Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators, 48819-48822 [2018-21039]
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daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR,
Email: OIRA_submission@
omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Pre-Claim
Review Demonstration for Home Health
Services; Use: Section 402(a)(1)(J) of the
Social Security Amendments of 1967
(42 U.S.C. 1395b–1(a)(1)(J)) authorizes
the Secretary to ‘‘develop or
demonstrate improved methods for the
investigation and prosecution of fraud
in the provision of care or services
under the health programs established
by the Social Security Act (the Act).’’
Pursuant to this authority, the CMS
seeks to develop and implement a
Medicare demonstration project, which
CMS believes will help assist in
developing improved procedures for the
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identification, investigation, and
prosecution of Medicare fraud occurring
among Home Health Agencies (HHA)
providing services to Medicare
beneficiaries.
This revised demonstration would
help assist in developing improved
procedures for the identification,
investigation, and prosecution of
potential Medicare fraud. The
demonstration would help make sure
that payments for home health services
are appropriate through either pre-claim
or postpayment review, thereby working
towards the prevention and
identification of potential fraud, waste,
and abuse; the protection of Medicare
Trust Funds from improper payments;
and the reduction of Medicare appeals.
CMS proposes initially implementing
the demonstration in Illinois, Ohio,
North Carolina, Florida, and Texas with
the option to expand to other states in
the Palmetto/JM jurisdiction. CMS
proposes starting the demonstration in
Illinois on December 10, 2018. Under
this demonstration, CMS proposes to
offer choices for providers to
demonstrate their compliance with
CMS’ home health policies. Providers in
the demonstration states may participate
in either 100 percent pre-claim review
or 100 percent postpayment review.
These providers will continue to be
subject to a review method until the
HHA reaches the target affirmation or
claim approval rate. Once a HHA
reaches the target pre-claim review
affirmation or post-payment review
claim approval rate, it may choose to be
relieved from claim reviews, except for
a spot check of their claims to ensure
continued compliance. Providers who
do not wish to participate in either 100
percent pre-claim or postpayment
reviews have the option to furnish home
health services and submit the
associated claim for payment without
undergoing such reviews; however, they
will receive a 25 percent payment
reduction on all claims submitted for
home health services and may be
eligible for review by the Recovery
Audit Contractor.
The information required under this
collection is required by Medicare
contractors to determine proper
payment or if there is a suspicion of
fraud. Under the pre-claim review
option, HHA will send the pre-claim
review request along with all required
documentation to the Medicare
contractor for review prior to submitting
the final claim for payment. If a claim
is submitted without a pre-claim review
decision on file, the Medicare contractor
will request the information from the
HHA to determine if payment is
appropriate. For the postpayment
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48819
review option, the Medicare contractor
will also request the information from
the HHA that submitted the claim for
payment, to determine if payment was
appropriate. Comments were received in
response to the 60-day notice. Form
Number: CMS–10599 (OMB control
number: 0938–1311); Frequency:
Occasionally; Affected Public: Private
Sector (Business or other for-profits and
Not-for-profits); Number of
Respondents: 941,287; Total Annual
Responses: 1,330,980; Total Annual
Hours: 670,375. (For questions regarding
this collection contact Jennifer
McMullen (410) 786–7635).
Dated: September 21, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–20994 Filed 9–26–18; 8:45 am]
BILLING CODE 4120–01–P
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 or Agency) 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 information
collections regarding financial
disclosure by clinical investigators.
DATES: Submit either electronic or
written comments on the collection of
information by November 26, 2018.
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 November 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
SUMMARY:
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
at the end of November 26, 2018.
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.
daltland on DSKBBV9HB2PROD with NOTICES
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
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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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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.
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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.
SUPPLEMENTARY INFORMATION:
Financial Disclosure by Clinical
Investigators—21 CFR Part 54
OMB Control Number 0910–0396—
Extension
Respondents to this collection are
sponsors of marketing applications that
contain clinical data from studies
covered by the applicable 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.
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
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 ............................................................................
Biologics:
Biologics license application (BLA) ..........................................................
BLA efficacy supplement .........................................................................
Medical Devices:
Premarket approval (PMA) ...............................................................
PMA supplement ...............................................................................
Reclassification devices ....................................................................
510(k) ................................................................................................
1 Source:
Number of
applications
affected
Number of
trials
Number of
investigators
35
26
3 to 10 ...........
3 to 100.
173
1,152
6,774
86
250
383
1 to 3 .............
1.1 ..................
1 .....................
10 to 30.
2.
2.
22
16
19
14
3 to 10 ...........
1 to 3 .............
3 to 100.
10 to 30.
48
23
3
4,000
48
23
1
200
1
1
1
1
10 to 20.
3 to 10.
3 to 10.
3 to 10.
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
responses per
respondent
Number of
respondents
21 CFR section
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 ...........................
1,050
105
1
1
1,050
105
1
5
1,050
525
Total ..............................................................................
........................
........................
........................
........................
1,575
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping Burden
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 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 re´sume´s or curriculum
vitae. FDA estimates that 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
recordkeepers
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21 CFR section
Recordkeeping—54.6 .......................
1 There
Number of
records per
recordkeeper
1,050
Total annual
records
1
1,050
Average burden per recordkeeping
0.25 (15 minutes) .............................
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
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Total hours 2
263
48822
Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
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 mean,
10 minutes, for the average burden per
disclosure. The number of respondents
is the sum of the number of affected
applications multiplied by the mean
(rounded) of the estimated number of
investigators for each application type
(see table 1).
TABLE 4—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
7,894
Total annual
disclosures
1
7,894
Average burden per disclosure
0.17 (10 minutes) .............................
Total hours 2
1,342
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Our estimated burden for the
information collection reflects an
overall increase of 222 hours and a
corresponding increase of 893
responses/records. We attribute this
adjustment to an increase in the number
of affected applications and the number
of investigators. No program changes
were made.
Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21039 Filed 9–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2969]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Assessment of
Combination Product Review Practices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a proposed
information collection involving
interviews with entities that submit a
Request for Designation (RFD) or preRFD, an Investigational New Drug (IND)
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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Jkt 244001
application or pre-IND request, or a New
Drug Application (NDA) or Biologics
License Application (BLA) for a
combination product to FDA.
Submit either electronic or
written comments on the collection of
information by November 26, 2018.
DATES:
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 November 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 26, 2018.
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.
ADDRESSES:
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.
PO 00000
Frm 00030
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• 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–
2018–N–2969 for ‘‘Assessment of
Combination Product Review
Practices.’’ 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.
• 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
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]]>Agencies
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48819-48822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21039]
-----------------------------------------------------------------------
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 or Agency) 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 information collections regarding financial
disclosure by clinical investigators.
DATES: Submit either electronic or written comments on the collection
of information by November 26, 2018.
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 November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time
[[Page 48820]]
at the end of November 26, 2018. 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.
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.gpo.gov/fdsys/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.
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. 3501-3520), 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--21 CFR Part 54
OMB Control Number 0910-0396--Extension
Respondents to this collection are sponsors of marketing
applications that contain clinical data from studies covered by the
applicable 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.
[[Page 48821]]
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), 35 26 3 to 10............... 3 to 100.
new molecular entity (NME).
NDA non-NME:
NDA efficacy supplement. 173 86 1 to 3................ 10 to 30.
Abbreviated new drug 1,152 250 1.1................... 2.
application (ANDA).
ANDA supplement......... 6,774 383 1..................... 2.
Biologics:
Biologics license 22 19 3 to 10............... 3 to 100.
application (BLA).
BLA efficacy supplement..... 16 14 1 to 3................ 10 to 30.
Medical Devices:
Premarket approval (PMA) 48 48 1 to 3................ 10 to 20.
PMA supplement.......... 23 23 1 to 3................ 3 to 10.
Reclassification devices 3 1 1..................... 3 to 10.
510(k).................. 4,000 200 1..................... 3 to 10.
----------------------------------------------------------------------------------------------------------------
\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 1,050 1 1,050 1 1,050
(2)--Form FDA 3454.............
Disclosure--54.4(a)(3)--Form FDA 105 1 105 5 525
3455...........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,575
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Recordkeeping Burden
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 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 that 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
recordkeepers recordkeeper records recordkeeping \2\
----------------------------------------------------------------------------------------------------------------
Recordkeeping--54.6........... 1,050 1 1,050 0.25 (15 263
minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers have been rounded.
[[Page 48822]]
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
mean, 10 minutes, for the average burden per disclosure. The number of
respondents is the sum of the number of affected applications
multiplied by the mean (rounded) of the estimated number of
investigators for each application type (see table 1).
Table 4--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure \2\
----------------------------------------------------------------------------------------------------------------
54.4(b)--Clinical 7,894 1 7,894 0.17 (10 1,342
Investigators. minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers have been rounded.
Our estimated burden for the information collection reflects an
overall increase of 222 hours and a corresponding increase of 893
responses/records. We attribute this adjustment to an increase in the
number of affected applications and the number of investigators. No
program changes were made.
Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21039 Filed 9-26-18; 8:45 am]
BILLING CODE 4164-01-P
