80 FR 62550 - National Institute of Environmental Health Sciences; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 200 (October 16, 2015)

Page Range		62550-62551
FR Document		2015-26341

Federal Register, Volume 80 Issue 200 (Friday, October 16, 2015)

[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62550-62551]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26341]


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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, [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.

(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

62550 Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices

Even if an oversight body does not request The current appendices Appendix M–II, reasonable accommodations, should
that a particular protocol be reviewed by the Description of the Proposal; Appendix M–III, notify the Contact Person listed below
RAC, the NIH Director, after consultation (if Informed Consent; Appendix M–IV, Privacy; in advance of the meeting.
needed) with appropriate regulatory and Appendix M–V, Special Issues are
authorities, may initiate RAC review if (a) the proposed to be deleted in their entirety, The meeting will be closed to the
protocol has one or more of the except for Appendix M–III–B–2-b, Long Term public as indicated below in accordance
characteristics listed above (i, ii, or iii) and Follow-Up which will be updated to include with the provisions set forth in section
public RAC review and discussion would a reference to FDA’s current guidance on this 552b(c)(6), Title 5 U.S.C., as amended
provide a clear and obvious benefit to the issue and will become Appendix M–II. for the review, discussion, and
scientific community or public; or (b) the Appendix M–II is proposed to be evaluation of individual intramural
protocol otherwise raises significant
scientific, societal, or ethical concerns.
amended as follows: programs and projects conducted by the
Completion of the registration process is Appendix M–II. Long Term Follow-Up National Institute of Environmental
defined as: (1) Receipt by the Principal Health Sciences, including
Investigator of a letter from the NIH OSP To permit evaluation of long-term safety consideration of personnel
indicating that protocol registration process and efficacy of gene transfer, prospective qualifications and performance, and the
is complete and that enrollment may subjects should be informed that they are competence of individual investigators,
proceed; or (2) receipt by the Principal expected to cooperate in long-term follow-up
that extends beyond the active phase of the the disclosure of which would
Investigator of a letter from the NIH after constitute a clearly unwarranted
public RAC review that summarizes the study. A list of persons who can be contacted
committee’s key comments and in the event that questions arise during the invasion of personal privacy.
recommendations (if any). follow-up period should be provided to the Name of Committee: Board of Scientific
A complete human gene transfer protocol investigator. In addition, the investigator Counselors, NIEHS.
package must be submitted at least eight should request that subjects continue to Date: November 15–17, 2015.
weeks before a scheduled RAC meeting to be provide a current address and telephone Closed: November 15, 2015, 7 p.m. to 10
reviewed at that upcoming meeting. number. p.m.
After a human gene transfer experiment is The subjects should be informed that any Agenda: To review and evaluate
publicly reviewed by the full RAC at a significant findings resulting from the study programmatic and personnel issues.
regularly scheduled meeting, the NIH OSP will be made known in a timely manner to Place: Doubletree Guest Suites, 2515
will send a letter summarizing the RAC’s key them and/or their parent or guardian Meridian Parkway, Research Triangle Park,
comments and recommendations (if any) including new information about the NC 27713.
regarding the protocol to the Principal experimental procedure, the harms and Open: November 16, 2015, 8:30 a.m. to
Investigator(s), oversight bodies, and benefits experienced by other individuals 11:50 a.m.
regulatory authorities as appropriate. involved in the study, and any long-term Agenda: Scientific Presentations.
Completion of RAC review is defined as effects that have been observed. Place: Nat. Inst. of Environmental Health
receipt by the Principal Investigator(s) of a Additional guidance is available in the Sciences, Building 101, Rodbell Auditorium,
letter from the NIH OSP summarizing the FDA Guidance for Industry: Gene Therapy Rooms 101 ABC, 111 T. W. Alexander Drive,
Clinical Trials—Observing Subjects for
committee’s findings. Unless the NIH Research Triangle Park, NC 27709.
Delayed Adverse Events (available at the
determines that there are exceptional Closed: November 16, 2015, 11:50 a.m. to
following URL: http://www.fda.gov/
circumstances, the letter containing 1:30 p.m.
BiologicsBloodVaccines/
recommendations and comments made Agenda: To review and evaluate
GuidanceComplianceRegulatoryInformation/
following public review will be sent within programmatic and personnel issues.
Guidances/CellularandGeneTherapy/
10 working days after the completion of the Place: Nat. Inst. of Environmental Health
default.htm).
RAC meeting at which the protocol was Sciences, Building 101, Rodbell Auditorium,
Appendix M–VI Footnotes of Appendix M
reviewed. Rooms 101 ABC, 111 T. W. Alexander Drive,
will be renumbered to Appendix M–III.
RAC meetings will be open to the public Research Triangle Park, NC 27709.
Footnotes of Appendix M. There will be no
except where trade secrets or confidential amendment to the language. Open: November 16, 2015, 1:30 p.m. to 3
commercial information are reviewed. To p.m.
enable all aspects of the protocol review Dated: October 9, 2015. Agenda: Poster Session.
process to be open to the public, information Francis S. Collins, Place: Nat. Inst. of Environmental Health
provided in response to Appendix M–I–A Sciences, Building 101, Rodbell Auditorium,
Director, National Institutes of Health.
should not contain trade secrets or Rooms 101 ABC, 111 T. W. Alexander Drive,
confidential commercial or financial [FR Doc. 2015–26388 Filed 10–15–15; 8:45 am] Research Triangle Park, NC 27709.
information. An application submitted to the BILLING CODE 4140–01–P Closed: November 16, 2015, 3 p.m. to 3:30
NIH OSP shall not contain any document p.m.
that is designated as ‘confidential’ in its Agenda: To review and evaluate
entirety. In the event that a determination has DEPARTMENT OF HEALTH AND programmatic and personnel issues.
been made that a specific portion of a HUMAN SERVICES Place: Nat. Inst. of Environmental Health
document submitted as one of the items Sciences, Building 101, Rodbell Auditorium,
described in Appendix M should be National Institutes of Health Rooms 101 ABC, 111 T. W. Alexander Drive,
considered as confidential commercial or Research Triangle Park, NC 27709.
financial information or a trade secret, each National Institute of Environmental Open: November 16, 2015, 3:45 p.m. to
item must be clearly identified as such. The Health Sciences; Notice of Meeting 5:25 p.m.
cover letter (attached to the submitted Agenda: Scientific Presentations.
material) shall: (1) Clearly designate the Pursuant to section 10(d) of the Place: Nat. Inst. of Environmental Health
information that is considered as confidential Federal Advisory Committee Act, as Sciences, Building 101, Rodbell Auditorium,
commercial or financial information or a amended (5 U.S.C. App.), notice is Rooms 101 ABC, 111 T. W. Alexander Drive,
trade secret; and (2) explain and justify each hereby given of a meeting of the Board Research Triangle Park, NC 27709.
srobinson on DSK5SPTVN1PROD with NOTICES

designation to demonstrate with specificity of Scientific Counselors, NIEHS. Closed: November 16, 2015, 5:25 p.m. to
how release of that information will reveal a 5:55 p.m.
The meeting will be open to the
trade secret or will result in substantial Agenda: To review and evaluate
competitive harm. public as indicated below, with programmatic and personnel issues.
There are no proposed amendments to attendance limited to space available. Place: Nat. Inst. of Environmental Health
Appendix M–I–C, Reporting Requirements Individuals who plan to attend and Sciences, Building 101, Rodbell Auditorium,
and Appendix M–I–D, Safety Assessments in need special assistance, such as sign Rooms 101 ABC, 111 T. W. Alexander Drive,
Human Gene Transfer Research. language interpretation or other Research Triangle Park, NC 27709.

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Document Created: 2015-12-14 15:24:05
Document Modified: 2015-12-14 15:24:05

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		November 15-17, 2015.
FR Citation		80 FR 62550

80 FR 62550 - National Institute of Environmental Health Sciences; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 200 (October 16, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health