
[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38905-38908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0144]


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 Paperwork Reduction Act of 1995 
(the 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

[[Page 38906]]

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 September 8, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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. 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 is already 
approved by OMB. The OMB control numbers and expiration dates for 
submitting FDA 3674 under the following parts are: 21 CFR parts 312 and 
314 (human drugs) are 0910-0014, expiring April 30, 2015, and 0910-
0001, expiring September 30, 2014; 21 CFR parts 312 and 601 (biological 
products) are 0910-0014 and 0910-0338, expiring January 31, 2017; 21 
CFR parts 807 and 814 (devices) are 0910-0120, expiring January 31, 
2017, and 0910-0231, expiring January 31, 2017.
    Title VIII of the Food and Drug Administration Amendments Act of 
2007 (Public Law 110-85) amended the PHS Act by adding section 402(j). 
The provisions require additional information to be submitted to the 
clinical trials data bank, http://www.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/National Library of Medicine, including expanded information on 
clinical trials and information on the results of 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.
    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.
    In January 2009, FDA issued ``Guidance for Sponsors, Industry, 
Researchers, Investigators, and Food and Drug Administration Staff--
Certifications to Accompany Drug, Biological Product, and Device 
Applications/Submissions: Compliance With Section 402(j) of The Public 
Health Service Act, Added By Title VIII of the Food and Drug 
Administration Amendments Act of 2007'' available at http://www.fda.gov/regulatoryInformation/guidances/ucm125335.htm. This 
guidance identified the applications and submissions that FDA 
considered should be accompanied by the certification form, Form FDA 
3674. The applications and submissions noted in the guidance are 
reflected in the burden analysis.

Investigational New Drug Applications

    FDA's Center for Drug Evaluation and Research (CDER) received 1,564 
investigational new drug applications (INDs) and 14,328 clinical 
protocol IND amendments in calendar year (CY) 2013. 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 
451 new INDs and 492 clinical protocol IND amendments in CY 2013. 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

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mandatory certification requirements under section 402(j)(5)(B) of the 
PHS Act, is 15,892 for CDER plus 943 for CBER, or 16,835 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 which 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 
http://www.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 2013, CDER and CBER received 226 new drug applications (NDA)/
biologics license applications (BLA)/resubmissions and 932 NDA/BLA 
amendments for which certifications are needed. CDER and CBER received 
198 efficacy supplements/resubmissions to previously approved NDAs/BLAs 
in CY 2013. 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 530 new applications for premarket approvals (PMA), 510(k) 
submissions containing clinical information, PMA supplements, 
applications for humanitarian device exemptions (HDE) and amendments in 
CY 2013. 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 1,001 abbreviated new 
drug applications (ANDAs) in 2013. OGD received 989 bioequivalence 
amendments/supplements in 2013. 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 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).............            1,564   ..............               1           1,546  0.25 (15 minutes)................             387
Clinical Protocol Amendments (IND).           14,328   ..............               1          14,328  0.25 (15 minutes)................           3,582
New Marketing Applications/          ................             191               1             191  0.75 (45 minutes)................             143
 Resubmissions (NDA/BLA).
Clinical Amendments to Marketing     ................             932               1             932  0.75 (45 minutes)................             699
 Applications.
Efficacy Supplements/Resubmissions.  ................             173               1             173  0.75 (45 minutes)................             130
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                                                                          CBER
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New Applications (IND).............              451   ..............               1             451  0.25 (15 minutes)................             113
Clinical Protocol Amendments (IND).              492   ..............               1             492  0.25 (15 minutes)................             123
New Marketing Applications/          ................              35               1              35  0.75 (45 minutes)................              26
 Resubmissions (NDA/BLA).
Clinical Amendments to Marketing     ................               0               1               0  0.75 (45 minutes)................               1
 Applications.
Efficacy Supplements/Resubmissions   ................              25               1              25  0.75 (45 minutes)................              19
 (BLA only).
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                                                                          CDRH
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New Marketing Applications           ................             530               1             530  0.75 (45 minutes)................             398
 (includes PMAs, HDEs, Supplements
 and 510(k)s expected to contain
 clinical data).
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                                                                           OGD
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Original Applications..............  ................           1,001               1           1,001  0.75 (45 minutes)................             751
BE Supplements/Amendments..........  ................             989               1             989  0.75 (45 minutes)................             742
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    Total..........................  ................  ..............  ..............  ..............  .................................           7,114
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15992 Filed 7-8-14; 8:45 am]
BILLING CODE 4164-01-P


