83 FR 17663 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 78 (April 23, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 78 (April 23, 2018)
| Page Range | 17663-17665 | |
| FR Document | 2018-08383 |
[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)] [Notices] [Pages 17663-17665] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08383] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-FY-0840; Docket No. CDC-2018-0036] 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. ----------------------------------------------------------------------- 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 ``Formative Research and Tool Development''. DATES: CDC must receive written comments on or before June 22, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0036 by any of the following methods:Federal eRulemaking Portal: Regulations.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. 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 Leroy A. Richardson, 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 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, 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 Formative Research and Tool Development (OMB Control Number 0920- 0840, Expiration Date 1/31/2019)--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 approval of a three-year extension to the generic information collection plan titled ``Formative Research and Tool Development.'' CDC designed this information collection project 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, [[Page 17664]] communications, health promotion, and research project development for NCHHSTP's four priority disease prevention focus areas: (1) HIV/AIDS; (2) sexually transmitted diseases/infections (STD/STI); (3) viral hepatitis, tuberculosis elimination (TB); and (4) 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 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 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 information collection approval request will include CDC studies to investigate 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 information collection approval request will also include 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. CDC will use the information collected 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 CDC will cover 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. There is no cost to participants other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Type of respondent Form name Number of responses per Average hours Total response respondents respondent per response burden (hours) ---------------------------------------------------------------------------------------------------------------- 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. General public and health care Survey of 30,000 1 30/60 15,000 providers. Individual. --------------------------------------------------------------------------------- Total..................... ................ .............. .............. .............. 46,516 ---------------------------------------------------------------------------------------------------------------- [[Page 17665]] 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. 2018-08383 Filed 4-20-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices 17663
HIV prevention activities and use of client demographics and behavioral risk gathering and maintaining data,
funds in HIV prevention nationwide. characteristics with an estimate of document compilation, review of data,
CDC HIV prevention program grantees 207,186 burden hours, an increase from and data entry or upload into the web
will collect, enter or upload, and report the previously approved, 206,226 based system.
agency-identifying information, budget burden hours. Data collection will There are no additional costs to
data, intervention information, and include searching existing data sources, respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Health Departments .......................... Health Department Reporting .......... 66 2 1,435.5 189,486
Community-based Organization ....... Community-Based Organization Re- 150 2 59 17,700
porting.
Total ........................................... ........................................................... ........................ ........................ ........................ 207,186
Leroy A. Richardson, • Mail: Leroy A. Richardson, for the proper performance of the
Chief, Information Collection Review Office, Information Collection Review Office, functions of the agency, including
Office of Scientific Integrity, Office of the Centers for Disease Control and whether the information will have
Associate Director for Science, Office of the Prevention, 1600 Clifton Road NE, MS– practical utility;
Director, Centers for Disease Control and D74, Atlanta, Georgia 30329. 2. Evaluate the accuracy of the
Prevention. Instructions: All submissions received agency’s estimate of the burden of the
[FR Doc. 2018–08382 Filed 4–20–18; 8:45 am] must include the agency name and proposed collection of information,
BILLING CODE 4163–18–P Docket Number. CDC will post, without including the validity of the
change, all relevant comments to methodology and assumptions used;
Regulations.gov. 3. Enhance the quality, utility, and
DEPARTMENT OF HEALTH AND Please note: Submit all comments clarity of the information to be
HUMAN SERVICES through the Federal eRulemaking portal collected; and
(regulations.gov) or by U.S. mail to the 4. Minimize the burden of the
Centers for Disease Control and address listed above. collection of information on those who
Prevention FOR FURTHER INFORMATION CONTACT: To are to respond, including through the
[60Day–FY–0840; Docket No. CDC–2018– request more information on the use of appropriate automated,
0036] proposed project or to obtain a copy of electronic, mechanical, or other
the information collection plan and technological collection techniques or
Proposed Data Collection Submitted instruments, contact Leroy A. other forms of information technology,
for Public Comment and Richardson, Information Collection e.g., permitting electronic submissions
Recommendations Review Office, Centers for Disease of responses.
AGENCY: Centers for Disease Control and Control and Prevention, 1600 Clifton 5. Assess information collection costs.
Prevention (CDC), Department of Health Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email: Proposed Project
and Human Services (HHS).
omb@cdc.gov. Formative Research and Tool
ACTION: Notice with comment period. Development (OMB Control Number
SUPPLEMENTARY INFORMATION: Under the
SUMMARY: The Centers for Disease Paperwork Reduction Act of 1995 (PRA) 0920–0840, Expiration Date
Control and Prevention (CDC), as part of (44 U.S.C. 3501–3520), Federal agencies 1/31/2019)—Extension—National
its continuing effort to reduce public must obtain approval from the Office of Center for HIV/AIDS, Viral Hepatitis,
burden and maximize the utility of Management and Budget (OMB) for each STD, TB Prevention (NCHHSTP),
government information, invites the collection of information they conduct Centers for Disease Control and
general public and other Federal or sponsor. In addition, the PRA also Prevention (CDC).
agencies the opportunity to comment on requires Federal agencies to provide a Background and Brief Description
a proposed and/or continuing 60-day notice in the Federal Register
concerning each proposed collection of The Centers for Disease Control and
information collection, as required by
information, including each new Prevention, National Center for HIV/
the Paperwork Reduction Act of 1995.
proposed collection, each proposed AIDS, Viral Hepatitis, STD, and TB
This notice invites comment on a
extension of existing collection of Prevention (NCHHSTP) requests
proposed information collection project
information, and each reinstatement of approval for an approval of a three-year
titled ‘‘Formative Research and Tool
previously approved information extension to the generic information
Development’’.
collection before submitting the collection plan titled ‘‘Formative
DATES: CDC must receive written collection to the OMB for approval. To Research and Tool Development.’’ CDC
amozie on DSK30RV082PROD with NOTICES
comments on or before June 22, 2018. comply with this requirement, we are designed this information collection
ADDRESSES: You may submit comments, publishing this notice of a proposed project to allow CDC’s National Center
identified by Docket No. CDC–2018– data collection as described below. for HIV/AIDS, Viral Hepatitis, STD, and
0036 by any of the following methods: The OMB is particularly interested in TB Prevention (NCHHSTP) to conduct
• Federal eRulemaking Portal: comments that will help: formative research information
Regulations.gov. Follow the instructions 1. Evaluate whether the proposed collection activities used to inform
for submitting comments. collection of information is necessary many aspects of surveillance,
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![Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices 17665
Leroy A. Richardson, and Administrator, NCEH/ATSDR, are DEPARTMENT OF HEALTH AND
Chief, Information Collection Review Office, authorized under Section 301 (42 U.S.C. HUMAN SERVICES
Office of Scientific Integrity, Office of the 241) and Section 311 (42 U.S.C. 243) of
Associate Director for Science, Office of the the Public Health Service Act, as Food and Drug Administration
Director, Centers for Disease Control and
amended, to: (1) Conduct, encourage, [Docket No. FDA–2018–N–1242]
Prevention.
cooperate with, and assist other
[FR Doc. 2018–08383 Filed 4–20–18; 8:45 am]
appropriate public authorities, scientific Advisory Committee; Arthritis
BILLING CODE 4163–18–P
institutions, and scientists in the Advisory Committee, Renewal
conduct of research, investigations,
AGENCY: Food and Drug Administration,
DEPARTMENT OF HEALTH AND experiments, demonstrations, and
HHS.
HUMAN SERVICES studies relating to the causes, diagnosis,
treatment, control, and prevention of ACTION:Notice; renewal of advisory
physical and mental diseases and other committee.
Centers for Disease Control and
Prevention impairments; (2) assist states and their SUMMARY: The Food and Drug
political subdivisions in the prevention Administration (FDA) is announcing the
Board of Scientific Counselors, of infectious diseases and other renewal of the Arthritis Advisory
National Center for Environmental preventable conditions and in the Committee by the Commissioner of
Health/Agency for Toxic Substances promotion of health and wellbeing; and Food and Drugs (the Commissioner).
and Disease Registry (BSC, NCEH/ (3) train state and local personnel in The Commissioner has determined that
ATSDR) health work. The BSC, NCEH/ATSDR it is in the public interest to renew the
AGENCY: Centers for Disease Control and provides advice and guidance to the Arthritis Advisory Committee for an
Prevention (CDC), Department of Health Secretary, HHS; the Director, CDC and additional 2 years beyond the charter
and Human Services (HHS). Administrator, ATSDR; and the expiration date. The new charter will be
ACTION: Notice of meeting. Director, NCEH/ATSDR, regarding in effect until April 5, 2020.
program goals, objectives, strategies, and DATES: Authority for the Arthritis
SUMMARY: In accordance with the priorities in fulfillment of the agency’s Advisory Committee will expire on
Federal Advisory Committee Act, the mission to protect and promote people’s April 5, 2020, unless the Commissioner
CDC announces the following meeting health. The board provides advice and formally determines that renewal is in
for the Board of Scientific Counselors, guidance that will assist NCEH/ATSDR the public interest.
National Center for Environmental in ensuring scientific quality, FOR FURTHER INFORMATION CONTACT:
Health/Agency for Toxic Substances timeliness, utility, and dissemination of Yinghua Wang, Center for Drug
and Disease Registry (BSC, NCEH/ results. The board also provides Evaluation and Research, Food and
ATSDR). This meeting is open to the guidance to help NCEH/ATSDR work Drug Administration, 10903 New
public, limited only by available more efficiently and effectively with its Hampshire Ave., Bldg. 31, Rm. 2417,
seating. The meeting room
various constituents and to fulfill its Silver Spring, MD 20993–0002, 301–
accommodates approximately 60
mission in protecting America’s health. 796–9001, email: AAC@fda.hhs.gov.
people. The public is also welcome to
listen to the meeting by calling 888– Matters to be Considered: The agenda SUPPLEMENTARY INFORMATION: Pursuant
989–4501, passcode 9885805, limited by will include discussions on Recovery to 41 CFR 102–3.65 and approval by the
100 lines. The deadline for notification Efforts to Address Environmental Health Department of Health and Human
of attendance is May 14, 2018. The Impacts after the 2017 Hurricanes, Services pursuant to 45 CFR part 11 and
public comment period is scheduled on NCEH/ATSDR Program Responses to by the General Services Administration,
June 5, 2018 from 2:30 p.m. until 2:45 BSC Guidance and Action Items, PFAS FDA is announcing the renewal of the
p.m., EDT and June 6, 2018 from 10:10 multi-site study, PEASE, Biomonitoring Arthritis Advisory Committee (the
a.m. until 10:25 a.m., EDT. Individuals for PFAS in children, Use of Citizen Committee). The Committee is a
wishing to make a comment during Science for Assessment of Health Risks, discretionary Federal advisory
Public Comment period, please email Statistical Inferences in Environmental committee established to provide advice
your name, organization, and phone Epidemiology, and NCEH/ASTDR work to the Commissioner.
number by May 7, 2018 to Amanda The Committee advises the
with tribes/Tribal Programs. Agenda
Malasky at amalasky@cdc.gov. Commissioner or designee in
items are subject to change as priorities
discharging responsibilities as they
DATES: The meeting will be held on June dictate.
relate to helping to ensure safe and
5, 2018, 8:30 a.m. to 4:00 p.m., EDT and The Director, Management Analysis effective drugs for human use and, as
June 6, 2018, 8:30 a.m. to 11:30 a.m., and Services Office, has been delegated required, any other product for which
EDT. the authority to sign Federal Register FDA has regulatory responsibility.
ADDRESSES: CDC, 4770 Buford Highway, notices pertaining to announcements of The Committee reviews and evaluates
CDC Building 106, Room 1B, Atlanta, meetings and other committee data concerning the safety and
GA 30341. management activities, for both the effectiveness of marketed and
FOR FURTHER INFORMATION CONTACT: Centers for Disease Control and investigational human drug products for
Shirley Little, Program Analyst, NCEH/ Prevention and the Agency for Toxic use in the treatment of arthritis,
ATSDR, CDC, 4770 Buford Hwy., Mail Substances and Disease Registry. rheumatism, and related diseases, and
amozie on DSK30RV082PROD with NOTICES
Stop F–45, Atlanta, GA 30341, makes appropriate recommendations to
telephone (770) 488–0577; email snl7@ Elizabeth Millington, the Commissioner.
cdc.gov. Acting Director, Management Analysis and The Committee shall consist of a core
SUPPLEMENTARY INFORMATION: Services Office, Centers for Disease Control of 11 voting members including the
Purpose: The Secretary, Department and Prevention. Chair. Members and the Chair are
of Health and Human Services (HHS) [FR Doc. 2018–08367 Filed 4–20–18; 8:45 am] selected by the Commissioner or
and by delegation, the Director, CDC BILLING CODE 4163–19–P designee from among authorities
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Document Created: 2018-04-21 00:33:01
Document Modified: 2018-04-21 00:33:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before June 22, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, 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] | |
| FR Citation | 83 FR 17663 |
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