Appendix 5 - 60 Day FRN - TANF Case Studies

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Federal Register / Vol. 84, No. 91 / Friday, May 10, 2019 / Notices

dog from Egypt, including a dog from
Egypt that is being imported from a
third-party country. Such approvals will
be granted on a limited and case-by-case
basis and at CDC’s discretion.
Individuals seeking to import a dog
from Egypt must submit the Application
for a Permit to Import a Dog
Inadequately Immunized Against
Rabies, which is currently approved
under OMB Control Number 0920–0134
Foreign Quarantine Regulations (exp.
03/31/2022).
To request the advance written
approval of the CDC, you must send an
email to the Director, Division of Global
Migration and Quarantine, at
cdcanimalimports@cdc.gov, requesting
an application. Once you receive
instructions and the permit application,
your request must be submitted at least
10 business days before the date on
which you intend the dog to enter the
United States. A request cannot be made
at the port of entry upon arrival into the
United States. As required by the permit
application, your request must present
sufficient, reliable evidence
conclusively demonstrating that the dog
you wish to import is immune from
rabies. Such evidence includes a valid
rabies vaccination certificate that was
issued in the United States or official
government documents demonstrating
the reliability of the vaccine, vaccine
provider, and conditions under which
the vaccine was stored. The evidence
you present must also demonstrate the
authenticity of the documents relied
upon. Your written request must further
explain how you intend to establish, for
example, through identifying markers,
microchip, or tattoo, that the dog being
imported is the same dog identified in
the official government documents you
provided to the CDC. If the official
government documents are not written
in English, then they must be
accompanied by English language
translations of the official government
documents, the authenticity of which
has been attested to by a person licensed
by the government to perform acts in
legal affairs.
CDC will respond to your request in
writing and may impose additional
conditions in granting the approval. You
must present CDC’s written response
and approval upon entry into the United
States. If your request for advance
approval is denied, CDC’s written denial
will constitute final agency action.
VI. Terms of This Notice
Pursuant to 42 CFR 71.63 and 42 CFR
71.51(e), HHS/CDC hereby suspends,
until further notice, the importation of
any dog from Egypt, including dogs
from Egypt that are imported from third-

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party countries if the dogs have been
present in those countries for less than
six months. This notice will become
effective on May 10, 2019, and will be
remain in place subject to periodic
review by the CDC until appropriate
safeguards to prevent importation of
CRVV from Egypt have been
established.
Dated: May 6, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2019–09654 Filed 5–9–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; State Temporary Assistance
for Needy Families Case Studies (New
Collection)
Office of Planning, Research,
and Evaluation; Administration for
Children and Families; HHS.
ACTION: Request for public comment.
AGENCY:

The Office of Planning,
Research, and Evaluation (OPRE) is
proposing a data collection activity as
part of the State Temporary Assistance
for Needy Families (TANF) Case Studies
project. This study seeks to document
innovative employment and training
programs for low-income individuals
including TANF recipients and examine
the ways the programs provide or link
families to wraparound services. Over a
three-year period, the study will
conduct up to 12 comprehensive
qualitative case studies and up to 20
profiles of innovative programs to
showcase promising approaches.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing
OPREinfocollection@acf.hhs.gov.
Alternatively, copies can also 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,
SUMMARY:

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emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:

Description: The State TANF Case
Studies project will involve several
phases including: (1) Identifying
innovative programs through a scan of
the field and engagement with
stakeholders; (2) visiting up to 12
selected programs to collect detailed
information and produce
comprehensive case studies of these
programs to enhance policymakers’ and
other stakeholders’ understanding of
promising programs helping lowincome individuals to succeed in the
labor force; and (3) gathering
information through telephone
interviews to produce up to 20 shorter
case studies. The proposed information
collection activities are: (1) Semistructured interviews with program and
partner administrators and frontline
staff; (2) in-depth interviews with
participants to better inform and
enhance understanding of client
experiences and perspectives; (3) a
guided case review with frontline staff
to capture information about client
characteristics as well as intensity,
frequency, duration, and sequencing of
services; and (4) an observation of
program services, such as case
management sessions, intakes and
referrals, services delivered in a
classroom setting, and work sites. The
study will take place over a three year
period.
Respondents: Respondents include
program administrators, frontline
program staff, and program participants.
Program administrators include staff
who administer and supervise the case
study program under review; TANF and
employment and training programs;
child care and other wraparound
supports; and other workforce programs
and partners such as community
colleges, adult basic education
providers, and employers; and state
decision makers, as appropriate.
Frontline program staff include intake
workers, case managers, job developers,
and other direct service providers who
work at TANF agencies and American
Job Centers, employment and training
providers such as community colleges,
and providers of wraparound supports,
such as child care subsidy frontline
staff. TANF and other low-income
program participants will also be
respondents. All participants will be
able to opt out of participating in the
data collection activities.

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ANNUAL BURDEN ESTIMATES
Total
number of
respondents

Instrument
Semi-structured program staff interview guide ....................
In-depth participant interview guide .....................................
Case review guide ...............................................................

Estimated Total Annual Burden
Hours: 91.
Comments: 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 comments and suggestions submitted
within 60 days of this publication.
Authority: Sec. 413, Pub. L. 115–31.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–09658 Filed 5–9–19; 8:45 am]
BILLING CODE 4184–09–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1798]

Maximal Usage Trials for Topically
Applied Active Ingredients Being
Considered for Inclusion in an Overthe-Counter Monograph: Study
Elements and Considerations;
Guidance for Industry; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

200
24
24

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Maximal
Usage Trials for Topically Applied
Active Ingredients Being Considered for
Inclusion in an Over-the-Counter
Monograph: Study Elements and
Considerations.’’ This guidance
represents FDA’s current thinking on
the conduct of in vivo absorption trials
for topically applied active ingredients
that are under consideration for

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inclusion in an over-the-counter (OTC)
monograph.
DATES: The announcement of the
guidance is published in the Federal
Register on May 10, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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’’).
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.’’

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Number of
responses per
respondent

67
8
8

Written/Paper Submissions
Notice of availability.

SUMMARY:

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Annual
number of
respondents

1
1
2

Average
burden hours
per response
1
1.5
.75

Annual
burden hours
67
12
12

Instructions: All submissions received
must include the Docket No. FDA–
2019–D–1798 for ‘‘Maximal Usage Trials
for Topically Applied Active
Ingredients Being Considered for
Inclusion in an Over-the-Counter
Monograph: Study Elements and
Considerations; Guidance for Industry.’’
Received comments 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

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