83 FR 34853 - Center for Scientific Review; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 141 (July 23, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 141 (July 23, 2018)
| Page Range | 34853-34854 | |
| FR Document | 2018-15606 |
[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)] [Notices] [Pages 34853-34854] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15606] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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: Center for Scientific Review Special Emphasis Panel; Urologic and Urogynecologic Applications. Date: July 20, 2018. Time: 10:00 a.m. to 11:00 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ganesan Ramesh, Ph.D., Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, 301-827-5467, [email protected]. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Review of Aging Applications. Date: August 13, 2018. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). [[Page 34854]] Contact Person: Samuel C. Edwards, Ph.D., Chief, BDCN IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435- 1246, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA-RM18-018: Somatic Cell Genome Editing Dissemination and Coordinating Center (U24). Date: August 16, 2018. Time: 2:00 p.m. to 4:00 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: Elena Smirnova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5187, MSC 7840, Bethesda, MD 20892, 301-357-9112, [email protected]. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: July 16, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018-15606 Filed 7-20-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 34853
TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when This notice is being published less than 15
days prior to the meeting due to the timing
CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current
thinking of FDA on, among other things, limitations imposed by the review and
UCTS—Continued funding cycle.
the product-specific design of BE
Beclomethasone dipropionate. studies to support ANDAs. They do not (Catalogue of Federal Domestic Assistance
Betamethasone dipropionate. Program Nos. 93.306, Comparative Medicine;
establish any rights for any person and 93.333, Clinical Research, 93.306, 93.333,
Betrixaban. are not binding on FDA or the public.
Ciprofloxacin. 93.337, 93.393–93.396, 93.837–93.844,
You can use an alternative approach if 93.846–93.878, 93.892, 93.893, National
Deferasirox.
Dexamethasone; Neomycin sulfate; Poly-
it satisfies the requirements of the Institutes of Health, HHS)
myxin b sulfate. applicable statutes and regulations. This Dated: July 17, 2018.
Epinephrine. guidance is not subject to Executive
Sylvia L. Neal,
Ethinyl estradiol; Norethindrone acetate. Order 12866.
Program Analyst, Office of Federal Advisory
Finafloxacin.
Fluocinolone acetonide.
IV. Electronic Access Committee Policy.
Loteprednol etabonate. [FR Doc. 2018–15605 Filed 7–20–18; 8:45 am]
Persons with access to the internet
Mecamylamine hydrochloride. BILLING CODE 4140–01–P
Methscopolamine bromide.
may obtain the draft guidances at either
Methylphenidate. https://www.fda.gov/Drugs/Guidance
Metyrosine. ComplianceRegulatoryInformation/ DEPARTMENT OF HEALTH AND
Moxifloxacin hydrochloride. Guidances/default.htm or https:// HUMAN SERVICES
Nebivolol hydrochloride; Valsartan. www.regulations.gov.
Nimodipine. Dated: July 18, 2018. National Institutes of Health
Nitisinone.
Omeprazole. Leslie Kux,
Center for Scientific Review; Notice of
Rifapentine. Associate Commissioner for Policy. Closed Meetings
Ritonavir. [FR Doc. 2018–15735 Filed 7–20–18; 8:45 am]
Sodium polystyrene sulfonate. BILLING CODE 4164–01–P Pursuant to section 10(d) of the
Triamcinolone acetonide. Federal Advisory Committee Act, as
Valbenazine tosylate. amended, notice is hereby given of the
DEPARTMENT OF HEALTH AND following meetings.
III. Drug Products for Which Revised HUMAN SERVICES The meetings will be closed to the
Draft Product-Specific Guidances are public in accordance with the
Available National Institutes of Health provisions set forth in sections
FDA is announcing the availability of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Center for Scientific Review; Notice of as amended. The grant applications and
revised draft product-specific guidances
Closed Meeting the discussions could disclose
for industry for drug products
containing the following active confidential trade secrets or commercial
Pursuant to section 10(d) of the property such as patentable material,
ingredients: Federal Advisory Committee Act, as and personal information concerning
amended, notice is hereby given of the individuals associated with the grant
TABLE 2—REVISED DRAFT PRODUCT- following meeting.
SPECIFIC GUIDANCES FOR DRUG applications, the disclosure of which
The meeting will be closed to the would constitute a clearly unwarranted
PRODUCTS public in accordance with the invasion of personal privacy.
provisions set forth in sections Name of Committee: Center for Scientific
Abiraterone acetate.
Dapagliflozin propanediol; Metformin hydro-
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Review Special Emphasis Panel; Urologic
chloride. as amended. The grant applications and and Urogynecologic Applications.
Diclofenac sodium. the discussions could disclose Date: July 20, 2018.
Donepezil hydrochloride; Memantine hydro- confidential trade secrets or commercial Time: 10:00 a.m. to 11:00 a.m.
chloride. property such as patentable material, Agenda: To review and evaluate grant
Esomeprazole strontium. and personal information concerning applications.
Ethosuximide. Place: National Institutes of Health, 6701
individuals associated with the grant Rockledge Drive, Bethesda, MD 20892
Glatiramer acetate. applications, the disclosure of which
Hydrocodone bitartrate. (Telephone Conference Call).
would constitute a clearly unwarranted Contact Person: Ganesan Ramesh, Ph.D.,
Lansoprazole.
Latanoprost.
invasion of personal privacy. Center for Scientific Review, National
Leucovorin calcium. Name of Committee: Center for Scientific Institutes of Health, 6701 Rockledge Drive,
Methylphenidate hydrochloride. Review Special Emphasis Panel; PAR–17– Room 2182, MSC 7818, Bethesda, MD 20892,
Morphine sulfate; Naltrexone hydrochloride. 031: Role of Age-Associated Metabolic 301–827–5467, ganesan.ramesh@nih.gov.
Nisoldipine. Changes in Alzhemimer’s Disease. This notice is being published less than 15
Oxycodone hydrochloride. Date: July 31, 2018. days prior to the meeting due to the timing
Ticagrelor. Time: 10:00 a.m. to 2:00 p.m. limitations imposed by the review and
Triamcinolone acetonide. Agenda: To review and evaluate grant funding cycle.
applications. Name of Committee: Center for Scientific
For a complete history of previously Place: National Institutes of Health, 6701 Review Special Emphasis Panel; PAR Panel:
amozie on DSK3GDR082PROD with NOTICES1
published Federal Register notices Rockledge Drive, Bethesda, MD 20892 Review of Aging Applications.
related to product-specific guidances, go (Virtual Meeting). Date: August 13, 2018.
Contact Person: Samuel C. Edwards, Ph.D., Time: 10:00 a.m. to 1:00 p.m.
to https://www.regulations.gov and
Chief, BDCN IRG, Center for Scientific Agenda: To review and evaluate grant
enter Docket No. FDA–2007–D–0369. Review, National Institutes of Health, 6701 applications.
These draft guidances are being Rockledge Drive, Room 5210, MSC 7846, Place: National Institutes of Health, 6701
issued consistent with FDA’s good Bethesda, MD 20892, (301) 435–1246, Rockledge Drive, Bethesda, MD 20892
guidance practices regulation (21 CFR edwardss@csr.nih.gov. (Virtual Meeting).
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![34854 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices
Contact Person: Samuel C. Edwards, Ph.D., Agenda: To review and evaluate personnel This notice is being published less than 15
Chief, BDCN IRG, Center for Scientific qualifications and performance, and days prior to the meeting due to the timing
Review, National Institutes of Health, 6701 competence of individual investigators. limitations imposed by the review and
Rockledge Drive, Room 5210, MSC 7846, Place: National Institutes of Health, funding cycle.
Bethesda, MD 20892, (301) 435–1246, National Institute on Alcohol Abuse and (Catalogue of Federal Domestic Assistance
edwardss@csr.nih.gov. Alcoholism, 5625 Fishers Lane, Bethesda, Program Nos. 93.233, National Center for
Name of Committee: Center for Scientific MD 20892. Sleep Disorders Research; 93.837, Heart and
Review Special Emphasis Panel; RFA– Contact Person: George Kunos, M.D., Ph.D. Vascular Diseases Research; 93.838, Lung
RM18–018: Somatic Cell Genome Editing Scientific Director, National Institutes of Diseases Research; 93.839, Blood Diseases
Dissemination and Coordinating Center Health, National Institute on Alcohol Abuse and Resources Research, National Institutes
(U24). and Alcoholism, 5625 Fishers Lane, Room of Health, HHS)
Date: August 16, 2018. 2s–24a Rockville, MD 20852 301–443–2069
gkunos@mail.nih.gov. Dated: July 17, 2018
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance Michelle D. Trout,
applications. Program Nos. 93.271, Alcohol Research Program Analyst, Office of Federal Advisory
Place: National Institutes of Health, 6701 Career Development Awards for Scientists Committee Policy.
Rockledge Drive, Bethesda, MD 20892 and Clinicians; 93.272, Alcohol National [FR Doc. 2018–15620 Filed 7–20–18; 8:45 am]
(Telephone Conference Call). Research Service Awards for Research BILLING CODE 4140–01–P
Contact Person: Elena Smirnova, Ph.D., Training; 93.273, Alcohol Research Programs;
Scientific Review Officer, Center for 93.891, Alcohol Research Center Grants;
Scientific Review, National Institutes of 93.701, ARRA Related Biomedical Research
DEPARTMENT OF HEALTH AND
Health, 6701 Rockledge Drive, Room 5187, and Research Support Awards., National
MSC 7840, Bethesda, MD 20892, 301–357– Institutes of Health, HHS) HUMAN SERVICES
9112, smirnove@csr.nih.gov. Dated: July 17, 2018. National Institutes of Health
(Catalogue of Federal Domestic Assistance Melanie J. Pantoja,
Program Nos. 93.306, Comparative Medicine; National Heart, Lung, and Blood
93.333, Clinical Research, 93.306, 93.333, Program Analyst, Office of Federal Advisory
Committee Policy. Institute; Notice of Closed Meeting
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National [FR Doc. 2018–15610 Filed 7–20–18; 8:45 am] Pursuant to section 10(d) of the
Institutes of Health, HHS) BILLING CODE 4140–01–P Federal Advisory Committee Act, as
Dated: July 16, 2018. amended, notice is hereby given of the
Natasha M. Copeland, following meeting.
DEPARTMENT OF HEALTH AND The meeting will be closed to the
Program Analyst, Office of Federal Advisory
HUMAN SERVICES public in accordance with the
Committee Policy.
[FR Doc. 2018–15606 Filed 7–20–18; 8:45 am] National Institutes of Health provisions set forth in sections
BILLING CODE 4140–01–P 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
National Heart, Lung, and Blood as amended. The grant applications and
Institute; Notice of Closed Meeting the discussions could disclose
DEPARTMENT OF HEALTH AND confidential trade secrets or commercial
HUMAN SERVICES Pursuant to section 10(d) of the property such as patentable material,
Federal Advisory Committee Act, as and personal information concerning
National Institutes of Health amended, notice is hereby given of the individuals associated with the grant
following meeting. applications, the disclosure of which
National Institute on Alcohol Abuse The meeting will be closed to the would constitute a clearly unwarranted
and Alcoholism; Notice of Closed public in accordance with the invasion of personal privacy.
Meeting provisions set forth in section Name of Committee: National Heart,
552b(c)(6), Title 5 U.S.C., as amended. Lung, and Blood Institute Special
Pursuant to section 10(d) of the The grant applications and the
Federal Advisory Committee Act, as Emphasis Panel Opportunities for
discussions could disclose confidential Collaborative Research at the NIH
amended, notice is hereby given of a trade secrets or commercial property
meeting of the Board of Scientific Clinical Center.
such as patentable material, and Date: August 9, 2018.
Counselors, NIAAA. personal information concerning Time: 1:00 p.m. to 5:00 p.m.
The meeting will be closed to the individuals associated with the grant Agenda: To review and evaluate grant
public as indicated below in accordance applications, the disclosure of which applications.
with the provisions set forth in section would constitute a clearly unwarranted Place: National Institutes of Health,
552b(c)(6), Title 5 U.S.C., as amended invasion of personal privacy. 6701 Rockledge Drive, Bethesda, MD
for the review, discussion, and
Name of Committee: National Heart, Lung, 20892, (Telephone Conference Call).
evaluation of individual intramural and Blood Institute Special Emphasis Panel, Contact Person: William J Johnson,
programs and projects conducted by the NHLBI R13 Conference Review. Ph.D., Scientific Review Officer, Office
National Institute on Alcohol Abuse and Date: August 2–3, 2018. of Scientific Review/DERA, National
Alcoholism, including consideration of Time: 9:00 a.m. to 12:00 p.m. Heart, Lung, and Blood Institute, 6701
personnel qualifications and Agenda: To review and evaluate grant
applications.
Rockledge Drive, Room 7178, Bethesda,
performance, and the competence of
Place: National Institutes of Health, 6701 MD 20892–7924, (301–827–7938)
individual investigators, the disclosure
amozie on DSK3GDR082PROD with NOTICES1
Rockledge Drive, Bethesda, MD 20892 johnsonwj@nhlbi.nih.gov.
of which would constitute a clearly
unwarranted invasion of personal (Virtual Meeting). (Catalogue of Federal Domestic Assistance
Contact Person: Stephanie J. Webb, Ph.D., Program Nos. 93.233, National Center for
privacy. Scientific Review Officer, Office of Scientific Sleep Disorders Research; 93.837, Heart and
Name of Committee: Board of Scientific Review/DERA, National Heart, Lung, and Vascular Diseases Research; 93.838, Lung
Counselors, NIAAA. Blood Institute, 6701 Rockledge Drive, Room Diseases Research; 93.839, Blood Diseases
Date: October 2, 2018. 7196, Bethesda, MD 20892, 301–435–0291, and Resources Research, National Institutes
Time: 8:00 a.m. to 6:00 p.m. stephanie.webb@nih.gov. of Health, HHS)
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Document Created: 2018-07-21 00:49:08
Document Modified: 2018-07-21 00:49:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | July 20, 2018. | |
| FR Citation | 83 FR 34853 |
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