Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions, 28955-28958 [2020-10359]
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Our estimated burden for the
information collection reflects an
overall decrease of 113 hours despite a
corresponding increase of 1,650
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years but a decrease in the amount
of time spent entering data due to IT
efficiencies that have been built into the
MedSun reporting system to reduce data
entry by user facilities.
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10353 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0275]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Certification to
Accompany Drug, Biological Product,
and Device Applications or
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the requirements for certain FDA
applications or submissions to be
accompanied by a certification, Form
FDA 3674, to ensure all applicable
statutory requirements have been met.
DATES: Submit either electronic or
written comments on the collection of
information by July 13, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 13, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 13, 2020. Comments
received by mail/hand delivery/courier
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SUMMARY:
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(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0275 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Certification to Accompany Drug,
Biological Product, and Device
Applications or Submissions.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
PO 00000
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28955
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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.
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
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.
jbell on DSKJLSW7X2PROD with NOTICES
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 March 31,
2022, and OMB control number 0910–
0001, expiring March 31, 2021; 21 CFR
parts 312 and 601 (biological products),
OMB control number 0910–0014,
expiring March 31, 2022, and OMB
control number 0910–0338, expiring
February 28, 2023; 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, 2023.
Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110–85)
amended the PHS Act by adding section
402(j). The provisions broadened the
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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 (the FD&C Act).
One provision, section 402(j)(5)(B) of
the PHS Act, requires that a certification
accompany human drug, biological, and
device product submissions made to
FDA. Specifically, at the time of
submission of an application under
sections 505, 515, or 520(m) of the
FD&C Act (21 U.S.C. 355, 360e, or
360j(m)), or under section 351 of the
PHS Act (42 U.S.C. 262), or submission
of a report under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)), such
application or submission must be
accompanied by a certification, Form
FDA 3674, that all applicable
requirements of section 402(j) of the
PHS Act have been met. Where
available, such certification must
include the appropriate National
Clinical Trial (NCT) numbers that are
assigned upon submission of required
information to the NIH databank at
https://clinicaltrials.gov/.
The proposed extension of the
collection of information is necessary to
satisfy the previously mentioned
statutory requirement. The importance
of obtaining these data relates to
adherence to the legal requirements for
submissions to the clinical trials registry
and results data bank and ensuring that
individuals and organizations
submitting applications or reports to
FDA under the listed provisions of the
FD&C Act or the PHS Act adhere to the
appropriate legal and regulatory
requirements for certifying to having
complied with those requirements. The
failure to submit the certification
required by section 402(j)(5)(B) of the
PHS Act, and the knowing submission
of a false certification, are both
prohibited acts under section 301 of the
FD&C Act (21 U.S.C. 331). Violations are
subject to civil money penalties. Form
FDA 3674 provides a convenient
mechanism for sponsors/applicants/
submitters to satisfy the certification
requirements of the statutory provision.
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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. FDA last updated this
guidance in 2017.
Investigational New Drug
Applications. FDA’s Center for Drug
Evaluation and Research (CDER)
received 1,661 investigational new drug
applications (INDs) and 11,328 clinical
protocol IND amendments in calendar
year (CY) 2019. 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 639 new
INDs and 581 clinical protocol IND
amendments in CY 2019. 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 12,989 for CDER plus 1,220 for
CBER, or 14,209 submissions per year.
The minutes per response is the
estimated number of minutes that a
respondent would spend preparing the
information to be submitted to FDA
under section 402(j)(5)(B) of the PHS
Act, including the time it takes to enter
the necessary information on the form.
Based on its experience with current
submissions, FDA estimates that
approximately 15 minutes on average
would be needed per response for
certifications that accompany IND
applications and clinical protocol
amendment submissions. It is assumed
that most submissions to investigational
applications will reference only a few
protocols for which the sponsor/
applicant/submitter has obtained a NCT
number from https://clinicaltrials.gov/
prior to making the submission to FDA.
It is also assumed that the sponsor/
applicant/submitter has electronic
capabilities allowing them to retrieve
the information necessary to complete
the form in an efficient manner.
Marketing Applications/Submissions.
In CY 2019, CDER and CBER received
252 new drug applications (NDA)/
biologics license applications (BLA)/
premarket approvals (PMA)/
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
resubmissions and 701 NDA/BLA
amendments for which certifications are
needed. CDER and CBER received 295
efficacy supplements/resubmissions to
previously approved NDAs/BLAs in CY
2019. CDER and CBER received 893
abbreviated new drug applications
(ANDAs) in CY 2019. CDER received
765 bioequivalence amendments/
supplements in CY 2019. 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 324 new applications for PMA,
510(k) submissions containing clinical
information, PMA supplements,
applications for humanitarian device
exemptions (HDE) and amendments in
CY 2019. CDRH anticipates that
application, amendment, supplement,
and annual report 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
28957
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
Average
burden per
response
Total annual
responses
Total hours
CDER
New Applications (IND) .....
Clinical Protocol Amendments (IND).
New Marketing Applications/Resubmissions
(NDA/BLA).
Clinical Amendments to
Marketing Applications.
Efficacy Supplements/Resubmissions.
Abbreviated New Drug Applications (ANDA)—
Original Applications.
ANDA Bioequivalence Supplements/Amendments.
1,661
11,328
........................
........................
1
1
1,661
11,328
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
415
2,832
..............................
220
1
220
0.75 (45 minutes) ...........
165
..............................
701
1
701
0.75 (45 minutes) ...........
526
..............................
257
1
257
0.75 (45 minutes) ...........
193
..............................
892
1
892
0.75 (45 minutes) ...........
669
..............................
765
1
765
0.75 (45 minutes) ...........
573
CBER
New Applications (IND) .....
Clinical Protocol Amendments (IND).
New Marketing Applications/Resubmissions
(NDA/BLA/PMA).
Clinical Amendments to
Marketing Applications.
Efficacy Supplements/Resubmissions (BLA only).
Abbreviated New Drug Applications (ANDA)—
Original Applications.
ANDA Bioequivalence Supplements/Amendments.
639
581
........................
........................
1
1
639
581
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
160
145
..............................
32
1
32
0.75 (45 minutes) ...........
24
..............................
0
1
0
0.75 (45 minutes) ...........
0
..............................
38
1
38
0.75 (45 minutes) ...........
28
..............................
1
1
1
0.75 (45 minutes) ...........
1
..............................
0
1
0
0.75 (45 minutes) ...........
0
CDRH
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New Marketing Applications (includes PMAs,
HDEs, Supplements and
510(k)s expected to contain clinical data).
Total ...........................
1 There
..............................
324
1
324
0.75 (45 minutes) ...........
243
..............................
........................
........................
........................
........................................
5,974
are no capital costs or operating and maintenance costs associated with this collection of information.
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28958
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10359 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0618]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Products
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.
DATES: Submit written comments
(including recommendations) on the
collection of information by June 15,
2020.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0025. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
jbell on DSKJLSW7X2PROD with NOTICES
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
Electronic Products
OMB Control Number 0910–0025—
Extension
Under sections 532 through 542 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360ii through
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360ss), FDA has the responsibility to
protect the public from unnecessary
exposure of radiation from electronic
products. The regulations issued under
these authorities are listed in Title 21 of
the Code of Federal Regulations, chapter
I, subchapter J, parts 1000 through 1050
(21 CFR parts 1000 through 1050).
Section 532 of the FD&C Act directs
the Secretary of Health and Human
Services (the Secretary), to establish and
carry out an electronic product radiation
control program, including the
development, issuance, and
administration of performance
standards to control the emission of
electronic product radiation from
electronic products. The program is
designed to protect the public health
and safety from electronic radiation, and
the FD&C Act authorizes the Secretary
to procure (by negotiation or otherwise)
electronic products for research and
testing purposes and to sell or otherwise
dispose of such products. Section 534(g)
of the FD&C Act directs the Secretary to
review and evaluate industry testing
programs on a continuing basis; and
section 535(e) and (f) of the FD&C Act
directs the Secretary to immediately
notify manufacturers of, and ensure
correction of, radiation defects or
noncompliance with performance
standards. Section 537(b) of the FD&C
Act contains the authority to require
manufacturers of electronic products to
establish and maintain records
(including testing records), make
reports, and provide information to
determine whether the manufacturer
has acted in compliance.
The regulations under parts 1002
through 1010 specify reports to be
provided by manufacturers and
distributors to FDA and records to be
maintained in the event of an
investigation of a safety concern or a
product recall. FDA conducts laboratory
compliance testing of products covered
by regulations for product standards in
parts 1020, 1030, 1040, and 1050.
FDA details product-specific
performance standards that specify
information to be supplied with the
product or require specific reports. The
information collections are either
specifically called for in the FD&C Act
or were developed to aid the Agency in
performing its obligations under the
FD&C Act. The data reported to FDA
and the records maintained are used by
FDA and the industry to make decisions
and take actions that protect the public
from radiation hazards presented by
electronic products. This information
refers to the identification of, location
of, operational characteristics of, quality
assurance programs for, and problem
identification and correction of
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electronic products. The data provided
to users and others are intended to
encourage actions to reduce or eliminate
radiation exposures.
FDA uses the following forms to aid
respondents in the submission of
information for this information
collection:
• Form FDA 2579 ‘‘Report of
Assembly of a Diagnostic X-Ray
System’’
• Form FDA 2767 ‘‘Notice of
Availability of Sample Electronic
Product’’
• Form FDA 2877 ‘‘Declaration for
Imported Electronic Products Subject
to Radiation Control Standards’’
• Form FDA 3649 ‘‘Accidental
Radiation Occurrence (ARO)’’
• Form FDA 3626 ‘‘A Guide for the
Submission of Initial Reports on
Diagnostic X-Ray Systems and Their
Major Components’’
• Form FDA 3627 ‘‘Diagnostic X-Ray
CT [Computed Tomography] Products
Radiation Safety Report’’
• Form FDA 3628 ‘‘General Annual
Report (Includes Medical, Analytical,
and Industrial X-Ray Products Annual
Report)’’
• Form FDA 3629 ‘‘Abbreviated
Report’’
• Form FDA 3630 ‘‘Guide for
Preparing Product Reports on
Sunlamps and Sunlamp Products’’
• Form FDA 3631 ‘‘Guide for
Preparing Annual Reports on
Radiation Safety Testing of Sunlamp
Products’’
• Form FDA 3632 ‘‘Guide for
Preparing Product Reports on Lasers
and Products Containing Lasers’’
• Form FDA 3633 ‘‘General Variance
Request’’
• Form FDA 3634 ‘‘Television
Products Annual Report’’
• Form FDA 3635 ‘‘Laser Light Show
Notification’’
• Form FDA 3636 ‘‘Guide for
Preparing Annual Reports on
Radiation Safety Testing of Laser and
Laser Light Show Products’’
• Form FDA 3637 ‘‘Laser Original
Equipment Manufacturer (OEM)
Report’’
• Form FDA 3638 ‘‘Guide for Filing
Annual Reports for X-Ray
Components and Systems’’
• Form FDA 3639 ‘‘Guidance for the
Submission of Cabinet X-Ray System
Reports Pursuant to 21 CFR 1020.40’’
• Form FDA 3640 ‘‘Reporting Guide
for Laser Light Shows and Displays’’
• Form FDA 3147 ‘‘Application for a
Variance From 21 CFR 1040.11(c) for
a Laser Light Show, Display, or
Device’’
• Form FDA 3641 ‘‘Cabinet X-Ray
Annual Report’’
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]]>Agencies
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28955-28958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0275]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Certification to Accompany Drug, Biological Product,
and Device Applications or Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the requirements for certain FDA
applications or submissions to be accompanied by a certification, Form
FDA 3674, to ensure all applicable statutory requirements have been
met.
DATES: Submit either electronic or written comments on the collection
of information by July 13, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 13, 2020. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0275 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Certification to Accompany Drug,
Biological Product, and Device Applications or Submissions.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
[[Page 28956]]
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 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 March 31, 2022, and OMB
control number 0910-0001, expiring March 31, 2021; 21 CFR parts 312 and
601 (biological products), OMB control number 0910-0014, expiring March
31, 2022, and OMB control number 0910-0338, expiring February 28, 2023;
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, 2023.
Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-85) amended the PHS Act by adding section
402(j). The provisions broadened the scope of clinical trials subject
to submitting information and required additional information to be
submitted to the clinical trials databank (https://clinicaltrials.gov/)
(FDA has verified the 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 (the FD&C Act).
One provision, section 402(j)(5)(B) of the PHS Act, requires that a
certification accompany human drug, biological, and device product
submissions made to FDA. Specifically, at the time of submission of an
application under sections 505, 515, or 520(m) of the FD&C Act (21
U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (42
U.S.C. 262), or submission of a report under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)), such application or submission must be
accompanied by a certification, Form FDA 3674, that all applicable
requirements of section 402(j) of the PHS Act have been met. Where
available, such certification must include the appropriate National
Clinical Trial (NCT) numbers that are assigned upon submission of
required information to the NIH databank at https://clinicaltrials.gov/.
The proposed extension of the collection of information is
necessary to satisfy the previously mentioned statutory requirement.
The importance of obtaining these data relates to adherence to the
legal requirements for submissions to the clinical trials registry and
results data bank and ensuring that individuals and organizations
submitting applications or reports to FDA under the listed provisions
of the FD&C Act or the PHS Act adhere to the appropriate legal and
regulatory requirements for certifying to having complied with those
requirements. The failure to submit the certification required by
section 402(j)(5)(B) of the PHS Act, and the knowing submission of a
false certification, are both prohibited acts under section 301 of the
FD&C Act (21 U.S.C. 331). Violations are subject to civil money
penalties. 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. FDA last updated this
guidance in 2017.
Investigational New Drug Applications. FDA's Center for Drug
Evaluation and Research (CDER) received 1,661 investigational new drug
applications (INDs) and 11,328 clinical protocol IND amendments in
calendar year (CY) 2019. 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
639 new INDs and 581 clinical protocol IND amendments in CY 2019. 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 12,989 for CDER plus 1,220 for CBER, or
14,209 submissions per year. The minutes per response is the estimated
number of minutes that a respondent would spend preparing the
information to be submitted to FDA under section 402(j)(5)(B) of the
PHS Act, including the time it takes to enter the necessary information
on the form.
Based on its experience with current submissions, FDA estimates
that approximately 15 minutes on average would be needed per response
for certifications that accompany IND applications and clinical
protocol amendment submissions. It is assumed that most submissions to
investigational applications will reference only a few protocols for
which the sponsor/applicant/submitter has obtained a NCT number from
https://clinicaltrials.gov/ prior to making the submission to FDA. It
is also assumed that the sponsor/applicant/submitter has electronic
capabilities allowing them to retrieve the information necessary to
complete the form in an efficient manner.
Marketing Applications/Submissions. In CY 2019, CDER and CBER
received 252 new drug applications (NDA)/biologics license applications
(BLA)/premarket approvals (PMA)/
[[Page 28957]]
resubmissions and 701 NDA/BLA amendments for which certifications are
needed. CDER and CBER received 295 efficacy supplements/resubmissions
to previously approved NDAs/BLAs in CY 2019. CDER and CBER received 893
abbreviated new drug applications (ANDAs) in CY 2019. CDER received 765
bioequivalence amendments/supplements in CY 2019. 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 324 new applications for PMA, 510(k) submissions containing
clinical information, PMA supplements, applications for humanitarian
device exemptions (HDE) and amendments in CY 2019. CDRH anticipates
that application, amendment, supplement, and annual report 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)........... 1,661 .............. 1 1,661 0.25 (15 minutes)................. 415
Clinical Protocol Amendments 11,328 .............. 1 11,328 0.25 (15 minutes)................. 2,832
(IND).
New Marketing Applications/ ................. 220 1 220 0.75 (45 minutes)................. 165
Resubmissions (NDA/BLA).
Clinical Amendments to Marketing ................. 701 1 701 0.75 (45 minutes)................. 526
Applications.
Efficacy Supplements/ ................. 257 1 257 0.75 (45 minutes)................. 193
Resubmissions.
Abbreviated New Drug Applications ................. 892 1 892 0.75 (45 minutes)................. 669
(ANDA)--Original Applications.
ANDA Bioequivalence Supplements/ ................. 765 1 765 0.75 (45 minutes)................. 573
Amendments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)........... 639 .............. 1 639 0.25 (15 minutes)................. 160
Clinical Protocol Amendments 581 .............. 1 581 0.25 (15 minutes)................. 145
(IND).
New Marketing Applications/ ................. 32 1 32 0.75 (45 minutes)................. 24
Resubmissions (NDA/BLA/PMA).
Clinical Amendments to Marketing ................. 0 1 0 0.75 (45 minutes)................. 0
Applications.
Efficacy Supplements/ ................. 38 1 38 0.75 (45 minutes)................. 28
Resubmissions (BLA only).
Abbreviated New Drug Applications ................. 1 1 1 0.75 (45 minutes)................. 1
(ANDA)--Original Applications.
ANDA Bioequivalence Supplements/ ................. 0 1 0 0.75 (45 minutes)................. 0
Amendments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Marketing Applications ................. 324 1 324 0.75 (45 minutes)................. 243
(includes PMAs, HDEs,
Supplements and 510(k)s expected
to contain clinical data).
Total........................ ................. .............. .............. .............. .................................. 5,974
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 28958]]
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10359 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P
