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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices
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 FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/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, 2404027500.
FOR FURTHER INFORMATION CONTACT:

Charles Andres, Center for Veterinary Medicine HFV180, Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 2404020653, charles.andres@fda.hhs.gov.
In the Federal Register of June 15, 2021, FDA
published a request for comments with a 90-day comment period to request comments on the use of study data exchange standards from persons involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of NDAs, ANDAs, or applications for conditional approval. Comments on the use of study data exchange standards will help us evaluate the potential use of study data exchange standards for animal studies submitted as part of the new animal drug approval process
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SUPPLEMENTARY INFORMATION:

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Interested persons were originally given until September 13, 2021, to comment on document. The Agency has received a request for a 60-day extension of the comment period. The request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the request for comments. FDA has considered the request and is extending the comment period for the request for comments for 60 days, until November 12, 2021. The Agency believes that a 60day extension allows adequate time for interested persons to submit comments.
Dated: August 20, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202118395 Filed 82521; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0008

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or Agency announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.
The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. The meeting will be open to the public.
DATES: The meeting will take place virtually on November 2 and 3, 2021, from 9 a.m. to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: https www.fda.gov/
advisory-committees/about-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings.
FOR FURTHER INFORMATION CONTACT:
Akinola Awojope, Center for Devices and Radiological Health, Food and Drug SUMMARY:

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Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 209930002, Akinola.Awojope@
fda.hhs.gov, 3016360512, or FDA
Advisory Committee Information Line, 18007418138 3014430572 in the Washington, DC area. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.
Therefore, you should always check the Agencys website at https
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On November 2, 2021, the committee will discuss and make recommendations on information about the benefit-risk profile of the Endologix AFX
endovascular graft system with regards to the risk of Type III endoleaks. FDA
requests panel input regarding the totality of data collected on AFX devices and whether further actions are necessary.
On November 3, 2021, the committee will discuss and make recommendations on the continued safety and effectiveness of endovascular stent grafts and how to strengthen realworld data collection on long-term performance of the devices, both for currently marketed devices and for future technologies. FDA intends to request panel input on the clinical outcomes that are most relevant to capture in the real world, along with their frequency and duration.
Additionally, FDA intends to seek input on data collection platforms, and how to incentivize and optimize real world data collection.
FDA intends to make background material available to the public no later than 2 business days before the meeting.
If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDAs website at the time of the advisory committee meeting, and the background material will be posted on FDAs website after the meeting. Background material and the link to the online teleconference meeting room will be available at https www.fda.gov/
advisory-committees/circulatory-systemdevices-panel/2021-meeting-materials-

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