Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability, 19923-19925 [2019-09338]
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Federal Register / Vol. 84, No. 88 / Tuesday, May 7, 2019 / Notices
FERC Form No. 3–Q, Quarterly
Financial Report of Electric Utilities,
Licensees, and Natural Gas Companies
OMB Control No.: 1902–0205.
Abstract: The FERC Form No. 3–Q is
a quarterly financial and operating
report for rate regulation, market
oversight analysis, and financial audits
which supplements the (a) FERC Form
Nos. 1 and 1–F, for the electric industry,
or the (b) FERC Form No. 2 (Annual
Report for Major Natural Gas
Companies; OMB Control No. 1902–
0028) and FERC Form No. 2–A (Annual
Report for Nonmajor Natural Gas
Companies; OMB Control No. 1902–
0030), for the natural gas industry. The
FERC Form No. 3–Q is submitted for all
Major and Nonmajor electric utilities,
licensees, and natural gas companies.6
FERC Form No. 3–Q includes a basic
set of financial statements:
• Comparative Balance Sheet,
• Statement of Income and Statement
of Retained Earnings,
• Statement of Cash Flows,
• Statement of Comprehensive
Income and Hedging Activities, and
• Supporting schedules containing
supplementary information.
Electric respondents report:
• Revenues and the related quantities
of electric sales and electricity
transmitted,
• Account balances for all electric
operation and maintenance expenses,
• Selected plant cost data; and
• Other statistical information.
19923
Natural gas respondents include:
• Monthly and quarterly quantities of
gas transported and associated revenues,
• Storage, terminaling and processing
services,
• Natural gas customer accounts and
details of service, and
• Operational expenses, depreciation,
depletion and amortization of gas plant.
Type of Respondent: Major and
nonmajor electric utilities, licensees,
and natural gas companies.
Estimate of Annual Burden: The
estimated annual burden and cost (as
rounded) follow. (The estimated hourly
cost used for the FERC Form No. 3–Q
is $79 (for wages plus benefits) and is
described above, under the FERC Form
No. 1.):
FERC FORM NO. 3–Q
Number of
respondents
Annual
number
of responses
per
respondent
Total
number
of
responses
Average burden
hours and cost
per response
Total annual
burden hours
and total
annual cost
Annual
cost per
respondent
($)
(1)
(2)
(1) * (2) = (3)
(4)
(3) * (4) = (5)
(5) ÷ (1)
FERC 3–Q (electric) ........
FERC 3–Q (natural gas)
Total for FERC 3–Q
212
165
3
3
636
495
168 hrs.; $13,272 ......................
167 hrs.; $13,193 ......................
106,848 hrs.; $8,440,992 ...............
82,665 hrs.; $6,530,535 .................
$39,816
$39,579
....................
........................
1,131
...................................................
189,513 hrs.; $14,971,527. ............
........................
Comments: Comments are invited on:
(1) Whether the collections of
information are necessary for the proper
performance of the functions of the
Commission, including whether the
information will have practical utility;
(2) the accuracy of the agency’s
estimates of the burden and cost of the
collections of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility and clarity of the
information collections; and (4) ways to
minimize the burden of the collections
of information on those who are to
respond, including the use of automated
collection techniques or other forms of
information technology.
Dated: April 30, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019–09297 Filed 5–6–19; 8:45 am]
jbell on DSK3GLQ082PROD with NOTICES
BILLING CODE 6717–01–P
6 18 CFR 260.1(b) states that for natural gas
companies as defined by the Natural Gas Act, Major
pertains to a company whose combined gas
transported or stored for a fee exceed 50 million Dth
VerDate Sep<11>2014
17:54 May 06, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1774]
Requests for Feedback and Meetings
for Medical Device Submissions: The
Q-Submission Program; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
device exemption (HDE) applications,
evaluation of automatic class III
designations (De Novo requests),
premarket notification (510(k))
submissions, Clinical Laboratory
Improvement Amendments (CLIA)
Waiver by Applications, Dual 510(k)
and CLIA Waiver by Application
Submissions, Accessory Classification
Requests, and certain investigational
new drug (IND) applications and
biologics license applications (BLAs).
The announcement of the
guidance is published in the Federal
Register on May 7, 2019.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program.’’ This guidance document
provides an overview of the
mechanisms available to applicants
through which they can request
feedback from or a meeting with FDA
regarding potential or planned medical
device investigational device exemption
(IDE) applications, premarket approval
applications (PMAs), humanitarian
ADDRESSES:
in each of the three previous calendar years. 18 CFR
260.2(b) states that for natural gas companies as
defined by the Natural Gas Act, Non-Major pertains
to a company not meeting the filing threshold for
FERC Form No. 2, but having total gas sales or
volume transactions exceeding 200,000 Dth in each
of the three previous calendar years.
SUMMARY:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
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
E:\FR\FM\07MYN1.SGM
07MYN1
19924
Federal Register / Vol. 84, No. 88 / Tuesday, May 7, 2019 / Notices
jbell on DSK3GLQ082PROD with NOTICES
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–
2018–D–1774 for ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program.’’ Received comments 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
VerDate Sep<11>2014
16:24 May 06, 2019
Jkt 247001
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program’’ to the Office of Policy,
Guidance and Policy Development,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, 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 that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6524; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
The pre-IDE program was established
in 1995 to provide applicants a
mechanism to obtain FDA feedback on
future IDE applications prior to their
submission. Over time, the pre-IDE
program evolved to include feedback on
PMA applications, HDE applications, De
Novo requests, and 510(k) submissions,
as well as to address whether a clinical
study requires submission of an IDE.
To capture this evolution, the
Secretary of Health and Human
Services’ 2012 Commitment Letter to
Congress regarding the Medical Device
User Fee Amendments of 2012 (MDUFA
III) included FDA’s commitment to
institute a structured process for
managing these interactions, referring to
them as ‘‘Pre-Submissions.’’ The PreSubmission Guidance, published
February 18, 2014, implemented the
broader Q-Submission (Q-Sub) Program,
which includes Pre-Submissions (PreSubs), as well as additional
opportunities to engage with FDA.
As part of the Medical Device User
Fee Amendments of 2017 (MDUFA IV),
industry and the Agency agreed to
refine the Q-Sub Program with changes
related to the scheduling of Pre-Sub
meetings and a new performance goal
on the timing of FDA feedback on PreSubs. This guidance reflects those
changes and clarifies other elements of
the Q-Sub program.
This guidance document provides an
overview of the mechanisms available to
submitters through which they can
request feedback from or a meeting with
FDA regarding potential or planned
medical device IDE applications, PMAs,
HDE applications, De Novo requests,
510(k) Submissions, CLIA Waiver by
Application, Dual 510(k) and CLIA
Waiver by Application Submissions,
Accessory Classification Requests, and
certain INDs and BLAs submitted to the
Center for Biologics Evaluation and
Research. FDA considered comments
received on the draft guidance, which
was announced in the Federal Register
of June 7, 2018 (83 FR 26482). FDA
revised the guidance as appropriate in
response to the comments. This
guidance supersedes the document
entitled ‘‘Requests for Feedback on
Medical Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff,’’
issued on September 29, 2017.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
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Federal Register / Vol. 84, No. 88 / Tuesday, May 7, 2019 / Notices
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
copy of the document. Please use the
document number 1677 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
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 the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
OMB control
No.
21 CFR Part or guidance
Topic
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’.
‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’.
‘‘Medical Device Accessories—Describing Accessories and Classification
Pathways’’.
312 ..................................................................................................................
601 ..................................................................................................................
807, subpart E ................................................................................................
812 ..................................................................................................................
814, subparts A through E .............................................................................
814, subpart H ................................................................................................
Q-submissions ........................................................
0910–0756
De Novo Requests .................................................
0910–0844
CLIA Waivers .........................................................
0910–0598
Accessories ............................................................
0910–0823
Investigational New Drug Application ....................
Biologics License Application .................................
Premarket Notification ............................................
Investigational Device Exemption ..........................
Premarket Approval ...............................................
Humanitarian Use Device; Humanitarian Device
Exemption.
0910–0014
0910–0338
0910–0120
0910–0078
0910–0231
0910–0332
Dated: May 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09338 Filed 5–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
jbell on DSK3GLQ082PROD with NOTICES
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm. Persons
unable to download an electronic copy
of ‘‘Requests for Feedback and Meetings
for Medical Device Submissions: The QSubmission Program’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
19925
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
VerDate Sep<11>2014
16:24 May 06, 2019
Jkt 247001
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Language and Communication Study
Section.
Date: June 3, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
Rockville, MD 20852.
Contact Person: Andrea B. Kelly, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184,
MSC 7770, Bethesda, MD 20892, (301) 455–
1761, kellya2@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Adult Psychopathology and Disorders
of Aging Study Section.
Date: June 3–4, 2019.
Time: 8:30 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marines’ Memorial Club & Hotel,
609 Sutter Street, San Francisco, CA 94102.
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, BBBP IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178,
MSC 7848, Bethesda, MD 20892, (301) 500–
5829, sechu@csr.nih.gov.
PO 00000
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Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Bacterial Pathogenesis Study Section.
Date: June 3–4, 2019.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Marci Scidmore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192,
MSC 7808, Bethesda, MD 20892, 301–435–
1149, marci.scidmore@nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group;
Integrative Physiology of Obesity and
Diabetes Study Section.
Date: June 4–5, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Warwick Denver, 1776 Grant Street,
Denver, CO 80203.
Contact Person: Raul Rojas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6185,
Bethesda, MD 20892, (301) 451–6319, rojasr@
mail.nih.gov.
E:\FR\FM\07MYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 88 (Tuesday, May 7, 2019)]
[Notices]
[Pages 19923-19925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09338]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1774]
Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program; Guidance for Industry and Food
and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Requests for Feedback
and Meetings for Medical Device Submissions: The Q-Submission
Program.'' This guidance document provides an overview of the
mechanisms available to applicants through which they can request
feedback from or a meeting with FDA regarding potential or planned
medical device investigational device exemption (IDE) applications,
premarket approval applications (PMAs), humanitarian device exemption
(HDE) applications, evaluation of automatic class III designations (De
Novo requests), premarket notification (510(k)) submissions, Clinical
Laboratory Improvement Amendments (CLIA) Waiver by Applications, Dual
510(k) and CLIA Waiver by Application Submissions, Accessory
Classification Requests, and certain investigational new drug (IND)
applications and biologics license applications (BLAs).
DATES: The announcement of the guidance is published in the Federal
Register on May 7, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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
[[Page 19924]]
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-2018-D-1774 for ``Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program.'' Received comments 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.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program'' to the Office of Policy, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, 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 that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
The pre-IDE program was established in 1995 to provide applicants a
mechanism to obtain FDA feedback on future IDE applications prior to
their submission. Over time, the pre-IDE program evolved to include
feedback on PMA applications, HDE applications, De Novo requests, and
510(k) submissions, as well as to address whether a clinical study
requires submission of an IDE.
To capture this evolution, the Secretary of Health and Human
Services' 2012 Commitment Letter to Congress regarding the Medical
Device User Fee Amendments of 2012 (MDUFA III) included FDA's
commitment to institute a structured process for managing these
interactions, referring to them as ``Pre-Submissions.'' The Pre-
Submission Guidance, published February 18, 2014, implemented the
broader Q-Submission (Q-Sub) Program, which includes Pre-Submissions
(Pre-Subs), as well as additional opportunities to engage with FDA.
As part of the Medical Device User Fee Amendments of 2017 (MDUFA
IV), industry and the Agency agreed to refine the Q-Sub Program with
changes related to the scheduling of Pre-Sub meetings and a new
performance goal on the timing of FDA feedback on Pre-Subs. This
guidance reflects those changes and clarifies other elements of the Q-
Sub program.
This guidance document provides an overview of the mechanisms
available to submitters through which they can request feedback from or
a meeting with FDA regarding potential or planned medical device IDE
applications, PMAs, HDE applications, De Novo requests, 510(k)
Submissions, CLIA Waiver by Application, Dual 510(k) and CLIA Waiver by
Application Submissions, Accessory Classification Requests, and certain
INDs and BLAs submitted to the Center for Biologics Evaluation and
Research. FDA considered comments received on the draft guidance, which
was announced in the Federal Register of June 7, 2018 (83 FR 26482).
FDA revised the guidance as appropriate in response to the comments.
This guidance supersedes the document entitled ``Requests for Feedback
on Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff,'' issued on September 29,
2017.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
[[Page 19925]]
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1677 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. 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
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
------------------------------------------------------------------------
OMB control
21 CFR Part or guidance Topic No.
------------------------------------------------------------------------
``Requests for Feedback on Q-submissions......... 0910-0756
Medical Device Submissions: The
Pre-Submission Program and
Meetings with Food and Drug
Administration Staff''.
``De Novo Classification Process De Novo Requests...... 0910-0844
(Evaluation of Automatic Class
III Designation)''.
``Recommendations: Clinical CLIA Waivers.......... 0910-0598
Laboratory Improvement
Amendments of 1988 (CLIA)
Waiver Applications for
Manufacturers of In Vitro
Diagnostic Devices''.
``Medical Device Accessories-- Accessories........... 0910-0823
Describing Accessories and
Classification Pathways''.
312............................. Investigational New 0910-0014
Drug Application.
601............................. Biologics License 0910-0338
Application.
807, subpart E.................. Premarket Notification 0910-0120
812............................. Investigational Device 0910-0078
Exemption.
814, subparts A through E....... Premarket Approval.... 0910-0231
814, subpart H.................. Humanitarian Use 0910-0332
Device; Humanitarian
Device Exemption.
------------------------------------------------------------------------
Dated: May 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09338 Filed 5-6-19; 8:45 am]
BILLING CODE 4164-01-P
