Submission for OMB Review; Comment Request, 52221-52222 [2018-22461]
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52221
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total
number of
respondents
Instrument
Pre-survey information form ................................................
Estimated Total Annual Burden
Hours: 3,300.
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.
DATES:
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.
ADDRESSES:
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
SUPPLEMENTARY INFORMATION:
Annual
number of
respondent
6,000
Number of
responses per
respondent
2,000
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. [8 U.S.C. 1523].
Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–22441 Filed 10–15–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Sponsorship Review Procedures
for Approval for Unaccompanied Alien
Children.
OMB No.: 0970–0278.
1
Average
burden hours
per response
0.05
Annual
burden hours
100
Description: The Administration for
Children (ACF), Office of Refugee
Resettlement (ORR) requests the
continuation of an existing information
collection under OMB control number
0970–0278, Reunification Procedures
for Unaccompanied Alien Children,
renamed to Sponsorship Review
Procedures for Approval of
Unaccompanied Alien Children. The
information collection allows ACF to
conduct suitability assessments to vet
potential sponsors of unaccompanied
alien children in accordance with a
Memorandum of Agreement (MOA)
between ORR and the Department of
Homeland Security. Specifically, the
information collection allows ORR to
obtain biometric and biographical
information from sponsors, adult
members of their household, and adult
care givers identified in a sponsor care
plan, where applicable. ORR in turn
shares the information collected with
other federal departments to conduct
background checks. The existing OMB
approval for these instruments expires
October 31, 2018.
Respondents: Sponsors, adult
household members, parents or legal
guardians of unaccompanied alien
children.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
amozie on DSK3GDR082PROD with NOTICES1
Family Reunification Application ......................................................................
Authorization for Release of Information .........................................................
Fingerprint Instructions ....................................................................................
Letter of Designation .......................................................................................
Estimated Total Annual Burden per
Respondent: 207,500.
Additional Information: Copies of the
existing 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.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
ACF first sought comments on this
revised collection of information on
May 11, 2018 (83 FR 22490) and again
VerDate Sep<11>2014
18:44 Oct 15, 2018
Jkt 247001
50,000
90,000
90,000
25,000
on August 24, 2018 (83 FR 42895). The
more recent request for comment
erroneously described the request as one
for emergency processing and
immediate approval. This notice
corrects that error to clarify that ACF is
seeking public comments on the
proposed information collection,
including aspects previously approved
under emergency processing, prior to its
renewal.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
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Sfmt 4703
Number of
responses per
respondent
1
1
1
1
Average
burden hours
per response
0.75
0.5
1.25
0.5
Total burden
hours
37,500
45,000
112,500
12,500
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:
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52222
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices
Desk Officer for the Administration for
Children and Families.
Robert A. Sargis,
Reports Clearance Officer.
[FR Doc. 2018–22461 Filed 10–15–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6617]
Developing Targeted Therapies in LowFrequency Molecular Subsets of a
Disease; 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 final
guidance for industry entitled
‘‘Developing Targeted Therapies in
Low-Frequency Molecular Subsets of a
Disease.’’ This final guidance
incorporates public comments to the
draft guidance published in the Federal
Register of December 18, 2017.
The pharmacological effect of a
targeted therapy is often related to a
particular molecular alteration, and
many diseases are caused by a range of
different molecular alterations (some of
which may be rare). Therefore, a
targeted therapy may have differential
effects among patients with the same
disease who have different molecular
alterations. The purpose of this
guidance is to describe general
approaches to evaluating the benefits
and risks of targeted therapeutics within
a clinically defined disease where some
molecular alterations may occur at low
frequencies.
DATES: The announcement of the
guidance is published in the Federal
Register on October 16, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
amozie on DSK3GDR082PROD with NOTICES1
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
VerDate Sep<11>2014
18:44 Oct 15, 2018
Jkt 247001
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–
2017–D–6617 for ‘‘Developing Targeted
Therapies in Low-Frequency Molecular
Subsets of a Disease.’’ 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
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Fmt 4703
Sfmt 4703
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 this 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; or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Michael Pacanowski, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 301–
796–3919; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Developing Targeted Therapies in
E:\FR\FM\16OCN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Notices]
[Pages 52221-52222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Sponsorship Review Procedures for Approval for Unaccompanied
Alien Children.
OMB No.: 0970-0278.
Description: The Administration for Children (ACF), Office of
Refugee Resettlement (ORR) requests the continuation of an existing
information collection under OMB control number 0970-0278,
Reunification Procedures for Unaccompanied Alien Children, renamed to
Sponsorship Review Procedures for Approval of Unaccompanied Alien
Children. The information collection allows ACF to conduct suitability
assessments to vet potential sponsors of unaccompanied alien children
in accordance with a Memorandum of Agreement (MOA) between ORR and the
Department of Homeland Security. Specifically, the information
collection allows ORR to obtain biometric and biographical information
from sponsors, adult members of their household, and adult care givers
identified in a sponsor care plan, where applicable. ORR in turn shares
the information collected with other federal departments to conduct
background checks. The existing OMB approval for these instruments
expires October 31, 2018.
Respondents: Sponsors, adult household members, parents or legal
guardians of unaccompanied alien children.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Family Reunification Application................ 50,000 1 0.75 37,500
Authorization for Release of Information........ 90,000 1 0.5 45,000
Fingerprint Instructions........................ 90,000 1 1.25 112,500
Letter of Designation........................... 25,000 1 0.5 12,500
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden per Respondent: 207,500.
Additional Information: Copies of the existing 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. Attention Reports Clearance Officer. All requests
should be identified by the title of the information collection. Email
address: [email protected].
ACF first sought comments on this revised collection of information
on May 11, 2018 (83 FR 22490) and again on August 24, 2018 (83 FR
42895). The more recent request for comment erroneously described the
request as one for emergency processing and immediate approval. This
notice corrects that error to clarify that ACF is seeking public
comments on the proposed information collection, including aspects
previously approved under emergency processing, prior to its renewal.
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:
[[Page 52222]]
Desk Officer for the Administration for Children and Families.
Robert A. Sargis,
Reports Clearance Officer.
[FR Doc. 2018-22461 Filed 10-15-18; 8:45 am]
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