e., what are our publication 

and dissemination priorities in service 

to our health impact goals? 

The purpose of this project is to 

evaluate the content, processes, and 

channels through which CDC 

communicates scientific information to 

partners and customers to ensure that 

health impact is maximized through the 

delivery of timely, effective, and 

credible information, which will result 

in optimal benefit for public health. The 

evaluation will help to ensure that these 

platforms meet subscriber and partner 

priorities, build CDC’s brand, and 

contribute to health impact goals. 

Feedback from the subscriber base is 

necessary to fully evaluate the 

performance of CDC’s platforms. 

At this time, the scope of this project 

is limited to five communication 

platforms owned and managed by CDC 

which transmits information primarily 

intended for scientific and professional 

audiences. However, future plans 

include adding additional publications 

as needed. The initial five 

communications platforms are: 

Emerging Infections Journal, MMWR, 

Epi-X, Preventing Chronic Diseases 

Journal, and Health Alert Network. We 

want to ensure that the timeliness, 

effectiveness, and credibility of this 

communication maximizes the health 

impact of that information, resulting in 

optimum benefit for public health. 

These channels include both print and 

electronic versions of the five platforms. 

There is no cost to respondents other 

than their time. The total estimated 

burden hours are 18,970.

ESTIMATES OF ANNUALIZED BURDEN HOURS

Form Respondents 

Responses 

per

respondent 

Hrs/response

(in hrs) 

MMWR ......................................................................................................................................... 30,000 1 20/60 

EID ............................................................................................................................................... 12,750 1 20/60 

PCD ............................................................................................................................................. 10,500 1 20/60 

Epi-X ............................................................................................................................................ 1,650 1 20/60 

HAN ............................................................................................................................................. 2,000 1 20/60 

Dated: August 18, 2005. 

Joan F. Karr, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention.

[FR Doc. 05–16894 Filed 8–24–05; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–05–05AF] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

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) 371–5983 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) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

How Miners Modify Their Behavior In 

Response To Personal Dust Monitor 

Information—New—National Institute 

for Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Federal Mine Safety & Health Act 

of 1977, Section 501, and the 

Occupational Safety and Health Act of 

1970, Public Law 91–256 enables CDC/

NIOSH to carry out research relevant to 

the health and safety of workers in the 

mining industry. The objective of this 

project is to document how coal miners 

can use real-time information from their 

personal dust monitors (PDM) to reduce 

their exposure to respirable dust. The 

specific aims are to (1) identify several 

specific examples of how miners use 

PDM information to discover which 

parts of their jobs and/or which aspects 

of their work environment may be 

causing them to be overexposed to 

respirable dust, and (2) identify the 

types of changes that miners could make 

in order to try to reduce their exposure. 

Although the most recent data on the 

prevalence of Coal Workers’ 

Pneumoconiosis (CWP) in the United 

States indicates that it is declining, 

substantial numbers of CWP cases 

continue to be diagnosed. In recent 

years, CWP has contributed to the 

deaths of approximately 1,000 people in 

the U.S. each year. 

A personal dust monitor (PDM) has 

recently been developed through a 

collaboration involving NIOSH, the 

Bituminous Coal Operators’ 

Association, the United Mine Workers 

of America, the National Mining 

Association, and Rupprecht & 

Patashnick Co., Inc. This new device 

represents a major advance in the tools 

available for assessing coal miners’ 

exposure to respirable dust levels. It 

will soon be field tested with coal 

miners throughout the U.S. As with the 

introduction of any new technology, it 

is very important to systematically 

document how workers react to it and 

make use of it. If miners know how to 

properly use the information PDMs are 

capable of providing, they should be 

able to make adjustments to their work 

place or work procedures that will 

reduce their exposure to respirable coal 

dust. 

Various parties have speculated about 

the processes by which miners will use 

the information to reduce their exposure 

to respirable dust. There appears to be 

great potential. However, no one knows 

precisely how miners performing a wide 

variety of tasks and jobs are actually 

going to use this new information to 

reduce their exposure to dust. It is 

assumed that, once PDMs are 

introduced, miners will eventually find 

new ways to reduce their exposure to 

49928 Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices 

dust. Once these discoveries are made, 

they need to be documented and shared 

throughout the industry. 

The diffusion of this innovation will 

occur much more rapidly and efficiently 

if this proposed study takes place. 

Effective strategies for using PDM 

information will be well documented 

and quickly shared throughout the coal 

industry. The alternative is to wait for 

the miners at each of the 482 actively 

producing coal mines in the U.S. to go 

through their own trial and error 

process of discovering how PDMs can 

and cannot be used to reduce dust 

exposure. The proposed study will help 

to significantly reduce the incidence of 

lung disease among coal miners, leading 

to improvements in their longevity and 

quality of life. 

The information for this study will be 

collected by conducting one-on-one 

structured interviews with 

approximately 20 miners at each of 5 

mines located throughout the major coal 

producing regions of the U.S. 

This survey will last 2 years. There 

will be no cost to respondents except 

their time to participate. The total 

estimated annualized burden hours are 

25.

ESTIMATE OF ANNUALIZED BURDEN TABLE

Respondents Number of respondents 

Number of responses per

respondent 

Average burden per

response

(in hours) 

Coal Miners .................................................................................................................................. 50 1 30/60 

Dated: August 18, 2005. 

Joan F. Karr, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention.

[FR Doc. 05–16895 Filed 8–24–05; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0296]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Financial 

Disclosure by Clinical Investigators

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 

information requiring the sponsor of any 

drug, biologic, or device marketing 

application to certify to the absence of 

clinical investigators and/or disclose 

those financial interests as required, 

when covered clinical studies are 

submitted to FDA in support of product 

marketing.

DATES: Submit written or electronic 

comments on the collection of 

information by October 24, 2005.

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:

Karen L. Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

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.

Financial Disclosure by Clinical 

Investigators (OMB Control Number 

0910–0396)—Extension

Respondents are sponsors of 

marketing applications that contain 

clinical data from studies covered by the 

regulations. These sponsors represent 

pharmaceutical, biologic and medical 

device firms. The applicant will incur 

reporting costs in order to comply with 

the final rule. Applicants will be 

required to submit, for example, the 

complete list of clinical investigators for 

each covered study, not employed by 

the applicant and/or sponsor of the 

covered study, and either certify to the 

absence of certain financial 

arrangements with clinical investigators 

or disclose the nature of those 

arrangements to FDA and the steps 

taken by the applicant or sponsor to 

minimize the potential for bias. The 

clinical investigator will have to supply 

information regarding financial interests 

or payments held in the sponsor of the 

covered study. FDA has said that it has 

no preference as to how this information 

is collected from investigators and that 

sponsors/applicants have the flexibility 

to collect the information in the most 

efficient and least burdensome manner 

that will be effective. FDA estimated