81 FR 76620 - Request for Data and Information on Zebrafish Embryo Chemical Screening
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 213 (November 3, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 213 (November 3, 2016)
| Page Range | 76620-76621 | |
| FR Document | 2016-26605 |
[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)] [Notices] [Pages 76620-76621] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26605] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Data and Information on Zebrafish Embryo Chemical Screening SUMMARY: The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests data and information on zebrafish embryo screening tests and protocol design, including pharmacokinetics measurements. 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 developmental effects in offspring. DATES: Receipt of information: Deadline is December 30, 2016. 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: (919) 316-4729. SUPPLEMENTARY INFORMATION: Background: NICEATM, which fosters the evaluation and promotion of alternative test methods for regulatory use, supports efforts to develop, validate, and implement alternative approaches for identifying potential developmental toxicants that replace, reduce, or refine animal use. Multiple regulatory agencies require testing a substance's potential to cause developmental toxicity, which may necessitate the use of large numbers of animals. Request for Information: NICEATM requests data and information related to chemical screening in the zebrafish embryo. Respondents should provide information on any activities relevant to the development or validation of zebrafish embryo screening assays. NICEATM is particularly interested in how the study design may influence measures of toxicity/bioactivity and the kinetics associated with chemical uptake. For comparative purposes, NICEATM also requests any available data from in vivo developmental studies using the same chemicals. NICEATM specifically requests information on efforts to optimize zebrafish embryo screening tests and protocol design including comparison of (1) zebrafish strains, (2) embryos with and without an intact chorion, and (3) static and static renewal exposures. NICEATM also requests available data on chemical uptake for developing a better understanding of pharmacokinetics in the zebrafish embryo model. 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 December 30, 2016. Please contact NICEATM at niceatm@niehs.nih.gov if you have questions or concerns about your submission. 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 [[Page 76621]] 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 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: October 27, 2016. Linda S. Birnbaum, Director, National Institute of Environmental, Health Sciences and National Toxicology Program. [FR Doc. 2016-26605 Filed 11-2-16; 8:45 am] BILLING CODE 4140-01-P
![76620 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices
drugshortages@fda.hhs.gov in regulations in part 211 (21 CFR part accordance with the requirements in
adherence to existing recall reporting 211) are approved under OMB control §§ 211.100(a) and 211.160(a); execution
regulations (21 CFR 7.40) (OMB control number 0190–0139. The guidance of the Plan should be documented in
number 0910–0249), or defect reporting encourages manufacturers to maintain accordance with the requirements
requirements for drug application records, in accordance with the CGMP described in § 211.100(b); and standard
products (21 CFR 314.81(b)(1)) and requirements (see, e.g., § 211.180) that operating procedures should be
therapeutic biological products support decisions to carry out changes reviewed and revised or supplementary
regulated by CDER (21 CFR 600.14) to approved procedures for procedures developed and approved to
(OMB control numbers 0910–0001 and manufacturing and release of products enable execution of the Plan.
0910–0458, respectively). under the Plan. The guidance states that
In addition, the following collections a Plan should be developed, written, FDA estimates the burden of this
of information found in FDA current reviewed, and approved within the information collection as follows:
good manufacturing practice (CGMP) site’s change control quality system in
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Absenteeism guidance responses per burden per Total hours
respondents responses
respondent response
Notify FDA of Plan Activation and Deactivation .................. 2 1 2 16 32
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Absenteeism guidance records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Develop Initial Plan .............................................................. 70 1 70 500 35,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 28, 2016. email: warren.casey@nih.gov; telephone: and without an intact chorion, and (3)
Leslie Kux, (919) 316–4729. static and static renewal exposures.
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: NICEATM also requests available data
[FR Doc. 2016–26527 Filed 11–2–16; 8:45 am] Background: NICEATM, which fosters on chemical uptake for developing a
BILLING CODE 4164–01–P the evaluation and promotion of better understanding of
alternative test methods for regulatory pharmacokinetics in the zebrafish
use, supports efforts to develop, embryo model.
DEPARTMENT OF HEALTH AND validate, and implement alternative Respondents to this request for
HUMAN SERVICES approaches for identifying potential information should include their name,
developmental toxicants that replace, affiliation (if applicable), mailing
National Institutes of Health reduce, or refine animal use. Multiple address, telephone, email, and
regulatory agencies require testing a sponsoring organization (if any) with
Request for Data and Information on their communications. The deadline for
substance’s potential to cause
Zebrafish Embryo Chemical Screening receipt of the requested information is
developmental toxicity, which may
SUMMARY: The National Toxicology necessitate the use of large numbers of December 30, 2016. Please contact
Program (NTP) Interagency Center for animals. NICEATM at niceatm@niehs.nih.gov if
the Evaluation of Alternative Request for Information: NICEATM you have questions or concerns about
Toxicological Methods (NICEATM) requests data and information related to your submission. Responses to this
requests data and information on chemical screening in the zebrafish notice will be posted at: http://
zebrafish embryo screening tests and embryo. Respondents should provide ntp.niehs.nih.gov/go/dev-nonanimal.
protocol design, including information on any activities relevant to Persons submitting responses will be
pharmacokinetics measurements. the development or validation of identified on the Web page by name and
Submitted information will be used to zebrafish embryo screening assays. affiliation or sponsoring organization, if
assess the state of the science and NICEATM is particularly interested in applicable.
determine technical needs for non- how the study design may influence Responses to this request are
animal test methods used to evaluate measures of toxicity/bioactivity and the voluntary. No proprietary, classified,
the potential of chemicals to induce kinetics associated with chemical confidential, or sensitive information
developmental effects in offspring. uptake. For comparative purposes, should be included in responses. This
NICEATM also requests any available request for information is for planning
mstockstill on DSK3G9T082PROD with NOTICES
DATES: Receipt of information: Deadline
is December 30, 2016. data from in vivo developmental studies purposes only and is not a solicitation
using the same chemicals. for applications or an obligation on the
ADDRESSES: Data and information NICEATM specifically requests part of the U.S. Government to provide
should be submitted electronically to information on efforts to optimize support for any ideas identified in
niceatm@niehs.nih.gov. zebrafish embryo screening tests and response to the request. Please note that
FOR FURTHER INFORMATION CONTACT: Dr. protocol design including comparison of the U.S. Government will not pay for
Warren Casey, Director, NICEATM; (1) zebrafish strains, (2) embryos with the preparation of any information
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![Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices 76621
submitted or for its use of that reasonably anticipated to be human DEPARTMENT OF HEALTH AND
information. carcinogens. The listing of a substance HUMAN SERVICES
Background Information on in the RoC indicates a potential hazard,
NICEATM: NICEATM conducts data but does not establish the exposure National Institutes of Health
analyses, workshops, independent conditions that pose a cancer hazard to
validation studies, and other activities National Toxicology Program Board of
individuals in their daily lives. For each
to assess new, revised, and alternative Scientific Counselors; Announcement
listed substance, the RoC provides
test methods and strategies. NICEATM of Meeting; Request for Comments
information from cancer studies that
also provides support for the support the listing, as well as SUMMARY: This notice announces the
Interagency Coordinating Committee on information about potential sources of next meeting of the National Toxicology
the Validation of Alternative Methods exposure and current federal regulations Program (NTP) Board of Scientific
(ICCVAM). The ICCVAM Authorization Counselors (BSC). The BSC, a federally
to limit exposures. Each edition of the
Act of 2000 (42 U.S.C. 285l–3) provides chartered, external advisory group
RoC is cumulative, that is, it lists newly
authority for ICCVAM and NICEATM in composed of scientists from the public
reviewed substances in addition to
the development of alternative test and private sectors, will review and
methods. Information about NICEATM substances listed in the previous
edition. Information about the RoC is provide advice on programmatic
and ICCVAM is found at http:// activities. The meeting is open to the
ntp.niehs.nih.gov/go/niceatm and available on the RoC Web site (http://
ntp.niehs.nih.gov/go/roc) or by public except for parts that are closed,
http://ntp.niehs.nih.gov/go/iccvam. as indicated on the agenda. Registration
contacting Dr. Lunn (see ADDRESSES).
Dated: October 27, 2016. is requested for both attendance and
Linda S. Birnbaum, NTP prepares the RoC on behalf of the oral comment and required to access the
Director, National Institute of Environmental,
Secretary of Health and Human webcast. Information about the meeting
Health Sciences and National Toxicology Services. For the 14th RoC, NTP and registration are available at http://
Program. followed an established, multi-step ntp.niehs.nih.gov/go/165.
[FR Doc. 2016–26605 Filed 11–2–16; 8:45 am] process with multiple opportunities for DATES: Meeting: December 14–15, 2016,
BILLING CODE 4140–01–P public input, and used established 8:30 a.m. Eastern Standard Time (EST)
criteria to evaluate the scientific on both days and continues to
evidence on each candidate substance adjournment.
DEPARTMENT OF HEALTH AND under review (http://ntp.niehs.nih.gov/ Written Public Comment
HUMAN SERVICES go/rocprocess). Submissions: Deadline is November 30,
New Listings in the 14th RoC: The 2016.
National Institutes of Health Registration for Oral Comments:
14th RoC contains 248 listings, some of
which consist of a class of structurally Deadline is December 7, 2016.
Announcement of Availability of the
related chemicals or agents. There are Registration to Attend and/or View
Fourteenth Report on Carcinogens
six new listings and one revised listing Webcast: Deadline is December 15,
SUMMARY: The Department of Health and 2016. Registration to view the meeting
in this edition. The revised listing is for
Human Services released the 14th via the webcast is required.
trichloroethylene, which was previously
Report on Carcinogens (RoC) to the ADDRESSES: Meeting Location: Rodbell
listed as reasonably anticipated to be a
public on November 3, 2016. The report Auditorium, Rall Building, National
human carcinogen and is now listed as
is available on the RoC Web site at: Institute of Environmental Health
http://ntp.niehs.nih.gov/go/roc or from known to be a human carcinogen. Five
Sciences (NIEHS), 111 T.W. Alexander
the Office of the RoC (see ADDRESSES). of the new listings are in the category of
Drive, Research Triangle Park, NC
known to be a human carcinogen:
DATES: The 14th RoC is available to the 27709.
Epstein Bar virus, Kaposi sarcoma- Meeting Web page: The preliminary
public on November 3, 2016.
associated herpesvirus, human T-cell agenda, registration, and other meeting
ADDRESSES: Dr. Ruth Lunn, Director,
lymphotropic virus type 1, human materials are at http://ntp.niehs.nih.gov/
Office of the RoC, National Toxicology immunodeficiency virus-type 1, and
Program (NTP), National Institute of go/165.
Merkel cell polyomavirus. The new Webcast: The meeting will be webcast
Environmental Health Sciences
listing in the category of reasonably on December 15; the URL will be
(NIEHS), P.O. Box 12233, MD K2–14,
Research Triangle Park, NC 27709; anticipated to be a human carcinogen is provided to those who register for
telephone: (919) 316–4637; FAX: (301) for cobalt and cobalt compounds that viewing.
480–2970; lunn@niehs.nih.gov. release cobalt ions in vivo.
FOR FURTHER INFORMATION CONTACT: Dr.
FOR FURTHER INFORMATION CONTACT: Dated: October 25, 2016. Lori White, Designated Federal Officer
Questions or comments concerning the Linda S. Birnbaum, for the BSC, Office of Liaison, Policy,
14th RoC should be directed to Dr. Lunn Director, National Institute of Environmental and Review, Division of NTP, NIEHS,
(see ADDRESSES). Health Science and National Toxicology P.O. Box 12233, K2–03, Research
SUPPLEMENTARY INFORMATION: Program. Triangle Park, NC 27709. Phone: 919–
[FR Doc. 2016–26604 Filed 11–2–16; 8:45 am] 541–9834, Fax: 301–480–3272, Email:
Background Information on the RoC whiteld@niehs.nih.gov. Hand Deliver/
BILLING CODE 4140–01–P
The RoC is a congressionally Courier address: 530 Davis Drive, Room
mstockstill on DSK3G9T082PROD with NOTICES
mandated document that identifies and K2124, Morrisville, NC 27560.
discusses agents, substances, mixtures, SUPPLEMENTARY INFORMATION:
or exposure circumstances (collectively Meeting and Registration: Parts of the
referred to as ‘‘substances’’) that may meeting are open to the public as
pose a hazard to human health because indicated on the agenda; in-person
of their carcinogenicity. Substances are attendance at NIEHS is limited only by
listed in the report as either known or the space available. Parts of the meeting
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Document Created: 2016-11-03 03:24:06
Document Modified: 2016-11-03 03:24:06
| 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 December 30, 2016. | |
| Contact | Dr. Warren Casey, Director, NICEATM; email: [email protected]; telephone: (919) 316-4729. | |
| FR Citation | 81 FR 76620 |
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