Attachment A - URM 60 Day Federal Register Notice

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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices

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.
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.

ADDRESSES:

Authority: Sec. 413, Pub. L. 115–31.
Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–20085 Filed 9–14–18; 8:45 am]
BILLING CODE 4184–09–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Descriptive Study of the
Unaccompanied Refugee Minors
Program (New Collection)
Office of Planning, Research,
and Evaluation; ACF; HHS.
ACTION: Request for public comment.
AGENCY:

The Office of Planning,
Research, and Evaluation (OPRE) at 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 better understand the
range of child welfare services and
benefits provided through the
Unaccompanied Refugee Minors (URM)
Program.
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 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. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION: The
information collection activities to be
submitted in the package include:
1. Survey of State Refugee
Coordinators (SRCs) from the 15 states
with URM programs.
2. Survey of URM Program Directors
from all 22 URM programs.
SUMMARY:

3. Survey of Private Custody Child
Welfare Agency Administrators from
nine states with private custody
arrangements.
4. Interviews with URM Program
Managers from six URM programs.
5. Interviews with URM Program Staff
(e.g. case managers, data managers) from
six URM programs.
6. Interviews with Child Welfare
Agency Administrators who have
contact with six URM programs.
7. Interviews with Community
Partners including leadership and line
staff from local organizations, such as
health care and mental health care
providers, legal aid organizations, and
faith-based groups serving the URM
population at six URM program sites.
8. Interviews with Community
Partners in the field of education, such
as school administrators and counselors,
and organizations providing English
language education and support at six
URM program sites.
9. Focus Groups for URM Youth from
six URM programs.
10. Focus Groups for URM Foster
Families from six URM programs.
Respondents: State Refugee
Coordinators and supporting staff, URM
Program Directors and supporting staff,
Child Welfare Agency Administrators
and supporting staff, URM program staff
(case workers, data managers, and other
staff), staff from community partner
organizations (e.g. health and mental
health service providers, education
service providers, faith-based
organizations), URM youth, and URM
foster families.

ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents

Instrument

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Survey of State Refugee Coordinators ............................................................
Survey of URM Program Directors ..................................................................
Survey of Private Custody Child Welfare Agency Administrators ...................
Interviews with URM Program Managers ........................................................
Interviews with URM Program Staff ................................................................
Interviews with Child Welfare Agency Administrators .....................................
Interviews with Community Partners [General] ...............................................
Interviews with Community Partners [Education] ............................................
Focus Groups with URM Youth .......................................................................
Focus Groups with URM Foster Families .......................................................

Estimated Total Annual Burden
Hours: 401.
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

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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.

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Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
1

Average
burden hours
per response

Annual burden
hours

0.67
1
0.67
1.5
1.25
1
1
1
1.5
1.5

Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.

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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices
Authority: Section 1110 of the Social
Security Act.

Electronic Submissions

Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–20068 Filed 9–14–18; 8:45 am]
BILLING CODE 4184–07–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2973]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Obtaining
Information for Evaluating Nominated
Bulk Drug Substances for Use in
Compounding Drug Products Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with FDA research
in obtaining information from medical
specialty groups and/or medical experts
regarding compounded drug products
that contain certain bulk drug
substances to support establishment of a
list of bulk drug substances under
section 503B of the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by November 16, 2018.
ADDRESSES: 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 November 16,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 16, 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.

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SUMMARY:

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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–N–2973 for ‘‘Obtaining
Information for Evaluating Nominated
Bulk Drug Substances for Use in
Compounding Drug Products Under
Section 503B of the Federal Food, Drug,
and Cosmetic Act.’’ 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

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46957

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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this

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