81 FR 4632 - Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals'); Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 17 (January 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 17 (January 27, 2016)
| Page Range | 4632-4633 | |
| FR Document | 2016-01610 |
[Federal Register Volume 81, Number 17 (Wednesday, January 27, 2016)] [Notices] [Pages 4632-4633] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01610] [[Page 4632]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4803] Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals'); Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is extending the comment period for the draft guidance for Industry and Food and Drug Administration Staff entitled ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').'' A notice of the availability of the draft guidance and our request for comments appeared in the Federal Register of December 31, 2015. We initially established February 29, 2016, as the deadline for the submission of requested comments that can help improve the Agency's policy for notifying the public about medical device ``emerging signals.'' The Agency is taking this action due to the unanticipated high-level of interest from external stakeholders and the medical device community and will allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals')''; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, which was announced in the Notice published December 31, 2015 (80 FR 81829). 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 29, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-4803 for ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the draft 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 ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals')'' 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: Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of December 31, 2015, FDA published a notice announcing the availability of a draft guidance entitled ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals'),'' with a 60-day comment period to request comments on the Agency's policy for [[Page 4633]] notifying the public about medical device ``emerging signals.'' FDA is extending the comment period for the publication notification of ``emerging signals'' for 30 days, until March 29, 2016. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments. II. 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 Center for Devices and Radiological Health 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 ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals')'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500027 to identify the guidance you are requesting. Dated: January 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01610 Filed 1-26-16; 8:45 am] BILLING CODE 4164-01-P
![4632 Federal Register / Vol. 81, No. 17 / Wednesday, January 27, 2016 / Notices
DEPARTMENT OF HEALTH AND including attachments, to http:// redacted/blacked out, will be available
HUMAN SERVICES www.regulations.gov will be posted to for public viewing and posted on http://
the docket unchanged. Because your www.regulations.gov. Submit both
Food and Drug Administration comment will be made public, you are copies to the Division of Dockets
[Docket No. FDA–2015–D–4803]
solely responsible for ensuring that your Management. If you do not wish your
comment does not include any name and contact information to be
Public Notification of Emerging confidential information that you or a made publicly available, you can
Postmarket Medical Device Signals third party may not wish to be posted, provide this information on the cover
(’Emerging Signals’); Draft Guidance such as medical information, your or sheet and not in the body of your
for Industry and Food and Drug anyone else’s Social Security number, or comments and you must identify this
Administration Staff; Extension of confidential business information, such information as ‘‘confidential.’’ Any
Comment Period as a manufacturing process. Please note information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
AGENCY: Food and Drug Administration, information, or other information that accordance with 21 CFR 10.20 and other
HHS. identifies you in the body of your applicable disclosure law. For more
ACTION: Notice; extension of comment comments, that information will be information about FDA’s posting of
period. posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
SUMMARY: The Food and Drug with confidential information that you the information at: http://www.fda.gov/
Administration (FDA or Agency) is do not wish to be made available to the regulatoryinformation/dockets/
extending the comment period for the public, submit the comment as a default.htm.
draft guidance for Industry and Food written/paper submission and in the Docket: For access to the docket to
and Drug Administration Staff entitled manner detailed (see ‘‘Written/Paper read background documents or the
‘‘Public Notification of Emerging Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Postmarket Medical Device Signals received, go to http://
Written/Paper Submissions
(’Emerging Signals’).’’ A notice of the www.regulations.gov and insert the
availability of the draft guidance and Submit written/paper submissions as docket number, found in brackets in the
our request for comments appeared in follows: heading of this document, into the
the Federal Register of December 31, • Mail/Hand delivery/Courier (for
‘‘Search’’ box and follow the prompts
2015. We initially established February written/paper submissions): Division of
and/or go to the Division of Dockets
29, 2016, as the deadline for the Dockets Management (HFA–305), Food
Management, 5630 Fishers Lane, Rm.
submission of requested comments that and Drug Administration, 5630 Fishers
1061, Rockville, MD 20852.
can help improve the Agency’s policy Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the draft
for notifying the public about medical • For written/paper comments
guidance document is available for
device ‘‘emerging signals.’’ The Agency submitted to the Division of Dockets
download from the Internet. See the
is taking this action due to the Management, FDA will post your
SUPPLEMENTARY INFORMATION section for
unanticipated high-level of interest from comment, as well as any attachments,
information on electronic access to the
external stakeholders and the medical except for information submitted,
guidance. Submit written requests for a
device community and will allow marked and identified, as confidential,
single hard copy of the draft guidance
interested persons additional time to if submitted as detailed in
document entitled ‘‘Public Notification
submit comments. ‘‘Instructions.’’
Instructions: All submissions received of Emerging Postmarket Medical Device
DATES: FDA is extending the comment
must include the Docket No. FDA– Signals (’Emerging Signals’)’’ to the
period on the ‘‘Public Notification of 2015–D–4803 for ‘‘Public Notification of Office of the Center Director, Guidance
Emerging Postmarket Medical Device Emerging Postmarket Medical Device and Policy Development, Center for
Signals (’Emerging Signals’)’’; Draft Signals (’Emerging Signals’).’’ Received Devices and Radiological Health, Food
Guidance for Industry and Food and comments will be placed in the docket and Drug Administration, 10903 New
Drug Administration Staff; Availability, and, except for those submitted as Hampshire Ave., Bldg. 66, Rm. 5431,
which was announced in the Notice ‘‘Confidential Submissions,’’ publicly Silver Spring, MD 20993–0002. Send
published December 31, 2015 (80 FR viewable at http://www.regulations.gov one self-addressed adhesive label to
81829). Although you can comment on or at the Division of Dockets assist that office in processing your
any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m., request.
10.115(g)(5)), to ensure that the Agency Monday through Friday. FOR FURTHER INFORMATION CONTACT:
considers your comment of this draft • Confidential Submissions—To Rebecca Nipper, Center for Devices and
guidance before it begins work on the submit a comment with confidential Radiological Health, Food and Drug
final version of the guidance, submit information that you do not wish to be Administration, 10903 New Hampshire
either electronic or written comments made publicly available, submit your Ave., Bldg. 66, Rm. 1540, Silver Spring,
on the draft guidance by March 29, comments only as a written/paper MD 20993–0002, 301–796–6527.
2016. submission. You should submit two SUPPLEMENTARY INFORMATION:
ADDRESSES: You may submit comments copies total. One copy will include the
information you claim to be confidential I. Background
asabaliauskas on DSK5VPTVN1PROD with NOTICES
as follows:
with a heading or cover note that states In the Federal Register of December
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS 31, 2015, FDA published a notice
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The announcing the availability of a draft
following way: Agency will review this copy, including guidance entitled ‘‘Public Notification
• Federal eRulemaking Portal: http:// the claimed confidential information, in of Emerging Postmarket Medical Device
www.regulations.gov. Follow the its consideration of comments. The Signals (’Emerging Signals’),’’ with a 60-
instructions for submitting comments. second copy, which will have the day comment period to request
Comments submitted electronically, claimed confidential information comments on the Agency’s policy for
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![Federal Register / Vol. 81, No. 17 / Wednesday, January 27, 2016 / Notices 4633
notifying the public about medical The current rate of 93⁄4%, as fixed by Security Boulevard, Baltimore, MD
device ‘‘emerging signals.’’ the Secretary of the Treasury, is certified 21244.
FDA is extending the comment period for the quarter ended December 31, Registration: Registration will be on a
for the publication notification of 2015. This rate is based on the Interest first-come, first-serve basis, limited to
‘‘emerging signals’’ for 30 days, until Rates for Specific Legislation, ‘‘National two (2) participants per organization for
March 29, 2016. The Agency believes Health Services Corps Scholarship the onsite location participation, and
that a 30-day extension allows adequate Program (42 U.S.C. 254o(b)(1)(A))’’ and three (3) participants per organization
time for interested persons to submit ‘‘National Research Service Award for the webinar participation. Each
comments. Program (42 U.S.C. 288(c)(4)(B)).’’ This individual can only register for either
II. Electronic Access interest rate will be applied to overdue the onsite location participation or
debt until the Department of Health and webinar participation. To change a
Persons interested in obtaining a copy Human Services publishes a revision. registration option from onsite to
of the draft guidance may do so by webinar participation, the registrant
downloading an electronic copy from Dated: January 13, 2016.
must cancel the existing registration
the Internet. A search capability for all David C. Horn.
(onsite or webinar) before attempting to
Center for Devices and Radiological Director, Office of Financial Policy and
register for the other option.
Health guidance documents is available Reporting.
Registration Instructions: To register
at http://www.fda.gov/MedicalDevices/ [FR Doc. 2016–01649 Filed 1–26–16; 8:45 am]
to attend the meeting either onsite or
DeviceRegulationandGuidance/ BILLING CODE 4150–04–P through webinar participation, visit the
GuidanceDocuments/default.htm. Registration for Technical Assistance
Guidance documents are also available Portal (REGTAP) at www.REGTAP.info.
at http://www.regulations.gov. Persons DEPARTMENT OF HEALTH AND
If not already a REGTAP user, register
unable to download an electronic copy HUMAN SERVICES
as a new user, log in and go to ‘‘My
of ‘‘Public Notification of Emerging Dashboard’’ and select ‘‘Training
Postmarket Medical Device Signals [CMS–9935–N2]
Events’’ to register for the onsite or
(’Emerging Signals’)’’ may send an email webinar event for the HHS-operated
request to CDRH-Guidance@fda.hhs.gov HHS-Operated Risk Adjustment
Methodology Meeting; March 31, 2016 Risk Adjustment Methodology Meeting.
to receive an electronic copy of the Registrants can only register to attend
document. Please use the document AGENCY: Centers for Medicare & the meeting onsite at CMS or remotely
number 1500027 to identify the Medicaid Services (CMS), HHS. by webinar.
guidance you are requesting. ACTION: Notice of meeting. FOR FURTHER INFORMATION CONTACT: For
Dated: January 21, 2016. further information, please send
Leslie Kux, SUMMARY: This notice announces the inquiries about the logistics of the
Associate Commissioner for Policy. rescheduling of the March 25, 2016 meeting to registrar@REGTAP.info.
[FR Doc. 2016–01610 Filed 1–26–16; 8:45 am]
meeting on the HHS-operated risk Users should submit inquiries and
adjustment program, which is open to comments pertaining to content covered
BILLING CODE 4164–01–P
the public. The purpose of this during the meeting to
stakeholder meeting is to solicit www.REGTAP.info. To submit an
DEPARTMENT OF HEALTH AND feedback on the HHS-operated risk inquiry in REGTAP, select ‘‘Submit an
HUMAN SERVICES adjustment methodology and to discuss Inquiry’’ from ‘‘My Dashboard’’ then
potential improvements to the HHS risk select ‘‘HHS-operated Risk Adjustment
Office of the Secretary adjustment methodology for the 2018 Methodology Meeting’’ from the Event
benefit year and beyond. This meeting, Title dropdown menu and enter the
Notice of Interest Rate on Overdue the ‘‘HHS-operated Risk Adjustment question or comment. Users can submit
Debts Methodology Conference,’’ will allow their comments and upload attachments
Section 30.18 of the Department of issuers, States, and other interested as needed. REGTAP will send the user
Health and Human Services’ claims parties to discuss the contents of a an acknowledgement upon receipt of
collection regulations (45 CFR part 30) White Paper to be published in advance the comment.
provides that the Secretary shall charge of this meeting. This meeting will also The CCIIO’s Press Office at (202) 690–
an annual rate of interest, which is provide an opportunity for participants 6145 will handle all press inquiries.
determined and fixed by the Secretary to ask clarifying questions. The
SUPPLEMENTARY INFORMATION:
of the Treasury after considering private comments and information HHS obtains
consumer rates of interest on the date through this meeting may be used in I. Background
that the Department of Health and future policy making for the HHS risk This notice announces a meeting on
Human Services becomes entitled to adjustment program. the HHS-operated risk adjustment
recovery. The rate cannot be lower than DATES: Date of Meeting: March 31, 2016 program to discuss potential
the Department of Treasury’s current from 9:00 a.m. to 4:30 p.m., Eastern improvements to the HHS risk
value of funds rate or the applicable rate daylight time (e.d.t.). adjustment methodology for the 2018
determined from the ‘‘Schedule of Deadline for Onsite Participation: benefit year and beyond. This meeting
Certified Interest Rates with Range of March 23, 2016, 5:00 p.m., e.d.t. will focus on the permanent risk
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Maturities’’ unless the Secretary waives Deadline for Webinar Meeting adjustment program under section 1343
interest in whole or part, or a different Participation: March 28, 2016, 5:00 p.m. of the Affordable Care Act when HHS is
rate is prescribed by statute, contract, or e.d.t. operating a risk adjustment program on
repayment agreement. The Secretary of Deadline for Requesting Special behalf of a State (referred to as the HHS-
the Treasury may revise this rate Accommodations: March 23, 2016, 5:00 operated risk adjustment program).
quarterly. The Department of Health and p.m. e.d.t. We are committed to stakeholder
Human Services publishes this rate in ADDRESSES: The meeting will be held at engagement in developing the detailed
the Federal Register. the CMS Single Site campus, 7500 processes of the HHS-operated risk
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Document Created: 2018-02-02 12:40:13
Document Modified: 2018-02-02 12:40:13
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period on the ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals')''; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, which was announced in the Notice published December 31, 2015 (80 FR 81829). 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 March 29, 2016. | |
| Contact | Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527. | |
| FR Citation | 81 FR 4632 |
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