Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7817 

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copies of this draft guidance to the 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access to the draft guidance document.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: 

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a draft guidance for industry entitled 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this draft guidance is to assist sponsors 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 

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. 

II. The Paperwork Reduction Act of 

1995 

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 

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. 

Dated: February 9, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02978 Filed 2–12–16; 8:45 am] 

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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] 

BILLING CODE 4165–15–P 

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