Procedures for Meetings of the Medical Devices Advisory Committee; Guidance for Industry and Food and Drug Administration Staff; Availability, 41626-41627 [2017-18549]
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41626
Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–0838]
Procedures for Meetings of the Medical
Devices Advisory Committee;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Procedures for
Meetings of the Medical Devices
Advisory Committee.’’ The Center for
Devices and Radiological Health (CDRH)
is issuing this guidance to provide
additional information regarding the
processes for meetings of the Medical
Devices Advisory Committee panels
other than the Medical Devices Dispute
Resolution Panel (DRP). This guidance
describes the general circumstances in
which CDRH consults with a panel, the
process for exchange of information
among CDRH, the members of the panel,
industry, and the public, and the
conduct of panel meetings. This
guidance supplements existing FDA
Agency-wide guidance on the conduct
of Advisory Committee meetings.
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: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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.
VerDate Sep<11>2014
17:53 Aug 31, 2017
Jkt 241001
• 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–
2015–D–0838 for ‘‘Procedures for
Meetings of the Medical Devices
Advisory Committee; Guidance for
Industry and Food and Drug
Administration Staff; Availability.’’
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 Office
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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.
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 ‘‘Procedures for
Meetings of the Medical Devices
Advisory Committee’’ 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. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
James Swink, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1609, Silver Spring,
MD 20993–0002, 301–796–6313.
SUPPLEMENTARY INFORMATION:
I. Background
CDRH is issuing this guidance to
provide additional information
regarding the processes for meetings of
the Medical Devices Advisory
Committee panels other than DRP. The
term ‘‘panel,’’ as used in this guidance,
refers to the panels established under
the Medical Devices Advisory
Committee charter excluding DRP. This
guidance describes the general
circumstances in which CDRH consults
with a panel of the Medical Devices
Advisory Committee, the process for
exchange of information among CDRH,
the members of the panel, industry, and
the public, and the conduct of panel
meetings. The Medical Devices
Advisory Committee includes 17 panels
other than DRP (Ref. 1). The panels,
according to their specialty area and
authorization, advise the Commissioner
of Food and Drugs in discharging
responsibilities as they relate to assuring
the safety and effectiveness of medical
devices, and as required, any other
E:\FR\FM\01SEN1.SGM
01SEN1
Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices
product for which FDA has regulatory
responsibility.
In the Federal Register of April 1,
2015 (80 FR 17439), FDA announced the
availability of the draft guidance.
Interested persons were invited to
comment by June 1, 2015. FDA revised
the guidance as appropriate in response
to the comments. This guidance is
intended to provide information for
industry and for CDRH staff on the
processes associated with a panel
meeting held for any of the reasons
identified in the guidance. This
guidance replaces the ‘‘Guidance on
Amended Procedures for Advisory
Panel Meetings’’ (Ref. 2) and the
guidance document entitled ‘‘Panel
Review of Premarket Approval
Applications #P91–2 blue book memo’’
(Ref. 3). This guidance supplements
existing FDA Agency-wide guidance on
the conduct of Advisory Committee
meetings.
sradovich on DSK3GMQ082PROD with NOTICES
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 current
thinking of FDA on the panel meeting
process for medical devices. 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.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Procedures for Meetings of the
Medical Devices Advisory Committee’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 413 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
VerDate Sep<11>2014
17:53 Aug 31, 2017
Jkt 241001
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 860 have
been approved under OMB control
number 0910–0138; the collections of
information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231; and the collections
of information in 21 CFR part 814,
subpart H have been approved under
OMB control number 0910–0332.
V. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES), and may be seen
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday;
they are also available electronically at
https://www.regulations.gov. FDA has
verified the Web site addresses, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
1. CDRH’s Medical Devices Advisory
Committee, available at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Medical
Devices/MedicalDevicesAdvisoryCommittee/
default.htm.
2. ‘‘Guidance for Industry and FDA Staff:
Guidance on Amended Procedures for
Advisory Panel Meetings,’’ July 2000,
available at https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
ucm073726.pdf.
3. ‘‘Panel Review of Premarket Approval
Applications #P91–2 (blue book memo),’’
May 1991, available at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
ucm081363.htm.
Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18549 Filed 8–31–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
41627
Program (the program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the program in
general, contact Lisa L. Reyes, Acting
Clerk, United States Court of Federal
Claims, 717 Madison Place NW.,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, MD 20857; (301) 443–6593,
or visit our Web site at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of HHS, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
E:\FR\FM\01SEN1.SGM
01SEN1
Agencies
[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)]
[Notices]
[Pages 41626-41627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18549]
[[Page 41626]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0838]
Procedures for Meetings of the Medical Devices Advisory
Committee; 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 the guidance entitled ``Procedures for Meetings of
the Medical Devices Advisory Committee.'' The Center for Devices and
Radiological Health (CDRH) is issuing this guidance to provide
additional information regarding the processes for meetings of the
Medical Devices Advisory Committee panels other than the Medical
Devices Dispute Resolution Panel (DRP). This guidance describes the
general circumstances in which CDRH consults with a panel, the process
for exchange of information among CDRH, the members of the panel,
industry, and the public, and the conduct of panel meetings. This
guidance supplements existing FDA Agency-wide guidance on the conduct
of Advisory Committee meetings.
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: You may submit comments 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 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-2015-D-0838 for ``Procedures for Meetings of the Medical Devices
Advisory Committee; Guidance for Industry and Food and Drug
Administration Staff; Availability.'' 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 Office 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.
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
``Procedures for Meetings of the Medical Devices Advisory Committee''
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. Send one self-addressed adhesive label to assist
that office in processing your request.
FOR FURTHER INFORMATION CONTACT: James Swink, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1609, Silver Spring, MD 20993-0002, 301-796-6313.
SUPPLEMENTARY INFORMATION:
I. Background
CDRH is issuing this guidance to provide additional information
regarding the processes for meetings of the Medical Devices Advisory
Committee panels other than DRP. The term ``panel,'' as used in this
guidance, refers to the panels established under the Medical Devices
Advisory Committee charter excluding DRP. This guidance describes the
general circumstances in which CDRH consults with a panel of the
Medical Devices Advisory Committee, the process for exchange of
information among CDRH, the members of the panel, industry, and the
public, and the conduct of panel meetings. The Medical Devices Advisory
Committee includes 17 panels other than DRP (Ref. 1). The panels,
according to their specialty area and authorization, advise the
Commissioner of Food and Drugs in discharging responsibilities as they
relate to assuring the safety and effectiveness of medical devices, and
as required, any other
[[Page 41627]]
product for which FDA has regulatory responsibility.
In the Federal Register of April 1, 2015 (80 FR 17439), FDA
announced the availability of the draft guidance. Interested persons
were invited to comment by June 1, 2015. FDA revised the guidance as
appropriate in response to the comments. This guidance is intended to
provide information for industry and for CDRH staff on the processes
associated with a panel meeting held for any of the reasons identified
in the guidance. This guidance replaces the ``Guidance on Amended
Procedures for Advisory Panel Meetings'' (Ref. 2) and the guidance
document entitled ``Panel Review of Premarket Approval Applications
#P91-2 blue book memo'' (Ref. 3). This guidance supplements existing
FDA Agency-wide guidance on the conduct of Advisory Committee meetings.
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
current thinking of FDA on the panel meeting process for medical
devices. 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. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Procedures for Meetings of
the Medical Devices Advisory Committee'' may send an email request to
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the
document. Please use the document number 413 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 860 have been approved under OMB control
number 0910-0138; the collections of information in 21 CFR part 814
have been approved under OMB control number 0910-0231; and the
collections of information in 21 CFR part 814, subpart H have been
approved under OMB control number 0910-0332.
V. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES), and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday; they are also available
electronically at https://www.regulations.gov. FDA has verified the Web
site addresses, as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.
1. CDRH's Medical Devices Advisory Committee, available at
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm.
2. ``Guidance for Industry and FDA Staff: Guidance on Amended
Procedures for Advisory Panel Meetings,'' July 2000, available at
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073726.pdf.
3. ``Panel Review of Premarket Approval Applications #P91-2
(blue book memo),'' May 1991, available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081363.htm.
Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18549 Filed 8-31-17; 8:45 am]
BILLING CODE 4164-01-P