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, 1363-1365 [2018-00354]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices
Board of Governors of the Federal Reserve
System, January 8, 2018.
Ann E. Misback,
Secretary of the Board.
Certification To Accompany Drug,
Biological Product, and Device
Applications or Submissions (Form
FDA 3674)
[FR Doc. 2018–00341 Filed 1–10–18; 8:45 am]
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
BILLING CODE P
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.
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.
SUMMARY:
Fax written comments on the
collection of information by February
12, 2018.
DATES:
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 oira_
submission@omb.eop.gov. 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.
ADDRESSES:
srobinson on DSK9F5VC42PROD with NOTICES
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
00:05 Jan 11, 2018
Jkt 244001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
1363
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
E:\FR\FM\11JAN1.SGM
11JAN1
1364
Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices
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 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) ................
Clinical Protocol Amendments
(IND).
New Marketing Applications/ Resubmissions (NDA/BLA).
Clinical Amendments to Marketing Applications.
Efficacy Supplements/ Resubmissions.
1,669
15,285
........................
........................
1
1
1,669
15,285
0.25 (15 minutes) ......
0.25 (15 minutes) ......
417
3,821
........................
198
1
198
0.75 (45 minutes) ......
149
........................
1,067
1
1,067
0.75 (45 minutes) ......
800
........................
219
1
219
0.75 (45 minutes) ......
164
srobinson on DSK9F5VC42PROD with NOTICES
CBER
New Applications (IND) ................
Clinical Protocol Amendments
(IND).
New Marketing Applications/ Resubmissions (NDA/BLA).
Clinical Amendments to Marketing Applications.
Efficacy Supplements/ Resubmissions (BLA only).
381
456
........................
........................
1
1
381
456
0.25 (15 minutes) ......
0.25 (15 minutes) ......
95
114
........................
54
1
54
0.75 (45 minutes) ......
41
........................
0
1
0
0.75 (45 minutes) ......
0
........................
34
1
34
0.75 (45 minutes) ......
26
1
330
0.75 (45 minutes) ......
247
CDRH
New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to
contain clinical data).
VerDate Sep<11>2014
00:05 Jan 11, 2018
........................
Jkt 244001
PO 00000
330
Frm 00038
Fmt 4703
Sfmt 4703
E:\FR\FM\11JAN1.SGM
11JAN1
Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices
1365
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
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
OGD
Original Applications ....................
Bioequivalence
Supplements/
Amendments.
........................
........................
1,036
698
1
1
........................
........................
0.75 (45 minutes) ......
0.75 (45 minutes) ......
777
524
Total ......................................
........................
........................
........................
........................
....................................
7,175
1There
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.
be submitted on or before March 12,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of March 12, 2018. 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.
[FR Doc. 2018–00354 Filed 1–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–3310 and FDA–
2016–E–3341]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ENTYCE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ENTYCE and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that animal drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by March 12, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
July 10, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
srobinson on DSK9F5VC42PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
00:05 Jan 11, 2018
Jkt 244001
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.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
• 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 Nos. FDA–
2016–E–3310 and FDA–2016–E–3341
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; ENTYCE.’’ 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 § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[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 [email protected]. 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,
[email protected].
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
