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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices C. Complete the Information Online To Update Your Establishments Annual Registration for FY 2022, or To Register a New Establishment for FY 2022
Go to the Center for Devices and Radiological Healths website at https
www.fda.gov/medical-devices/howstudy-and-market-your-device/deviceregistration-and-listing and click the Access Electronic Registration link on the left side of the page. This opens up a new page with important information about the FDA Unified Registration and Listing System FURLS. After reading this information, click on the Access Electronic Registration link in the middle of the page. This link takes you to an FDA Industry Systems page with tutorials that demonstrate how to create a new FURLS user account, if your establishment did not create an account in FY 2021. Manufacturers of licensed biologics should register in the BER
system at https www.fda.gov/vaccinesblood-biologics/guidance-complianceregulatory-information-biologics/
biologics-establishment-registration.
Enter your existing account ID and password to log into FURLS. From the FURLS/FDA Industry Systems menu, click on the Device Registration and Listing Module DRLM of FURLS
button. New establishments will need to register and existing establishments will update their annual registration using choices on the DRLM menu. When you choose to register or update your annual registration, the system will prompt you through the entry of information about your establishment and your devices. If you have any problems with this process, email: reglist@cdrh.fda.gov or call 3017967400 for assistance. Note:
This email address and this telephone number are for assistance with establishment registration only; they are not to be used for questions related to other aspects of medical device user fees. Problems with the BER system should be directed to https
www.accessdata.fda.gov/scripts/email/
cber/bldregcontact.cfm or call 240402
8360.

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D. Enter Your DFUF Order PIN and PCN
After completing your annual or initial registration and device listing, you will be prompted to enter your DFUF order PIN and PCN, when applicable. This process does not apply to establishments engaged only in the manufacture, preparation, propagation, compounding, or processing of licensed biologic devices. CBER will send invoices for payment of the establishment registration fee to such establishments.

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Dated: July 28, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202116408 Filed 73021; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2011N0658

Vithal K. Patel; Denial of Hearing; Final Debarment Order AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA is denying a request for a hearing submitted by Vithal K. Patel Mr. Patel and issuing an order under the Federal Food, Drug, and Cosmetic Act FD&C Act debarring Mr. Patel for 1 year from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Patel was convicted of conspiracy to commit a felony under Federal law for conduct relating to the regulation of drug products under the FD&C Act and that the type of conduct underlying the conviction undermined the process for the regulation of drugs. In determining the appropriateness and period of Mr.
Patels debarment, FDA considered the relevant factors listed in the FD&C Act.
Mr. Patel has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
DATES: This order is applicable August 2, 2021.
ADDRESSES: Any application for termination of debarment by Mr. Patel under section 306d of the FD&C Act application may be submitted as follows:
SUMMARY:

Electronic Submissions Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
An application submitted electronically, including attachments, to https
www.regulations.gov will be posted to the docket unchanged. Because your application will be made public, you are solely responsible for ensuring that your application 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 elses Social Security number, or
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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 application, that information will be posted on https www.regulations.gov.
If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application 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 HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in Instructions.
Instructions: All applications must include the Docket No. FDA2011N
0658. Received applications 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 between 9
a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo submit an application with confidential information that you do not wish to be made publicly available, submit your application 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 your application.
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 application and you must identify this information as confidential. Any information marked as confidential will not be disclosed
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