83_FR_47354 83 FR 47173 - Agency Forms Undergoing Paperwork Reduction Act Review

83 FR 47173 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 83, Issue 181 (September 18, 2018)

Page Range47173-47174
FR Document2018-20245

Federal Register, Volume 83 Issue 181 (Tuesday, September 18, 2018)
[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Notices]
[Pages 47173-47174]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20245]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0840]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``Formative Research and Tool Development'' 
to the Office of Management and Budget (OMB) for review and approval. 
CDC previously published a ``Proposed Data Collection Submitted for 
Public Comment and Recommendations'' notice on April 23, 2018 to obtain 
comments from the public and affected agencies. CDC received one 
comment related to the previous notice. This notice serves to allow an 
additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Formative Research and Tool Development (OMB Control No. 0920-0840, 
Expiration 1/31/2019)--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 
approval for an extension and a three year approval for the previously 
approved Generic Clearance, ``Formative Research and Tool 
Development''. 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 four 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.

[[Page 47174]]

    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 activities to 
adapt them to current needs. The information collected will be used to 
advise programs and provide capacity-building assistance tailored to 
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. The total burden hours for 
this collection is 46,516. Participation of respondents is voluntary. 
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................          56,840               1           10/60
Health care providers.................  Screener................          24,360               1           10/60
General public........................  Consent Forms...........          28,420               1            5/60
Health care providers.................  Consent Forms...........          12,180               1            5/60
General public........................  Individual Interview....           4,620               1               1
Health care providers.................  Individual Interview....           1,980               1               1
General public........................  Focus Group Interview...           2,800               1               2
Health care providers.................  Focus Group Interview...           1,200               1               2
General public........................  Survey of Individual....          21,000               1           30/60
Health care providers.................  Survey of Individual....           9,000               1           30/60
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting 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. 2018-20245 Filed 9-17-18; 8:45 am]
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                                                                            Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices                                                         47173

                                                                                                           ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                              Average
                                                                                                                                                                                              Number of
                                                                     Type of                                                                                                Number of                       burden per
                                                                                                                                 Form name                                                  responses per
                                                                   respondents                                                                                             respondents                       response
                                                                                                                                                                                              respondent     (in hours)

                                               U.S. General Population .................................   Landline Screener ..........................................         375,000                 1           1/60
                                                                                                           Cell Phone Screener ......................................           292,682                 1           1/60
                                                                                                           Field Test Screener ........................................             900                 1           1/60
                                               Annual Survey Respondents (Adults >18                       BRFSS Core Survey ......................................             480,000                 1          15/60
                                                 Years).                                                   BRFSS Optional Modules ..............................                440,000                 1          15/60
                                               Field Test Respondents (Adults >18 Years) ..                Field Test Survey ...........................................            500                 1          45/60



                                               Jeffrey M. Zirger,                                             (c) Enhance the quality, utility, and                         transmitted diseases/infections (STD/
                                               Acting Chief, Information Collection Review                  clarity of the information to be                                STI), viral hepatitis, tuberculosis
                                               Office, Office of Scientific Integrity, Office               collected;                                                      elimination and the Division of School
                                               of the Associate Director for Science, Office                  (d) Minimize the burden of the                                and Adolescent Heath (DASH).
                                               of the Director, Centers for Disease Control                 collection of information on those who                          Formative research is the basis for
                                               and Prevention.                                              are to respond, including, through the                          developing effective strategies including
                                               [FR Doc. 2018–20248 Filed 9–17–18; 8:45 am]                  use of appropriate automated,                                   communication channels, for
                                               BILLING CODE 4163–18–P                                       electronic, mechanical, or other                                influencing behavior change. It helps
                                                                                                            technological collection techniques or                          researchers identify and understand the
                                                                                                            other forms of information technology,                          characteristics/interests, behaviors and
                                               DEPARTMENT OF HEALTH AND                                     e.g., permitting electronic submission of                       needs of target populations that
                                               HUMAN SERVICES                                               responses; and                                                  influence their decisions and actions.
                                                                                                              (e) Assess information collection                                Formative research is integral in
                                               Centers for Disease Control and                              costs.
                                               Prevention                                                                                                                   developing programs, as well as
                                                                                                              To request additional information on
                                                                                                                                                                            improving existing and ongoing
                                                                                                            the proposed project or to obtain a copy
                                                                                                                                                                            programs. Formative research also looks
                                               [30Day–18–0840]                                              of the information collection plan and
                                                                                                                                                                            at the community in which a public
                                                                                                            instruments, call (404) 639–7570 or
                                               Agency Forms Undergoing Paperwork                                                                                            health intervention is being or will be
                                                                                                            send an email to omb@cdc.gov. Direct
                                               Reduction Act Review                                                                                                         implemented, and helps the project staff
                                                                                                            written comments and/or suggestions
                                                                                                                                                                            understand the interests, attributes and
                                                                                                            regarding the items contained in this
                                                  In accordance with the Paperwork                                                                                          needs of different populations and
                                                                                                            notice to the Attention: CDC Desk
                                               Reduction Act of 1995, the Centers for                                                                                       persons in that community. Formative
                                                                                                            Officer, Office of Management and
                                               Disease Control and Prevention (CDC)                                                                                         research is research that occurs before a
                                                                                                            Budget, 725 17th Street NW,
                                               has submitted the information                                                                                                program is designed and implemented,
                                                                                                            Washington, DC 20503 or by fax to (202)
                                               collection request titled ‘‘Formative                                                                                        or while a program is being conducted.
                                                                                                            395–5806. Provide written comments
                                               Research and Tool Development’’ to the                                                                                       NCHHSTP formative research is
                                                                                                            within 30 days of notice publication.
                                               Office of Management and Budget                                                                                              necessary for developing new programs
                                               (OMB) for review and approval. CDC                           Proposed Project                                                or adapting programs that deal with the
                                               previously published a ‘‘Proposed Data                         Formative Research and Tool                                   complexity of behaviors, social context,
                                               Collection Submitted for Public                              Development (OMB Control No. 0920–                              cultural identities, and health care that
                                               Comment and Recommendations’’                                0840, Expiration 1/31/2019)—                                    underlie the epidemiology of HIV/AIDS,
                                               notice on April 23, 2018 to obtain                           Extension—National Center for HIV/                              viral hepatitis, STDs, and TB in the U.S,
                                               comments from the public and affected                        AIDS, Viral Hepatitis, STD, TB                                  as well as for school and adolescent
                                               agencies. CDC received one comment                           Prevention (NCHHSTP), Centers for                               health. CDC conducts formative
                                               related to the previous notice. This                         Disease Control and Prevention (CDC).                           research to develop public-sensitive
                                               notice serves to allow an additional 30                                                                                      communication messages and user
                                               days for public and affected agency                          Background and Brief Description                                friendly tools prior to developing or
                                               comments.                                                       The Centers for Disease Control and                          recommending interventions, or care.
                                                  CDC will accept all comments for this                     Prevention, National Center for HIV/                            Sometimes these studies are entirely
                                               proposed information collection project.                     AIDS, Viral Hepatitis, STD, and TB                              behavioral but most often they are
                                               The Office of Management and Budget                          Prevention (NCHHSTP) requests                                   cycles of interviews and focus groups
                                               is particularly interested in comments                       approval for an extension and a three                           designed to inform the development of
                                               that:                                                        year approval for the previously                                a product.
                                                  (a) Evaluate whether the proposed                         approved Generic Clearance,                                        Products from these formative
                                               collection of information is necessary                       ‘‘Formative Research and Tool                                   research studies will be used for
                                               for the proper performance of the                            Development’’. This information                                 prevention of HIV/AIDS, Sexually
                                               functions of the agency, including                           collection request is designed to allow                         Transmitted Infections (STI), viral
daltland on DSKBBV9HB2PROD with NOTICES




                                               whether the information will have                            NCHHSTP to conduct formative                                    Hepatitis, and Tuberculosis. Findings
                                               practical utility;                                           research information collection                                 from these studies may also be
                                                  (b) Evaluate the accuracy of the                          activities used to inform many aspects                          presented as evidence to disease-
                                               agencies estimate of the burden of the                       of surveillance, communications, health                         specific National Advisory Committees,
                                               proposed collection of information,                          promotion, and research project                                 to support revisions to recommended
                                               including the validity of the                                development for NCHHSTP’s four                                  prevention and intervention methods, as
                                               methodology and assumptions used;                            priority diseases (HIV/AIDS, sexually                           well as new recommendations.


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                                               47174                            Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Notices

                                                  Much of CDC’s health communication                               health programs to assess needs related                              testing of technology-based instruments
                                               takes place within campaigns that have                              to initiation of a new program activity,                             and materials, (5) field testing of new
                                               fairly lengthy planning periods—                                    or expansion or changes in scope, or                                 methodologies and materials, (6)
                                               timeframes that accommodate the                                     implementation of existing program                                   investigation of mental models for
                                               standard Federal process for approving                              activities to adapt them to current                                  health decision-making, to inform
                                               data collections. Short term qualitative                            needs. The information collected will be                             health communication messages, and (7)
                                               interviewing and cognitive research                                 used to advise programs and provide                                  organizational needs assessments to
                                               techniques have previously proven                                   capacity-building assistance tailored to                             support development of capacity.
                                               invaluable in the development of                                    identified needs.
                                               scientifically valid and population-                                  Overall, these development activities                                Respondents who will participate in
                                               appropriate methods, interventions, and                             are intended to provide information that                             individual and group interviews
                                               instruments.                                                        will increase the success of the                                     (qualitative, cognitive, and computer
                                                  This request includes studies                                    surveillance or research projects                                    assisted development activities) are
                                               investigating the utility and                                       through increasing response rates and                                selected purposively from those who
                                               acceptability of proposed sampling and                              decreasing response error, thereby                                   respond to recruitment advertisements.
                                               recruitment methods, intervention                                   decreasing future data collection burden                             In addition to utilizing advertisements
                                               contents and delivery, questionnaire                                to the public. The studies that will be                              for recruitment, respondents who will
                                               domains, individual questions, and                                  covered under this request will include                              participate in research on survey
                                               interactions with project staff or                                  one or more of the following                                         methods may be selected purposively or
                                               electronic data collection equipment.                               investigational modalities: (1)                                      systematically from within an ongoing
                                               These activities will also provide                                  Structured and qualitative interviewing                              surveillance or research project. The
                                               information about how respondents                                   for surveillance, research, interventions                            total burden hours for this collection is
                                               answer questions and ways in which                                  and material development, (2) cognitive                              46,516. Participation of respondents is
                                               question response bias and error can be                             interviewing for development of specific                             voluntary. There is no cost to
                                               reduced. This request also includes                                 data collection instruments, (3)                                     participants other than their time.
                                               collection of information from public                               methodological research, (4) usability

                                                                                                                  ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                          Number of
                                                                                                                                                                                        Number of                       Average hours
                                                                 Type of respondent                                                       Form name                                                     responses per
                                                                                                                                                                                       respondents                      per response
                                                                                                                                                                                                          respondent

                                               General public .................................................   Screener .........................................................         56,840                 1           10/60
                                               Health care providers ......................................       Screener .........................................................         24,360                 1           10/60
                                               General public .................................................   Consent Forms ...............................................              28,420                 1            5/60
                                               Health care providers ......................................       Consent Forms ...............................................              12,180                 1            5/60
                                               General public .................................................   Individual Interview .........................................              4,620                 1               1
                                               Health care providers ......................................       Individual Interview .........................................              1,980                 1               1
                                               General public .................................................   Focus Group Interview ...................................                   2,800                 1               2
                                               Health care providers ......................................       Focus Group Interview ...................................                   1,200                 1               2
                                               General public .................................................   Survey of Individual ........................................              21,000                 1           30/60
                                               Health care providers ......................................       Survey of Individual ........................................               9,000                 1           30/60



                                               Jeffrey M. Zirger,                                                  Control and Prevention (CDC),                                        whichever occurs first. The public
                                               Acting Chief, Information Collection Review                         Department of Health and Human                                       online meeting will be a web-based
                                               Office, Office of Scientific Integrity, Office                      Services (HHS).                                                      event available only by remote access.
                                               of the Associate Director for Science, Office                       ACTION: Notice of draft document                                     Members of the public who wish to
                                               of the Director, Centers for Disease Control                                                                                             provide public comments should plan
                                               and Prevention.
                                                                                                                   available for public comment and online
                                                                                                                   public meeting.                                                      to login to the meeting at the start time
                                               [FR Doc. 2018–20245 Filed 9–17–18; 8:45 am]                                                                                              listed. Members of the public who
                                               BILLING CODE 4163–18–P                                              SUMMARY:    The National Institute for                               register with the NIOSH Docket Office,
                                                                                                                   Occupational Safety and Health                                       niocindocket@cdc.gov to attend the
                                                                                                                   (NIOSH) of the Centers for Disease                                   public meeting will be provided the
                                               DEPARTMENT OF HEALTH AND                                            Control and Prevention (CDC)                                         login information prior to the meeting.
                                               HUMAN SERVICES                                                      announces the availability of the                                    ADDRESSES: Written comments
                                                                                                                   following draft document for public                                  submitted to the docket must be
                                               Centers for Disease Control and
                                                                                                                   comment titled Current Intelligence                                  received by November 30, 2018. Written
                                               Prevention
                                                                                                                   Bulletin: Health Effects of Occupational                             comments may be submitted by either of
                                               [CDC–2016–0001; Docket Number NIOSH                                 Exposure to Silver Nanomaterials. To                                 the following methods:
                                               260–A]                                                              view the notice, document and related                                   • Federal eRulemaking Portal:
                                                                                                                   materials, visit https://                                            https://www.regulations.gov. Follow the
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                                               Revised Draft NIOSH Current                                         www.regulations.gov and enter CDC–                                   instructions for submitting comments.
                                               Intelligence Bulletin: Health Effects of                            2016–0001 in the search field and click                                 • Mail: NIOSH Docket Office, 1090
                                               Occupational Exposure to Silver                                     ‘‘Search’’.                                                          Tusculum Avenue, MS C–34,
                                               Nanomaterials                                                                                                                            Cincinnati, Ohio 45226–1998.
                                                                                                                   DATES: The public online meeting will
                                               AGENCY: National Institute for                                      be held on October 30, 2018, 1 p.m.–                                 FOR FURTHER INFORMATION CONTACT:
                                               Occupational Safety and Health                                      4:30 p.m., Eastern Time, or until the last                           Charles Geraci, NIOSH/EID/NTRC,
                                               (NIOSH) of the Centers for Disease                                  public commenter has spoken,                                         Robert A. Taft Laboratories, 1090


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Document Created: 2018-09-18 01:18:46
Document Modified: 2018-09-18 01:18:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation83 FR 47173 

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