Food and Drug Administration Science Forum 2021; Public Workshop, 17164-17165 [2021-06705]

Download as PDF 17164 Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices Page 2 - Revocation of ElJA201745 decontaminating compatible N95 respirators for single-user reuse by HCP to prevent exposure to pathogenic biological aitbofue partic.ulates when there are insufficient supplies offiltering fac¢piece respfrators (FFRs) resuiting from the COVID-19 pandemic, and that the known and potentfal benefits ofNova2200 outweigh the ~ow11 and R9tenihll.1isks Qf its use; Since then, FDA has become aware of new data and evidence suggesting that 3M Model 1860 and H:al.yardFLUIDSHIELD N95respirato:rs, the only compatible N95respiratorsidentifieditt thi.$ EUA, in:ay not mamtaiti adtlqllllte fitlilldfiltration efficiencyfollowing on¢ ( 1) decontamination cycle using the Nova2200, Specifically, I?Dt\ has reviewed new dataindicating thatJM Model 1&60N95 respirators maynotmaintainadequate fit and filtration efficiency after undergoing one (1) decontamination cycle using the Nova2200. 4 Additionally, FDA has become aware of preliminary evidence suggesting that duckbi11N95 resprnrtors, such as Halyard FLUIDSHIELD N9.5 respirators, maynotmai11tain adequate fit to support reuse. 5 A&such, FDAcanno. longerconcludethat itis reasonable to believe thatNova2200 may be effective in preventing HCP exposure to pathogenicbiologjcalaitbome particulates. Additionally, based on this new information, FDA caitno longer conclude that the known and potential benefits o:f'the N ova2200 outweigh the known and potentialrisks of its use; thrn,, the criteriaundersecfion 564(c) oftl1e Act for issuance ofan EUA are no longer met Moreover, based on the same information, and the potential risks to HCPfromusing decontaminated respirators with reduced.fit and filtration petfonnance, FDA has. concluded under section 564(g)(2)(G) of the Act that other circumstances .make revoca1ion>ofthjs EUAappropriate t9 protect the public healtkot safety. Accordingly, FDA hereby revokes EUA201745 for the Nova2200, pursuarit:to section 564(g)(:2)(B)andsection 564(gX2.)(C) oftheAct. As ofthe date ofthisletter, theNova2200js no h;>:nger authorizedf<>r eniergenc)' use t>y FDA. FDA encourages NovaSterilis Irie. to inform its customers ofthis xevocation. Notfoe ofthi!rrevocation will be published in the.Federal Register, pursuant to section 564(h)(l) ofthe.Act. Sincerely; DeniseM. Hinton-S ,~,{;:~\signed b>fooil;.M. \;:~~,2021JJ2.12: l5i47SH -OSni ... . RADM DeniseM. Hinton ChiefScienti$t Food and Drug Adminisfration 4 Diliailed test r~lts, can b~ found :fMww.cdc: I)eg;esysNE, Wang RC,~wan.E;.Ji'ilhil:iiir, Nqble.J;<\, ............ , <;orretil:tion U~tw¢iin:t<l9$}!xtepdetlt1seartd Reuse and i<"it Fail~ nan Emergency Department J;,\ll,1A, 2020;324(1):94~96. clcti:IQ, lQOlf.iama.2020.9843. · Dated: March 24, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2021–06711 Filed 3–31–21; 8:45 am] [Docket No. FDA–2021–N–0262] Food and Drug Administration BILLING CODE 4164–01–C jbell on DSKJLSW7X2PROD with NOTICES Food and Drug Administration Science Forum 2021; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA, Agency, or we) is SUMMARY: VerDate Sep<11>2014 19:02 Mar 31, 2021 Jkt 253001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 announcing the following virtual public workshop entitled ‘‘FDA Science Forum 2021.’’ The purpose of the public workshop is to inform the public about the groundbreaking science conducted at the Agency and to show how scientific research is used in FDA’s regulatory decisions to protect and promote public health. The public workshop will be held virtually on May 26, 2021 (Day 1), from 9 a.m. to 3:30 p.m. Eastern Time, and May 27, 2021 (Day 2), from 9 a.m. to 2 p.m. Eastern Time. See the DATES: E:\FR\FM\01APN1.SGM 01APN1 EN01AP21.008</GPH> 5 in the publi.cly-availa~ie test reportcat . . . . .. .. .. . · iniosh/rt tifte fuitotslttis · , · 039 Reda6red<so8: df Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: Please note that due to the impact of the COVID–19 pandemic, all participants will be joining this public workshop via an online teleconferencing platform. FOR FURTHER INFORMATION CONTACT: Rokhsareh Shahidzadeh, Office of Scientific Professional Development, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2383, Silver Spring, MD 20993, 301–796–8740, FDASciProDev@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The FDA Science Forum is held biennially to inform the public about the groundbreaking science conducted at the Agency and to show how scientific research is used in FDA’s regulatory decisions to protect and promote public health. Open to the public, industry, academia, patient advocates, government agencies, and current and potential collaborators, the 2-day event offers an opportunity to hear FDA scientific experts and nationally renowned scientists speak on a range of topics associated with regulatory science. jbell on DSKJLSW7X2PROD with NOTICES III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following website: https://www.fda.gov/ scienceforum. Registration is free. Persons interested in attending this public workshop must register by May 21, 2021, by 5 p.m. Eastern Time. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Rokhsareh Shahidzadeh (see FOR FURTHER INFORMATION CONTACT) no later than May 21, 2021, by 5 p.m. Eastern Time. Streaming Webcast of the Public Workshop: This public workshop will Jkt 253001 [FR Doc. 2021–06705 Filed 3–31–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–2306] TG United, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction Food and Drug Administration, HHS. The theme for the 2021 FDA Science Forum, ‘‘Science as the Foundation for Protecting and Promoting Public Health’’, will highlight areas of FDA research, including: (1) Improving clinical and postmarket evaluation; (2) substance use, misuse, and addiction; (3) product development and manufacturing; and (4) medical countermeasures, infectious disease, and pathogen-reduction technologies. 19:02 Mar 31, 2021 Dated: March 24, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. AGENCY: II. Topics for Discussion at the Public Workshop VerDate Sep<11>2014 be streamed via a webcast only. To register for the webcast, please visit the following website: https://www.fda.gov/ scienceforum. Participants interested in viewing via webcast must register by May 21, 2021, by 5 p.m. Eastern Time. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. ACTION: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of January 15, 2021. The document announced the withdrawal of approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants as of February 16, 2021. The document indicated that FDA was withdrawing approval of the following three ANDAs after receiving a withdrawal request from Upsher-Smith Laboratories, LLC., 6701 Evenstad Dr., Maple Grove, MN 55369: ANDA 084041, Chlordiazepoxide Hydrochloride (HCl) Capsules, 10 milligrams (mg); ANDA 084678, Chlordiazepoxide HCl Capsules, 5 mg; and ANDA 084679, Chlordiazepoxide HCl Capsules, 25 mg. Before FDA withdrew the approval of these ANDAs, Upsher-Smith Laboratories, LLC., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Upsher-Smith Laboratories, LLC., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 084041, 084678, and 084679 is still in effect. In addition, the document indicated that FDA was PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 withdrawing approval of ANDA 206061, Pravastatin Sodium Tablets, 20 mg, 40 mg, and 80 mg, after receiving a request from Hisun Pharmaceutical (Hangzhou) Co., Ltd. However, the document published with the incorrect applicant name for ANDA 206061. This document corrects that error. All other information for ANDA 206061 remains the same. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. In the Federal Register of Friday, January 15, 2021 (86 FR 4081), appearing on page 4081 in FR Doc. 2021–00833, the following corrections are made on page 4082 in the table: 1. The entries for ANDAs 084041, 084678, and 084679 are removed. 2. In the third column, third item from the bottom, the applicant name ‘‘Hisun Pharmaceuticals USA, Inc.’’ is corrected to read ‘‘Hisun Pharmaceuticals USA, Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd.’’ for ANDA 206061. SUPPLEMENTARY INFORMATION: Dated: March 29, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–06745 Filed 3–31–21; 8:45 am] Notice; correction. SUMMARY: 17165 BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0270] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. SUMMARY: E:\FR\FM\01APN1.SGM 01APN1

Agencies

[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17164-17165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06705]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0262]


Food and Drug Administration Science Forum 2021; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the following virtual public workshop entitled ``FDA Science 
Forum 2021.'' The purpose of the public workshop is to inform the 
public about the groundbreaking science conducted at the Agency and to 
show how scientific research is used in FDA's regulatory decisions to 
protect and promote public health.

DATES: The public workshop will be held virtually on May 26, 2021 (Day 
1), from 9 a.m. to 3:30 p.m. Eastern Time, and May 27, 2021 (Day 2), 
from 9 a.m. to 2 p.m. Eastern Time. See the

[[Page 17165]]

SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all participants will be joining this public workshop via an online 
teleconferencing platform.

FOR FURTHER INFORMATION CONTACT: Rokhsareh Shahidzadeh, Office of 
Scientific Professional Development, Office of the Chief Scientist, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 2383, Silver Spring, MD 20993, 301-796-
8740, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Science Forum is held biennially to inform the public about 
the groundbreaking science conducted at the Agency and to show how 
scientific research is used in FDA's regulatory decisions to protect 
and promote public health. Open to the public, industry, academia, 
patient advocates, government agencies, and current and potential 
collaborators, the 2-day event offers an opportunity to hear FDA 
scientific experts and nationally renowned scientists speak on a range 
of topics associated with regulatory science.

II. Topics for Discussion at the Public Workshop

    The theme for the 2021 FDA Science Forum, ``Science as the 
Foundation for Protecting and Promoting Public Health'', will highlight 
areas of FDA research, including: (1) Improving clinical and postmarket 
evaluation; (2) substance use, misuse, and addiction; (3) product 
development and manufacturing; and (4) medical countermeasures, 
infectious disease, and pathogen-reduction technologies.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://www.fda.gov/scienceforum. Registration is 
free. Persons interested in attending this public workshop must 
register by May 21, 2021, by 5 p.m. Eastern Time. Registrants will 
receive confirmation when they have been accepted.
    If you need special accommodations due to a disability, please 
contact Rokhsareh Shahidzadeh (see FOR FURTHER INFORMATION CONTACT) no 
later than May 21, 2021, by 5 p.m. Eastern Time.
    Streaming Webcast of the Public Workshop: This public workshop will 
be streamed via a webcast only. To register for the webcast, please 
visit the following website: https://www.fda.gov/scienceforum. 
Participants interested in viewing via webcast must register by May 21, 
2021, by 5 p.m. Eastern Time.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

    Dated: March 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06705 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P
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