82 FR 35975 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 147 (August 2, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 147 (August 2, 2017)
| Page Range | 35975-35976 | |
| FR Document | 2017-16192 |
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)] [Notices] [Pages 35975-35976] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16192] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of meetings of the National Diabetes and Digestive and Kidney Diseases Advisory Council. The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. 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 [[Page 35976]] applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council. Date: September 6, 2017. Open: 8:30 a.m. to 12:00 p.m. Agenda: To present the Director's Report and other scientific presentations. Place: National Institutes of Health, Natcher Building Forty- five, Conference Rooms E1/E2, 45 Center Drive, Bethesda, MD 20892. Closed: 3:45 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building Forty- five, Conference Rooms E1/E2, 45 Center Drive, Bethesda, MD 20892. Contact Person: Brent B. Stanfield, Ph.D., Director, Division of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd. Room 7323, MSC 5452, Bethesda, MD 20892, (301) 594-8843, [email protected]. Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council; Diabetes, Endocrinology and Metabolic Diseases. Date: September 6, 2017. Closed: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building Forty- five, Natcher Conference Center, Room E1, 45 Center Drive, Bethesda, MD 20892. Open: 2:00 p.m. to 3:30 p.m. Agenda: To review the Division's scientific and planning activities. Place: National Institutes of Health, Natcher Building Forty- five, Natcher Conference Center, Room E1, 45 Center Drive, Bethesda, MD 20892. Contact Person: Brent B. Stanfield, Ph.D., Director, Division of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd. Room 7323, MSC 5452, Bethesda, MD 20892, (301) 594-8843, [email protected]. Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council; Kidney, Urologic and Hematologic Diseases. Date: September 6, 2017. Open: 1:00 p.m. to 3:00 p.m. Agenda: To review the Division's scientific and planning activities. Place: National Institutes of Health, Natcher Building Forty- five, Natcher Conference Center, Room F2, 45 Center Drive, Bethesda, MD 20892. Closed: 3:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building Forty- five, Natcher Conference Center, Room F2, 45 Center Drive, Bethesda, MD 20892. Contact Person: Brent B. Stanfield, Ph.D., Director, Division of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd. Room 7323, MSC 5452, Bethesda, MD 20892, (301) 594-8843, [email protected]. Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council; Digestive Diseases and Nutrition. Date: September 6, 2017. Open: 1:00 p.m. to 2:00 p.m. Agenda: To review the Division's scientific and planning activities. Place: National Institutes of Health, Natcher Building Forty- five, Natcher Conference Center, Room F1, 45 Center Drive, Bethesda, MD 20892. Closed: 2:15 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building Forty- five, Natcher Conference Center, Room F1, 45 Center Drive, Bethesda, MD 20892. Contact Person: Brent B. Stanfield, Ph.D., Director, Division of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd. Room 7323, MSC 5452, Bethesda, MD 20892, (301) 594-8843, [email protected]. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Information is also available on the Institute's/Center's home page: www.niddk.nih.gov/fund/divisions/DEA/Council/coundesc.htm., where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: July 27, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017-16192 Filed 8-1-17; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35975
seeking nominations of qualified may include, but are not limited to, a consideration for membership on HHS
candidates to be considered for review of assurance systems, the Federal advisory committees.
appointment as members of the application of minimal research risk Appointment to this Committee shall be
Secretary’s Advisory Committee on standards, the granting of waivers, made without discrimination on the
Human Research Protections (SACHRP). education programs sponsored by basis of age, race, ethnicity, gender,
SACHRP provides advice and OHRP, and the ongoing monitoring and sexual orientation, disability, and
recommendations to the Secretary, HHS oversight of institutional review boards cultural, religious, or socioeconomic
(Secretary), through the Assistant and the institutions that sponsor status.
Secretary for Health, on matters research. Individuals who are selected to be
pertaining to the continuance and Nominations: The OHRP is requesting considered for appointment will be
improvement of functions within the nominations to fill four positions for required to provide detailed information
authority of HHS directed toward voting members of SACHRP. One regarding their financial holdings,
protections for human subjects in position will become vacant in January consultancies, and research grants or
research. SACHRP was established by 2018, with three others becoming vacant contracts. Disclosure of this information
the Secretary on October 1, 2002. OHRP in October 2018. Nominations of is necessary in order to determine if the
is seeking nominations of qualified potential candidates for consideration selected candidate is involved in any
candidates to fill four positions on the are being sought from a wide array of activity that may pose a potential
Committee membership that will be fields, including, but not limited to: conflict with the official duties to be
vacated during the 2018 calendar year. public health and medicine, behavioral performed as a member of SACHRP.
DATES: Nominations for membership on and social sciences, health
the Committee must be received no later administration, and biomedical ethics. Authority: 42 U.S.C. 217a, Section 222 of
To qualify for consideration of the Public Health Service Act, as amended.
than September 18, 2017.
appointment to the Committee, an The Committee is governed by the provisions
ADDRESSES: Nominations should be of Public Law 92–463, as amended (5 U.S.C.
mailed or delivered to Dr. Jerry individual must possess demonstrated
Appendix 2), which sets forth standards for
Menikoff, Director, Office for Human experience and expertise in any of the the formation and use of advisory
Research Protections, Department of several disciplines and fields pertinent committees.
Health and Human Services, 1101 to human subjects protection and/or
Dated: July 26, 2017.
Wootton Parkway, Suite 200, Rockville, clinical research.
The individuals selected for Julia Gorey,
MD 20852. Nominations will not be Executive Director, Secretary’s Advisory
accepted by email or by facsimile. appointment to the Committee can be
invited to serve a term of up to four Committee on Human Research Protections,
FOR FURTHER INFORMATION CONTACT: Julia Office for Human Research Protections
years. Committee members receive a
Gorey, Executive Director, SACHRP, [FR Doc. 2017–16156 Filed 8–1–17; 8:45 am]
stipend and reimbursement for per diem
Office for Human Research Protections,
and any travel expenses incurred for BILLING CODE 4150–36–P
1101 Wootton Parkway, Suite 200,
attending Committee meetings and/or
Rockville, MD 20852, telephone: 240–
conducting other business in the
453–8141. A copy of the Committee DEPARTMENT OF HEALTH AND
interest of the Committee. Interested
charter and list of the current members HUMAN SERVICES
applicants may self-nominate.
can be obtained by contacting Ms. Nominations should be typewritten.
Gorey, accessing the SACHRP Web site The following information should be National Institutes of Health
at www.hhs.gov/ohrp/sachrp, or included in the package of material
requesting via email at sachrp@ National Institute of Diabetes and
submitted for each individual being
osophs.dhhs.gov. Digestive and Kidney Diseases; Notice
nominated for consideration: (1) A letter
of Meetings
SUPPLEMENTARY INFORMATION: The of nomination that clearly states the
Committee provides advice on matters name and affiliation of the nominee, the Pursuant to section 10(d) of the
pertaining to the continuance and basis for the nomination (i.e., specific Federal Advisory Committee Act, as
improvement of functions within the attributes which qualify the nominee for amended (5 U.S.C. App.), notice is
authority of HHS directed toward service in this capacity), and a statement hereby given of meetings of the National
protections for human subjects in that the nominee is willing to serve as Diabetes and Digestive and Kidney
research. Specifically, the Committee a member of the Committee; (2) the Diseases Advisory Council.
provides advice relating to the nominator’s name, address, daytime The meetings will be open to the
responsible conduct of research telephone number, and the home and/ public as indicated below, with
involving human subjects with or work address, telephone number, and attendance limited to space available.
particular emphasis on special email address of the individual being Individuals who plan to attend and
populations such as neonates and nominated; and (3) a current copy of the need special assistance, such as sign
children, prisoners, the decisionally nominee’s curriculum vitae. Federal language interpretation or other
impaired, pregnant women, embryos employees should not be nominated for reasonable accommodations, should
and fetuses, individuals and consideration of appointment to this notify the Contact Person listed below
populations in international studies, Committee. in advance of the meeting.
investigator conflicts of interest and The Department makes every effort to The meetings will be closed to the
populations in which there are ensure that the membership of HHS public in accordance with the
Federal advisory committees is fairly provisions set forth in sections
sradovich on DSKBCFCHB2PROD with NOTICES
individually identifiable samples, data
or information. balanced in terms of points of view 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
In addition, the Committee is represented and the committee’s as amended. The grant applications and
responsible for reviewing selected function. Every effort is made to ensure the discussions could disclose
ongoing work and planned activities of that individuals from a broad confidential trade secrets or commercial
the OHRP and other offices/agencies representation of geographic areas, property such as patentable material,
within HHS responsible for human women and men, ethnic and minority and personal information concerning
subjects protection. These evaluations groups, and the disabled are given individuals associated with the grant
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![35976 Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
applications, the disclosure of which Room 7323, MSC 5452, Bethesda, MD 20892, Molecular Analysis for Therapy Choice
would constitute a clearly unwarranted (301) 594–8843, stanfibr@niddk.nih.gov. (MATCH) trial leadership (NCT
invasion of personal privacy. Name of Committee: National Diabetes and 02465060) invites applications for
Digestive and Kidney Diseases Advisory Clinical Laboratory Improvements
Name of Committee: National Diabetes and Council; Digestive Diseases and Nutrition.
Digestive and Kidney Diseases Advisory Program (CLIA) certified/accredited
Date: September 6, 2017.
Council. laboratories that test tumor specimens
Open: 1:00 p.m. to 2:00 p.m.
Date: September 6, 2017. Agenda: To review the Division’s scientific from patients utilizing Next Generation
Open: 8:30 a.m. to 12:00 p.m. and planning activities. Sequencing (NGS) assays to participate
Agenda: To present the Director’s Report Place: National Institutes of Health, in the NCI MATCH trial. The NCI
and other scientific presentations. Natcher Building Forty-five, Natcher MATCH trial has implemented a new
Place: National Institutes of Health, Conference Center, Room F1, 45 Center process for identifying patients for arms
Natcher Building Forty-five, Conference Drive, Bethesda, MD 20892.
Rooms E1/E2, 45 Center Drive, Bethesda, MD
with rare variant eligibility criteria.
Closed: 2:15 p.m. to 3:30 p.m. Laboratories will contact any of the
20892. Agenda: To review and evaluate grant
Closed: 3:45 p.m. to 4:30 p.m. approximately 1100 sites that have
applications.
Agenda: To review and evaluate grant activated NCI MATCH if a specimen
Place: National Institutes of Health,
applications. Natcher Building Forty-five, Natcher sent from one of these sites has a rare
Place: National Institutes of Health, Conference Center, Room F1, 45 Center variant that would potentially make the
Natcher Building Forty-five, Conference Drive, Bethesda, MD 20892. patient eligible for one of the treatment
Rooms E1/E2, 45 Center Drive, Bethesda, MD Contact Person: Brent B. Stanfield, Ph.D., arms open in this initiative.
20892. Director, Division of Extramural Activities,
Contact Person: Brent B. Stanfield, Ph.D., DATES: LOIs should be submitted to the
National Institutes of Diabetes and Digestive National Cancer Institute (NCI),
Director, Division of Extramural Activities, and Kidney Diseases, 6707 Democracy Blvd.
National Institutes of Diabetes and Digestive National Institutes of Health (NIH) on or
Room 7323, MSC 5452, Bethesda, MD 20892,
and Kidney Diseases, 6707 Democracy Blvd. (301) 594–8843, stanfibr@niddk.nih.gov.
before 5:00 p.m. EST on January 31,
Room 7323, MSC 5452, Bethesda, MD 20892, 2018.
(301) 594–8843, stanfibr@niddk.nih.gov. Any interested person may file written
comments with the committee by forwarding ADDRESSES: Submit LOIs by email to
Name of Committee: National Diabetes and the statement to the Contact Person listed on NCIMATCHLabApps@nih.gov. 9609
Digestive and Kidney Diseases Advisory this notice. The statement should include the
Council; Diabetes, Endocrinology and
Medical Center Drive, 3 West, Room
name, address, telephone number and when 526, MSC 9728, Rockville, MD 20892.
Metabolic Diseases. applicable, the business or professional
Date: September 6, 2017. FOR FURTHER INFORMATION CONTACT:
affiliation of the interested person.
Closed: 1:00 p.m. to 2:00 p.m. In the interest of security, NIH has Questions about this request for LOIs
Agenda: To review and evaluate grant instituted stringent procedures for entrance should be directed to
applications. onto the NIH campus. All visitor vehicles, NCIMATCHLabApps@nih.gov. James V.
Place: National Institutes of Health, including taxicabs, hotel, and airport shuttles Tricoli tricolij@mail.nih.gov can also
Natcher Building Forty-five, Natcher will be inspected before being allowed on
Conference Center, Room E1, 45 Center
provide further information.
campus. Visitors will be asked to show one SUPPLEMENTARY INFORMATION: NCI–
Drive, Bethesda, MD 20892. form of identification (for example, a
Open: 2:00 p.m. to 3:30 p.m. MATCH aims to establish whether
government-issued photo ID, driver’s license,
Agenda: To review the Division’s scientific
or passport) and to state the purpose of their patients with tumor mutations,
and planning activities. amplifications or translocations in one
visit.
Place: National Institutes of Health, of the genetic pathways of interest are
Information is also available on the
Natcher Building Forty-five, Natcher likely to derive clinical benefit (primary
Institute’s/Center’s home page:
Conference Center, Room E1, 45 Center
Drive, Bethesda, MD 20892.
www.niddk.nih.gov/fund/divisions/DEA/ objective: Objective response; secondary
Council/coundesc.htm., where an agenda and objective: Progression-free survival of at
Contact Person: Brent B. Stanfield, Ph.D.,
any additional information for the meeting least 6 months) if treated with agents
Director, Division of Extramural Activities,
will be posted when available. targeting that specific pathway in a
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd. (Catalogue of Federal Domestic Assistance single-arm design (see current arms
Room 7323, MSC 5452, Bethesda, MD 20892, Program Nos. 93.847, Diabetes, below).
(301) 594–8843, stanfibr@niddk.nih.gov. Endocrinology and Metabolic Research; Patients with histologically
93.848, Digestive Diseases and Nutrition
Name of Committee: National Diabetes and documented solid tumors, lymphomas
Research; 93.849, Kidney Diseases, Urology
Digestive and Kidney Diseases Advisory and multiple myeloma whose disease
and Hematology Research, National Institutes
Council; Kidney, Urologic and Hematologic has progressed following at least one
of Health, HHS)
Diseases. line of standard systemic therapy or for
Date: September 6, 2017. Dated: July 27, 2017.
whom no standard therapy exists are
Open: 1:00 p.m. to 3:00 p.m. David Clary,
Agenda: To review the Division’s scientific
eligible if they meet the eligibility
Program Analyst, Office of Federal Advisory criteria for the trial. Further information
and planning activities. Committee Policy.
Place: National Institutes of Health, about the NCI–MATCH trial may be
Natcher Building Forty-five, Natcher [FR Doc. 2017–16192 Filed 8–1–17; 8:45 am] found at http://ecog-acrin.org/trials/nci-
Conference Center, Room F2, 45 Center BILLING CODE 4140–01–P match-eay131.
Drive, Bethesda, MD 20892. The selected collaborating
Closed: 3:00 p.m. to 3:30 p.m. laboratories may only act (i.e., refer
Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND patients) on any of the rare variant arms
applications. HUMAN SERVICES
sradovich on DSKBCFCHB2PROD with NOTICES
for which their assay reports actionable
Place: National Institutes of Health, mutations of interest (aMOIs). The assay
Natcher Building Forty-five, Natcher National Institutes of Health
Conference Center, Room F2, 45 Center
must also report all exclusionary
Drive, Bethesda, MD 20892. Request for Letters of Interest for NCI– variants for the arm unless these occur
Contact Person: Brent B. Stanfield, Ph.D., MATCH Laboratories at a frequency of >1% in cancer
Director, Division of Extramural Activities, patients.
National Institutes of Diabetes and Digestive SUMMARY: The National Cancer Institute CLIA accredited/certified laboratories
and Kidney Diseases, 6707 Democracy Blvd. (NCI) in collaboration with the NCI located in the United States may be
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Document Created: 2017-08-02 07:09:47
Document Modified: 2017-08-02 07:09:47
| 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 | September 6, 2017. | |
| FR Citation | 82 FR 35975 |
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