80_FR_81021 80 FR 80773 - Submission for OMB Review; Comment Request

80 FR 80773 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 248 (December 28, 2015)

Page Range80773-80774
FR Document2015-32580

Federal Register, Volume 80 Issue 248 (Monday, December 28, 2015)
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80773-80774]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Refugee Microenterprise and Refugee Home-Based Child Care 
Microenterprise Development.
    OMB No.: 0970.
    Description: New data collection tool for refugee microenterprise 
and Refugee Home-Based Child Care Microenterprise Program.
    Respondents: Refugee Microenterprise Development Grantees and 
Refugee Home-Based Child Care Microenterprise Development.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Refugee Microenterprise Development.............              22               8               4              88
Refugee Home-Based Child Care Microenterprise                 23               7               4              92
 Development....................................
                                                 ---------------------------------------------------------------
    Total Burden................................  ..............  ..............  ..............             180
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: (180 hours x $30 per hour) 
$4,500 per year.

Explanation

The Refugee Microenterprise Development Program
     Currently, there are twenty two grantees (respondents) in 
the program and the semi-annual progress, which includes the data and 
information required, is submitted twice per year.
     The request covers one form (Form I. attached) which 
includes eight data points. Based on experience (the information was 
provided by technical assistance service provider in the past), it 
takes about two hours per respondent per six months (i.e., four hours 
per year per grantee (respondent) or 88 hours per year for all 
respondents) to complete the form.
     No survey will be undertaken since the collection of this 
data (information) is part of the implementation process of the project 
and its collection and reporting does not constitute a separate and 
additional cost to the grantees (respondents). The cost is covered by 
the grant the grantee receives. The grantees have Down Home database 
which captures and stores the data required for reporting. The grantee 
uploads the semi-annual report in Grant Solution where it is stored. 
ORR derives the data it requires for reporting and management decision 
from Grant Solution.
The Refugee Home-Based Child Care Microenterprise Development Group
     Currently, there are twenty three grantees (respondents) 
in the program and the semi-annual progress.
     The request covers one form (Form II. attached) which 
includes seven data points. It takes about two hours per respondent per 
six months (i.e., four hours per year grantee (respondent) or 92 hours 
per year for all respondents) to complete the form.
     The collection of this data (information) is part of the 
process and its collection and reporting does not include separate and 
additional cost to the grantees (respondents). The cost is covered by 
the grant the grantee receives. The grantees have database which 
captures and stores the data required for reporting. The grantee 
uploads the data required in Grant Solution where it is stored. ORR 
derives the data it requires for reporting and management decision from 
Grant Solution.

[[Page 80774]]

Additional Information

    Copies of the proposed collection may be obtained by writing to the 
Administration for Children and Families, Office of Planning, Research 
and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: 
ACF Reports Clearance Officer. All requests should be identified by the 
title of the information collection. Email address: 
[email protected].

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: Desk Officer for the Administration 
for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-32580 Filed 12-24-15; 8:45 am]
 BILLING CODE 4184-01-P



                                                                                      Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices                                                                                              80773

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

                                                  § 1305.4(l) Eligibility determination records (sample form) .............................                                           1,600                        478                          .10           76,480
                                                  § 1305.4(d)(2) ...................................................................................................                     20                          1                            2               40
                                                  § 1305.4(h),(i), and (j) ......................................................................................                     1,600                          1                           15           24,000
                                                  § 1305.4(l) Other Record Keeping ...................................................................                                1,600                          1                           15           24,000

                                                        Estimated Total Annual Burden Hours .....................................................                      ........................   ........................   ........................        124,520



                                                  Additional Information                                                   publication. Written comments and                                          DEPARTMENT OF HEALTH AND
                                                    Copies of the proposed collection may                                  recommendations for the proposed                                           HUMAN SERVICES
                                                  be obtained by writing to the                                            information collection should be sent
                                                                                                                           directly to the following: Office of                                       Administration for Children and
                                                  Administration for Children and
                                                                                                                           Management and Budget, Paperwork                                           Families
                                                  Families, Office of Planning, Research
                                                  and Evaluation, 370 L’Enfant                                             Reduction Project, Fax: 202–395–7285,
                                                                                                                                                                                                      Submission for OMB Review;
                                                  Promenade SW., Washington, DC 20447,                                     Email: OIRA_SUBMISSION@
                                                                                                                                                                                                      Comment Request
                                                  Attn: ACF Reports Clearance Officer. All                                 OMB.EOP.GOV.
                                                  requests should be identified by the title                                 Attn: Desk Officer for the                                                 Title: Refugee Microenterprise and
                                                  of the information collection. Email                                     Administration for Children and                                            Refugee Home-Based Child Care
                                                  address: infocollection@acf.hhs.gov.                                     Families.                                                                  Microenterprise Development.
                                                                                                                                                                                                        OMB No.: 0970.
                                                  OMB Comment                                                              Robert Sargis,                                                               Description: New data collection tool
                                                     OMB is required to make a decision                                    Reports Clearance Officer.                                                 for refugee microenterprise and Refugee
                                                  concerning the collection of information                                 [FR Doc. 2015–32565 Filed 12–24–15; 8:45 am]                               Home-Based Child Care Microenterprise
                                                  between 30 and 60 days after                                             BILLING CODE 4184–01–P
                                                                                                                                                                                                      Program.
                                                  publication of this document in the                                                                                                                   Respondents: Refugee Microenterprise
                                                  Federal Register. Therefore, a comment                                                                                                              Development Grantees and Refugee
                                                  is best assured of having its full effect                                                                                                           Home-Based Child Care Microenterprise
                                                  if OMB receives it within 30 days of                                                                                                                Development.

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

                                                  Refugee Microenterprise Development ...........................................................                                          22                          8                          4               88
                                                  Refugee Home-Based Child Care Microenterprise Development ...................                                                            23                          7                          4               92

                                                        Total Burden .............................................................................................     ........................   ........................   ........................            180



                                                    Estimated Total Annual Burden                                             • No survey will be undertaken since                                       • The request covers one form (Form
                                                  Hours: (180 hours × $30 per hour)                                        the collection of this data (information)                                  II. attached) which includes seven data
                                                  $4,500 per year.                                                         is part of the implementation process of                                   points. It takes about two hours per
                                                  Explanation                                                              the project and its collection and                                         respondent per six months (i.e., four
                                                                                                                           reporting does not constitute a separate                                   hours per year grantee (respondent) or
                                                  The Refugee Microenterprise                                              and additional cost to the grantees                                        92 hours per year for all respondents) to
                                                  Development Program                                                      (respondents). The cost is covered by                                      complete the form.
                                                     • Currently, there are twenty two                                     the grant the grantee receives. The                                           • The collection of this data
                                                  grantees (respondents) in the program                                    grantees have Down Home database                                           (information) is part of the process and
                                                  and the semi-annual progress, which                                      which captures and stores the data                                         its collection and reporting does not
                                                  includes the data and information                                        required for reporting. The grantee                                        include separate and additional cost to
                                                  required, is submitted twice per year.                                   uploads the semi-annual report in Grant                                    the grantees (respondents). The cost is
                                                                                                                           Solution where it is stored. ORR derives
                                                     • The request covers one form (Form                                                                                                              covered by the grant the grantee
                                                                                                                           the data it requires for reporting and                                     receives. The grantees have database
                                                  I. attached) which includes eight data
                                                                                                                           management decision from Grant
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                                                  points. Based on experience (the                                                                                                                    which captures and stores the data
                                                  information was provided by technical                                    Solution.                                                                  required for reporting. The grantee
                                                  assistance service provider in the past),                                The Refugee Home-Based Child Care                                          uploads the data required in Grant
                                                  it takes about two hours per respondent                                  Microenterprise Development Group                                          Solution where it is stored. ORR derives
                                                  per six months (i.e., four hours per year                                                                                                           the data it requires for reporting and
                                                  per grantee (respondent) or 88 hours per                                   • Currently, there are twenty three                                      management decision from Grant
                                                  year for all respondents) to complete the                                grantees (respondents) in the program                                      Solution.
                                                  form.                                                                    and the semi-annual progress.


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                                                  80774                      Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices

                                                  Additional Information                                  Furthermore, any interested person may                http://www.regulations.gov or at the
                                                    Copies of the proposed collection may                 petition FDA for a determination                      Division of Dockets Management
                                                  be obtained by writing to the                           regarding whether the applicant for                   between 9 a.m. and 4 p.m., Monday
                                                  Administration for Children and                         extension acted with due diligence                    through Friday.
                                                  Families, Office of Planning, Research                  during the regulatory review period by                   • Confidential Submissions—To
                                                  and Evaluation, 370 L’Enfant                            June 27, 2016. See ‘‘Petitions’’ in the               submit a comment with confidential
                                                  Promenade SW., Washington, DC 20447,                    SUPPLEMENTARY INFORMATION section for                 information that you do not wish to be
                                                  Attn: ACF Reports Clearance Officer. All                more information.                                     made publicly available, submit your
                                                  requests should be identified by the title              ADDRESSES: You may submit comments                    comments only as a written/paper
                                                  of the information collection. Email                    as follows:                                           submission. You should submit two
                                                  address: infocollection@acf.hhs.gov.                                                                          copies total. One copy will include the
                                                                                                          Electronic Submissions                                information you claim to be confidential
                                                  OMB Comment                                               Submit electronic comments in the                   with a heading or cover note that states
                                                     OMB is required to make a decision                   following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                  concerning the collection of information                  • Federal eRulemaking Portal: http://               CONFIDENTIAL INFORMATION’’. The
                                                  between 30 and 60 days after                            www.regulations.gov. Follow the                       Agency will review this copy, including
                                                  publication of this document in the                     instructions for submitting comments.                 the claimed confidential information, in
                                                  Federal Register. Therefore, a comment                  Comments submitted electronically,                    its consideration of comments. The
                                                  is best assured of having its full effect               including attachments, to http://                     second copy, which will have the
                                                  if OMB receives it within 30 days of                    www.regulations.gov will be posted to                 claimed confidential information
                                                  publication. Written comments and                       the docket unchanged. Because your                    redacted/blacked out, will be available
                                                  recommendations for the proposed                        comment will be made public, you are                  for public viewing and posted on
                                                  information collection should be sent                   solely responsible for ensuring that your             http://www.regulations.gov. Submit
                                                  directly to the following: Office of                    comment does not include any                          both copies to the Division of Dockets
                                                  Management and Budget, Paperwork                        confidential information that you or a                Management. If you do not wish your
                                                  Reduction Project, Email: OIRA_                         third party may not wish to be posted,                name and contact information to be
                                                  SUBMISSION@OMB.EOP.GOV. Attn:                           such as medical information, your or                  made publicly available, you can
                                                  Desk Officer for the Administration for                 anyone else’s Social Security number, or              provide this information on the cover
                                                  Children and Families.                                  confidential business information, such               sheet and not in the body of your
                                                                                                          as a manufacturing process. Please note               comments and you must identify this
                                                  Robert Sargis,                                          that if you include your name, contact                information as ‘‘confidential’’. Any
                                                  Reports Clearance Officer.                              information, or other information that                information marked as ‘‘confidential’’
                                                  [FR Doc. 2015–32580 Filed 12–24–15; 8:45 am]            identifies you in the body of your                    will not be disclosed except in
                                                  BILLING CODE 4184–01–P                                  comments, that information will be                    accordance with 21 CFR 10.20 and other
                                                                                                          posted on http://www.regulations.gov.                 applicable disclosure law. For more
                                                                                                            • If you want to submit a comment                   information about FDA’s posting of
                                                  DEPARTMENT OF HEALTH AND                                with confidential information that you                comments to public dockets, see 80 FR
                                                  HUMAN SERVICES                                          do not wish to be made available to the               56469, September 18, 2015, or access
                                                                                                          public, submit the comment as a                       the information at: http://www.fda.gov/
                                                  Food and Drug Administration                            written/paper submission and in the                   regulatoryinformation/dockets/
                                                  [Docket Nos. FDA–2013–E–1692 and FDA–                   manner detailed (see ‘‘Written/Paper                  default.htm.
                                                  2013–E–1691]                                            Submissions’’ and ‘‘Instructions’’).                     Docket: For access to the docket to
                                                                                                          Written/Paper Submissions                             read background documents or the
                                                  Determination of Regulatory Review                                                                            electronic and written/paper comments
                                                  Period for Purposes of Patent                              Submit written/paper submissions as                received, go to http://
                                                  Extension; KADCYLA                                      follows:                                              www.regulations.gov and insert the
                                                                                                             • Mail/Hand delivery/Courier (for
                                                  AGENCY:    Food and Drug Administration,                                                                      docket number, found in brackets in the
                                                                                                          written/paper submissions): Division of
                                                  HHS.                                                                                                          heading of this document, into the
                                                                                                          Dockets Management (HFA–305), Food
                                                  ACTION:   Notice.                                                                                             ‘‘Search’’ box and follow the prompts
                                                                                                          and Drug Administration, 5630 Fishers
                                                                                                                                                                and/or go to the Division of Dockets
                                                                                                          Lane, Rm. 1061, Rockville, MD 20852.
                                                  SUMMARY:   The Food and Drug                               • For written/paper comments                       Management, 5630 Fishers Lane, Rm.
                                                  Administration (FDA) has determined                     submitted to the Division of Dockets                  1061, Rockville, MD 20852.
                                                  the regulatory review period for                        Management, FDA will post your                        FOR FURTHER INFORMATION CONTACT:
                                                  KADCYLA and is publishing this notice                   comment, as well as any attachments,                  Beverly Friedman, Office of Regulatory
                                                  of that determination as required by                    except for information submitted,                     Policy, Food and Drug Administration,
                                                  law. FDA has made the determination                     marked and identified, as confidential,               10903 New Hampshire Ave., Bldg. 51,
                                                  because of the submission of an                         if submitted as detailed in                           Rm. 6250, Silver Spring, MD 20993,
                                                  application to the Director of the U.S.                 ‘‘Instructions.’’                                     301–796–3600.
                                                  Patent and Trademark Office (USPTO),                       Instructions: All submissions received             SUPPLEMENTARY INFORMATION:
                                                  Department of Commerce, for the                         must include the Docket Nos. FDA–
                                                  extension of a patent which claims that                                                                       I. Background
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                                                                                                          2013–E–1692 and FDA–2013–E–1691
                                                  human biological product.                               for ‘‘Determination of Regulatory                       The Drug Price Competition and
                                                  DATES: Anyone with knowledge that any                   Review Period for Purposes of Patent                  Patent Term Restoration Act of 1984
                                                  of the dates as published (see the                      Extension; KADCYLA’’.                                 (Pub. L. 98–417) and the Generic
                                                  SUPPLEMENTARY INFORMATION section) are                     Received comments will be placed in                Animal Drug and Patent Term
                                                  incorrect may submit either electronic                  the docket and, except for those                      Restoration Act (Pub. L. 100–670)
                                                  or written comments and ask for a                       submitted as ‘‘Confidential                           generally provide that a patent may be
                                                  redetermination by February 26, 2016.                   Submissions’’, publicly viewable at                   extended for a period of up to 5 years


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Document Created: 2018-03-02 09:24:40
Document Modified: 2018-03-02 09:24:40
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 Citation80 FR 80773 

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