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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

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. 

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 

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 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. 

ADDRESSES: 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 


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