[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46680-46682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2016-0063; 60Day-16-16AVC]


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 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 September 16, 
2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0063 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. 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.


[[Page 46681]]



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 the 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.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

Generic Clearance for CDC/ATSDR Formative Research and Tool Development 
(CDC)

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) requests 
approval for a new 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.
    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.

[[Page 46682]]

Participation of respondents is voluntary.
    There is no cost to participants other than their time. The total 
estimated annual burden is 8,000 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.)
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General public and health care providers.......  Screener...............................           4,000               1           10/60             667
                                                 Consent Forms..........................           2,000               1           10/60             333
                                                 Interview..............................           2,000               1               1           2,000
                                                 Focus group interview..................           2,000               1               2           4,000
                                                 Survey.................................           2,000               1           30/60           1,000
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           8,000
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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. 2016-16873 Filed 7-15-16; 8:45 am]
 BILLING CODE 4163-18-P