80 FR 17439 - Procedures for Meetings of the Medical Devices Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 62 (April 1, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 62 (April 1, 2015)
| Page Range | 17439-17440 | |
| FR Document | 2015-07438 |
[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)] [Notices] [Pages 17439-17440] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07438] ======================================================================= ----------------------------------------------------------------------- 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and Drug Administration [Docket No. FDA-2015-D-0838] Procedures for Meetings of the Medical Devices Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Procedures for Meetings of the Medical Devices Advisory Committee.''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 Dispute Resolution Panel (DRP). This guidance describes the general circumstances in which CDRH consults with a panel, the process for exchange of information between 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. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 1, 2015. 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 a single hard copy of the draft 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. Submit electronic comments on the draft guidance to http://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: 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 draft guidance to provide additional information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the DRP. The term ``panel,'' as used in this guidance, refers to the panels established under the Medical Devices Advisory Committee charter excluding the DRP. This guidance describes the [[Page 17440]] general circumstances in which CDRH consults with a panel of the Medical Devices Advisory Committee, the process for exchange of information between 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 the 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 product for which FDA has regulatory responsibility. This draft guidance is intended to provide more comprehensive 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. Once final, this guidance will replace 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 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on the panel meeting process for medical devices. 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 draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://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 [email protected] 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. Comments Interested persons may submit either electronic comments regarding this document to http://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 http://www.regulations.gov. VI. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified the Web site addresses, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. CDRH's Medical Devices Advisory Committee, available at http://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 http://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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081363.htm. Dated: March 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07438 Filed 3-31-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 17439
ADDRESSES: Interested parties may process for which we welcome your Committee panels other than the
participate in the dialogue through the insight, ideas, and feedback. Dispute Resolution Panel (DRP). This
online platform by reviewing the • Campaign 1—Reporting compliance guidance describes the general
information and participation dates requirements shared by prime and sub- circumstances in which CDRH consults
posted at www.cao.gov. awardees of Federal procurements and with a panel, the process for exchange
FOR FURTHER INFORMATION CONTACT: grants. of information between CDRH, the
Christopher Zeleznik at dataactpmo@ • Campaign 2—Procurement members of the panel, industry, and the
hhs.gov or 202–205–3514 or Emily practices, processes, and reporting. public, and the conduct of panel
Gartland at IAEOutreach@gsa.gov or • Campaign 3—Grants practices and meetings. This guidance supplements
703–605–2532. processes. existing FDA Agency-wide guidance on
SUPPLEMENTARY INFORMATION: Note—We are looking for ideas to the conduct of Advisory Committee
This notice announces a dialogue to reduce your burden through data meetings. This draft guidance is not
explore opportunities to streamline standards and changes to reporting final nor is it in effect at this time.
processes and reduce or eliminate procedures. We are interested in hearing DATES: Although you can comment on
burden in federal procurement and about proposed changes that can be any guidance at any time (see 21 CFR
grants processes. This dialogue furthers accomplished through executive 10.115(g)(5)), to ensure that the Agency
the goals of the President’s Management (regulatory, administrative, or considers your comment of this draft
Agenda, which lays the foundation for management) action, as well as guidance before it begins work on the
creating a 21st century government that potential legislative proposals where final version of the guidance, submit
delivers better results to the American requirements are based in statute. either electronic or written comments
people, and addresses requirements in To facilitate a national dialogue, an on the draft guidance by June 1, 2015.
the Digital Accountability and online platform will be launched in May ADDRESSES: An electronic copy of the
Transparency Act of 2014 (Public Law 2015 so that interested parties may guidance document is available for
113–101) to gain a better understanding submit ideas, comment on others, download from the Internet. See the
of the costs of compliance with Federal respond to questions posed by SUPPLEMENTARY INFORMATION section for
contracting and grants awards as well as moderators, and vote to indicate which information on electronic access to the
recommendations to standardize data, ideas they think are most promising and guidance. Submit written requests for a
eliminate unnecessary duplication, and impactful. Information on the platform, single hard copy of the draft guidance
reduce compliance costs. and the dates for participating in the document entitled ‘‘Procedures for
During last year’s Open Dialogue on dialogue, will be posted at www.cao.gov. Meetings of the Medical Devices
Federal Procurement, published in the A separate notice will beposted to Advisory Committee’’ to the Office of
Federal Register at 79 FR 22682, on address additional dialogue topics on the Center Director, Guidance and
April 23, 2014, many commenters federal procurement for conversation Policy Development, Center for Devices
pointed to the potential reduction of later in the spring and summer. and Radiological Health, Food and Drug
redundant reporting and related Dated: March 27, 2015. Administration, 10903 New Hampshire
processes as one way to improve the William Clark, Ave., Bldg. 66, Rm. 5431, Silver Spring,
efficiency and effectiveness of the Director, Office of Government-wide MD 20993–0002. Send one self-
government’s acquisition practices. This Acquisition Policy, Office of Acquisition addressed adhesive label to assist that
feedback is helping to support ongoing Policy, Office of Government-wide Policy. office in processing your request.
efforts to modernize the IT [FR Doc. 2015–07441 Filed 3–31–15; 8:45 am] Submit electronic comments on the
infrastructure supporting Federal BILLING CODE 6820–EP–P
draft guidance to http://
procurement data collection and www.regulations.gov. Submit written
display, which will include comments to the Division of Dockets
development of a single Web site for Management (HFA–305), Food and Drug
DEPARTMENT OF HEALTH AND
Federal contractors to use for federal Administration, 5630 Fishers Lane, Rm.
HUMAN SERVICES
contract reporting requirements. 1061, Rockville, MD 20852. Identify
Management of federal contract and Food and Drug Administration comments with the docket number
grant business arrangements requires found in brackets in the heading of this
multiple layers of reporting across [Docket No. FDA–2015–D–0838] document.
multiple agencies. In some cases, lack of FOR FURTHER INFORMATION CONTACT:
Procedures for Meetings of the Medical
standardization results in slight (or James Swink, Center for Devices and
Devices Advisory Committee; Draft
significant) variations in reports that Radiological Health, Food and Drug
Guidance for Industry and Food and
create additional administrative and Administration, 10903 New Hampshire
Drug Administration Staff; Availability
burdensome requirements for awardees Ave., Bldg. 66, Rm. 1609, Silver Spring,
that could be readily rectified. This AGENCY: Food and Drug Administration, MD 20993–0002, 301–796–6313.
dialogue is intended to continue the HHS. SUPPLEMENTARY INFORMATION:
conversation begun last year in the ACTION: Notice.
context of federal procurement and I. Background
expand it to cover federal grants by SUMMARY: The Food and Drug CDRH is issuing this draft guidance to
identifying opportunities for reducing Administration (FDA) is announcing the provide additional information
mstockstill on DSK4VPTVN1PROD with NOTICES
burden, discussing ideas for availability of the draft guidance regarding the processes for meetings of
standardizing processes and forms, and entitled ‘‘Procedures for Meetings of the the Medical Devices Advisory
identifying recommended actions to Medical Devices Advisory Committee.’’ Committee panels other than the DRP.
reduce costs and eliminate duplication The Center for Devices and Radiological The term ‘‘panel,’’ as used in this
for awardees. The open dialogue focuses Health (CDRH) is issuing this guidance guidance, refers to the panels
on three topics (campaigns). Each to provide additional information established under the Medical Devices
campaign focuses on a unique aspect of regarding the processes for meetings of Advisory Committee charter excluding
the Federal contracting and grants the Medical Devices Advisory the DRP. This guidance describes the
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![17440 Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices
general circumstances in which CDRH IV. Paperwork Reduction Act of 1995 DeviceRegulationandGuidance/
consults with a panel of the Medical GuidanceDocuments/ucm081363.htm.
Devices Advisory Committee, the This guidance refers to previously
Dated: March 26, 2015.
process for exchange of information approved collections of information
found in FDA regulations. These Leslie Kux,
between CDRH, the members of the Associate Commissioner for Policy.
panel, industry, and the public, and the collections of information are subject to
conduct of panel meetings. The Medical review by the Office of Management and [FR Doc. 2015–07438 Filed 3–31–15; 8:45 am]
Devices Advisory Committee includes Budget (OMB) under the Paperwork BILLING CODE 4164–01–P
17 panels other than the DRP (Ref. 1). Reduction Act of 1995 (44 U.S.C. 3501–
The panels, according to their specialty 3520). The collections of information in
21 CFR part 807, subpart E have been DEPARTMENT OF HEALTH AND
area and authorization, advise the HUMAN SERVICES
Commissioner of Food and Drugs in approved under OMB control number
discharging responsibilities as they 0910–0120; the collections of
information in 21 CFR part 860 have Advisory Council on Alzheimer’s
relate to assuring the safety and Research, Care, and Services; Meeting
effectiveness of medical devices, and as been approved under OMB control
required, any other product for which number 0910–0138; the collections of AGENCY: Assistant Secretary for
FDA has regulatory responsibility. information in 21 CFR part 814 have Planning and Evaluation, HHS.
This draft guidance is intended to been approved under OMB control ACTION: Notice of meeting.
provide more comprehensive number 0910–0231; and the collections
information for industry and for CDRH of information in 21 CFR part 814, SUMMARY: This notice announces the
staff on the processes associated with a subpart H have been approved under public meeting of the Advisory Council
panel meeting held for any of the OMB control number 0910–0332. on Alzheimer’s Research, Care, and
reasons identified in the guidance. Once V. Comments Services (Advisory Council). The
final, this guidance will replace the Advisory Council on Alzheimer’s
‘‘Guidance on Amended Procedures for Interested persons may submit either Research, Care, and Services provides
Advisory Panel Meetings’’ (Ref. 2) and electronic comments regarding this advice on how to prevent or reduce the
the guidance document entitled ‘‘Panel document to http://www.regulations.gov burden of Alzheimer’s disease and
Review of Premarket Approval or written comments to the Division of related dementias on people with the
Applications #P91–2 blue book memo’’ Dockets Management (see ADDRESSES). It disease and their caregivers. During the
(Ref. 3). This guidance supplements is only necessary to send one set of April meeting, the Advisory Council
existing FDA Agency-wide guidance on comments. Identify comments with the will build on the goals of White House
the conduct of Advisory Committee docket number found in brackets in the Conference on Aging (WHCOA) through
meetings. heading of this document. Received a half-day session with dementia-
comments may be seen in the Division focused panels on each WHCOA topic
II. Significance of Guidance
of Dockets Management between 9 a.m. area: Healthy aging, long-term services
This draft guidance is being issued and 4 p.m., Monday through Friday, and and supports, retirement security, and
consistent with FDA’s good guidance will be posted to the docket at http:// elder justice. Following this session, the
practices regulation (21 CFR 10.115). www.regulations.gov. Advisory Council will also hold a brief
The draft guidance, when finalized, will discussion on the 2015 Update to the
represent the Agency’s current thinking VI. References
National Plan to Address Alzheimer’s,
on the panel meeting process for The following references have been as well as a discussion of international
medical devices. It does not create or placed on display in the Division of events on dementia.
confer any rights for or on any person Dockets Management (see ADDRESSES), DATES: The meeting will be held on
and does not operate to bind FDA or the and may be seen by interested persons April 28th, 2015 from 9:00 a.m. to 5:00
public. An alternative approach may be between 9 a.m. and 4 p.m., Monday p.m. EDT.
used if such approach satisfies the through Friday, and are available ADDRESSES: The meeting will be held in
requirements of the applicable statute electronically at http://
and regulations. Room 800 in the Hubert H. Humphrey
www.regulations.gov. (FDA has verified Building, 200 Independence Avenue
III. Electronic Access the Web site addresses, but we are not SW., Washington, DC 20201.
responsible for any subsequent changes Comments: Time is allocated in the
Persons interested in obtaining a copy to the Web sites after this document
of the draft guidance may do so by afternoon on the agenda to hear public
publishes in the Federal Register.) comments. The time for oral comments
downloading an electronic copy from
the Internet. A search capability for all 1. CDRH’s Medical Devices Advisory will be limited to two (2) minutes per
CDRH guidance documents is available Committee, available at http://www.fda.gov/ individual. In lieu of oral comments,
AdvisoryCommittees/ formal written comments may be
at http://www.fda.gov/MedicalDevices/ CommitteesMeetingMaterials/
DeviceRegulationandGuidance/ submitted for the record to Rohini
MedicalDevices/
GuidanceDocuments/default.htm. MedicalDevicesAdvisoryCommittee/
Khillan, OASPE, 200 Independence
Guidance documents are also available default.htm. Avenue SW., Room 424E, Washington,
at http://www.regulations.gov. Persons 2. ‘‘Guidance for Industry and FDA Staff: DC 20201. Comments may also be sent
unable to download an electronic copy Guidance on Amended Procedures for to napa@hhs.gov. Those submitting
Advisory Panel Meetings,’’ July 2000, written comments should identify
mstockstill on DSK4VPTVN1PROD with NOTICES
of ‘‘Procedures for Meetings of the
Medical Devices Advisory Committee’’ available at http://www.fda.gov/downloads/ themselves and any relevant
may send an email request to CDRH- MedicalDevices/ organizational affiliations.
DeviceRegulationandGuidance/
Guidance@fda.hhs.gov to receive an GuidanceDocuments/ucm073726.pdf. FOR FURTHER INFORMATION CONTACT:
electronic copy of the document. Please 3. ‘‘Panel Review of Premarket Approval Rohini Khillan (202) 690–5932,
use the document number 413 to Applications #P91–2 (blue book memo),’’ rohini.khillan@hhs.gov. Note: Seating
identify the guidance you are May 1991, available at http://www.fda.gov/ may be limited. Those wishing to attend
requesting. MedicalDevices/ the meeting must send an email to
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Document Created: 2015-12-18 11:04:23
Document Modified: 2015-12-18 11:04:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 1, 2015. | |
| 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. | |
| FR Citation | 80 FR 17439 |
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