Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability, 18918-18919 [2014-07546]
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18918
Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Notices
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–07530 Filed 4–3–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0147]
Types of Communication During the
Review of Medical Device
Submissions; Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Types of Communication During the
Review of Medical Device
Submissions.’’ The purpose of this
guidance is to update the Agency’s
approach to Interactive Review and
other additional types of
communication, to reflect FDA’s
implementation of the Medical Device
User Fee Act of 2007 (MDUFA II)
Commitment Letters and of
undertakings agreed to in connection
with the Medical Device User Fee
Amendments of 2012 (MDUFA III).
These new Agency communication
commitments are to increase the
efficiency of the review process.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: 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
single copies of the guidance document
entitled ‘‘Types of Communication
During the Review of Medical Device
Submissions’’ to the Office of the Center
Director, 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 the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Administration, 1401
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:37 Apr 03, 2014
Jkt 232001
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–847–8149. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Samie Allen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1533, Silver Spring,
MD 20993–0002, 301–796–6055, or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the letters dated September 27,
2007, from the Secretary of Health and
Human Services to the Chairman of the
Committee on Health, Education, Labor,
and Pensions of the U.S. Senate and the
Chairman of the Committee on Energy
and Commerce of the U.S. House of
Representatives setting out the goals of
section 201(c) of MDUFA II, Title II of
the Food and Drug Administration
Amendments of 2007 (FDAAA) (21
U.S.C. 379i note), FDA committed to
developing a guidance document that
describes an interactive review process
between FDA and industry for specific
medical device premarket submissions.
Further, during discussions with
representatives of the medical device
industry in the development of the
Agency’s recommendations for MDUFA
III, Title II of the Food and Drug
Administration Safety and Innovation
Act, Public Law 112–144 (July 9, 2012)
(21 U.S.C. 301 note), the Agency
proposed process improvements to
provide further transparency into the
review process, including new
communication commitments.
In the Federal Register on March 5,
2013 (78 FR 14305), FDA announced the
availability of the draft guidance
document. Interested persons were
invited to comment by June 3, 2013.
Four comments were received and, in
general, were supportive of the
guidance. However, the comments
contained multiple recommendations
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
pertaining to the content of the guidance
and the need for clarification,
particularly for the Interactive Review
section. In response to these comments,
FDA revised the guidance document to
restructure the Interactive Review
section to clarify how this process
works and to include references to
additional submission types for which
Interactive Review pertains. Although
several commenters expressed concern
about FDA’s intention to limit the last
round of Interactive Review to 7 days,
we did not modify the guidance because
this approach is needed in order to
appropriately balance the intent of
interactive review with FDA’s
commitment to meet the performance
goals agreed upon as part of MDUFA III.
In response to comments regarding our
intention to limit the issuance of second
Additional Information (AI) letters for
510(k) submissions, the guidance was
modified slightly to clarify the
circumstances in which a second AI
letter might be issued, but remains
unchanged in explaining that these
circumstances will remain limited and
at FDA’s discretion. FDA will
continually assess any impacts that the
limited use of a second AI letter may
have, and, if needed, may consider
modifications to this approach. In
addition to modifications to the
Interactive Review section, we clarified
other items throughout the guidance,
and included Pre-Submissions as a
submission type subject to Acceptance
Communication. This document
supersedes ‘‘Interactive Review for
Medical Device Submissions: 510(k)s,
Original PMAs, PMA Supplements,
Original BLAs, and BLA Supplements’’
dated February 28, 2008.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on communication
during a medical device premarket
submission review to provide further
transparency into, and to increase the
efficiency of, the review process. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
E:\FR\FM\04APN1.SGM
04APN1
Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Notices
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
CBER at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm. To receive ‘‘Types of
Communication During the Review of
Medical Device Submissions,’’ you may
either send an email request to dsmica@
fda.hhs.gov to receive an electronic
copy of the document or send a fax
request to 301–847–8149 to receive a
hard copy. Please use the document
number 1804 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E, have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 814, subpart
B, have been approved under OMB
control number 0910–0231; and the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2014–07546 Filed 4–3–14; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:37 Apr 03, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Information Collection Request Title:
Rural Health Network Development
Planning Performance Improvement
and Measurement System Database
OMB No. 0915–xxxx—NEW
Abstract: The purpose of the Rural
Health Network Development Planning
(Network Planning) program, authorized
by Section 330A(f) of the Public Health
Service Act, 42 U.S.C. 254c(f), as
amended by section 201, Public Law
107–251 of the Health Care Safety Net
Amendments of 2002, is to assist in the
development of an integrated healthcare
network, if the network participants do
not have a history of collaborative
efforts. The Network Planning program
helps to promote the planning and
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18919
development of health care networks in
order to: (i) Achieve efficiencies; (ii)
expand access to, coordinate, and
improve the quality of essential health
care services; and (iii) strengthen the
rural health care system as a whole.
This program brings together key parts
of a rural health care delivery system,
particularly those entities that may not
have collaborated in the past under a
formal relationship, to work together to
establish and improve local capacity
and coordination of care. This grant
program supports 1 year of planning
with the primary goal of helping
networks create a foundation for their
infrastructure and focusing member
efforts to address important regional or
local community health needs.
Need and Proposed Use of the
Information: Performance measures
were developed to provide routine data
for the program and to enable HRSA to
aggregate program data. These measures
cover the principal topic areas of
interest to the Office of Rural Health
Policy, including: (a) Network
infrastructure; (b) network
collaboration; (c) sustainability; and (d)
network assessment. Several measures
will be used for this program.
Summary of Prior Comments and
Agency Response
A 60-day Federal Register Notice was
published in the Federal Register on
December 5, 2013, Vol. 78, No. 234; pp.
73200–01. There were no comments.
Likely Respondents: The respondents
would be Rural Health Network
Development Planning grant recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to respond to a collection
of information; to search data sources; to
complete and review the collection of
information; and to transmit or
otherwise disclose the information. The
total annual burden hours estimated for
this ICR are summarized in the table
below.
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Notices]
[Pages 18918-18919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07546]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0147]
Types of Communication During the Review of Medical Device
Submissions; Guidance for Industry and Food and Drug Administration
Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Types of Communication During
the Review of Medical Device Submissions.'' The purpose of this
guidance is to update the Agency's approach to Interactive Review and
other additional types of communication, to reflect FDA's
implementation of the Medical Device User Fee Act of 2007 (MDUFA II)
Commitment Letters and of undertakings agreed to in connection with the
Medical Device User Fee Amendments of 2012 (MDUFA III). These new
Agency communication commitments are to increase the efficiency of the
review process.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: 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 single copies of the guidance document entitled ``Types of
Communication During the Review of Medical Device Submissions'' to the
Office of the Center Director, 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 the Office of Communication, Outreach and Development (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Samie Allen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1533, Silver Spring, MD 20993-0002, 301-796-6055,
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the letters dated September 27, 2007, from the Secretary of
Health and Human Services to the Chairman of the Committee on Health,
Education, Labor, and Pensions of the U.S. Senate and the Chairman of
the Committee on Energy and Commerce of the U.S. House of
Representatives setting out the goals of section 201(c) of MDUFA II,
Title II of the Food and Drug Administration Amendments of 2007 (FDAAA)
(21 U.S.C. 379i note), FDA committed to developing a guidance document
that describes an interactive review process between FDA and industry
for specific medical device premarket submissions. Further, during
discussions with representatives of the medical device industry in the
development of the Agency's recommendations for MDUFA III, Title II of
the Food and Drug Administration Safety and Innovation Act, Public Law
112-144 (July 9, 2012) (21 U.S.C. 301 note), the Agency proposed
process improvements to provide further transparency into the review
process, including new communication commitments.
In the Federal Register on March 5, 2013 (78 FR 14305), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by June 3, 2013. Four comments were
received and, in general, were supportive of the guidance. However, the
comments contained multiple recommendations pertaining to the content
of the guidance and the need for clarification, particularly for the
Interactive Review section. In response to these comments, FDA revised
the guidance document to restructure the Interactive Review section to
clarify how this process works and to include references to additional
submission types for which Interactive Review pertains. Although
several commenters expressed concern about FDA's intention to limit the
last round of Interactive Review to 7 days, we did not modify the
guidance because this approach is needed in order to appropriately
balance the intent of interactive review with FDA's commitment to meet
the performance goals agreed upon as part of MDUFA III. In response to
comments regarding our intention to limit the issuance of second
Additional Information (AI) letters for 510(k) submissions, the
guidance was modified slightly to clarify the circumstances in which a
second AI letter might be issued, but remains unchanged in explaining
that these circumstances will remain limited and at FDA's discretion.
FDA will continually assess any impacts that the limited use of a
second AI letter may have, and, if needed, may consider modifications
to this approach. In addition to modifications to the Interactive
Review section, we clarified other items throughout the guidance, and
included Pre-Submissions as a submission type subject to Acceptance
Communication. This document supersedes ``Interactive Review for
Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements,
Original BLAs, and BLA Supplements'' dated February 28, 2008.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on communication during a medical device
premarket submission review to provide further transparency into, and
to increase the efficiency of, the review process. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all Center for Devices and
Radiological Health guidance documents is available at https://
www.fda.gov/MedicalDevices/
[[Page 18919]]
DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov or from CBER
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``Types
of Communication During the Review of Medical Device Submissions,'' you
may either send an email request to dsmica@fda.hhs.gov to receive an
electronic copy of the document or send a fax request to 301-847-8149
to receive a hard copy. Please use the document number 1804 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B, have been approved under OMB
control number 0910-0231; and the collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338.
V. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07546 Filed 4-3-14; 8:45 am]
BILLING CODE 4160-01-P