81_FR_76833 81 FR 76620 - Request for Data and Information on Zebrafish Embryo Chemical Screening

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)

Page Range76620-76621
FR Document2016-26605

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.

Federal Register, Volume 81 Issue 213 (Thursday, November 3, 2016)
[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]


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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
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                                                  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
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                                                  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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesReceipt of information: Deadline is December 30, 2016.
ContactDr. Warren Casey, Director, NICEATM; email: [email protected]; telephone: (919) 316-4729.
FR Citation81 FR 76620 

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