Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting, 6792-6793 [2019-03562]

Download as PDF 6792 Federal Register / Vol. 84, No. 40 / Thursday, February 28, 2019 / Notices ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Number of responses per respondent 38 55 21 9 36 26 48 12 54 54 1 1 1 1 1 1 1 1 1 1 Survey of State Refugee Coordinators ............................................................ Survey of URM Program Directors .................................................................. Survey of Private Custody Child Welfare Agency Administrators ................... Interviews with URM Program Managers ........................................................ Interviews with URM Program Staff ................................................................ Interviews with Child Welfare Agency Administrators ..................................... Interviews with Community Partners [General] ............................................... Interviews with Community Partners [Education] ............................................ Focus Groups with URM Youth ....................................................................... Focus Groups with URM Foster Families ....................................................... Estimated Total Annual Burden Hours: 410. Authority: Section 1110 of the Social Security Act. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–03489 Filed 2–27–19; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0639] Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). The general function of the committee is to provide advice and recommendations to the Agency on research being conducted at the NCTR. At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on March 19, 2019, from 8 a.m. to 5:45 p.m., and on March 20, 2019, from 8 a.m. to 11:30 a.m. ADDRESSES: Heifer Village, 1 World Avenue, Little Rock, AR 72202. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm and https://www.heifer.org/what-you-can- khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:52 Feb 27, 2019 Jkt 247001 do/experience-heifer/heifer-village/ index.html. FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993–0002, 301–796–8892; or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On March 19, 2019, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the SAB Subcommittee Site Visit Report and a response to this review. There will be updates from the NCTR Research Divisions and a public comment session. On March 20, 2019, there will be a statement given by the FDA Chief Scientist. The Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, and Center for Tobacco Products will each briefly discuss their center-specific research strategic needs and potential areas of collaboration. Following an open discussion of all the information presented, the open PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Average burden hours per response 0.67 1 0.67 1.5 1.5 1 1 1 1.5 1.5 Annual burden hours 25 55 14 14 54 26 48 12 81 81 session of the meeting will close so the SAB members can discuss personnel issues at NCTR at the end of each day. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On March 19, 2019, from 8 a.m. to 5:45 p.m., and March 20, 2019, from 8 a.m. to 11:30 a.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 12, 2019. Oral presentations from the public will be scheduled between approximately 1:15 p.m. and 2:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 14, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 14, 2019. E:\FR\FM\28FEN1.SGM 28FEN1 Federal Register / Vol. 84, No. 40 / Thursday, February 28, 2019 / Notices Closed Committee Deliberations: On March 19, 2019, from 5:45 p.m. to 6 p.m., and March 20, 2019, from 11:30 a.m. to 12 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be closed to permit discussion of information concerning individuals associated with the research programs at NCTR. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Donna Mendrick at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 25, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–03562 Filed 2–27–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–3631] Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption AGENCY: Food and Drug Administration, HHS. khammond on DSKBBV9HB2PROD with NOTICES ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each SUMMARY: VerDate Sep<11>2014 17:52 Feb 27, 2019 Jkt 247001 proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the standards for the growing, harvesting, packing, and holding of produce for human consumption. Submit either electronic or written comments on the collection of information by April 29, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 29, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 6793 Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–D–3631 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations .gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and E:\FR\FM\28FEN1.SGM 28FEN1

Agencies

[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Notices]
[Pages 6792-6793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0639]


Science Advisory Board to the National Center for Toxicological 
Research Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Science Advisory 
Board (SAB) to the National Center for Toxicological Research (NCTR). 
The general function of the committee is to provide advice and 
recommendations to the Agency on research being conducted at the NCTR. 
At least one portion of the meeting will be closed to the public.

DATES: The meeting will be held on March 19, 2019, from 8 a.m. to 5:45 
p.m., and on March 20, 2019, from 8 a.m. to 11:30 a.m.

ADDRESSES: Heifer Village, 1 World Avenue, Little Rock, AR 72202. 
Answers to commonly asked questions including information regarding 
special accommodations due to a disability, visitor parking, and 
transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm and https://www.heifer.org/what-you-can-do/experience-heifer/heifer-village/index.html.

FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for 
Toxicological Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-
796-8892; or FDA Advisory Committee Information Line, 1-800-741-8138 
(301-443-0572 in the Washington, DC area). A notice in the Federal 
Register about last minute modifications that impact a previously 
announced advisory committee meeting cannot always be published quickly 
enough to provide timely notice. Therefore, you should always check the 
Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm 
and scroll down to the appropriate advisory committee meeting link, or 
call the advisory committee information line to learn about possible 
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On March 19, 2019, the SAB Chair will welcome the 
participants, and the NCTR Director will provide a Center-wide update 
on scientific initiatives and accomplishments during the past year. The 
SAB will be presented with an overview of the SAB Subcommittee Site 
Visit Report and a response to this review. There will be updates from 
the NCTR Research Divisions and a public comment session.
    On March 20, 2019, there will be a statement given by the FDA Chief 
Scientist. The Center for Biologics and Evaluation and Research, Center 
for Drug Evaluation and Research, Center for Devices and Radiological 
Health, Center for Food Safety and Applied Nutrition, and Center for 
Tobacco Products will each briefly discuss their center-specific 
research strategic needs and potential areas of collaboration.
    Following an open discussion of all the information presented, the 
open session of the meeting will close so the SAB members can discuss 
personnel issues at NCTR at the end of each day.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On March 19, 2019, from 8 a.m. to 5:45 p.m., and March 
20, 2019, from 8 a.m. to 11:30 a.m., the meeting is open to the public. 
Interested persons may present data, information, or views, orally or 
in writing, on issues pending before the committee. Written submissions 
may be made to the contact person on or before March 12, 2019. Oral 
presentations from the public will be scheduled between approximately 
1:15 p.m. and 2:15 p.m. Those individuals interested in making formal 
oral presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before March 14, 2019. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by March 14, 
2019.

[[Page 6793]]

    Closed Committee Deliberations: On March 19, 2019, from 5:45 p.m. 
to 6 p.m., and March 20, 2019, from 11:30 a.m. to 12 p.m., the meeting 
will be closed to permit discussion where disclosure would constitute a 
clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). 
This portion of the meeting will be closed to permit discussion of 
information concerning individuals associated with the research 
programs at NCTR.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Donna Mendrick at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03562 Filed 2-27-19; 8:45 am]
 BILLING CODE 4164-01-P