80_FR_42642 80 FR 42505 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

80 FR 42505 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 137 (July 17, 2015)

Page Range42505-42506
FR Document2015-17559

Federal Register, Volume 80 Issue 137 (Friday, July 17, 2015) 
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42505-42506]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17559]


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

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.

[[Page 42506]]

    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 September 15, 2015, from 
8:30 a.m. to 2:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 
20993. 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.
    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/cbervrbpac0915/.
    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, 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 September 15, 2015, from 8:30 a.m. to 2:30 p.m., the 
committee will meet in open session to discuss and make recommendations 
on the safety and immunogenicity of Seasonal Trivalent Influenza 
Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) 
manufactured by Novartis.
    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 
September 8, 2015. Oral presentations from the public will be scheduled 
between approximately 12:15 p.m. to 1:15 p.m. on September 15, 2015. 
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 
August 31, 2015. 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 1, 
2015.
    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 
physical disabilities or special needs. If you require special 
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: July 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17559 Filed 7-16-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices 42505 • Do your symptoms come and go? If 3. How has your ability to cope with accommodations because of a disability, so, do you know of anything that makes symptoms changed over time? please contact Graham Thompson (see your symptoms better? Worse? • Do your symptoms come and go? If FOR FURTHER INFORMATION CONTACT) at 4. How has your condition affected so, do you know of anything that makes least 7 days before the meeting. your social interactions, including your symptoms better? Worse? Patients who are interested in relationships with family and friends? 4. What worries you most about your presenting comments as part of the 5. How has your condition affected condition? initial panel discussions will be asked your mood (for example: depression, 5. How has your condition affected to indicate in their registration which apathy, patience/tolerance for your social interactions, including topic(s) they wish to address. These frustration)? relationships with family and friends? patients also must send to Topic 2: Patients’ Perspectives on Topic 2: Patients’ Perspectives on PatientFocused@fda.hhs.gov a brief Current Approaches To Treating HD Current Approaches To Treating PD summary of responses to the topic questions by September 8, 2015. 1. What are you currently doing to 1. What are you currently doing to Panelists will be notified of their help treat your condition or its help treat your condition or its selection approximately 7 days before symptoms? (Examples may include symptoms? (Examples may include the public meeting. We will try to prescription medicines, over-the- prescription medicines, over-the- accommodate all patients and patient counter products, and other therapies counter products, and other therapies stakeholders who wish to speak, either including non-drug therapies such as including non-drug therapies such as through the panel discussion or diet modification and exercise.) diet modification and exercise.) audience participation; however, the (a) What specific symptoms do your • What specific symptoms do your duration of comments may be limited by treatments address? treatments address (for example: time constraints. (b) How has your treatment regimen depression, constipation, memory changed over time, and why? difficulty, sleepiness, ability to move)? IV. Comments 2. How well does your current 2. How well does your current Regardless if you attend the public treatment regimen treat the most treatment regimen treat the most meeting, you can submit electronic or significant symptoms of your disease? significant symptoms of your disease? • How well do these treatments written responses to the questions (a) How well do these treatments pertaining to HD Topics 1 and 2 and PD improve your ability to do specific improve your ability to do specific activities that are important to you in Topics 1 and 2 to the public docket (see activities that are important to you in ADDRESSES) by November 23, 2015. your daily life? your daily life? 3. What are the most significant Received comments may be seen in the (b) How well have these treatments Division of Dockets Management worked for you as your condition has downsides to your current treatments, and how do they affect your daily life? between 9 a.m. and 4 p.m., Monday changed over time? through Friday, and will be posted to 3. What are the most significant (Examples of downsides may include bothersome side effects, need to visit the docket at http:// downsides to your current treatments, www.regulations.gov. and how do they affect your daily life? your doctor or take medications (Examples of downsides may include frequently, cause sleepiness, etc.) V. Transcripts 4. Assuming there is no complete cure bothersome side effects, interacts with As soon as a transcript is available, for your condition, what would you other medications, need to visit your FDA will post it at http://www.fda.gov/ look for in an ideal treatment for your doctor more frequently, etc.) Drugs/NewsEvents/ucm451807.htm. 4. Assuming there is no complete cure condition or a specific aspect of your for your condition, what would you condition? Dated: July 13, 2015. look for in an ideal treatment for your III. Meeting Attendance and Leslie Kux, condition or a specific aspect of your Participation Associate Commissioner for Policy. condition? If you wish to attend this meeting, [FR Doc. 2015–17556 Filed 7–16–15; 8:45 am] BILLING CODE 4164–01–P C. Parkinson’s Disease Discussion visit https://pfddhuntingtonparkinson. Questions eventbrite.com. Please register by September 14, 2015. If you are unable to DEPARTMENT OF HEALTH AND Topic 1: Disease Symptoms and Daily attend the meeting in person, you can Impacts That Matter Most to Patients HUMAN SERVICES register to view a live webcast of the 1. Of all the symptoms that you meeting. When you register, you can Food and Drug Administration experience because of your condition, indicate whether you plan to attend the which one to three symptoms have the morning session on HD, the afternoon [Docket No. FDA–2015–N–0001] most significant impact on your life? session on PD, or both. You will also be (Examples may include difficulty asked to indicate in your registration if Vaccines and Related Biological moving, pain, constipation, difficulty you plan to attend in person or via the Products Advisory Committee; Notice concentrating or remembering, daytime webcast. Seating will be limited, so of Meeting sleepiness, etc.) early registration is recommended. 2. Are there specific activities that are Registration is free and will be on a first- AGENCY: Food and Drug Administration, important to you but that you cannot do come, first-served basis. However, FDA HHS. srobinson on DSK5SPTVN1PROD with NOTICES at all or as fully as you would like may limit the number of participants ACTION: Notice. because of your condition? (Examples of from each organization based on space activities may include daily hygiene, limitations. Registrants will receive This notice announces a forthcoming feeding, dressing, etc.) confirmation once they have been meeting of a public advisory committee • How do your symptoms affect your accepted. Onsite registration on the day of the Food and Drug Administration daily life on the best days? On the worst of the meeting will be based on space (FDA). The meeting will be open to the days? availability. If you need special public. VerDate Sep<11>2014 20:59 Jul 16, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1

42506 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices Name of Committee: Vaccines and the meeting. Background material is DEPARTMENT OF HEALTH AND Related Biological Products Advisory available at http://www.fda.gov/ HUMAN SERVICES Committee. AdvisoryCommittees/Calendar/ General Function of the Committee: default.htm. Scroll down to the Health Resources and Services To provide advice and appropriate advisory committee meeting Administration recommendations to the Agency on link. FDA’s regulatory issues. Agency Information Collection Date and Time: The meeting will be Procedure: Interested persons may Activities: Proposed Collection: Public held on September 15, 2015, from 8:30 present data, information, or views, Comment Request a.m. to 2:30 p.m. orally or in writing, on issues pending before the committee. Written AGENCY: Health Resources and Services Location: FDA White Oak Campus, submissions may be made to the contact Administration, HHS. 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room person on or before September 8, 2015. ACTION: Notice. (Rm. 1503), Silver Spring, MD 20993. Oral presentations from the public will SUMMARY: In compliance with the Answers to commonly asked questions be scheduled between approximately requirement for opportunity for public including information regarding special 12:15 p.m. to 1:15 p.m. on September comment on proposed data collection accommodations due to a disability, 15, 2015. Those individuals interested projects (Section 3506(c)(2)(A) of the visitor parking, and transportation may in making formal oral presentations Paperwork Reduction Act of 1995), the be accessed at: http://www.fda.gov/ should notify the contact person and Health Resources and Services AdvisoryCommittees/ submit a brief statement of the general Administration (HRSA) announces AboutAdvisoryCommittees/ nature of the evidence or arguments plans to submit an Information ucm408555.htm. they wish to present, the names and Collection Request (ICR), described For those unable to attend in person, addresses of proposed participants, and below, to the Office of Management and the meeting will also be webcast and an indication of the approximate time Budget (OMB). Prior to submitting the will be available at the following link requested to make their presentation on ICR to OMB, HRSA seeks comments https://collaboration.fda.gov/ or before August 31, 2015. Time allotted from the public regarding the burden cbervrbpac0915/. Contact Person: Sujata Vijh or Denise for each presentation may be limited. If estimate, below, or any other aspect of Royster, Center for Biologics Evaluation the number of registrants requesting to the ICR. and Research, Food and Drug speak is greater than can be reasonably DATES: Comments on this Information Administration, 10903 New Hampshire accommodated during the scheduled Collection Request must be received no Ave., Bldg. 71, Rm. 6128, Silver Spring, open public hearing session, FDA may later than September 15, 2015. MD 20993–0002, 240–402–7107 or 240– conduct a lottery to determine the ADDRESSES: Submit your comments to 402–8158, or FDA Advisory Committee speakers for the scheduled open public paperwork@hrsa.gov or mail the HRSA Information Line, 1–800–741–8138 hearing session. The contact person will Information Collection Clearance (301–443–0572 in the Washington, DC notify interested persons regarding their Officer, Room 10C–03, Parklawn area). A notice in the Federal Register request to speak by September 1, 2015. Building, 5600 Fishers Lane, Rockville, about last minute modifications that Persons attending FDA’s advisory MD 20857. impact a previously announced committee meetings are advised that the FOR FURTHER INFORMATION CONTACT: To advisory committee meeting cannot Agency is not responsible for providing request more information on the always be published quickly enough to access to electrical outlets. proposed project or to obtain a copy of provide timely notice. Therefore, you the data collection plans and draft should always check the Agency’s Web FDA welcomes the attendance of the instruments, email paperwork@hrsa.gov site at http://www.fda.gov/ public at its advisory committee or call the HRSA Information Collection AdvisoryCommittees/default.htm and meetings and will make every effort to Clearance Officer at (301) 443–1984. scroll down to the appropriate advisory accommodate persons with physical SUPPLEMENTARY INFORMATION: When committee meeting link, or call the disabilities or special needs. If you submitting comments or requesting advisory committee information line to require special accommodations due to information, please include the learn about possible modifications a disability, please contact Sujata Vijh at information request collection title for before coming to the meeting. least 7 days in advance of the meeting. reference. Agenda: On September 15, 2015, from FDA is committed to the orderly Information Collection Request Title: 8:30 a.m. to 2:30 p.m., the committee conduct of its advisory committee Bureau of Health Workforce (BHW) will meet in open session to discuss and meetings. Please visit our Web site at Uniform Data System (UDS). make recommendations on the safety http://www.fda.gov/ OMB No. 0915–XXXX—NEW. and immunogenicity of Seasonal Abstract: The UDS is the Bureau of AdvisoryCommittees/ Trivalent Influenza Vaccine, Surface Primary Health Care’s (BPHC’s) annual AboutAdvisoryCommittees/ Antigen, Inactivated, Adjuvanted with reporting system for HRSA-supported ucm111462.htm for procedures on MF59 (FLUAD) manufactured by health centers. The UDS is a program public conduct during advisory performance reporting system that Novartis. FDA intends to make background committee meetings. tracks a variety of information, material available to the public no later Notice of this meeting is given under including patient demographics, than 2 business days before the meeting. the Federal Advisory Committee Act (5 services provided, staffing, clinical srobinson on DSK5SPTVN1PROD with NOTICES If FDA is unable to post the background U.S.C. app. 2). indicators, utilization rates, costs, and material on its Web site prior to the Dated: July 10, 2015. revenues. BHW proposes that HRSA meeting, the background material will Nurse Managed Health Clinic (NMHC) Leslie Kux, be made publicly available at the grantees and Interprofessional location of the advisory committee Associate Commissioner for Policy. Collaborative Practice (IPCP) program meeting, and the background material [FR Doc. 2015–17559 Filed 7–16–15; 8:45 am] cooperative agreement awardees also will be posted on FDA’s Web site after BILLING CODE 4164–01–P submit data into the UDS. VerDate Sep<11>2014 20:59 Jul 16, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1


Document Created: 2018-02-23 09:20:58
Document Modified: 2018-02-23 09:20:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation80 FR 42505 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR