[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]


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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.

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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\
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                                   Total number      Number of
        Application type                of         applications      Number of trials            Number of
                                   applications      affected                                  investigators
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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.
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\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\
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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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...........................
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    Total.......................  ..............  ..............  ..............  ..............           1,575
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\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\
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                                                   Number of                     Average burden
        21 CFR section             Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping         \2\
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Recordkeeping--54.6...........           1,050               1           1,050  0.25 (15                     263
                                                                                 minutes).
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\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\
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                                                   Number of
        21 CFR section             Number of      disclosures    Total annual    Average burden     Total hours
                                  respondents   per respondent    disclosures    per disclosure         \2\
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54.4(b)--Clinical                        7,894               1           7,894  0.17 (10                   1,342
 Investigators.                                                                  minutes).
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\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