81 FR 42718 - Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 126 (June 30, 2016)

Page Range		42718-42719
FR Document		2016-15444

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 for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring.

Federal Register, Volume 81 Issue 126 (Thursday, June 30, 2016)

[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42718-42719]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Data and Information on Technologies Used for 
Identifying Potential Developmental Toxicants

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 for identifying potential developmental toxicants. 
Submitted information will be used to assess the state of the science 
and determine technical needs for non-animal test methods used to 
evaluate the potential of chemicals to induce adverse effects in 
offspring.

DATES: Receipt of information: Deadline is August 15, 2016.

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

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: [email protected]; telephone: (919) 316-4729.

SUPPLEMENTARY INFORMATION: 
    Background: NICEATM, which fosters the evaluation and promotion of 
alternative test methods for regulatory use, is supporting efforts to 
develop, validate, and implement alternative approaches for identifying 
potential developmental toxicants. The goal of these alternative 
approaches is to replace, reduce, or refine the use of animals in 
testing. Testing a chemical's potential to cause developmental toxicity 
is required by multiple regulatory agencies and may require the use of 
large numbers of animals.
    Request for Information: NICEATM requests available data and 
information on approaches and/or technologies currently used to 
identify potential developmental toxicants. Respondents should provide 
information on any activities relevant to the development or validation 
of alternatives to in vivo developmental toxicity test methods 
currently required by regulatory agencies, including data from non-
animal chemical tests for developmental hazard potential. NICEATM also 
requests any available data resulting from in vivo developmental 
studies, ethical human or animal studies, or accidental human 
exposures, using the same chemicals.
    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 August 15, 2016. 
Responses to this notice will be posted at: http://ntp.niehs.nih.gov/go/dev-nonanimal. 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 submitted or for its use 
of that information.

[[Page 42719]]

    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 in the development of alternative test methods. 
Information about NICEATM and ICCVAM is found at http://ntp.niehs.nih.gov/go/niceatm and http://ntp.niehs.nih.gov/go/iccvam.

    Dated: June 24, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-15444 Filed 6-29-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices 42719

Background Information on and Transplantation Research; 93.856, simultaneously detected by each
NICEATM: NICEATM conducts data Microbiology and Infectious Diseases respective objective lens along a
analyses, workshops, independent Research, National Institutes of Health, HHS) respective longitudinal axis. Including
validation studies, and other activities Dated: June 24, 2016. multiple lenses will improve the
to assess new, revised, and alternative Natasha M. Copeland, penetration depth and at the same time
test methods and strategies. NICEATM Program Analyst, Office of Federal Advisory decrease the loss of detail because of
also provides support for the Committee Policy. scattering. The system also can
Interagency Coordinating Committee on [FR Doc. 2016–15443 Filed 6–29–16; 8:45 am] overcome losses in spatial resolution
the Validation of Alternative Methods BILLING CODE 4140–01–P
because of the scattering of the
(ICCVAM). The ICCVAM Authorization excitation and emission light.
Act of 2000 (42 U.S.C. 285l–3) provides Potential Commercial Applications:
authority for ICCVAM and NICEATM in DEPARTMENT OF HEALTH AND —High resolution multi-photon
the development of alternative test HUMAN SERVICES microscopy
methods. Information about NICEATM —Deep tissue visualization
and ICCVAM is found at http:// National Institutes of Health —Competitive Advantages:
ntp.niehs.nih.gov/go/niceatm and —Improved signal-to-noise ratio
http://ntp.niehs.nih.gov/go/iccvam. Government-Owned Inventions; —improved spatial resolution
Availability for Licensing —Development Stage:
Dated: June 24, 2016.
John R. Bucher, AGENCY: National Institutes of Health, • Prototype
Associate Director, National Toxicology HHS. Inventors: Yicong Wu (NIBIB), Hari
Program. ACTION: Notice. Shroff (NIBIB), Jianyong Tang (NIAID),
[FR Doc. 2016–15444 Filed 6–29–16; 8:45 am] Ronald Germain (NIAID).
SUMMARY: The inventions listed below Intellectual Property: HHS Reference
BILLING CODE 4140–01–P
are owned by an agency of the U.S. No. E–229–2015/0; U.S. Provisional
Government and are available for Patent Application 62/210,153 filed
DEPARTMENT OF HEALTH AND licensing in the U.S. in accordance with August 26, 2015.
HUMAN SERVICES 35 U.S.C. 209 and 37 CFR part 404 to Licensing Contact: Michael
achieve expeditious commercialization Shmilovich, Esq, CLP; 301–435–5019;
National Institutes of Health of results of federally-funded research shmilovm@mail.nih.gov.
and development.
National Institute of Allergy and Dated: June 24, 2016.
FOR FURTHER INFORMATION CONTACT:
Infectious Diseases; Notice of Closed Michael Shmilovich,
Licensing information may be obtained
Meeting by emailing the indicated licensing Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Pursuant to section 10(d) of the contact at the National Heart, Lung, and
Office of Technology Transfer and
Federal Advisory Committee Act, as Blood, Office of Technology Transfer Development.
amended (5 U.S.C. App.), notice is and Development Office of Technology
[FR Doc. 2016–15441 Filed 6–29–16; 8:45 am]
hereby given of the following meeting. Transfer, 31 Center Drive Room 4A29,
BILLING CODE 4140–01–P
The meeting will be closed to the MSC2479, Bethesda, MD 20892–2479;
public in accordance with the telephone: 301–402–5579. A signed
provisions set forth in sections Confidential Disclosure Agreement may DEPARTMENT OF HEALTH AND
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., be required to receive any unpublished HUMAN SERVICES
as amended. The grant applications and information.
the discussions could disclose SUPPLEMENTARY INFORMATION: National Institutes of Health
confidential trade secrets or commercial Technology description follows.
property such as patentable material, National Cancer Institute; Notice of
Multi-Photon Microscopy System Closed Meetings
and personal information concerning Configured for Multiview Non-Linear
individuals associated with the grant Optical Imaging Pursuant to section 10(d) of the
applications, the disclosure of which Federal Advisory Committee Act, as
would constitute a clearly unwarranted This invention is a microscopy device
and system for multi-photon amended (5 U.S.C. App.), notice is
invasion of personal privacy. hereby given of the following meeting.
microscopy utilizing multi-view
Name of Committee: National Institute of nonlinear optical imaging. Nonlinear The meeting will be closed to the
Allergy and Infectious Diseases Special public in accordance with the
Emphasis Panel.
optical imaging remains the premier
technique for deep-tissue imaging in provisions set forth in sections
Date: July 27, 2016. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Time: 2:00 p.m. to 5:00 p.m. which typically a multi photon
arrangement may be used to illuminate as amended. The grant applications and
Agenda: To review and evaluate grant
applications. and excite a sample. However, the the discussions could disclose
Place: National Institutes of Health, 5601 penetration depth, signal-to-noise ratio, confidential trade secrets or commercial
Fishers Lane, Rockville, MD 20892, and resolution of this technique is property such as patentable material,
(Telephone Conference Call). ultimately limited by scattering. The and personal information concerning
Contact Person: James T. Snyder, Ph.D., present system addresses these issues by individuals associated with the grant
mstockstill on DSK3G9T082PROD with NOTICES

Scientific Review Officer, Scientific Review applications, the disclosure of which
Program, Division of Extramural Activities/
sequential excitation of a sample
through three or more objective lenses would constitute a clearly unwarranted
Room 3G31B, National Institutes of Health, invasion of personal privacy.
NIAID, 5601 Fishers Lane MSC 9823, oriented at different axes intersecting
Bethesda, MD 20892–9823, (240) 669–5060, the sample. Each objective lens is Name of Committee: National Cancer
james.snyder@nih.gov. capable of focused sequential excitation Institute Special Emphasis Panel; Member
(Catalogue of Federal Domestic Assistance that elicits fluorescence emissions from Conflict SEP.
Program Nos. 93.855, Allergy, Immunology, the excited sample, which is then Date: July 6, 2016.

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Document Created: 2018-02-08 07:45:14
Document Modified: 2018-02-08 07:45:14

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
Dates		Receipt of information: Deadline is August 15, 2016.
Contact		Dr. Warren Casey, Director, NICEATM; email: [email protected]; telephone: (919) 316-4729.
FR Citation		81 FR 42718

81 FR 42718 - Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 126 (June 30, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health