81_FR_14167 81 FR 14116 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

81 FR 14116 - 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 51 (March 16, 2016)

Page Range14116-14117
FR Document2016-05930

Federal Register, Volume 81 Issue 51 (Wednesday, March 16, 2016) 
[Federal Register Volume 81, Number 51 (Wednesday, March 16, 2016)]
[Notices]
[Pages 14116-14117]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed 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 May 11, 2016, from 1 
p.m. to 4:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 
20993-0002. 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 https://collaboration.fda.gov/vrbpac0516/.
    Contact Person: Sujata Vijh or Rosanna Harvey, 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, [email protected], or 240-402-8072, 
[email protected] respectively, 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 May 11, 2016, the committee will participate via 
teleconference. In open session, the committee will hear updates of the 
research program in the Laboratory of Bacterial Polysaccharides, 
Division of Bacterial, Parasitic, and Allergenic Products, Center for 
Biologics Evaluation and Research, 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 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: On May 11, 2016, from 1 p.m. to 3:25 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 3, 2016. Oral presentations from the public will be 
scheduled between approximately 2:25 p.m. and 3:25 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 
April 25, 2016. 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

[[Page 14117]]

notify interested persons regarding their request to speak by April 26, 
2016.
    Closed Committee Deliberations: On May 11, 2016, from 3:25 p.m. to 
4:30 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 committee will discuss the report of 
the intramural research program and make recommendations regarding 
personnel staffing decisions.
    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: March 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05930 Filed 3-15-16; 8:45 am]
BILLING CODE 4164-01-P

14116 Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices Inc., proposed for the treatment of Notice of this meeting is given under Federal Register about last minute adults with type 2 diabetes mellitus. the Federal Advisory Committee Act modifications that impact a previously FDA intends to make background (5 U.S.C. app. 2). announced advisory committee meeting material available to the public no later Dated: March 11, 2016. cannot always be published quickly than 2 business days before the meeting. Jill Hartzler Warner, enough to provide timely notice. If FDA is unable to post the background Associate Commissioner for Special Medical Therefore, you should always check the material on its Web site prior to the Programs. Agency’s Web site at http:// meeting, the background material will [FR Doc. 2016–05931 Filed 3–15–16; 8:45 am] www.fda.gov/AdvisoryCommittees/ be made publicly available at the default.htm and scroll down to the BILLING CODE 4164–01–P location of the advisory committee appropriate advisory committee meeting meeting, and the background material link, or call the advisory committee will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND information line to learn about possible the meeting. Background material is HUMAN SERVICES modifications before coming to the available at http://www.fda.gov/ meeting. AdvisoryCommittees/Calendar/ Food and Drug Administration Agenda: On May 11, 2016, the default.htm. Scroll down to the committee will participate via [Docket No. FDA–2016–N–0001] appropriate advisory committee meeting teleconference. In open session, the link. Vaccines and Related Biological committee will hear updates of the Procedure: Interested persons may Products Advisory Committee; Notice research program in the Laboratory of present data, information, or views, of Meeting Bacterial Polysaccharides, Division of orally or in writing, on issues pending Bacterial, Parasitic, and Allergenic AGENCY: Food and Drug Administration, Products, Center for Biologics before the committee. Written HHS. submissions may be made to the contact Evaluation and Research, FDA. ACTION: Notice. FDA intends to make background person on or before May 10, 2016. Oral presentations from the public will be material available to the public no later This notice announces a forthcoming scheduled between approximately 1 than 2 business days before the meeting. meeting of a public advisory committee p.m. and 2 p.m. Those individuals If FDA is unable to post the background of the Food and Drug Administration interested in making formal oral material on its Web site prior to the (FDA). At least one portion of the presentations should notify the contact meeting, the background material will meeting will be closed to the public. person and submit a brief statement of Name of Committee: Vaccines and be made publicly available at the the general nature of the evidence or Related Biological Products Advisory location of the advisory committee arguments they wish to present, the Committee. meeting, and the background material names and addresses of proposed General Function of the Committee: will be posted on FDA’s Web site after participants, and an indication of the To provide advice and the meeting. Background material is approximate time requested to make recommendations to the Agency on available at http://www.fda.gov/ their presentation on or before May 2, FDA’s regulatory issues. AdvisoryCommittees/Calendar/ 2016. Time allotted for each Date and Time: The meeting will be default.htm. Scroll down to the presentation may be limited. If the held on May 11, 2016, from 1 p.m. to appropriate advisory committee meeting number of registrants requesting to 4:30 p.m. link. speak is greater than can be reasonably Location: FDA White Oak Campus, Procedure: On May 11, 2016, from 1 accommodated during the scheduled 10903 New Hampshire Ave., Building p.m. to 3:25 p.m., the meeting is open open public hearing session, FDA may 31 Conference Center, the Great Room to the public. Interested persons may conduct a lottery to determine the (Rm. 1503), Silver Spring, MD 20993– present data, information, or views, speakers for the scheduled open public 0002. Answers to commonly asked orally or in writing, on issues pending hearing session. The contact person will questions including information before the committee. Written notify interested persons regarding their regarding special accommodations due submissions may be made to the contact request to speak by May 3, 2016. to a disability, visitor parking, and person on or before May 3, 2016. Oral transportation may be accessed at: presentations from the public will be Persons attending FDA’s advisory http://www.fda.gov/ scheduled between approximately 2:25 committee meetings are advised that the AdvisoryCommittees/ p.m. and 3:25 p.m. Those individuals Agency is not responsible for providing AboutAdvisoryCommittees/ interested in making formal oral access to electrical outlets. ucm408555.htm. For those unable to presentations should notify the contact FDA welcomes the attendance of the attend in person, the meeting will also person and submit a brief statement of public at its advisory committee be Webcast and will be available at the general nature of the evidence or meetings and will make every effort to https://collaboration.fda.gov/ arguments they wish to present, the accommodate persons with disabilities. vrbpac0516/. names and addresses of proposed If you require accommodations due to a Contact Person: Sujata Vijh or participants, and an indication of the disability, please contact LaToya Bonner Rosanna Harvey, Center for Biologics approximate time requested to make at least 7 days in advance of the Evaluation and Research, Food and their presentation on or before April 25, meeting. Drug Administration, 10903 New 2016. Time allotted for each mstockstill on DSK4VPTVN1PROD with NOTICES FDA is committed to the orderly Hampshire Ave., Bldg. 71, Rm. 6128, presentation may be limited. If the conduct of its advisory committee Silver Spring, MD 20993–0002, 240– number of registrants requesting to meetings. Please visit our Web site at 402–7107, sujata.vijh@fda.hhs.gov, or speak is greater than can be reasonably http://www.fda.gov/Advisory 240–402–8072, rosanna.harvey@ accommodated during the scheduled Committees/AboutAdvisoryCommittees/ fda.hhs.gov respectively, or FDA open public hearing session, FDA may ucm111462.htm for procedures on Advisory Committee Information Line, conduct a lottery to determine the public conduct during advisory 1–800–741–8138 (301–443–0572 in the speakers for the scheduled open public committee meetings. Washington, DC area). A notice in the hearing session. The contact person will VerDate Sep<11>2014 18:11 Mar 15, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1

Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices 14117 notify interested persons regarding their of the Department of Health and Human Services Administration, 5600 Fishers request to speak by April 26, 2016. Services (the Secretary) on a range of Lane, Room 15N39, Rockville, Maryland Closed Committee Deliberations: On issues including the supply and 20857; (2) call (301) 443–0430; or (3) May 11, 2016, from 3:25 p.m. to 4:30 distribution of physicians in the United send an email to jweiss@hrsa.gov. p.m., the meeting will be closed to States, current and future physician Jackie Painter, permit discussion where disclosure shortages or excesses, issues relating to would constitute a clearly unwarranted foreign medical school graduates, the Director, Division of the Executive Secretariat. invasion of personal privacy (5 U.S.C. nature and financing of medical [FR Doc. 2016–05877 Filed 3–15–16; 8:45 am] 552b(c)(6)). The committee will discuss education training, and the BILLING CODE 4165–15–P the report of the intramural research development of performance measures program and make recommendations and longitudinal evaluation of medical regarding personnel staffing decisions. education programs. COGME’s reports DEPARTMENT OF HEALTH AND Persons attending FDA’s advisory are submitted to the Secretary and HUMAN SERVICES committee meetings are advised that the ranking members of the Senate National Institutes of Health Agency is not responsible for providing Committee on Health, Education, Labor, access to electrical outlets. and Pensions and the House of Center for Scientific Review; Notice of FDA welcomes the attendance of the Representatives Committee on Energy Closed Meetings public at its advisory committee and Commerce. meetings and will make every effort to COGME will start its official meeting Pursuant to section 10(d) of the accommodate persons with disabilities. at 8:30 a.m. each day. Discussion will Federal Advisory Committee Act, as If you require accommodations due to a focus on finalizing the draft of COGME’s amended (5 U.S.C. App.), notice is disability, please contact Sujata Vijh at Diversity Resource Paper and the hereby given of the following meetings. least 7 days in advance of the meeting. development of a vision, mission, and The meetings will be closed to the FDA is committed to the orderly guiding principles for graduate medical public in accordance with the conduct of its advisory committee education. provisions set forth in sections meetings. Please visit our Web site at Agenda: The COGME agenda will be 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., http://www.fda.gov/ available 2 days prior to the meeting on as amended. The grant applications and AdvisoryCommittees/ the HRSA Web site at http:// the discussions could disclose AboutAdvisoryCommittees/ www.hrsa.gov/advisorycommittees/ confidential trade secrets or commercial ucm111462.htm for procedures on bhpradvisory/cogme/index.html. property such as patentable material, public conduct during advisory SUPPLEMENTARY INFORMATION: Requests and personal information concerning committee meetings. to make oral comments or provide individuals associated with the grant Notice of this meeting is given under written comments to the COGME should applications, the disclosure of which the Federal Advisory Committee Act (5 be sent to Dr. Joan Weiss, Designated would constitute a clearly unwarranted U.S.C. app. 2). Federal Official, using the address and invasion of personal privacy. Dated: March 11, 2016. phone number below. Individuals who Name of Committee: Center for Scientific Jill Hartzler Warner, plan to participate on the conference Review Special Emphasis Panel; Integrated Associate Commissioner for Special Medical call and webinar should notify Dr. Physiology of Obesity. Programs. Weiss at least 3 days prior to the Date: March 30, 2016. [FR Doc. 2016–05930 Filed 3–15–16; 8:45 am] meeting, using the address and phone Time: 12:00 p.m. to 1:00 p.m. number below. Individuals who plan to Agenda: To review and evaluate grant BILLING CODE 4164–01–P attend and need special assistance, such applications. Place: National Institutes of Health, 6701 as sign language interpretation or other Rockledge Drive, Bethesda, MD 20892 DEPARTMENT OF HEALTH AND reasonable accommodations, should (Telephone Conference Call). HUMAN SERVICES notify the contact person listed below at Contact Person: Raul Rojas, Ph.D., least 10 days prior to the meeting. Scientific Review Officer, Center for Health Resources and Service Members of the public will have the Scientific Review, 6701 Rockledge Drive Administration opportunity to provide comments. Room 6185, Bethesda, MD 20892, (301) 451– Interested parties should refer to the 6319, rojasr@mail.nih.gov. Council on Graduate Medical meeting subject as the HRSA Council on Name of Committee: Center for Scientific Education; Notice of Meeting Graduate Medical Education. Review Special Emphasis Panel; Urological In accordance with section 10(a)(2) of • The conference call-in number is 1– Applications. 800–619–2521. The passcode is Date: April 1, 2016. the Federal Advisory Committee Act Time: 2:00 p.m. to 4:00 p.m. (Public Law 92–463), notice is hereby 9271697. Agenda: To review and evaluate grant given of the following meeting: • The webinar link is https:// applications. Name: Council on Graduate Medical hrsa.connectsolutions.com/cogme- Place: National Institutes of Health, 6701 Education (COGME). council/. Rockledge Drive, Bethesda, MD 20892 Dates and Times: April 7, 2016 (Day FOR FURTHER INFORMATION CONTACT: (Telephone Conference Call). 1—8:30 a.m.–5:00 p.m., EST). April 8, Anyone requesting information Contact Person: Ryan G. Morris, Ph.D., regarding the COGME should contact Scientific Review Officer, Center for 2016 (Day 2—8:30 a.m.–3:00 p.m., EST). Scientific Review, National Institutes of mstockstill on DSK4VPTVN1PROD with NOTICES Place: In-Person Meeting with Dr. Joan Weiss, Designated Federal Health, 6701 Rockledge Drive, Room 4205, Webinar/Conference Call Component, Official within the Bureau of Health MSC 7814, Bethesda, MD 20892, 301–435– 5600 Fishers Lane, Room 5A02, Workforce, Health Resources and 1501, morrisr@csr.nih.gov. Rockville, MD 20857. Services Administration, in one of three Name of Committee: Center for Scientific Status: The meeting will be open to ways: (1) Send a request to the following Review Special Emphasis Panel; Pediatric the public. address: Dr. Joan Weiss, Designated AIDS. Purpose: The COGME provides advice Federal Official, Bureau of Health Date: April 1, 2016. and recommendations to the Secretary Workforce, Health Resources and Time: 12:30 p.m. to 2:30 p.m. VerDate Sep<11>2014 18:11 Mar 15, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1


Document Created: 2016-03-15 23:44:13
Document Modified: 2016-03-15 23:44:13
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 Citation81 FR 14116 
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