Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators, 68500-68502 [2021-26182]
Download as PDF
<![CDATA[
68500
Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / 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, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 ‘‘Financial
Disclosure by Clinical Investigators.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 31, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 31,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 31, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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
VerDate Sep<11>2014
16:49 Dec 01, 2021
Jkt 256001
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2012–N–0280 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Financial
Disclosure by Clinical Investigators.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
E:\FR\FM\02DEN1.SGM
02DEN1
68501
Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
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.
Table 1 shows information that is the
basis of the estimated number of
respondents in tables 2 through 4.
TABLE 1—ESTIMATED NUMBER OF APPLICATIONS, CLINICAL TRIALS, AND INVESTIGATORS SUBJECT TO THE REGULATION
BY TYPE OF APPLICATION 1
Total number
of applications
Application type
Drugs:
New drug application (NDA), new molecular entity (NME) .....................
NDA non-NME .........................................................................................
NDA efficacy supplement .........................................................................
Abbreviated new drug application (ANDA) ..............................................
ANDA supplement ....................................................................................
CBER Biologics:
Biologics license application (BLA) ..........................................................
BLA efficacy supplement .........................................................................
CDER Biologics:
BLAs .........................................................................................................
BLA efficacy supplements ........................................................................
Medical Devices:
Premarket approval (PMA) ......................................................................
PMA supplement ......................................................................................
Reclassification devices ...........................................................................
510(k) .......................................................................................................
De Novo requests ....................................................................................
Number of
applications
affected
Number of
trials
Number of
investigators
55
78
196
821
10,894
55
37
119
1
1
3 to 10 ...........
3 to 10 ...........
1 to 3 .............
1.1 ..................
1 .....................
3 to 100
3 to 100
10 to 30
2
2
10
30
10
30
3 to 10 ...........
1 to 3 .............
3 to 100
10 to 30
25
102
25
65
3 to 10 ...........
1 to 3 .............
3 to 100
10 to 30
39
29
0
3,947
63
39
29
0
247
57
1 to 31 ...........
to 3 .................
0 .....................
1 .....................
1 to 3 .............
10 to 20
3 to 10
0
3 to 10
10 to 20
Source: Agency estimates.
FDA estimates the burden of this
collection of information as follows:
Reporting Burden
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 that almost all
applicants submit a certification
statement under § 54.4(a)(1) and (2).
Preparation of the statement using Form
FDA 3454 should require no more than
1 hour per study. The number of
respondents is based on the estimated
number of affected applications.
When certification is not possible and
disclosure is made using Form FDA
3455, the applicant must describe,
under § 54.4(a)(3), the financial
arrangements or interests and the steps
that were taken to minimize the
potential for bias in the affected study.
As the applicant would be fully aware
of those arrangements and the steps
taken to address them, describing them
will be straightforward. The Agency
estimates that it will take about 5 hours
to prepare this narrative. Based on our
experience with this collection, FDA
estimates that approximately 10 percent
of the respondents with affected
applications will submit disclosure
statements.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Certification—54.4(a)(1) and (2)—Form FDA 3454 ............
Disclosure—54.4(a)(3)—Form FDA 3455 ...........................
715
72
1
1
715
72
1
5
715
360
Total ..............................................................................
........................
........................
........................
........................
1,075
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping Burden
Under § 54.6 (21 CFR 54.6), the
sponsors of covered studies must
maintain complete records of
VerDate Sep<11>2014
16:49 Dec 01, 2021
Jkt 256001
compensation agreements with any
compensation paid to nonemployee
clinical investigators, including
information showing any financial
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
interests held by the clinical
investigator, for 2 years after the date of
approval of the applications. Sponsors
of covered studies maintain many
E:\FR\FM\02DEN1.SGM
02DEN1
68502
Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
records regarding 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.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours 2
Recordkeeping—54.6 ..........................................................
715
1
715
0.25
179
1 There
2
are no capital costs or operating and maintenance costs associated with this collection of information.
Numbers have been rounded.
Third-Party Disclosure Burden
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 the
time required for this task may range
from 5 to 15 minutes; we used the
median, 10 minutes, for the average
burden per disclosure (see table 1).
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours 2
54.4(b)—Clinical Investigators ...........................................
13,082
1
13,082
0.17
2,224
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
The burden for this information
collection request has changed since the
last OMB approval. Our estimated
burden for the information collection
reflects a 298 hour increase. We have
adjusted our estimated burden for the
information collection to reflect the
number of submissions we received in
the last few years. Additionally, for
products regulated by the Center for
Devices and Radiological Health, we
now include De Novo requests as a type
of application that may rely on clinical
studies. For products regulated by the
Center for Drug Evaluation and
Research, we now include biologics
license applications (BLAs) and BLA
efficacy supplements that were
inadvertently excluded from our last
information collection request as a type
of application.
Food and Drug Administration
[Docket No. FDA–2021–N–1145]
Aurolife Pharma LLC, et al.;
Withdrawal of Approval of Five
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: November 24, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of five
abbreviated new drug applications
(ANDAs) from multiple applicants. The
applicants notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
[FR Doc. 2021–26182 Filed 12–1–21; 8:45 am]
DATES:
BILLING CODE 4164–01–P
lotter on DSK11XQN23PROD with NOTICES1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Approval is withdrawn as of
January 3, 2022.
Application No.
Drug
Applicant
ANDA 072514 ....
Clorazepate Dipotassium Tablets, 3.75 milligrams (mg), 7.5
mg, and 15 mg.
Ondansetron Hydrochloride Injection, Equivalent to (EQ) 2
mg base/milliliters (mL).
Fluconazole in Dextrose 5% Injection, 200 mg/100 mL (2 mg/
mL) and 400 mg/200 mL (2 mg/mL).
Aurolife Pharma LLC, 2400 U.S. Hwy. 130 N, Dayton, NJ
08810.
Hospira, Inc., 275 N Field Dr., Bldg. H1, Lake Forest, IL
60045.
Woodward Pharma Services LLC, 47220 Cartier Dr., Wixom,
MI 48393.
ANDA 077840 ....
ANDA 077988 ....
VerDate Sep<11>2014
16:49 Dec 01, 2021
Jkt 256001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
E:\FR\FM\02DEN1.SGM
02DEN1
]]>Agencies
[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68500-68502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26182]
[[Page 68500]]
-----------------------------------------------------------------------
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 ``Financial Disclosure by
Clinical Investigators.''
DATES: Submit either electronic or written comments on the collection
of information by January 31, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 31, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 31, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2012-N-0280 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Financial Disclosure by Clinical
Investigators.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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
[[Page 68501]]
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.
Table 1 shows information that is the basis of the estimated number
of respondents in tables 2 through 4.
Table 1--Estimated Number of Applications, Clinical Trials, and Investigators Subject to the Regulation by Type
of Application \1\
----------------------------------------------------------------------------------------------------------------
Total number Number of
Application type of applications Number of trials Number of
applications affected investigators
----------------------------------------------------------------------------------------------------------------
Drugs:
New drug application (NDA), 55 55 3 to 10............... 3 to 100
new molecular entity (NME).
NDA non-NME................. 78 37 3 to 10............... 3 to 100
NDA efficacy supplement..... 196 119 1 to 3................ 10 to 30
Abbreviated new drug 821 1 1.1................... 2
application (ANDA).
ANDA supplement............. 10,894 1 1..................... 2
CBER Biologics:
Biologics license 10 10 3 to 10............... 3 to 100
application (BLA).
BLA efficacy supplement..... 30 30 1 to 3................ 10 to 30
CDER Biologics:
BLAs........................ 25 25 3 to 10............... 3 to 100
BLA efficacy supplements.... 102 65 1 to 3................ 10 to 30
Medical Devices:
Premarket approval (PMA).... 39 39 1 to 31............... 10 to 20
PMA supplement.............. 29 29 to 3.................. 3 to 10
Reclassification devices.... 0 0 0..................... 0
510(k)...................... 3,947 247 1..................... 3 to 10
De Novo requests............ 63 57 1 to 3................ 10 to 20
----------------------------------------------------------------------------------------------------------------
Source: Agency estimates.
FDA estimates the burden of this collection of information as
follows:
Reporting Burden
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 that almost all applicants submit a certification
statement under Sec. 54.4(a)(1) and (2). Preparation of the statement
using Form FDA 3454 should require no more than 1 hour per study. The
number of respondents is based on the estimated number of affected
applications.
When certification is not possible and disclosure is made using
Form FDA 3455, the applicant must describe, under Sec. 54.4(a)(3), the
financial arrangements or interests and the steps that were taken to
minimize the potential for bias in the affected study. As the applicant
would be fully aware of those arrangements and the steps taken to
address them, describing them will be straightforward. The Agency
estimates that it will take about 5 hours to prepare this narrative.
Based on our experience with this collection, FDA estimates that
approximately 10 percent of the respondents with affected applications
will submit disclosure statements.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Certification--54.4(a)(1) and 715 1 715 1 715
(2)--Form FDA 3454.............
Disclosure--54.4(a)(3)--Form FDA 72 1 72 5 360
3455...........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,075
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Recordkeeping Burden
Under Sec. 54.6 (21 CFR 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 2 years after the date of approval of the
applications. Sponsors of covered studies maintain many
[[Page 68502]]
records regarding 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.
Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours \2\
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping--54.6................................................ 715 1 715 0.25 179
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
Third-Party Disclosure Burden
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 the time
required for this task may range from 5 to 15 minutes; we used the
median, 10 minutes, for the average burden per disclosure (see table
1).
Table 4--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures per Total annual Average burden Total hours \2\
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(b)--Clinical Investigators................................... 13,082 1 13,082 0.17 2,224
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
The burden for this information collection request has changed
since the last OMB approval. Our estimated burden for the information
collection reflects a 298 hour increase. We have adjusted our estimated
burden for the information collection to reflect the number of
submissions we received in the last few years. Additionally, for
products regulated by the Center for Devices and Radiological Health,
we now include De Novo requests as a type of application that may rely
on clinical studies. For products regulated by the Center for Drug
Evaluation and Research, we now include biologics license applications
(BLAs) and BLA efficacy supplements that were inadvertently excluded
from our last information collection request as a type of application.
Dated: November 24, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26182 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P
