Notice of Correction, 7817 [2016-03106]
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Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
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copies to the Division of Dockets
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provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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Submit written requests for single
copies of this draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
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label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Sofia Chaudhry, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3317,
Silver Spring, MD 20993–0002, 301–
796–4157.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Allergic Rhinitis: Developing Drug
Products for Treatment.’’ The purpose of
this draft guidance is to assist sponsors
in the development of drug and biologic
products for the treatment of SAR and
PAR. Information about the
pathophysiology and treatment of
allergic rhinitis and its subtypes, SAR
VerDate Sep<11>2014
22:15 Feb 12, 2016
Jkt 238001
7817
and PAR, has grown markedly in the
past decade. The recommendations in
this draft guidance are based on an
assessment of important issues raised in
the review of both adult and pediatric
allergic rhinitis clinical trials and the
Agency’s current understanding of the
mechanism of the two related disorders
of SAR and PAR. The pathophysiology
of SAR and PAR are similar in terms of
the chemical mediators produced and
end-organ manifestations, with
differences between the two entities
primarily based on the causes and
duration of disease. The trial design
issues pertaining to SAR and PAR are
also similar. Thus, these two categories
are treated collectively in this draft
guidance as allergic rhinitis, with
differences in recommendations for the
design of SAR and PAR trials indicated.
This draft guidance revises the draft
guidance for industry entitled ‘‘Allergic
Rhinitis: Clinical Development
Programs for Drug Products’’ issued
April 2000. All of the public comments
we received for the draft guidance have
been considered and the draft guidance
has been revised as appropriate.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the development of drug products for
the treatment of allergic rhinitis. 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. The Paperwork Reduction Act of
1995
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Phase 1 Effective: November 6, 2015
Phase 1 Submission Deadline: January
29, 2016, 11:59 p.m. ET
Phase 1 Judging Period: January 30–
February 28, 2016
Phase 1 Winners Announced: March 8,
2016
Phase 2 Begins: March 11, 2016
Phase 2 Submission Deadline: August
11, 2016
Phase 2 Judging Period: August 12–
September 16, 2016
Phase 2 Winners Announced: Week of
September 19, 2016
Phase 3 Begins: September 26, 2016
Phase 3 Submission Deadline: March
26, 2017
Phase 3 Winner Announced: May 2017
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Dated: January 29, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016–02978 Filed 2–12–16; 8:45 am]
[FR Doc. 2016–03106 Filed 2–12–16; 8:45 am]
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This draft guidance refers to
previously approved collections of
information that 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
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014.
III. Electronic Access
PO 00000
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Health Resources and Services
Administration
Notice of Correction
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
Notice; correction.
The Health Resources and
Services Administration published a
notice in the Federal Register, 80 FR
55861 (September 17, 2015) announcing
the Bridging the Word Gap Competition
Challenge. This correction notice
extends the deadline for Phase 1
submissions by approximately 4 weeks
to allow for additional submissions.
Accordingly, the remaining timelines
for all subsequent phases and judging
periods will also be extended by
approximately 4 weeks.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jessie Buerlein, Public Health Analyst,
Maternal and Child Health Bureau,
Health Resources and Services
Administration, 5600 Fishers Lane
Rockville, MD 20852, jbuerlein@
hrsa.gov, 301–443–8931.
Correction
In the Federal Register 80 FR 55861
(September 17, 2015), please make the
following corrections:
In the Summary section, correct dates
of each phase to read:
Dates for each phase are as follows:
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]]>Agencies
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Page 7817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03106]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Correction
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration published a
notice in the Federal Register, 80 FR 55861 (September 17, 2015)
announcing the Bridging the Word Gap Competition Challenge. This
correction notice extends the deadline for Phase 1 submissions by
approximately 4 weeks to allow for additional submissions. Accordingly,
the remaining timelines for all subsequent phases and judging periods
will also be extended by approximately 4 weeks.
FOR FURTHER INFORMATION CONTACT: Jessie Buerlein, Public Health
Analyst, Maternal and Child Health Bureau, Health Resources and
Services Administration, 5600 Fishers Lane Rockville, MD 20852,
jbuerlein@hrsa.gov, 301-443-8931.
Correction
In the Federal Register 80 FR 55861 (September 17, 2015), please
make the following corrections:
In the Summary section, correct dates of each phase to read:
Dates for each phase are as follows:
Phase 1 Effective: November 6, 2015
Phase 1 Submission Deadline: January 29, 2016, 11:59 p.m. ET
Phase 1 Judging Period: January 30-February 28, 2016
Phase 1 Winners Announced: March 8, 2016
Phase 2 Begins: March 11, 2016
Phase 2 Submission Deadline: August 11, 2016
Phase 2 Judging Period: August 12-September 16, 2016
Phase 2 Winners Announced: Week of September 19, 2016
Phase 3 Begins: September 26, 2016
Phase 3 Submission Deadline: March 26, 2017
Phase 3 Winner Announced: May 2017
Dated: January 29, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016-03106 Filed 2-12-16; 8:45 am]
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