[Federal Register Volume 86, Number 28 (Friday, February 12, 2021)]
[Notices]
[Pages 9346-9348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-0840 Docket No. CDC-2021-0010]


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 ``NCHHSTP Generic Clearance 
Formative Research and Tool Development''. This information collection 
request is 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: CDC must receive written comments on or before April 13, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0010 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. 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 Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; 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,

[[Page 9347]]

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

    NCHHSTP Generic Clearance Formative Research and Tool Development 
(OMB Control No. 0920-0840, Exp. 10/31/2021)--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.
    Much of CDC's health communication takes place within campaigns 
that have 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. Participation by 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.

[[Page 9348]]

 
General public and health care  Survey of                 30,000               1           30/60          15,000
 providers.                      Individual.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          46,516
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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. 2021-02952 Filed 2-11-21; 8:45 am]
BILLING CODE 4163-18-P