Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators, 18385-18386 [E9-9148]
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18385
Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Number of
respondents *
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
NBCCEDP Grantees .......................................................................................
68
2
4
544
Dated: April 15, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–9155 Filed 4–21–09; 8:45 am]
comments should be identified with the
OMB control number 0910–0396. Also
include the FDA docket number found
in brackets in the heading of this
document.
BILLING CODE 4163–18–P
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0637]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Financial
Disclosure by Clinical Investigators
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 22,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
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.
In the Federal Register of December
29, 2008 (73 FR 79493), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. Two comments were
received, one comment expressed
support for this information collection.
The second comment raised several
issues, first, the issue of the current cost
the commenter incurs in the collection
of Financial Disclosure and the estimate
of substantial operating costs the
commenter incurs in operating costs to
support the collection of investigator
financial information. FDA appreciates
the comment and based on this new
data, submitted by the commenter, will
undertake a new evaluation whether
there are capital costs or operating and
maintenance costs associated with this
collection of information. FDA also
appreciates the comment concerning the
definition of ‘‘clinical investigator’’ and
will forward the comment to the FDA
office responsible for this collection of
information to consider in any future
rulemaking. However, these definitions
are codified in 21 CFR 54.2.
FDA also appreciates the comment
regarding the use of Form FDA 1572 to
minimize burden. However, 21 CFR
54.4 requires the use of Form FDA 3454
and Form FDA 3455. This comment will
also be forwarded to the FDA office
responsible for this collection of
information to consider in any future
rulemaking.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
54.4(a)(1) and (a)(2)—Form FDA
3454
Total Annual
Responses
Hours per
Response
1
1,000
5
5,000
100
1
100
20
2,000
46,000
54.4(b)
.25
11,500
1
11,500
Total
1There
Total Hours
1,000
54.4(a)(3)—Form FDA 3455
dwashington3 on PROD1PC60 with NOTICES
Annual Frequency per
Response
18,500
are no capital costs or operating and maintenance costs associated with this collection of information.
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15:31 Apr 21, 2009
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18386
Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
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
21 CFR Section
54.6
Annual Frequency per
Recordkeeping
1,000
Total Annual
Records
1
Hours per Record
1,000
.25
Total
1There
250
250
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9148 Filed 4–21–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
operating a Fetal Alcohol Spectrum
Disorder (FASD) Center of Excellence
which addresses FASD mainly by
providing trainings and technical
assistance; and developing and
supporting systems of care that respond
to FASD using effective evidence based
practices and interventions.
Currently the integration of evidencebased practices into service delivery
organizations is being accomplished
through subcontracts. One such
intervention which integrates
prevention strategies into service
delivery organizations is the ParentChild Assistance Program (PCAP)
targeting pregnant or postpartum
women. The PCAP programs uses the
following 12 data collection tools.
Proposed Project: Parent-Child
Assistance Program (P–CAP) in the
Fetal Alcohol Spectrum Disorder
(FASD) Center of Excellence—New
Description of Instruments/Activity for
Parent-Child Assistance Program (P–
CAP)
Since 2001, SAMHSA’s Center for
Substance Abuse Prevention has been
Instrument/activity
Description
At Baseline/Enrollment:
CRSQ ..........................................................
ASI—Part A .................................................
ASI—Part B & Twin .....................................
Demographic Data .......................................
dwashington3 on PROD1PC60 with NOTICES
Total Hours
Process Monitoring:
Weekly Advocate Time Summary ...............
Monthly Updates ..........................................
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The Community Referral Screening Questionnaire (CRSQ) is a screening form administered to
individuals referred to PCAP. The purpose of the form is to determine eligibility for enrollment in PCAP.
The Alcohol Severity Index (ASI) Part A is an intake interview administered at client enrollment. The ASI Part A includes questions about past 30 day alcohol use, lifetime use, age at
first use, month and year of last use, range of use (T–ACE), and use during pregnancy,
thereby providing a thorough assessment of alcohol consumption.
The Alcohol Severity Index (ASI) Part B is an intake interview administered as soon as possible after the target child birth. The ASI Part B includes questions about the target child at
birth and alcohol use during the pregnancy. If the target birth is of twins then the Twins Addendum form is administered.
The Demographic Questionnaire is administered after client enrollment. The questionnaire includes race, educational attainment, martial status, and an alcohol assessment.
The PCAP Weekly Advocate Time Summary Sheet is administered on a weekly basis. The
form tracks time spent on the phone, in person, or providing transportation to each client.
The Monthly Update form is administered on a monthly basis. The form records any changes
in drug and alcohol use, pregnancy, child custody, and sources of income.
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]]>Agencies
[Federal Register Volume 74, Number 76 (Wednesday, April 22, 2009)]
[Notices]
[Pages 18385-18386]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9148]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0637]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Financial Disclosure
by Clinical Investigators
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May
22, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0396.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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.
In the Federal Register of December 29, 2008 (73 FR 79493), FDA
published a 60-day notice requesting public comment on the information
collection provisions. Two comments were received, one comment
expressed support for this information collection. The second comment
raised several issues, first, the issue of the current cost the
commenter incurs in the collection of Financial Disclosure and the
estimate of substantial operating costs the commenter incurs in
operating costs to support the collection of investigator financial
information. FDA appreciates the comment and based on this new data,
submitted by the commenter, will undertake a new evaluation whether
there are capital costs or operating and maintenance costs associated
with this collection of information. FDA also appreciates the comment
concerning the definition of ``clinical investigator'' and will forward
the comment to the FDA office responsible for this collection of
information to consider in any future rulemaking. However, these
definitions are codified in 21 CFR 54.2.
FDA also appreciates the comment regarding the use of Form FDA 1572
to minimize burden. However, 21 CFR 54.4 requires the use of Form FDA
3454 and Form FDA 3455. This comment will also be forwarded to the FDA
office responsible for this collection of information to consider in
any future rulemaking.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(a)(1) and (a)(2)--Form FDA 3454 1,000 1 1,000 5 5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(a)(3)--Form FDA 3455 100 1 100 20 2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(b) 46,000 .25 11,500 1 11,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................. .................... ................. ................. 18,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 18386]]
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 Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours per Record 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: April 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9148 Filed 4-21-09; 8:45 am]
BILLING CODE 4160-01-S
