[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Pages 1363-1365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00354]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: Fax written comments on the collection of information by 
February 12, 2018.

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 <a href="/cdn-cgi/l/email-protection#dcb3b5aebd83afa9beb1b5afafb5b3b29cb3b1bef2b9b3acf2bbb3aa"><span class="__cf_email__" data-cfemail="16797f6477496563747b7f65657f797856797b743873796638717960">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0616. 
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, 
<a href="/cdn-cgi/l/email-protection#29797b687a5d484f4f694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="dc8c8e9d8fa8bdbaba9cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a>.

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 February 28, 2019, and 
OMB control number 0910-0001, expiring December 31, 2017; 21 CFR parts 
312 and 601 (biological products), OMB control number 0910-0014, 
expiring February 28, 2019, and OMB control number 0910-0338, expiring 
March 31, 2020; and 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, 2020.
    Title VIII of the Food and Drug Administration Amendments Act of 
2007 (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 databank, 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. The 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. In 2017, we updated the 
guidance to include references to the NIH Final Rule implementing 
402(j) of the PHS Act (42 U.S.C. 282(j)). The final rule, published on 
September 21, 2016 (81 FR 64982) (42 CFR part 11), clarifies the 
requirements for submission of clinical trial information to https://clinicaltrials.gov.
    Investigational New Drug Applications. FDA's Center for Drug 
Evaluation and Research (CDER) received 1,669 investigational new drug 
applications (INDs) and 15,285 clinical protocol IND amendments in 
calendar year (CY) 2016. 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 
381 new

[[Page 1364]]

INDs and 456 clinical protocol IND amendments in CY 2016. 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 protocol submissions) 
subject to mandatory certification requirements under section 
402(j)(5)(B) of the PHS Act is 16,954 for CDER plus 837 for CBER, or 
17,791 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 an 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 2016, CDER and CBER 
received 252 new drug applications (NDA)/biologics license applications 
(BLA)/resubmissions and 1,067 NDA/BLA amendments for which 
certifications are needed. CDER and CBER received 253 efficacy 
supplements/resubmissions to previously approved NDAs/BLAs in CY 2016. 
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 330 new applications for premarket approvals (PMA), 510(k) 
submissions containing clinical information, PMA supplements, 
applications for humanitarian device exemptions (HDE) and amendments in 
CY 2016. CDRH anticipates that application, amendment, supplement, and 
annual report submission rates will remain at or near this level in the 
near future.
    FDA's Office of Generic Drugs (OGD) received 1,036 abbreviated new 
drug applications (ANDAs) in 2016. OGD received 698 bioequivalence 
amendments/supplements in 2016. OGD anticipates that application, 
amendment, and supplement 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 that 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 September 22, 2017 (82 FR 44417), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                         Number of        Number of
                                        respondents      respondents      Number of     Total annual
        FDA Center/Activity          (investigational    (marketing     responses per     responses       Average burden per response       Total hours
                                       applications)    applications)    respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CDER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND).............            1,669   ..............               1           1,669  0.25 (15 minutes)................             417
Clinical Protocol Amendments (IND).           15,285   ..............               1          15,285  0.25 (15 minutes)................           3,821
New Marketing Applications/          ................             198               1             198  0.75 (45 minutes)................             149
 Resubmissions (NDA/BLA).
Clinical Amendments to Marketing     ................           1,067               1           1,067  0.75 (45 minutes)................             800
 Applications.
Efficacy Supplements/ Resubmissions  ................             219               1             219  0.75 (45 minutes)................             164
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CBER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND).............              381   ..............               1             381  0.25 (15 minutes)................              95
Clinical Protocol Amendments (IND).              456   ..............               1             456  0.25 (15 minutes)................             114
New Marketing Applications/          ................              54               1              54  0.75 (45 minutes)................              41
 Resubmissions (NDA/BLA).
Clinical Amendments to Marketing     ................               0               1               0  0.75 (45 minutes)................               0
 Applications.
Efficacy Supplements/ Resubmissions  ................              34               1              34  0.75 (45 minutes)................              26
 (BLA only).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CDRH
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Marketing Applications           ................             330               1             330  0.75 (45 minutes)................             247
 (includes PMAs, HDEs, Supplements
 and 510(k)s expected to contain
 clinical data).
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 1365]]

 
                                                                           OGD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Original Applications..............  ................           1,036               1  ..............  0.75 (45 minutes)................             777
Bioequivalence Supplements/          ................             698               1  ..............  0.75 (45 minutes)................             524
 Amendments.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ................  ..............  ..............  ..............  .................................           7,175
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: January 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00354 Filed 1-10-18; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>