80 FR 74106 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 228 (November 27, 2015)

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 ``Comprehensive HIV Prevention and Care for Men Who Have Sex with Men of Color.'' Seven U.S. health departments will form, lead, and coordinate a collaborative with 37 community-based organizations (CBOs), clinics and other health providers, behavioral health and social health providers in their jurisdictions. The collaborative will report standardized program monitoring and evaluation (M&E) data to the health department and then the health department will report the same M&E data to CDC.

[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74106-74108]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30130]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16ET; Docket No. CDC-2015-0107]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing 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 ``Comprehensive HIV Prevention 
and Care for Men Who Have Sex with Men of Color.'' Seven U.S. health 
departments will form, lead, and coordinate a collaborative with 37 
community-based organizations (CBOs), clinics and other health 
providers, behavioral health and social health providers in their 
jurisdictions. The collaborative will report standardized program 
monitoring and evaluation (M&E) data to the health department and then 
the health department will report the same M&E data to CDC.

DATES: Written comments must be received on or before January 26, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0107 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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

[[Page 74107]]

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

    Comprehensive HIV Prevention and Care for Men Who Have Sex With Men 
of Color--New--National Center for HIV/AIDS, Viral Hepatitis, STD, and 
TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Approximately 50,000 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 US population most heavily affected by HIV infection. 
Among MSM, those who are black and Hispanic comprise 58% of all new 
infections. To address the burden of HIV in this population, high 
impact HIV prevention approaches should be implemented by state, local, 
and territorial health departments to reduce new HIV infections among 
MSM of color, and to improve outcomes along the HIV continuum of care 
for MSM of color living with HIV.
    Antiretroviral (ARV) medications for pre-exposure prophylaxis 
(PrEP) can be used for HIV prevention by MSM at substantial risk for 
HIV acquisition or by those with a possible HIV exposure in the past 72 
hours post-exposure prophylaxis (nPEP). The daily use of co-formulated 
tenofovir disoproxil fumarate and emtricitabine (marketed as Truvada) 
for PrEP has been proven to significantly reduce the risk of HIV 
acquisition among sexually active MSM. In July 2012, the US Food and 
Drug Administration approved an HIV prevention indication for Truvada, 
and in May 2014 CDC published clinical practice guidelines for 
provision of PrEP. Given the high incidence of HIV among MSM of color, 
those who are sexually active are considered at risk for HIV 
acquisition and thus could benefit from prevention services such as 
routine and frequent HIV screening with lab-based 4th generation HIV 
tests, routine screening for STDs, assessment of PrEP eligibility, 
provision of PrEP (if at substantial risk for HIV acquisition), 
provision of nPEP (if a possible HIV exposure occurred in the past 72 
hours), and/or other risk reduction interventions.
    Among people living with HIV (PLWH), ARV treatment can suppress HIV 
viral load, which both improves health outcomes of individuals and 
reduces the risk of HIV transmission. Two studies, one that 
demonstrated the effectiveness of ARV treatment in preventing HIV 
transmission, and one that demonstrated improved health outcomes for 
individuals whose ARV treatment was initiated immediately, have led to 
increased public health focus on interventions and strategies designed 
to initiate ARV treatment, link, retain, and re-engage PLWH in HIV 
care, and to provide support for adherence to ARV medications.
    The purpose of this project is to support state and local health 
departments to develop and implement demonstration projects for 
provision of comprehensive HIV prevention and care services for MSM of 
color by creating a collaborative with CBOs, clinics and other health 
care providers, and behavioral health and social services providers in 
their jurisdiction. Behavioral health services include mental health 
and substance abuse treatment to enable MSM of color to utilize HIV 
prevention and care services; social services include services that 
promote access to housing, job counseling, and employment services to 
enable MSM of color to utilize HIV prevention and care services.
    Comprehensive models of HIV prevention and care for MSM of color 
will be developed and implemented by a collaborative that is led by the 
jurisdiction's health department and includes the following: Health 
care providers (e.g., federally qualified health centers (FQHCs), FQHC 
Look-Alikes, other clinics, or health care providers); HIV care 
providers (e.g., clinics funded through the Ryan White HIV/AIDS Program 
(RWHAP clinics), other HIV care clinics, or HIV care providers); 
behavioral health and social services providers (i.e., mental health 
and substance abuse services, housing programs, and job training or 
employment services); and community based organizations (CBOs). 
Principles of high impact prevention should guide the selection and 
implementation of activities and strategies to focus on MSM of color at 
substantial risk for HIV infection (i.e., eligible for prevention with 
PrEP), and those living with HIV. MSM of color who are at risk for HIV 
acquisition (i.e., sexually active) but not eligible for or decline 
PrEP will be provided risk reduction interventions, partner services if 
diagnosed with an STD, re-testing for HIV and STDs in 3-6 months, and 
behavioral health and social services. The risk of HIV acquisition 
should be assessed at every encounter with an individual, and MSM of 
color at substantial risk of HIV acquisition should be offered PrEP 
when indicated by the risk assessment.
    There are a total of 24 required HIV prevention and care services 
that must be provided by the health department collaborative for this 
project. This is to include thirteen HIV prevention services for MSM of 
color at substantial risk for HIV infection and eleven HIV care 
services for MSM of color living with HIV infection. The following are 
the thirteen HIV prevention services: 1. HIV testing services that use 
lab-based 4th generation HIV tests; 2. Assessment of indications for 
pre-exposure prophylaxis (PrEP) and non-occupational post- exposure 
prophylaxis (nPEP); 3. Provision of PrEP and nPEP; 4. Adherence 
interventions for PrEP and nPEP; 5. Immediate linkage to care, ARV 
treatment, and partner services for those diagnosed with acute HIV 
infection; 6. Expedient linkage to care, ARV treatment, and partner

[[Page 74108]]

services for those diagnosed with established HIV infection; 7. STD 
screening and treatment; 8. Partner services for patients with STDs; 9. 
Behavioral risk reduction interventions; 10. Screening for behavioral 
health and social services' needs; 11. Linkage to behavioral health and 
social services; 12. Navigators to assist accessing HIV prevention and 
behavioral health and social services; 13. Navigators to assist 
enrollment in a health plan. The following are the eleven HIV care 
services: 1. HIV primary care, including antiretroviral (ARV) 
treatment; 2. Retention interventions; 3. Re-engagement interventions; 
4. Adherence interventions; 5. STD screening and treatment; 6. Partner 
services; 7. Behavioral risk reduction interventions; 8. Screening 
patients for behavioral health and social services' needs; 9. Linkage 
to behavioral health and social services; 10. Navigators to assist 
linking to care and accessing behavioral health and social services; 
11. Navigators to assist enrollment in a health plan.
    CDC HIV program grantees will collect, enter or upload, and report 
agency-identifying information, budget data, information on the HIV 
prevention and care services, and client demographic characteristics 
with an estimate of 2,466 burden hours. It is estimated that the 37 
respondents will see approximately 200 patients per year. The 
respondents will take about 20 minutes to enter the data for each of 
the 200 patients using the monitoring and evaluation form.

                                                            Estimated Annualized Burden Hours
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                                                                                                          Number of     Average  burden
              Type of  respondents                             Form name                 Number of      responses per    per  response     Total burden
                                                                                        respondents       respondent       (in hours)         hours
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Health jurisdictions............................  Health Department Collaborative...              37              200            20/60            2,466
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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. 2015-30130 Filed 11-25-15; 8:45 am]
 BILLING CODE 4163-18-P