Submission for OMB Review; Comment Request, 17419-17420 [2018-08233]
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17419
Federal Register / Vol. 83, No. 76 / Thursday, April 19, 2018 / Notices
secure means of their choice (e.g., webbased application, fax or email).
As part of this revision, CDC requests
approval for a number of changes and
adjustments:
• CDC is discontinuing all Ebola
related forms;
• CDC is discontinuing all current
maritime-related forms except a
condensed maritime TB contact
outbreak contact investigation follow up
forms;
• no changes are requested of the Air
or Land associated forms; however
adjustments in burden are requested.
The proposed changes will result in a
decrease of 673 burden hours (from 782
burden hours to 109 hours).
There is no cost to respondents other
than their time to complete the form and
submit the data to CDC.
investigation follow-up form in an Excel
format;
• CDC is requesting a downward
revision of the estimated number of TB
contact investigation forms used
annually, but an upward revision of the
amount of time requested from each
respondent;
• CDC is requesting addition of
varicella and influenza like illness
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Cruise Ship Physicians/Cargo Ship Managers
Clinically Active TB Contact Investigation
Outcome Reporting Form—Maritime.
Varicella Investigation Outcome Reporting
Form.
Influenza Like Illness Investigation Outcome
Reporting Form.
General Contact Investigation Outcome Reporting Form—Air.
TB Contact Investigation Outcome Reporting
Form—Air.
Measles Contact Investigation Outcome Reporting Form—Air.
Rubella Contact Investigation Outcome Reporting Form—Air.
General Contact Investigation Outcome Reporting Form—Land.
Cruise Ship Physicians/Cargo Ship Managers
Cruise Ship Physicians/Cargo Ship Managers
State/Local public health staff .........................
State/Local public health staff .........................
State/Local public health staff .........................
State/Local public health staff .........................
State/Local public health staff .........................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2018–08163 Filed 4–18–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: TANF Office Culture Study.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), U.S.
Number of
responses per
respondent
Number of
respondents
Type of respondents
Department of Health and Human
Services (HHS) is proposing data
collection activities as part of a project
to identify and describe exemplars of
TANF organizational culture as well as
successful strategies human services
offices have undertaken to improve their
organizational culture. This qualitative
study intends to use this information to
increase understanding of how various
agencies’ organizational cultures
influence TANF clients’ experiences,
service delivery, and frontline workers.
The information collection activities
to be submitted in the package include:
(1) Leadership and supervisor
interviews will collect information on
program structure and staffing, client
experiences, agency goals and
performance management,
organizational learning and innovation,
cultural congruence across service
Average
burden per
response
(in hours)
15
1
20/60
29
1
20/60
45
1
20/60
34
1
5/60
547
1
5/60
324
1
5/60
27
1
5/60
15
1
5/60
providers, and the perception of the
organizational culture change, if
applicable.
(2) Frontline workers’ interviews will
collect information about frontline
staffs’ role in service delivery, client
experiences, peer interaction and social
institutions within the agency, agency
goals, organizational learning and
innovation, and the perception of the
organizational culture change initiative,
if applicable.
(3) The focus groups will collect
information about program participants’
perceptions of agency processes, their
communication with agency staff, and
their assessment of the agency’s
organizational culture.
Respondents: Individuals receiving
TANF and related services, TANF
directors, and managers and staff at
local TANF offices.
daltland on DSKBBV9HB2PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Leadership and Supervisor Interview Guide .......................
Frontline Staff Interview Guide ............................................
Focus Group Guide .............................................................
VerDate Sep<11>2014
17:49 Apr 18, 2018
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Frm 00061
Annual
number of
respondents
24
12
54
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
8
4
18
E:\FR\FM\19APN1.SGM
1
1
1
19APN1
Average
burden
hours per
response
1.5
1
1.5
Annual
burden
hours
12
4
27
17420
Federal Register / Vol. 83, No. 76 / Thursday, April 19, 2018 / Notices
Estimated Total Annual Burden
Hours: 43.
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,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–08233 Filed 4–18–18; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1098]
Metered Dose Inhaler and Dry Powder
Inhaler Drug Products—Quality
Considerations; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Metered
Dose Inhaler (MDI) and Dry Powder
Inhaler (DPI) Drug Products—Quality
Considerations.’’ The purpose of this
guidance is to provide
recommendations to industry on the
development and manufacture of
inhalation aerosols (also known as
metered dose inhalers, or MDIs) and
inhalation powders (also known as dry
powder inhalers, or DPIs). Although not
explicitly discussed, some of the
principles and recommendations
provided in this guidance may be
applicable to nasal delivery products, as
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:49 Apr 18, 2018
Jkt 244001
well. The recommendations in this
guidance can apply to MDI and DPI
products intended for local or systemic
effect.
DATES: Submit either electronic or
written comments on the draft guidance
by June 18, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1098 for ‘‘Metered Dose Inhaler
(MDI) and Dry Powder Inhaler (DPI)
Drug Products—Quality
Considerations.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave. Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Richard Lostritto, Center for Drug
E:\FR\FM\19APN1.SGM
19APN1
]]>Agencies
[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)]
[Notices]
[Pages 17419-17420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08233]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: TANF Office Culture Study.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF),
U.S. Department of Health and Human Services (HHS) is proposing data
collection activities as part of a project to identify and describe
exemplars of TANF organizational culture as well as successful
strategies human services offices have undertaken to improve their
organizational culture. This qualitative study intends to use this
information to increase understanding of how various agencies'
organizational cultures influence TANF clients' experiences, service
delivery, and frontline workers.
The information collection activities to be submitted in the
package include:
(1) Leadership and supervisor interviews will collect information
on program structure and staffing, client experiences, agency goals and
performance management, organizational learning and innovation,
cultural congruence across service providers, and the perception of the
organizational culture change, if applicable.
(2) Frontline workers' interviews will collect information about
frontline staffs' role in service delivery, client experiences, peer
interaction and social institutions within the agency, agency goals,
organizational learning and innovation, and the perception of the
organizational culture change initiative, if applicable.
(3) The focus groups will collect information about program
participants' perceptions of agency processes, their communication with
agency staff, and their assessment of the agency's organizational
culture.
Respondents: Individuals receiving TANF and related services, TANF
directors, and managers and staff at local TANF offices.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Total number Annual number responses per hours per Annual burden
of respondents of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Leadership and Supervisor 24 8 1 1.5 12
Interview Guide................
Frontline Staff Interview Guide. 12 4 1 1 4
Focus Group Guide............... 54 18 1 1.5 27
----------------------------------------------------------------------------------------------------------------
[[Page 17420]]
Estimated Total Annual Burden Hours: 43.
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, Attn: OPRE Reports Clearance Officer. All
requests should be identified by the title of the information
collection. Email address: [email protected].
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of 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:
[email protected], Attn: Desk Officer for the Administration
for Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018-08233 Filed 4-18-18; 8:45 am]
BILLING CODE 4184-09-P
