83 FR 18310 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 81 (April 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 81 (April 26, 2018)
| Page Range | 18310-18311 | |
| FR Document | 2018-08711 |
[Federal Register Volume 83, Number 81 (Thursday, April 26, 2018)] [Notices] [Pages 18310-18311] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08711] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1489] 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. At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on May 17, 2018, from 8 a.m. to 4:45 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/vrbpac2018/. FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas or Rosanna Harvey, 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 and 240-402-8072, rosanna.harvey@fda.hhs.gov, 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 May 17, 2018, under Topic I, the Center for Biologics Evaluation and Research's (CBER) VRBPAC will meet in open session to discuss approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant. Also on May 17, 2018, under Topic II, the committee will meet in open session to hear an overview of the research program in the Laboratory of Respiratory Viral Diseases (LRVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA. 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 May 17, 2018, from 8 a.m. to 4:10 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 May 10, 2018. Oral presentations from the public will be scheduled between approximately 12:35 p.m. to 1:20 p.m. for the GBS vaccine portion of the meeting, and 3:50 p.m. to 4:05 p.m. for the overview portion of the LRVD Site Visit. 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 May 2, 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 May 3, 2018. Closed Committee Deliberations: On May 17, 2018, from 4:10 p.m. to 4:45 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)). The recommendations of the advisory committee regarding the progress of the investigator's research will, along with other information, be used in making personnel and staffing decisions regarding individual scientists. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy. 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 at least 7 days in advance of the meeting (see, FOR FURTHER INFORMATION CONTACT). 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 [[Page 18311]] 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: April 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-08711 Filed 4-25-18; 8:45 am] BILLING CODE 4164-01-P
![18310 Federal Register / Vol. 83, No. 81 / Thursday, April 26, 2018 / Notices
supplement were not provided, the For those unable to attend in person, present data, information, or views,
project would be less able to address the the meeting will also be webcast and orally or in writing, on issues pending
significant unmet needs of additional will be available at the following link: before the committee. Written
Holocaust survivors. Similarly, the https://collaboration.fda.gov/ submissions may be made to the contact
project would be unable to expand its vrbpac2018/. person on or before May 10, 2018. Oral
current technical assistance and training FOR FURTHER INFORMATION CONTACT: presentations from the public will be
efforts in PCTI concepts and Serina Hunter-Thomas or Rosanna scheduled between approximately 12:35
approaches, let alone reach beyond Harvey, Center for Biologics Evaluation p.m. to 1:20 p.m. for the GBS vaccine
traditional providers of services to this and Research, Food and Drug portion of the meeting, and 3:50 p.m. to
population to train more ‘‘mainstream’’ Administration, 10903 New Hampshire 4:05 p.m. for the overview portion of the
providers of aging services. Ave., Bldg. 71, Rm. 6338, Silver Spring, LRVD Site Visit. Those individuals
For More Information Contact: For MD 20993–0002, 240–402–5771, interested in making formal oral
further information or comments serina.hunter-thomas@fda.hhs.gov and presentations should notify the contact
regarding this program supplement, 240–402–8072, rosanna.harvey@ person and submit a brief statement of
contact Greg Link, U.S. Department of fda.hhs.gov, or FDA Advisory the general nature of the evidence or
Health and Human Services, Committee Information Line, 1–800– arguments they wish to present, the
Administration for Community Living, 741–8138 (301–443–0572 in the names and addresses of proposed
Administration on Aging, Office of Washington, DC area). A notice in the participants, and an indication of the
Supportive and Caregiver Services: Federal Register about last minute approximate time requested to make
telephone (202)–795–7386; email modifications that impact a previously their presentation on or before May 2,
greg.link@acl.hhs.gov. announced advisory committee meeting 2018. Time allotted for each
Dated: April 18, 2018. cannot always be published quickly presentation may be limited. If the
Mary Lazare, enough to provide timely notice. number of registrants requesting to
Therefore, you should always check the speak is greater than can be reasonably
Principal Deputy Administrator.
Agency’s website at https:// accommodated during the scheduled
[FR Doc. 2018–08708 Filed 4–25–18; 8:45 am]
www.fda.gov/AdvisoryCommittees/ open public hearing session, FDA may
BILLING CODE 4154–01–P conduct a lottery to determine the
default.htm and scroll down to the
appropriate advisory committee meeting speakers for the scheduled open public
link, or call the advisory committee hearing session. The contact person will
DEPARTMENT OF HEALTH AND
information line to learn about possible notify interested persons regarding their
HUMAN SERVICES
modifications before coming to the request to speak by May 3, 2018.
Food and Drug Administration meeting. Closed Committee Deliberations: On
SUPPLEMENTARY INFORMATION:
May 17, 2018, from 4:10 p.m. to 4:45
[Docket No. FDA–2018–N–1489] Agenda: On May 17, 2018, under p.m., the meeting will be closed to
Topic I, the Center for Biologics permit discussion where disclosure
Vaccines and Related Biological Evaluation and Research’s (CBER) would constitute a clearly unwarranted
Products Advisory Committee; Notice VRBPAC will meet in open session to invasion of personal privacy (5 U.S.C.
of Meeting discuss approaches for demonstrating 552b(c)(6)). The recommendations of the
effectiveness of group B streptococcus advisory committee regarding the
AGENCY: Food and Drug Administration, progress of the investigator’s research
(GBS) vaccines intended for use in
HHS. will, along with other information, be
pregnant women to protect the newborn
ACTION: Notice. infant. Also on May 17, 2018, under used in making personnel and staffing
Topic II, the committee will meet in decisions regarding individual
SUMMARY: The Food and Drug scientists.
Administration (FDA) announces a open session to hear an overview of the
research program in the Laboratory of We believe that public discussion of
forthcoming public advisory committee these recommendations on individual
meeting of the Vaccines and Related Respiratory Viral Diseases (LRVD),
Division of Viral Products, Office of scientists would constitute an
Biological Products Advisory unwarranted invasion of personal
Committee (VRBPAC). The general Vaccines Research and Review, CBER,
FDA. privacy.
function of the committee is to provide Persons attending FDA’s advisory
FDA intends to make background
advice and recommendations to the committee meetings are advised that the
material available to the public no later
Agency on FDA’s regulatory issues. At Agency is not responsible for providing
than 2 business days before the meeting.
least one portion of the meeting will be access to electrical outlets.
If FDA is unable to post the background
closed to the public. FDA welcomes the attendance of the
material on its website prior to the
DATES: The meeting will be held on May meeting, the background material will public at its advisory committee
17, 2018, from 8 a.m. to 4:45 p.m. be made publicly available at the meetings and will make every effort to
ADDRESSES: FDA White Oak Campus, location of the advisory committee accommodate persons with disabilities.
10903 New Hampshire Ave., Bldg. 31 meeting, and the background material If you require accommodations due to a
Conference Center, the Great Room (Rm. will be posted on FDA’s website after disability, please contact Serina Hunter-
1503), Silver Spring, MD 20993–0002. the meeting. Background material is Thomas at least 7 days in advance of the
Answers to commonly asked questions available at https://www.fda.gov/ meeting (see, FOR FURTHER INFORMATION
amozie on DSK30RV082PROD with NOTICES
including information regarding special AdvisoryCommittees/Calendar/ CONTACT).
accommodations due to a disability, default.htm. Scroll down to the FDA is committed to the orderly
visitor parking, and transportation may appropriate advisory committee meeting conduct of its advisory committee
be accessed at: https://www.fda.gov/ link. meetings. Please visit our website at:
AdvisoryCommittees/ Procedure: On May 17, 2018, from 8 https://www.fda.gov/
AboutAdvisoryCommittees/ a.m. to 4:10 p.m., the meeting is open AdvisoryCommittees/AboutAdvisory
ucm408555.htm. to the public. Interested persons may Committees/ucm111462.htm for
VerDate Sep<11>2014 16:58 Apr 25, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\26APN1.SGM 26APN1](https://thefederalregister.org/doc/83_FR_18391/page/1.svg)
![Federal Register / Vol. 83, No. 81 / Thursday, April 26, 2018 / Notices 18311
procedures on public conduct during Submit either electronic or written identified, as confidential, if submitted
advisory committee meetings. comments on this public meeting by as detailed in ‘‘Instructions.’’
Notice of this meeting is given under that date. Please note that late, untimely Instructions: All submissions received
the Federal Advisory Committee Act (5 filed comments will not be considered. must include Docket No. FDA–2018–N–
U.S.C. app. 2). Electronic comments must be submitted 1439 for ‘‘Pediatric Advisory Committee
Dated: April 20, 2018. on or before May 10, 2018. The https:// and the Endocrinologic and Metabolic
Leslie Kux, www.regulations.gov electronic filing Drugs Advisory Committee; Notice of
Associate Commissioner for Policy.
system will accept comments until Meeting; Establishment of a Public
midnight Eastern Time at the end of Docket; Request for Comments.’’
[FR Doc. 2018–08711 Filed 4–25–18; 8:45 am]
May 10, 2018. Comments received by Received comments, those filed in a
BILLING CODE 4164–01–P
mail/hand delivery/courier (for written/ timely manner (see ADDRESSES), will be
paper submissions) will be considered placed in the docket and, except for
timely if they are postmarked or the those submitted as ‘‘Confidential
DEPARTMENT OF HEALTH AND
delivery service acceptance receipt is on Submissions,’’ publicly viewable at
HUMAN SERVICES
or before that date. https://www.regulations.gov or at the
Food and Drug Administration Comments received on or before May Dockets Management Staff between 9
4, 2018, will be provided to the a.m. and 4 p.m., Monday through
[Docket No. FDA–2018–N–1439] committee. Comments received after Friday.
that date will be taken into • Confidential Submissions—To
Pediatric Advisory Committee and the
consideration by FDA. submit a comment with confidential
Endocrinologic and Metabolic Drugs
You may submit comments as information that you do not wish to be
Advisory Committee; Notice of
follows: made publicly available, submit your
Meeting; Establishment of a Public
comments only as a written/paper
Docket; Request for Comments Electronic Submissions submission. You should submit two
AGENCY: Food and Drug Administration, Submit electronic comments in the copies total. One copy will include the
HHS. following way: information you claim to be confidential
ACTION: Notice; establishment of a • Federal eRulemaking Portal: with a heading or cover note that states
public docket; request for comments. https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ FDA
SUMMARY: The Food and Drug Comments submitted electronically, will review this copy, including the
Administration (FDA) announces a including attachments, to https:// claimed confidential information, in its
forthcoming public advisory committee www.regulations.gov will be posted to consideration of comments. The second
meeting of the Pediatric Advisory the docket unchanged. Because your copy, which will have the claimed
Committee (PAC) and the comment will be made public, you are confidential information redacted/
Endocrinologic and Metabolic Drugs solely responsible for ensuring that your blacked out, will be available for public
Advisory Committee (EMDAC). At least comment does not include any viewing and posted on https://
one portion of the meeting will be confidential information that you or a www.regulations.gov. Submit both
closed to the public. The general third party may not wish to be posted, copies to the Dockets Management Staff.
function of the committees is to provide such as medical information, your or If you do not wish your name and
advice and recommendations to FDA on anyone else’s Social Security number, or contact information be made publicly
regulatory issues. FDA is establishing a confidential business information, such available, you can provide this
docket for public comments on this as a manufacturing process. Please note information on the cover sheet and not
document. that if you include your name, contact in the body of your comments and you
DATES: The meeting will be held on May information, or other information that must identify the information as
11, 2018, from 8 a.m. to 6 p.m. This is identifies you in the body of your ‘‘confidential.’’ Any information marked
a reschedule of a postponed meeting comments, that information will be as ‘‘confidential’’ will not be disclosed
announced in the Federal Register of posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
January 23, 2018 (83 FR 3156), • If you want to submit a comment and other applicable disclosure law. For
originally scheduled for March 22, 2018. with confidential information that you more information about FDA’s posting
An amendment to the Federal Register do not wish to be made available to the of comments to public dockets, see 80
notice was published on March 16, 2018 public, submit the comment as a FR 56469, September 18, 2015, or access
(83 FR 11755). written/paper submission and in the the information at: https://www.gpo.gov/
ADDRESSES: Tommy Douglas Conference manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
Center, 10000 New Hampshire Ave., Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Silver Spring, MD 20903. Answers to Docket: For access to the docket to
Written/Paper Submissions read background documents or the
commonly asked questions about FDA
Advisory Committee meetings may be Submit written/paper submissions as electronic and written/paper comments
accessed at: https://www.fda.gov/ follows: received, go to https://
AdvisoryCommittees/ • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
AboutAdvisoryCommittees/ written/paper submissions): Dockets docket number, found in brackets in the
ucm408555.htm. Information about the Management Staff (HFA–305), Food and heading of this document, into the
amozie on DSK30RV082PROD with NOTICES
Tommy Douglas Conference Center can Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
be accessed at https:// Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
www.tommydouglascenter.com. • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
FDA is establishing a docket for submitted to the Dockets Management Rockville, MD 20852.
public comment on this meeting. The Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
docket number is FDA–2018–N–1439. well as any attachments, except for Marieann Brill, Office of the
The docket will close on May 10, 2018. information submitted, marked and Commissioner, Food and Drug
VerDate Sep<11>2014 16:58 Apr 25, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\26APN1.SGM 26APN1](https://thefederalregister.org/doc/83_FR_18391/page/2.svg)
Document Created: 2018-11-02 08:19:21
Document Modified: 2018-11-02 08:19:21
| 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 | The meeting will be held on May 17, 2018, from 8 a.m. to 4:45 p.m. | |
| Contact | Serina Hunter-Thomas or Rosanna Harvey, 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, [email protected] and 240-402-8072, [email protected], 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. | |
| FR Citation | 83 FR 18310 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR