Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting, 17609-17610 [2021-06930]

Download as PDF 17609 Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Vending Operator Contact Information; 101.8(e)(1) .................................................. 3,279 125 409,875 0.025 (1.5 minutes). Total ............................................................................................................. .................... ........................ .................... Activity; 21 CFR section 1 There Dated: March 30, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–06933 Filed 4–2–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1647] Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) announces a forthcoming virtual public advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Research. The general function of the committee is to provide advice and recommendations to the Agency on research being conducted at the National Center for Toxicological Research (NCTR). At least one portion of the meeting will be closed to the public. DATES: The meeting will be held virtually on May 11, 2021, from 8 a.m. to 5:55 p.m., Central Standard Time, and on May 12, 2021 from 8 a.m. to 11:30 a.m., Central Standard Time. ADDRESSES: Please note that due to the impact of this COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https:// www.fda.gov/advisory-committees/ about-advisory-committees/commonquestions-and-answers-about-fdaadvisory-committee-meetings. The meeting will be webcast both days and SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES 10,247 1,474,537 are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. ACTION: ............................... Total hours VerDate Sep<11>2014 17:23 Apr 02, 2021 Jkt 253001 will be available at the following link: https://collaboration.fda.gov/nctr1000/. 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/advisory-committees and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before joining the meeting. SUPPLEMENTARY INFORMATION: Agenda: On May 11, 2021, the Science Advisory Board 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 Science Advisory Board will be presented with an overview of the Science Advisory Board Subcommittee Site Visit Report and a response to this review. The Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, Center for Tobacco Products, and the Office of Regulatory Affairs will each briefly discuss their specific research strategic needs and potential areas of collaboration. On May 12, 2021, there will be updates from the NCTR Research Divisions and a public comment session. Following an open discussion of all the information presented, the open session of the meeting will close so the Science Advisory Board members can discuss personnel issues at NCTR. 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 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 material on its website prior to the meeting, the background material will be made publicly available at https:// collaboration.fda.gov/nctr1000/, and the recording plus transcript will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/advisorycommittees/advisory-committeecalendar. Scroll down to the appropriate advisory committee meeting link. Procedure: On May 11, 2021, from 8 a.m. to 5:55 p.m., Central Standard Time, and May 12, 2021, from 8 a.m. to 11:30 a.m., Central Standard Time, 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 (see FOR FURTHER INFORMATION CONTACT) on or before May 4, 2021. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Central Standard Time. 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 April 26, 2021. 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 April 27, 2021. Closed Committee Deliberations: On May 12, 2021, from 11:30 a.m. to 12 p.m., Central Standard Time, 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 E:\FR\FM\05APN1.SGM 05APN1 17610 Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices associated with the research programs at NCTR. 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 14 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/about-advisory-committees/ public-conduct-during-fda-advisorycommittee-meetings 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: March 30, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–06930 Filed 4–2–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0405] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority AGENCY: Food and Drug Administration, HHS. 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 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 the information collections related to Medical Device Recall Authority. DATES: Submit either electronic or written comments on the collection of information by June 4, 2021. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:23 Apr 02, 2021 Jkt 253001 considered. Electronic comments must be submitted on or before June 4, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 4, 2021. 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. 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 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–N–0405 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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 follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR E:\FR\FM\05APN1.SGM 05APN1

Agencies

[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17609-17610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06930]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1647]


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

DATES: The meeting will be held virtually on May 11, 2021, from 8 a.m. 
to 5:55 p.m., Central Standard Time, and on May 12, 2021 from 8 a.m. to 
11:30 a.m., Central Standard Time.

ADDRESSES: Please note that due to the impact of this COVID-19 
pandemic, all meeting participants will be joining this advisory 
committee meeting via an online teleconferencing platform. Answers to 
commonly asked questions about FDA advisory committee meetings may be 
accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. The meeting will be webcast both days and will be available 
at the following link: https://collaboration.fda.gov/nctr1000/.

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/advisory-committees and scroll 
down to the appropriate advisory committee meeting link, or call the 
advisory committee information line to learn about possible 
modifications before joining the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On May 11, 2021, the Science Advisory Board 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 Science Advisory Board will be presented with an 
overview of the Science Advisory Board Subcommittee Site Visit Report 
and a response to this review. The Center for Biologics Evaluation and 
Research, Center for Drug Evaluation and Research, Center for Devices 
and Radiological Health, Center for Food Safety and Applied Nutrition, 
Center for Tobacco Products, and the Office of Regulatory Affairs will 
each briefly discuss their specific research strategic needs and 
potential areas of collaboration.
    On May 12, 2021, there will be updates from the NCTR Research 
Divisions and a public comment session. Following an open discussion of 
all the information presented, the open session of the meeting will 
close so the Science Advisory Board members can discuss personnel 
issues at NCTR.
    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 https://collaboration.fda.gov/nctr1000/, and the recording plus transcript will 
be posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/advisory-committees/advisory-committee-calendar. Scroll down to the appropriate advisory committee 
meeting link.
    Procedure: On May 11, 2021, from 8 a.m. to 5:55 p.m., Central 
Standard Time, and May 12, 2021, from 8 a.m. to 11:30 a.m., Central 
Standard Time, 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 (see FOR FURTHER INFORMATION CONTACT) on or before 
May 4, 2021. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Central Standard Time. 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 
April 26, 2021. 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 April 27, 2021.
    Closed Committee Deliberations: On May 12, 2021, from 11:30 a.m. to 
12 p.m., Central Standard Time, 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

[[Page 17610]]

associated with the research programs at NCTR.
    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 14 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings 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: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06930 Filed 4-2-21; 8:45 am]
BILLING CODE 4164-01-P

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