81 FR 76590 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 213 (November 3, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 213 (November 3, 2016)
| Page Range | 76590-76591 | |
| FR Document | 2016-26501 |
[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)] [Notices] [Pages 76590-76591] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26501] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-17CA]; Docket No. CDC-2016-0105] 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 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 information collection project entitled ``Positive Health Check Evaluation Trial.'' CDC is requesting a three-year approval for a data collection effort designed to evaluate effectiveness of the Positive Health Check (PHC) online tool created by RTI and CDC. This CDC and Research Triangle Institute (RTI) developed tool delivers tailored evidence based prevention messages to HIV positive patients, on improving clinical outcomes and retention in care of HIV positive patients with unsuppressed viral loads. This data collection is also designed to assess the feasibility of implementing the intervention in clinics and the cost of the intervention. DATES: Written comments must be received on or before January 3, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0105 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. 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 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 Positive Health Check Evaluation Trial--New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description HIV transmission continues to be an urgent public health challenge in the United States. According to CDC, approximately 1.2 million people are living with HIV, with close to 50,000 new cases each year. Antiretroviral therapy (ART) suppresses the plasma HIV viral load (VL) and people living with HIV (PLWH) who are treated with ART--compared with those who are not--have a substantially reduced risk of transmitting HIV sexually, through drug sharing, or from mother to child. However, it is estimated that only 19% to 28% of people who are infected with HIV in the United States have an undetectable HIV VL. To enhance HIV prevention efforts, implementable, effective, scalable interventions are needed that focus on enhancing prevention and care to improve the health of and reduce HIV transmission risk among PLWH. The Positive Health Check (PHC) intervention is based on earlier computer- based interventions that were proven efficacious for HIV prevention. The PHC intervention approach is innovative in multiple ways. First, it uses an interactive video doctor to deliver tailored messages that meet specific patient needs related to adherence, sexual risk reduction, engagement in care, mother-to-child transmission, and drug use. Second, this intervention is designed specifically to support patient behavior change by providing useful tips to practice between visits. These tips are patient driven and populated on a handout while patients use the PHC intervention, thereby increasing engagement and the likelihood of success. Third, PHC supports patient-provider communication by also generating a set [[Page 76591]] of questions that patients would like to ask their provider. These behavior change tips and questions are also populated on a Patient Handout that patients may share with their provider. As such, PHC supports patients and providers during their clinical encounter and promotes communication. Finally, the PHC intervention has been designed from the onset for wide-scale dissemination. Its flexible digital strategy provides access on multiple devices and platforms. This approach makes PHC an important intervention strategy to improve public health in communities that have a high incidence of HIV infection. This data collection has four primary aims: (1) Implement a randomized trial to test the efficacy of the PHC intervention for improving clinical health outcomes, specifically viral load and retention in care; (2)conduct a feasibility assessment to determine strategies to facilitate implementation and integration of PHC into HIV primary care clinics; (3) collect and document data on the cost of PHC intervention implementation; and (4) document the standard of care at each participating clinic. The awardee of this cooperative agreement is RTI. RTI has subcontracted with four clinical sites to implement the trial. The sub-contractors are the Atlanta VA Medical Center (Atlanta, Georgia), Hillsborough County Health Department (Tampa, Florida), Rutgers Infectious Disease Practice (Newark, New Jersey), and Crescent Care (New Orleans, Louisiana). The four clinical sites are well suited for this work, given the high rates of patients with elevated viral loads. During the 24-month implementation period, 1,010 patients will be enrolled into the trial (505 intervention arm and 505 control arm) across the four clinics to evaluate the effectiveness of the PHC intervention. To assess the effectiveness of the PHC intervention, patients randomized to the intervention arm will provide their responses to the patient tailoring questions embedded within the intervention and all enrolled patients will consent to have their de- identified clinical values be made available via passive data collection via the electronic medical record. In addition to the main trial, three to five key staff at each clinic site will be selected to participate in the PHC feasibility assessment which includes an online survey and qualitative interviews. Finally, clinic staff who participate in the implementation of the PHC intervention will provide data on the cost of implementing the PHC intervention. It is estimated that the total burden hours for all data collection activities is 315. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Total response Type of respondent Form name Number of responses per per response burden (in respondents respondent (in hours) hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Persons eligible for study...................... PHC intervention trial consent.... 505 1 5/60 42 Staff online survey consent....... 20 1 5/60 2 Enrolled participants........................... PHC tailoring questions........... 505 3 5/60 126 Online clinic staff survey........ 20 3 15/60 15 Clinic staff qualitative interview 20 3 40/60 40 Non-research labor cost 12 3 75/60 45 questionnaire. PHC labor cost questionnaire...... 12 3 75/60 45 ------------------------------------------------------------------- Total....................................... .................................. ............... ............... ............... 315 -------------------------------------------------------------------------------------------------------------------------------------------------------- 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. 2016-26501 Filed 11-2-16; 8:45 am] BILLING CODE 4163-18-P
![76590 Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices
Prevention and the Agency for Toxic Prevention, 1600 Clifton Road NE., MS– provide information to or for a Federal
Substances and Disease Registry. D74, Atlanta, Georgia 30329. agency. This includes the time needed
Instructions: All submissions received to review instructions; to develop,
Claudette Grant,
must include the agency name and acquire, install and utilize technology
Acting Director, Management Analysis and Docket Number. All relevant comments and systems for the purpose of
Services Office, Centers for Disease Control
received will be posted without change collecting, validating and verifying
and Prevention.
to Regulations.gov, including any information, processing and
[FR Doc. 2016–26570 Filed 11–2–16; 8:45 am]
personal information provided. For maintaining information, and disclosing
BILLING CODE 4163–18–P
access to the docket to read background and providing information; to train
documents or comments received, go to personnel and to be able to respond to
Regulations.gov. a collection of information, to search
DEPARTMENT OF HEALTH AND
Please note: All public comment data sources, to complete and review
HUMAN SERVICES the collection of information; and to
should be submitted through the
Centers for Disease Control and Federal eRulemaking portal transmit or otherwise disclose the
Prevention (Regulations.gov) or by U.S. mail to the information.
address listed above. Proposed Project
[60Day–17–17CA]; Docket No. CDC–2016–
FOR FURTHER INFORMATION CONTACT: To
0105]
request more information on the Positive Health Check Evaluation
proposed project or to obtain a copy of Trial—New—National Center for HIV/
Proposed Data Collection Submitted AIDS, Viral Hepatitis, STD, and TB
for Public Comment and the information collection plan and
Prevention (NCHHSTP), Centers for
Recommendations instruments, contact the Information
Disease Control and Prevention (CDC).
Collection Review Office, Centers for
AGENCY: Centers for Disease Control and Disease Control and Prevention, 1600 Background and Brief Description
Prevention (CDC), Department of Health Clifton Road NE., MS–D74, Atlanta, HIV transmission continues to be an
and Human Services (HHS). Georgia 30329; phone: 404–639–7570; urgent public health challenge in the
ACTION: Notice with comment period. Email: omb@cdc.gov. United States. According to CDC,
SUPPLEMENTARY INFORMATION: Under the approximately 1.2 million people are
SUMMARY: The Centers for Disease Paperwork Reduction Act of 1995 (PRA) living with HIV, with close to 50,000
Control and Prevention (CDC), as part of (44 U.S.C. 3501–3520), Federal agencies new cases each year. Antiretroviral
its continuing efforts to reduce public must obtain approval from the Office of therapy (ART) suppresses the plasma
burden and maximize the utility of Management and Budget (OMB) for each HIV viral load (VL) and people living
government information, invites the collection of information they conduct with HIV (PLWH) who are treated with
general public and other Federal or sponsor. In addition, the PRA also ART—compared with those who are
agencies to take this opportunity to requires Federal agencies to provide a not—have a substantially reduced risk
comment on proposed and/or 60-day notice in the Federal Register of transmitting HIV sexually, through
continuing information collections, as concerning each proposed collection of drug sharing, or from mother to child.
required by the Paperwork Reduction information, including each new However, it is estimated that only 19%
Act of 1995. This notice invites proposed collection, each proposed to 28% of people who are infected with
comment on a proposed information extension of existing collection of HIV in the United States have an
collection project entitled ‘‘Positive information, and each reinstatement of undetectable HIV VL. To enhance HIV
Health Check Evaluation Trial.’’ CDC is previously approved information prevention efforts, implementable,
requesting a three-year approval for a collection before submitting the effective, scalable interventions are
data collection effort designed to collection to OMB for approval. To needed that focus on enhancing
evaluate effectiveness of the Positive comply with this requirement, we are prevention and care to improve the
Health Check (PHC) online tool created publishing this notice of a proposed health of and reduce HIV transmission
by RTI and CDC. This CDC and data collection as described below. risk among PLWH. The Positive Health
Research Triangle Institute (RTI) Comments are invited on: (a) Whether Check (PHC) intervention is based on
developed tool delivers tailored the proposed collection of information earlier computer-based interventions
evidence based prevention messages to is necessary for the proper performance that were proven efficacious for HIV
HIV positive patients, on improving of the functions of the agency, including prevention.
clinical outcomes and retention in care whether the information shall have The PHC intervention approach is
of HIV positive patients with practical utility; (b) the accuracy of the innovative in multiple ways. First, it
unsuppressed viral loads. This data agency’s estimate of the burden of the uses an interactive video doctor to
collection is also designed to assess the proposed collection of information; (c) deliver tailored messages that meet
feasibility of implementing the ways to enhance the quality, utility, and specific patient needs related to
intervention in clinics and the cost of clarity of the information to be adherence, sexual risk reduction,
the intervention. collected; (d) ways to minimize the engagement in care, mother-to-child
DATES: Written comments must be burden of the collection of information transmission, and drug use. Second, this
received on or before January 3, 2017. on respondents, including through the intervention is designed specifically to
ADDRESSES: You may submit comments, use of automated collection techniques support patient behavior change by
identified by Docket No. CDC–2016– or other forms of information providing useful tips to practice
mstockstill on DSK3G9T082PROD with NOTICES
0105 by any of the following methods: technology; and (e) estimates of capital between visits. These tips are patient
• Federal eRulemaking Portal: or start-up costs and costs of operation, driven and populated on a handout
Regulations.gov. Follow the instructions maintenance, and purchase of services while patients use the PHC intervention,
for submitting comments. to provide information. Burden means thereby increasing engagement and the
• Mail: Leroy A. Richardson, the total time, effort, or financial likelihood of success. Third, PHC
Information Collection Review Office, resources expended by persons to supports patient-provider
Centers for Disease Control and generate, maintain, retain, disclose or communication by also generating a set
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![Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices 76591
of questions that patients would like to strategies to facilitate implementation intervention. To assess the effectiveness
ask their provider. These behavior and integration of PHC into HIV primary of the PHC intervention, patients
change tips and questions are also care clinics; (3) collect and document randomized to the intervention arm will
populated on a Patient Handout that data on the cost of PHC intervention provide their responses to the patient
patients may share with their provider. implementation; and (4) document the tailoring questions embedded within the
As such, PHC supports patients and standard of care at each participating intervention and all enrolled patients
providers during their clinical clinic. The awardee of this cooperative will consent to have their de-identified
encounter and promotes agreement is RTI. RTI has subcontracted clinical values be made available via
communication. Finally, the PHC with four clinical sites to implement the passive data collection via the electronic
intervention has been designed from the trial. The sub-contractors are the Atlanta
medical record. In addition to the main
onset for wide-scale dissemination. Its VA Medical Center (Atlanta, Georgia),
trial, three to five key staff at each clinic
flexible digital strategy provides access Hillsborough County Health Department
on multiple devices and platforms. This (Tampa, Florida), Rutgers Infectious site will be selected to participate in the
approach makes PHC an important Disease Practice (Newark, New Jersey), PHC feasibility assessment which
intervention strategy to improve public and Crescent Care (New Orleans, includes an online survey and
health in communities that have a high Louisiana). The four clinical sites are qualitative interviews.
incidence of HIV infection. well suited for this work, given the high Finally, clinic staff who participate in
This data collection has four primary rates of patients with elevated viral the implementation of the PHC
aims: (1) Implement a randomized trial loads. intervention will provide data on the
to test the efficacy of the PHC During the 24-month implementation cost of implementing the PHC
intervention for improving clinical period, 1,010 patients will be enrolled intervention. It is estimated that the
health outcomes, specifically viral load into the trial (505 intervention arm and total burden hours for all data collection
and retention in care; (2)conduct a 505 control arm) across the four clinics activities is 315.
feasibility assessment to determine to evaluate the effectiveness of the PHC
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average burden Total response
Number of
Type of respondent Form name responses per per response burden
respondents respondent (in hours) (in hours)
Persons eligible for study ..... PHC intervention trial consent ............. 505 1 5/60 42
Staff online survey consent .................. 20 1 5/60 2
Enrolled participants ............. PHC tailoring questions ........................ 505 3 5/60 126
Online clinic staff survey ...................... 20 3 15/60 15
Clinic staff qualitative interview ............ 20 3 40/60 40
Non-research labor cost questionnaire 12 3 75/60 45
PHC labor cost questionnaire .............. 12 3 75/60 45
Total ............................... ............................................................... .......................... .......................... .......................... 315
Leroy A. Richardson, SUMMARY: NIOSH announces the comment period (76 FR 64353). On
Chief, Information Collection Review Office, availability of the following final April 11, 2012, NIOSH published an
Office of Scientific Integrity, Office of the publication: ‘‘Criteria for a expanded charge for peer reviewers (77
Associate Director for Science, Office of the Recommended Standard: Occupational FR 21777) and then on December 26,
Director, Centers for Disease Control and Exposure to Diacetyl and 2,3-
Prevention.
2013, NIOSH published another notice
pentanedione’’ [DHHS(NIOSH) (78 FR 78363) for review of revised
[FR Doc. 2016–26501 Filed 11–2–16; 8:45 am] Publication Number 2016–111]. Chapters 6 and 8 of the Criteria
BILLING CODE 4163–18–P
DATES: The final criteria document was document. All comments received were
published October 31, 2016. reviewed and accepted where
DEPARTMENT OF HEALTH AND ADDRESSES: This document may be appropriate. Comments for Docket 245
HUMAN SERVICES obtained at the following link: http:// are available at: http://www.cdc.gov/
www.cdc.gov/niosh/docs/2016–111. niosh/docket/archive/docket245.html.
Centers for Disease Control and FOR FURTHER INFORMATION CONTACT: Comments for Docket 245–A can be
Prevention Lauralynn McKernan, NIOSH/Division found in the docket at:
[CDC–2013–0021; Docket Number NIOSH– of Surveillance, Hazard Evaluations and www.regulations.gov, Docket No. CDC–
245, 245–A] Field Studies, 1090 Tusculum Avenue, 2013–0021.
MS R–12, Cincinnati, OH 45226. 513– Dated: October 28, 2016.
Issuance of Final Guidance Publication 533–8542 (not a toll free number). John Howard,
AGENCY: National Institute for SUPPLEMENTARY INFORMATION: On July Director, National Institute for Occupational
25, 2011, NIOSH published a notice of
mstockstill on DSK3G9T082PROD with NOTICES
Occupational Safety and Health Safety and Health, Centers for Disease Control
(NIOSH) of the Centers for Disease public meeting and request for and Prevention.
Control and Prevention (CDC), comments on the draft ‘‘Criteria for a [FR Doc. 2016–26507 Filed 11–2–16; 8:45 am]
Department of Health and Human Recommended Standard: Occupational
BILLING CODE 4163–19–P
Services (HHS). Exposure to Diacetyl and 2,3-
pentanedione.’’ in the Federal Register
ACTION: Notice of issuance of final
(76 FR 44338). On October 18, 2011,
guidance publication.
NIOSH published an extension of
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Document Created: 2016-11-03 03:23:50
Document Modified: 2016-11-03 03:23:50
| 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 | Written comments must be received on or before January 3, 2017. | |
| 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] | |
| FR Citation | 81 FR 76590 |
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