[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Pages 36540-36542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-15-0840; Docket No. CDC-2015-0046]


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 a proposed 
extension of the ``Formative Research and Tool Development'' 
information collection. Project activities are designed 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, 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 (TB), and school 
and adolescent health (DASH).

DATES: Written comments must be received on or before August 24, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0046 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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. 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 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

[[Page 36541]]

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

    Formative Research and Tool Development--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's, National Center 
for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) 
requests approval for an extension and a three-year approval for its 
generic information collection plan entitled ``Formative Research and 
Tool Development''. Project activities are designed 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, 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 (TB), and 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 also integral in 
developing programs as well as improving existing and ongoing programs. 
NCHHSTP formative research helps develop new 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 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 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. Also, there is no cost 
to participants other than their time.

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                                                                     Number of                         Total
      Type of respondent            Form name        Number of     responses per  Average  hours     response
                                                    respondents     respondent     per  response   burden (hrs.)
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General public and health care  Screener........          97,440               1           10/60          16,240
 providers.
General public and health care  Consent Forms...          48,720               1            5/60           4,060
 providers.
General public and health care  Individual                 7,920               1               1           7,920
 providers.                      interview.
General public and health care  Group interview.           4,800               1               2           9,600
 providers.

[[Page 36542]]

 
General public and health care  Survey of                 36,000               1           30/60          18,000
 providers.                      Individual.
                                                 ---------------------------------------------------------------
    Total.....................  ................         194,880  ..............  ..............          55,820
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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. 2015-15551 Filed 6-24-15; 8:45 am]
 BILLING CODE 4163-18-P