Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45261 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–0236 for ‘‘Nonallergic Rhinitis: 

Developing Drug Products for 

Treatment; Guidance for Industry; 

Availability.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Chin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 3340, Silver Spring, 

MD 20993, 240–402–5005. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Nonallergic Rhinitis: Developing Drug 

Products for Treatment.’’ The purpose of 

this guidance is to assist applicants of 

new drug applications and biologics 

license applications in developing drug 

products for the treatment of nonallergic 

rhinitis (NAR) in children and adults. 

This guidance incorporates the 

comments received and finalizes the 

draft guidance of the same name issued 

on February 16, 2016 (81 FR 7811). All 

the public comments received on the 

draft guidance have been considered 

and the guidance has been revised 

primarily to update references and to 

clarify. 

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 developing drug 

products for treatment of nonallergic 

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. This guidance is not 

subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This 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 guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: August 29, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19247 Filed 9–5–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental and 

Craniofacial Research; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, 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 

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 

Dental and Craniofacial Research Special 

Emphasis Panel. 

Date: October 18, 2018. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Democracy One, Room 651, 6701 Rockledge 

Drive, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Nisan Bhattacharyya, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, NIDCR, NIH, 6701 

Democracy Boulevard, Suite 668, Bethesda, 

MD 20892, 301–451–2405, nisan_

bhattacharyya@nih.gov. 


daltland on DSKBBV9HB2PROD with NOTICES
45262 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel. 

Date: October 30, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Morrison Clark Hotel, NW, 1015 L 

Street NW, Washington, DC 20001. 

Contact Person: Crina Frincu, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute of Dental and 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy Blvd., Suite 662, 

Bethesda, MD 20892, cfrincu@mail.nih.gov. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel; Secondary Data Analysis. 

Date: November 1, 2018. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Guo He Zhang, MPH, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Natl. Institute of Dental and 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy Boulevard, Suite 

672, Bethesda, MD 20892, zhanggu@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: August 30, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19319 Filed 9–5–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting Microbiology, Infectious 

Diseases and AIDS Initial Review Group 

Microbiology and Infectious Diseases B 

Subcommittee. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

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: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group; Microbiology and Infectious Diseases 

B Subcommittee MID–B September Review 

Meeting. 

Date: September 25–26, 2018. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Ellen S. Buczko, Ph.D., 

Scientific Review Officer, Scientific Review 

Program Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616 Bethesda, MD 

20892–7616, 301–451–2676, ebuczko1@

niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: August 30, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19317 Filed 9–5–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, 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 

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; R13 Conference 

Grant Applications. 

Date: September 27, 2018. 

Time: 11:00 a.m. to 12:30 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: Jian Yang, Ph.D., Scientific 

Review Officer, Review Branch, DEA, 

NIDDK, National Institutes of Health, Room 

7111, 6707 Democracy Boulevard, Bethesda, 

MD 20892–5452, (301) 594–7799, yangj@

extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; PAR–17–123: 

Biomarkers for NIDDK Using Biosamples 

from the Repository (R01). 

Date: October 2, 2018. 

Time: 11:00 a.m. to 1:00 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: Najma S. Begum, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7349, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8894, 

begumn@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; PAR–17–270: 

NIDDK Central Repositories Non-renewable 

Sample Access (X01). 

Date: October 3, 2018. 

Time: 1:00 p.m. to 2:30 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: Najma S. Begum, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7349, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8894, 

begumn@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK–KUHFellowship Review Meeting. 

Date: October 5, 2018. 

Time: 8:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Contact Person: Xiaodu Guo, MD, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7023, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–4719, 

guox@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Time-Sensitive 

Obesity Policy. 

Date: October 5, 2018. 

Time: 1:30 p.m. to 3:30 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, 


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