80_FR_66215 80 FR 66007 - Agency Forms Undergoing Paperwork Reduction Act Review

80 FR 66007 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 208 (October 28, 2015)

Page Range66007-66008
FR Document2015-27431

Federal Register, Volume 80 Issue 208 (Wednesday, October 28, 2015)
[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66007-66008]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27431]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0840]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 
Washington, DC 20503 or by fax to (202) 395-5806. Written comments 
should be received within 30 days of this notice.

Proposed Project

    Formative Research and Tool Development (OMB Control No. 0920-0840, 
Expiration 02/29/2016)--Extension--National Center for HIV/AIDS, Viral 
Hepatitis, STD, TB Prevention (NCHHSTP), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention, National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) requests a 
three-year approval and extension of the ``Formative Research and Tool 
Development'' generic information collection plan. This information 
collection request is designed to allow NCHHSTP to conduct formative 
research information collection activities used to inform many aspects 
of surveillance, communications, health promotion, and research project 
development for NCHHSTP's 4 priority diseases (HIV/AIDS, sexually 
transmitted diseases/infections (STD/STI), viral hepatitis, 
tuberculosis elimination and the Division of School and Adolescent 
Heath (DASH).
    Formative research is the basis for developing effective strategies 
including communication channels, for influencing behavior change. It 
helps researchers identify and understand the characteristics--
interests, behaviors and needs--of target populations that influence 
their decisions and actions.
    Formative research is integral in developing programs as well as 
improving existing and ongoing programs. Formative research also looks 
at the community in which a public health intervention is being or will 
be implemented and helps the project staff understand the interests, 
attributes and needs of different populations and persons in that 
community. Formative research is research that occurs before a program 
is designed and implemented, or while a program is being conducted.
    NCHHSTP formative research is necessary for developing new programs 
or adapting programs that deal with the complexity of behaviors, social 
context, cultural identities, and health care that underlie the 
epidemiology of HIV/AIDS, viral hepatitis, STDs, and TB in the U.S, as 
well as for school and adolescent health.
    CDC conducts formative research to develop public-sensitive 
communication messages and user friendly tools prior to developing or 
recommending interventions, or care. Sometimes these studies are 
entirely behavioral but most often they are cycles of interviews and 
focus groups designed to inform the development of a product.
    Products from these formative research studies will be used for 
prevention of HIV/AIDS, Sexually Transmitted Infections (STI), viral 
Hepatitis, and Tuberculosis. Findings from these studies may also be 
presented as evidence to disease-specific National Advisory Committees, 
to support revisions to recommended prevention and intervention 
methods, as well as new recommendations.
    Much of CDC's health communication takes place within campaigns 
that have fairly lengthy planning periods--timeframes that accommodate 
the standard Federal process for approving data collections. Short term 
qualitative interviewing and cognitive research techniques have 
previously proven invaluable in the development of scientifically valid 
and population-appropriate methods, interventions, and instruments.
    This request includes studies investigating the utility and 
acceptability of proposed sampling and recruitment methods, 
intervention contents and delivery, questionnaire domains, individual 
questions, and interactions with project staff or electronic data 
collection equipment. These activities will also provide information 
about how respondents answer questions and ways in which question 
response bias and error can be reduced.
    This request also includes collection of information from public 
health programs to assess needs related to initiation of a new program 
activity or expansion or changes in scope or implementation of existing 
program

[[Page 66008]]

activities to adapt them to current needs. The information collected 
will be used to advise programs and provide capacity-building 
assistance tailored to the identified needs.
    Overall, these development activities are intended to provide 
information that will increase the success of the surveillance or 
research projects through increasing response rates and decreasing 
response error, thereby decreasing future data collection burden to the 
public. The studies that will be covered under this request will 
include one or more of the following investigational modalities: (1) 
Structured and qualitative interviewing for surveillance, research, 
interventions and material development, (2) cognitive interviewing for 
development of specific data collection instruments, (3) methodological 
research (4) usability testing of technology-based instruments and 
materials, (5) field testing of new methodologies and materials, (6) 
investigation of mental models for health decision-making, to inform 
health communication messages, and (7) organizational needs assessments 
to support development of capacity. Respondents who will participate in 
individual and group interviews (qualitative, cognitive, and computer 
assisted development activities) are selected purposively from those 
who respond to recruitment advertisements.
    In addition to utilizing advertisements for recruitment, 
respondents who will participate in research on survey methods may be 
selected purposively or systematically from within an ongoing 
surveillance or research project. Participation of respondents is 
voluntary. The total burden hours are 55,820. There is no cost to 
participants other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
          Type of respondent                    Form name            Number of     responses per   Average hours
                                                                    respondents     respondent     per response
----------------------------------------------------------------------------------------------------------------
General public........................  Screener Att6...........          68,208               1           10/60
Healthcare providers..................  Screener Att6...........          29,232               1           10/60
General public........................  Consent Forms Att9......          34,104               1            5/60
Healthcare providers..................  Consent Forms Att9......          14,616               1            5/60
General public........................  Individual interview               5,544               1               1
                                         Att4.
Healthcare providers..................  Individual Interview               2,376               1               1
                                         Att4.
General Public........................  Focus Group Interview              3,360               1               2
                                         Att7.
Healthcare providers..................  Focus Group Interview              1,440               1               2
                                         Att7.
General public........................  Survey of Individual              25,200               1           30/60
                                         Att5.
Healthcare providers..................  Survey of Individual              10,800               1           30/60
                                         Att5.
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-27431 Filed 10-27-15; 8:45 am]
 BILLING CODE 4163-18-P



                                                                            Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices                                          66007

                                                  Subcontractors, published in the                        (c) Enhance the quality, utility, and                 health intervention is being or will be
                                                  Federal Register, is being withdrawn                    clarity of the information to be                      implemented and helps the project staff
                                                  and is no longer accepting comments.                    collected; (d) Minimize the burden of                 understand the interests, attributes and
                                                  DATES: Effective: October 28, 2015.                     the collection of information on those                needs of different populations and
                                                  FOR FURTHER INFORMATION CONTACT: Mr.                    who are to respond, including through                 persons in that community. Formative
                                                  Curtis E. Glover, Sr., Procurement                      the use of appropriate automated,                     research is research that occurs before a
                                                  Analyst, GSA, at 202–501–1448, or via                   electronic, mechanical, or other                      program is designed and implemented,
                                                  email to curtis.glover@gsa.gov.                         technological collection techniques or                or while a program is being conducted.
                                                                                                          other forms of information technology,                   NCHHSTP formative research is
                                                  SUPPLEMENTARY INFORMATION:
                                                                                                          e.g., permitting electronic submission of             necessary for developing new programs
                                                  A. Purpose                                              responses; and (e) Assess information                 or adapting programs that deal with the
                                                    The notice, published in the Federal                  collection costs.                                     complexity of behaviors, social context,
                                                  Register at 80 FR 60383, on October 6,                     To request additional information on               cultural identities, and health care that
                                                  2015, requesting comments regarding a                   the proposed project or to obtain a copy              underlie the epidemiology of HIV/AIDS,
                                                  new information collection, 9000–00XX;                  of the information collection plan and                viral hepatitis, STDs, and TB in the U.S,
                                                  Payment to Small Business                               instruments, call (404) 639–7570 or                   as well as for school and adolescent
                                                  Subcontractors, is being withdrawn. The                 send an email to omb@cdc.gov. Direct                  health.
                                                                                                          written comments and/or suggestions                      CDC conducts formative research to
                                                  notice is being withdrawn because it is
                                                                                                          regarding the items contained in this                 develop public-sensitive
                                                  associated with a rule which is still in
                                                                                                          notice to the Attention: CDC Desk                     communication messages and user
                                                  process, and has not been published.
                                                                                                          Officer, Office of Management and                     friendly tools prior to developing or
                                                  Comments are no longer being sought at
                                                                                                          Budget, Washington, DC 20503 or by fax                recommending interventions, or care.
                                                  this time; however, the public will have
                                                                                                          to (202) 395–5806. Written comments                   Sometimes these studies are entirely
                                                  a chance to comment once the rule is
                                                                                                          should be received within 30 days of                  behavioral but most often they are
                                                  published.                                                                                                    cycles of interviews and focus groups
                                                                                                          this notice.
                                                  Edward Loeb,                                                                                                  designed to inform the development of
                                                                                                          Proposed Project                                      a product.
                                                  Acting Director, Federal Acquisition Policy
                                                  Division, Office of Governmentwide                        Formative Research and Tool                            Products from these formative
                                                  Acquisition Policy, Office of Acquisition               Development (OMB Control No. 0920–                    research studies will be used for
                                                  Policy, Office of Governmentwide Policy.                0840, Expiration 02/29/2016)—                         prevention of HIV/AIDS, Sexually
                                                  [FR Doc. 2015–27432 Filed 10–27–15; 8:45 am]            Extension—National Center for HIV/                    Transmitted Infections (STI), viral
                                                  BILLING CODE 6820–EP–P                                  AIDS, Viral Hepatitis, STD, TB                        Hepatitis, and Tuberculosis. Findings
                                                                                                          Prevention (NCHHSTP), Centers for                     from these studies may also be
                                                                                                          Disease Control and Prevention (CDC).                 presented as evidence to disease-
                                                  DEPARTMENT OF HEALTH AND                                                                                      specific National Advisory Committees,
                                                                                                          Background and Brief Description                      to support revisions to recommended
                                                  HUMAN SERVICES
                                                                                                             The Centers for Disease Control and                prevention and intervention methods, as
                                                  Centers for Disease Control and                         Prevention, National Center for HIV/                  well as new recommendations.
                                                  Prevention                                              AIDS, Viral Hepatitis, STD, and TB                       Much of CDC’s health communication
                                                                                                          Prevention (NCHHSTP) requests a three-                takes place within campaigns that have
                                                  [30Day–16–0840]                                         year approval and extension of the                    fairly lengthy planning periods—
                                                  Agency Forms Undergoing Paperwork                       ‘‘Formative Research and Tool                         timeframes that accommodate the
                                                  Reduction Act Review                                    Development’’ generic information                     standard Federal process for approving
                                                                                                          collection plan. This information                     data collections. Short term qualitative
                                                     The Centers for Disease Control and                  collection request is designed to allow               interviewing and cognitive research
                                                  Prevention (CDC) has submitted the                      NCHHSTP to conduct formative                          techniques have previously proven
                                                  following information collection request                research information collection                       invaluable in the development of
                                                  to the Office of Management and Budget                  activities used to inform many aspects                scientifically valid and population-
                                                  (OMB) for review and approval in                        of surveillance, communications, health               appropriate methods, interventions, and
                                                  accordance with the Paperwork                           promotion, and research project                       instruments.
                                                  Reduction Act of 1995. The notice for                   development for NCHHSTP’s 4 priority                     This request includes studies
                                                  the proposed information collection is                  diseases (HIV/AIDS, sexually                          investigating the utility and
                                                  published to obtain comments from the                   transmitted diseases/infections (STD/                 acceptability of proposed sampling and
                                                  public and affected agencies.                           STI), viral hepatitis, tuberculosis                   recruitment methods, intervention
                                                     Written comments and suggestions                     elimination and the Division of School                contents and delivery, questionnaire
                                                  from the public and affected agencies                   and Adolescent Heath (DASH).                          domains, individual questions, and
                                                  concerning the proposed collection of                      Formative research is the basis for                interactions with project staff or
                                                  information are encouraged. Your                        developing effective strategies including             electronic data collection equipment.
                                                  comments should address any of the                      communication channels, for                           These activities will also provide
                                                  following: (a) Evaluate whether the                     influencing behavior change. It helps                 information about how respondents
                                                  proposed collection of information is                   researchers identify and understand the               answer questions and ways in which
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                                                  necessary for the proper performance of                 characteristics—interests, behaviors and              question response bias and error can be
                                                  the functions of the agency, including                  needs—of target populations that                      reduced.
                                                  whether the information will have                       influence their decisions and actions.                   This request also includes collection
                                                  practical utility; (b) Evaluate the                        Formative research is integral in                  of information from public health
                                                  accuracy of the agencies estimate of the                developing programs as well as                        programs to assess needs related to
                                                  burden of the proposed collection of                    improving existing and ongoing                        initiation of a new program activity or
                                                  information, including the validity of                  programs. Formative research also looks               expansion or changes in scope or
                                                  the methodology and assumptions used;                   at the community in which a public                    implementation of existing program


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                                                  66008                            Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices

                                                  activities to adapt them to current                                 Structured and qualitative interviewing                           individual and group interviews
                                                  needs. The information collected will be                            for surveillance, research, interventions                         (qualitative, cognitive, and computer
                                                  used to advise programs and provide                                 and material development, (2) cognitive                           assisted development activities) are
                                                  capacity-building assistance tailored to                            interviewing for development of specific                          selected purposively from those who
                                                  the identified needs.                                               data collection instruments, (3)                                  respond to recruitment advertisements.
                                                    Overall, these development activities                             methodological research (4) usability
                                                  are intended to provide information that                                                                                                In addition to utilizing advertisements
                                                                                                                      testing of technology-based instruments                           for recruitment, respondents who will
                                                  will increase the success of the                                    and materials, (5) field testing of new
                                                  surveillance or research projects                                                                                                     participate in research on survey
                                                                                                                      methodologies and materials, (6)                                  methods may be selected purposively or
                                                  through increasing response rates and
                                                                                                                      investigation of mental models for                                systematically from within an ongoing
                                                  decreasing response error, thereby
                                                  decreasing future data collection burden                            health decision-making, to inform                                 surveillance or research project.
                                                  to the public. The studies that will be                             health communication messages, and (7)                            Participation of respondents is
                                                  covered under this request will include                             organizational needs assessments to                               voluntary. The total burden hours are
                                                  one or more of the following                                        support development of capacity.                                  55,820. There is no cost to participants
                                                  investigational modalities: (1)                                     Respondents who will participate in                               other than their time.
                                                                                                                     ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                         Number of
                                                                                                                                                                                        Number of                      Average hours
                                                                    Type of respondent                                                      Form name                                                  responses per
                                                                                                                                                                                       respondents                     per response
                                                                                                                                                                                                         respondent

                                                  General public .................................................   Screener Att6 .................................................         68,208                1           10/60
                                                  Healthcare providers .......................................       Screener Att6 .................................................         29,232                1           10/60
                                                  General public .................................................   Consent Forms Att9 .......................................              34,104                1            5/60
                                                  Healthcare providers .......................................       Consent Forms Att9 .......................................              14,616                1            5/60
                                                  General public .................................................   Individual interview Att4 .................................              5,544                1               1
                                                  Healthcare providers .......................................       Individual Interview Att4 .................................              2,376                1               1
                                                  General Public ................................................    Focus Group Interview Att7 ...........................                   3,360                1               2
                                                  Healthcare providers .......................................       Focus Group Interview Att7 ...........................                   1,440                1               2
                                                  General public .................................................   Survey of Individual Att5 ................................              25,200                1           30/60
                                                  Healthcare providers .......................................       Survey of Individual Att5 ................................              10,800                1           30/60



                                                  Leroy A. Richardson,                                                created the Maternal, Infant, and Early                           will support 5-year cooperative
                                                  Chief, Information Collection Review Office,                        Childhood Home Visiting Program                                   agreements to conduct community
                                                  Office of Scientific Integrity, Office of the                       (MIECHV) and authorized the Secretary                             needs assessments, plan for and
                                                  Associate Director for Science, Office of the                       of HHS (in Section 511(h)(2)(A)) to                               implement high-quality, culturally-
                                                  Director, Centers for Disease Control and                           award grants to Indian tribes (or a                               relevant, evidence-based home visiting
                                                  Prevention.                                                         consortium of Indian tribes), tribal                              programs in at-risk Tribal communities,
                                                  [FR Doc. 2015–27431 Filed 10–27–15; 8:45 am]                        organizations, or urban Indian                                    and participate in research and
                                                  BILLING CODE 4163–18–P                                              organizations to conduct an early                                 evaluation activities to build the
                                                                                                                      childhood home visiting program. The                              knowledge base on home visiting among
                                                                                                                      legislation set aside 3 percent of the                            Native populations.
                                                  DEPARTMENT OF HEALTH AND                                            total MIECHV program appropriation
                                                  HUMAN SERVICES                                                                                                                          In Year 1 of the cooperative
                                                                                                                      (authorized in Section 511(j)) for grants
                                                                                                                                                                                        agreement, grantees must (1) conduct a
                                                                                                                      to tribal entities. Tribal MIECHV grants,
                                                  Administration for Children and                                                                                                       comprehensive community needs and
                                                                                                                      to the greatest extent practicable, are to
                                                  Families                                                                                                                              readiness assessment and (2) develop a
                                                                                                                      be consistent with the requirements of
                                                                                                                                                                                        plan to respond to identified needs.
                                                  Proposed Information Collection                                     the MIECHV grants to states and
                                                                                                                                                                                        Specifically, grantees will be required to
                                                  Activity; Comment Request                                           jurisdictions (authorized in Section
                                                                                                                      511(c)), and include conducting a needs                           conduct or update a needs and
                                                    Proposed Project: Implementation                                  assessment and establishing                                       readiness assessment, and develop an
                                                  Plan Guidance for the Tribal Maternal,                              quantifiable, measurable benchmarks.                              implementation plan to respond to
                                                  Infant, and Early Childhood Home                                      The Administration for Children and                             those needs, including a plan for
                                                  Visiting Grant Program.                                             Families, Office of Child Care and Office                         performance measurement and CQI and
                                                    Title: Tribal Maternal, Infant, and                               of the Deputy Assistant Secretary for                             participating in or conducting rigorous
                                                  Early Childhood Home Visiting Program                               Early Childhood Development, in                                   evaluation activities. Grantees will be
                                                  Needs Assessment and Implementation                                 collaboration with the Health Resources                           expected to submit the needs
                                                  Plan.                                                               and Services Administration, Maternal                             assessment and implementation plan
                                                    OMB No.: 0970–0389.                                               and Child Health Bureau, plans to                                 within 10 months of the Year 1 award
                                                    Description: Social Security Act, Title                           awarded grants for the Tribal Maternal,                           date.
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                                                  V, Section 511 (42 U.S.C. 711), as added                            Infant, and Early Childhood Home                                    Respondents: Tribal Maternal, Infant,
                                                  by § 2951 of the Patient Protection and                             Visiting Program (Tribal Home Visiting).                          and Early Childhood Home Visiting
                                                  Affordable Care Act (Pub. L. 111–148),                              The Tribal Home Visiting grant awards                             Program Year 1 Grantees.




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Document Created: 2018-02-27 08:57:44
Document Modified: 2018-02-27 08:57:44
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 66007 

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