Proposed Data Collection Submitted for Public Comment and Recommendations, 40059-40060 [2019-17291]

Download as PDF 40059 Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS), was established to address this issue. The Million Hearts® Hospital/Health System Recognition Program engages, equips, and supports leading clinical institutions across the country to excel in cardiovascular health and care. Hospitals and health systems are critical to population health, given their direct connection to people at risk for CVD, as well as those who have had a cardiac or cerebrovascular event and remain at risk for having a subsequent event. Hospitals are also the largest component of the health care sector, and in total employ over 5.4 million people—the second largest source of private sector jobs. Whether migrating towards value-based reimbursement or simply striving for a significant impact in reducing the devastation of heart attacks and strokes, hospitals and health systems are positioned to improve the health of the population they serve by implementing high-impact, evidence-based strategies. Achieving a Million Hearts® Hospital/ Health System designation signals a commitment to not only clinical quality, but population health overall. CDC is requesting approval for 297 annual burden hours. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Form name Medical & Health Service Manager ................ Medical & Health Service Manager ................ Recognition Program Application ................... Interview Guide .............................................. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–17286 Filed 8–12–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–19–1178; Docket No. CDC–2019– 0065] Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: jspears on DSK3GMQ082PROD with NOTICES Number of respondents Type of respondents 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 Comprehensive HIV Prevention and Care for Men Who Have Sex with Men of Color. This study is designed to support state and local health departments to develop and implement demonstration projects for provision of comprehensive human immunodeficiency virus (HIV) prevention and care services for men VerDate Sep<11>2014 17:51 Aug 12, 2019 Jkt 247001 who have sex with men (MSM) of color by creating a collaborative with community based organizations (CBOs), clinics and other health care providers, and behavioral health and social services providers in their jurisdiction. DATES: CDC must receive written comments on or before October 15, 2019. ADDRESSES: You may submit comments, identified by Docket No. CDC–2019– 0065 by any of the following methods: • Federal eRulemaking Portal: 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–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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS– D74, Atlanta, Georgia 30329; phone: 404–639–7570; Email: omb@cdc.gov. 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 100 60 Number of responses per respondent 1 1 Average burden per response (in hours) 160/60 30/60 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 Comprehensive HIV Prevention and Care for Men Who Have Sex With Men of Color (OMB Control No. 0920–1178, Exp. 4/30/2020)—Extension—National E:\FR\FM\13AUN1.SGM 13AUN1 40060 Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Approximately 40,000 people in the United States are newly infected with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) remain the population most affected by HIV infection in the United States (US). Among MSM, those who are black and Hispanic comprise 64% of all new infections. Goals of the National HIV Prevention Strategy and the new initiative ‘‘Ending the HIV Epidemic: A Plan for America’’ include increasing the number of MSM of color living with HIV infection who achieve HIV viral suppression with antiretroviral treatment (ART), and decreasing the number of new HIV infections among MSM of color at risk of acquiring an HIV infection. Achieving these outcomes requires that men utilize a broad variety of HIV prevention and care services. The continuum of HIV prevention services includes HIV testing, offering HIVnegative men at risk for acquiring HIV infection biomedical interventions such as preexposure prophylaxis (PrEP) or postexposure prophylaxis (PEP), prescribing the medications needed for PrEP or PEP, adhering to these independent management and diverse funding streams and administration of each collaborative member, the health departments will need to work cooperatively with CDC to form and sustain this collaborative and to provide technical assistance and support for them to deliver high quality HIV prevention and care services to men who require them. CDC needs to understand facilitators and barriers to developing and sustaining a community collaborative to guide the technical assistance it provides to the collaborative so it can optimally deliver all of the required HIV prevention and care services to all men who require them. Because many of the service providers in the collaborative are not part of the health department organizational structure or co-located within a health department facility or clinic, the health departments will support navigators to help MSM of color to utilize all of the services. In order to provide technical assistance to ensure effective navigation models, CDC must understand the characteristics of the various models; how they integrate service utilization within the collaborative structure, and the number of men who they assist in utilizing services. CDC requests approval for 1,543 annual burden hours. There are no other costs to respondents other than their time. medications as prescribed, returning for follow-up visits to support adherence, and monitoring potential medication side effects. Lab-based Antigen/ Antibody HIV testing is recommended because it is the most sensitive HIV diagnostic test, allowing acute HIV infection to be diagnosed, and allowing health departments to prioritize initiation of treatment early in the course of infection to improve long-term health outcomes and prevent secondary HIV transmission. State and local health departments are authorized to provide HIV testing, prevention, and care services, and are essential partners in carrying out Thrive’s programmatic goals. The continuum of HIV care services includes HIV testing and notifying HIV-positive men of their results, linking HIV-positive men to their initial HIV clinic visit, prescribing antiretroviral medications to treat HIV infection, adhering to antiretroviral medications, being retained or reengaged in care, and achieving HIV viral suppression. These services will be provided by a community collaborative led by the health department, which consists of several partners: Community-based organizations (CBOs), healthcare providers, behavioral healthcare providers, and social service providers. But, because of the fragmented nature of U.S. healthcare system, and the ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Total burden (in hours) Form name THRIVE Partners ........... Monitoring and Evaluation Data Elements on HIV Prevention and Care Services. Qualitative Interview: Collaborative Process Evaluation. Collaborative Assessment Tool ........................... Monitoring and Evaluation Data Elements on HIV Prevention and Care Services. Qualitative Interview: Collaborative Process Evaluation. Collaborative Assessment Tool ........................... Funding Allocation Report ................................... 80 2 9 1,440 80 1 40/60 53 80 7 1 2 20/60 1 27 14 7 1 40/60 5 7 7 1 1 20/60 20/60 2 2 .............................................................................. ........................ ........................ ........................ 1,543 THRIVE Awardees ........ Total ........................ Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. jspears on DSK3GMQ082PROD with NOTICES Average burden per response (in hours) Type of respondent [FR Doc. 2019–17291 Filed 8–12–19; 8:45 am] BILLING CODE 4163–18–P VerDate Sep<11>2014 17:51 Aug 12, 2019 Jkt 247001 PO 00000 Frm 00041 Fmt 4703 Sfmt 9990 E:\FR\FM\13AUN1.SGM 13AUN1

Agencies

[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40059-40060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17291]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-1178; Docket No. CDC-2019-0065]


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 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 Comprehensive HIV Prevention and 
Care for Men Who Have Sex with Men of Color. This study is designed to 
support state and local health departments to develop and implement 
demonstration projects for provision of comprehensive human 
immunodeficiency virus (HIV) prevention and care services for men who 
have sex with men (MSM) of color by creating a collaborative with 
community based organizations (CBOs), clinics and other health care 
providers, and behavioral health and social services providers in their 
jurisdiction.

DATES: CDC must receive written comments on or before October 15, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0065 by any of the following methods:
     Federal eRulemaking Portal: 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-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 Jeffrey M. Zirger, 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

    Comprehensive HIV Prevention and Care for Men Who Have Sex With Men 
of Color (OMB Control No. 0920-1178, Exp. 4/30/2020)--Extension--
National

[[Page 40060]]

Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Approximately 40,000 people in the United States are newly infected 
with HIV each year. Gay, bisexual, and other men who have sex with men 
(MSM) remain the population most affected by HIV infection in the 
United States (US). Among MSM, those who are black and Hispanic 
comprise 64% of all new infections. Goals of the National HIV 
Prevention Strategy and the new initiative ``Ending the HIV Epidemic: A 
Plan for America'' include increasing the number of MSM of color living 
with HIV infection who achieve HIV viral suppression with 
antiretroviral treatment (ART), and decreasing the number of new HIV 
infections among MSM of color at risk of acquiring an HIV infection.
    Achieving these outcomes requires that men utilize a broad variety 
of HIV prevention and care services. The continuum of HIV prevention 
services includes HIV testing, offering HIV-negative men at risk for 
acquiring HIV infection biomedical interventions such as preexposure 
prophylaxis (PrEP) or postexposure prophylaxis (PEP), prescribing the 
medications needed for PrEP or PEP, adhering to these medications as 
prescribed, returning for follow-up visits to support adherence, and 
monitoring potential medication side effects. Lab-based Antigen/
Antibody HIV testing is recommended because it is the most sensitive 
HIV diagnostic test, allowing acute HIV infection to be diagnosed, and 
allowing health departments to prioritize initiation of treatment early 
in the course of infection to improve long-term health outcomes and 
prevent secondary HIV transmission. State and local health departments 
are authorized to provide HIV testing, prevention, and care services, 
and are essential partners in carrying out Thrive's programmatic goals. 
The continuum of HIV care services includes HIV testing and notifying 
HIV-positive men of their results, linking HIV-positive men to their 
initial HIV clinic visit, prescribing antiretroviral medications to 
treat HIV infection, adhering to antiretroviral medications, being 
retained or re-engaged in care, and achieving HIV viral suppression.
    These services will be provided by a community collaborative led by 
the health department, which consists of several partners: Community-
based organizations (CBOs), healthcare providers, behavioral healthcare 
providers, and social service providers. But, because of the fragmented 
nature of U.S. healthcare system, and the independent management and 
diverse funding streams and administration of each collaborative 
member, the health departments will need to work cooperatively with CDC 
to form and sustain this collaborative and to provide technical 
assistance and support for them to deliver high quality HIV prevention 
and care services to men who require them. CDC needs to understand 
facilitators and barriers to developing and sustaining a community 
collaborative to guide the technical assistance it provides to the 
collaborative so it can optimally deliver all of the required HIV 
prevention and care services to all men who require them.
    Because many of the service providers in the collaborative are not 
part of the health department organizational structure or co-located 
within a health department facility or clinic, the health departments 
will support navigators to help MSM of color to utilize all of the 
services. In order to provide technical assistance to ensure effective 
navigation models, CDC must understand the characteristics of the 
various models; how they integrate service utilization within the 
collaborative structure, and the number of men who they assist in 
utilizing services. CDC requests approval for 1,543 annual burden 
hours. There are no other costs to respondents other than their time.

                                                            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)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
THRIVE Partners................................  Monitoring and Evaluation Data Elements              80               2               9           1,440
                                                  on HIV Prevention and Care Services.
                                                 Qualitative Interview: Collaborative                 80               1           40/60              53
                                                  Process Evaluation.
                                                 Collaborative Assessment Tool..........              80               1           20/60              27
THRIVE Awardees................................  Monitoring and Evaluation Data Elements               7               2               1              14
                                                  on HIV Prevention and Care Services.
                                                 Qualitative Interview: Collaborative                  7               1           40/60               5
                                                  Process Evaluation.
                                                 Collaborative Assessment Tool..........               7               1           20/60               2
                                                 Funding Allocation Report..............               7               1           20/60               2
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           1,543
--------------------------------------------------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-17291 Filed 8-12-19; 8:45 am]
BILLING CODE 4163-18-P