Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments; Extension of Comment Period, 54455-54456 [2021-21403]

Download as PDF 54455 Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices not intended to address any performance appraisal processes that any State, local, Territorial, or Tribal agency may use to evaluate its employees’ performance. Funding opportunities are available to respondents who choose to implement the ERPS; however, these opportunities are limited and contingent upon the availability of funds, and are available to those respondents who currently have an egg inspection contract with FDA and thus are subject to auditing. A copy of the ERPS has been posted to FDA–2021–N–0341 and is available at https://www.regulations.gov. In the Federal Register of May 14, 2021 (86 FR 26528), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Type of respondents; activity Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours State, local, Territorial, and/or Tribal Governments; submission of data elements to FDA consistent with ERPS 10 10 100 50 5,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on our experience with similar information collection, we estimate an initial 10 respondents will participate in the ERPS, and assume an average of 50 burden hours per response is necessary for the attendant recordkeeping and submission of data elements to FDA. We expect participation in the ERPS to increase. Finally, upon submission of the Information Collection Request, we are correcting an inadvertent calculation error in the total burden hours as displayed on page 26530, in Table 1, in our 60-day notice in the Federal Register of May 14, 2021 (86 FR 26528). Dated: September 24, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–21367 Filed 9–30–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2021–N–0843] Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments; Extension of Comment Period Food and Drug Administration, HHS. Notice; request for information and comments; extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled ‘‘Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments’’ that appeared in the Federal Register of SUMMARY: VerDate Sep<11>2014 18:04 Sep 30, 2021 Jkt 256001 FDA is extending the comment period for the notice published on August 9, 2021 (86 FR 43553). Submit either electronic or written comments by November 30, 2021. DATES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 30, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 30, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: Electronic Submissions Food and Drug Administration AGENCY: August 9, 2021. The Agency is taking this action to allow interested persons additional time to submit comments. 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. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 • 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– 2021–N–0843 for ‘‘Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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, 240–402–7500. • 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 E:\FR\FM\01OCN1.SGM 01OCN1 54456 Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices 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.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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Alexandra Lucas, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–0230, Drug_Device_ Transition_Inquiry@fda.hhs.gov. In the Federal Register of August 9, 2021 (86 FR 43553), FDA published a notice announcing that implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 U.S. app. Lexis 10928 (April 16, 2021) is expected to require some approved products to transition from drug status to device status. That notice provides a 60-day comment period and solicits public comment to inform the Agency’s deliberations about products potentially impacted by the Genus decision and the way in which impacted products should be transitioned from drug to device status. FDA is extending the comment period until November 30, 2021, based on requests FDA received from relevant stakeholders. The Agency believes that an additional 60 days will allow adequate time for interested persons to submit comments to inform the SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:04 Sep 30, 2021 Jkt 256001 Agency’s implementation of the Genus decision. Dated: September 28, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–21403 Filed 9–30–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0269] Sitesh Bansi Patel: Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sitesh Bansi Patel for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Patel was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Patel was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 8, 2021 (30 days after receipt of the notice), Mr. Patel has not responded. Mr. Patel’s failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter. DATES: This order is applicable October 1, 2021. ADDRESSES: Submit applications for termination of debarment to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500, or at https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Enforcement (ELEM–4029), Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240–402–8743, or at debarments@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C)) permits FDA to debar an individual from importing an PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 article of food or offering such an article for import into the United States if FDA finds, as required by section 306(b)(3)(A) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any food. On February 19, 2020, Mr. Patel was convicted as defined in section 306(l)(1)(A) of the FD&C Act, in the U. S. District Court for the Northern District of Texas-Dallas Division, when the court accepted Mr. Patel’s plea of guilty and entered judgment against him for the offense of conspiracy to introduce misbranded food into interstate commerce with an intent to defraud and mislead in violation of 18 U.S.C. 371 (21 U.S.C. 331(a) and 333(a)(2)). FDA’s finding that the debarment is appropriate is based on the felony conviction referenced herein. The factual basis for this conviction is as follows: As contained in the Factual Resume, dated February 22, 2019, Mr. Patel was the Vice President of S.K. Laboratories, LLC, and in that role did business with USP Labs. Beginning in or around October 2008 and continuing until at least in or around August 2014, Mr. Patel and others working at USP Labs and S.K. Laboratories engaged in a plan to import a variety of compounds for use and prospective use in dietary supplements with false labeling. To further this plan, Mr. Patel and his coconspirators ordered a variety of potential dietary compounds from a Chinese company as prospective and actual ingredients for use in dietary supplements, and instructed and agreed to have those powders labeled falsely as other food substances. USP Labs sold dietary supplements called Jack3d and OxyElite Pro, both of which originally contained a substance called 1,3dimethylamylamine (DMAA), which is also known as methylhexaneamine. The DMAA used in Jack3d and OxyElite Pro was a synthetic stimulant manufactured in China. Mr. Patel and his coconspirators came to understand that importing and selling purported natural, plant-based substances would be easier than selling synthetic stimulants. USP Labs imported DMAA using false and fraudulent Certificates of Analysis (COAs) and other false and fraudulent documentation and labeling. Some of the false COAs that USP Labs caused to be created for DMAA shipments stated falsely that the substance in the shipments had been extracted from the geranium plant. In a September 2008 email, Mr. Patel instructed one of his co-conspirators, ‘‘Have your supplier create a COA like this.’’ In an email exchange from May E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54455-54456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0843]


Genus Medical Technologies LLC Versus Food and Drug 
Administration; Request for Information and Comments; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information and comments; extension of 
comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice entitled ``Genus Medical 
Technologies LLC Versus Food and Drug Administration; Request for 
Information and Comments'' that appeared in the Federal Register of 
August 9, 2021. The Agency is taking this action to allow interested 
persons additional time to submit comments.

DATES: FDA is extending the comment period for the notice published on 
August 9, 2021 (86 FR 43553). Submit either electronic or written 
comments by November 30, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 30, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 30, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2021-N-0843 for ``Genus Medical Technologies LLC Versus Food and 
Drug Administration; Request for Information and Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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, 240-402-7500.
     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

[[Page 54456]]

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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Alexandra Lucas, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-0230, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 9, 2021 
(86 FR 43553), FDA published a notice announcing that implementation of 
a decision from the U.S. Court of Appeals for the District of Columbia 
Circuit in Genus Med. Techs., LLC v. FDA, 2021 U.S. app. Lexis 10928 
(April 16, 2021) is expected to require some approved products to 
transition from drug status to device status. That notice provides a 
60-day comment period and solicits public comment to inform the 
Agency's deliberations about products potentially impacted by the Genus 
decision and the way in which impacted products should be transitioned 
from drug to device status.
    FDA is extending the comment period until November 30, 2021, based 
on requests FDA received from relevant stakeholders. The Agency 
believes that an additional 60 days will allow adequate time for 
interested persons to submit comments to inform the Agency's 
implementation of the Genus decision.

    Dated: September 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21403 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P

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