Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators, 49928-49929 [05-16915]
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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
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.
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
ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of respondents
Respondents
Number of responses per
respondent
50
1
Coal Miners ..................................................................................................................................
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.
VerDate jul<14>2003
15:58 Aug 24, 2005
Jkt 205001
ADDRESSES: Submit electronic
comments on the collection of
information to: https://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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Average burden per
response
(in hours)
30/60
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
E:\FR\FM\25AUN1.SGM
25AUN1
Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices
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.
49929
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours Per Response
Total Hours
1,000
100
46,000
21 CFR Section
1
1
.25
1,000
100
11,500
5
20
.1
5,000
2,000
11,500
18,500
54.4(a)(1) and (a)(2)
54.4(a)(3)
54.4
Total
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
No. of
Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
Hours Per
Recordkeeper
Total Hours
1,000
21 CFR Section
1
1,000
.25
250
250
54.6
Total
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
VerDate jul<14>2003
15:58 Aug 24, 2005
Jkt 205001
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
PO 00000
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Fmt 4703
Sfmt 4703
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 https://
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
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 70, Number 164 (Thursday, August 25, 2005)]
[Notices]
[Pages 49928-49929]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16915]
-----------------------------------------------------------------------
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: https://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
[[Page 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 Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual
Section Respondents per Response Responses Hours Per Response Total Hours
----------------------------------------------------------------------------------------------------------------
54.4(a)(1) 1,000 1 1,000 5 5,000
and (a)(2)
54.4(a)(3) 100 1 100 20 2,000
54.4 46,000 .25 11,500 .1 11,500
Total ............... .................. ..................... ..................... 18,500
----------------------------------------------------------------------------------------------------------------
\1\There 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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Hours Per
21 CFR Section Recordkeepers Recordkeeping Total Annual Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.6 1,000 1 1,000 .25 250
Total .................. ..................... ..................... ..................... 250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There 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
