82 FR 42685 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 174 (September 11, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 174 (September 11, 2017)
| Page Range | 42685-42686 | |
| FR Document | 2017-19129 |
[Federal Register Volume 82, Number 174 (Monday, September 11, 2017)] [Notices] [Pages 42685-42686] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19129] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4851] 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. The meeting will be open to the public. Members will participate via teleconference. DATES: The meeting will be held on October 4, 2017, from 1 p.m. to 4:30 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. 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/cbervrbpac2017. 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: Serina Hunter-Thomas or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, 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 Web site 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 October 4, 2017, the VRBPAC will meet in an open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2018 southern hemisphere 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 Web site 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 Web site 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: 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 September 27, 2017. 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 [[Page 42686]] 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 September 19, 2017. 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 September 20, 2017. 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. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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: September 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-19129 Filed 9-8-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices 42685
Background on the Task Force: The and the guard force will then direct accommodations due to a disability,
Task Force is an independent, visitors to the designated parking area. visitor parking, and transportation may
nonfederal panel whose members are Upon arrival at the facility, visitors must be accessed at: https://www.fda.gov/
appointed by the CDC Director. Task present government-issued photo AdvisoryCommittees/
Force members represent a broad range identification (e.g., a valid federal AboutAdvisoryCommittees/
of research, practice, and policy identification badge, state driver’s ucm408555.htm.
expertise in prevention, wellness, health license, state non-driver’s identification FOR FURTHER INFORMATION CONTACT:
promotion, and public health. The Task card, or passport). Non-U.S. citizens Serina Hunter-Thomas or Rosanna
Force was convened in 1996 by the must complete the required security Harvey, Center for Biologics Evaluation
Department of Health and Human paperwork prior to the meeting date and and Research, Food and Drug
Services (HHS) to identify community must present a valid passport, visa, Administration, 10903 New Hampshire
preventive programs, services, and Permanent Resident Card, or other type Ave., Bldg. 71, Rm. 6307C, Silver
policies that increase healthy longevity, of work authorization document upon Spring, MD 20993–0002, 240–402–5771
save lives and dollars, and improve arrival at the facility. All persons serina.hunter-thomas@fda.hhs.gov and
Americans’ quality of life. CDC is entering the building must pass through 240–402–8072, rosanna.harvey@
mandated to provide ongoing a metal detector. CDC Security fda.hhs.gov, or FDA Advisory
administrative, research, and technical personnel will issue a visitor’s ID badge Committee Information Line, 1–800–
support for the operations of the Task at the entrance to Building 19. Visitors 741–8138 (301–443–0572 in the
Force. During its meetings, the Task may receive an escort to the meeting Washington, DC area). A notice in the
Force considers the findings of room. All items brought to HHS/CDC Federal Register about last minute
systematic reviews on existing research are subject to inspection. modifications that impact a previously
and practice-based evidence and issues Dated: September 6, 2017. announced advisory committee meeting
recommendations. Task Force cannot always be published quickly
Sandra Cashman,
recommendations are not mandates for enough to provide timely notice.
compliance or spending. Instead, they Executive Secretary, Centers for Disease
Control and Prevention. Therefore, you should always check the
provide information about evidence- Agency’s Web site at https://
based options that decision makers and [FR Doc. 2017–19203 Filed 9–8–17; 8:45 am]
BILLING CODE 4163–18–P
www.fda.gov/AdvisoryCommittees/
stakeholders can consider when they are default.htm and scroll down to the
determining what best meet the specific appropriate advisory committee meeting
needs, preferences, available resources, link, or call the advisory committee
and constraints of their jurisdictions DEPARTMENT OF HEALTH AND
HUMAN SERVICES information line to learn about possible
and constituents. The Task Force’s modifications before coming to the
recommendations, along with the Food and Drug Administration meeting.
systematic reviews of the evidence on
which they are based, are compiled in [Docket No. FDA–2017–N–4851] SUPPLEMENTARY INFORMATION:
the Guide to Community Preventive Agenda: On October 4, 2017, the
Services (The Community Guide). Vaccines and Related Biological VRBPAC will meet in an open session
Matters proposed for discussion: Products Advisory Committee; Notice to discuss and make recommendations
Cardiovascular Disease Prevention of Meeting on the selection of strains to be included
(Mobile Health Interventions for in an influenza virus vaccine for the
AGENCY: Food and Drug Administration,
Cardiovascular Disease Prevention); 2018 southern hemisphere influenza
HHS.
Diabetes Prevention and Control season. FDA intends to make
ACTION: Notice. background material available to the
(Lifestyle Interventions to Reduce Risk
of Gestational Diabetes); Nutrition SUMMARY: The Food and Drug public no later than 2 business days
(Gardening-Based Interventions to Administration (FDA) announces a before the meeting. If FDA is unable to
Increase Fruit and Vegetable Intake); forthcoming public advisory committee post the background material on its Web
Obesity Prevention and Control (School- meeting of the Vaccines and Related site prior to the meeting, the background
based Diet and Physical Activity Biological Products Advisory material will be made publicly available
Interventions); and Women’s Health Committee (VRBPAC). The general at the location of the advisory
(Primary Prevention of Intimate Partner function of the committee is to provide committee meeting, and the background
Violence and Sexual Violence Among advice and recommendations to the material will be posted on FDA’s Web
Youth). The agenda is subject to change Agency on FDA’s regulatory issues. The site after the meeting. Background
without notice. meeting will be open to the public. material is available at https://
Roybal Campus Security Guidelines: Members will participate via www.fda.gov/AdvisoryCommittees/
The Edward R. Roybal Campus is the teleconference. Calendar/default.htm. Scroll down to
headquarters of the CDC and is located the appropriate advisory committee
DATES: The meeting will be held on
at 1600 Clifton Road NE., Atlanta, meeting link.
Georgia. The meeting is being held in a October 4, 2017, from 1 p.m. to 4:30 Procedure: Interested persons may
Federal government building; therefore, p.m. present data, information, or views,
Federal security measures are ADDRESSES: FDA White Oak Campus, orally or in writing, on issues pending
asabaliauskas on DSKBBXCHB2PROD with NOTICES
applicable. 10903 New Hampshire Ave., Bldg. 31 before the committee. Written
All meeting attendees must register by Conference Center, the Great Room (Rm. submissions may be made to the contact
the dates outlined under Meeting 1503), Silver Spring, MD 20993–0002. person on or before September 27, 2017.
Accessability. In planning your arrival For those unable to attend in person, the Oral presentations from the public will
time, please take into account the need meeting will also be webcast and will be be scheduled between approximately
to park and clear security. All visitors available at the following link: https:// 1:15 p.m. and 2:15 p.m. Those
must enter the Edward R. Roybal collaboration.fda.gov/cbervrbpac2017. individuals interested in making formal
Campus through the front entrance on Answers to commonly asked questions oral presentations should notify the
Clifton Road. Vehicles may be searched, including information regarding special contact person and submit a brief
VerDate Sep<11>2014 16:34 Sep 08, 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1](https://thefederalregister.org/doc/82_FR_42859/page/1.svg)
![42686 Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices
statement of the general nature of the as amended by the Food and Drug DEPARTMENT OF HEALTH AND
evidence or arguments they wish to Administration Safety and Innovation HUMAN SERVICES
present, the names and addresses of Act (FDASIA), authorizes FDA to award
proposed participants, and an priority review vouchers to sponsors of National Institutes of Health
indication of the approximate time approved rare pediatric disease product
requested to make their presentation on Government-Owned Inventions;
applications that meet certain criteria. Availability for Licensing
or before September 19, 2017. Time FDA is required to publish notice of the
allotted for each presentation may be award of the priority review voucher. AGENCY: National Institutes of Health,
limited. If the number of registrants FDA has determined that KYMRIAH HHS.
requesting to speak is greater than can (tisagenlecleucel), manufactured by ACTION: Notice.
be reasonably accommodated during the
Novartis Pharmaceuticals Corporation,
scheduled open public hearing session, SUMMARY: The invention listed below is
meets the criteria for a priority review owned by an agency of the U.S.
FDA may conduct a lottery to determine
the speakers for the scheduled open voucher. Government and is available for
public hearing session. The contact FOR FURTHER INFORMATION CONTACT: licensing to achieve expeditious
person will notify interested persons Gretchen Opper, Center for Biologics commercialization of results of
regarding their request to speak by Evaluation and Research, Food and federally-funded research and
September 20, 2017. Drug Administration, 10903 New development. Foreign patent
Persons attending FDA’s advisory Hampshire Ave., Bldg. 71, Rm. 7301, applications are filed on selected
committee meetings are advised that the Silver Spring, MD 20993–0002, 240– inventions to extend market coverage
Agency is not responsible for providing 402–7911. for companies and may also be available
access to electrical outlets. for licensing.
FDA welcomes the attendance of the SUPPLEMENTARY INFORMATION: FDA is FOR FURTHER INFORMATION CONTACT: Dr.
public at its advisory committee announcing the issuance of a priority Vince Contreras, 240–669–2823;
meetings and will make every effort to review voucher to the sponsor of an Vince.Contreras@nih.gov. Licensing
accommodate persons with disabilities. approved rare pediatric disease product information and copies of the patent
If you require accommodations due to a application. Under section 529 of the applications listed below may be
disability, please contact Serina Hunter- FD&C Act (21 U.S.C. 360ff), which was obtained by communicating with the
Thomas at least 7 days in advance of the added by FDASIA, FDA will award indicated licensing contact at the
meeting. priority review vouchers to sponsors of Technology Transfer and Intellectual
FDA is committed to the orderly approved rare pediatric disease product Property Office, National Institute of
conduct of its advisory committee applications that meet certain criteria. Allergy and Infectious Diseases, 5601
meetings. Please visit our Web site at: Fishers Lane, Rockville, MD 20852; tel.
FDA has determined that KYMRIAH
https://www.fda.gov/ 301–496–2644. A signed Confidential
(tisagenlecleucel), manufactured by
AdvisoryCommittees/ Disclosure Agreement will be required
AboutAdvisoryCommittees/ Novartis Pharmaceuticals Corporation,
meets the criteria for a priority review to receive copies of unpublished patent
ucm111462.htm for procedures on applications.
public conduct during advisory voucher. KYMRIAH (tisagenlecleucel) is
indicated for the treatment of patients SUPPLEMENTARY INFORMATION:
committee meetings. Technology description follows.
Notice of this meeting is given under up to 25 years of age with B-cell
the Federal Advisory Committee Act (5 precursor acute lymphoblastic leukemia Broadly Neutralizing Antibodies
U.S.C. app. 2). (ALL) that is refractory or in second or Against HIV–1 Directed to the CD4
Dated: September 5, 2017. later relapse. Binding Site of HIV Envelope Protein
Anna K. Abram, For further information about the Rare Description of Technology
Deputy Commissioner for Policy, Planning, Pediatric Disease Priority Review Inhibiting the ability of HIV–1, the
Legislation, and Analysis. Voucher Program and for a link to the virus that causes AIDS, to infect cells is
[FR Doc. 2017–19129 Filed 9–8–17; 8:45 am] full text of section 529 of the FD&C Act, one approach to both prevention and
BILLING CODE 4164–01–P go tohttps://www.fda.gov/ForIndustry/ treatment of HIV. Scientists at the
DevelopingProductsfor NIAID Vaccine Research Center have
RareDiseasesConditions/ isolated and characterized neutralizing
DEPARTMENT OF HEALTH AND RarePediatricDiseasePriorityVoucher antibodies (VRC01, 02, 03, and 07) that
HUMAN SERVICES Program/default.htm. For further bind to the CD4 binding site of HIV–1
information about KYMRIAH envelope glycoprotein gp120. These
Food and Drug Administration
(tisagenlecleucel), go to the Center for human monoclonal antibodies can
[Docket No. FDA–2017–N–0809] Biologics Evaluation and Research potentially be used as a therapeutic to:
cellular and gene therapy products Web (1) Treat an HIV infection, (2) decrease
Issuance of Priority Review Voucher; site at https://www.fda.gov/Biologics and prevent HIV-transmission from
Rare Pediatric Disease Product mother to infant, and (3) be effectively
BloodVaccines/CellularGeneTherapy
AGENCY: Food and Drug Administration, Products/ApprovedProducts/ combined with anti-retroviral drug
asabaliauskas on DSKBBXCHB2PROD with NOTICES
HHS. default.htm. therapy. Additionally, the antibodies
ACTION: Notice. can be used for detection of HIV–1
Dated: September 5, 2017.
infection in biological samples,
SUMMARY: The Food and Drug Anna K. Abram, including body fluids; and tissues from
Administration (FDA) is announcing the Deputy Commissioner for Policy, Planning, biopsies, autopsies, and pathology
issuance of a priority review voucher to Legislation, and Analysis. specimens.
the sponsor of a rare pediatric disease [FR Doc. 2017–19130 Filed 9–8–17; 8:45 am] VRC01 has been tested in several
product application. The Federal Food, BILLING CODE 4164–01–P phase I clinical trials for safety and
Drug, and Cosmetic Act (the FD&C Act), pharmacokinetics in infants, adults, and
VerDate Sep<11>2014 16:34 Sep 08, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1](https://thefederalregister.org/doc/82_FR_42859/page/2.svg)
Document Created: 2017-09-09 00:03:59
Document Modified: 2017-09-09 00:03:59
| 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 October 4, 2017, from 1 p.m. to 4:30 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. 6307C, 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 Web site 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 | 82 FR 42685 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR