83_FR_45434 83 FR 45261 - National Institute of Dental and Craniofacial Research; Notice of Closed Meetings

83 FR 45261 - National Institute of Dental and Craniofacial Research; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 173 (September 6, 2018)

Page Range45261-45262
FR Document2018-19319

Federal Register, Volume 83 Issue 173 (Thursday, September 6, 2018) 
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45261-45262]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19319]


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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, 
[email protected].


[[Page 45262]]


    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, [email protected].

    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, [email protected].

(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

Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45261 • If you want to submit a comment the information at: https://www.gpo.gov/ II. Paperwork Reduction Act of 1995 with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- do not wish to be made available to the 23389.pdf. This guidance refers to previously public, submit the comment as a Docket: For access to the docket to approved collections of information that written/paper submission and in the read background documents or the are subject to review by the Office of manner detailed (see ‘‘Written/Paper electronic and written/paper comments Management and Budget (OMB) under Submissions’’ and ‘‘Instructions’’). received, go to https:// the Paperwork Reduction Act of 1995 www.regulations.gov and insert the (44 U.S.C. 3501–3520). The collections Written/Paper Submissions docket number, found in brackets in the of information in 21 CFR part 312 have Submit written/paper submissions as heading of this document, into the been approved under OMB control follows: ‘‘Search’’ box and follow the prompts number 0910–0014. • Mail/Hand Delivery/Courier (for and/or go to the Dockets Management written/paper submissions): Dockets III. Electronic Access Staff, 5630 Fishers Lane, Rm. 1061, Management Staff (HFA–305), Food and Rockville, MD 20852. Persons with access to the internet Drug Administration, 5630 Fishers You may submit comments on any may obtain the guidance at either Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR https://www.fda.gov/Drugs/Guidance • For written/paper comments 10.115(g)(5)). ComplianceRegulatoryInformation/ submitted to the Dockets Management Submit written requests for single Guidances/default.htm or https:// Staff, FDA will post your comment, as copies of this guidance to the Division www.regulations.gov. well as any attachments, except for of Drug Information, Center for Drug information submitted, marked and Evaluation and Research, Food and Dated: August 29, 2018. identified, as confidential, if submitted Drug Administration, 10001 New Leslie Kux, as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Associate Commissioner for Policy. Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– [FR Doc. 2018–19247 Filed 9–5–18; 8:45 am] must include the Docket No. FDA– 0002. Send one self-addressed adhesive BILLING CODE 4164–01–P 2016–D–0236 for ‘‘Nonallergic Rhinitis: label to assist that office in processing Developing Drug Products for your requests. See the SUPPLEMENTARY Treatment; Guidance for Industry; INFORMATION section for electronic DEPARTMENT OF HEALTH AND Availability.’’ Received comments will access to the guidance document. HUMAN SERVICES be placed in the docket and, except for FOR FURTHER INFORMATION CONTACT: those submitted as ‘‘Confidential Stacy Chin, Center for Drug Evaluation National Institutes of Health Submissions,’’ publicly viewable at and Research, Food and Drug https://www.regulations.gov or at the National Institute of Dental and Administration, 10903 New Hampshire Dockets Management Staff between 9 Ave., Bldg. 22, Rm. 3340, Silver Spring, Craniofacial Research; Notice of a.m. and 4 p.m., Monday through MD 20993, 240–402–5005. Closed Meetings Friday. SUPPLEMENTARY INFORMATION: • Confidential Submissions—To Pursuant to section 10(d) of the submit a comment with confidential I. Background Federal Advisory Committee Act, as information that you do not wish to be FDA is announcing the availability of amended, notice is hereby given of the made publicly available, submit your a guidance for industry entitled following meetings. comments only as a written/paper ‘‘Nonallergic Rhinitis: Developing Drug The meetings will be closed to the submission. You should submit two Products for Treatment.’’ The purpose of public in accordance with the copies total. One copy will include the this guidance is to assist applicants of provisions set forth in sections information you claim to be confidential new drug applications and biologics 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., with a heading or cover note that states license applications in developing drug as amended. The grant applications and ‘‘THIS DOCUMENT CONTAINS products for the treatment of nonallergic the discussions could disclose CONFIDENTIAL INFORMATION.’’ The rhinitis (NAR) in children and adults. confidential trade secrets or commercial Agency will review this copy, including This guidance incorporates the property such as patentable material, the claimed confidential information, in comments received and finalizes the and personal information concerning its consideration of comments. The draft guidance of the same name issued individuals associated with the grant second copy, which will have the on February 16, 2016 (81 FR 7811). All applications, the disclosure of which claimed confidential information the public comments received on the would constitute a clearly unwarranted redacted/blacked out, will be available draft guidance have been considered invasion of personal privacy. for public viewing and posted on and the guidance has been revised Name of Committee: National Institute of https://www.regulations.gov. Submit primarily to update references and to Dental and Craniofacial Research Special both copies to the Dockets Management clarify. Emphasis Panel. Staff. If you do not wish your name and This guidance is being issued Date: October 18, 2018. contact information to be made publicly consistent with FDA’s good guidance Time: 1:00 p.m. to 5:00 p.m. available, you can provide this practices regulation (21 CFR 10.115). Agenda: To review and evaluate grant information on the cover sheet and not The guidance represents the current applications. in the body of your comments and you thinking of FDA on developing drug Place: National Institutes of Health, must identify this information as products for treatment of nonallergic Democracy One, Room 651, 6701 Rockledge daltland on DSKBBV9HB2PROD with NOTICES ‘‘confidential.’’ Any information marked rhinitis. It does not establish any rights Drive, Bethesda, MD 20892 (Telephone Conference Call). as ‘‘confidential’’ will not be disclosed for any person and is not binding on Contact Person: Nisan Bhattacharyya, except in accordance with 21 CFR 10.20 FDA or the public. You can use an Ph.D., Scientific Review Officer, Scientific and other applicable disclosure law. For alternative approach if it satisfies the Review Branch, NIDCR, NIH, 6701 more information about FDA’s posting requirements of the applicable statutes Democracy Boulevard, Suite 668, Bethesda, of comments to public dockets, see 80 and regulations. This guidance is not MD 20892, 301–451–2405, nisan_ FR 56469, September 18, 2015, or access subject to Executive Order 12866. bhattacharyya@nih.gov. VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1

45262 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices Name of Committee: National Institute of would constitute a clearly unwarranted Contact Person: Jian Yang, Ph.D., Scientific Dental and Craniofacial Research Special invasion of personal privacy. Review Officer, Review Branch, DEA, Emphasis Panel. NIDDK, National Institutes of Health, Room Date: October 30, 2018. Name of Committee: Microbiology, 7111, 6707 Democracy Boulevard, Bethesda, Time: 8:00 a.m. to 5:00 p.m. Infectious Diseases and AIDS Initial Review MD 20892–5452, (301) 594–7799, yangj@ Group; Microbiology and Infectious Diseases extra.niddk.nih.gov. Agenda: To review and evaluate grant B Subcommittee MID–B September Review applications. Name of Committee: National Institute of Meeting. Place: Morrison Clark Hotel, NW, 1015 L Diabetes and Digestive and Kidney Diseases Date: September 25–26, 2018. Street NW, Washington, DC 20001. Time: 9:00 a.m. to 5:00 p.m. Special Emphasis Panel; PAR–17–123: Contact Person: Crina Frincu, Ph.D., Agenda: To review and evaluate grant Biomarkers for NIDDK Using Biosamples Scientific Review Officer, Scientific Review applications. from the Repository (R01). Branch, National Institute of Dental and Place: National Institutes of Health, 5601 Date: October 2, 2018. Craniofacial Research, National Institutes of Fishers Lane, Rockville, MD 20892 Time: 11:00 a.m. to 1:00 p.m. Health, 6701 Democracy Blvd., Suite 662, (Telephone Conference Call). Agenda: To review and evaluate grant Bethesda, MD 20892, cfrincu@mail.nih.gov. Contact Person: Ellen S. Buczko, Ph.D., applications. Name of Committee: National Institute of Scientific Review Officer, Scientific Review Place: National Institutes of Health, Two Dental and Craniofacial Research Special Program Division of Extramural Activities, Democracy Plaza, 6707 Democracy Emphasis Panel; Secondary Data Analysis. National Institutes of Health/NIAID, 6700B Boulevard, Bethesda, MD 20892 (Telephone Date: November 1, 2018. Rockledge Drive, MSC 7616 Bethesda, MD Conference Call). Time: 1:00 p.m. to 5:00 p.m. 20892–7616, 301–451–2676, ebuczko1@ Contact Person: Najma S. Begum, Ph.D., Agenda: To review and evaluate grant niaid.nih.gov. Scientific Review Officer, Review Branch, applications. (Catalogue of Federal Domestic Assistance DEA, NIDDK, National Institutes of Health, Place: National Institutes of Health, 6701 Program Nos. 93.855, Allergy, Immunology, Room 7349, 6707 Democracy Boulevard, Rockledge Drive, Bethesda, MD 20892 and Transplantation Research; 93.856, Bethesda, MD 20892–5452, (301) 594–8894, (Telephone Conference Call). Microbiology and Infectious Diseases begumn@niddk.nih.gov. Contact Person: Guo He Zhang, MPH, Research, National Institutes of Health, HHS) Name of Committee: National Institute of Ph.D., Scientific Review Officer, Scientific Diabetes and Digestive and Kidney Diseases Dated: August 30, 2018. Review Branch, Natl. Institute of Dental and Special Emphasis Panel; PAR–17–270: Craniofacial Research, National Institutes of Natasha M. Copeland, NIDDK Central Repositories Non-renewable Health, 6701 Democracy Boulevard, Suite Program Analyst, Office of Federal Advisory Sample Access (X01). 672, Bethesda, MD 20892, zhanggu@ Committee Policy. Date: October 3, 2018. mail.nih.gov. [FR Doc. 2018–19317 Filed 9–5–18; 8:45 am] Time: 1:00 p.m. to 2:30 p.m. (Catalogue of Federal Domestic Assistance BILLING CODE 4140–01–P Agenda: To review and evaluate grant Program Nos. 93.121, Oral Diseases and applications. Disorders Research, National Institutes of Place: National Institutes of Health, Two Health, HHS) Democracy Plaza, 6707 Democracy DEPARTMENT OF HEALTH AND Boulevard, Bethesda, MD 20892 (Telephone Dated: August 30, 2018. HUMAN SERVICES Conference Call). Natasha M. Copeland, Contact Person: Najma S. Begum, Ph.D., National Institutes of Health Scientific Review Officer, Review Branch, Program Analyst, Office of Federal Advisory Committee Policy. DEA, NIDDK, National Institutes of Health, National Institute of Diabetes and Room 7349, 6707 Democracy Boulevard, [FR Doc. 2018–19319 Filed 9–5–18; 8:45 am] Digestive and Kidney Diseases; Notice Bethesda, MD 20892–5452, (301) 594–8894, BILLING CODE 4140–01–P of Closed Meetings begumn@niddk.nih.gov. Pursuant to section 10(d) of the Name of Committee: National Institute of Federal Advisory Committee Act, as Diabetes and Digestive and Kidney Diseases DEPARTMENT OF HEALTH AND Special Emphasis Panel; NIDDK–KUH- HUMAN SERVICES amended, notice is hereby given of the Fellowship Review Meeting. following meetings. Date: October 5, 2018. National Institutes of Health The meetings will be closed to the Time: 8:00 a.m. to 4:00 p.m. public in accordance with the Agenda: To review and evaluate grant National Institute of Allergy and provisions set forth in sections applications. Infectious Diseases; Notice of Closed 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Place: Embassy Suites at the Chevy Chase Meeting as amended. The grant applications and Pavilion, 4300 Military Road NW, the discussions could disclose Washington, DC 20015. Pursuant to section 10(d) of the confidential trade secrets or commercial Contact Person: Xiaodu Guo, MD, Ph.D., Federal Advisory Committee Act, as property such as patentable material, Scientific Review Officer, Review Branch, amended, notice is hereby given of a DEA, NIDDK, National Institutes of Health, and personal information concerning meeting Microbiology, Infectious Room 7023, 6707 Democracy Boulevard, individuals associated with the grant Bethesda, MD 20892–5452, (301) 594–4719, Diseases and AIDS Initial Review Group applications, the disclosure of which guox@extra.niddk.nih.gov. Microbiology and Infectious Diseases B would constitute a clearly unwarranted Subcommittee. Name of Committee: National Institute of invasion of personal privacy. Diabetes and Digestive and Kidney Diseases The meeting will be closed to the Name of Committee: National Institute of Special Emphasis Panel; Time-Sensitive public in accordance with the Diabetes and Digestive and Kidney Diseases Obesity Policy. provisions set forth in sections Special Emphasis Panel; R13 Conference Date: October 5, 2018. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Grant Applications. Time: 1:30 p.m. to 3:30 p.m. daltland on DSKBBV9HB2PROD with NOTICES as amended. The grant applications and Date: September 27, 2018. Agenda: To review and evaluate grant Time: 11:00 a.m. to 12:30 p.m. applications. the discussions could disclose Agenda: To review and evaluate grant Place: National Institutes of Health, Two confidential trade secrets or commercial applications. Democracy Plaza, 6707 Democracy property such as patentable material, Place: National Institutes of Health, Two Boulevard, Bethesda, MD 20892 (Telephone and personal information concerning Democracy Plaza, 6707 Democracy Conference Call). individuals associated with the grant Boulevard, Bethesda, MD 20892 (Telephone Contact Person: Michele L. Barnard, Ph.D., applications, the disclosure of which Conference Call). Scientific Review Officer, Review Branch, VerDate Sep<11>2014 16:56 Sep 05, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1


Document Created: 2018-09-05 23:56:14
Document Modified: 2018-09-05 23:56:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesOctober 18, 2018.
FR Citation83 FR 45261 
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