[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66001-66003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-0840; Docket No. CDC-2023-0078]


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 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''. This information 
collection request is designed to allow CDC's National Center for HIV, 
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 November 27, 
2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0078 by any of the following methods:
     Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 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;
    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; and
    5. Assess information collection costs.

Proposed Project

    Formative Research and Tool Development (OMB Control No. 0920-

[[Page 66002]]

0840, Exp. 7/31/2024)--Extension--National Center for HIV, Viral 
Hepatitis, STD, TB Prevention (NCHHSTP), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), National 
Center for HIV, 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 to develop 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.
    CDC requests OMB approval for an estimated 6,657 annual burden 
hours. Participation of respondents is voluntary, and 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................  Screener........          56,840               1           10/60           9,473
Health care providers.........  Screener........          24,360               1           10/60           4,060
General public................  Consent Forms...          28,420               1            5/60           2,368
Health care providers.........  Consent Forms...          12,180               1            5/60           1,015
General public................  Individual                 4,620               1               1           4,620
                                 Interview.
Health care providers.........  Individual                 1,980               1               1           1,980
                                 Interview.
General public................  Focus Group                2,800               1               2           5,600
                                 Interview.
Health care providers.........  Focus Group                1,200               1               2           2,400
                                 Interview.
General public................  Survey of                 21,000               1           30/60          10,500
                                 Individual.
Health care providers.........  Survey of                  9,000               1           30/60           4,500
                                 Individual.
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[[Page 66003]]

 
    Total.....................  ................  ..............  ..............  ..............          46,516
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-20761 Filed 9-25-23; 8:45 am]
BILLING CODE 4163-18-P