Request for Data and Information on Technologies Used To Detect and Measure Botulinum Neurotoxin, 27622-27623 [2018-12726]

Download as PDF 27622 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Natalia Komissarova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, MSC 7846, Bethesda, MD 20892, 301–435– 1206, komissar@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Immune Mechanism: Activation, Regulation and Tolerance. Date: July 11, 2018. Time: 12:30 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Patrick K. Lai, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2215, MSC 7812, Bethesda, MD 20892, 301–435– 1052, laip@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: June 7, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–12671 Filed 6–12–18; 8:45 am] BILLING CODE 4140–01–P Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Ivan K. Navarro, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4242, MSC 9550, Bethesda, MD 20892, 301–827–5833, ivan.navarro@ nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3 (Clinical Trials Optional). Date: August 16, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Ivan K. Navarro, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4242, MSC 9550, Bethesda, MD 20892, 301–827–5833, ivan.navarro@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: June 7, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–12674 Filed 6–12–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute on Drug Abuse; Notice of Closed Meetings amozie on DSK3GDR082PROD with NOTICES1 National Institutes of Health National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; SEP for Medications Development. Date: June 27, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 Request for Data and Information on Technologies Used To Detect and Measure Botulinum Neurotoxin AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used to detect and measure botulinum neurotoxin (BoNT). Submitted information will be used to assess the state of the science and determine technical needs for nonanimal test methods that are used to detect the presence of BoNT and measure potency of BoNT preparations. DATES: Receipt of information: Deadline is July 11, 2018. SUMMARY: PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 Data and information should be submitted electronically to niceatm@niehs.nih.gov. FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (984) 287–3118. SUPPLEMENTARY INFORMATION: Background: NICEATM fosters the evaluation and promotion of alternative test methods for regulatory use. As part of this activity, NICEATM supports efforts to develop, validate, and implement alternative approaches for biologics tests, including those used to detect the presence of BoNT and measure potency of BoNT preparations. Tests to detect and measure BoNT are required by multiple federal agencies for regulatory and other decision contexts. Currently, the standard test for these endpoints is a mouse lethality assay that can use large numbers of animals. Request for Information: NICEATM requests available data and information on approaches and/or technologies currently used to detect the presence of BoNT and measure potency of BoNT preparations. Respondents should provide information on any activities relevant to the development or validation of alternatives to in vivo test methods currently used by federal agencies for regulatory and other decision contexts. NICEATM also requests available data from in vivo BoNT tests used for similar applications as the proposed alternative, such as distinguishing between BoNT serotypes in biological matrix samples or measuring the potency of therapeutic BoNT preparations. Respondents to this request for information should include their name, affiliation (if applicable), mailing address, telephone, email, and sponsoring organization (if any) with their communications. The deadline for receipt of the requested information is July 11, 2018. Responses to this notice will be posted at: https://ntp.niehs. nih.gov/go/bont. Persons submitting responses will be identified on the web page by name and affiliation or sponsoring organization, if applicable. Responses to this request are voluntary. No proprietary, classified, confidential, or sensitive information should be included in responses. This request for information is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to the request. Please note that the U.S. Government will not pay for the preparation of any information ADDRESSES: E:\FR\FM\13JNN1.SGM 13JNN1 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices submitted or for its use of that information. Background Information on NICEATM: NICEATM conducts data analyses, workshops, independent validation studies, and other activities to assess new, revised, and alternative test methods and strategies. NICEATM also provides support for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3) provides authority for ICCVAM and NICEATM involvement in activities relevant to the development of alternative test methods. Information about NICEATM and ICCVAM can be found at https:// ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam. Dated: June 6, 2018. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2018–12726 Filed 6–12–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2018–0002] determinations and communities affected for City of Appleton, Outagamie County, Wisconsin. DATES: These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities. ADDRESSES: The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https:// msc.fema.gov for comparison. Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below. FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646–7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Map Information eXchange (FMIX) online at https:// www.floodmaps.fema.gov/fhm/fmx_ main.html. The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided. Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below. The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, SUPPLEMENTARY INFORMATION: Changes in Flood Hazard Determinations Federal Emergency Management Agency; DHS. ACTION: Notice; correction. AGENCY: On April 5, 2018, FEMA published in the Federal Register a changes in flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 83 FR 14646– 14650. The table provided here represents the changes in flood hazard SUMMARY: and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4. Correction In the changes in flood hazard determination notice published at 83 FR 14646–14650 in the April 5, 2018, issue of the Federal Register, FEMA published a table with erroneous information. This table contained inaccurate information as to the effective date of modification and community identification number for the City of Appleton, Outagamie County, Wisconsin featured in the table. In this document, FEMA is publishing a table containing the accurate information. The information provided below should be used in lieu of that previously published. (Catalog of Federal Domestic Assistance No. 97.022, ‘‘Flood Insurance.’’) David I. Maurstad, Deputy Associate Administrator for Insurance and Mitigation (Acting), Department of Homeland Security, Federal Emergency Management Agency. Location and case No. Chief executive officer of community Community map repository Date of modification Wisconsin: Outagamie amozie on DSK3GDR082PROD with NOTICES1 State and county City of Appleton (17– 05–3854P). The Honorable Timothy Hanna, Mayor, City of Appleton City Hall, 100 North Appleton Street, Appleton, WI 54911. City Hall, 100 North Appleton Street, Appleton, WI 54911. Feb. 16, 2018 .... [FR Doc. 2018–12643 Filed 6–12–18; 8:45 am] BILLING CODE 9110–12–P VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 27623 E:\FR\FM\13JNN1.SGM 13JNN1 Community No. 555542

Agencies

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27622-27623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12726]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Data and Information on Technologies Used To Detect 
and Measure Botulinum Neurotoxin

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) requests 
available data and information on approaches and/or technologies 
currently used to detect and measure botulinum neurotoxin (BoNT). 
Submitted information will be used to assess the state of the science 
and determine technical needs for non-animal test methods that are used 
to detect the presence of BoNT and measure potency of BoNT 
preparations.

DATES: Receipt of information: Deadline is July 11, 2018.

ADDRESSES: Data and information should be submitted electronically to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: [email protected]; telephone: (984) 287-3118.

SUPPLEMENTARY INFORMATION: 
    Background: NICEATM fosters the evaluation and promotion of 
alternative test methods for regulatory use. As part of this activity, 
NICEATM supports efforts to develop, validate, and implement 
alternative approaches for biologics tests, including those used to 
detect the presence of BoNT and measure potency of BoNT preparations. 
Tests to detect and measure BoNT are required by multiple federal 
agencies for regulatory and other decision contexts. Currently, the 
standard test for these endpoints is a mouse lethality assay that can 
use large numbers of animals.
    Request for Information: NICEATM requests available data and 
information on approaches and/or technologies currently used to detect 
the presence of BoNT and measure potency of BoNT preparations. 
Respondents should provide information on any activities relevant to 
the development or validation of alternatives to in vivo test methods 
currently used by federal agencies for regulatory and other decision 
contexts. NICEATM also requests available data from in vivo BoNT tests 
used for similar applications as the proposed alternative, such as 
distinguishing between BoNT serotypes in biological matrix samples or 
measuring the potency of therapeutic BoNT preparations.
    Respondents to this request for information should include their 
name, affiliation (if applicable), mailing address, telephone, email, 
and sponsoring organization (if any) with their communications. The 
deadline for receipt of the requested information is July 11, 2018. 
Responses to this notice will be posted at: https://ntp.niehs.nih.gov/go/bont. Persons submitting responses will be identified on the web 
page by name and affiliation or sponsoring organization, if applicable.
    Responses to this request are voluntary. No proprietary, 
classified, confidential, or sensitive information should be included 
in responses. This request for information is for planning purposes 
only and is not a solicitation for applications or an obligation on the 
part of the U.S. Government to provide support for any ideas identified 
in response to the request. Please note that the U.S. Government will 
not pay for the preparation of any information

[[Page 27623]]

submitted or for its use of that information.
    Background Information on NICEATM: NICEATM conducts data analyses, 
workshops, independent validation studies, and other activities to 
assess new, revised, and alternative test methods and strategies. 
NICEATM also provides support for the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-3) provides authority for 
ICCVAM and NICEATM involvement in activities relevant to the 
development of alternative test methods.
    Information about NICEATM and ICCVAM can be found at https://ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam.

    Dated: June 6, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-12726 Filed 6-12-18; 8:45 am]
 BILLING CODE 4140-01-P

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