Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions, 38905-38908 [2014-15992]
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–15927 Filed 7–8–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Methodology for Determining
Whether an Increase in a State’s Child
Poverty Rate is the Result of the TANF
Program
OMB No.: 0970–0186
Description
In accordance with Section 413(i) of
the Social Security Act and 45 CFR part
284, the Department of Health and
Human Services (HHS) intends to
extend without change the following
information collection requirements.
For instances when Census Bureau data
show that a States child poverty rate
increased by 5 percent or more from one
year to the next, a State may submit
independent estimates of its child
poverty rate. If HHS determines that the
States independent estimates are not
more reliable than the Census Bureau
estimates, HHS will require the State to
submit an assessment of the impact of
the TANF program(s) in the State on the
child poverty rate. If HHS determines
from the assessment and other
information that the child poverty rate
in the State increased as a result of the
TANF program(s) in the State, HHS will
then require the State to submit a
corrective action plan.
Respondents
The respondents are the 50 States and
the District of Columbia. When reliable
Census Bureau data become available
for the Territories, additional
respondents might include Guam,
Puerto Rico, and the Virgin Islands.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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Optional Submission of Data on Child Poverty from an Independent Source
Assessment of the Impact of TANF on the Increase in Child Poverty ...........
Corrective Action Plan .....................................................................................
Estimated Total Annual Burden
Hours: 14,688.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
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Number of
responses per
respondent
51
51
51
Average
burden hours
per response
1
1
1
Total burden
hours
8
120
160
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
AGENCY:
[FR Doc. 2014–15944 Filed 7–8–14; 8:45 am]
ACTION:
BILLING CODE 4184–01–P
SUMMARY:
408
6,120
8,160
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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
Food and Drug Administration,
HHS.
Notice.
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
Sfmt 4703
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
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 https://
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
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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, https://
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
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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
https://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 https://
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
38907
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
Number of
respondents
(investigational
applications)
FDA center activity
Number of
respondents
(marketing
applications)
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
CDER
New Applications (IND) ................
1,564
Clinical Protocol Amendments
14,328
(IND).
New Marketing Applications/R Re- ........................
submissions (NDA/BLA).
Clinical Amendments to Mar- ........................
keting Applications.
Efficacy Supplements/Resubmis- ........................
sions.
........................
........................
1
1
1,546
14,328
0.25 (15 minutes) ......
0.25 (15 minutes) ......
387
3,582
191
1
191
0.75 (45 minutes) ......
143
932
1
932
0.75 (45 minutes) ......
699
173
1
173
0.75 (45 minutes) ......
130
CBER
New Applications (IND) ................
Clinical Protocol Amendments
(IND).
New Marketing Applications/Resubmissions (NDA/BLA).
Clinical Amendments to Marketing Applications.
Efficacy Supplements/Resubmissions (BLA only).
451
492
........................
........................
1
1
451
492
0.25 (15 minutes) ......
0.25 (15 minutes) ......
113
123
........................
35
1
35
0.75 (45 minutes) ......
26
........................
0
1
0
0.75 (45 minutes) ......
1
........................
25
1
25
0.75 (45 minutes) ......
19
1
530
0.75 (45 minutes) ......
398
1
1
1,001
989
0.75 (45 minutes) ......
0.75 (45 minutes) ......
751
742
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CDRH
New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to
contain clinical data).
........................
530
OGD
Original Applications ....................
BE Supplements/Amendments ....
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........................
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989
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
(investigational
applications)
FDA center activity
Total ......................................
1 There
Number of
respondents
(marketing
applications)
Number of
responses per
respondent
Total annual
responses
Average burden
per response
........................
........................
........................
........................
....................................
[FR Doc. 2014–15992 Filed 7–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0852]
Draft Guidance for Industry: Design
and Analysis of Shedding Studies for
Virus or Bacteria-Based Gene Therapy
and Oncolytic Products; Availability
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Design and
Analysis of Shedding Studies for Virus
or Bacteria-Based Gene Therapy and
Oncolytic Products’’ dated July 2014.
The draft guidance document provides
sponsors of virus or bacteria-based gene
therapy products (VBGT products) and
oncolytic viruses or bacteria (oncolytic
products) with recommendations on
how to conduct shedding studies during
preclinical and clinical development.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 19,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
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20:08 Jul 08, 2014
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
Notice.
SUMMARY:
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7,114
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.
AGENCY:
Total hours
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FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Design and Analysis of
Shedding Studies for Virus or BacteriaBased Gene Therapy and Oncolytic
Products’’ dated July 2014. The draft
guidance document provides sponsors
of oncolytic and VBGT products with
recommendations on how to conduct
shedding studies during preclinical and
clinical development. Oncolytic and
VBGT products are derived from
infectious viruses or bacteria. In general,
these product-based viruses and bacteria
are not as infectious or as virulent as the
parent strain of virus or bacterium.
Nonetheless, FDA is issuing this
guidance because the possibility that
infectious product-based viruses and
bacteria may be shed by a patient raises
safety concerns related to the risk of
transmission to untreated individuals.
To understand the risk associated with
product shedding, sponsors should
collect data in the target patient
population in clinical trials before
licensure.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
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of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 600 have
been approved under OMB control
number 0910–0308; the collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338; and the collections
of information in 21 CFR part 50 have
been approved under OMB control
number 0910–0755.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit either electronic comments
regarding this document to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15991 Filed 7–8–14; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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, https://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 https://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
[[Page 38907]]
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
https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)............. 1,564 .............. 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Marketing Applications ................ 530 1 530 0.75 (45 minutes)................ 398
(includes PMAs, HDEs, Supplements
and 510(k)s expected to contain
clinical data).
--------------------------------------------------------------------------------------------------------------------------------------------------------
OGD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Original Applications.............. ................ 1,001 1 1,001 0.75 (45 minutes)................ 751
BE Supplements/Amendments.......... ................ 989 1 989 0.75 (45 minutes)................ 742
--------------------------------------------------------------------------------------------------------------------
[[Page 38908]]
Total.......................... ................ .............. .............. .............. ................................. 7,114
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
