80 FR 26929 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 90 (May 11, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 90 (May 11, 2015)
| Page Range | 26929-26930 | |
| FR Document | 2015-11257 |
[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)] [Notices] [Pages 26929-26930] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11257] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Pulmonary-Allergy Drugs 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: Pulmonary-Allergy Drugs 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 June 11, 2015, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. 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: Kristina Toliver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847- 8533, email: [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: The committee will discuss biologics license application (BLA) 125526, for mepolizumab for injection, submitted by GlaxoSmithKline for the proposed indication of add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma identified by blood eosinophils greater than or equal to 150 cells/microliter at initiation of treatment or blood eosinophils greater than or equal to 300 cells/microliter in the past 12 months. 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 May 28, 2015. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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 May 19, 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 [[Page 26930]] 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 May 20, 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 Kristina Toliver 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: May 5, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-11257 Filed 5-8-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices 26929
I. CBER Vaccines and Related nonvoting industry representatives will 741–8138 (301–443–0572 in the
Biological Products Advisory not participate in the selection process). Washington, DC area). A notice in the
Committee FDA seeks to include the views of Federal Register about last minute
women, and men, members of all racial modifications that impact a previously
The CBER Vaccines and Related and ethnic groups, and individuals with announced advisory committee meeting
Biological Products Advisory and without disabilities on its advisory cannot always be published quickly
Committee (the Committee) reviews and committees and, therefore encourages enough to provide timely notice.
evaluates data concerning the safety, nominations of appropriately qualified Therefore, you should always check the
effectiveness, and appropriate use of candidates from these groups. Agency’s Web site at http://
vaccines and related biological products This notice is issued under the www.fda.gov/AdvisoryCommittees/
which are intended for use in the Federal Advisory Committee Act (5 default.htm and scroll down to the
prevention, treatment, or diagnosis of U.S.C. app. 2) and 21 CFR part 14, appropriate advisory committee meeting
human diseases, and, as required, any relating to advisory committees. link, or call the advisory committee
other product for which FDA has Dated: May 5, 2015. information line to learn about possible
regulatory responsibility. The modifications before coming to the
Jill Hartzler Warner,
Committee also considers the quality meeting.
and relevance of FDA’s research Associate Commissioner for Special Medical
Agenda: The committee will discuss
Programs.
program which provides scientific biologics license application (BLA)
[FR Doc. 2015–11258 Filed 5–8–15; 8:45 am]
support for the regulation of these 125526, for mepolizumab for injection,
products and makes appropriate BILLING CODE 4164–01–P submitted by GlaxoSmithKline for the
recommendations to the Commissioner proposed indication of add-on
of Food and Drugs. maintenance treatment in patients 12
DEPARTMENT OF HEALTH AND years and older with severe eosinophilic
II. Selection Procedure HUMAN SERVICES asthma identified by blood eosinophils
Any industry organization interested Food and Drug Administration greater than or equal to 150 cells/
in participating in the selection of an microliter at initiation of treatment or
[Docket No. FDA–2015–N–0001] blood eosinophils greater than or equal
appropriate nonvoting member to
represent industry interests should send to 300 cells/microliter in the past 12
Pulmonary-Allergy Drugs Advisory months.
a letter stating that interest to the FDA Committee; Notice of Meeting
contact (see FOR FURTHER INFORMATION FDA intends to make background
CONTACT) within 30 days of publication AGENCY: Food and Drug Administration, material available to the public no later
(see DATES). Within the subsequent 30 HHS. than 2 business days before the meeting.
days, FDA will send a letter to each ACTION: Notice. If FDA is unable to post the background
organization that has expressed an material on its Web site prior to the
interest, attaching a complete list of all This notice announces a forthcoming meeting, the background material will
meeting of a public advisory committee be made publicly available at the
such organizations; and a list of all
of the Food and Drug Administration location of the advisory committee
nominees along with their current
(FDA). The meeting will be open to the meeting, and the background material
resumes. The letter will also state that
public. will be posted on FDA’s Web site after
it is the responsibility of the interested
Name of Committee: Pulmonary- the meeting. Background material is
organizations to confer with one another
Allergy Drugs Advisory Committee. available at http://www.fda.gov/
and to select a candidate, within 60
General Function of the Committee: AdvisoryCommittees/Calendar/
days after the receipt of the FDA letter,
To provide advice and default.htm. Scroll down to the
to serve as the nonvoting member to
recommendations to the Agency on appropriate advisory committee meeting
represent industry interests for the
FDA’s regulatory issues. link.
committee. The interested organizations Date and Time: The meeting will be Procedure: Interested persons may
are not bound by the list of nominees in held on June 11, 2015, from 8 a.m. to 5 present data, information, or views,
selecting a candidate. However, if no p.m. orally or in writing, on issues pending
individual is selected within 60 days, Location: Hilton Washington DC before the committee. Written
the Commissioner will select the North/Gaithersburg, Grand Ballroom, submissions may be made to the contact
nonvoting member to represent industry 620 Perry Pkwy., Gaithersburg, MD person on or before May 28, 2015. Oral
interests. 20877. Answers to commonly asked presentations from the public will be
III. Application Procedure questions including information scheduled between approximately 1
regarding special accommodations due p.m. and 2 p.m. Those individuals
Individuals may self-nominate and/or to a disability, visitor parking, and interested in making formal oral
an organization may nominate one or transportation may be accessed at: presentations should notify the contact
more individuals to serve as a nonvoting http://www.fda.gov/ person and submit a brief statement of
industry representative. Contact AdvisoryCommittees/ the general nature of the evidence or
information, a current curriculum vitae, AboutAdvisoryCommittees/ arguments they wish to present, the
and the name of the committee of ucm408555.htm. names and addresses of proposed
interest should be sent to the FDA Contact Person: Kristina Toliver, participants, and an indication of the
Advisory Committee Membership Center for Drug Evaluation and approximate time requested to make
tkelley on DSK3SPTVN1PROD with NOTICES
Nomination Portal (see ADDRESSES) Research, Food and Drug their presentation on or before May 19,
within 30 days of publication (see Administration, 10903 New Hampshire 2015. Time allotted for each
DATES). FDA will forward all Ave., Bldg. 31, Rm. 2417, Silver Spring, presentation may be limited. If the
nominations to the organizations MD 20993–0002, 301–796–9001, FAX: number of registrants requesting to
expressing interest in participating in 301–847–8533, email: speak is greater than can be reasonably
the selection process for the committee. PADAC@fda.hhs.gov, or FDA Advisory accommodated during the scheduled
(Persons who nominate themselves as Committee Information Line, 1–800– open public hearing session, FDA may
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![26930 Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices
conduct a lottery to determine the Institutes of Health (NIH) has submitted instruments must be requested in
speakers for the scheduled open public to the Office of Management and Budget writing.
hearing session. The contact person will (OMB) a request for review and Proposed Collection: National
notify interested persons regarding their approval of the information collection Institute of Health Neurobiobank Tissue
request to speak by May 20, 2015. listed below. This proposed information Access Request—Existing without OMB
Persons attending FDA’s advisory collection was previously published in Clearance—National Institute of Mental
committee meetings are advised that the the Federal Register on February 13, Health (NIMH), National Institute of
Agency is not responsible for providing 2015, page 8723 and allowed 60-days Health (NIH).
access to electrical outlets. for public comment. No public
FDA welcomes the attendance of the comments were received. The purpose Need and Use of Information
public at its advisory committee of this notice is to allow an additional Collection: NIMH is seeking OMB
meetings and will make every effort to 30 days for public comment. The approval for two Neurobiobank data
accommodate persons with physical National Institute of Mental Health collections: (1) Pre-Mortem Donor
disabilities or special needs. If you (NIMH), National Institutes of Health, Recruitment Form, and (2) Tissue
require special accommodations due to may not conduct or sponsor, and the Access Request Form. The pre-mortem
a disability, please contact Kristina respondent is not required to respond donor form will collect information
Toliver at least 7 days in advance of the to, an information collection that has from potential donors to ensure and
meeting. been extended, revised, or implemented enable appropriate research use of the
FDA is committed to the orderly on or after October 1, 1995, unless it tissues and biospecimens. Knowledge
conduct of its advisory committee displays a currently valid OMB control about the health history surrounding a
meetings. Please visit our Web site at number. particular tissue or biospecimen is
http://www.fda.gov/ Direct Comments To OMB: Written essential to ethical scientific research
AdvisoryCommittees/ comments and/or suggestions regarding conducted upon it. The tissue access
AboutAdvisoryCommittees/ the item(s) contained in this notice, request form will collect information
ucm111462.htm for procedures on especially regarding the estimated from researchers who wish to gain
public conduct during advisory public burden and associated response access to the tissue stored throughout
committee meetings. time, should be directed to the: Office the Neurobiobank network, The NIH
Notice of this meeting is given under of Management and Budget, Office of Neurobiobank Tissue Access Request
the Federal Advisory Committee Act (5 Regulatory Affairs, OIRA_submission@ form is necessary to verify that the
U.S.C. app. 2). omb.eop.gov or by fax to 202–395–6974, researcher ‘‘Recipient’’ Principal
Dated: May 5, 2015. Attention: NIH Desk Officer. Investigators and their organization or
Jill Hartzler Warner, Comment Due Date: Comments corporations applying to use the tissue
Associate Commissioner for Special Medical regarding this information collection are is qualified to conduct human tissue
Programs. best assured of having their full effect if research and have approved assurance
[FR Doc. 2015–11257 Filed 5–8–15; 8:45 am] received within 30-days of the date of from the DHHS Office of Human
BILLING CODE 4164–01–P this publication. Research Protections to access tissue or
FOR FURTHER INFORMATION CONTACT: To biospecimens from the National
obtain a copy of the data collection Neurobiobank for research purposes.
DEPARTMENT OF HEALTH AND plans and instruments or request more The primary use of this information is
HUMAN SERVICES information on the proposed project to document, track, monitor, and
contact: NIMH Project Clearance evaluate the appropriate use of the
National Institutes of Health Liaison, Science Policy and Evaluation Neurobiobank tissue and biospecimen
Branch, OSPPC, NIMH, NIH, resources, as well as to notify interested
Submission for OMB Review; 30-Day recipients of updates, corrections, or
Neuroscience Center, 6001 Executive
Comment Request National Institute of other changes to the system.
Boulevard, MSC 9667, Rockville Pike,
Health Neurobiobank Tissue Access
Bethesda, MD 20892, or call 301–443– OMB approval is requested for 3
Request
4335 or Email your request, including years. There are no costs to respondents
SUMMARY: Under the provisions of your address to: other than their time. The total
Section 3507(a)(1)(D) of the Paperwork nimhprapubliccomments@mail.nih.gov. estimated annualized burden hours are
Reduction Act of 1995, the National Formal requests for additional plans and 38.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Total annual
Number of Frequency burden per
Form burden
respondents of response response hours
(in hours)
Neurobiobank Tissue Access Request ........................................................................... 50 1 30/60 25
Pre-Mortem Donor Recruitment Form ............................................................................. 50 1 15/60 13
Total .......................................................................................................................... 100 .................... .................... 38
tkelley on DSK3SPTVN1PROD with NOTICES
Dated: May 5, 2015.
Keisha L. Shropshire,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2015–11332 Filed 5–8–15; 8:45 am]
BILLING CODE 4140–01–P
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Document Created: 2018-02-21 10:26:15
Document Modified: 2018-02-21 10:26:15
| 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 26929 |
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