Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities, 49391 [2018-21319]
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Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
Estimated Total Annual Burden
Hours (Rounded from 523.98): 524.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research, and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
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having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–21226 Filed 9–28–18; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Administration on Intellectual and
Developmental Disabilities, President’s
Committee for People With Intellectual
Disabilities
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
Thursday, November 8, 2018
from 9:00 a.m. to 4:30 p.m.; and Friday,
November 9, 2018 from 9:00 a.m. to 4:30
p.m. These meetings will be open to the
general public.
ADDRESSES: These meetings will be held
at the U.S. Access Board, located at
1331 F Street NW, Suite 800,
Washington, DC 20004. Individuals who
would like to participate via conference
call may do so by dialing toll-free #: 1–
888–949–2790, when prompted enter
pass code: 1989852. Individuals whose
full participation in the meeting will
require special accommodations (e.g.,
sign language interpreting services,
assistive listening devices, materials in
alternative format such as large print or
Braille) should notify Ms. Allison Cruz,
Director, Office of Innovation, via email
at Allison.Cruz@acl.hhs.gov, or via
amozie on DSK3GDR082PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:50 Sep 28, 2018
Jkt 247001
telephone at 202–795–7334, no later
than Monday, October 19, 2018. The
PCPID will attempt to accommodate
requests made after this date, but cannot
guarantee the ability to grant requests
received after the deadline. All meeting
sites are barrier free, consistent with the
Americans with Disabilities Act (ADA)
and the Federal Advisory Committee
Act (FACA).
FOR FURTHER INFORMATION CONTACT: Ms.
Allison Cruz, Director, Office of
Innovation, 330 C Street SW, Switzer
Building, Room 1114, Washington, DC
20201. Telephone: 202–795–7334. Fax:
202–795–7334. Email: Allison.Cruz@
acl.hhs.gov
The
PCPID acts in an advisory capacity to
the President and the Secretary of
Health and Human Services on a broad
range of topics relating to programs,
services and support for individuals
with intellectual disabilities. The PCPID
executive order stipulates that the
Committee shall: (1) Provide such
advice concerning intellectual
disabilities as the President or the
Secretary of Health and Human Services
may request; and (2) provide advice to
the President concerning the following
for people with intellectual disabilities:
(A) Expanding employment
opportunities; (B) connecting people to
services; (C) supporting families and
caregivers; (D) strengthening the
networks; and (E) protecting rights and
preventing abuse.
Agenda: The Committee Members
will discuss preparation of the PCPID
2019 Report to the President, including
its content and format, and related data
collection and analysis required to
complete the writing of the Report.
SUPPLEMENTARY INFORMATION:
Dated: September 24, 2018.
Mary Lazare,
Principal Deputy Administrator,
Administration for Community Living.
[FR Doc. 2018–21319 Filed 9–28–18; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
49391
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Contents
of a Complete Submission for Threshold
Analyses and Human Factors
Submissions to an IND, NDA, BLA, or
ANDA.’’ The draft guidance provides
recommendations to industry and FDA
staff regarding the content and
submission procedures for use-related
risk analyses, human factors validation
study protocols and reports, threshold
analyses, and comparative use human
factors study protocols and reports.
DATES: Submit either electronic or
written comments on the draft guidance
by November 30, 2018 to ensure that the
Agency considers your comments in
this review.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
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• If you want to submit a comment
with confidential information that you
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public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Food and Drug Administration
[Docket No. FDA–2018–D–3275]
Contents of a Complete Submission
for Threshold Analyses and Human
Factors Submissions to Drug and
Biologic Applications; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice of availability.
Frm 00039
Fmt 4703
Sfmt 4703
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
E:\FR\FM\01OCN1.SGM
01OCN1
Agencies
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Page 49391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21319]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Administration on Intellectual and Developmental Disabilities,
President's Committee for People With Intellectual Disabilities
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
DATES: Thursday, November 8, 2018 from 9:00 a.m. to 4:30 p.m.; and
Friday, November 9, 2018 from 9:00 a.m. to 4:30 p.m. These meetings
will be open to the general public.
ADDRESSES: These meetings will be held at the U.S. Access Board,
located at 1331 F Street NW, Suite 800, Washington, DC 20004.
Individuals who would like to participate via conference call may do so
by dialing toll-free #: 1-888-949-2790, when prompted enter pass code:
1989852. Individuals whose full participation in the meeting will
require special accommodations (e.g., sign language interpreting
services, assistive listening devices, materials in alternative format
such as large print or Braille) should notify Ms. Allison Cruz,
Director, Office of Innovation, via email at [email protected],
or via telephone at 202-795-7334, no later than Monday, October 19,
2018. The PCPID will attempt to accommodate requests made after this
date, but cannot guarantee the ability to grant requests received after
the deadline. All meeting sites are barrier free, consistent with the
Americans with Disabilities Act (ADA) and the Federal Advisory
Committee Act (FACA).
FOR FURTHER INFORMATION CONTACT: Ms. Allison Cruz, Director, Office of
Innovation, 330 C Street SW, Switzer Building, Room 1114, Washington,
DC 20201. Telephone: 202-795-7334. Fax: 202-795-7334. Email:
[email protected]
SUPPLEMENTARY INFORMATION: The PCPID acts in an advisory capacity to
the President and the Secretary of Health and Human Services on a broad
range of topics relating to programs, services and support for
individuals with intellectual disabilities. The PCPID executive order
stipulates that the Committee shall: (1) Provide such advice concerning
intellectual disabilities as the President or the Secretary of Health
and Human Services may request; and (2) provide advice to the President
concerning the following for people with intellectual disabilities: (A)
Expanding employment opportunities; (B) connecting people to services;
(C) supporting families and caregivers; (D) strengthening the networks;
and (E) protecting rights and preventing abuse.
Agenda: The Committee Members will discuss preparation of the PCPID
2019 Report to the President, including its content and format, and
related data collection and analysis required to complete the writing
of the Report.
Dated: September 24, 2018.
Mary Lazare,
Principal Deputy Administrator, Administration for Community Living.
[FR Doc. 2018-21319 Filed 9-28-18; 8:45 am]
BILLING CODE 4154-01-P