83 FR 27622 - Request for Data and Information on Technologies Used To Detect and Measure Botulinum Neurotoxin

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 114 (June 13, 2018)

Page Range		27622-27623
FR Document		2018-12726

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.

Federal Register, Volume 83 Issue 114 (Wednesday, June 13, 2018)

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27622-27623]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12726]


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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 http://ntp.niehs.nih.gov/go/niceatm and http://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

27622 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices

Place: National Institutes of Health, 6701 Place: Hilton Garden Inn Bethesda, 7301 ADDRESSES: Data and information
Rockledge Drive, Bethesda, MD 20892 Waverly Street, Bethesda, MD 20814. should be submitted electronically to
(Virtual Meeting). Contact Person: Ivan K. Navarro, Ph.D., niceatm@niehs.nih.gov.
Contact Person: Natalia Komissarova, Scientific Review Officer, Office of
Ph.D., Scientific Review Officer, Center for Extramural Policy and Review, Division of FOR FURTHER INFORMATION CONTACT: Dr.
Scientific Review, National Institutes of Extramural Research, National Institute on Warren Casey, Director, NICEATM;
Health, 6701 Rockledge Drive, Room 5207, Drug Abuse, NIH, DHHS, 6001 Executive email: warren.casey@nih.gov; telephone:
MSC 7846, Bethesda, MD 20892, 301–435– Boulevard, Room 4242, MSC 9550, Bethesda, (984) 287–3118.
1206, komissar@mail.nih.gov. MD 20892, 301–827–5833, ivan.navarro@
nih.gov. SUPPLEMENTARY INFORMATION:
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member Name of Committee: National Institute on Background: NICEATM fosters the
Conflict: Immune Mechanism: Activation, Drug Abuse Special Emphasis Panel; evaluation and promotion of alternative
Regulation and Tolerance. Development of Medications to Prevent and test methods for regulatory use. As part
Date: July 11, 2018. Treat Opioid Use Disorders and Overdose of this activity, NICEATM supports
Time: 12:30 p.m. to 3:00 p.m. (UG3/UH3 (Clinical Trials Optional). efforts to develop, validate, and
Agenda: To review and evaluate grant Date: August 16, 2018. implement alternative approaches for
applications. Time: 8:00 a.m. to 5:00 p.m.
Place: National Institutes of Health, 6701
biologics tests, including those used to
Agenda: To review and evaluate
Rockledge Drive, Bethesda, MD 20892 detect the presence of BoNT and
cooperative agreement applications.
(Virtual Meeting). Place: Bethesda North Marriott Hotel & measure potency of BoNT preparations.
Contact Person: Patrick K. Lai, Ph.D., Conference Center, 5701 Marinelli Road, Tests to detect and measure BoNT are
Scientific Review Officer, Center for Bethesda, MD 20852. required by multiple federal agencies for
Scientific Review, National Institutes of Contact Person: Ivan K. Navarro, Ph.D., regulatory and other decision contexts.
Health, 6701 Rockledge Drive, Room 2215, Scientific Review Officer, Office of Currently, the standard test for these
MSC 7812, Bethesda, MD 20892, 301–435– Extramural Policy and Review, Division of endpoints is a mouse lethality assay that
1052, laip@csr.nih.gov. Extramural Research, National Institute on can use large numbers of animals.
(Catalogue of Federal Domestic Assistance Drug Abuse, NIH, DHHS, 6001 Executive
Request for Information: NICEATM
Program Nos. 93.306, Comparative Medicine; Boulevard, Room 4242, MSC 9550, Bethesda,
93.333, Clinical Research, 93.306, 93.333, MD 20892, 301–827–5833, ivan.navarro@ requests available data and information
93.337, 93.393–93.396, 93.837–93.844, nih.gov. on approaches and/or technologies
93.846–93.878, 93.892, 93.893, National (Catalogue of Federal Domestic Assistance currently used to detect the presence of
Institutes of Health, HHS) Program Nos.: 93.279, Drug Abuse and BoNT and measure potency of BoNT
Dated: June 7, 2018. Addiction Research Programs, National preparations. Respondents should
Institutes of Health, HHS) provide information on any activities
David D. Clary,
Dated: June 7, 2018. relevant to the development or
Program Analyst, Office of Federal Advisory
validation of alternatives to in vivo test
Committee Policy. Natasha M. Copeland,
methods currently used by federal
[FR Doc. 2018–12671 Filed 6–12–18; 8:45 am] Program Analyst, Office of Federal Advisory
agencies for regulatory and other
BILLING CODE 4140–01–P Committee Policy.
decision contexts. NICEATM also
[FR Doc. 2018–12674 Filed 6–12–18; 8:45 am]
requests available data from in vivo
BILLING CODE 4140–01–P
BoNT tests used for similar applications
DEPARTMENT OF HEALTH AND
as the proposed alternative, such as
HUMAN SERVICES
distinguishing between BoNT serotypes
DEPARTMENT OF HEALTH AND
National Institutes of Health in biological matrix samples or
HUMAN SERVICES
measuring the potency of therapeutic
National Institute on Drug Abuse; National Institutes of Health BoNT preparations.
Notice of Closed Meetings Respondents to this request for
Request for Data and Information on information should include their name,
Pursuant to section 10(d) of the Technologies Used To Detect and affiliation (if applicable), mailing
Federal Advisory Committee Act, as Measure Botulinum Neurotoxin address, telephone, email, and
amended, notice is hereby given of the
sponsoring organization (if any) with
following meetings. AGENCY: National Institutes of Health,
The meetings will be closed to the their communications. The deadline for
HHS. receipt of the requested information is
public in accordance with the
provisions set forth in sections ACTION: Notice. July 11, 2018. Responses to this notice
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., will be posted at: https://ntp.niehs.
SUMMARY: The National Toxicology nih.gov/go/bont. Persons submitting
as amended. The grant applications and Program (NTP) Interagency Center for
the discussions could disclose responses will be identified on the web
the Evaluation of Alternative page by name and affiliation or
confidential trade secrets or commercial Toxicological Methods (NICEATM)
property such as patentable material, sponsoring organization, if applicable.
requests available data and information Responses to this request are
and personal information concerning on approaches and/or technologies
individuals associated with the grant voluntary. No proprietary, classified,
currently used to detect and measure confidential, or sensitive information
applications, the disclosure of which botulinum neurotoxin (BoNT).
would constitute a clearly unwarranted should be included in responses. This
Submitted information will be used to request for information is for planning
invasion of personal privacy.
amozie on DSK3GDR082PROD with NOTICES1

assess the state of the science and purposes only and is not a solicitation
Name of Committee: National Institute on determine technical needs for non- for applications or an obligation on the
Drug Abuse Special Emphasis Panel; SEP for animal test methods that are used to
Medications Development.
part of the U.S. Government to provide
detect the presence of BoNT and support for any ideas identified in
Date: June 27, 2018. measure potency of BoNT preparations.
Time: 8:00 a.m. to 5:00 p.m. response to the request. Please note that
Agenda: To review and evaluate grant DATES: Receipt of information: Deadline the U.S. Government will not pay for
applications. is July 11, 2018. the preparation of any information

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Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27623

submitted or for its use of that determinations and communities and are in accordance with the National
information. affected for City of Appleton, Outagamie Flood Insurance Act of 1968, 42 U.S.C.
Background Information on County, Wisconsin. 4001 et seq., and with 44 CFR part 65.
NICEATM: NICEATM conducts data DATES: These flood hazard The FIRM and FIS report are the basis
analyses, workshops, independent determinations will be finalized on the of the floodplain management measures
validation studies, and other activities dates listed in the table below and that the community is required either to
to assess new, revised, and alternative revise the FIRM panels and FIS report adopt or to show evidence of having in
test methods and strategies. NICEATM in effect prior to this determination for effect in order to qualify or remain
also provides support for the the listed communities. qualified for participation in the
Interagency Coordinating Committee on National Flood Insurance Program
ADDRESSES: The affected communities
the Validation of Alternative Methods (NFIP).
are listed in the table below. Revised
(ICCVAM). The ICCVAM Authorization
flood hazard information for each These flood hazard determinations,
Act of 2000 (42 U.S.C. 285l–3) provides
community is available for inspection at together with the floodplain
authority for ICCVAM and NICEATM
both the online location and the management criteria required by 44 CFR
involvement in activities relevant to the
respective community map repository 60.3, are the minimum that are required.
development of alternative test
address listed in the table below. They should not be construed to mean
methods.
Information about NICEATM and Additionally, the current effective FIRM that the community must change any
ICCVAM can be found at http:// and FIS report for each community are existing ordinances that are more
ntp.niehs.nih.gov/go/niceatm and accessible online through the FEMA stringent in their floodplain
http://ntp.niehs.nih.gov/go/iccvam. Map Service Center at https:// management requirements. The
msc.fema.gov for comparison. community may at any time enact
Dated: June 6, 2018. Submit comments and/or appeals to stricter requirements of its own or
Brian R. Berridge, the Chief Executive Officer of the pursuant to policies established by other
Associate Director, National Toxicology community as listed in the table below. Federal, State, or regional entities. The
Program. flood hazard determinations are in
FOR FURTHER INFORMATION CONTACT: Rick
[FR Doc. 2018–12726 Filed 6–12–18; 8:45 am] accordance with 44 CFR 65.4.
Sacbibit, Chief, Engineering Services
BILLING CODE 4140–01–P Branch, Federal Insurance and Correction
Mitigation Administration, FEMA, 400
C Street SW, Washington, DC 20472, In the changes in flood hazard
DEPARTMENT OF HOMELAND (202) 646–7659, or (email) determination notice published at 83 FR
SECURITY patrick.sacbibit@fema.dhs.gov; or visit 14646–14650 in the April 5, 2018, issue
the FEMA Map Information eXchange of the Federal Register, FEMA
Federal Emergency Management (FMIX) online at https:// published a table with erroneous
Agency www.floodmaps.fema.gov/fhm/fmx_ information. This table contained
[Docket ID FEMA–2018–0002] main.html. inaccurate information as to the
effective date of modification and
SUPPLEMENTARY INFORMATION: The
Changes in Flood Hazard community identification number for
specific flood hazard determinations are
Determinations the City of Appleton, Outagamie
not described for each community in
County, Wisconsin featured in the table.
AGENCY: Federal Emergency this notice. However, the online
In this document, FEMA is publishing
Management Agency; DHS. location and local community map
a table containing the accurate
ACTION: Notice; correction.
repository address where the flood
information. The information provided
hazard determination information is
below should be used in lieu of that
SUMMARY: On April 5, 2018, FEMA available for inspection is provided.
previously published.
published in the Federal Register a Any request for reconsideration of
changes in flood hazard determination flood hazard determinations must be (Catalog of Federal Domestic Assistance No.
notice that contained an erroneous submitted to the Chief Executive Officer 97.022, ‘‘Flood Insurance.’’)
table. This notice provides corrections of the community as listed in the table David I. Maurstad,
to that table, to be used in lieu of the below. Deputy Associate Administrator for Insurance
information published at 83 FR 14646– The modifications are made pursuant and Mitigation (Acting), Department of
14650. The table provided here to section 201 of the Flood Disaster Homeland Security, Federal Emergency
represents the changes in flood hazard Protection Act of 1973, 42 U.S.C. 4105, Management Agency.

Location and case Date of Community
State and county Chief executive officer of community Community map repository
No. modification No.

Wisconsin: Outagamie City of Appleton (17– The Honorable Timothy Hanna, Mayor, City City Hall, 100 North Appleton Feb. 16, 2018 .... 555542
05–3854P). of Appleton City Hall, 100 North Appleton Street, Appleton, WI 54911.
Street, Appleton, WI 54911.
amozie on DSK3GDR082PROD with NOTICES1

[FR Doc. 2018–12643 Filed 6–12–18; 8:45 am]
BILLING CODE 9110–12–P

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Document Created: 2018-06-12 23:59:40
Document Modified: 2018-06-12 23:59:40

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Receipt of information: Deadline is July 11, 2018.
Contact		Dr. Warren Casey, Director, NICEATM; email: [email protected]; telephone: (984) 287-3118.
FR Citation		83 FR 27622

83 FR 27622 - Request for Data and Information on Technologies Used To Detect and Measure Botulinum Neurotoxin

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 114 (June 13, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health