81 FR 49683 - National Cancer Institute Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 145 (July 28, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 145 (July 28, 2016)
| Page Range | 49683-49684 | |
| FR Document | 2016-17810 |
[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)] [Notices] [Pages 49683-49684] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17810] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 Cancer Institute Special Emphasis Panel; NCI SPORE Review Meeting. Date: October 7, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Rockville, 1750 Rockville Pike, Rockville, MD 20892. Contact Person: Majed M. Hamawy, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W120, Rockville, MD 20892-9750, 240-276-6457, [email protected]. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Program Project Review III (P01). Date: October 13-14, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Klaus B. Piontek, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W612, Rockville, MD 20892-9750, 240-276-5413, [email protected]. Name of Committee: National Cancer Institute Special Emphasis Panel; Questions in Cancer Systems Biology. Date: October 13, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Caterina Bianco, MD, Ph.D., Scientific Review Officer, Research Programs Review, Branch Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room [[Page 49684]] 7W610, Rockville, MD 20892-9750, 240-276-6459, [email protected]. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Provocative Question #10. Date: November 3, 2016. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W030, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Denise L. Stredrick, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W640, Rockville, MD 20892-9750, 240-276-5053, [email protected]. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: July 22, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016-17810 Filed 7-27-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices 49683
IV. Fee Payment Options and Food and Drug Administration. Your DEPARTMENT OF HEALTH AND
Procedures payment can be mailed to: Food and HUMAN SERVICES
A. Initial BPD, Reactivation, Drug Administration, P.O. Box 979108,
St. Louis, MO 63197–9000. If you prefer National Institutes of Health
Application, and Supplement Fees
to send a check by a courier such as
The fees established in the new fee National Cancer Institute Notice of
Federal Express or United Parcel
schedule are effective October 1, 2016. Closed Meetings
Service, the courier may deliver the
The initial BPD fee for a product is due
check and printed copy of the cover Pursuant to section 10(d) of the
when the sponsor submits an IND that
sheet to: U.S. Bank, ATTN: Government Federal Advisory Committee Act, as
FDA determines is intended to support
Lockbox 979108, 1005 Convention amended (5 U.S.C. App.), notice is
a biosimilar biological product
Plaza, St. Louis, MO 63101. (Note: This hereby given of the following meetings.
application for the product or within 5
U.S. Bank address is for courier delivery The meetings will be closed to the
calendar days after FDA grants the first
only. Contact U.S. Bank at 314–418– public in accordance with the
BPD meeting for the product, whichever
4013 if you have any questions provisions set forth in sections
occurs first. Sponsors who have
concerning courier delivery.) Please 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
discontinued participation in the BPD
make sure that the FDA post office box as amended. The grant applications and
program must pay the reactivation fee
number (P.O. Box 979108) is written on the discussions could disclose
by the earlier of the following dates: No
confidential trade secrets or commercial
later than 5 calendar days after FDA the check, bank draft, or postal money
grants the sponsor’s request for a BPD property such as patentable material,
order.
meeting for that product, or upon the and personal information concerning
If paying by wire transfer, please individuals associated with the grant
date of submission of an IND describing
reference your unique user fee ID applications, the disclosure of which
an investigation that FDA determines is
number when completing your transfer. would constitute a clearly unwarranted
intended to support a biosimilar
biological product application. The originating financial institution invasion of personal privacy.
The application or supplement fee for may charge a wire transfer fee. Please Name of Committee: National Cancer
a biosimilar biological product is due ask your financial institution about the Institute Special Emphasis Panel; NCI SPORE
upon submission of the application or fee and include it with your payment to Review Meeting.
supplement. ensure that your fee is fully paid. The Date: October 7, 2016.
To make a payment of the initial BPD, account information is as follows: U.S. Time: 8:00 a.m. to 6:00 p.m.
reactivation, supplement, or application Agenda: To review and evaluate grant
Department of Treasury, TREAS NYC,
applications.
fee, complete the Biosimilar User Fee 33 Liberty St., New York, NY 10045, Place: Hilton Rockville, 1750 Rockville
Cover Sheet, available on FDA’s Web Acct. No.: 75060099, Routing No.: Pike, Rockville, MD 20892.
site (http://www.fda.gov/bsufa) and 021030004, SWIFT: FRNYUS33, Contact Person: Majed M. Hamawy, Ph.D.,
generate a user fee identification (ID) Beneficiary: FDA, 8455 Colesville Rd., Scientific Review Officer, Research Programs
number. Payment must be made in U.S. 14th Floor, Silver Spring, MD 20993– Review Branch, Division of Extramural
currency by electronic check, check, 0002. Activities, National Cancer Institute, 9609
bank draft, U.S. postal money order, or Medical Center Drive, Room 7W120,
wire transfer. The preferred payment The tax identification number of FDA Rockville, MD 20892–9750, 240–276–6457,
method is online using electronic check is 53–0196965. mh101v@nih.gov.
(Automated Clearing House (ACH) also Name of Committee: National Cancer
B. Annual BPD, Establishment, and Institute Special Emphasis Panel; NCI
known as eCheck) or credit card Product Fees Program Project Review III (P01).
(Discover, VISA, MasterCard, American Date: October 13–14, 2016.
Express). Secure electronic payments FDA will issue invoices for annual Time: 8:00 a.m. to 5:00 p.m.
can be submitted using the User Fees BPD, biosimilar biological product Agenda: To review and evaluate grant
Payment Portal at https:// establishment, and biosimilar biological applications.
userfees.fda.gov/pay. Once you search product fees under the new fee schedule Place: Bethesda North Marriott Hotel &
for your invoice, click ‘‘Pay Now’’ to be in August 2016. Payment instructions Conference Center, 5701 Marinelli Road,
redirected to Pay.gov. Note that will be included in the invoices. North Bethesda, MD 20852.
electronic payment options are based on Contact Person: Klaus B. Piontek, Ph.D.,
Payment will be due on October 1, 2016. Scientific Review Officer, Research Programs
the balance due. Payment by credit card If sponsors join the BPD program after Review Branch, Division of Extramural
is available for balances less than the annual BPD invoices have been Activities, National Cancer Institute, 9609
$25,000. If the balance exceeds this issued in August 2016, FDA will issue Medical Center Drive, Room 7W612,
amount, only the ACH option is invoices in November 2016 to firms Rockville, MD 20892–9750, 240–276–5413,
available. Payments must be drawn on subject to fees for FY 2017 that qualify klaus.piontek@nih.gov.
U.S bank accounts as well as U.S. credit Name of Committee: National Cancer
for the annual BPD fee after the August
cards. Institute Special Emphasis Panel; Questions
FDA has partnered with the U.S. 2016 billing. FDA will issue invoices in
in Cancer Systems Biology.
Department of the Treasury to use November 2017 for any annual products Date: October 13, 2016.
http://www.pay.gov, a Web-based and establishments subject to fees for Time: 8:00 a.m. to 6:00 p.m.
payment application, for online FY 2017 that qualify for fee assessments Agenda: To review and evaluate grant
electronic payment. The Pay.gov feature after the August 2016 billing. applications.
Place: Bethesda North Marriott Hotel &
Lhorne on DSK30JT082PROD with NOTICES
is available on FDA’s Web site after Dated: July 22, 2016.
Conference Center, 5701 Marinelli Road,
completing the Biosimilar User Fee Leslie Kux, North Bethesda, MD 20852.
Cover Sheet and generating the user fee Contact Person: Caterina Bianco, MD,
Associate Commissioner for Policy.
ID number. Ph.D., Scientific Review Officer, Research
Please include the user fee ID number [FR Doc. 2016–17800 Filed 7–27–16; 8:45 am]
Programs Review, Branch Division of
on your check, bank draft, or postal BILLING CODE 4164–01–P Extramural Activities, National Cancer
money order, and make it payable to the Institute, 9609 Medical Center Drive, Room
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![49684 Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices
7W610, Rockville, MD 20892–9750, 240– quality, utility, and clarity of the areas for improvement, scope of
276–6459, biancoc@mail.nih.gov. information to be collected; and (d) IECMHC implementation across the
Name of Committee: National Cancer ways to minimize the burden of the State or Tribe, and IECMHC impact on
Institute Special Emphasis Panel; NCI collection of information on childcare and pre-K expulsion rates.
Provocative Question #10. respondents, including through the use
Date: November 3, 2016. Data-collection efforts will focus on
Time: 11:00 a.m. to 3:00 p.m.
of automated collection techniques or two types of respondents: (1) Mental
Agenda: To review and evaluate grant other forms of information technology. health consultants employed at
applications. Proposed Project: National Center of maternal and child health, behavioral
Place: National Cancer Institute Shady Excellence for Infant and Early health, child care, Head Start, education
Grove, 9609 Medical Center Drive, Room
7W030, Rockville, MD 20850, (Telephone Childhood Mental Health and child welfare agencies, and (2) State
Conference Call). Consultation—NEW or tribal representatives who have been
Contact Person: Denise L. Stredrick, Ph.D., The Substance Abuse and Mental selected to lead the implementation,
Scientific Review Officer, Special Review Health Services Administration’s expansion and sustainability of IECMHC
Branch, Division of Extramural Activities, (SAMHSA), Center for Mental Health in their state or tribal community.
National Cancer Institute, 9609 Medical
Center Drive, Room 7W640, Rockville, MD Services, in partnership with the Health The mental health consultants will be
20892–9750, 240–276–5053, stredrid@ Resources and Services Administration asked to provide background
mail.nih.gov. (HRSA) and the Administration for information on their prior experience in
(Catalogue of Federal Domestic Assistance Children and Families (ACF), the IECMHC field, feedback
Program Nos. 93.392, Cancer Construction; announces the establishment of the immediately following the trainings,
93.393, Cancer Cause and Prevention National Center of Excellence (CoE) for and follow-up feedback approximately
Research; 93.394, Cancer Detection and Infant and Early Childhood Mental two months after receiving training and/
Diagnosis Research; 93.395, Cancer Health Consultation (IECMHC), a new or technical assistance. Specific sample
Treatment Research; 93.396, Cancer Biology program to advance the implementation questions will include level of
Research; 93.397, Cancer Centers Support; of high-quality infant and early satisfaction with the training/technical
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
childhood mental health consultation assistance, perceptions of knowledge
HHS) across the nation through the acquired, intentions to use training
development of tools, resources, content, extent of implementation of
Dated: July 22, 2016. training, technical assistance, and content, and opinions regarding the
Melanie J. Gray, collaborative public and private training’s cultural appropriateness for
Program Analyst, Office of Federal Advisory partnerships. Its primary goals will be to its audience.
Committee Policy. promote the healthy social and
State/tribal representatives will be
[FR Doc. 2016–17810 Filed 7–27–16; 8:45 am] emotional development of infants and
asked to report on the reach and impact
BILLING CODE 4140–01–P young children and to prevent mental,
of the IECMHC program in the past year,
emotional and behavioral disorders
level of satisfaction with IECMHC,
within this age group. Major activities
DEPARTMENT OF HEALTH AND suggested improvements for the
for the CoE include convening a
HUMAN SERVICES program, and emerging state/tribal
national expert workgroup and to lead
needs that the program could address.
the workgroup in developing a state-of-
Substance Abuse and Mental Health IECMHC mentors, whose primary role
the-art Toolkit of the latest research and
Services Administration best practices for IECMHC (e.g., training, will be to work with the state/tribal
implementation, evaluation and representatives to implement the
Agency Information Collection IECMHC Toolkit, will gather specific
financing) for early childhood settings,
Activities: Proposed Collection; information from the representatives,
including early care and education and
Comment Request including recommended IECMHC
home visiting programs. The CoE will
In compliance with Section also create a dissemination and training professional standards for mental health
3506(c)(2)(A) of the Paperwork plan for the Toolkit, and provide consultants, state- or tribal-level
Reduction Act of 1995 concerning intensive training and technical evaluations of IECMHC impact, and
opportunity for public comment on assistance to states and tribes to help financing for the continuation of
proposed collections of information, the them build their capacity to implement, IECMHC. For programs also receiving
Substance Abuse and Mental Health fund and evaluate IECMHC efforts funding from the Maternal Infant and
Services Administration (SAMHSA) successfully. Early Childhood Home Visiting
will publish periodic summaries of To monitor the reach, implementation (MIECHV) program, representatives will
proposed projects. To request more and impact of the CoE’s multiple efforts, be asked to report on selected MIECHV
information on the proposed projects or learn which practices work for which outcome measures relating to maternal
to obtain a copy of the information populations, and gauge overall and newborn health; school readiness
collection plans, call the SAMHSA applicability and utility of the Toolkit to and achievement; and coordination and
Reports Clearance Officer on (240) 276– infant and early childhood mental referrals for other community resources
1243. health consultation, the CoE intends to and supports.
Comments are invited on: (a) Whether employ a variety of standardized SAMHSA will use this data to
the proposed collections of information process and outcome measures that determine whether funded activities are
are necessary for the proper have been specifically designed to progressing as expected, provide
Lhorne on DSK30JT082PROD with NOTICES
performance of the functions of the reduce participant burden. Measures guidance to improve how work is being
agency, including whether the will explore the related professional conducted, assess the impact of
information shall have practical utility; background and experience of IECMHC IECMHC on child-serving systems, and
(b) the accuracy of the agency’s estimate participants, degree of satisfaction with inform subsequent national, state, tribal
of the burden of the proposed collection IECMHC trainings and technical and community policy and planning
of information; (c) ways to enhance the assistance (TTA), usefulness of the TTA, decisions.
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Document Created: 2016-07-28 01:47:43
Document Modified: 2016-07-28 01:47:43
| 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 7, 2016. | |
| FR Citation | 81 FR 49683 |
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