Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators, 18371-18373 [2022-06661]
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Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The information
collected by the Project Impact
Assessment Survey is needed for two
main reasons: (1) To collect crucial
information required to report on the
ANA established Government
Performance and Results Act measures,
and (2) to properly abide by ANA’s
congressionally mandated statute (42
U.S.C. 2992 et seq.) found within the
Native American Programs Act of 1974,
as amended, which states that ANA will
evaluate projects assisted through ANA
grant dollars ‘‘including evaluations that
describe and measure the impact of
such projects, their effectiveness in
achieving stated goals, their impact on
related programs, and their structure
and mechanisms for delivery of
services.’’ The information collected
with this survey will fulfill ANA’s
statutory requirement and will also
serve as an important planning and
performance tool for ANA.
Updates to this information collection
address the Indian Community
Economic Enhancement Act of 2020
(Pub. L. 116–261). It also addresses the
flexibilities and assistance offered under
COVID–19 recovery assistance.
Respondents: Tribal Governments,
Native American nonprofit
organizations, and Tribal Colleges and
Universities.
BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ANA Project Outcome Assessment Survey ..................................................
85
1
6
510
Estimated Total Burden Hours: 510.
Authority: 42 U.S.C. 2992.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–06652 Filed 3–29–22; 8:45 am]
BILLING CODE 4184–34–P
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, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
SUMMARY:
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by April 29,
2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0396. Also include
the FDA docket number found in
brackets in the heading of this
document.
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: 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.
In the Federal Register of December 2,
2021 (86 FR 68500), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
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
khammond on DSKJM1Z7X2PROD with NOTICES
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:
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Sfmt 4703
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.
E:\FR\FM\30MRN1.SGM
30MRN1
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Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices
TABLE 1—ESTIMATED NUMBER OF APPLICATIONS, CLINICAL TRIALS, AND INVESTIGATORS SUBJECT TO THE REGULATION
BY TYPE OF APPLICATION 1—Continued
Total
number of
applications
Application type
BLAs .........................................................................................................
BLA efficacy supplements ........................................................................
Medical Devices:
Premarket approval (PMA) ......................................................................
PMA supplement ......................................................................................
Reclassification devices ...........................................................................
510(k) .......................................................................................................
De Novo requests ....................................................................................
1 Source:
Number of
applications
affected
25
102
25
65
39
29
0
3,947
63
39
29
0
247
57
Number of
trials
Number of
investigators
3 to 10 ...........
1 to 3 .............
3 to 100.
10 to 30.
1
1
0
1
1
10 to 20.
3 to 10.
0.
3 to 10.
10 to 20.
to 31 ...........
to 3 .............
.....................
.....................
to 3 .............
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
21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
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
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
records regarding clinical investigators,
Under § 54.6 (21 CFR 54.6), the
sponsors of covered studies must
maintain complete records of
compensation agreements with any
compensation paid to nonemployee
including protocol agreements and
investigator re´sume´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.
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
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
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
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accurate certification or disclosure
statements. Clinical investigators are
accustomed to supplying such
information when applying for research
grants. Also, most people know the
PO 00000
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\30MRN1.SGM
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18373
Federal Register / Vol. 87, No. 61 / Wednesday, March 30, 2022 / Notices
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 BURDEN1
54.4(b)—Clinical Investigators .............................................
1 There
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section
I
13,082
I
1
Average
burden per
disclosure
Total annual
disclosures
I
13,082
I
0.17
Total hours 2
I
2,224
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. Upon review, we have corrected
an inadvertent omission regarding the
number of BLAs and BLA efficacy
supplements received by our Center for
Drug Evaluation and Research and used,
in part, as a basis for calculating the
cumulative burden estimate. We have
corrected that error here, as reflected in
table 1.
Dated: March 24, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation,
and International Affairs, U.S. Food and Drug
Administration.
[FR Doc. 2022–06661 Filed 3–29–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Application for Health Center
Program Recipients for Deemed Public
Health Service Employment With
Liability Protections Under the Federal
Tort Claims Act, 0906–0035, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
SUMMARY:
VerDate Sep<11>2014
17:14 Mar 29, 2022
Jkt 256001
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than April 29, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the acting HRSA
Information Collection Clearance Officer
at paperwork@hrsa.gov or call (301)
443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Application for Health Center Program
Recipients for Deemed Public Health
Service Employment with Liability
Protections Under the Federal Tort
Claims Act (FTCA), OMB No. 0906–
0035—Revision.
Abstract: Section 224(g)–(n) of the
Public Health Service (PHS) Act (42
U.S.C. 233(g)–(n)), as amended,
authorizes the ‘‘deeming’’ of entities
receiving funds under section 330 of the
PHS Act as PHS employees for the
purposes of receiving FTCA coverage.
The Health Center Program is
administered by HRSA’s Bureau of
Primary Health Care (BPHC). Health
centers submit deeming applications
annually to BPHC in the prescribed
form and manner in order to obtain
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
deemed PHS employee status for this
purpose.
The FTCA Program has a web-based
application system, the Electronic
Handbooks. These electronic
application forms decrease the time and
effort required to complete the older,
paper-based OMB approved FTCA
application forms. The application
includes: Contact Information; Section
1: Review of Risk Management Systems;
Section 2: Quality Improvement/Quality
Assurance; Section 3: Credentialing and
Privileging; Section 4: Claims
Management; and Section 5: Additional
Information, Certification, and
Signatures.
HRSA is proposing several changes to
the Application for Health Center
Program Award Recipients for Deemed
PHS Employment with Liability
Protections under the FTCA, to be used
for health center deeming applications
for calendar year 2022 and thereafter, to
clarify questions posed and required
documentation. Specifically, the
Application includes the following
proposed changes:
• Updated application language:
Throughout the application, alternate
terminology was utilized to provide
greater clarity and specificity. These
changes were based on stakeholder
feedback and information received from
the HRSA Health Center Program
Support. These changes are not
substantive in nature.
• Some questions were removed from
Quality Improvement/Quality
Assurance Section, as these questions
are similar to information that is also
collected in the Risk Management
Section. This change is intended to
reduce duplicative information
collection.
• For the Credentialing and
Privileging Section, in this cycle, the
application will return to the previous
process of submitting a Credentialing
List with providers’ credentialing and
privileging information.
A 60-day notice published in the
Federal Register, 86 Fed Reg. 72250
(December 21, 2021). There were no
public comments.
E:\FR\FM\30MRN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Pages 18371-18373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06661]
-----------------------------------------------------------------------
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, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by April 29, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0396. Also include the FDA docket
number found in brackets in the heading of this document.
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: 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.
In the Federal Register of December 2, 2021 (86 FR 68500), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
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:
[[Page 18372]]
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 1 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.
----------------------------------------------------------------------------------------------------------------
\1\ 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 records
regarding 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.
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
[[Page 18373]]
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 Burden1
--------------------------------------------------------------------------------------------------------------------------------------------------------
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. Upon review, we have corrected an inadvertent
omission regarding the number of BLAs and BLA efficacy supplements
received by our Center for Drug Evaluation and Research and used, in
part, as a basis for calculating the cumulative burden estimate. We
have corrected that error here, as reflected in table 1.
Dated: March 24, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-06661 Filed 3-29-22; 8:45 am]
BILLING CODE 4164-01-P
