Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting, 54756-54757 [2018-23742]

Download as PDF 54756 Federal Register / Vol. 83, No. 211 / Wednesday, October 31, 2018 / Notices usually precludes eligibility for financial assistance in paying for private coverage. CMS and AE will use the DoD data to authenticate identity, determine eligibility for financial assistance (including an advance tax credit and cost-sharing reduction, which are types of insurance affordability programs), and determine the amount of the financial assistance. Categories of Individuals The categories of individuals whose information is involved in the matching program are active duty service members and their family members and retirees and their family members whose TRICARE eligibility records at DoD match data provided to DoD by CMS (submitted by AEs) about individual consumers who are applying for or are enrolled in private health insurance coverage under a qualified health plan through a federallyfacilitated or state-based health insurance exchange. Categories of Records The categories of records used in the matching program are identity records and minimum essential coverage period records. The data elements are as follows: A. From CMS to DoD For each applicant or enrollee seeking an eligibility determination, CMS will submit a request file to DoD that may contain, but is not limited to, the following specified data elements in a fixed record format: Transaction ID, social security number (SSN), first name, middle name, surname, date of birth, gender, requested qualified health plan (QHP) coverage effective date, requested QHP coverage end date. B. From DoD to CMS amozie on DSK3GDR082PROD with NOTICES1 For each applicant or enrollee seeking an eligibility determination, DoD will provide CMS with data indicating whether or not the individual is eligible for MEC through TRICARE during the applicable QHP coverage period. The data may contain, but is not limited to, the following specified data elements in a fixed record format: Insurance end date, person SSN identification, response code, response code text. System(s) of Records The records used in this matching program are disclosed from the following systems of records, as authorized by routine uses published in the System of Records Notices (SORNs) cited below: VerDate Sep<11>2014 18:06 Oct 30, 2018 Jkt 247001 A. CMS System of Records b MCMS Health Insurance Exchanges System (HIX), CMS System No. 09–70–0560, last published in full at 78 FR 63211 (Oct. 23, 2013), as amended at 83 FR 6591 (Feb. 14, 2018). B. DoD Systems of Records b SDMDC 02 DoD, Defense Enrollment Eligibility Reporting Systems (DEERS), 80 FR 68304 (Nov. 4, 2015), as amended at 81 FR 49210 (July 27, 2016). 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. [FR Doc. 2018–23780 Filed 10–30–18; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4120–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [[Docket No. FDA–2018–N–3844] 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 December 4, 2018, from 8:00 a.m. to 5:45 p.m., and on December 5, 2018, from 8:00 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. 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 SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Agenda: On December 4, 2018, the SAB Chairperson 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 December 5, 2018, 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 the 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 December 4, 2018, from 8:00 a.m. to 5:45 p.m., and December 5, 2018, from 8:00 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 November 27, 2018. Oral presentations E:\FR\FM\31OCN1.SGM 31OCN1 54757 Federal Register / Vol. 83, No. 211 / Wednesday, October 31, 2018 / Notices from the public will be scheduled between approximately 1:15 p.m. and 2:15 p.m. on December 4, 2018. 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 November 19, 2018. 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 November 19, 2018. Closed Committee Deliberations: On December 4, 2018, from 5:45 p.m. to 6:00 p.m., and December 5, 2018, from 11:30 a.m. to 12:00 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: October 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23742 Filed 10–30–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–0313] Agency Information Collection Request: 30-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before November 30, 2018. SUMMARY: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Sherrette Funn, Sherrette.Funn@hhs.gov or (202) 795–7714. When submitting comments or requesting information, please include the document identifier 0990–0313–30D and project title for reference. ADDRESSES: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the SUPPLEMENTARY INFORMATION: Number of respondents amozie on DSK3GDR082PROD with NOTICES1 Type of respondent following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collection: The Nation Blood Collection & Utilization Survey (NBCUS). Type of Collection: Extension on a previously approved collection. OMB No. 0990–0313- Office of the Assistant Secretary for Health—Office of HIV/AIDS and Infectious Disease Policy (OHAIDP). Abstract: Length of request: 3 years. The Nation Blood Collection & Utilization Survey (NBCUS) is a biennial survey of the blood collection and utilization community to produce reliable and accurate estimates of national and regional collections, utilization and safety of all blood products. The 2019 NBCUS is funded by Department of Health and Human Services (DHHS/OASH) and performed by the Centers for Disease Control and Prevention (CDC). In previous years, a similar survey was performed under the auspices of the National Blood Data Resource Center (NBDRC), a private subsidiary of AABB (formerly known as the American Association of Blood Banks), with private funding. In 2005, 2007, 2009, and 2011 the survey was funded by HHS/OS/OASH and performed under contract by AABB. The CDC has since performed the 2013, 2015, and 2017 iterations of the NBCUS. Type of respondent: U.S. Blood Collection Centers (number sampled: 70), U.S. Hospital Blood Banks (number sampled: 2850); frequency: biennial; and the affected public: private businesses. Estimated Annualized Burden Table Number responses per respondent Average burden per response (in hours) Total burden hours Hospital Blood Banks ...................................................................................... Blood Collection Centers ................................................................................. 2850 70 1 1 2 2 5700 140 Total .......................................................................................................... 2920 ........................ ........................ 5840 VerDate Sep<11>2014 18:06 Oct 30, 2018 Jkt 247001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1

Agencies

[Federal Register Volume 83, Number 211 (Wednesday, October 31, 2018)]
[Notices]
[Pages 54756-54757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[[Docket No. FDA-2018-N-3844]


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 December 4, 2018, from 8:00 a.m. to 
5:45 p.m., and on December 5, 2018, from 8:00 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.

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 December 4, 2018, the SAB Chairperson 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 December 5, 2018, 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 
the 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 December 4, 2018, from 8:00 a.m. to 5:45 p.m., and 
December 5, 2018, from 8:00 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 November 27, 
2018. Oral presentations

[[Page 54757]]

from the public will be scheduled between approximately 1:15 p.m. and 
2:15 p.m. on December 4, 2018. 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 November 19, 2018. 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 November 19, 2018.
    Closed Committee Deliberations: On December 4, 2018, from 5:45 p.m. 
to 6:00 p.m., and December 5, 2018, from 11:30 a.m. to 12:00 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: October 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23742 Filed 10-30-18; 8:45 am]
 BILLING CODE 4164-01-P