83_FR_34282 83 FR 34143 - National Institute on Drug Abuse; Notice of Closed Meeting

83 FR 34143 - National Institute on Drug Abuse; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 139 (July 19, 2018)

Page Range34143-34144
FR Document2018-15358

Federal Register, Volume 83 Issue 139 (Thursday, July 19, 2018) 
[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Pages 34143-34144]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15358]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Drug Abuse; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meeting.
    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.,

[[Page 34144]]

as amended. The contract proposals and the discussions could disclose 
confidential trade secrets or commercial property such as patentable 
material, and personal information concerning individuals associated 
with the contract proposals, the disclosure of which would constitute a 
clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Drug Abuse Special 
Emphasis Panel; NIDA International Research and Training Program 
Support Services (1158).
    Date: August 9, 2018.
    Time: 10:00 a.m. to 2:00 p.m.
    Agenda: To review and evaluate contract proposals.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).
    Contact Person: Susan O. McGuire, Ph.D., Scientific Review 
Officer, Office of Extramural Policy and Review, National Institute 
on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive 
Blvd., Room 4245, Rockville, MD 20852, 301-827-5817, 
[email protected].

(Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug 
Abuse and Addiction Research Programs, National Institutes of 
Health, HHS)

    Dated: July 13, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-15358 Filed 7-18-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 34143 written/paper submission and in the electronic and written/paper comments possible/actual quality issues that manner detailed (see ‘‘Written/Paper received, go to https:// require submission of a FAR, the Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the contents of the FAR, who submits the docket number, found in brackets in the FAR, and when, where, and how they Written/Paper Submissions heading of this document, into the should submit it. The draft guidance Submit written/paper submissions as ‘‘Search’’ box and follow the prompts also addresses followup and final FARs, follows: and/or go to the Dockets Management which are not required under • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, § 314.81(b), and recommends their written/paper submissions): Dockets Rockville, MD 20852. submission to inform FDA of the status Management Staff (HFA–305), Food and You may submit comments on any of root cause investigations and Drug Administration, 5630 Fishers guidance at any time (see 21 CFR corrective actions taken, if any. Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). This draft guidance is being issued • For written/paper comments Submit written requests for single consistent with FDA’s good guidance submitted to the Dockets Management copies of the draft guidance to the practices regulation (21 CFR 10.115). Staff, FDA will post your comment, as Division of Drug Information, Center for The draft guidance, when finalized, will well as any attachments, except for Drug Evaluation and Research, Food represent the current thinking of FDA information submitted, marked and and Drug Administration, 10001 New on field alert report submissions. It does identified, as confidential, if submitted Hampshire Ave., Hillandale Building, not establish any rights for any person as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– and is not binding on FDA or the public. Instructions: All submissions received 0002, or to the Office of You can use an alternative approach if must include the Docket No. FDA– Communication, Outreach and it satisfies the requirements of the 2018–D–2326 for ‘‘Field Alert Report Development, Center for Biologics applicable statutes and regulations. This Submission: Questions and Answers; Evaluation and Research, Food and guidance is not subject to Executive Draft Guidance for Industry.’’ Received Drug Administration, 10903 New Order 12866. comments will be placed in the docket and, except for those submitted as Hampshire Ave., Bldg. 71, Rm. 3128, II. Paperwork Reduction Act of 1995 ‘‘Confidential Submissions,’’ publicly Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to The draft guidance refers to viewable at https://www.regulations.gov previously approved collections of or at the Dockets Management Staff assist that office in processing your requests. See the SUPPLEMENTARY information that are subject to review by between 9 a.m. and 4 p.m., Monday the Office of Management and Budget INFORMATION section for electronic through Friday. (OMB) under the Paperwork Reduction • Confidential Submissions—To access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Act of 1995 (44 U.S.C. 3501–3520). The submit a comment with confidential Mamta Gautam-Basak, Center for Drug collections of information in 21 CFR information that you do not wish to be Evaluation and Research, Food and part 314 have been approved under made publicly available, submit your Drug Administration, 10903 New OMB control number 0910–0001. comments only as a written/paper submission. You should submit two Hampshire Ave., Bldg. 21, Rm. 2508, III. Electronic Access copies total. One copy will include the Silver Spring, MD 20993–0002, 301– Persons with access to the internet information you claim to be confidential 796–0712; Stephen Ripley, Center for may obtain the draft guidance at https:// with a heading or cover note that states Biologics Evaluation and Research, www.fda.gov/Drugs/Guidance ‘‘THIS DOCUMENT CONTAINS Food and Drug Administration, 10903 ComplianceRegulatoryInformation/ CONFIDENTIAL INFORMATION.’’ The New Hampshire Ave., Bldg. 71, Rm. Guidances/default.htm, https:// Agency will review this copy, including 7301, Silver Spring, MD 20993–0002, www.fda.gov/BiologicsBloodVaccines/ the claimed confidential information, in 240–402–7911; or Rachel Harrington, GuidanceComplianceRegulatory its consideration of comments. The Office of Regulatory Affairs, Food and Information/default.htm, or https:// second copy, which will have the Drug Administration, 10903 New www.regulations.gov. claimed confidential information Hampshire Ave., Bldg. 32, Rm. 4339, redacted/blacked out, will be available Silver Spring, MD 20993–0002, 410– Dated: July 13, 2018. for public viewing and posted on 779–5441. Leslie Kux, https://www.regulations.gov. Submit SUPPLEMENTARY INFORMATION: Associate Commissioner for Policy. both copies to the Dockets Management [FR Doc. 2018–15389 Filed 7–18–18; 8:45 am] I. Background Staff. If you do not wish your name and BILLING CODE 4164–01–P contact information to be made publicly FDA is announcing the availability of available, you can provide this a draft guidance for industry entitled information on the cover sheet and not ‘‘Field Alert Report Submission: DEPARTMENT OF HEALTH AND in the body of your comments and you Questions and Answers.’’ The FAR HUMAN SERVICES must identify this information as regulations found in 21 CFR ‘‘confidential.’’ Any information marked 314.81(b)(1) and 314.98(b) establish an National Institutes of Health as ‘‘confidential’’ will not be disclosed early warning system to help protect National Institute on Drug Abuse; except in accordance with 21 CFR 10.20 patient health. Under these regulations, Notice of Closed Meeting and other applicable disclosure law. For NDA and ANDA applicants must submit certain information to FDA about sradovich on DSK3GMQ082PROD with NOTICES more information about FDA’s posting Pursuant to section 10(d) of the of comments to public dockets, see 80 distributed drug products regulated by Federal Advisory Committee Act, as FR 56469, September 18, 2015, or access the Center for Drug Evaluation and amended, notice is hereby given of the the information at: https://www.gpo.gov/ Research or the Center for Biologics following meeting. fdsys/pkg/FR-2015-09-18/pdf/2015- Evaluation and Research. The meeting will be closed to the 23389.pdf. The draft guidance addresses the FAR public in accordance with the Docket: For access to the docket to submission requirements and focuses on provisions set forth in sections read background documents or the topics such as the incidents and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., VerDate Sep<11>2014 17:34 Jul 18, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1

34144 Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices as amended. The contract proposals and Translational Research Network (NBSTRN) MSC 9529, Bethesda, MD 20892–9529, (301) the discussions could disclose August 13, 2018. 496–9223, ana.olariu@nih.gov. confidential trade secrets or commercial Time: 1:00 p.m. to 4:00 p.m. (Catalogue of Federal Domestic Assistance Agenda: To review and evaluate contract Program Nos. 93.853, Clinical Research property such as patentable material, proposals. Related to Neurological Disorders; 93.854, and personal information concerning Place: National Institutes of Health, 6710 B individuals associated with the contract Biological Basis Research in the Rockledge Drive, Bethesda, MD 20892 Neurosciences, National Institutes of Health, proposals, the disclosure of which (Telephone Conference Call). HHS) would constitute a clearly unwarranted Contact Person: Sathasiva B. Kandasamy, invasion of personal privacy. Ph.D., Scientific Review Administrator, Dated: July 13, 2018. Division of Scientific Review, National Natasha M. Copeland, Name of Committee: National Institute on Institute of Child Health and Human Program Analyst, Office of Federal Advisory Drug Abuse Special Emphasis Panel; NIDA Development, 6710B Rockledge Drive, Committee Policy. International Research and Training Program Bethesda, MD 20892, (301) 435–6680, [FR Doc. 2018–15359 Filed 7–18–18; 8:45 am] Support Services (1158). skandasa@mail.nih.gov. Date: August 9, 2018. BILLING CODE 4140–01–P Time: 10:00 a.m. to 2:00 p.m. (Catalogue of Federal Domestic Assistance Agenda: To review and evaluate contract Program Nos. 93.864, Population Research; proposals. 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation DEPARTMENT OF HEALTH AND Place: National Institutes of Health, HUMAN SERVICES Neuroscience Center, 6001 Executive Research; 93.209, Contraception and Boulevard, Rockville, MD 20852 (Telephone Infertility Loan Repayment Program, National Institutes of Health, HHS) Substance Abuse and Mental Health Conference Call). Services Administration Contact Person: Susan O. McGuire, Ph.D., Dated: July 13, 2018. Scientific Review Officer, Office of Ronald J. Livingston, Jr., Extramural Policy and Review, National Center for Substance Abuse Institute on Drug Abuse, National Institutes Program Analyst, Office of Federal Advisory Prevention; Notice of Meeting of Health, DHHS, 6001 Executive Blvd., Committee Policy. Room 4245, Rockville, MD 20852, 301–827– [FR Doc. 2018–15357 Filed 7–18–18; 8:45 am] Pursuant to Public Law 92–463, 5817, mcguireso@mail.nih.gov. BILLING CODE 4140–01–P notice is hereby given for the meeting of (Catalogue of Federal Domestic Assistance the Substance Abuse and Mental Health Program No.: 93.279, Drug Abuse and Services Administration’s (SAMHSA) Addiction Research Programs, National DEPARTMENT OF HEALTH AND Center for Substance Abuse Prevention Institutes of Health, HHS) HUMAN SERVICES National Advisory Council (CSAP NAC) Dated: July 13, 2018. on August 1, 2018. National Institutes of Health The Council was established to advise Natasha M. Copeland, the Secretary, Department of Health and Program Analyst, Office of Federal Advisory National Institute of Neurological Human Services (HHS); the Assistant Committee Policy. Disorders and Stroke; Notice of Closed Secretary for Mental Health and [FR Doc. 2018–15358 Filed 7–18–18; 8:45 am] Meetings Substance Use, SAMHSA; and Director, BILLING CODE 4140–01–P Pursuant to section 10(d) of the CSAP concerning matters relating to the Federal Advisory Committee Act, as activities carried out by and through the amended, notice is hereby given of the Center and the policies respecting such DEPARTMENT OF HEALTH AND following meeting. activities. HUMAN SERVICES The meeting will be closed to the The meeting will be open to the National Institutes of Health public in accordance with the public and will include the discussion provisions set forth in sections of the substance use prevention Eunice Kennedy Shriver National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., workforce and opioid use prevention. Institute of Child Health & Human as amended. The grant applications and The meeting will also include updates Development; Notice of Closed the discussions could disclose on CSAP program developments. Meeting confidential trade secrets or commercial The meeting will be held in Rockville, property such as patentable material, Maryland. Attendance by the public Pursuant to section 10(d) of the and personal information concerning will be limited to the space available. Federal Advisory Committee Act, as individuals associated with the grant Interested persons may present data, amended, notice is hereby given of the applications, the disclosure of which information, or views, orally or in following meeting. would constitute a clearly unwarranted writing, on issues pending before the The meeting will be closed to the invasion of personal privacy. Council. Written submissions should be public in accordance with the forwarded to the contact person on or provisions set forth in sections Name of Committee: National Institute of Neurological Disorders and Stroke Special before one week prior to the meeting. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Emphasis Panel; Planning Grant to Develop Oral presentations from the public will as amended. The contract proposals and Phase III Clinical Trials for LBD. be scheduled at the conclusion of the the discussions could disclose Date: August 6, 2018. meeting. Individuals interested in confidential trade secrets or commercial Time: 3:00 p.m. to 4:30 p.m. making oral presentations should notify property such as patentable material, Agenda: To review and evaluate grant the contact on or before one week prior and personal information concerning applications. to the meeting. Five minutes maximum sradovich on DSK3GMQ082PROD with NOTICES individuals associated with the contract Place: National Institutes of Health, will be allotted for each presentation. proposals, the disclosure of which Neuroscience Center, 6001 Executive To attend onsite, submit written or would constitute a clearly unwarranted Boulevard, Rockville, MD 20852 (Telephone Conference Call). brief oral comments, or request special invasion of personal privacy. Contact Person: Ana Olariu, Ph.D., accommodations for persons with Name of Committee: National Institute of Scientific Review Officer, Scientific Review disabilities, please register at the Child Health and Human Development Branch, NINDS/NIH/DHHS, Neuroscience SAMHSA Committees’ website, http:// Special Emphasis Panel; Newborn Screening Center, 6001 Executive Blvd., Suite 3208, nac.samhsa.gov/Registration/ VerDate Sep<11>2014 17:34 Jul 18, 2018 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1


Document Created: 2018-07-19 01:34:58
Document Modified: 2018-07-19 01:34:58
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
DatesAugust 9, 2018.
FR Citation83 FR 34143 
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