[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17663-17665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08383]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-FY-0840; Docket No. CDC-2018-0036]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Formative Research and Tool 
Development''.

DATES: CDC must receive written comments on or before June 22, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0036 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Formative Research and Tool Development (OMB Control Number 0920-
0840, Expiration Date 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 approval of a three-year extension to the generic 
information collection plan titled ``Formative Research and Tool 
Development.'' CDC designed this information collection project to 
allow CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP) to conduct formative research information 
collection activities used to inform many aspects of surveillance,

[[Page 17664]]

communications, health promotion, and research project development for 
NCHHSTP's four priority disease prevention focus areas: (1) HIV/AIDS; 
(2) sexually transmitted diseases/infections (STD/STI); (3) viral 
hepatitis, tuberculosis elimination (TB); and (4) school and adolescent 
health (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 information collection approval request will include CDC 
studies to investigate 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 information collection approval request will also include 
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. CDC will use the information collected 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 CDC will cover 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.
    There is no cost to participants other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of
      Type of respondent            Form name        Number of     responses per   Average hours  Total response
                                                    respondents     respondent     per response   burden (hours)
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General public and health care  Screener........          81,200               1           10/60          13,533
 providers.
General public and health care  Consent Forms...          40,600               1            5/60           3,383
 providers.
General public and health care  Individual                 6,600               1               1           6,600
 providers.                      Interview.
General public and health care  Focus Group                4,000               1               2           8,000
 providers.                      Interview.
General public and health care  Survey of                 30,000               1           30/60          15,000
 providers.                      Individual.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          46,516
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[[Page 17665]]

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. 2018-08383 Filed 4-20-18; 8:45 am]
 BILLING CODE 4163-18-P