80_FR_68759 80 FR 68545 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request

80 FR 68545 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 214 (November 5, 2015)

Page Range68545-68545
FR Document2015-28156

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

Federal Register, Volume 80 Issue 214 (Thursday, November 5, 2015)
[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Page 68545]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: HHS-OS-0990-New-30D]


Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary (OS), Department of 
Health and Human Services, has submitted an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB) for review and approval. The ICR is for a new collection. 
Comments submitted during the first public review of this ICR will be 
provided to OMB. OMB will accept further comments from the public on 
this ICR during the review and approval period.

DATES: Comments on the ICR must be received on or before December 7, 
2015.

ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via 
facsimile to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance 
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the Information Collection Request Title 
and document identifier HHS-OS-0990-New-30D for reference.
    Information Collection Request Title: Information Collection 
Request Title: Evaluation of the Office on Women's Health Coalition for 
a Healthier Community Initiative.
    Abstract: This collection is to provide data for the national 
evaluation of the U.S. Department of Health and Human Services (HHS), 
Office on Women's Health (OWH) Coalition for a Healthier Community 
(CHC) Initiative. The initiative supports 10 communities with grants to 
support coalitions in implementing gender-based public health systems 
approaches, evidence-based health interventions, and outreach and 
education activities to reduce barriers to and enhance facilitators of 
improvements in women and girls' health. Each of the grantees has 
implemented an IRB-approved local evaluation; however, OWH is seeking 
to collect core data across grantees to examine the extent to which the 
Government's investment has resulted in achieving OWH-related Healthy 
People 2020 priorities and yields lessons learned upon which to plan 
future initiatives related to its mission.
    Likely Respondents: The proposed collection includes plans for 
interviews with key staff (project directors, project coordinators, 
local evaluators), coalition members (including chairs and co-chairs), 
and community leaders connected to the coalitions. These respondents 
will also complete online surveys about their perceptions of the 
changes in their community as a result of coalition activities. Program 
participants and other community members exposed to the coalitions' 
activities through social media will also complete online surveys. 
Project directors and local evaluators also annually provide 
information to OWH on their coalition's functioning, the status of the 
cost-effectiveness analysis for their coalition's interventions, and 
the coalition's plans for sustainability. The following table 
summarizes the ``Total Estimated Annualized Burden--Hours'' by form and 
type of respondent.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                    Form name                       respondents    responses per   response  (in       hours
                                                                    respondent         hrs)
----------------------------------------------------------------------------------------------------------------
1--Key Persons Discussion Guide for Telephone                 90               2               1             180
 Interviews.....................................
2--Key Persons, Coalition Members, and Community             200               1           20/60              67
 Leaders Online Survey..........................
3--Coalition Participants and Other Community                510               1           20/60             170
 Members Online Survey..........................
4--Grantee Annual Report on Coalition                         10               2               2              40
 Functioning, Cost-Effectiveness, and
 Sustainability Planning........................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             457
----------------------------------------------------------------------------------------------------------------


Terry Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-28156 Filed 11-4-15; 8:45 am]
 BILLING CODE 4150-33-P



                                                                                       Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices                                                                                                68545

                                                  Leroy A. Richardson,                                                        accept further comments from the                                            facilitators of improvements in women
                                                  Chief, Information Collection Review Office,                                public on this ICR during the review                                        and girls’ health. Each of the grantees
                                                  Office of Scientific Integrity, Office of the                               and approval period.                                                        has implemented an IRB-approved local
                                                  Associate Director for Science, Office of the                               DATES: Comments on the ICR must be                                          evaluation; however, OWH is seeking to
                                                  Director, Centers for Disease Control and                                   received on or before December 7, 2015.                                     collect core data across grantees to
                                                  Prevention.
                                                                                                                              ADDRESSES: Submit your comments to                                          examine the extent to which the
                                                  [FR Doc. 2015–28153 Filed 11–4–15; 8:45 am]
                                                                                                                              OIRA_submission@omb.eop.gov or via                                          Government’s investment has resulted
                                                  BILLING CODE 4163–18–P
                                                                                                                              facsimile to (202) 395–5806.                                                in achieving OWH-related Healthy
                                                                                                                              FOR FURTHER INFORMATION CONTACT:                                            People 2020 priorities and yields
                                                  DEPARTMENT OF HEALTH AND                                                    Information Collection Clearance staff,                                     lessons learned upon which to plan
                                                  HUMAN SERVICES                                                              Information.CollectionClearance@                                            future initiatives related to its mission.
                                                                                                                              hhs.gov or (202) 690–6162.                                                     Likely Respondents: The proposed
                                                  Office of the Secretary                                                     SUPPLEMENTARY INFORMATION: When                                             collection includes plans for interviews
                                                                                                                              submitting comments or requesting                                           with key staff (project directors, project
                                                  [Document Identifier: HHS–OS–0990–New–
                                                  30D]                                                                        information, please include the                                             coordinators, local evaluators), coalition
                                                                                                                              Information Collection Request Title                                        members (including chairs and co-
                                                  Agency Information Collection                                               and document identifier HHS–OS–                                             chairs), and community leaders
                                                  Activities; Submission to OMB for                                           0990–New–30D for reference.                                                 connected to the coalitions. These
                                                  Review and Approval; Public Comment                                           Information Collection Request Title:
                                                                                                                                                                                                          respondents will also complete online
                                                  Request                                                                     Information Collection Request Title:
                                                                                                                                                                                                          surveys about their perceptions of the
                                                                                                                              Evaluation of the Office on Women’s
                                                  AGENCY:       Office of the Secretary, HHS.                                                                                                             changes in their community as a result
                                                                                                                              Health Coalition for a Healthier
                                                                                                                              Community Initiative.                                                       of coalition activities. Program
                                                  ACTION:       Notice.
                                                                                                                                Abstract: This collection is to provide                                   participants and other community
                                                  SUMMARY:   In compliance with section                                       data for the national evaluation of the                                     members exposed to the coalitions’
                                                  3507(a)(1)(D) of the Paperwork                                              U.S. Department of Health and Human                                         activities through social media will also
                                                  Reduction Act of 1995, the Office of the                                    Services (HHS), Office on Women’s                                           complete online surveys. Project
                                                  Secretary (OS), Department of Health                                        Health (OWH) Coalition for a Healthier                                      directors and local evaluators also
                                                  and Human Services, has submitted an                                        Community (CHC) Initiative. The                                             annually provide information to OWH
                                                  Information Collection Request (ICR),                                       initiative supports 10 communities with                                     on their coalition’s functioning, the
                                                  described below, to the Office of                                           grants to support coalitions in                                             status of the cost-effectiveness analysis
                                                  Management and Budget (OMB) for                                             implementing gender-based public                                            for their coalition’s interventions, and
                                                  review and approval. The ICR is for a                                       health systems approaches, evidence-                                        the coalition’s plans for sustainability.
                                                  new collection. Comments submitted                                          based health interventions, and                                             The following table summarizes the
                                                  during the first public review of this ICR                                  outreach and education activities to                                        ‘‘Total Estimated Annualized Burden—
                                                  will be provided to OMB. OMB will                                           reduce barriers to and enhance                                              Hours’’ by form and type of respondent.

                                                                                                                    TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                                                      Average
                                                                                                                                                                                                        Number of
                                                                                                                                                                             Number of                                              burden per              Total burden
                                                                                                   Form name                                                                                          responses per
                                                                                                                                                                            respondents                                              response                  hours
                                                                                                                                                                                                        respondent                    (in hrs)

                                                  1—Key Persons Discussion Guide for Telephone Interviews .........................                                                            90                           2                          1             180
                                                  2—Key Persons, Coalition Members, and Community Leaders Online Sur-
                                                   vey ................................................................................................................                      200                            1                  20/60                  67
                                                  3—Coalition Participants and Other Community Members Online Survey .....                                                                   510                            1                  20/60                 170
                                                  4—Grantee Annual Report on Coalition Functioning, Cost-Effectiveness,
                                                   and Sustainability Planning ..........................................................................                                      10                           2                          2              40

                                                        Total ..........................................................................................................   ........................   ........................   ........................            457



                                                  Terry Clark,                                                                DEPARTMENT OF HEALTH AND                                                    SUMMARY:    The Office for Human
                                                  Asst Information Collection Clearance                                       HUMAN SERVICES                                                              Research Protections (OHRP), Office of
                                                  Officer.                                                                                                                                                the Assistant Secretary for Health, and
                                                                                                                              [Docket No. FDA–2015–D–3638]
                                                  [FR Doc. 2015–28156 Filed 11–4–15; 8:45 am]                                                                                                             the Food and Drug Administration
                                                  BILLING CODE 4150–33–P                                                      Minutes of Institutional Review Board                                       (FDA) are announcing the availability of
                                                                                                                              Meetings: Guidance for Institutions                                         a draft guidance entitled ‘‘Minutes of
                                                                                                                              and Institutional Review Boards; Draft                                      Institutional Review Board (IRB)
                                                                                                                              Guidance; Availability                                                      Meetings: Guidance for Institutions and
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                                                                                                                                                                          IRBs.’’ The draft guidance is intended
                                                                                                                              AGENCY:  The Office for Human Research                                      for institutions and IRBs that are
                                                                                                                              Protections, Office of the Assistant                                        responsible for the review and oversight
                                                                                                                              Secretary for Health, Office of the                                         of human subject research conducted or
                                                                                                                              Secretary, and the Food and Drug                                            supported by the U.S. Department of
                                                                                                                              Administration, HHS.
                                                                                                                                                                                                          Health and Human Services (HHS) or
                                                                                                                              ACTION: Notice.                                                             regulated by FDA. The purpose of the


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Document Created: 2015-12-14 15:02:30
Document Modified: 2015-12-14 15:02:30
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
ActionNotice.
DatesComments on the ICR must be received on or before December 7, 2015.
ContactInformation Collection Clearance staff, [email protected] or (202) 690-6162.
FR Citation80 FR 68545 

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