Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 17052-17053 [2015-07299]
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Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Alicia Barbieri Stuart, Office of
Translational Sciences, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4547,
Silver Spring, MD 20993–0002, 301–
796–3852.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Critical Path Innovation Meetings.’’
The guidance describes the purpose and
scope of a CPIM and how to request
such a meeting. A CPIM provides the
opportunity to discuss a methodology or
technology proposed by the meeting
requester and for CDER to provide
general advice on how the methodology
or technology might enhance drug
development. During a CPIM, CDER will
identify some of the larger gaps in
existing knowledge that requesters
might consider addressing in the course
of their work. The discussions and
background information submitted
through the CPIM are nonbinding on
both FDA and CPIM requesters. The
CPIM initiative meets Prescription Drug
User Fee Act (PDUFA) V
Reauthorization Goal IX.A, ‘‘Enhancing
Regulatory Science and Expediting Drug
Development’’ by ‘‘Promoting
Innovation Through Enhanced
Communication Between FDA and
Sponsors During Drug Development.’’
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Critical Path
Innovation Meetings.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
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are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in 21 CFR part 312
(investigational new drug applications)
has been approved under OMB control
number 0910–0014. The collection of
information in 21 CFR part 314 (new
drug applications) has been approved
under OMB control number 0910–0001.
The collection of information resulting
from formal meetings between
interested persons and FDA has been
approved under OMB control number
0910–0429.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: March 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07272 Filed 3–30–15; 8:45 am]
BILLING CODE 4164–01–P
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: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
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recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 12, 2015, from 8 a.m. to 4
p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD 20877.
The hotel phone number is 301–977–
8900.
Contact Person: Cindy Hong, 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:
PADAC@fda.hhs.gov, 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 https://
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
new drug application (NDA) 206038,
lumacaftor/ivacaftor combination tablets
for oral use, submitted by Vertex
Pharmaceuticals, proposed for the
treatment of cystic fibrosis (CF) in
patients age 12 years and older who are
homozygous for the F508del mutation in
the cystic fibrosis transmembrane
conductance regulator (CFTR) gene.
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 https://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 April 27, 2015. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
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Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices
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 17,
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 April 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 Cindy Hong
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
https://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 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–07299 Filed 3–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Time-Sensitive
Obesity.
Date: April 27, 2015.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 753, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–8898,
barnardm@extra.niddk.nih.gov
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Pragmatic Research
and Natural Experiments.
Date: May 6, 2015.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 753, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–8898,
barnardm@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: March 25, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–07255 Filed 3–30–15; 8:45 am]
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
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17053
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extension of
Certification of Maintenance of Effort
on Help America Vote Act, Payments
for Protection and Advocacy Systems
(P&A Voting Access Narrative Annual
Report)
Administration on Intellectual
and Developmental Disabilities,
Administration for Community Living,
HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for public comment on
the proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
relating to the Help America Vote Act
(HAVA), Public Law 107–252, title II,
subtitle D, section 291, Payments for
Protection and Advocacy Systems
(P&As Narrative Annual Report).
DATES: Submit written or electronic
comments on the collection of
information by June 1, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to: melvenia.wright@
acl.hhs.gov.
Submit written comments on the
collection of information to
Administration for Community Living,
1 Massachusetts Avenue NW., Room
4716, Washington, DC 20001, attention
Melvenia Wright.
FOR FURTHER INFORMATION CONTACT:
Melvenia Wright, Program Specialist,
Administration for Community Living,
Washington, DC 20001. Telephone:
(202) 357–3486; email melvenia.wright@
acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency request
or requirements that members of the
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17052-17053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07299]
-----------------------------------------------------------------------
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 May 12, 2015, from 8
a.m. to 4 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel phone number is 301-
977-8900.
Contact Person: Cindy Hong, 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: PADAC@fda.hhs.gov, 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 https://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 new drug application (NDA)
206038, lumacaftor/ivacaftor combination tablets for oral use,
submitted by Vertex Pharmaceuticals, proposed for the treatment of
cystic fibrosis (CF) in patients age 12 years and older who are
homozygous for the F508del mutation in the cystic fibrosis
transmembrane conductance regulator (CFTR) gene.
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 https://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
April 27, 2015. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals
[[Page 17053]]
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 17, 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 April 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 Cindy Hong 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 https://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 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-07299 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P
