82 FR 52302 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 217 (November 13, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 217 (November 13, 2017)
| Page Range | 52302-52304 | |
| FR Document | 2017-24473 |
[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)] [Notices] [Pages 52302-52304] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24473] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-17AUZ; Docket No. CDC-2017-0065] 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 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 ``Project NICE: Navigating Insurance Coverage Expansion''. Project NICE will evaluate the efficacy of an in-person health insurance enrollment assistance intervention among Black and Hispanic men who have sex with [[Page 52303]] men (MSM) and Transgender persons living in the Chicago, Illinois metropolitan area. DATES: CDC must receive written comments on or before January 12, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2017- 0065 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 Project NICE: Navigating Insurance Coverage Expansion--New-- National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC seeks to request a three-year OMB approval to evaluate the efficacy of an in-person health insurance enrollment assistance intervention among 1,000 Black and Hispanic MSM and Transgender persons ages >=18 years living in the Chicago, Illinois metropolitan area. CDC will invite individuals attending HIV testing outreach events, or seeking care in select clinics in Chicago to participate in the study after an HIV testing session. Researchers will collect study participants' sociodemographic, risk behavior, and insurance coverage information as part of study enrollment. Each quarter, researchers will abstract outcome evaluation data (linkage to and retention in HIV- related care, referrals for mental health or substance use, and other health outcomes) from study participant's electronic medical records (EMRs). Researchers will also assess intervention cost-effectiveness. CDC funded this study through a cooperative agreement with the University of Chicago Medicine (UCM). Three partner agencies will conduct the intervention: (1) University of Chicago Medicine (UCM) (the lead partner agency), (2) Howard Brown Health, and (3) Chicago House and Social Service Agency (Chicago House). The three partner agencies each have a history of providing clinical care, HIV testing outreach, and in-person health insurance enrollment assistance for Chicago's MSM and Transgender communities. As part of this study, CDC will evaluate the in-person health insurance enrollment assistance. Specifically, researchers will evaluate whether moving the delivery of in-person health insurance enrollment assistance, from the first clinic visit after receipt of an HIV test result, to earlier in the care continuum, during the HIV testing event, will impact health outcomes. Therefore, this study does not introduce new intervention activities or burden on the participants or the agency staff; it reorders the sequence of delivery of standard practice. Only the addition of data collection forms and procedures will be new, and the additional burden will be to partner agency staff workload and participant experience. In 2013, MSM accounted for 81% of new HIV infections among males and 65% of all new HIV infections. In 2010, health officials reported 10,600 new HIV infections for African-American (Black) MSM, 11,200 for White MSM, and 6,700 for Hispanic MSM. Through a 2008 systematic review, researchers found HIV rates among Black and Hispanic Transgender women to be 56% and 16%, respectively. Black and Hispanic MSM and Transgender persons face obstacles in seeking medical care and following through with referrals or appointments, including lack of health insurance. This study will implement a structural intervention. The goal of this study is to test whether providing in-person assistance for first- time private health insurance or Medicaid enrollment, changing to a different insurance plan, or understanding how to use current insurance policies following HIV testing will: (1) Increase the proportion of participants who obtain health insurance; (2) result in better health outcomes among participants (e.g., achieving viral suppression, remaining HIV negative); (3) improve the linkage and retention rates for HIV care (i.e., HIV treatment, Pre-exposure Prophylaxis (PrEP)) and other HIV-associated health services (e.g., mental health counseling, substance use treatment) of participants, especially those diagnosed with HIV; and (4) increase HIV care linkage and retention rates sufficiently to justify the cost of implementing the intervention (cost-benefit analysis) among Black and Hispanic MSM and Transgender persons age 18 or older in the Chicago, Illinois metropolitan area. Randomized controlled trials (RCTs) of structural interventions are rare. Nevertheless, CDC will use a RCT design to enhance scientific validity and the policy impact of the intervention, and help researchers assess the efficacy of this intervention as an emerging practice prior to dissemination to HIV prevention service providers nationwide. [[Page 52304]] This project aligns with National HIV/AIDS Strategy 2020 and Health People 2020 objectives. This structural intervention aligns with the OMB's emphasis on application of behavioral insights in that it restructures the context (i.e., after HIV testing) in which health- related decision-making (i.e., health insurance enrollment) occurs in order to promote the selection of beneficial options. The proposed health insurance enrollment assistance project has the potential for widespread health improvements for Black and Hispanic MSM and Transgender persons regardless of their HIV status. The study will enroll 1,000 participants over 12 months to reach adequate power calculations (500 into the intervention arm, and 500 into the control arm). After an HIV testing session at an outreach event or clinic visit, a partner-agency staff person will invite an individual to participate in the study. If interested, participants will complete a consent form. Staff will screen individuals using the Eligibility Form, which will take approximately five minutes to complete. Researchers would need to screen approximately 1,500 individuals in order to identify and enroll 1,000 eligible study participants. If eligible and interested in participating, individuals will complete the Participant Enrollment Form, which will take approximately 35 minutes to complete. Researchers then will offer in-person health insurance enrollment to randomized intervention arm participants. This enrollment will take a maximum of 60 minutes to complete. The study's in-person health insurance enrollment assistance will take the same amount of time as standard practice health insurance enrollment assistance. The total estimated annualized hourly burden anticipated for this study is 1,458 hours. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response Total burden respondents respondent (in hours) hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Study participant.............................. Consent Form........................... 1,500 1 10/60 250 Study participant.............................. Eligibility Form....................... 1,500 1 5/60 125 Study participant.............................. Participant Enrollment Form............ 1,000 1 35/60 583 Study participant (Intervention arm ONLY)...... ACTIVITY: In-person health insurance 500 1 1 500 enrollment assistance. --------------------------------------------------------------- Total...................................... ....................................... .............. .............. .............. 1,458 -------------------------------------------------------------------------------------------------------------------------------------------------------- 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. 2017-24473 Filed 11-9-17; 8:45 am] BILLING CODE 4163-18-P
![52302 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
clinical linkages. Through this identified key partners (e.g., coalition CDC intends to also seek OMB
initiative, DCPC intends to help address members, providers, patient navigators), approval to conduct semi-structured
the public health needs of cancer and semi-structured telephone interviews by telephone with a
survivors. To facilitate evidence- interviews with NCCCP DP15–1501 purposive sample of one program
informed policymaking and quality grantee program directors and program director and one program manager for
improvement of federal programs, CDC managers. The data from the survey and each of the six grantee sites (12
needs a comprehensive evaluation to semi-structured interviews will provide respondents total). CDC will conduct
characterize survivorship interventions additional insight into program efforts. the semi-structured interviews with the
and document outcomes. CDC is requesting OMB approval to same respondents at two time points for
CDC seeks to request OMB approval conduct a Web-based Grantee survey a total estimated burden of 36 hours.
to collect information needed for this using Survey Gizmo to a purposive CDC will ask the respondents to
evaluation. The proposed information
sample of one program director and one provide information on the following:
collection will focus on how each
program manager for each of the six (1) Administration of the Behavioral
grantee has expanded their knowledge
grantee sites (12 respondents total) and Risk Factor Surveillance System Cancer
of cancer survivor needs, increased
to conduct a Web-based Partner Survey Survivorship Module; (2)
utilization of surveillance data to inform
of 10 self-identified key partners in each communication, education, and training
program planning by providers and
of 6 grantees for a total of 60 activities to support the implementation
coalition members, and enhanced
respondents. CDC will administer the of cancer survivorship interventions; (3)
partnerships to facilitate and broaden
Web-based surveys to the same community clinical linkage strategies to
program reach. CDC will also collect
respondents at two time points for a support cancer survivors, knowledge
data on challenges encountered and
addressed, factors that facilitated total estimated burden of 8 hours for the regarding best practices for survivorship
implementation, and lessons learned Web-based Grantee Survey and 40 hours care; partnership engagement; (4)
along the way. The requested for the Web-based Partner Survey. dissemination of evidence-based
information does not currently exist for CDC will ask the respondents to survivorship interventions; and (5)
organizations and entities working to provide information regarding the type recommendations for improving the
improve cancer survivorship needs. of respondent; their use of surveillance implementation of evidence-based
With this data, CDC will gain critical data to inform survivorship survivorship interventions.
insights for improving achieving interventions; communication, CDC will analyze the collected
immediate strategic efforts and goals to education, and training activities to information and use in aggregate to
improve the public health needs of support the implementation of inform future efforts to support cancer
cancer survivors. survivorship interventions; partnership survivors and to initiate evidence-
CDC plans to collect information engagement; challenges and facilitators informed program decisions when
during two cycles of the program using regarding the implementation of rolling this initiative out to all NCCCP
a Web-based Grantee survey of NCCCP evidence-based cancer survivorship grantees. Without this data collection,
DP15–1501 grantee program directors strategies; reach of cancer survivorship CDC will not be able to provide tailored
and program managers, a Web-based interventions; and respondent technical assistance to its grantees and
Partner Survey of grantees’ self- background information. communicate program efforts.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response (in hours)
respondent (in hours)
NCCCP Grantee Program Director .. Web-based Grantee survey ............. 12 2 20/60 8
Semi-structured telephone interview 12 2 1.50 36
NCCCP Grantee Partner .................. Web-based Partner survey .............. 60 2 20/60 40
Total ........................................... ........................................................... ........................ ........................ ........................ 84
Leroy A. Richardson, DEPARTMENT OF HEALTH AND SUMMARY: The Centers for Disease
Chief, Information Collection Review Office, HUMAN SERVICES Control and Prevention (CDC), as part of
Office of Scientific Integrity, Office of the its continuing effort to reduce public
Associate Director for Science, Office of the Centers for Disease Control and burden and maximize the utility of
Director, Centers for Disease Control and Prevention government information, invites the
Prevention. general public and other Federal
[FR Doc. 2017–24523 Filed 11–9–17; 8:45 am] [60Day–17–17AUZ; Docket No. CDC–2017– agencies to take this opportunity to
BILLING CODE 4163–18–P 0065] comment on proposed and/or
asabaliauskas on DSKBBXCHB2PROD with NOTICES
continuing information collections, as
Proposed Data Collection Submitted required by the Paperwork Reduction
for Public Comment and Act of 1995. This notice invites
Recommendations comment on ‘‘Project NICE: Navigating
AGENCY: Centers for Disease Control and Insurance Coverage Expansion’’. Project
Prevention (CDC), Department of Health NICE will evaluate the efficacy of an in-
and Human Services (HHS). person health insurance enrollment
assistance intervention among Black
ACTION: Notice with comment period.
and Hispanic men who have sex with
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![52304 Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Notices
This project aligns with National HIV/ The study will enroll 1,000 If eligible and interested in
AIDS Strategy 2020 and Health People participants over 12 months to reach participating, individuals will complete
2020 objectives. This structural adequate power calculations (500 into the Participant Enrollment Form, which
intervention aligns with the OMB’s the intervention arm, and 500 into the will take approximately 35 minutes to
emphasis on application of behavioral control arm). complete. Researchers then will offer in-
insights in that it restructures the After an HIV testing session at an person health insurance enrollment to
context (i.e., after HIV testing) in which outreach event or clinic visit, a partner- randomized intervention arm
health-related decision-making (i.e., agency staff person will invite an participants. This enrollment will take a
individual to participate in the study. If
health insurance enrollment) occurs in maximum of 60 minutes to complete.
interested, participants will complete a
order to promote the selection of The study’s in-person health insurance
consent form. Staff will screen
beneficial options. The proposed health enrollment assistance will take the same
individuals using the Eligibility Form,
insurance enrollment assistance project which will take approximately five amount of time as standard practice
has the potential for widespread health minutes to complete. Researchers would health insurance enrollment assistance.
improvements for Black and Hispanic need to screen approximately 1,500 The total estimated annualized hourly
MSM and Transgender persons individuals in order to identify and burden anticipated for this study is
regardless of their HIV status. enroll 1,000 eligible study participants. 1,458 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response hours
respondent (in hours)
Study participant ................................ Consent Form .................................. 1,500 1 10/60 250
Study participant ................................ Eligibility Form ................................. 1,500 1 5/60 125
Study participant ................................ Participant Enrollment Form ............ 1,000 1 35/60 583
Study participant (Intervention arm ACTIVITY: In-person health insur- 500 1 1 500
ONLY). ance enrollment assistance.
Total ........................................... .......................................................... ........................ ........................ ........................ 1,458
Leroy A. Richardson, collection of information) and to allow Division of Regulations Development,
Chief, Information Collection Review Office, 60 days for public comment on the Attention: Document Identifier/OMB
Office of Scientific Integrity, Office of the proposed action. Interested persons are Control Number __, Room C4–26–05,
Associate Director for Science, Office of the invited to send comments regarding our 7500 Security Boulevard, Baltimore,
Director, Centers for Disease Control and burden estimates or any other aspect of Maryland 21244–1850.
Prevention. this collection of information, including To obtain copies of a supporting
[FR Doc. 2017–24473 Filed 11–9–17; 8:45 am] the necessity and utility of the proposed statement and any related forms for the
BILLING CODE 4163–18–P information collection for the proper proposed collection(s) summarized in
performance of the agency’s functions, this notice, you may make your request
the accuracy of the estimated burden, using one of following:
DEPARTMENT OF HEALTH AND ways to enhance the quality, utility, and 1. Access CMS’ Web site address at
HUMAN SERVICES clarity of the information to be http://www.cms.hhs.gov/
collected, and the use of automated PaperworkReductionActof1995.
Centers for Medicare & Medicaid collection techniques or other forms of 2. Email your request, including your
Services information technology to minimize the address, phone number, OMB number,
[Document Identifiers: CMS–R–48 and information collection burden. and CMS document identifier, to
CMS–10421] DATES: Comments must be received by Paperwork@cms.hhs.gov.
January 12, 2018. 3. Call the Reports Clearance Office at
Agency Information Collection (410) 786–1326.
ADDRESSES: When commenting, please
Activities: Proposed Collection; FOR FURTHER INFORMATION CONTACT:
reference the document identifier or
Comment Request William Parham at (410) 786–4669.
OMB control number. To be assured
AGENCY: Centers for Medicare & consideration, comments and SUPPLEMENTARY INFORMATION:
Medicaid Services, HHS. recommendations must be submitted in Contents
ACTION: Notice. any one of the following ways:
1. Electronically. You may send your This notice sets out a summary of the
SUMMARY: The Centers for Medicare & comments electronically to http:// use and burden associated with the
Medicaid Services (CMS) is announcing www.regulations.gov. Follow the following information collections. More
detailed information can be found in
asabaliauskas on DSKBBXCHB2PROD with NOTICES
an opportunity for the public to instructions for ‘‘Comment or
comment on CMS’ intention to collect Submission’’ or ‘‘More Search Options’’ each collection’s supporting statement
information from the public. Under the to find the information collection and associated materials (see
Paperwork Reduction Act of 1995 (the document(s) that are accepting ADDRESSES).
PRA), federal agencies are required to comments. CMS–R–48 Hospital Conditions of
publish notice in the Federal Register 2. By regular mail. You may mail Participation and Supporting
concerning each proposed collection of written comments to the following Regulations
information (including each proposed address: CMS, Office of Strategic CMS–10421 Fee-for-Service Recovery
extension or reinstatement of an existing Operations and Regulatory Affairs, Audit Prepayment Review
VerDate Sep<11>2014 18:38 Nov 09, 2017 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\13NON1.SGM 13NON1](https://thefederalregister.org/doc/82_FR_52519/page/3.svg)
Document Created: 2017-11-10 01:18:15
Document Modified: 2017-11-10 01:18:15
| 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 January 12, 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 | 82 FR 52302 |
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