Federal Register / Vol. 70, No.

164 / Thursday, August 25, 2005 / Notices 49927

• Which audiences (e.g., doctors, channels through which CDC intended for scientific and professional
local health officials, researchers, etc.) communicates scientific information to audiences. However, future plans
receive their information from which partners and customers to ensure that include adding additional publications
CDC platforms? health impact is maximized through the as needed. The initial five
• How often and with what purpose delivery of timely, effective, and communications platforms are:
do they access CDC platforms? credible information, which will result Emerging Infections Journal, MMWR,
• How satisfied are subscribers of the in optimal benefit for public health. The Epi-X, Preventing Chronic Diseases
platforms with the content and delivery evaluation will help to ensure that these Journal, and Health Alert Network. We
of information? platforms meet subscriber and partner want to ensure that the timeliness,
• Are there ways to enhance the priorities, build CDC’s brand, and
platforms for the subscriber through effectiveness, and credibility of this
contribute to health impact goals. communication maximizes the health
improvements to current offerings or Feedback from the subscriber base is
through new products / services? impact of that information, resulting in
necessary to fully evaluate the optimum benefit for public health.
• Who are our most critical target
audiences, i.e., what are our publication performance of CDC’s platforms. These channels include both print and
and dissemination priorities in service At this time, the scope of this project electronic versions of the five platforms.
to our health impact goals? is limited to five communication There is no cost to respondents other
The purpose of this project is to platforms owned and managed by CDC than their time. The total estimated
evaluate the content, processes, and which transmits information primarily burden hours are 18,970.

ESTIMATES OF ANNUALIZED BURDEN HOURS

Responses
Hrs/response
Form Respondents per (in hrs)
respondent

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. Proposed Project deaths of approximately 1,000 people in
Joan F. Karr, the U.S. each year.
How Miners Modify Their Behavior In A personal dust monitor (PDM) has
Acting Reports Clearance Officer, Centers for Response To Personal Dust Monitor
Disease Control and Prevention. recently been developed through a
Information—New—National Institute collaboration involving NIOSH, the
[FR Doc. 05–16894 Filed 8–24–05; 8:45 am] for Occupational Safety and Health Bituminous Coal Operators’
BILLING CODE 4163–18–P (NIOSH), Centers for Disease Control Association, the United Mine Workers
and Prevention (CDC). of America, the National Mining
Background and Brief Description Association, and Rupprecht &
DEPARTMENT OF HEALTH AND
Patashnick Co., Inc. This new device
HUMAN SERVICES The Federal Mine Safety & Health Act represents a major advance in the tools
of 1977, Section 501, and the available for assessing coal miners’
Centers for Disease Control and
Occupational Safety and Health Act of exposure to respirable dust levels. It
Prevention 1970, Public Law 91–256 enables CDC/ will soon be field tested with coal
NIOSH to carry out research relevant to miners throughout the U.S. As with the
[30Day–05–05AF] the health and safety of workers in the introduction of any new technology, it
mining industry. The objective of this is very important to systematically
Proposed Data Collections Submitted project is to document how coal miners document how workers react to it and
for Public Comment and can use real-time information from their make use of it. If miners know how to
Recommendations personal dust monitors (PDM) to reduce properly use the information PDMs are
their exposure to respirable dust. The capable of providing, they should be
The Centers for Disease Control and specific aims are to (1) identify several able to make adjustments to their work
Prevention (CDC) publishes a list of specific examples of how miners use place or work procedures that will
information collection requests under PDM information to discover which reduce their exposure to respirable coal
review by the Office of Management and parts of their jobs and/or which aspects dust.
Budget (OMB) in compliance with the of their work environment may be Various parties have speculated about
Paperwork Reduction Act (44 U.S.C. causing them to be overexposed to the processes by which miners will use
Chapter 35). To request a copy of these respirable dust, and (2) identify the the information to reduce their exposure
requests, call the CDC Reports Clearance types of changes that miners could make to respirable dust. There appears to be
Officer at (404) 371–5983 or send an e- in order to try to reduce their exposure. great potential. However, no one knows
mail to omb@cdc.gov. Send written Although the most recent data on the precisely how miners performing a wide
comments to CDC Desk Officer, Office of prevalence of Coal Workers’ variety of tasks and jobs are actually
Management and Budget, Washington, Pneumoconiosis (CWP) in the United going to use this new information to
DC or by fax to (202) 395–6974. Written States indicates that it is declining, reduce their exposure to dust. It is
comments should be received within 30 substantial numbers of CWP cases assumed that, once PDMs are
days of this notice. continue to be diagnosed. In recent introduced, miners will eventually find
years, CWP has contributed to the new ways to reduce their exposure to

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

dust. Once these discoveries are made, producing coal mines in the U.S. to go structured interviews with
they need to be documented and shared through their own trial and error approximately 20 miners at each of 5
throughout the industry. process of discovering how PDMs can mines located throughout the major coal
The diffusion of this innovation will and cannot be used to reduce dust producing regions of the U.S.
occur much more rapidly and efficiently exposure. The proposed study will help
This survey will last 2 years. There
if this proposed study takes place. to significantly reduce the incidence of
Effective strategies for using PDM will be no cost to respondents except
lung disease among coal miners, leading
information will be well documented their time to participate. The total
to improvements in their longevity and
and quickly shared throughout the coal quality of life. estimated annualized burden hours are
industry. The alternative is to wait for The information for this study will be 25.
the miners at each of the 482 actively collected by conducting one-on-one

ESTIMATE OF ANNUALIZED BURDEN TABLE

Average bur-
Number of re-
Number of re- den per
Respondents sponses per
spondents response
respondent (in hours)

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

Dated: August 18, 2005. ADDRESSES: Submit electronic the information will have practical
Joan F. Karr, comments on the collection of utility; (2) the accuracy of FDA’s
Acting Reports Clearance Officer, Centers for information to: http://www.fda.gov/ estimate of the burden of the proposed
Disease Control and Prevention. dockets/ecomments. Submit written collection of information, including the
[FR Doc. 05–16895 Filed 8–24–05; 8:45 am] comments on the collection of validity of the methodology and
BILLING CODE 4163–18–P information to the Division of Dockets assumptions used; (3) ways to enhance
Management (HFA–305), Food and Drug the quality, utility, and clarity of the
Administration, 5630 Fishers Lane, rm. information to be collected; and (4)
DEPARTMENT OF HEALTH AND 1061, Rockville, MD 20852. All ways to minimize the burden of the
HUMAN SERVICES comments should be identified with the collection of information on
docket number found in brackets in the respondents, including through the use
Food and Drug Administration heading of this document. of automated collection techniques,
[Docket No. 2005N–0296] FOR FURTHER INFORMATION CONTACT: when appropriate, and other forms of
Karen L. Nelson, Office of Management information technology.
Agency Information Collection Programs (HFA–250), Food and Drug
Activities; Proposed Collection; Financial Disclosure by Clinical
Administration, 5600 Fishers Lane, Investigators (OMB Control Number
Comment Request; Financial Rockville, MD 20857, 301–827–1482.
Disclosure by Clinical Investigators 0910–0396)—Extension
SUPPLEMENTARY INFORMATION: Under the
AGENCY: Food and Drug Administration, PRA (44 U.S.C. 3501–3520), Federal Respondents are sponsors of
HHS. agencies must obtain approval from the marketing applications that contain
ACTION: Notice. Office of Management and Budget clinical data from studies covered by the
(OMB) for each collection of regulations. These sponsors represent
SUMMARY: The Food and Drug information they conduct or sponsor. pharmaceutical, biologic and medical
Administration (FDA) is announcing an ‘‘Collection of information’’ is defined device firms. The applicant will incur
opportunity for public comment on the in 44 U.S.C. 3502(3) and 5 CFR reporting costs in order to comply with
proposed collection of certain 1320.3(c) and includes agency requests the final rule. Applicants will be
information by the agency. Under the or requirements that members of the required to submit, for example, the
Paperwork Reduction Act of 1995 (the public submit reports, keep records, or complete list of clinical investigators for
PRA), Federal agencies are required to provide information to a third party. each covered study, not employed by
publish notice in the Federal Register Section 3506(c)(2)(A) of the PRA (44 the applicant and/or sponsor of the
concerning each proposed collection of U.S.C. 3506(c)(2)(A)) requires Federal covered study, and either certify to the
information, including each proposed agencies to provide a 60-day notice in absence of certain financial
extension of an existing collection of the Federal Register concerning each arrangements with clinical investigators
information, and to allow 60 days for proposed collection of information, or disclose the nature of those
public comment in response to the including each proposed extension of an arrangements to FDA and the steps
notice. This notice solicits comments on existing collection of information, taken by the applicant or sponsor to
information requiring the sponsor of any before submitting the collection to OMB minimize the potential for bias. The
drug, biologic, or device marketing for approval. To comply with this clinical investigator will have to supply
application to certify to the absence of requirement, FDA is publishing notice information regarding financial interests
clinical investigators and/or disclose of the proposed collection of or payments held in the sponsor of the
those financial interests as required, information set forth in this document. covered study. FDA has said that it has
when covered clinical studies are With respect to the following no preference as to how this information
submitted to FDA in support of product collection of information, FDA invites is collected from investigators and that
marketing. comments on these topics: (1) Whether sponsors/applicants have the flexibility
DATES: Submit written or electronic the proposed collection of information to collect the information in the most
comments on the collection of is necessary for the proper performance efficient and least burdensome manner
information by October 24, 2005. of FDA’s functions, including whether that will be effective. FDA estimated

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