[Federal Register Volume 84, Number 164 (Friday, August 23, 2019)]
[Notices]
[Pages 44308-44309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-1154; Docket No. CDC-2019-0072]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on a proposed and/
or continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on ``Generic 
Clearance for CDC/ATSDR Formative Research and Tool Development''. This 
information collection request is designed to allow CDC to conduct 
formative research information collection activities used to inform 
aspects of surveillance, communications, health promotion, and research 
project development.

DATES: Written comments must be received on or before October 22, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0072 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey Zirger, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted 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 Jeffrey Zirger, 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 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 respond, including through the use of automated, electronic, 
mechanical, or other technilogical collection techniques or other forms 
of information technology; e.g., permitting electronic submissions of 
responses.
    5. Assess information costs.

Proposed Project

    Generic Clearance for CDC/ATSDR Formative Research and Tool 
Development--Extension--Office of Science (OS), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) requests 
approval for an extension of a generic clearance for CDC/ATSDR 
Formative Research and Tool Development. This information collection 
request is designed to allow CDC to conduct formative research 
information collection activities used to inform many aspects of 
surveillance, communications, health promotion, and research project 
development at CDC. 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 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 occurs before a program is designed and 
implemented, or while a program is being conducted.
    At CDC, 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 diseases and conditions in the U.S. 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.

[[Page 44309]]

    Products from these formative research studies will be used for 
prevention of disease. 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 activities to adapt them to current needs. The information 
collected will be used to advise programs and provide capacity-building 
assistance tailored to identify 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. There is no cost to participants other than their time. The 
total estimated annual burden is 20,000 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 (hrs.)
----------------------------------------------------------------------------------------------------------------
General public and health care  Screener........          10,000               1           15/60           2,500
 providers.
                                Interview.......           5,000               1               1           5,000
                                Focus group                5,000               1               2          10,000
                                 interview.
                                Survey..........           5,000               1           30/60           2,500
 
    Total.....................  ................          25,000  ..............  ..............          20,000
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-18211 Filed 8-22-19; 8:45 am]
 BILLING CODE 4163-18-P