National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting, 1427 [2015-00119]
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Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices
to provide a list of the final guidance
documents that issued in 2007, 1997,
and 1987, and so on. CDRH will
consider the information received from
this retrospective review when
determining priorities for updating
guidance documents. Based upon this
experience, CDRH will establish a
process for ongoing periodic review of
final guidance that takes into account
the value provided by the review and
the resource implications to conduct the
review.
Under the GGPs regulation at
§ 10.115(f)(4), the public may, at any
time, suggest that CDRH revise or
withdraw an already existing guidance
document. The suggestion should
address why the guidance document
should be revised or withdrawn and, if
applicable, how it should be revised.
Stakeholders are advised to examine the
list or previously issued final guidances
provided by CDRH on the annual
agenda Web site but feedback on any
guidance is appreciated.
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III. Web Site Location of Guidance Lists
This notice announces the Web site
location of the two lists of guidance
documents which CDRH is intending to
publish during FY 2015. To access these
two lists, visit FDA’s Web site at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MDUFAIII/ucm321367.htm.
We note that the Agency is not required
to publish every guidance on either list
if the resources needed would be to the
detriment of meeting quantitative
review timelines and statutory
obligations. The Agency is not
precluded from issuing guidance
documents that are not on either list.
FDA and CDRH priorities are subject
to change at any time. Topics on this
and past guidance priority lists may be
removed or modified based on current
priorities. CDRH’s experience in
guidance development has shown that
there are many reasons that CDRH staff
may not complete the entire agenda of
guidances it undertakes. Staffs are
frequently diverted from guidance
development to other priority activities.
In addition, at any time new issues may
arise to be addressed in guidance that
could not have been anticipated at the
time the annual list is generated. These
may involve newly identified public
health issues.
IV. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: January 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00115 Filed 1–8–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the meeting of the
National Advisory Council on Alcohol
Abuse and Alcoholism.
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.
A portion of the meeting 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 Advisory
Council on Alcohol Abuse and Alcoholism,
National Cancer Advisory Board, and
National Advisory Council on Drug Abuse.
Open: February 4, 2015.
Time: 9 a.m. to 2 p.m.
Agenda: Presentation of NIAAA, NCI and
NIDA Director’s Update, Concept Clearance,
Scientific Reports, and other topics within
the scope of the Collaborative Research on
Addiction at NIH (CRAN).
Place: National Institutes of Health, 5635
Fishers Lane, Terrace Level Conference
Room, Rockville, MD 20852.
Contact Person: Abraham P. Bautista,
Ph.D., Director, Office of Extramural
Activities, National Institute on Alcohol
Abuse and Alcoholism, National Institutes of
PO 00000
Frm 00042
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1427
Health, 5635 Fishers Lane, Room 2085,
Rockville, MD 20852, (301) 443–9737,
bautista@mail.nih.gov.
Paulette Gray, Ph.D., Director, Office of
Extramural Research, National Cancer
Institute, National Institutes of Health, 9609
Medical Center Drive, Room 7W444,
Rockville, MD 20892, (240) 276–6340,
grayp@dea.nci.nih.gov.
Mark Swieter, Ph.D., Acting Director,
Office of Extramural Affairs, National
Institute on Drug Abuse, National Institutes
of Health, 6001 Executive Blvd., Room 4243,
Rockville, MD 20852, (301) 435–1389,
mswieter@nida.nih.gov.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
Closed: February 4, 2015.
Time: 2 p.m. to 5:30 p.m.
Agenda: Presentation of BSC intramural
evaluation report and review of grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Terrace Level Conference
Room, Rockville, MD 20852.
Open: February 5, 2015.
Time: 9 a.m. to 2 p.m.
Agenda: Presentation of NIAAA Director’s
report, concept clearance, scientific lectures
and other topics on alcohol abuse and
alcoholism of interest to the public and
NIAAA’s stakeholders.
Place: National Institutes of Health, 5635
Fishers Lane, Terrace Level Conference
Room, Rockville, MD 20852.
Contact Person: Abraham P. Bautista,
Ph.D., Director, Office of Extramural
Activities, National Institute on Alcohol
Abuse and Alcoholism, National Institutes of
Health, 5635 Fishers Lane, Room 2085,
Rockville, MD 20852, (301) 443–9737,
bautista@mail.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.
Information is also available on the
Institute’s/Center’s home page: https://
www.niaaa.nih.gov/AboutNIAAA/
AdvisoryCounci/Pages/default.aspx, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: January 5, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–00119 Filed 1–8–15; 8:45 am]
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Agencies
[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Page 1427]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00119]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of
Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the meeting of
the National Advisory Council on Alcohol Abuse and Alcoholism.
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.
A portion of the meeting 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 Advisory Council on Alcohol Abuse
and Alcoholism, National Cancer Advisory Board, and National
Advisory Council on Drug Abuse.
Open: February 4, 2015.
Time: 9 a.m. to 2 p.m.
Agenda: Presentation of NIAAA, NCI and NIDA Director's Update,
Concept Clearance, Scientific Reports, and other topics within the
scope of the Collaborative Research on Addiction at NIH (CRAN).
Place: National Institutes of Health, 5635 Fishers Lane, Terrace
Level Conference Room, Rockville, MD 20852.
Contact Person: Abraham P. Bautista, Ph.D., Director, Office of
Extramural Activities, National Institute on Alcohol Abuse and
Alcoholism, National Institutes of Health, 5635 Fishers Lane, Room
2085, Rockville, MD 20852, (301) 443-9737, bautista@mail.nih.gov.
Paulette Gray, Ph.D., Director, Office of Extramural Research,
National Cancer Institute, National Institutes of Health, 9609
Medical Center Drive, Room 7W444, Rockville, MD 20892, (240) 276-
6340, grayp@dea.nci.nih.gov.
Mark Swieter, Ph.D., Acting Director, Office of Extramural
Affairs, National Institute on Drug Abuse, National Institutes of
Health, 6001 Executive Blvd., Room 4243, Rockville, MD 20852, (301)
435-1389, mswieter@nida.nih.gov.
Name of Committee: National Advisory Council on Alcohol Abuse
and Alcoholism.
Closed: February 4, 2015.
Time: 2 p.m. to 5:30 p.m.
Agenda: Presentation of BSC intramural evaluation report and
review of grant applications.
Place: National Institutes of Health, 5635 Fishers Lane, Terrace
Level Conference Room, Rockville, MD 20852.
Open: February 5, 2015.
Time: 9 a.m. to 2 p.m.
Agenda: Presentation of NIAAA Director's report, concept
clearance, scientific lectures and other topics on alcohol abuse and
alcoholism of interest to the public and NIAAA's stakeholders.
Place: National Institutes of Health, 5635 Fishers Lane, Terrace
Level Conference Room, Rockville, MD 20852.
Contact Person: Abraham P. Bautista, Ph.D., Director, Office of
Extramural Activities, National Institute on Alcohol Abuse and
Alcoholism, National Institutes of Health, 5635 Fishers Lane, Room
2085, Rockville, MD 20852, (301) 443-9737, bautista@mail.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.
Information is also available on the Institute's/Center's home
page: https://www.niaaa.nih.gov/AboutNIAAA/AdvisoryCounci/Pages/default.aspx, where an agenda and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.271,
Alcohol Research Career Development Awards for Scientists and
Clinicians; 93.272, Alcohol National Research Service Awards for
Research Training; 93.273, Alcohol Research Programs; 93.891,
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical
Research and Research Support Awards, National Institutes of Health,
HHS)
Dated: January 5, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-00119 Filed 1-8-15; 8:45 am]
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