80 FR 57005 - 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 182 (September 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 182 (September 21, 2015)
| Page Range | 57005-57006 | |
| FR Document | 2015-23550 |
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)] [Notices] [Pages 57005-57006] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23550] ----------------------------------------------------------------------- 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 November 13, 2015, from 8:45 a.m. to 4 p.m. Location: 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/vrbpac1115/. 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, 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 November 13, 2015, the committee will meet in open session to discuss considerations for evaluation of the safety and effectiveness of vaccines administered to pregnant women to protect the infant. 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 October 29, 2015. Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 11:45 a.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 [[Page 57006]] requested to make their presentation on or before October 21, 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 October 22, 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 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: September 15, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-23550 Filed 9-18-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices 57005
benefit-risk determinations, device business and/or home address, asked questions including information
labeling, unmet clinical needs, available telephone number, and email address if regarding special accommodations due
alternatives, patient reported outcomes available. Nominations should specify to a disability, visitor parking, and
and device-related quality of life or the advisory committee for which the transportation may be accessed at:
health status issues are among the topics nominee is recommended within 30 http://www.fda.gov/
that may be considered by the days of publication of this document AdvisoryCommittees/
Committee. Members are knowledgeable (see DATES). In addition, nominations AboutAdvisoryCommittees/
in areas such as clinical research, should also acknowledge that the ucm408555.htm.
primary care patient experience, health nominee is aware of the nomination, Contact Person: Sujata Vijh or Denise
care needs of patient groups in the unless self-nominated. FDA will Royster, Center for Biologics Evaluation
United States, or are experienced in the forward all nominations to the and Research, Food and Drug
work of patient and health professional organizations expressing interest in Administration, 10903 New Hampshire
organizations, methodologies for participating in the selection process for Ave., Bldg. 71, Rm. 6128, Silver Spring,
eliciting patient preferences, and the Committee. Only interested industry MD 20993–0002, 240–402–7107 or 240–
strategies for communicating benefits, organizations participate in the 402–8158, or FDA Advisory Committee
risks and clinical outcomes to patients selection process. Persons who Information Line, 1–800–741–8138
and research subjects. The nominate themselves as nonvoting (301–443–0572 in the Washington, DC
Commissioner of Food and Drugs (the industry representatives will not area). A notice in the Federal Register
Commissioner), or designee, shall have participate in the selection process. about last minute modifications that
the authority to select from a group of This notice is issued under the impact a previously announced
individuals nominated by industry to Federal Advisory Committee Act (5 advisory committee meeting cannot
serve temporarily as nonvoting members U.S.C. app. 2) and 21 CFR part 14, always be published quickly enough to
who are identified with industry relating to advisory committees. provide timely notice. Therefore, you
interests. The number of temporary should always check the Agency’s Web
Dated: September 15, 2015.
members selected for a particular site at http://www.fda.gov/
Jill Hartzler Warner, AdvisoryCommittees/default.htm and
meeting will depend on the meeting
topic(s). Associate Commissioner for Special Medical scroll down to the appropriate advisory
Programs. committee meeting link, or call the
II. Selection Procedure [FR Doc. 2015–23522 Filed 9–18–15; 8:45 am] advisory committee information line to
Any industry organization interested BILLING CODE 4164–01–P learn about possible modifications
in participating in the selection of an before coming to the meeting.
appropriate nonvoting member to Agenda: On November 13, 2015, the
represent industry interest must send a DEPARTMENT OF HEALTH AND committee will meet in open session to
letter stating that interest to the FDA HUMAN SERVICES discuss considerations for evaluation of
contact (see FOR FURTHER INFORMATION the safety and effectiveness of vaccines
CONTACT) within 30 days of publication
Food and Drug Administration
administered to pregnant women to
of this document (see DATES). Within the [Docket No. FDA–2015–N–0001] protect the infant. FDA intends to make
subsequent 30 days, FDA will send a background material available to the
letter to each organization that has Vaccines and Related Biological public no later than 2 business days
expressed an interest, attaching a Products Advisory Committee; Notice before the meeting. If FDA is unable to
complete list of all such organizations; of Meeting post the background material on its Web
and a list of all nominees along with AGENCY: Food and Drug Administration, site prior to the meeting, the background
their current resumes. The letter will HHS. material will be made publicly available
also state that it is the responsibility of at the location of the advisory
ACTION: Notice.
the interested organizations to confer committee meeting, and the background
with one another and to select a This notice announces a forthcoming material will be posted on FDA’s Web
candidate or candidates (to serve in a meeting of a public advisory committee site after the meeting. Background
pool of individuals, with varying areas of the Food and Drug Administration material is available at http://
of expertise), to represent industry (FDA). The meeting will be open to the www.fda.gov/AdvisoryCommittees/
interest for the Committee, within 60 public. Calendar/default.htm. Scroll down to
days after the receipt of the FDA letter. Name of Committee: Vaccines and the appropriate advisory committee
The interested organizations are not Related Biological Products Advisory meeting link.
bound by the list of nominees in Committee. Procedure: Interested persons may
selecting a candidate or candidates. General Function of the Committee: present data, information, or views,
However, if no individual is selected To provide advice and orally or in writing, on issues pending
within 60 days, the Commissioner will recommendations to the Agency on before the committee. Written
select temporary nonvoting members (or FDA’s regulatory issues. submissions may be made to the contact
pool of individuals) to represent Date and Time: The meeting will be person on or before October 29, 2015.
industry interests. held on November 13, 2015, from 8:45 Oral presentations from the public will
a.m. to 4 p.m. be scheduled between approximately
III. Nomination Procedure Location: FDA White Oak Campus, 10:45 a.m. to 11:45 a.m. Those
Individuals may self nominate and/or 10903 New Hampshire Ave., Bldg. 31 individuals interested in making formal
rmajette on DSK7SPTVN1PROD with NOTICES
an organization may nominate one or Conference Center, the Great Room (Rm. oral presentations should notify the
more individuals to serve as a 1503), Silver Spring, MD, 20993–0002. contact person and submit a brief
temporary nonvoting industry For those unable to attend in person, the statement of the general nature of the
representative. Nominations should meeting will also be Webcast and will evidence or arguments they wish to
include a cover letter and a current, be available at the following link present, the names and addresses of
complete resume or curriculum vitae for https://collaboration.fda.gov/ proposed participants, and an
each nominee, including a current vrbpac1115/. Answers to commonly indication of the approximate time
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![57006 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
requested to make their presentation on Date and Time: The meeting will be before the committee. Written
or before October 21, 2015. Time held on December 9, 2015, from 8 a.m. submissions may be made to the contact
allotted for each presentation may be to 5 p.m. person on or before November 24, 2015.
limited. If the number of registrants Location: FDA White Oak Campus, Oral presentations from the public will
requesting to speak is greater than can 10903 New Hampshire Ave., Bldg. 31 be scheduled between approximately 1
be reasonably accommodated during the Conference Center, the Great Room (Rm. p.m. and 2 p.m. Those individuals
scheduled open public hearing session, 1503), Silver Spring, MD 20993–0002. interested in making formal oral
FDA may conduct a lottery to determine Answers to commonly asked questions presentations should notify the contact
the speakers for the scheduled open including information regarding special
person and submit a brief statement of
public hearing session. The contact accommodations due to a disability,
the general nature of the evidence or
person will notify interested persons visitor parking, and transportation may
be accessed at: http://www.fda.gov/ arguments they wish to present, the
regarding their request to speak by names and addresses of proposed
October 22, 2015. AdvisoryCommittees/
AboutAdvisoryCommittees/ participants, and an indication of the
Persons attending FDA’s advisory
ucm408555.htm. approximate time requested to make
committee meetings are advised that the
Agency is not responsible for providing Contact Person: Cindy Hong, Center their presentation on or before
access to electrical outlets. for Drug Evaluation and Research, Food November 16, 2015. Time allotted for
FDA welcomes the attendance of the and Drug Administration, 10903 New each presentation may be limited. If the
public at its advisory committee Hampshire Ave., Bldg. 31, Rm. 2417, number of registrants requesting to
meetings and will make every effort to Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably
accommodate persons with disabilities. 796–9001, FAX: 301–847–8533, accommodated during the scheduled
If you require accommodations due to a PADAC@fda.hhs.gov, or FDA Advisory open public hearing session, FDA may
disability, please contact Sujata Vijh at Committee Information Line, 1–800– conduct a lottery to determine the
least 7 days in advance of the meeting. 741–8138 (301–443–0572 in the speakers for the scheduled open public
FDA is committed to the orderly Washington, DC area). A notice in the hearing session. The contact person will
conduct of its advisory committee Federal Register about last minute notify interested persons regarding their
meetings. Please visit our Web site at modifications that impact a previously request to speak by November 17, 2015.
http://www.fda.gov/ announced advisory committee meeting
cannot always be published quickly Persons attending FDA’s advisory
AdvisoryCommittees/ committee meetings are advised that the
AboutAdvisoryCommittees/ enough to provide timely notice.
Therefore, you should always check the Agency is not responsible for providing
ucm111462.htm for procedures on access to electrical outlets.
public conduct during advisory Agency’s Web site at http://
www.fda.gov/AdvisoryCommittees/ FDA welcomes the attendance of the
committee meetings.
default.htm and scroll down to the public at its advisory committee
Notice of this meeting is given under
appropriate advisory committee meeting meetings and will make every effort to
the Federal Advisory Committee Act (5
link, or call the advisory committee accommodate persons with disabilities.
U.S.C. app. 2).
information line to learn about possible If you require accommodations due to a
Dated: September 15, 2015. modifications before coming to the
Jill Hartzler Warner,
disability, please contact Cindy Hong at
meeting.
Agenda: The committee will discuss least 7 days in advance of the meeting.
Associate Commissioner for Special Medical
Programs. biologics license application 761033, FDA is committed to the orderly
[FR Doc. 2015–23550 Filed 9–18–15; 8:45 am] reslizumab for injection, submitted by conduct of its advisory committee
BILLING CODE 4164–01–P Teva Pharmaceutical Industries, Ltd., meetings. Please visit our Web site at
for the proposed indication to reduce http://www.fda.gov/
exacerbations, relieve symptoms, and AdvisoryCommittees/
DEPARTMENT OF HEALTH AND improve lung function in adults and AboutAdvisoryCommittees/
HUMAN SERVICES adolescents 12 years of age and above, ucm111462.htm for procedures on
with asthma and elevated blood public conduct during advisory
Food and Drug Administration eosinophils, who are inadequately committee meetings.
controlled on inhaled corticosteroids.
[Docket No. FDA–2015–N–0001] Notice of this meeting is given under
FDA intends to make background
material available to the public no later the Federal Advisory Committee Act (5
Pulmonary-Allergy Drugs Advisory U.S.C. app. 2).
Committee; Notice of Meeting than 2 business days before the meeting.
If FDA is unable to post the background Dated: September 15, 2015.
AGENCY: Food and Drug Administration, material on its Web site prior to the Jill Hartzler Warner,
HHS. meeting, the background material will
Associate Commissioner for Special Medical
ACTION: Notice. be made publicly available at the Programs.
location of the advisory committee
[FR Doc. 2015–23556 Filed 9–18–15; 8:45 am]
This notice announces a forthcoming meeting, and the background material
meeting of a public advisory committee will be posted on FDA’s Web site after BILLING CODE 4164–01–P
of the Food and Drug Administration the meeting. Background material is
(FDA). The meeting will be open to the available at http://www.fda.gov/
rmajette on DSK7SPTVN1PROD with NOTICES
public. AdvisoryCommittees/Calendar/
Name of Committee: Pulmonary- default.htm. Scroll down to the
Allergy Drugs Advisory Committee. appropriate advisory committee meeting
General Function of the Committee: link.
To provide advice and Procedure: Interested persons may
recommendations to the Agency on present data, information, or views,
FDA’s regulatory issues. orally or in writing, on issues pending
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Document Created: 2015-12-15 09:39:22
Document Modified: 2015-12-15 09:39:22
| 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 | 80 FR 57005 |
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