Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators, 18826-18827 [2012-7405]
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18826
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0280]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Financial
Disclosure by Clinical Investigators
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 collection on financial
disclosure by clinical investigators.
DATES: Submit either electronic or
written comments on the collection of
information by May 29, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
SUMMARY:
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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 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).
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
Average
burden
per response
Total annual
responses
Total hours
54.4(a)(1) and (a)(2)—Form FDA 3454 ...............................
54.4(a)(3)—Form FDA 3455 ................................................
902
90
1
1
902
90
1
5
902
450
Total ..............................................................................
........................
........................
........................
........................
1,352
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
tkelley on DSK3SPTVN1PROD with NOTICES
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
VerDate Mar<15>2010
17:29 Mar 27, 2012
Jkt 226001
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,
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\28MRN1.SGM
28MRN1
18827
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
54.6 ......................................................................................
1 There
Number of
records per
recordkeeper
1,000
Total annual
records
1
1,000
Average burden per recordkeeping
0.25
Total hours
250
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR Section
54.4(b) ..................................................................................
1 There
[FR Doc. 2012–7405 Filed 3–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Draft Guidance for Industry on
Bioequivalence Recommendations for
Iron Sucrose Injection; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Bioequivalence
Recommendations for Iron Sucrose.’’
The recommendations provide specific
guidance on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for iron sucrose injection.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 29, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
10,554
Total annual
disclosures
1
10,554
Average
burden
per disclosure
0.17
Total hours
1,794
are no capital costs or operating and maintenance costs associated with the collection of information.
Dated: March 22, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Number of
disclosures
per
respondent
VerDate Mar<15>2010
17:29 Mar 27, 2012
Jkt 226001
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–8608.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm. As described in
that guidance, FDA adopted this process
as a means to develop and disseminate
product-specific BE recommendations
and provide a meaningful opportunity
for the public to consider and comment
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
on those recommendations. This notice
announces the availability of draft BE
recommendations for iron sucrose
injection.
Venofer (iron sucrose injection), new
drug application 021135, was initially
approved by FDA in November 2000.
There are no approved ANDAs for this
product. FDA is now issuing a draft
guidance for industry on BE
recommendations for generic iron
sucrose injection (Draft Iron Sucrose
Injection BE Recommendations).
In March 2005, Luitpold
Pharmaceuticals, Inc. (Luitpold),
manufacturer of the reference listed
drug (RLD), Venofer, submitted (through
its attorneys) a citizen petition
requesting that FDA withhold approval
of any ANDA or 505(b)(2) application
for a generic iron sucrose injection
unless certain conditions were satisfied,
including conditions related to
demonstrating BE (Docket No. FDA–
2005–P–0319, formerly 2005P–0095/
CP1). FDA is reviewing the issues raised
in the petition and is also reviewing the
supplemental information and
comments that have been submitted to
the docket for that petition. FDA will
consider any comments on the Draft
Iron Sucrose Injection BE
Recommendations before responding to
Luitpold’s citizen petition.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for iron sucrose injection. It
does not create or confer any rights for
E:\FR\FM\28MRN1.SGM
28MRN1
]]>Agencies
[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18826-18827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7405]
[[Page 18826]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0280]
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 collection on
financial disclosure by clinical investigators.
DATES: Submit either electronic or written comments on the collection
of information by May 29, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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 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).
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
----------------------------------------------------------------------------------------------------------------
54.4(a)(1) and (a)(2)--Form FDA 902 1 902 1 902
3454...........................
54.4(a)(3)--Form FDA 3455....... 90 1 90 5 450
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,352
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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
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.
[[Page 18827]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
54.6............................ 1,000 1 1,000 0.25 250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
54.4(b)......................... 10,554 1 10,554 0.17 1,794
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the collection of information.
Dated: March 22, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7405 Filed 3-27-12; 8:45 am]
BILLING CODE 4160-01-P
