Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 28430-28431 [2018-13098]
Download as PDF
<![CDATA[
28430
Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Notices
to the State Medicaid Agency and the
Protection and Advocacy Organization.
They are also required to provide
residents the restraint and seclusion
policy in writing, and to document in
the residents’ records all activities
involving the use of restraint and
seclusion. Form Number: CMS–R–306
(OMB Control Number 0938–0833);
Frequency: Occasionally; Affected
Public: Private sector (Business or other
for-profits); Number of Respondents:
390; Total Annual Responses:
1,466,823; Total Annual Hours: 449,609.
(For policy questions regarding this
collection contact Kirsten Jensen at 410–
786–8146).
Dated: June 14, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–13149 Filed 6–18–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects: Emergency
Repatriation (After Analysis
Questionnaire).
Title: Evaluation of Services provided
to Repatriates.
OMB No.:
Description: The Department of
Health and Human Services,
Administration for Children and
Families, Office of Refugee Resettlement
(ORR) is conducting an after event
analysis of the activation of the
Emergency Repatriation Plan and
overall response during recent
emergency repatriation. In an effort to
strengthen our operations, learn from
our experience, and ensure quality
services in future similar efforts.
(Evaluation of services provided).
Respondents: Repatriates
(International Social Services ISS–USA).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
daltland on DSKBBV9HB2PROD with NOTICES
1 (Repatriates Questionnaire) Assessment .....................................................
1 (State Questionnaire Assessment) ...............................................................
Estimated Total Annual Burden
Hours: 2 Hours.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
VerDate Sep<11>2014
17:55 Jun 18, 2018
Jkt 244001
Number of
responses per
respondent
100–5000
100–500
1
1
Average
burden hours
per response
Total burden
hours
1
1
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
SUMMARY:
Robert A. Sargis,
Reports Clearance Officer.
1
1
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–13060 Filed 6–18–18; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0545; FDA–
2013–N–0878; FDA–2014–N–0998; FDA–
2014–N–1076; FDA–2017–N–6162; FDA–
2011–N–0510; FDA–2014–N–1414; FDA–
2008–D–0610; FDA–2010–D–0073; FDA–
2013–N–0080; FDA–2017–N–6397; FDA–
2014–D–0313; FDA–2014–N–1030; and
FDA–2014–D–1837]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00022
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19JNN1.SGM
19JNN1
Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Notices
28431
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Infant Formula Requirements ..................................................................................................................................
Premarket Notification for a New Dietary Ingredient ...............................................................................................
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring ..............................................
Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical
Current Good Manufacturing Practice .................................................................................................................
Requests for Inspection by an Accredited Person Under the Inspection for Accredited Persons Program ..........
Substances Prohibited from Use in Animal Food or Feed .....................................................................................
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under
21 CFR 884.5300 .................................................................................................................................................
Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements
During an Influenza Pandemic .............................................................................................................................
Guidance on Consultation Procedures: Foods Derived From New Plant Varieties ...............................................
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices ......................
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments .................................................................
Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with
the Office of Orphan Products Development .......................................................................................................
Food Allergen Labeling and Reporting ....................................................................................................................
Transfer of a Premarket Notification Clearance ......................................................................................................
Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13098 Filed 6–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Ryan White HIV/AIDS Program Parts A
and B Integrated HIV Planning
Implementation Cooperative
Agreement to John Snow, Inc. (JSI),
U69HA30144
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of non-competitive FY
2018 supplemental award.
AGENCY:
This noncompetitive
supplement award to JSI will support
and strengthen current Ryan White HIV/
AIDS Program (RWHAP) Part A and Part
B priority setting and resource
allocation processes to ensure people
living with HIV are linked to care,
remain engaged in care, and achieve
viral suppression.
FOR FURTHER INFORMATION CONTACT: Dr.
Rene Sterling, Acting Director, Division
of State HIV/AIDS Programs, HIV/AIDS
Bureau, HRSA; 5600 Fishers Lane,
Room 09W50, Rockville, MD 20857;
Phone: (301) 443–9017, Email:
rsterling@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: JSI
(U69HA30144).
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:55 Jun 18, 2018
Jkt 244001
Amount of Non-Competitive Award:
$300,000 in FY 2018.
Period of Funding: July 1, 2018,
through June 30, 2019.
CFDA Number: No. 93.145.
Authority: Sections 2606 and 2654(b)
of the Public Health Service Act, as
amended by the Ryan White HIV/AIDS
Treatment Extension Act of 2009 (Pub.
L. 111–87).
Justification: In 2016, JSI was awarded
a 3-year cooperative agreement under
HRSA–16–082 RWHAP Integrated HIV
Planning Implementation (CFDA
93.145), authorized by Sections 2606
and 2654(b) of the Public Health Service
Act, as amended by the Ryan White
HIV/AIDS Treatment Extension Act of
2009 (Pub. L. 111–87). The cooperative
agreement was established to provide
technical assistance to RWHAP Parts A
and B recipients and their planning
bodies regarding: (1) The integration of
HIV planning across prevention, care,
and treatment service delivery systems;
and (2) the development,
implementation, monitoring, and
evaluation of Integrated HIV Prevention
and Care Plans. RWHAP Parts A and B
recipients and planning bodies use
Integrated Plans to better inform and
coordinate HIV prevention and care
program planning, resource allocation,
and continuous quality improvement
efforts to meet the HIV service delivery
needs within their jurisdictions.
The proposed supplemental funding
will provide RWHAP Parts A and B
recipients with additional technical
assistance (TA) specifically focused on
resource allocation planning and
implementation. These additional TA
activities will build upon data elements
identified in the Integrated Plan and
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Date
approval
expires
0910–0256
0910–0330
0910–0409
5/31/2021
5/31/2021
5/31/2021
0910–0563
0910–0569
0910–0627
5/31/2021
5/31/2021
5/31/2021
0910–0633
5/31/2021
0910–0701
0910–0704
0910–0741
5/31/2021
5/31/2021
5/31/2021
0910–0782
5/31/2021
0910–0787
0910–0792
0910–0852
5/31/2021
5/31/2021
5/31/2021
provide jurisdictions with strategies,
tools, and resources to effectively
allocate annual available resources to
prioritize HIV unmet needs. The TA
activities will be directed at addressing
more efficient and proactive methods in
the Priority Setting and Resource
Allocation (PSRA) process to increase
the ability of health care providers and
systems to ensure people living with
HIV are linked to care, remain engaged
in care, and achieve HIV viral
suppression.
Dated: June 12, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018–13121 Filed 6–18–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
E:\FR\FM\19JNN1.SGM
19JNN1
]]>Agencies
[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Notices]
[Pages 28430-28431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0545; FDA-2013-N-0878; FDA-2014-N-0998; FDA-
2014-N-1076; FDA-2017-N-6162; FDA-2011-N-0510; FDA-2014-N-1414; FDA-
2008-D-0610; FDA-2010-D-0073; FDA-2013-N-0080; FDA-2017-N-6397; FDA-
2014-D-0313; FDA-2014-N-1030; and FDA-2014-D-1837]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
[[Page 28431]]
Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Infant Formula Requirements............. 0910-0256 5/31/2021
Premarket Notification for a New Dietary 0910-0330 5/31/2021
Ingredient.............................
Regulations for In Vivo 0910-0409 5/31/2021
Radiopharmaceuticals Used for Diagnosis
and Monitoring.........................
Guidance for Industry: Formal Dispute 0910-0563 5/31/2021
Resolution; Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice....
Requests for Inspection by an Accredited 0910-0569 5/31/2021
Person Under the Inspection for
Accredited Persons Program.............
Substances Prohibited from Use in Animal 0910-0627 5/31/2021
Food or Feed...........................
Class II Special Controls Guidance 0910-0633 5/31/2021
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21 CFR
884.5300...............................
Guidance for Industry: Postmarketing 0910-0701 5/31/2021
Adverse Event Reporting for Medical
Products and Dietary Supplements During
an Influenza Pandemic..................
Guidance on Consultation Procedures: 0910-0704 5/31/2021
Foods Derived From New Plant Varieties.
Human Subject Protection; Acceptance of 0910-0741 5/31/2021
Data From Clinical Investigations for
Medical Devices........................
Food Labeling; Calorie Labeling of 0910-0782 5/31/2021
Articles of Food in Vending Machines
and Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail
Food Establishments....................
Guidance for Industry, Researchers, 0910-0787 5/31/2021
Patient Groups, and Food and Drug
Administration Staff on Meetings with
the Office of Orphan Products
Development............................
Food Allergen Labeling and Reporting.... 0910-0792 5/31/2021
Transfer of a Premarket Notification 0910-0852 5/31/2021
Clearance..............................
------------------------------------------------------------------------
Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13098 Filed 6-18-18; 8:45 am]
BILLING CODE 4164-01-P
