[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10104-10106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0275]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Certification To 
Accompany Drug, Biological Product, and Device Applications or 
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 March 22, 2021.

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 0910-0616. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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.

Certification To Accompany Drug, Biological Product, and Device 
Applications or Submissions (Form FDA 3674)

OMB Control Number 0910-0616--Extension

    The information required under section 402(j)(5)(B) of the Public 
Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in 
the form of a certification, Form FDA 3674, which accompanies 
applications and submissions currently submitted to FDA and already 
approved by OMB. The OMB control numbers and expiration dates for those 
applications and submissions are: 21 CFR parts 312 and 314 (human 
drugs), OMB control number 0910-0014, expiring March 31, 2022, and OMB 
control number 0910-0001, expiring March 31, 2021; 21 CFR parts 312 and 
601 (biological products), OMB control number 0910-0014, expiring March 
31, 2022, and OMB control number 0910-0338, expiring February 28, 2023; 
21 CFR parts 807 and 814 (devices), OMB control number 0910-0120, 
expiring June 30, 2020, and OMB control number 0910-0231, expiring 
March 31, 2023.
    Title VIII of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) (Pub. L. 110-85) amended the PHS Act by adding section 
402(j). The provisions broadened the scope of clinical trials subject 
to submitting information and required additional information to be 
submitted to the clinical trials databank (https://clinicaltrials.gov/) 
(FDA has verified the website address, but FDA is not responsible for 
any subsequent changes to the website after this document publishes in 
the Federal Register) previously established by the National Institutes 
of Health (NIH)/National Library of Medicine. This includes expanded 
information on applicable clinical trials and summary information on 
the results of certain clinical trials. The provisions include 
responsibilities for FDA as well as several amendments to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act).
    One provision, section 402(j)(5)(B) of the PHS Act, requires that a 
certification accompany human drug, biological, and device product 
submissions made to FDA. Specifically, at the time of submission of an 
application under sections 505, 515, or 520(m) of the FD&C Act (21 
U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42 
U.S.C. 262), or submission of a report under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)), such application or submission must be 
accompanied by a certification, Form FDA 3674, that all applicable 
requirements of section 402(j) of the PHS Act have been met. Where 
available, such certification must include the appropriate National 
Clinical Trial (NCT) numbers that are assigned upon submission of 
required information to the NIH databank at https://clinicaltrials.gov/
.
    The proposed extension of the collection of information is 
necessary to satisfy the previously mentioned statutory requirement. 
The importance of obtaining these data relates to adherence to the 
legal requirements for submissions to the clinical trials registry and 
results data bank and ensuring that individuals and organizations 
submitting applications or reports to FDA under the listed provisions 
of the FD&C Act or the PHS Act adhere to the appropriate legal and 
regulatory requirements for certifying to having complied with those 
requirements. The failure to submit the certification required by 
section 402(j)(5)(B) of the PHS Act, and the knowing submission of a 
false certification, are both prohibited acts under section 301 of the 
FD&C Act (21 U.S.C. 331). Violations are subject to civil money 
penalties. Form FDA 3674 provides a convenient mechanism for sponsors/
applicants/submitters to satisfy the certification requirements of the 
statutory provision.
    To assist sponsors/applicants/submitters in understanding the 
statutory requirements associated with Form FDA 3674, we have provided 
a guidance available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This guidance recommends the applications and 
submissions FDA considers should be accompanied by the certification 
form, Form FDA 3674. The applications and submissions identified in the 
guidance are reflected in the burden analysis. FDA last updated this 
guidance in 2017.
    Investigational New Drug Applications. FDA's Center for Drug 
Evaluation and Research (CDER) received 1,661 investigational new drug 
applications (INDs) and 11,328 clinical protocol IND amendments in 
calendar year (CY) 2019. CDER anticipates that IND and clinical 
protocol amendment submission rates will remain at or near this level 
in the near future.
    FDA's Center for Biologics Evaluation and Research (CBER) received 
639 new INDs and 581 clinical protocol IND amendments in CY 2019. CBER 
anticipates that IND and clinical protocol amendment submission rates 
will remain at or near this level in the near future. The estimated 
total number of submissions (new INDs and new

[[Page 10105]]

protocol submissions) subject to mandatory certification requirements 
under section 402(j)(5)(B) of the PHS Act, is 12,989 for CDER plus 
1,220 for CBER, or 14,209 submissions per year. The minutes per 
response is the estimated number of minutes that a respondent would 
spend preparing the information to be submitted to FDA under section 
402(j)(5)(B) of the PHS Act, including the time it takes to enter the 
necessary information on the form.
    Based on its experience with current submissions, FDA estimates 
that approximately 15 minutes on average would be needed per response 
for certifications that accompany IND applications and clinical 
protocol amendment submissions. It is assumed that most submissions to 
investigational applications will reference only a few protocols for 
which the sponsor/applicant/submitter has obtained a NCT number from 
https://clinicaltrials.gov/ prior to making the submission to FDA. It 
is also assumed that the sponsor/applicant/submitter has electronic 
capabilities allowing them to retrieve the information necessary to 
complete the form in an efficient manner.
    Marketing Applications/Submissions. In CY 2019, CDER and CBER 
received 252 new drug applications (NDA)/biologics license applications 
(BLA)/premarket approvals (PMA)/resubmissions and 701 NDA/BLA 
amendments for which certifications are needed. CDER and CBER received 
295 efficacy supplements/resubmissions to previously approved NDAs/BLAs 
in CY 2019. CDER and CBER received 893 abbreviated new drug 
applications (ANDAs) in CY 2019. CDER received 765 bioequivalence 
amendments/supplements in CY 2019. CDER and CBER anticipate that new 
drug/biologic applications/resubmissions and efficacy supplement 
submission rates will remain at or near this level in the near future.
    FDA's Center for Devices and Radiological Health (CDRH) received a 
total of 324 new applications for PMA, 510(k) submissions containing 
clinical information, PMA supplements, applications for humanitarian 
device exemptions (HDE) and amendments in CY 2019. CDRH anticipates 
that application, amendment, supplement, and annual report submission 
rates will remain at or near this level in the near future.
    Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s, 
and ANDAs and experience with current submissions of Form FDA 3674, FDA 
estimates that approximately 45 minutes on average would be needed per 
response for certifications which accompany NDA, BLA, PMA, HDE, 510(k), 
and ANDA marketing applications and submissions. It is assumed that the 
sponsor/applicant/submitter has electronic capabilities allowing them 
to retrieve the information necessary to complete the form in an 
efficient manner.
    In the Federal Register of May 14, 2020 (85 FR 28955), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
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                                               Number of        Number of
                                              respondents      respondents      Number of       Total                                            Total
           FDA; center activity            (investigational    (marketing     responses per    annual        Average  burden per  response       hours
                                             applications)    applications)    respondent     responses
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                                                                          CDER
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New Applications (IND)...................            1,661   ..............               1       1,661  0.25 (15 minutes)...................        415
Clinical Protocol Amendments (IND).......           11,328   ..............               1      11,328  0.25 (15 minutes)...................      2,832
New Marketing Applications/Resubmissions   ................             220               1         220  0.75 (45 minutes)...................        165
 (NDA/BLA).
Clinical Amendments to Marketing           ................             701               1         701  0.75 (45 minutes)...................        526
 Applications.
Efficacy Supplements/Resubmissions.......  ................             257               1         257  0.75 (45 minutes)...................        193
Abbreviated New Drug Applications (ANDA)-- ................             892               1         892  0.75 (45 minutes)...................        669
 Original Applications.
ANDA Bioequivalence Supplements/           ................             765               1         765  0.75 (45 minutes)...................        573
 Amendments.
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                                                                          CBER
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New Applications (IND)...................              639   ..............               1         639  0.25 (15 minutes)...................        160
Clinical Protocol Amendments (IND).......              581   ..............               1         581  0.25 (15 minutes)...................        145
New Marketing Applications/Resubmissions   ................              32               1          32  0.75 (45 minutes)...................         24
 (NDA/BLA/PMA).
Clinical Amendments to Marketing           ................               0               1           0  0.75 (45 minutes)...................          0
 Applications.
Efficacy Supplements/Resubmissions (BLA    ................              38               1          38  0.75 (45 minutes)...................         28
 only).
Abbreviated New Drug Applications (ANDA)-- ................               1               1           1  0.75 (45 minutes)...................          1
 Original Applications.
ANDA Bioequivalence Supplements/           ................               0               1           0  0.75 (45 minutes)...................          0
 Amendments.
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                                                                          CDRH
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New Marketing Applications (includes       ................             324               1         324  0.75 (45 minutes)...................        243
 PMAs, HDEs, Supplements and 510(k)s
 expected to contain clinical data).
Total....................................  ................  ..............  ..............  ..........  ....................................      5,974
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 10106]]

    Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03243 Filed 2-17-21; 8:45 am]
BILLING CODE 4164-01-P