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 

Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices 49929

that the total reporting costs of sponsors 

would be less than $450,000 annually. 

Costs could also occur after a marketing 

application is submitted if FDA 

determines that the financial interests of 

an investigator raise significant 

questions about the integrity of the data.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section 

No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses Hours Per Response Total Hours 

54.4(a)(1) and (a)(2) 1,000 1 1,000 5 5,000

54.4(a)(3) 100 1 100 20 2,000

54.4 46,000 .25 11,500 .1 11,500

Total 18,500

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

The sponsors of covered studies will 

be required to maintain complete 

records of compensation agreements 

with any compensation paid to 

nonemployee clinical investigators, 

including information showing any 

financial interests held by the clinical 

investigator, for a time period of 2 years 

after the date of approval of the 

applications. This time is consistent 

with the current recordkeeping 

requirements for other information 

related to marketing applications for 

human drugs, biologics, and medical 

devices. Currently, sponsors of covered 

studies must maintain many records 

with regard to clinical investigators, 

including protocol agreements and 

investigator resumes or curriculum 

vitae. FDA estimates than an average of 

15 minutes will be required for each 

recordkeeper to add this record to 

clinical investigators’ file.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section 

No. of

Recordkeepers

Annual Frequency per

Recordkeeping Total Annual Records 

Hours Per

Recordkeeper Total Hours 

54.6 1,000 1 1,000 .25 250

Total 250

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

Dated: August 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–16915 Filed 8–24–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D–0264]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Ribonucleic Acid Preanalytical 

Systems (Ribonucleic Acid Collection, 

Stabilization and Purification Systems 

for Real Time Polymerase Chain 

Reaction Used in Molecular Diagnostic 

Testing); Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: RNA Preanalytical Systems 

(RNA Collection, Stabilization and 

Purification Systems for RT–PCR used 

in Molecular Diagnostic Testing).’’ This 

guidance document describes a means 

by which Ribonucleic Acid (RNA) 

preanalytical systems may comply with 

the requirement of special controls for 

class II devices. Elsewhere in this issue 

of the Federal Register, FDA is 

publishing a final rule to classify RNA 

preanalytical systems into class II 

(special controls). This guidance 

document is immediately in effect as the 

special control for RNA preanalytical 

systems but it remains subject to 

comment in accordance with the 

agency’s good guidance practices 

(GGPs).

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

RNA Preanalytical Systems (RNA 

Collection, Stabilization and 

Purification Systems for RT–PCR used 

in Molecular Diagnostic Testing)’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance.

Submit written comments concerning 

this 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.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT: Uwe 

Scherf, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0496.

SUPPLEMENTARY INFORMATION:

I. Background

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying RNA preanalytical systems 

into class II (special controls) under