82 FR 41626 - Procedures for Meetings of the Medical Devices Advisory Committee; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 169 (September 1, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 169 (September 1, 2017)
| Page Range | 41626-41627 | |
| FR Document | 2017-18549 |
[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)] [Notices] [Pages 41626-41627] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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 [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. 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
![41626 Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices
DEPARTMENT OF HEALTH AND • If you want to submit a comment of comments to public dockets, see 80
HUMAN SERVICES with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
Food and Drug Administration public, submit the comment as a fdsys/pkg/FR–2015–09–18/pdf/2015–
[Docket No. FDA–2015–D–0838] written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Procedures for Meetings of the Medical Submissions’’ and ‘‘Instructions’’). read background documents or the
Devices Advisory Committee; Written/Paper Submissions electronic and written/paper comments
Guidance for Industry and Food and received, go to https://
Drug Administration Staff; Availability Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for heading of this document, into the
HHS. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
ACTION: Notice of availability. Management Staff (HFA–305), Food and and/or go to the Dockets Management
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
Administration (FDA or Agency) is • For written/paper comments An electronic copy of the guidance
announcing the availability of the submitted to the Dockets Management
guidance entitled ‘‘Procedures for document is available for download
Staff, FDA will post your comment, as from the internet. See the
Meetings of the Medical Devices well as any attachments, except for
Advisory Committee.’’ The Center for SUPPLEMENTARY INFORMATION section for
information submitted, marked and
Devices and Radiological Health (CDRH) information on electronic access to the
identified, as confidential, if submitted
is issuing this guidance to provide guidance. Submit written requests for a
as detailed in ‘‘Instructions.’’
additional information regarding the Instructions: All submissions received single hard copy of the guidance
processes for meetings of the Medical must include the Docket No. FDA– document entitled ‘‘Procedures for
Devices Advisory Committee panels 2015–D–0838 for ‘‘Procedures for Meetings of the Medical Devices
other than the Medical Devices Dispute Meetings of the Medical Devices Advisory Committee’’ to the Office of
Resolution Panel (DRP). This guidance Advisory Committee; Guidance for the Center Director, Guidance and
describes the general circumstances in Industry and Food and Drug Policy Development, Center for Devices
which CDRH consults with a panel, the Administration Staff; Availability.’’ and Radiological Health, Food and Drug
process for exchange of information Received comments will be placed in Administration, 10903 New Hampshire
among CDRH, the members of the panel, the docket and, except for those Ave., Bldg. 66, Rm. 5431, Silver Spring,
industry, and the public, and the submitted as ‘‘Confidential MD 20993–0002. Send one self-
conduct of panel meetings. This Submissions,’’ publicly viewable at addressed adhesive label to assist that
guidance supplements existing FDA https://www.regulations.gov or at the office in processing your request.
Agency-wide guidance on the conduct Dockets Management Staff Office FOR FURTHER INFORMATION CONTACT:
of Advisory Committee meetings. between 9 a.m. and 4 p.m., Monday James Swink, Center for Devices and
DATES: Submit either electronic or through Friday. Radiological Health, Food and Drug
written comments on this guidance at • Confidential Submissions—To Administration, 10903 New Hampshire
any time. General comments on Agency submit a comment with confidential Ave., Bldg. 66, Rm. 1609, Silver Spring,
guidance documents are welcome at any information that you do not wish to be MD 20993–0002, 301–796–6313.
time. made publicly available, submit your SUPPLEMENTARY INFORMATION:
ADDRESSES: You may submit comments comments only as a written/paper
submission. You should submit two I. Background
as follows:
copies total. One copy will include the CDRH is issuing this guidance to
Electronic Submissions information you claim to be confidential provide additional information
Submit electronic comments in the with a heading or cover note that states regarding the processes for meetings of
following way: ‘‘THIS DOCUMENT CONTAINS the Medical Devices Advisory
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The Committee panels other than DRP. The
https://www.regulations.gov. Follow the Agency will review this copy, including term ‘‘panel,’’ as used in this guidance,
instructions for submitting comments. the claimed confidential information, in refers to the panels established under
Comments submitted electronically, its consideration of comments. The the Medical Devices Advisory
including attachments, to https:// second copy, which will have the Committee charter excluding DRP. This
www.regulations.gov will be posted to claimed confidential information guidance describes the general
the docket unchanged. Because your redacted/blacked out, will be available circumstances in which CDRH consults
comment will be made public, you are for public viewing and posted on with a panel of the Medical Devices
solely responsible for ensuring that your https://www.regulations.gov. Submit Advisory Committee, the process for
comment does not include any both copies to the Dockets Management exchange of information among CDRH,
confidential information that you or a Staff. If you do not wish your name and the members of the panel, industry, and
third party may not wish to be posted, contact information to be made publicly the public, and the conduct of panel
such as medical information, your or available, you can provide this meetings. The Medical Devices
anyone else’s Social Security number, or information on the cover sheet and not Advisory Committee includes 17 panels
sradovich on DSK3GMQ082PROD with NOTICES
confidential business information, such in the body of your comments and you other than DRP (Ref. 1). The panels,
as a manufacturing process. Please note must identify this information as according to their specialty area and
that if you include your name, contact ‘‘confidential.’’ Any information marked authorization, advise the Commissioner
information, or other information that as ‘‘confidential’’ will not be disclosed of Food and Drugs in discharging
identifies you in the body of your except in accordance with 21 CFR 10.20 responsibilities as they relate to assuring
comments, that information will be and other applicable disclosure law. For the safety and effectiveness of medical
posted on https://www.regulations.gov. more information about FDA’s posting devices, and as required, any other
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![Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices 41627
product for which FDA has regulatory Reduction Act of 1995 (44 U.S.C. 3501– Program (the program), as required by
responsibility. 3520). The collections of information in the Public Health Service (PHS) Act, as
In the Federal Register of April 1, 21 CFR part 807, subpart E have been amended. While the Secretary of HHS is
2015 (80 FR 17439), FDA announced the approved under OMB control number named as the respondent in all
availability of the draft guidance. 0910–0120; the collections of proceedings brought by the filing of
Interested persons were invited to information in 21 CFR part 860 have petitions for compensation under the
comment by June 1, 2015. FDA revised been approved under OMB control Program, the United States Court of
the guidance as appropriate in response number 0910–0138; the collections of Federal Claims is charged by statute
to the comments. This guidance is information in 21 CFR part 814 have with responsibility for considering and
intended to provide information for been approved under OMB control acting upon the petitions.
industry and for CDRH staff on the number 0910–0231; and the collections FOR FURTHER INFORMATION CONTACT: For
processes associated with a panel of information in 21 CFR part 814, information about requirements for
meeting held for any of the reasons subpart H have been approved under filing petitions, and the program in
identified in the guidance. This OMB control number 0910–0332. general, contact Lisa L. Reyes, Acting
guidance replaces the ‘‘Guidance on Clerk, United States Court of Federal
Amended Procedures for Advisory V. References
Claims, 717 Madison Place NW.,
Panel Meetings’’ (Ref. 2) and the The following references are on Washington, DC 20005, (202) 357–6400.
guidance document entitled ‘‘Panel display in the Dockets Management For information on HRSA’s role in the
Review of Premarket Approval Staff (see ADDRESSES), and may be seen program, contact the Director, National
Applications #P91–2 blue book memo’’ by interested persons between 9 a.m. Vaccine Injury Compensation Program,
(Ref. 3). This guidance supplements and 4 p.m., Monday through Friday; 5600 Fishers Lane, Room 08N146B,
existing FDA Agency-wide guidance on they are also available electronically at Rockville, MD 20857; (301) 443–6593,
the conduct of Advisory Committee https://www.regulations.gov. FDA has or visit our Web site at: http://
meetings. verified the Web site addresses, as of the www.hrsa.gov/vaccinecompensation/
date this document publishes in the index.html.
II. Significance of Guidance
Federal Register, but Web sites are
This guidance is being issued SUPPLEMENTARY INFORMATION: The
subject to change over time.
consistent with FDA’s good guidance program provides a system of no-fault
1. CDRH’s Medical Devices Advisory compensation for certain individuals
practices regulation (21 CFR 10.115). Committee, available at https://
The guidance represents the current who have been injured by specified
www.fda.gov/AdvisoryCommittees/
thinking of FDA on the panel meeting CommitteesMeetingMaterials/Medical childhood vaccines. Subtitle 2 of Title
process for medical devices. It does not Devices/MedicalDevicesAdvisoryCommittee/ XXI of the PHS Act, 42 U.S.C. 300aa–
establish any rights for any person and default.htm. 10 et seq., provides that those seeking
is not binding on FDA or the public. 2. ‘‘Guidance for Industry and FDA Staff: compensation are to file a petition with
You can use an alternative approach if Guidance on Amended Procedures for the U.S. Court of Federal Claims and to
Advisory Panel Meetings,’’ July 2000, serve a copy of the petition on the
it satisfies the requirements of the available at https://www.fda.gov/downloads/
applicable statutes and regulations. This Secretary of HHS, who is named as the
MedicalDevices/DeviceRegulationand
guidance is not subject to Executive Guidance/GuidanceDocuments/
respondent in each proceeding. The
Order 12866. ucm073726.pdf. Secretary has delegated this
3. ‘‘Panel Review of Premarket Approval responsibility under the program to
III. Electronic Access Applications #P91–2 (blue book memo),’’ HRSA. The Court is directed by statute
Persons interested in obtaining a copy May 1991, available at https://www.fda.gov/ to appoint special masters who take
of the guidance may do so by MedicalDevices/DeviceRegulationand evidence, conduct hearings as
downloading an electronic copy from Guidance/GuidanceDocuments/ appropriate, and make initial decisions
ucm081363.htm. as to eligibility for, and amount of,
the internet. A search capability for all
Center for Devices and Radiological Dated: August 28, 2017. compensation.
Health guidance documents is available Anna K. Abram, A petition may be filed with respect
at https://www.fda.gov/MedicalDevices/ Deputy Commissioner for Policy, Planning, to injuries, disabilities, illnesses,
DeviceRegulationandGuidance/ Legislation, and Analysis. conditions, and deaths resulting from
GuidanceDocuments/default.htm. [FR Doc. 2017–18549 Filed 8–31–17; 8:45 am] vaccines described in the Vaccine Injury
Guidance documents are also available BILLING CODE 4164–01–P Table (the table) set forth at 42 CFR
at https://www.regulations.gov. Persons 100.3. This Table lists for each covered
unable to download an electronic copy childhood vaccine the conditions that
of ‘‘Procedures for Meetings of the DEPARTMENT OF HEALTH AND may lead to compensation and, for each
Medical Devices Advisory Committee’’ HUMAN SERVICES condition, the time period for
may send an email request to CDRH- occurrence of the first symptom or
Guidance@fda.hhs.gov to receive an Health Resources and Services manifestation of onset or of significant
electronic copy of the document. Please Administration aggravation after vaccine
use the document number 413 to administration. Compensation may also
National Vaccine Injury Compensation be awarded for conditions not listed in
identify the guidance you are
Program; List of Petitions Received the Table and for conditions that are
requesting.
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Health Resources and Services manifested outside the time periods
IV. Paperwork Reduction Act of 1995 specified in the Table, but only if the
Administration (HRSA), Department of
This guidance refers to previously Health and Human Services (HHS). petitioner shows that the condition was
approved collections of information ACTION: Notice. caused by one of the listed vaccines.
found in FDA regulations. These Section 2112(b)(2) of the PHS Act, 42
collections of information are subject to SUMMARY: HRSA is publishing this U.S.C. 300aa–12(b)(2), requires that
review by the Office of Management and notice of petitions received under the ‘‘[w]ithin 30 days after the Secretary
Budget (OMB) under the Paperwork National Vaccine Injury Compensation receives service of any petition filed
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Document Created: 2017-09-01 01:50:49
Document Modified: 2017-09-01 01:50:49
| 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 of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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 | 82 FR 41626 |
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