Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators, 66542-66543 [2015-27559]
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66542
Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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–2012–N–0280]
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.
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 November
30, 2015.
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:
202–395–7285, or emailed 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: FDA
PRA Staff, Office of Operations, Food
SUMMARY:
Financial Disclosure by Clinical
Investigators OMB Control Number
0910–0396—Extension
Respondents to this collection are
sponsors of marketing applications that
contain clinical data from studies
covered by the regulations. These
sponsors represent pharmaceutical,
biologic, and medical device firms.
Respondents are also clinical
investigators who provide financial
information to the sponsors of
marketing applications.
Under § 54.4(a) (21 CFR 54.4(a)),
applicants submitting an application
that relies on clinical studies must
submit a complete list of clinical
investigators who participated in a
covered clinical study, and must either
certify to the absence of certain financial
arrangements with clinical investigators
(Form FDA 3454) or, under § 54.4(a)(3),
disclose to FDA the nature of those
arrangements and the steps taken by the
applicant or sponsor to minimize the
potential for bias (Form FDA 3455).
Under § 54.6, the sponsors of covered
studies must 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. Sponsors of covered
studies 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 the
clinical investigators’ file.
Under § 54.4(b), clinical investigators
supply to the sponsor of a covered study
financial information sufficient to allow
the sponsor to submit complete and
accurate certification or disclosure
statements. Clinical investigators are
accustomed to supplying such
information when applying for research
grants. Also, most people know the
financial holdings of their immediate
family and records of such interests are
generally accessible because they are
needed for preparing tax records. For
these reasons, FDA estimates that it will
take clinical investigators 15 minutes to
submit such records to the sponsor.
In the Federal Register of April 29,
2015 (80 FR 23803), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although two comments
were received, none were responsive to
the four collection of information topics
solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Certification—54.4(a)(1) and (a)(2)—Form FDA 3454 ........
Disclosure—54.4(a)(3)—Form FDA 3455 ...........................
1,000
100
1
1
1,000
100
1
5
1,000
500
Total ..............................................................................
........................
........................
........................
........................
1,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of recordkeepers
asabaliauskas on DSK5VPTVN1PROD with NOTICES
21 CFR Section
Number of records
per recordkeeper
1,000
1
Recordkeeping—54.6 ...............................
1 There
Total annual
records
1,000
Average burden
per recordkeeping
0.25
(15 minutes) .....
are no capital costs or operating and maintenance costs associated with this collection of information.
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23:37 Oct 28, 2015
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Total hours
250
Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
66543
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
54.4(b)—Clinical Investigators ..........................................
1 There
Number of disclosures per
respondent
Number of
respondents
21 CFR Section
7,106
1
OMB control number 0910–0802. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
[FR Doc. 2015–27559 Filed 10–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2015–27558 Filed 10–28–15; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2013–D–0286]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Formal
Meetings Between the Food and Drug
Administration and Biosimilar
Biological Product Sponsors or
Applicants
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
7,106
Average burden
per disclosure
0.17
(10 minutes) .....
Total hours
1,208
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Formal
Meetings Between the Food and Drug
Administration and Biosimilar
Biological Product Sponsors or
Applicant’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On June
25, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Guidance for Industry on
Formal Meetings Between the Food and
Drug Administration and Biosimilar
Biological Product Sponsors or
Applicant’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
SUMMARY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Total annual
disclosures
VerDate Sep<11>2014
23:37 Oct 28, 2015
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3579]
Using Technologies and Innovative
Methods To Conduct Food and Drug
Administration-Regulated Clinical
Investigations of Investigational
Drugs; Establishment of a Public
Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the establishment of a
public docket to solicit input from a
broad group of stakeholders on the
scope and direction of the use of
technologies and innovative methods in
the conduct of clinical investigations.
Specifically, FDA seeks information to
understand individual and industry
experiences with the use of such
technologies to more efficiently conduct
clinical research. FDA also seeks
stakeholder perspectives on possible
barriers to implementing these
technologies and methods to conduct
clinical investigations.
DATES: Submit electronic or written
comments by December 28, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–3579 for ‘‘Using Technologies
and Innovative Methods to Conduct
FDA-Regulated Clinical Investigations
of Investigational Drugs.’’ Please
identify the specific question or issue
that the comment addresses. Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
E:\FR\FM\29OCN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66542-66543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27559]
[[Page 66542]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0280]
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
November 30, 2015.
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: 202-395-7285, or emailed 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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 to this collection are sponsors of marketing
applications that contain clinical data from studies covered by the
regulations. These sponsors represent pharmaceutical, biologic, and
medical device firms. Respondents are also clinical investigators who
provide financial information to the sponsors of marketing
applications.
Under Sec. 54.4(a) (21 CFR 54.4(a)), applicants submitting an
application that relies on clinical studies must submit a complete list
of clinical investigators who participated in a covered clinical study,
and must either certify to the absence of certain financial
arrangements with clinical investigators (Form FDA 3454) or, under
Sec. 54.4(a)(3), disclose to FDA the nature of those arrangements and
the steps taken by the applicant or sponsor to minimize the potential
for bias (Form FDA 3455).
Under Sec. 54.6, the sponsors of covered studies must 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.
Sponsors of covered studies maintain many records with regard to
clinical investigators, including protocol agreements and investigator
r[eacute]sum[eacute]s or curriculum vitae. FDA estimates than an
average of 15 minutes will be required for each recordkeeper to add
this record to the clinical investigators' file.
Under Sec. 54.4(b), clinical investigators supply to the sponsor
of a covered study financial information sufficient to allow the
sponsor to submit complete and accurate certification or disclosure
statements. Clinical investigators are accustomed to supplying such
information when applying for research grants. Also, most people know
the financial holdings of their immediate family and records of such
interests are generally accessible because they are needed for
preparing tax records. For these reasons, FDA estimates that it will
take clinical investigators 15 minutes to submit such records to the
sponsor.
In the Federal Register of April 29, 2015 (80 FR 23803), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, none
were responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Certification--54.4(a)(1) and 1,000 1 1,000 1 1,000
(a)(2)--Form FDA 3454..........
Disclosure--54.4(a)(3)--Form FDA 100 1 100 5 500
3455...........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual
21 CFR Section recordkeepers per recordkeeper records Average burden per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping--54.6...................... 1,000 1 1,000 0.25 250
(15 minutes).....................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 66543]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(b)--Clinical Investigators................ 7,106 1 7,106 0.17 1,208
(10 minutes)...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27559 Filed 10-28-15; 8:45 am]
BILLING CODE 4164-01-P
