83 FR 50946 - Center for Scientific Review; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 196 (October 10, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 196 (October 10, 2018)
| Page Range | 50946-50947 | |
| FR Document | 2018-21898 |
[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)] [Notices] [Pages 50946-50947] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21898] ----------------------------------------------------------------------- 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; Neurobiology of Learning and Memory. Date: October 24, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street NW, Washington, DC 20037. Contact Person: Alexei Kondratyev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, 301-435-1785, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Health Disparities in and Caregiving for Alzheimer's Disease. Date: November 2, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Gabriel B. Fosu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3108, MSC 7808, Bethesda, MD 20892, (301) 435-3562, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowship: Infectious Diseases and Microbiology. Date: November 5-6, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Palomar, 2121 P Street NW, Washington, DC 20037. Contact Person: Tamara Lyn McNealy, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3188, Bethesda, MD 20892, 301- 827-2372, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Risk, Prevention and Health Behavior. Date: November 5-6, 2018. Time: 8:00 a.m. to 5:00 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: Martha M. Faraday, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, (301) 435-3575, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Bioengineering Sciences and Technologies. [[Page 50947]] Date: November 5, 2018. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD 20892, (301) 404-7419, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Nephrology. Date: November 5, 2018. Time: 1:00 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: Julia Spencer Barthold, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Traumatic Brain Injury. Date: November 5, 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: Alexander Yakovlev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5206, MSC 7846, Bethesda, MD 20892-7846, 301-435-1254, [email protected]. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Healthcare Delivery and Methodologies. Date: November 5, 2018. Time: 12:00 p.m. to 3:00 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: Jacinta Bronte-Tinkew, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3164, MSC 7770, Bethesda, MD 20892, (301) 806-0009, [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: October 2, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018-21898 Filed 10-9-18; 8:45 am] BILLING CODE 4140-01-P
![50946 Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices
and Drug Administration, 10001 New proposed generic TDS products. FDA the discussions could disclose
Hampshire Ave., Hillandale Building, also specifically invites comments confidential trade secrets or commercial
4th Floor, Silver Spring, MD 20993– regarding the comparative assessment of property such as patentable material,
0002. Send one self-addressed adhesive sensitization itself, i.e., whether there and personal information concerning
label to assist that office in processing are clinical scenarios where a individuals associated with the grant
your requests. See the SUPPLEMENTARY comparative sensitization assessment applications, the disclosure of which
INFORMATION section for electronic may be uninformative when done in would constitute a clearly unwarranted
access to the draft guidance document. addition to a comparative irritation invasion of personal privacy.
FOR FURTHER INFORMATION CONTACT: assessment. Name of Committee: Center for Scientific
Diana Solana-Sodeinde, Center for Drug This draft guidance is being issued Review Special Emphasis Panel;
Evaluation and Research, Food and consistent with FDA’s good guidance Neurobiology of Learning and Memory.
Drug Administration, 10903 New practices regulation (21 CFR 10.115). Date: October 24, 2018.
Hampshire Ave., Bldg. 75, Rm. 2724, The draft guidance, when finalized, will Time: 8:00 a.m. to 5:00 p.m.
represent the current thinking of FDA Agenda: To review and evaluate grant
Silver Spring, MD 20993–0002, 240– applications.
402–3908. on ‘‘Assessing the Irritation and
Place: The Fairmont Washington, DC, 2401
SUPPLEMENTARY INFORMATION:
Sensitization Potential of Transdermal M Street NW, Washington, DC 20037.
and Topical Delivery Systems for Contact Person: Alexei Kondratyev, Ph.D.,
I. Background ANDAs.’’ It does not establish any rights Scientific Review Officer, Center for
FDA is announcing the availability of for any person and is not binding on Scientific Review, National Institutes of
a draft guidance for industry entitled FDA or the public. You can use an Health, 6701 Rockledge Drive, Room 5200,
alternative approach if it satisfies the MSC 7846, Bethesda, MD 20892, 301–435–
‘‘Assessing the Irritation and 1785, kondratyevad@csr.nih.gov.
Sensitization Potential of Transdermal requirements of the applicable statutes
and regulations. This guidance is not Name of Committee: Center for Scientific
and Topical Delivery Systems for Review Special Emphasis Panel; PAR Panel:
ANDAs.’’ subject to Executive Order 12866.
Health Disparities in and Caregiving for
The components and composition of II. Paperwork Reduction Act of 1995 Alzheimer’s Disease.
a TDS formulation, including the nature Date: November 2, 2018.
This draft guidance refers to Time: 8:00 a.m. to 5:00 p.m.
of the drug substance and/or the
previously approved collections of Agenda: To review and evaluate grant
occlusivity of the TDS materials, in
information found in FDA regulations. applications.
conjunction with other factors such as
These collections of information are Place: National Institutes of Health, 6701
the environmental humidity or the Rockledge Drive, Bethesda, MD 20892.
subject to review by the Office of
condition of the skin, may have the Contact Person: Gabriel B. Fosu, Ph.D.,
Management and Budget (OMB) under
potential to irritate the skin or lead to Scientific Review Officer, Center for
the Paperwork Reduction Act of 1995
a sensitization reaction. Such reactions Scientific Review, National Institutes of
(44 U.S.C. 3501–3520). The collections Health, 6701 Rockledge Drive, Room 3108,
can be unpleasant to the patient and
of information in 21 CFR 314.94 have MSC 7808, Bethesda, MD 20892, (301) 435–
may affect patient compliance, skin
been approved under OMB control 3562, fosug@csr.nih.gov.
permeability, and/or adhesion of the
number 0910–0001. Name of Committee: Center for Scientific
TDS to the skin. The collective
consequence of these potential effects Review Special Emphasis Panel; Fellowship:
III. Electronic Access
Infectious Diseases and Microbiology.
could create uncertainty about the Persons with access to the internet Date: November 5–6, 2018.
resulting drug delivery profile and may obtain the draft guidance at either Time: 8:00 a.m. to 5:00 p.m.
uncertainty about the rate and extent of https://www.fda.gov/Drugs/Guidance Agenda: To review and evaluate grant
drug absorption from the TDS. ComplianceRegulatoryInformation/ applications.
Therefore, applicants should perform a Place: Hotel Palomar, 2121 P Street NW,
Guidances/default.htm or https:// Washington, DC 20037.
comparative assessment of the test (T) www.regulations.gov.
and reference (R) TDS products using an Contact Person: Tamara Lyn McNealy,
Dated: October 3, 2018. Ph.D., Scientific Review Officer, Center for
appropriately designed skin I/S study Scientific Review, National Institutes of
with human subjects to demonstrate Leslie Kux,
Health, 6701 Rockledge Drive, Room 3188,
that the potential for a skin irritation or Associate Commissioner for Policy. Bethesda, MD 20892, 301–827–2372,
sensitization reaction with the T TDS is [FR Doc. 2018–21958 Filed 10–9–18; 8:45 am] tamara.mcnealy@nih.gov.
no worse than the reaction observed BILLING CODE 4164–01–P Name of Committee: Center for Scientific
with the R TDS. Review Special Emphasis Panel;
This draft guidance provides Fellowships: Risk, Prevention and Health
recommendations for the design and DEPARTMENT OF HEALTH AND Behavior.
conduct of studies to evaluate the in HUMAN SERVICES Date: November 5–6, 2018.
Time: 8:00 a.m. to 5:00 p.m.
vivo skin I/S potential of a proposed Agenda: To review and evaluate grant
TDS. The recommendations in this draft National Institutes of Health
applications.
guidance relate exclusively to studies Place: Embassy Suites at the Chevy Chase
Center for Scientific Review; Notice of
submitted in support of an ANDA. Pavilion, 4300 Military Road NW,
Closed Meetings
The Agency is seeking comments on Washington, DC 20015.
the recommendations reflected in the Pursuant to section 10(d) of the Contact Person: Martha M. Faraday, Ph.D.,
draft guidance announced in this notice. Federal Advisory Committee Act, as Scientific Review Officer, Center for
amozie on DSK3GDR082PROD with NOTICES1
In addition, FDA invites comments on Scientific Review, National Institutes of
amended, notice is hereby given of the Health, 6701 Rockledge Drive, Room 3110,
the scales and any alternative following meetings. MSC 7808, Bethesda, MD 20892, (301) 435–
approaches, including those The meetings will be closed to the 3575, faradaym@csr.nih.gov.
recommended by international public in accordance with the Name of Committee: Center for Scientific
regulatory agencies, that may have been provisions set forth in sections Review Special Emphasis Panel; Member
used with success for the comparative 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Conflict: Bioengineering Sciences and
assessment of the I/S potential for as amended. The grant applications and Technologies.
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![Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices 50947
Date: November 5, 2018. DEPARTMENT OF HOMELAND Further, you are authorized to make
Time: 11:00 a.m. to 3:00 p.m. SECURITY changes to this declaration for the approved
Agenda: To review and evaluate grant assistance to the extent allowable under the
applications. Federal Emergency Management Stafford Act.
Place: National Institutes of Health, 6701 Agency
Rockledge Drive, Bethesda, MD 20817,
The time period prescribed for the
(Telephone Conference Call). [Internal Agency Docket No. FEMA–4396– implementation of section 310(a),
Contact Person: Nitsa Rosenzweig, Ph.D., DR; Docket ID FEMA–2018–0001] Priority to Certain Applications for
Scientific Review Officer, Center for Public Facility and Public Housing
Scientific Review, National Institutes of Commonwealth of the Northern Assistance, 42 U.S.C. 5153, shall be for
Health, 6701 Rockledge Drive, Room 4152, Mariana Islands; Major Disaster and a period not to exceed six months after
MSC 7760, Bethesda, MD 20892, (301) 404– Related Determinations the date of this declaration.
7419, rosenzweign@csr.nih.gov. The Federal Emergency Management
Name of Committee: Center for Scientific AGENCY: Federal Emergency
Agency (FEMA) hereby gives notice that
Review Special Emphasis Panel; Member Management Agency, DHS.
pursuant to the authority vested in the
Conflict: Topics in Nephrology. ACTION: Notice. Administrator, under Executive Order
Date: November 5, 2018. 12148, as amended, Benigno Bern Ruiz,
Time: 1:00 p.m. to 4:00 p.m. SUMMARY: This is a notice of the
Presidential declaration of a major of FEMA is appointed to act as the
Agenda: To review and evaluate grant
applications. disaster for the Commonwealth of the Federal Coordinating Officer for this
Place: National Institutes of Health, 6701 Northern Mariana Islands (FEMA–4396– major disaster.
Rockledge Drive, Bethesda, MD 20892, DR), dated September 29, 2018, and The following areas of the
(Telephone Conference Call). related determinations. Commonwealth of the Northern Mariana
Contact Person: Julia Spencer Barthold, DATES: The declaration was issued
Islands have been designated as
MD, Scientific Review Officer, Center for
September 29, 2018. adversely affected by this major disaster:
Scientific Review, National Institutes of
FOR FURTHER INFORMATION CONTACT: The islands of Rota, Saipan, and Tinian for
Health, 6701 Rockledge Drive, Bethesda, MD
Dean Webster, Office of Response and Individual Assistance.
20892, julia.barthold@nih.gov.
The islands of Rota, Saipan and Tinian for
Name of Committee: Center for Scientific Recovery, Federal Emergency
Public Assistance.
Review Special Emphasis Panel; Member Management Agency, 500 C Street SW, All areas within the Commonwealth of the
Conflict: Traumatic Brain Injury. Washington, DC 20472, (202) 646–2833. Northern Mariana Islands are eligible for
Date: November 5, 2018. SUPPLEMENTARY INFORMATION: Notice is assistance under the Hazard Mitigation Grant
Time: 1:00 p.m. to 5:00 p.m. hereby given that, in a letter dated Program.
Agenda: To review and evaluate grant September 29, 2018, the President The following Catalog of Federal Domestic
applications.
issued a major disaster declaration Assistance Numbers (CFDA) are to be used
Place: National Institutes of Health, 6701 for reporting and drawing funds: 97.030,
Rockledge Drive, Bethesda, MD 20892, under the authority of the Robert T.
Stafford Disaster Relief and Emergency Community Disaster Loans; 97.031, Cora
(Telephone Conference Call). Brown Fund; 97.032, Crisis Counseling;
Contact Person: Alexander Yakovlev, Assistance Act, 42 U.S.C. 5121 et seq.
97.033, Disaster Legal Services; 97.034,
Ph.D., Scientific Review Officer, Center for (the ‘‘Stafford Act’’), as follows:
Disaster Unemployment Assistance (DUA);
Scientific Review, National Institutes of I have determined that the damage in 97.046, Fire Management Assistance Grant;
Health, 6701 Rockledge Drive, Room 5206, certain areas of the Commonwealth of the 97.048, Disaster Housing Assistance to
MSC 7846, Bethesda, MD 20892–7846, 301– Northern Mariana Islands resulting from Individuals and Households In Presidentially
435–1254, yakovleva@csr.nih.gov. Typhoon Mangkhut during the period of Declared Disaster Areas; 97.049,
Name of Committee: Center for Scientific September 10 to September 11, 2018, is of Presidentially Declared Disaster Assistance—
Review Special Emphasis Panel; Member sufficient severity and magnitude to warrant Disaster Housing Operations for Individuals
Conflict: Healthcare Delivery and a major disaster declaration under the Robert and Households; 97.050, Presidentially
Methodologies. T. Stafford Disaster Relief and Emergency Declared Disaster Assistance to Individuals
Date: November 5, 2018. Assistance Act, 42 U.S.C. 5121 et seq. (the and Households—Other Needs; 97.036,
Time: 12:00 p.m. to 3:00 p.m. ‘‘Stafford Act’’). Therefore, I declare that such Disaster Grants—Public Assistance
Agenda: To review and evaluate grant a major disaster exists in the Commonwealth (Presidentially Declared Disasters); 97.039,
applications. of the Northern Mariana Islands. Hazard Mitigation Grant.
Place: National Institutes of Health, 6701 In order to provide Federal assistance, you
Rockledge Drive, Bethesda, MD 20892, are hereby authorized to allocate from funds Brock Long,
(Telephone Conference Call). available for these purposes such amounts as Administrator, Federal Emergency
Contact Person: Jacinta Bronte-Tinkew, you find necessary for Federal disaster Management Agency.
Ph.D., Scientific Review Officer, Center for assistance and administrative expenses. [FR Doc. 2018–21927 Filed 10–9–18; 8:45 am]
Scientific Review, National Institutes of You are authorized to provide Individual
BILLING CODE 9111–11–P
Health, 6701 Rockledge Drive, Room 3164, Assistance and Public Assistance in the
MSC 7770, Bethesda, MD 20892, (301) 806– designated areas and Hazard Mitigation
0009, brontetinkewjm@csr.nih.gov. throughout the Commonwealth. Consistent
with the requirement that Federal assistance DEPARTMENT OF HOMELAND
(Catalogue of Federal Domestic Assistance SECURITY
be supplemental, any Federal funds provided
Program Nos. 93.306, Comparative Medicine;
under the Stafford Act for Hazard Mitigation
93.333, Clinical Research, 93.306, 93.333, Federal Emergency Management
and Other Needs Assistance will be limited
93.337, 93.393–93.396, 93.837–93.844, to 75 percent of the total eligible costs. Agency
93.846–93.878, 93.892, 93.893, National Federal funds provided under the Stafford
amozie on DSK3GDR082PROD with NOTICES1
Institutes of Health, HHS) Act for Public Assistance also will be limited [Internal Agency Docket No. FEMA–4366–
Dated: October 2, 2018. to 75 percent of the total eligible costs, with DR; Docket ID FEMA–2018–0001]
Sylvia L. Neal, the exception of projects that meet the
eligibility criteria for a higher Federal cost- Hawaii; Amendment No. 4 to Notice of
Program Analyst, Office of Federal Advisory
sharing percentage under the Public a Major Disaster Declaration
Committee Policy.
Assistance Alternative Procedures Pilot
[FR Doc. 2018–21898 Filed 10–9–18; 8:45 am] Program for Debris Removal implemented AGENCY:Federal Emergency
BILLING CODE 4140–01–P pursuant to section 428 of the Stafford Act. Management Agency, DHS.
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Document Created: 2018-10-10 17:37:17
Document Modified: 2018-10-10 17:37:17
| 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 | October 24, 2018. | |
| FR Citation | 83 FR 50946 |
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