National Advisory Council on the National Health Service Corps; Notice of Meeting, 35368-35369 [2016-13052]
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35368
Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices
and submission for each suffix does not
provide a basis by which the estimate
was calculated or whether it is broadly
applicable. We find this figure rather
high and retain our original estimate of
6 hours. The latter figure is based on our
familiarity with the average amount of
time required by similar submissions to
FDA. At the same time, the comment
also suggested that we failed to
adequately account for the time spent
on creating proposed suffixes. In
consideration, therefore, we have
revised our estimate upward to account
for burden associated with creating and
submitting up to 10 proposed suffixes
for designation, as reflected in table 1.
FDA estimates the information
collection burden as follows:
Description of Respondents:
Respondents to the collection are
sponsors of biological product
applications.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Information for the Proposed Proper Name for Biological
Products Submitted Under Section 351(a) of the PHS
Act ....................................................................................
Information for the Proposed Proper Name for Biosimilar
Products and Interchangeable Products Submitted
Under Section 351(k) of the PHS Act ..............................
Total ..............................................................................
1 There
Average
burden per
response
Total annual
responses
Total hours
20
2
40
420
16,800
3
2
6
420
2,520
........................
........................
........................
........................
19,320
are no capital costs or operating and maintenance costs associated with this collection of information.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
collections of information for the
submission of a biologics license
application (BLA) and changes
(supplements) to an approved
application under 21 CFR part 601 have
been approved under OMB control
number 0910–0338. The collections of
information for the submission of a BLA
under section 351(k) of the PHS Act
(biosimilar products and
interchangeable products) have been
approved under OMB control number
0910–0719.
Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12885 Filed 6–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on the
National Health Service Corps; Notice
of Meeting
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
the National Health Service Corps
(NACNHSC).
Dates and Times: June 22, 2016 11:00
a.m.–5:00 p.m. EST.
Place: U.S. Department of Health and
Human Services, Health Resources and
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18:30 Jun 01, 2016
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Services Administration, Conference
Room #5E29, 5600 Fishers Lane,
Rockville, Maryland 20857, Webinar
and Conference Call Format.
Status: This advisory council meeting
will be open to the public.
Purpose: The NACNHSC provides
advice and recommendations to the
Secretary of the U.S. Department of
Health and Human Services (HHS) and,
by designation, the Administrator of the
Health Resources and Services
Administration (HRSA) on a range of
issues including identifying the
priorities for the National Health
Service Corps (NHSC) and policy
revisions.
Agenda: The NACNHSC will refine
the Council’s top priorities for the
NHSC and will continue to work on the
draft of formal recommendations to
submit to the HHS Secretary and the
HRSA Administrator. During the March
2016 NACNHSC meeting, the Council
identified its priorities for the NHSC.
The Council will continue the
discussion on how the priorities meet
the goals of the 2016 Bureau of Health
Workforce Strategic Plan. The priority
areas include, but are not limited to,
telehealth, Medication Assisted
Treatment (MAT) certification,
mentorship and NHSC discipline
expansion, specifically for mental and
behavioral and oral health providers.
The content of the agenda is subject to
change prior to the meeting. The
NACNHSC final agenda and call-in
information will be available 3 days in
advance of the meeting at https://
nhsc.hrsa.gov/corpsexperience/aboutus/
nationaladvisorycouncil/
meetingsummaries/.
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FOR FURTHER INFORMATION CONTACT:
Please send requests for information to
Dawn Smith, Bureau of Health
Workforce, HRSA, in one of two ways:
(1) Send a request to the following
address: Dawn Smith, Bureau of Health
Workforce, Health Resources and
Services Administration, Room 14N70B,
5600 Fishers Lane, Rockville, Maryland
20857; or (2) send an email to dsmith3@
hrsa.gov.
SUPPLEMENTARY INFORMATION: Further
information regarding the NACNHSC,
including the roster of members and
past meeting summaries, is available at:
https://nhsc.hrsa.gov/corpsexperience/
aboutus/nationaladvisorycouncil/
meetingsummaries/.
Members of the public and interested
parties may request to participate in the
meeting by contacting Dawn Smith via
email at dsmith3@hrsa.gov to obtain
access information. Access will be
granted on a first come, first served
basis. Individuals who plan to attend
and need special assistance, such as
sign language interpretation or other
reasonable accommodations, should
notify the contact person listed above at
least 10 days prior to the meeting.
Public participants may submit written
statements in advance of the scheduled
meeting. If you would like to provide
oral public comment during the
meeting, please register with Dawn
Smith. Public comment will be limited
to 3 minutes per speaker. Statements
and comments can be addressed to
Dawn Smith by emailing her at dsmith@
hrsa.gov.
In addition, please be advised that
committee members are given copies of
all written statements submitted from
the public. Any further public
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Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices
participation will be solely at the
discretion of the Chair, with approval of
the Designated Federal Official.
Registration through the designated
contact for the public comment session
is required.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–13052 Filed 6–1–16; 8:45 am]
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Dated: May 26, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–12895 Filed 6–1–16; 8:45 am]
Submission for OMB Review; 30-Day
Comment Request; Population
Assessment of Tobacco and Health
(PATH) Study (NIDA)
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute on Drug Abuse;
Notice of Closed Meeting
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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, National
Institute of Neurological Disorders and
Stroke.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
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 Neurological
Disorders and Stroke, 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, National Institute of
Neurological Disorders and Stroke.
Date: June 12–14, 2016.
Time: 6:00 p.m. to 11:30 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Alan P. Koretsky, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institute of Neurological
Disorders and Stroke, NIH, 35 Convent Drive,
Room GF144, Bethesda, MD 20892, (301)
435–2232, koretskya@ninds.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS).
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35369
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 meeting.
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel—
Research Support Services for NIDA AIDS
Program (1209).
Date: June 21, 2016.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Lyle Furr, Scientific
Review Officer, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS).
Dated: May 26, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–12894 Filed 6–1–16; 8:45 am]
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National Institutes of Health
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on March 11, 2016,
pages 12913–12914 and allowed 60days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institutes of Health may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_Submission@
omb.eop.gov or by fax to (202) 395–
6974, Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project,
contact: Dr. Kevin P. Conway, Deputy
Director, Division of Epidemiology,
Services, and Prevention Research,
NIDA, NIH, 6001 Executive Boulevard,
Room 5185, Rockville, MD 20852; or
call non-toll-free number (301) 443–
8755 or Email your request, including
your address to: PATHprojectofficer@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Methodological
Studies for the Population Assessment
of Tobacco and Health (PATH) Study
(NIDA), 0925–0675, expiration date 5/
31/2016—Reinstatement Without
Change—NIDA, NIH, in partnership
SUMMARY:
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Agencies
[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Pages 35368-35369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13052]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Council on the National Health Service Corps;
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: National Advisory Council on the National Health Service
Corps (NACNHSC).
Dates and Times: June 22, 2016 11:00 a.m.-5:00 p.m. EST.
Place: U.S. Department of Health and Human Services, Health
Resources and Services Administration, Conference Room #5E29, 5600
Fishers Lane, Rockville, Maryland 20857, Webinar and Conference Call
Format.
Status: This advisory council meeting will be open to the public.
Purpose: The NACNHSC provides advice and recommendations to the
Secretary of the U.S. Department of Health and Human Services (HHS)
and, by designation, the Administrator of the Health Resources and
Services Administration (HRSA) on a range of issues including
identifying the priorities for the National Health Service Corps (NHSC)
and policy revisions.
Agenda: The NACNHSC will refine the Council's top priorities for
the NHSC and will continue to work on the draft of formal
recommendations to submit to the HHS Secretary and the HRSA
Administrator. During the March 2016 NACNHSC meeting, the Council
identified its priorities for the NHSC. The Council will continue the
discussion on how the priorities meet the goals of the 2016 Bureau of
Health Workforce Strategic Plan. The priority areas include, but are
not limited to, telehealth, Medication Assisted Treatment (MAT)
certification, mentorship and NHSC discipline expansion, specifically
for mental and behavioral and oral health providers. The content of the
agenda is subject to change prior to the meeting. The NACNHSC final
agenda and call-in information will be available 3 days in advance of
the meeting at https://nhsc.hrsa.gov/corpsexperience/aboutus/nationaladvisorycouncil/meetingsummaries/.
FOR FURTHER INFORMATION CONTACT: Please send requests for information
to Dawn Smith, Bureau of Health Workforce, HRSA, in one of two ways:
(1) Send a request to the following address: Dawn Smith, Bureau of
Health Workforce, Health Resources and Services Administration, Room
14N70B, 5600 Fishers Lane, Rockville, Maryland 20857; or (2) send an
email to dsmith3@hrsa.gov.
SUPPLEMENTARY INFORMATION: Further information regarding the NACNHSC,
including the roster of members and past meeting summaries, is
available at: https://nhsc.hrsa.gov/corpsexperience/aboutus/nationaladvisorycouncil/meetingsummaries/.
Members of the public and interested parties may request to
participate in the meeting by contacting Dawn Smith via email at
dsmith3@hrsa.gov to obtain access information. Access will be granted
on a first come, first served basis. Individuals who plan to attend and
need special assistance, such as sign language interpretation or other
reasonable accommodations, should notify the contact person listed
above at least 10 days prior to the meeting. Public participants may
submit written statements in advance of the scheduled meeting. If you
would like to provide oral public comment during the meeting, please
register with Dawn Smith. Public comment will be limited to 3 minutes
per speaker. Statements and comments can be addressed to Dawn Smith by
emailing her at dsmith@hrsa.gov.
In addition, please be advised that committee members are given
copies of all written statements submitted from the public. Any further
public
[[Page 35369]]
participation will be solely at the discretion of the Chair, with
approval of the Designated Federal Official. Registration through the
designated contact for the public comment session is required.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-13052 Filed 6-1-16; 8:45 am]
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