National Institute of Environmental Health Sciences; Notice of Meeting, 62550-62551 [2015-26341]
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62550
Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
Even if an oversight body does not request
that a particular protocol be reviewed by the
RAC, the NIH Director, after consultation (if
needed) with appropriate regulatory
authorities, may initiate RAC review if (a) the
protocol has one or more of the
characteristics listed above (i, ii, or iii) and
public RAC review and discussion would
provide a clear and obvious benefit to the
scientific community or public; or (b) the
protocol otherwise raises significant
scientific, societal, or ethical concerns.
Completion of the registration process is
defined as: (1) Receipt by the Principal
Investigator of a letter from the NIH OSP
indicating that protocol registration process
is complete and that enrollment may
proceed; or (2) receipt by the Principal
Investigator of a letter from the NIH after
public RAC review that summarizes the
committee’s key comments and
recommendations (if any).
A complete human gene transfer protocol
package must be submitted at least eight
weeks before a scheduled RAC meeting to be
reviewed at that upcoming meeting.
After a human gene transfer experiment is
publicly reviewed by the full RAC at a
regularly scheduled meeting, the NIH OSP
will send a letter summarizing the RAC’s key
comments and recommendations (if any)
regarding the protocol to the Principal
Investigator(s), oversight bodies, and
regulatory authorities as appropriate.
Completion of RAC review is defined as
receipt by the Principal Investigator(s) of a
letter from the NIH OSP summarizing the
committee’s findings. Unless the NIH
determines that there are exceptional
circumstances, the letter containing
recommendations and comments made
following public review will be sent within
10 working days after the completion of the
RAC meeting at which the protocol was
reviewed.
RAC meetings will be open to the public
except where trade secrets or confidential
commercial information are reviewed. To
enable all aspects of the protocol review
process to be open to the public, information
provided in response to Appendix M–I–A
should not contain trade secrets or
confidential commercial or financial
information. An application submitted to the
NIH OSP shall not contain any document
that is designated as ‘confidential’ in its
entirety. In the event that a determination has
been made that a specific portion of a
document submitted as one of the items
described in Appendix M should be
considered as confidential commercial or
financial information or a trade secret, each
item must be clearly identified as such. The
cover letter (attached to the submitted
material) shall: (1) Clearly designate the
information that is considered as confidential
commercial or financial information or a
trade secret; and (2) explain and justify each
designation to demonstrate with specificity
how release of that information will reveal a
trade secret or will result in substantial
competitive harm.
There are no proposed amendments to
Appendix M–I–C, Reporting Requirements
and Appendix M–I–D, Safety Assessments in
Human Gene Transfer Research.
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The current appendices Appendix M–II,
Description of the Proposal; Appendix M–III,
Informed Consent; Appendix M–IV, Privacy;
and Appendix M–V, Special Issues are
proposed to be deleted in their entirety,
except for Appendix M–III–B–2-b, Long Term
Follow-Up which will be updated to include
a reference to FDA’s current guidance on this
issue and will become Appendix M–II.
Appendix M–II is proposed to be
amended as follows:
Appendix M–II. Long Term Follow-Up
To permit evaluation of long-term safety
and efficacy of gene transfer, prospective
subjects should be informed that they are
expected to cooperate in long-term follow-up
that extends beyond the active phase of the
study. A list of persons who can be contacted
in the event that questions arise during the
follow-up period should be provided to the
investigator. In addition, the investigator
should request that subjects continue to
provide a current address and telephone
number.
The subjects should be informed that any
significant findings resulting from the study
will be made known in a timely manner to
them and/or their parent or guardian
including new information about the
experimental procedure, the harms and
benefits experienced by other individuals
involved in the study, and any long-term
effects that have been observed.
Additional guidance is available in the
FDA Guidance for Industry: Gene Therapy
Clinical Trials—Observing Subjects for
Delayed Adverse Events (available at the
following URL: https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/
Guidances/CellularandGeneTherapy/
default.htm).
Appendix M–VI Footnotes of Appendix M
will be renumbered to Appendix M–III.
Footnotes of Appendix M. There will be no
amendment to the language.
Dated: October 9, 2015.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2015–26388 Filed 10–15–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIEHS.
The meeting 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
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reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Environmental
Health Sciences, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIEHS.
Date: November 15–17, 2015.
Closed: November 15, 2015, 7 p.m. to 10
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Doubletree Guest Suites, 2515
Meridian Parkway, Research Triangle Park,
NC 27713.
Open: November 16, 2015, 8:30 a.m. to
11:50 a.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 16, 2015, 11:50 a.m. to
1:30 p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Open: November 16, 2015, 1:30 p.m. to 3
p.m.
Agenda: Poster Session.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 16, 2015, 3 p.m. to 3:30
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Open: November 16, 2015, 3:45 p.m. to
5:25 p.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 16, 2015, 5:25 p.m. to
5:55 p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
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srobinson on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
Closed: November 16, 2015, 6:15 p.m. to 10
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Doubletree Guest Suites, 2515
Meridian Parkway, Research Triangle Park,
NC 27713.
Open: November 17, 2015, 8:30 a.m. to
10:10 a.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 17, 2015, 10:10 a.m. to
10:40 a.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Open: November 17, 2015, 10:55 a.m. to 12
p.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 17, 2015, 12 p.m. to 1:30
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Contact Person: Darryl C. Zeldin, Scientific
Director & Principal Investigator, Division of
Intramural Research, National Institute of
Environmental Health Sciences, NIH, 111
TW Alexander Drive, Maildrop A2–09,
Research Triangle Park, NC 27709, 919–541–
1169, zeldin@niehs.nih.gov.
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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: October 9, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–26341 Filed 10–15–15; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2015–0950]
Sewage Treatment Technology—Type
Approval of Marine Sanitation Devices
Coast Guard, DHS.
Notice of meeting.
AGENCY:
ACTION:
The Coast Guard will conduct
a public workshop in Washington, DC to
discuss sewage treatment technologies,
issues concerning testing of marine
sanitation devices for type approval,
and issues concerning gray water. This
workshop is intended to be an
interactive exchange of information
between policymakers, industry experts,
and interested members of the public.
DATES: The workshop will be held on
Tuesday and Wednesday, December 8
and 9, 2015 beginning at 9:30 a.m. and
ending at 4 p.m., Eastern Time. This
workshop is open to the public. Please
note that the workshop has a limited
number of seats and may close early if
all business is finished. Contact the
Coast Guard (see FOR FURTHER
INFORMATION CONTACT) by December 4,
2015 to reserve seating. The comment
period for the docket closes January 9,
2016.
ADDRESSES: The workshop will be held
in conference rooms 8, 9, and 10 of the
Department of Transportation
Headquarters Building, 1200 New Jersey
Ave. SE., Washington, DC 20590. The
building is accessible by public
transportation (Navy Yard subway
station) or taxi. Parking for privatelyowned vehicles is available nearby. Due
to security requirements, each visitor
must present a valid government-issued
photo identification (for example, a
driver’s license) in order to gain
entrance to the building. Contact the
Coast Guard (see FOR FURTHER
INFORMATION CONTACT) to facilitate the
security process related to building
access, or to request reasonable
accommodation.
You may submit comments identified
by docket number USCG–2015–0950
using the Federal eRulemaking Portal at
https://www.regulations.gov. See
SUPPLEMENTARY INFORMATION for further
instructions on submitting comments.
FOR FURTHER INFORMATION CONTACT: If
you have questions concerning the
workshop, please call or email Mr.
Wayne Lundy, U.S. Coast Guard;
telephone 202–372–1379, email
Wayne.M.Lundy@uscg.mil or Ms.
Katherine Weiler, Environmental
Protection Agency; telephone 202–566–
1280, email Weiler.Katherine@epa.gov.
SUMMARY:
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62551
Your
comment is important to us. If you
submit a comment, please include the
docket number shown at the beginning
of this notice and provide a reason for
each suggestion or recommendation.
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact us (see
FOR FURTHER INFORMATION CONTACT) for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that Web site’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments are posted or a final rule is
published.
We accept anonymous comments. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided. For more about privacy and
the docket, you may review a Privacy
Act notice regarding the Federal Docket
Management System in the March 24,
2005, issue of the Federal Register (70
FR 15086).
This workshop is sponsored by the
Coast Guard and the Environmental
Protection Agency and is intended to be
an interactive exchange of information
between policymakers, industry experts,
and interested members of the public.
The primary topics that will be
discussed include:
• Sewage treatment technologies;
• Issues concerning testing of marine
sanitation devices for type approval;
• Simple on board checks for
verifying performance of marine
sanitation devices;
• Impact of gray water on the
environment;
• Impact on the ship from processing
gray water;
• Technologies for processing of gray
water;
• Analytes for considering
technologies treating gray water;
• Issues associated with existing
federal standards and MARPOL Annex
IV equipment standards (International
Maritime Organization (IMO) resolution
MEPC.227(64));
• Impact of No Discharge Zones; and
• Revision of an industry consensus
standard, ASTM F2363—‘‘Standard
Specification for Sewage and Graywater
Flow Through Treatment Systems’’.
Please note that the workshop has a
limited number of seats and may close
early if all business is finished.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62550-62551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26341]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences; Notice of
Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
Board of Scientific Counselors, NIEHS.
The meeting 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 meeting will be closed to the public as indicated below in
accordance with the provisions set forth in section 552b(c)(6), Title 5
U.S.C., as amended for the review, discussion, and evaluation of
individual intramural programs and projects conducted by the National
Institute of Environmental Health Sciences, including consideration of
personnel qualifications and performance, and the competence of
individual investigators, the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy.
Name of Committee: Board of Scientific Counselors, NIEHS.
Date: November 15-17, 2015.
Closed: November 15, 2015, 7 p.m. to 10 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Doubletree Guest Suites, 2515 Meridian Parkway, Research
Triangle Park, NC 27713.
Open: November 16, 2015, 8:30 a.m. to 11:50 a.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 16, 2015, 11:50 a.m. to 1:30 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Open: November 16, 2015, 1:30 p.m. to 3 p.m.
Agenda: Poster Session.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 16, 2015, 3 p.m. to 3:30 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Open: November 16, 2015, 3:45 p.m. to 5:25 p.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 16, 2015, 5:25 p.m. to 5:55 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
[[Page 62551]]
Closed: November 16, 2015, 6:15 p.m. to 10 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Doubletree Guest Suites, 2515 Meridian Parkway, Research
Triangle Park, NC 27713.
Open: November 17, 2015, 8:30 a.m. to 10:10 a.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 17, 2015, 10:10 a.m. to 10:40 a.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Open: November 17, 2015, 10:55 a.m. to 12 p.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Closed: November 17, 2015, 12 p.m. to 1:30 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, Rooms 101 ABC, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709.
Contact Person: Darryl C. Zeldin, Scientific Director &
Principal Investigator, Division of Intramural Research, National
Institute of Environmental Health Sciences, NIH, 111 TW Alexander
Drive, Maildrop A2-09, Research Triangle Park, NC 27709, 919-541-
1169, zeldin@niehs.nih.gov.
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.
(Catalogue of Federal Domestic Assistance Program Nos. 93.115,
Biometry and Risk Estimation--Health Risks from Environmental
Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund Hazardous Substances--Basic
Research and Education; 93.894, Resources and Manpower Development
in the Environmental Health Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114, Applied Toxicological Research
and Testing, National Institutes of Health, HHS)
Dated: October 9, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-26341 Filed 10-15-15; 8:45 am]
BILLING CODE 4140-01-P
