Proposed Information Collection Activity; Comment Request, 60200-60201 [2017-27306]
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
age and older through educating and
training first responders and other key
community sectors on the prevention of
prescription drug/opioid overdoserelated deaths, including the purchase
and distribution of naloxone. SAMHSA
is funding the grant and CDC is
responsible for conducting the grantee
evaluation.
The intended use of the resulting data
is to increase CDC and SAMHSA
understanding of the scope and impact
of the program on overdose fatalities
responders, social service providers,
laypersons including end users and
their family and friend. All focus groups
and interviews will be analyzed through
qualitative content analysis, including
utilization of a systematic coding
scheme.
Total burden in hours for this
collection is 381. There are no costs to
respondents other than their time. CDC
requests a three-year OMB approval to
collect the necessary project-related
information.
and how program effectiveness may
vary among different sub-populations
and settings, and to increase knowledge
of barriers and facilitators to program
implementation.
Researchers will use key informant
interviews and focus groups with
participants in the activities enacted by
the twelve state grant recipients.
Participants will include state
administrators of the grant and other
PDO/Naloxone stakeholders including
advisory council members, first
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Type of respondents
Form name
PDO/Naloxone Advisory Committee Members
and Grantees.
PDO/Naloxone Grantees ................................
PDO/Naloxone Stakeholders and Partners ....
PDO/Naloxone Laypersons ............................
Focus Group Discussion Guide .....................
140
1
1.5
Key Informant Interview Guide for Grantees
Key Informant Interview Guide for Partners ..
Key
Informant
Interview
Guide
for
Laypersons.
Recruitment contact script .............................
36
84
24
1
1
1
1
1
1
284
1
5/60
Key Informant Selection Tool .........................
12
1
15/60
All participants (PDO Naloxone grantees, advisory committee, stakeholders and partners, laypersons).
PDO/Naloxone Grantees ................................
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. 2017–27257 Filed 12–18–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: ACF Generic Clearance for
Mandatory Grant Financial Reports.
OMB No.: 0970—New.
Description: OMB has granted
permission for ACF to submit a request
for a generic clearance to be used for the
financial reports used in the
administration of mandatory grants.
This clearance supports the
Departments initiative of Generating
Efficiencies through Streamlined
Processes by employing an abbreviated
process.
If approved program offices will be at
liberty to tailor a financial report to their
specific needs rather than adhering to a
standard form.
Respondents: States and Territories.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Mandatory Grant Financial Reports .................................................................
sradovich on DSK3GMQ082PROD with NOTICES
Instrument
900
4
5
18,000
Estimated Total Annual Burden
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
VerDate Sep<11>2014
17:47 Dec 18, 2017
Jkt 244001
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
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Fmt 4703
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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
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
E:\FR\FM\19DEN1.SGM
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–27306 Filed 12–18–17; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6716]
New Insights for Product Development
and Bioequivalence Assessments of
Generic Orally Inhaled and Nasal Drug
Products; Public Workshop; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘New Insights for
Product Development and
Bioequivalence Assessments of Generic
Orally Inhaled and Nasal Drug
Products.’’ The purposes of the
workshop are to present the outcomes
from the research projects conducted
under the Generic Drug User Fee
Amendments (GDUFA) Regulatory
Science Research Program; discuss how
regulatory science initiatives have
helped address regulatory science
knowledge gaps by providing insights
on factors that influence the
performance of generic orally inhaled
and nasal drug products (OINDPs);
share the Agency’s experience on the
utility of novel analytical tools and
methods developed under the regulatory
science initiative for generic OINDP
product development and
bioequivalence assessments; and obtain
input from the public on what, when,
where, and how analytical methods and
procedures should be applied in the
development and review of abbreviated
new drug applications (ANDAs) for
complex OINDPs.
DATES: The public workshop will be
held on January 9, 2018, from 8:30 a.m.
to 4:30 p.m. Individuals who wish to
attend the workshop must register by
December 30, 2017. Submit either
electronic or written comments on this
public workshop by February 14, 2018.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: The public workshop will
be held at FDA White Oak Campus,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:47 Dec 18, 2017
Jkt 244001
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503 B+C), Silver Spring, MD 20993–
0002. Entrance for the public workshop
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before February 14, 2018. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of February 14, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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.
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60201
• 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–
2017–N–6716 for ‘‘New Insights for
Product Development and
Bioequivalence Assessments of Generic
Orally Inhaled and Nasal Drug
Products.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential 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.
E:\FR\FM\19DEN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60200-60201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27306]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: ACF Generic Clearance for Mandatory Grant Financial Reports.
OMB No.: 0970--New.
Description: OMB has granted permission for ACF to submit a request
for a generic clearance to be used for the financial reports used in
the administration of mandatory grants. This clearance supports the
Departments initiative of Generating Efficiencies through Streamlined
Processes by employing an abbreviated process.
If approved program offices will be at liberty to tailor a
financial report to their specific needs rather than adhering to a
standard form.
Respondents: States and Territories.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Mandatory Grant Financial Reports........... 900 4 5 18,000
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden 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: [email protected]. 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 respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to
[[Page 60201]]
comments and suggestions submitted within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017-27306 Filed 12-18-17; 8:45 am]
BILLING CODE 4184-01-P
