
[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7388-7390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03828]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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: Fax written comments on the collection of information by April 
3, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 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.
    Table 1 of this document 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\
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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:

[[Page 7389]]

 
    New drug application (NDA),               35              26  3 to 10...............  3 to 100.
     new molecular entity (NME).
    NDA nonNME:
        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.

    In the Federal Register of September 27, 2018 (83 FR 48819), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment, however, it was 
not responsive to the four collection of information topics solicited 
and therefore this comment will not be discussed in this document.
    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 (a)(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
 (a)(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 resumes or curriculum 
vitae. FDA estimates that an average of 15 minutes will be required for 
each recordkeeper to add this record to the clinical investigator's 
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 \2\
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Recordkeeping--54.6................................................           1,050                1            1,050             0.25              263
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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 7390]]

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 of the estimated number of investigators for 
each application type (rounded) (see table 1 of this document).

                                               Table 4--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                           21 CFR section                               Number of     disclosures per    Total annual    Average burden  Total hours \2\
                                                                       respondents       respondent      disclosures     per disclosure
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54.4(b)--Clinical Investigators....................................           7,894                1            7,894             0.17            1,342
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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: February 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03828 Filed 3-1-19; 8:45 am]
 BILLING CODE 4164-01-P


