81 FR 491 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 3 (January 6, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 3 (January 6, 2016)
| Page Range | 491-492 | |
| FR Document | 2015-33263 |
[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)] [Notices] [Pages 491-492] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-33263] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting will be held on March 4, 2016, from 8:30 a.m. to 3 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 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 Web cast and will be available at the following link https://collaboration.fda.gov/vrbpac030416/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Contact Person: Sujata Vijh or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, 240- 402-7107 or 240-402-8158, email: [email protected] or [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 http://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. Agenda: On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 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 http://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 February 19, 2016. Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:40 p.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 February 10, 2016. Time allotted for each presentation may be [[Page 492]] 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 February 11, 2016. 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 Sujata Vijh 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 http://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: December 31, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-33263 Filed 1-5-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Notices 491
The purpose of the public meeting is on a live Webcast. Registration is free AboutAdvisoryCommittees/
to report on FDA’s progress and will be on a first-come, first-served ucm408555.htm.
implementing the Action Plan, to basis. Onsite registration on the day of Contact Person: Sujata Vijh or Denise
discuss how stakeholders have been the meeting will be based on space Royster, Center for Biologics Evaluation
affected by these changes, and to solicit availability. Information on how to and Research, Food and Drug
feedback and recommendations for access the Webcast will be posted Administration, 10903 New Hampshire
further implementation from interested approximately 5 days before the meeting Ave., Bldg. 71, Rm. 6128, Silver Spring,
parties and stakeholders. at: http://www.fda.gov/ MD 20993–0002, 240–402–7107 or 240–
Some questions we would like the ForHealthProfessionals/ 402–8158, email: Sujata.vijh@
public to comment on during the LearningActivities/ucm470074.htm. fda.hhs.gov or denise.royster@
meeting include: If you need special accommodations fda.hhs.gov or FDA Advisory Committee
1. What approaches have been due to a disability, please contact Information Line, 1–800–741–8138
successful in addressing key barriers to FDASIA907@fda.hhs.gov at least 7 days (301–443–0572 in the Washington, DC
recruiting diverse clinical trial in advance. Persons attending the public area). A notice in the Federal Register
populations? meeting are advised that FDA is not about last minute modifications that
2. What are your key limitations to responsible for providing access to impact a previously announced
conducting meaningful data analysis of electrical outlets. advisory committee meeting cannot
underrepresented groups? always be published quickly enough to
Dated: December 30, 2015.
3. What have you learned about best provide timely notice. Therefore, you
practices for recruiting a broad Leslie Kux, should always check the Agency’s Web
representation of subjects for clinical Associate Commissioner for Policy. site at http://www.fda.gov/
trials? Which practices have been [FR Doc. 2015–33261 Filed 1–5–16; 8:45 am] AdvisoryCommittees/default.htm and
successful and why? Which have not BILLING CODE 4164–01–P scroll down to the appropriate advisory
and why? committee meeting link, or call the
4. What communication strategies advisory committee information line to
have you successfully used that were DEPARTMENT OF HEALTH AND learn about possible modifications
also sensitive to the needs of HUMAN SERVICES before coming to the meeting.
underrepresented populations? Agenda: On March 4, 2016, the
5. What are potential methods FDA Food and Drug Administration committee will meet in open session to
should consider using to effectively [Docket No. FDA–2015–N–0001] discuss and make recommendations on
communicate meaningful information the selection of strains to be included in
on demographic analyses to a diverse Vaccines and Related Biological the influenza virus vaccines for the
public? Products Advisory Committee; Notice 2016–2017 influenza season.
6. What are some of the actual or of Meeting FDA intends to make background
potential unintended consequences of material available to the public no later
data transparency you have encountered AGENCY: Food and Drug Administration, than 2 business days before the meeting.
related to reporting demographic HHS. If FDA is unable to post the background
subgroup analysis? ACTION: Notice. material on its Web site prior to the
Stakeholders are invited to provide meeting, the background material will
brief comments on these topics during This notice announces a forthcoming be made publicly available at the
the public comment portion of the meeting of a public advisory committee location of the advisory committee
meeting, but are not limited to of the Food and Drug Administration meeting, and the background material
discussing only the previous topics. (FDA). The meeting will be open to the will be posted on FDA’s Web site after
Since the day-long meeting may not public. the meeting. Background material is
provide enough time to fully address all Name of Committee: Vaccines and available at http://www.fda.gov/
of these issues, we encourage interested Related Biological Products Advisory AdvisoryCommittees/Calendar/
groups to submit longer explanations Committee. default.htm. Scroll down to the
and comments to the docket. General Function of the Committee: appropriate advisory committee meeting
To provide advice and link.
II. Registration and Request for Oral recommendations to the Agency on Procedure: Interested persons may
Presentations FDA’s regulatory issues. present data, information, or views,
FDA will try to accommodate all Date and Time: The meeting will be orally or in writing, on issues pending
participant requests to speak; however, held on March 4, 2016, from 8:30 a.m. before the committee. Written
the duration of comments may be to 3 p.m. submissions may be made to the contact
limited by time constraints. Those Location: FDA White Oak Campus, person on or before February 19, 2016.
wishing to make oral presentations will 10903 New Hampshire Ave., Building Oral presentations from the public will
be asked to send a brief summary of 31 Conference Center, the Great Room be scheduled between approximately
their comments and registration (Rm. 1503), Silver Spring, MD 20993– 12:40 p.m. and 1:40 p.m. Those
information (including name, title, firm 0002. For those unable to attend in individuals interested in making formal
name, address, telephone, email person, the meeting will also be Web oral presentations should notify the
address, and fax number), and should cast and will be available at the contact person and submit a brief
mstockstill on DSK4VPTVN1PROD with NOTICES
register by February 1, 2016, by following link https:// statement of the general nature of the
emailing FDASIA907@fda.hhs.gov. collaboration.fda.gov/vrbpac030416/. evidence or arguments they wish to
All other participants are asked to Answers to commonly asked questions present, the names and addresses of
register online at: http://www.fda.gov/ including information regarding special proposed participants, and an
ForHealthProfessionals/ accommodations due to a disability, indication of the approximate time
LearningActivities/ucm470074.htm by visitor parking, and transportation may requested to make their presentation on
February 13, 2016, whether they plan to be accessed at: http://www.fda.gov/ or before February 10, 2016. Time
attend in person or listen to the meeting AdvisoryCommittees/ allotted for each presentation may be
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![492 Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Notices
limited. If the number of registrants Date: January 14, 2016. Contact Person: Gerald L. McLaughlin,
requesting to speak is greater than can Time: 1:00 p.m. to 2:30 p.m. Ph.D., Scientific Review Officer, Office of
be reasonably accommodated during the Agenda: To review and evaluate grant Extramural Policy and Review, National
applications. Institute on Drug Abuse, NIH, DHHS, 6001
scheduled open public hearing session,
Place: National Institutes of Health, Executive Blvd., Room 4238, MSC 9550,
FDA may conduct a lottery to determine Neuroscience Center, 6001 Executive Bethesda, MD 20892–9550, 301–402–6626,
the speakers for the scheduled open Boulevard, Rockville, MD 20852 (Telephone gm145a@nih.gov.
public hearing session. The contact Conference Call). (Catalogue of Federal Domestic Assistance
person will notify interested persons Contact Person: Joel A. Saydoff, Ph.D., Program No.: 93.279, Drug Abuse and
regarding their request to speak by Scientific Review Officer, Scientific Review Addiction Research Programs, National
February 11, 2016. Branch, Division of Extramural Research, Institutes of Health, HHS)
Persons attending FDA’s advisory NINDS/NIH/DHHS/Neuroscience Center,
committee meetings are advised that the 6001 Executive Boulevard, Suite 3205, MSC Dated: December 31, 2015.
Agency is not responsible for providing 9529, Bethesda, MD 20892–9529, 301–435– Natasha M. Copeland,
9223, joel.saydoff@nih.gov.
access to electrical outlets. Program Analyst, Office of Federal Advisory
FDA welcomes the attendance of the This notice is being published less than 15 Committee Policy.
public at its advisory committee days prior to the meeting due to the timing [FR Doc. 2015–33252 Filed 1–5–16; 8:45 am]
meetings and will make every effort to limitations imposed by the review and
BILLING CODE 4140–01–P
accommodate persons with disabilities. funding cycle.
If you require accommodations due to a (Catalogue of Federal Domestic Assistance
disability, please contact Sujata Vijh at Program Nos. 93.853, Clinical Research DEPARTMENT OF HEALTH AND
least 7 days in advance of the meeting. Related to Neurological Disorders; 93.854, HUMAN SERVICES
FDA is committed to the orderly Biological Basis Research in the
conduct of its advisory committee Neurosciences, National Institutes of Health, National Institutes of Health
HHS)
meetings. Please visit our Web site at
http://www.fda.gov/ Dated: December 31, 2015. National Institute of Mental Health;
AdvisoryCommittees/ Melanie J. Gray, Notice of Closed Meetings
AboutAdvisoryCommittees/ Program Analyst, Office of Federal Advisory
Pursuant to section 10(d) of the
ucm111462.htm for procedures on Committee Policy.
Federal Advisory Committee Act, as
public conduct during advisory [FR Doc. 2015–33256 Filed 1–5–16; 8:45 am]
amended (5 U.S.C. App.), notice is
committee meetings. BILLING CODE 4140–01–P
hereby given of the following meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5 The meetings will be closed to the
U.S.C. app. 2). DEPARTMENT OF HEALTH AND public in accordance with the
HUMAN SERVICES provisions set forth in sections
Dated: December 31, 2015. 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Leslie Kux, as amended. The grant applications and
National Institutes of Health
Associate Commissioner for Policy. the discussions could disclose
[FR Doc. 2015–33263 Filed 1–5–16; 8:45 am] National Institute on Drug Abuse confidential trade secrets or commercial
BILLING CODE 4164–01–P Notice of Closed Meeting property such as patentable material,
and personal information concerning
Pursuant to section 10(d) of the individuals associated with the grant
DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as applications, the disclosure of which
HUMAN SERVICES amended (5 U.S.C. App), notice is would constitute a clearly unwarranted
hereby given of the following meeting. invasion of personal privacy.
National Institutes of Health The meeting will be closed to the
Name of Committee: National Institute of
public in accordance with the Mental Health Special Emphasis Panel,
National Institute of Neurological provisions set forth in sections
Disorders and Stroke; Notice of Closed Confirmatory Efficacy Clinical Trials of Non-
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Pharmacological Interventions for Mental
Meetings as amended. The contract proposals and Disorders.
Pursuant to section 10(d) of the the discussions could disclose Date: January 21, 2016.
Federal Advisory Committee Act, as confidential trade secrets or commercial Time: 12:30 p.m. to 5:00 p.m.
amended (5 U.S.C. App.), notice is property such as patentable material, Agenda: To review and evaluate grant
and personal information concerning applications.
hereby given of the following meetings.
individuals associated with the contract Place: National Institutes of Health,
The meetings will be closed to the
Neuroscience Center, 6001 Executive
public in accordance with the proposals, the disclosure of which Boulevard, Rockville, MD 20852, (Telephone
provisions set forth in sections would constitute a clearly unwarranted Conference Call).
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., invasion of personal privacy. Contact Person: Marcy Ellen Burstein,
as amended. The grant applications and Name of Committee: National Institute on Ph.D., Scientific Review Officer, Division of
the discussions could disclose Drug Abuse Special Emphasis Panel; Extramural Activities, National Institute of
confidential trade secrets or commercial Development of Primer and Reference Tool to Mental Health, NIH, Neuroscience Center,
property such as patentable material, Assess Neonatal Abstinence Syndrome 6001 Executive Blvd., Room 6143, MSC 9606,
and personal information concerning (1210). Bethesda, MD 20892–9606, 301–443–9699,
mstockstill on DSK4VPTVN1PROD with NOTICES
Date: January 15, 2016. bursteinme@mail.nih.gov.
individuals associated with the grant
applications, the disclosure of which Time: 11:00 a.m. to 2:30 p.m. Name of Committee: National Institute of
Agenda: To review and evaluate contract Mental Health Special Emphasis Panel,
would constitute a clearly unwarranted
proposals. Interventions.
invasion of personal privacy. Place: National Institutes of Health, Date: January 28, 2016.
Name of Committee: National Institute of Neuroscience Center, 6001 Executive Time: 2:00 p.m. to 3:00 p.m.
Neurological Disorders and Stroke Special Boulevard, Rockville, MD 20852, (Telephone Agenda: To review and evaluate grant
Emphasis Panel; X01’s BRAC Review. Conference Call). applications.
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Document Created: 2016-01-06 04:01:31
Document Modified: 2016-01-06 04:01:31
| 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. | |
| FR Citation | 81 FR 491 |
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