83_FR_52421 83 FR 52221 - Submission for OMB Review; Comment Request

83 FR 52221 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 83, Issue 200 (October 16, 2018)

Page Range52221-52222
FR Document2018-22461

Federal Register, Volume 83 Issue 200 (Tuesday, October 16, 2018)
[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Notices]
[Pages 52221-52222]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22461]


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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.
    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]
 BILLING CODE P



                                                                                  Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices                                                           52221

                                                                                                                  ANNUAL BURDEN ESTIMATES—Continued
                                                                                                                                          Total                 Annual          Number of           Average         Annual
                                                                                Instrument                                              number of              number of      responses per       burden hours   burden hours
                                                                                                                                       respondents            respondent        respondent        per response

                                              Pre-survey information form ................................................                         6,000              2,000                1              0.05            100



                                               Estimated Total Annual Burden                                        agency’s estimate of the burden of the                         Description: The Administration for
                                              Hours: 3,300.                                                         proposed collection of information; (c)                     Children (ACF), Office of Refugee
                                              DATES: Comments due within 60 days of                                 the quality, utility, and clarity of the                    Resettlement (ORR) requests the
                                              publication. In compliance with the                                   information to be collected; and (d)                        continuation of an existing information
                                              requirements of Section 3506(c)(2)(A) of                              ways to minimize the burden of the                          collection under OMB control number
                                              the Paperwork Reduction Act of 1995,                                  collection of information on                                0970–0278, Reunification Procedures
                                              the Administration for Children and                                   respondents, including through the use                      for Unaccompanied Alien Children,
                                              Families is soliciting public comment                                 of automated collection techniques or                       renamed to Sponsorship Review
                                              on the specific aspects of the                                        other forms of information technology.                      Procedures for Approval of
                                              information collection described above.                               Consideration will be given to                              Unaccompanied Alien Children. The
                                                                                                                    comments and suggestions submitted                          information collection allows ACF to
                                              ADDRESSES:   Copies of the proposed                                   within 60 days of this publication.                         conduct suitability assessments to vet
                                              collection of information can be                                                                                                  potential sponsors of unaccompanied
                                                                                                                       Authority: Sec. 413. [8 U.S.C. 1523].
                                              obtained and comments may be                                                                                                      alien children in accordance with a
                                              forwarded by writing to the                                           Emily B. Jabbour,                                           Memorandum of Agreement (MOA)
                                              Administration for Children and                                       ACF/OPRE Certifying Officer.                                between ORR and the Department of
                                              Families, Office of Planning, Research,                               [FR Doc. 2018–22441 Filed 10–15–18; 8:45 am]                Homeland Security. Specifically, the
                                              and Evaluation, 330 C Street SW,                                      BILLING CODE 4184–01–P                                      information collection allows ORR to
                                              Washington, DC 20201, Attn: OPRE                                                                                                  obtain biometric and biographical
                                              Reports Clearance Officer. Email                                                                                                  information from sponsors, adult
                                              address: OPREinfocollection@                                          DEPARTMENT OF HEALTH AND                                    members of their household, and adult
                                              acf.hhs.gov. All requests should be                                   HUMAN SERVICES                                              care givers identified in a sponsor care
                                              identified by the title of the information                                                                                        plan, where applicable. ORR in turn
                                              collection.                                                           Administration for Children and                             shares the information collected with
                                              SUPPLEMENTARY INFORMATION:       The                                  Families                                                    other federal departments to conduct
                                              Department specifically requests                                                                                                  background checks. The existing OMB
                                                                                                                    Submission for OMB Review;
                                              comments on (a) whether the proposed                                                                                              approval for these instruments expires
                                                                                                                    Comment Request
                                              collection of information is necessary                                                                                            October 31, 2018.
                                              for the proper performance of the                                       Title: Sponsorship Review Procedures                         Respondents: Sponsors, adult
                                              functions of the agency, including                                    for Approval for Unaccompanied Alien                        household members, parents or legal
                                              whether the information shall have                                    Children.                                                   guardians of unaccompanied alien
                                              practical utility; (b) the accuracy of the                              OMB No.: 0970–0278.                                       children.

                                                                                                                             ANNUAL BURDEN ESTIMATES
                                                                                                                                                                                Number of           Average
                                                                                                                                                               Number of                                         Total burden
                                                                                            Instrument                                                                        responses per       burden hours
                                                                                                                                                              respondents                                           hours
                                                                                                                                                                                respondent        per response

                                              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                                   on August 24, 2018 (83 FR 42895). The                       document in the Federal Register.
                                              Respondent: 207,500.                                                  more recent request for comment                             Therefore, a comment is best assured of
                                                Additional Information: Copies of the                               erroneously described the request as one                    having its full effect if OMB receives it
                                              existing collection may be obtained by                                for emergency processing and                                within 30 days of publication. Written
                                              writing to the Administration for                                     immediate approval. This notice                             comments and recommendations for the
                                              Children and Families, Office of                                      corrects that error to clarify that ACF is                  proposed information collection should
                                              Planning, Research and Evaluation, 330                                seeking public comments on the                              be sent directly to the following: Office
                                              C Street SW, Washington, DC 20201.                                    proposed information collection,                            of Management and Budget, Paperwork
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                                              Attention Reports Clearance Officer. All                              including aspects previously approved                       Reduction Project, Email: OIRA_
                                              requests should be identified by the title                            under emergency processing, prior to its                    SUBMISSION@OMB.EOP.GOV, Attn:
                                              of the information collection. Email                                  renewal.
                                              address: infocollection@acf.hhs.gov.                                    OMB Comment: OMB is required to
                                                ACF first sought comments on this                                   make a decision concerning the
                                              revised collection of information on                                  collection of information between 30
                                              May 11, 2018 (83 FR 22490) and again                                  and 60 days after publication of this


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                                              52222                        Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Notices

                                              Desk Officer for the Administration for                 solely responsible for ensuring that your             contact information to be made publicly
                                              Children and Families.                                  comment does not include any                          available, you can provide this
                                                                                                      confidential information that you or a                information on the cover sheet and not
                                              Robert A. Sargis,
                                                                                                      third party may not wish to be posted,                in the body of your comments and you
                                              Reports Clearance Officer.                              such as medical information, your or                  must identify this information as
                                              [FR Doc. 2018–22461 Filed 10–15–18; 8:45 am]            anyone else’s Social Security number, or              ‘‘confidential.’’ Any information marked
                                              BILLING CODE P                                          confidential business information, such               as ‘‘confidential’’ will not be disclosed
                                                                                                      as a manufacturing process. Please note               except in accordance with 21 CFR 10.20
                                                                                                      that if you include your name, contact                and other applicable disclosure law. For
                                              DEPARTMENT OF HEALTH AND                                information, or other information that                more information about FDA’s posting
                                              HUMAN SERVICES                                          identifies you in the body of your                    of comments to public dockets, see 80
                                                                                                      comments, that information will be                    FR 56469, September 18, 2015, or access
                                              Food and Drug Administration                            posted on https://www.regulations.gov.                the information at: https://www.gpo.gov/
                                              [Docket No. FDA–2017–D–6617]                              • If you want to submit a comment                   fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                                                                      with confidential information that you                23389.pdf.
                                              Developing Targeted Therapies in Low-                   do not wish to be made available to the                  Docket: For access to the docket to
                                              Frequency Molecular Subsets of a                        public, submit the comment as a                       read background documents or the
                                              Disease; Guidance for Industry;                         written/paper submission and in the                   electronic and written/paper comments
                                              Availability                                            manner detailed (see ‘‘Written/Paper                  received, go to https://
                                                                                                      Submissions’’ and ‘‘Instructions’’).                  www.regulations.gov and insert the
                                              AGENCY:    Food and Drug Administration,
                                              HHS.                                                    Written/Paper Submissions                             docket number, found in brackets in the
                                              ACTION:   Notice of availability.                                                                             heading of this document, into the
                                                                                                         Submit written/paper submissions as                ‘‘Search’’ box and follow the prompts
                                                                                                      follows:                                              and/or go to the Dockets Management
                                              SUMMARY:   The Food and Drug                               • Mail/Hand delivery/Courier (for
                                              Administration (FDA or Agency) is                                                                             Staff, 5630 Fishers Lane, Rm. 1061,
                                                                                                      written/paper submissions): Dockets
                                              announcing the availability of a final                                                                        Rockville, MD 20852.
                                                                                                      Management Staff (HFA–305), Food and
                                              guidance for industry entitled                                                                                   You may submit comments on any
                                                                                                      Drug Administration, 5630 Fishers
                                              ‘‘Developing Targeted Therapies in                                                                            guidance at any time (see 21 CFR
                                                                                                      Lane, Rm. 1061, Rockville, MD 20852.
                                              Low-Frequency Molecular Subsets of a                                                                          10.115(g)(5)).
                                                                                                         • For written/paper comments
                                              Disease.’’ This final guidance                                                                                   Submit written requests for single
                                                                                                      submitted to the Dockets Management
                                              incorporates public comments to the                                                                           copies of this guidance to the Division
                                                                                                      Staff, FDA will post your comment, as
                                              draft guidance published in the Federal                                                                       of Drug Information, Center for Drug
                                                                                                      well as any attachments, except for
                                              Register of December 18, 2017.                                                                                Evaluation and Research, Food and
                                                                                                      information submitted, marked and
                                                 The pharmacological effect of a                                                                            Drug Administration, 10001 New
                                                                                                      identified, as confidential, if submitted
                                              targeted therapy is often related to a                                                                        Hampshire Ave., Hillandale Building,
                                                                                                      as detailed in ‘‘Instructions.’’
                                              particular molecular alteration, and                       Instructions: All submissions received             4th Floor, Silver Spring, MD 20993–
                                              many diseases are caused by a range of                  must include the Docket No. FDA–                      0002; or the Office of Communication,
                                              different molecular alterations (some of                2017–D–6617 for ‘‘Developing Targeted                 Outreach, and Development, Center for
                                              which may be rare). Therefore, a                        Therapies in Low-Frequency Molecular                  Biologics Evaluation and Research
                                              targeted therapy may have differential                  Subsets of a Disease.’’ Received                      (CBER), Food and Drug Administration,
                                              effects among patients with the same                    comments will be placed in the docket                 10903 New Hampshire Ave., Bldg. 71,
                                              disease who have different molecular                    and, except for those submitted as                    Rm. 3128, Silver Spring, MD 20993–
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                                              guidance is to describe general                         viewable at https://www.regulations.gov               label to assist that office in processing
                                              approaches to evaluating the benefits                   or at the Dockets Management Staff                    your requests. The guidance may also be
                                              and risks of targeted therapeutics within               between 9 a.m. and 4 p.m., Monday                     obtained by mail by calling CBER at 1–
                                              a clinically defined disease where some                 through Friday.                                       800–835–4709 or 240–402–8010. See
                                              molecular alterations may occur at low                     • Confidential Submissions—To                      the SUPPLEMENTARY INFORMATION section
                                              frequencies.                                            submit a comment with confidential                    for electronic access to the guidance
                                              DATES: The announcement of the                          information that you do not wish to be                document.
                                              guidance is published in the Federal                    made publicly available, submit your                  FOR FURTHER INFORMATION CONTACT:
                                              Register on October 16, 2018.                           comments only as a written/paper                      Michael Pacanowski, Center for Drug
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                                              electronic or written comments on                       copies total. One copy will include the               Drug Administration, 10903 New
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                                              follows:                                                with a heading or cover note that states              Silver Spring, MD 20993–0002, 301–
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                                              Electronic Submissions                                  CONFIDENTIAL INFORMATION.’’ The                       Biologics Evaluation and Research,
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                                              following way:                                          the claimed confidential information, in              New Hampshire Ave., Bldg. 71, Rm.
                                                • Federal eRulemaking Portal:                         its consideration of comments. The                    7301, Silver Spring, MD 20993–0002,
amozie on DSK3GDR082PROD with NOTICES1




                                              https://www.regulations.gov. Follow the                 second copy, which will have the                      240–402–7911.
                                              instructions for submitting comments.                   claimed confidential information                      SUPPLEMENTARY INFORMATION:
                                              Comments submitted electronically,                      redacted/blacked out, will be available
                                              including attachments, to https://                      for public viewing and posted on                      I. Background
                                              www.regulations.gov will be posted to                   https://www.regulations.gov. Submit                      FDA is announcing the availability of
                                              the docket unchanged. Because your                      both copies to the Dockets Management                 a guidance for industry entitled
                                              comment will be made public, you are                    Staff. If you do not wish your name and               ‘‘Developing Targeted Therapies in


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Document Created: 2018-10-15 23:42:25
Document Modified: 2018-10-15 23:42:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation83 FR 52221 

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