83 FR 14867 - Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 67 (April 6, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 67 (April 6, 2018)
| Page Range | 14867-14869 | |
| FR Document | 2018-07057 |
[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)] [Notices] [Pages 14867-14869] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07057] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/iccvamforum-2018. DATES: Meeting: May 24, 2018, 9:00 a.m. to approximately 4:00 p.m. Eastern Daylight Time (EDT). Registration for Onsite Meeting: Deadline is May 11, 2018. Registration for Webcast: Deadline is May 24, 2018. Submission of Oral Public Statements: Deadline is May 11, 2018. ADDRESSES: Meeting Location: William H. Natcher Conference Center, National Institutes of Health, Bethesda, MD 20892. Meeting web page: The [[Page 14868]] preliminary agenda, registration, and other meeting materials are at http://ntp.niehs.nih.gov/go/iccvamforum-2018. FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); email: warren.casey@nih.gov; telephone: (984) 287-3118. SUPPLEMENTARY INFORMATION: Background: ICCVAM, a congressionally mandated committee, promotes the development and validation of alternative testing strategies that protect human health and the environment while replacing, reducing, or refining animal use. ICCVAM's goals include promotion of national and international partnerships between governmental and nongovernmental groups, including academia, industry, advocacy groups, and other key stakeholders. To foster these partnerships ICCVAM initiated annual public forums in 2014 to share information and facilitate direct communication of ideas and suggestions from stakeholders (79 FR 25136). This year's meeting will be held on May 24, 2018, at the National Institutes of Health (NIH) in Bethesda, MD. The meeting will include presentations by NICEATM and ICCVAM members on current activities related to the development and validation of alternative test methods and approaches, including activities relevant to implementation of the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States (83 FR 7487). Following each presentation, there will be an opportunity for participants to ask questions of the ICCVAM members. Instructions for submitting questions will be provided to remote participants prior to the webcast. The agenda will also include time for participants to make public oral statements relevant to the ICCVAM mission and current activities. Preliminary Agenda and Other Meeting Information: The preliminary agenda, list of discussion topics, background materials, ICCVAM roster, and public statements submitted prior to the meeting will be posted by May 17 at http://ntp.niehs.nih.gov/go/iccvamforum-2018. Interested individuals are encouraged to visit this web page to stay abreast of the most current meeting information. Meeting and Registration: This meeting is open to the public with time scheduled for questions and oral public statements following presentations from ICCVAM and NICEATM. The public may attend the meeting at NIH, where attendance is limited only by the space available, or view remotely by webcast. Those planning to attend the meeting in person are encouraged to register at http://ntp.niehs.nih.gov/go/iccvamforum-2018 by May 11, 2018, to facilitate planning for appropriate meeting space. Those planning to view the webcast must register at http://ntp.niehs.nih.gov/go/iccvamforum-2018; registration will be available through May 24, 2018. The URL for the webcast will be provided in the email confirming registration. NIH visitor and security information is available at http://www.nih.gov/about/visitor/index.htm. Individuals with disabilities who need accommodation to participate in this event should contact Dr. Elizabeth Maull at phone: (984) 287-3157 or email: maull@niehs.nih.gov. TTY users should contact the Federal TTY Relay Service at 800-877-8339. Requests should be made at least five business days in advance of the event. Request for Oral Public Statements: Each presentation will be followed by an opportunity for participants to ask questions of the presenter. Attendees need not register in advance for the opportunity to ask questions or make comments specific to presentations. Instructions for submitting questions or comments will be provided to remote participants prior to the webcast. In addition to time for questions or comments following each scheduled presentation, time will be allotted during the meeting for oral public statements with associated slides on topics relevant to ICCVAM's mission. The number and length of presentations may be limited based on available time. Submitters will be identified by their name and affiliation and/or sponsoring organization, if applicable. Persons submitting public statements and/or associated slides should include their name, affiliation (if any), mailing address, telephone, email, and sponsoring organization (if any) with the document. National Toxicology Program guidelines for public statements are at http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf. Persons wishing to present oral public statements should email their statement to ICCVAMquestions@niehs.nih.gov by May 11, 2018, to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Written statements may supplement and expand the oral presentation. Public statements will be distributed to NICEATM and ICCVAM members before the meeting. Registration for oral public statements will be available onsite, although onsite registration and time allotted for these statements may be limited based on the number of individuals who register to make statements and available time. If registering onsite and reading from written text, please bring 20 copies of the statement for distribution and to supplement the record. Persons wishing to present oral public statements are strongly encouraged to present their comments in person to facilitate effective interaction with ICCVAM members. However, there will also be the opportunity to present public statements by teleconference line. Persons who are unable to attend the meeting in person and wish to present oral public statements should email ICCVAMquestions@niehs.nih.gov by May 11, 2018 to arrange to present statements via teleconference line. Responses to this notice are voluntary. No proprietary, classified, confidential, or sensitive information should be included in statements submitted in response to this notice or presented during the meeting. This request for input 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. Background Information on ICCVAM and NICEATM: ICCVAM is an interagency committee composed of representatives from 16 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods and integrated testing strategies with regulatory applicability. ICCVAM also promotes the scientific validation and regulatory acceptance of testing methods that more accurately assess the safety and hazards of chemicals and products and replace, reduce, or refine animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) establishes ICCVAM as a permanent interagency committee of NIEHS and provides the authority for ICCVAM involvement in activities relevant to the development of alternative test methods. Additional information about ICCVAM can be found at http://ntp.niehs.nih.gov/go/iccvam. [[Page 14869]] NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts and publishes analyses and evaluations of data from new, revised, and alternative testing approaches. NICEATM and ICCVAM work collaboratively to evaluate new and improved testing approaches applicable to the needs of U.S. federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies for validation studies and technical evaluations. Additional information about NICEATM can be found at http://ntp.niehs.nih.gov/go/niceatm. Dated: April 2, 2018. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2018-07057 Filed 4-5-18; 8:45 am] BILLING CODE 4140-01-P
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effectively reducing morbidity and representatives from such federal contracts. Disclosure of this information
mortality in newborns and children agencies, public health constituencies, is necessary in order to determine if the
having or at risk for heritable disorders. and medical professional societies. selected candidate is involved in any
In addition, the Committee provides Interested applicants may self-nominate activity that may pose a potential
advice and recommendations to the or be nominated by another individual conflict with the official duties to be
Secretary concerning the grants and or organization. Nominees must reside performed as a member of the
projects authorized under section 1109 in the United States. Committee.
of the PHSA and technical information Individuals selected for appointment Authority: Section 1111 of the Public
to develop policies and priorities for to the Committee will be invited to Health Service Act (PHSA), as amended by
grants, including those that will serve for up to four (4) years. Members the Newborn Screening Saves Lives
enhance the ability of the state and local who are not federal officers or Reauthorization Act of 2014 (42 U.S.C. 300b–
health agencies to provide for newborn permanent federal employees are 10). The Committee is governed by the
and child screening, counseling and appointed as special government Federal Advisory Committee Act (FACA), as
health care services for newborns, and employees and receive a stipend and amended (5 U.S.C. App.), and 41 CFR part
children having or at risk for heritable reimbursement for per diem and travel 102–3, which set forth standards for the
disorders. expenses incurred for attending formation and use of advisory committees.
The Committee reviews and reports Committee meetings and/or conducting Dated: March 30, 2018.
regularly on newborn and childhood other business on behalf of the Lori A. Roche,
screening practices for heritable Committee, as authorized by section 5 Acting Deputy Director, Division of the
disorders, recommends improvements U.S.C. 5703 for persons employed Executive Secretariat.
in the national newborn and childhood intermittently in government service. [FR Doc. 2018–07005 Filed 4–5–18; 8:45 am]
heritable screening programs, and Members who are officers or employees BILLING CODE 4165–15–P
recommends conditions for inclusion in of the United States Government shall
the Recommended Uniform Screening not receive additional compensation for
Panel (RUSP). The Committee’s service on the Committee, but receive DEPARTMENT OF HEALTH AND
recommendations regarding additional per diem and travel expenses incurred HUMAN SERVICES
conditions/inherited disorders for for attending Committee meetings and/
screening that have been adopted by the or conducting other business on behalf National Institutes of Health
Secretary are included in the RUSP and of the Committee.
constitute part of the comprehensive The following information must be Interagency Coordinating Committee
guidelines supported by HRSA pursuant included in the package of materials on the Validation of Alternative
to section 2713 of the PHSA, codified at submitted for each individual being Methods; Notice of Public Meeting;
42 U.S.C. 300gg–13. Under this nominated for consideration: (1) A Request for Public Input
provision, non-grandfathered health statement that includes the name and
affiliation of the nominee and a clear AGENCY: National Institutes of Health,
plans and group and individual health
statement regarding the basis for the HHS.
insurance issuers are required to cover
screenings included in the HRSA- nomination, including the area(s) of ACTION: Notice.
supported comprehensive guidelines expertise that may qualify a nominee for
SUMMARY: The Interagency Coordinating
without charging a co-payment, co- service on the Committee, as described
Committee on the Validation of
insurance, or deductible for plan years above; (2) confirmation the nominee is
Alternative Methods (ICCVAM) will
(i.e., in the individual market, policy willing to serve as a member of the
hold a public forum to share
years) beginning on or after the date that Committee; (3) the nominee’s contact
information and facilitate direct
is one (1) year from the Secretary’s information (include home address,
communication of ideas and suggestions
adoption of the condition for screening. work address, daytime telephone
from stakeholders. Interested persons
Nominations: HRSA is requesting number, and an email address); and (4)
nominations to fill up to three (3) a current copy of the nominee’s may attend in person or view the
positions for voting members to serve on curriculum vitae. Nomination packages meeting remotely by webcast. Time will
the Committee. The Secretary appoints may be submitted directly by the be set aside for questions and public
committee members with the expertise individual being nominated or by the statements on the topics discussed.
needed to fulfill the duties of the person/organization recommending the Registration is requested for both public
Committee established under section candidate. attendance and oral statements, and
1111(b) of the PHSA, as amended by the HHS will endeavor to ensure that the required for remote access. Information
Newborn Screening Saves Lives membership of the Committee is fairly about the meeting and registration are
Reauthorization Act of 2014 (Act; 42 balanced in terms of points of view available at http://ntp.niehs.nih.gov/go/
U.S.C. 300b–10(b)). Areas of expertise represented and that individuals from a iccvamforum-2018.
include medical, technical, or scientific broad representation of geographic DATES:
professionals with special expertise in areas, gender, ethnic and minority Meeting: May 24, 2018, 9:00 a.m. to
the field of heritable disorders or in groups, as well as individuals with approximately 4:00 p.m. Eastern
providing screening, counseling, testing, disabilities, are considered for Daylight Time (EDT).
or specialty services for newborns and membership. Appointments shall be Registration for Onsite Meeting:
children with, or at risk for having, made without discrimination on the Deadline is May 11, 2018.
heritable disorders; and/or who have basis of age, ethnicity, gender, sexual Registration for Webcast: Deadline is
daltland on DSKBBV9HB2PROD with NOTICES
expertise in ethics (e.g., bioethics) and orientation, and cultural, religious, or May 24, 2018.
infectious diseases and who have socioeconomic status. Submission of Oral Public Statements:
worked and published material in the Individuals who are selected to be Deadline is May 11, 2018.
area of newborn screening; and/or are considered for appointment will be ADDRESSES: Meeting Location: William
members of the public having special required to provide detailed information H. Natcher Conference Center, National
expertise about or concern with regarding their financial holdings, Institutes of Health, Bethesda, MD
heritable disorders; and/or consultancies, and research grants or 20892. Meeting web page: The
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![Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices 14869
NICEATM administers ICCVAM, Dated: April 3, 2018. Time: 5:00 p.m. to 5:00 p.m.
provides scientific and operational Melanie J. Pantoja, Agenda: To review and evaluate grant
support for ICCVAM-related activities, Program Analyst, Office of Federal Advisory applications.
Place: Bethesda North Marriott Hotel &
and conducts and publishes analyses Committee Policy.
Conference Center, 5701 Marinelli Road,
and evaluations of data from new, [FR Doc. 2018–07059 Filed 4–5–18; 8:45 am] North Bethesda, MD 20852.
revised, and alternative testing BILLING CODE 4140–01–P Contact Person: Clifford W. Schweinfest,
approaches. NICEATM and ICCVAM Ph.D., Scientific Review Officer, Special
work collaboratively to evaluate new Review Branch, Division of Extramural
and improved testing approaches DEPARTMENT OF HEALTH AND Activities, National Cancer Institute, NIH,
applicable to the needs of U.S. federal HUMAN SERVICES 9609 Medical Center Drive, Room 7W108,
agencies. Bethesda, MD 20892–9750, 240–276–633,
NICEATM and ICCVAM welcome the National Institutes of Health schweinfestcw@mail.nih.gov.
public nomination of new, revised, and Name of Committee: National Cancer
alternative test methods and strategies National Cancer Institute; Notice of Institute Special Emphasis Panel; SEP–2: NCI
for validation studies and technical Closed Meetings Clinical Translational R21 and Omnibus R03.
Date: May 21–22, 2018.
evaluations. Additional information Pursuant to section 10(d) of the Time: 5:00 p.m. to 6:00 p.m.
about NICEATM can be found at http:// Federal Advisory Committee Act, as Agenda: To review and evaluate grant
ntp.niehs.nih.gov/go/niceatm. amended, notice is hereby given of the applications.
Dated: April 2, 2018. following meetings. Place: Bethesda North Marriott Hotel &
Brian R. Berridge,
The meetings will be closed to the Conference Center, 5701 Marinelli Road,
public in accordance with the North Bethesda, MD 20852.
Associate Director, National Toxicology Contact Person: Hasan Siddiqui, Ph.D.,
Program.
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review Officer, Special Review
[FR Doc. 2018–07057 Filed 4–5–18; 8:45 am] Branch, Division of Extramural Activities,
as amended. The grant applications and National Cancer Institute, NIH, 9609 Medical
BILLING CODE 4140–01–P
the discussions could disclose Center Drive, Room 7W240 Bethesda, MD
confidential trade secrets or commercial 20892–9750, 240–276–5122, hasan.siddiqui@
DEPARTMENT OF HEALTH AND property such as patentable material, nih.gov.
HUMAN SERVICES and personal information concerning Name of Committee: National Cancer
individuals associated with grant Institute Special Emphasis Panel;
National Institutes of Health applications, the disclosure of which Transitional Fellowship.
would constitute a clearly unwarranted Date: May 31–June 1, 2018.
National Institute on Aging; Notice of invasion of personal privacy. Time: 8:00 a.m. to 4:00 p.m.
Closed Meeting Agenda: To review and evaluate grant
Name of Committee: National Cancer applications.
Institute Special Emphasis Panel; R25
Pursuant to section 10(d) of the Place: Bethesda Marriott Suites, 6711
Review. Democracy Boulevard, Bethesda, MD 20817.
Federal Advisory Committee Act, as Date: May 9, 2018.
amended, notice is hereby given of the Contact Person: Reed A. Graves, Ph.D.,
Time: 1:00 p.m. to 4:00 p.m.
following meeting. Scientific Review Officer, Research
Agenda: To review and evaluate grant
Technology and Contract Review Branch,
The meeting will be closed to the applications.
Division of Extramural Activities, National
public in accordance with the Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room Cancer Institute, NIH, 9609 Medical Center
provisions set forth in sections Drive, Room 7W106, Bethesda, MD 20892–
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 7W110, Rockville, MD 20850 (Telephone
Conference Call). 9750, 240–276–6384, gravesr@mail.nih.gov.
as amended. The grant applications and Contact Person: Robert E. Bird, Ph.D., Name of Committee: National Cancer
the discussions could disclose Scientific Review Officer, Research Program Institute Special Emphasis Panel; SEP–6: NCI
confidential trade secrets or commercial Review Branch, Division of Extramural Omnibus.
property such as patentable material, Activities, National Cancer Institute, NIH, Date: June 1, 2018.
and personal information concerning 9609 Medical Center Drive, Room 7W110, Time: 8:00 a.m. to 5:00 p.m.
individuals associated with the grant Bethesda, MD 20892–9750 240–276–6344, Agenda: To review and evaluate grant
applications, the disclosure of which birdr@mail.nih.gov. applications.
Name of Committee: National Cancer Place: Bethesda North Marriott Hotel &
would constitute a clearly unwarranted
Institute Special Emphasis Panel; SEP–1: NCI Conference Center, 5701 Marinelli Road,
invasion of personal privacy. North Bethesda, MD 20852.
Clinical Translational R21 and Omnibus R03.
Name of Committee: National Institute on Date: May 17, 2018. Contact Person: Saejeong J. Kim, Ph.D.,
Aging Special Emphasis Panel HIV Time: 7:30 a.m. to 6:00 p.m. Scientific Review Officer, Special Review
Neurodegeneration. Agenda: To review and evaluate grant Branch, Division of Extramural Activities,
Date: May 30, 2018. applications. National Cancer Institute, NIH, 9609 Medical
Time: 1:00 p.m. to 6:00 p.m. Place: Hyatt Regency Bethesda, One Center Drive, Room 7W649, Bethesda, MD
Agenda: To review and evaluate grant Bethesda Metro Center, 7400 Wisconsin 20892–9750, 240–276–5179, saejeong.kim@
applications. Avenue, Bethesda, MD 20814. nih.gov.
Place: National Institute on Aging, Contact Person: Robert S. Coyne, Ph.D., Name of Committee: National Cancer
Gateway Building, Suite 2W200, 7201 Scientific Review Officer, Special Review Institute Initial Review Group; Subcommittee
Wisconsin Avenue, Bethesda, MD 20892. Branch, Division of Extramural Activities, I—Transition to Independence.
Contact Person: Anita H. Undale, Ph.D., National Cancer Institute, NIH, 9609 Medical Date: June 6–7, 2018.
daltland on DSKBBV9HB2PROD with NOTICES
MD, Scientific Review Branch, National Center Drive, Room 7W236, Bethesda, MD Time: 4:00 p.m. to 5:00 p.m.
Institute on Aging, Gateway Building, Suite 20892–9750, 240–276–5120, coyners@ Agenda: To review and evaluate grant
2W200, 7201 Wisconsin Avenue, Bethesda, mail.nih.gov. applications.
MD 20892, 240–747–7825, anita.undale@ Name of Committee: National Cancer Place: Hyatt Regency Crystal City, 2799
nih.gov. Institute Special Emphasis Panel; Jefferson Davis Highway, Arlington, VA
(Catalogue of Federal Domestic Assistance Partnerships in Cancer Research (P20) and 22202.
Program Nos. 93.866, Aging Research, Cancer Health Equity (U54). Contact Person: Delia Tang, MD, Scientific
National Institutes of Health, HHS) Date: May 21–22, 2018. Review Officer, Research Programs Review
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Document Created: 2018-11-01 09:15:17
Document Modified: 2018-11-01 09:15:17
| 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 | Meeting: May 24, 2018, 9:00 a.m. to approximately 4:00 p.m. Eastern Daylight Time (EDT). | |
| Contact | Dr. Warren Casey, Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); email: [email protected]; telephone: (984) 287-3118. | |
| FR Citation | 83 FR 14867 |
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