Notice of Correction, 7817 [2016-03106]

Download as PDF 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 for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can 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: http://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 http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Allergic Rhinitis: Developing Drug Products for Treatment.’’ The purpose of this draft guidance is to assist sponsors in the development of drug and biologic products for the treatment of SAR and PAR.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 http://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// 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] BILLING CODE 4164–01–P BILLING CODE 4165–15–P 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 Frm 00076 Fmt 4703 Sfmt 9990 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: E:\FR\FM\16FEN1.SGM 16FEN1

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]


-----------------------------------------------------------------------

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]
BILLING CODE 4165-15-P