[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38905-38908]
From the Federal Register Online via the Government Publishing 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
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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, [email protected].
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