Notice2023-20761
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 26, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 185 (Tuesday, September 26, 2023)</title>
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[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 66001-66003]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#c9a6a4ab89aaadaae7aea6bf"><span class="__cf_email__" data-cfemail="402f2d22002324236e272f36">[email protected]</span></a>.
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
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