
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44417-44420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the

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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 the 
requirements for certain FDA applications or submissions to be 
accompanied by a certification, Form FDA 3674, to ensure all applicable 
statutory requirements have been met.

DATES: Submit either electronic or written comments on the collection 
of information by November 21, 2017.

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 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 21, 2017. 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-2011-N-0275 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Certification to Accompany Drug, 
Biological Product, and Device Applications or Submissions.'' 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, 
PRAStaff@fda.hhs.gov.

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.

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.

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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; 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 (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 Web site address, but FDA is not responsible for 
any subsequent changes to the Web site 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 (the 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. 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 (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 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 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 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

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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.
    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 annual
         FDA center activity           (investigational    (marketing     responses per     responses      Average burden per response      Total hours
                                         applications)    applications)    respondent
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                                                                          CDER
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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
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                                                                          CBER
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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).
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                                                                          CDRH
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New Marketing Applications (includes   ................             330               1             330  0.75 (45 minutes)..............             247
 PMAs, HDEs, Supplements and 510(k)s
 expected to contain clinical data).
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                                                                           OGD
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Original Applications................  ................           1,036               1  ..............  0.75 (45 minutes)..............             777
Bioequivalence Supplements/Amendments  ................             698               1  ..............  0.75 (45 minutes)..............             524
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    Total............................  ................  ..............  ..............  ..............  ...............................           7,175
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20227 Filed 9-21-17; 8:45 am]
 BILLING CODE 4164-01-P


