Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 9344-9345 [2019-04708]

Download as PDF 9344 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices consolidate or coordinate their presentations and request time for a joint presentation. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by 11:59 p.m. Eastern Time on March 20, 2019, for the first meeting, June 26, 2019, for the second meeting, and January 30, 2020, for the third meeting. FDA will notify registered presenters of their scheduled presentation time. If selected for presentation, any presentation materials must be emailed to eprompt@fda.hhs.gov no later than 11:59 p.m. Eastern Time on March 22, 2019, for the first meeting, July 10, 2019, for the second meeting, and February 12, 2020, for the third meeting. Persons registered to speak should check in before the meeting and are encouraged to arrive early to ensure their designated order of presentation. Participants who are not present when called may not be permitted to speak at a later time. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. An agenda will be made available at least 3 days before each public meeting at https://www.fda.gov/Drugs/NewsEvents/ ucm621215.htm. Streaming Webcast of the Public Meetings and Video of the Public Meetings: The second and third public meetings will also be webcast; the URL will be posted at https://www.fda.gov/ Drugs/NewsEvents/ucm621215.htm at least 1 day before each meeting. A video record of the public workshops will be available at the same website address for 1 year. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Surveillance/ AdverseDrugEffects/ucm115894.htm. VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 Dated: March 11, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–04730 Filed 3–13–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1045] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. Consistent with FDA’s regulations, notice is being published with less than 15 days prior to the date of the meeting based on a determination that an immediate meeting of the Vaccines and Related Biological Products Advisory Committee is needed. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019– 2020 seasonal influenza vaccines. DATES: The meeting will be held on March 22, 2019, from 8:30 a.m. to 2:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. 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 those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://collaboration.fda.gov/ vrbpac032019. SUMMARY: FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 6338, Silver Spring, MD 20993–0002, 240–402–5771, serina.hunter-thomas@ fda.hhs.gov; or Monique Hill, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993–0002, 301–796–4620, monique.hill@ fda.hhs.gov; or the 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 22, 2019, in followup to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019– 2020 seasonal influenza vaccines, the Center for Biologics Evaluation and Research will reconvene the VRBPAC to discuss and make recommendations specifically on the H3N2 strain. The VRBPAC previously met on March 6, 2019, and made recommendations on the selection of all other strains to be included in seasonal influenza virus vaccines for the 2019–2020 influenza season. 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 22, 2019, from 8:30 a.m. to 2:30 p.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 15, 2019. On March 22, 2019, oral presentations from the public will be scheduled between E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices approximately 10:30 a.m. to 11:30 a.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 15, 2019. 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 Serina HunterThomas (see FOR FURTHER INFORMATION CONTACT) 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: March 8, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–04708 Filed 3–13–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–0661] Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the SUMMARY: VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 availability of a draft guidance for industry entitled ‘‘Modifications to Compliance Policy for Certain Deemed Tobacco Products.’’ The draft guidance discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products and describes how FDA intends to prioritize its enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization. DATES: Submit either electronic or written comments on the draft guidance by April 15, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: 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.’’ PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 9345 Instructions: All submissions received must include the Docket No. FDA– 2019–D–0661 for ‘‘Modifications to Compliance Policy for Certain Deemed Tobacco Products.’’ Received comments 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 follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this draft guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002. Send one self-addressed E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9344-9345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1045]


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Vaccines and Related 
Biological Products Advisory Committee (VRBPAC). The general function 
of the committee is to provide advice and recommendations to the Agency 
on FDA's regulatory issues. Consistent with FDA's regulations, notice 
is being published with less than 15 days prior to the date of the 
meeting based on a determination that an immediate meeting of the 
Vaccines and Related Biological Products Advisory Committee is needed. 
This Federal Register notice could not be published 15 days prior to 
the date of the meeting due to a delay by the World Health Organization 
(WHO) in recommending H3N2 strain for inclusion in the 2019-2020 
seasonal influenza vaccines.

DATES: The meeting will be held on March 22, 2019, from 8:30 a.m. to 
2:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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 those unable to attend in person, the meeting will also be 
webcast and will be available at the following link: https://collaboration.fda.gov/vrbpac032019.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 
240-402-5771, serina.hunter-thomas@fda.hhs.gov; or Monique Hill, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-
0002, 301-796-4620, monique.hill@fda.hhs.gov; or the 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 22, 2019, in followup to a delay by the World 
Health Organization (WHO) in recommending H3N2 strain for inclusion in 
the 2019-2020 seasonal influenza vaccines, the Center for Biologics 
Evaluation and Research will reconvene the VRBPAC to discuss and make 
recommendations specifically on the H3N2 strain. The VRBPAC previously 
met on March 6, 2019, and made recommendations on the selection of all 
other strains to be included in seasonal influenza virus vaccines for 
the 2019-2020 influenza season.
    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 22, 2019, from 8:30 a.m. to 2:30 p.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 15, 2019. On March 22, 2019, oral presentations from 
the public will be scheduled between

[[Page 9345]]

approximately 10:30 a.m. to 11:30 a.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 15, 2019.
    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 Serina Hunter-Thomas (see FOR FURTHER INFORMATION CONTACT) 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: March 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04708 Filed 3-13-19; 8:45 am]
 BILLING CODE 4164-01-P

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