Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-Forming Fish and Fishery Products-Decomposition and Histamine; Reopening of the Comment Period, 14538-14539 [2022-05476]

Download as PDF 14538 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices party. Medicare beneficiaries can submit the Medicare Authorization to Disclose Personal Health Information electronically at Medicare.gov. Beneficiaries may also submit the Medicare Authorization to Disclose Personal Health Information by mailing a complete and valid authorization form to Medicare. Beneficiaries can submit the Medicare Authorization to Disclose Personal Health Information verbally over the phone by calling Medicare. Form Number: CMS–10106 (OMB control number: 0938–0930); Frequency: Occasionally; Affected Public: Individuals or households; Number of Respondents: 1,000,000; Total Annual Responses: 1,000,000; Total Annual Hours: 250,000. (For policy questions regarding this collection contact Sam Jenkins at 410–786–3261.) Dated: March 9, 2022. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2022–05360 Filed 3–14–22; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0367] Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-Forming Fish and Fishery Products— Decomposition and Histamine; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or we) is reopening the comment period for the draft Compliance Policy Guide entitled ‘‘Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine’’ that published in the Federal Register of December 27, 2021. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested parties to develop and submit data, other information, and comments before FDA begins work on the final guidance. DATES: FDA is reopening the comment period for the draft Compliance Policy Guide announced in the Federal Register on December 27, 2021 (86 FR 73295). Submit either electronic or khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:10 Mar 14, 2022 Jkt 256001 written comments on the draft guidance by April 14, 2022, to ensure that we consider your comments before we begin work on the final guidance. ADDRESSES: You may submit comments on any guidance at any time 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– 2021–D–0367 for ‘‘Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine.’’ 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 between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 • 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.’’ We will review this copy, including the claimed confidential information, in our 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: Steven Bloodgood, Division of Seafood Safety (HFS–325), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–5316, email: Steven.Bloodgood@fda.hhs.gov; or Jessica Larkin, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2378. SUPPLEMENTARY INFORMATION: In the Federal Register of December 27, 2021 (86 FR 73295), we published a notice announcing the availability of a draft Compliance Policy Guide (CPG) entitled ‘‘Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and E:\FR\FM\15MRN1.SGM 15MRN1 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices Histamine (CPG 7108.24).’’ This draft CPG would update and replace existing guidance for FDA staff on adulteration associated with decomposition and histamine identified during surveillance sampling and testing of fish and fishery products susceptible to histamine formation. We gave interested parties until February 25, 2022, to submit comments before we began work on the final guidance. FDA has received a request for a 30day extension for this comment period to allow additional time for interested parties to develop and submit data, other information, and comments for this draft Compliance Policy Guide before we begin work on the final version of the guidance. We have considered this request and are reopening the comment period for 30 days. FDA believes that this additional 30 days will allow adequate time for any interested parties to submit data, other information, and comments before we begin work on the final guidance. Dated: March 10, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–05476 Filed 3–14–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0968] Nayade Varona: Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Nayade Varona 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 Ms. Varona was convicted of a felony under Federal law for conduct related to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Ms. Varona was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of December 22, 2021 (30 days after receipt of the notice), Ms. Varona had not responded. Ms. Varona’s failure to respond and request a hearing within khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:10 Mar 14, 2022 Jkt 256001 the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action. DATES: This order is applicable March 15, 2022. ADDRESSES: Submit applications for termination of debarment to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402– 7500, or at 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: I. Background Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product under the FD&C Act. On August 11, 2021, Ms. Varona was convicted as defined in section 306(l)(1) of the FD&C Act in the U.S. District Court for the Southern District of Florida, Miami Division, when the court accepted her plea of guilty and entered judgment against her for one count of Conspiracy to Defraud the United States in violation of 18 U.S.C. 371. The factual basis for this conviction is as follows: As contained in the Information, entered into the docket on March 16, 2021, and the Factual Proffer in Support of Ms. Varona’s guilty plea, entered into the docket on June 8, 2021, both from her case, Ms. Varona was employed as an assistant study coordinator at Tellus Clinical Research (Tellus). Tellus was a medical clinic that conducted clinical trials on behalf of pharmaceutical company sponsors. A drug manufacturer (Sponsor) initiated a clinical trial concerning a new investigational drug intended to treat patients suffering from irritable bowel syndrome (Study or IBS Trial). The Sponsor retained a Contract Research Organization (CRO) to manage various aspects of the IBS Trial. CRO entered into a contract with Tellus and Martin Valdes, a medical doctor serving as a clinical investigator for clinical trials conducted at Tellus and as the clinical investigator for the IBS Trial. The study PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 14539 protocol for the IBS Trial required subjects to make periodic scheduled visits to the clinical trial site for which they were paid $100 per visit. During some of these visits, subjects were required to provide blood samples for pharmacokinetic analysis, receive physical exams by clinical trial staff, and undergo electrocardiograms. Subjects were also required to use an ‘‘ediary’’ system to report their daily experience with the Study drugs. They would do this by making daily phone calls to a number maintained by a third party and answering automated questions nonverbally by touch-tone buttons. In her role as an assistant study coordinator, Ms. Varona was responsible for administering procedures to subjects in the Study and creating written records reflecting the participation in the Study. However, Ms. Varona and her co-conspirators engaged in an effort to impair, impede, and obstruct FDA’s legitimate function of regulating clinical trials of drugs in order to obtain money. Ms. Varona and her co-conspirators did this by fabricating medical records to portray persons as legitimate Study subjects when they were not. She and her coconspirators falsified these records to make it appear that the Study subjects had consented to participating in the Study, satisfied the Study’s eligibility criteria, appeared for scheduled visits at the Study’s site, taken Study drugs as required, and received checks as payment for site visits, among other things. For example, Ms. Varona represented that she had seen a purported Study subject, spoken to her about her dietary habits, lifestyle, and exercise regimen, collected a urine sample, taken vital signs, and dispensed the Study drug to her when Ms. Varona well knew that the individual was not a Study subject and that these representations were false. Ms. Varona also knew that one or more of her coconspirators placed telephone calls to the e-diary system for the purposes of reporting fabricated data on behalf of purportedly legitimate Study subjects. As a result of this conviction, FDA sent Ms. Varona by certified mail on November 8, 2021, a notice proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(A) of the FD&C Act, that Ms. Varona was convicted, as set forth in section 306(l)(1) of the FD&C Act, of a felony under Federal law for conduct relating to the development or approval, including the process of development or E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14538-14539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05476]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0367]


Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-
Forming Fish and Fishery Products--Decomposition and Histamine; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the draft Compliance Policy Guide entitled 
``Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming 
Fish and Fishery Products--Decomposition and Histamine'' that published 
in the Federal Register of December 27, 2021. We are taking this action 
in response to a request from stakeholders to extend the comment period 
to allow additional time for interested parties to develop and submit 
data, other information, and comments before FDA begins work on the 
final guidance.

DATES: FDA is reopening the comment period for the draft Compliance 
Policy Guide announced in the Federal Register on December 27, 2021 (86 
FR 73295). Submit either electronic or written comments on the draft 
guidance by April 14, 2022, to ensure that we consider your comments 
before we begin work on the final guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2021-D-0367 for ``Compliance Policy Guide Sec. 540.525 Scombrotoxin 
(Histamine)-forming Fish and Fishery Products--Decomposition and 
Histamine.'' 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 
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.'' We will review 
this copy, including the claimed confidential information, in our 
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: Steven Bloodgood, Division of Seafood 
Safety (HFS-325), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-5316, email: [email protected]; or Jessica Larkin, 
Center for Food Safety and Applied Nutrition, Office of Regulations and 
Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 27, 2021 
(86 FR 73295), we published a notice announcing the availability of a 
draft Compliance Policy Guide (CPG) entitled ``Sec. 540.525 
Scombrotoxin (Histamine)-forming Fish and Fishery Products--
Decomposition and

[[Page 14539]]

Histamine (CPG 7108.24).'' This draft CPG would update and replace 
existing guidance for FDA staff on adulteration associated with 
decomposition and histamine identified during surveillance sampling and 
testing of fish and fishery products susceptible to histamine 
formation. We gave interested parties until February 25, 2022, to 
submit comments before we began work on the final guidance.
    FDA has received a request for a 30-day extension for this comment 
period to allow additional time for interested parties to develop and 
submit data, other information, and comments for this draft Compliance 
Policy Guide before we begin work on the final version of the guidance. 
We have considered this request and are reopening the comment period 
for 30 days. FDA believes that this additional 30 days will allow 
adequate time for any interested parties to submit data, other 
information, and comments before we begin work on the final guidance.

    Dated: March 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05476 Filed 3-14-22; 8:45 am]
BILLING CODE 4164-01-P

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