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)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 228 (November 27, 2015)
| Page Range | 74106-74108 | |
| FR Document | 2015-30130 |
[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hours) hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Health jurisdictions............................ Health Department Collaborative... 37 200 20/60 2,466 -------------------------------------------------------------------------------------------------------------------------------------------------------- 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
![74106 Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices
• Regulations.gov: http:// description applicable to the supplies. SUMMARY: The Centers for Disease
www.regulations.gov. The Government will use these Control and Prevention (CDC), as part of
Submit comments via the Federal descriptions as well as other its continuing efforts to reduce public
eRulemaking portal by searching the information available to determine the burden and maximize the utility of
OMB control number. Select the link classification description most government information, invites the
‘‘Submit a Comment’’ that corresponds appropriate and advantageous to the general public and other Federal
with ‘‘Information Collection 9000– government. agencies to take this opportunity to
0055, Freight Classification comment on proposed and/or
B. Annual Reporting Burden
Description’’. Follow the instructions continuing information collections, as
provided at the ‘‘Submit a Comment’’ Respondents: 3,000. required by the Paperwork Reduction
screen. Please include your name, Responses per Respondent: 3. Act of 1995. This notice invites
company name (if any), and Annual Responses: 9,000. comment on a proposed information
‘‘Information Collection 9000–0055, Hours per Response: .167. collection project entitled
Freight Classification Description’’ on Total Burden Hours: 1,503. ‘‘Comprehensive HIV Prevention and
your attached document. C. Public Comments Care for Men Who Have Sex with Men
• Mail: General Services of Color.’’ Seven U.S. health
Public comments are particularly
Administration, Regulatory Secretariat departments will form, lead, and
invited on: Whether this collection of
Division (MVCB), 1800 First Street NW., coordinate a collaborative with 37
information is necessary for the proper
Washington, DC 20405. ATTN: Ms. community-based organizations (CBOs),
performance of functions of the Federal
Flowers/IC 9000–0055, Freight clinics and other health providers,
Acquisition Regulations (FAR), and
Classification Description. behavioral health and social health
whether it will have practical utility;
Instructions: Please submit comments providers in their jurisdictions. The
whether our estimate of the public
only and cite Information Collection collaborative will report standardized
burden of this collection of information
9000–0055, Freight Classification program monitoring and evaluation
is accurate, and based on valid
Description, in all correspondence (M&E) data to the health department
assumptions and methodology; ways to
related to this collection. Comments and then the health department will
enhance the quality, utility, and clarity
received generally will be posted report the same M&E data to CDC.
of the information to be collected; and
without change to http:// DATES: Written comments must be
ways in which we can minimize the
www.regulations.gov, including any received on or before January 26, 2016.
burden of the collection of information
personal and/or business confidential
on those who are to respond, through ADDRESSES: You may submit comments,
information provided. To confirm
the use of appropriate technological identified by Docket No. CDC–2015–
receipt of your comment(s), please
collection techniques or other forms of 0107 by any of the following methods:
check www.regulations.gov,
information technology. • Federal eRulemaking Portal:
approximately two to three days after Obtaining Copies of Proposals: Regulation.gov. Follow the instructions
submission to verify posting (except Requesters may obtain a copy of the for submitting comments.
allow 30 days for posting of comments information collection documents from • Mail: Leroy A. Richardson,
submitted by mail). the General Services Administration, Information Collection Review Office,
FOR FURTHER INFORMATION CONTACT: Mr. Regulatory Secretariat Division (MVCB), Centers for Disease Control and
Curtis E. Glover, Sr., Procurement 1800 First Street NW., Washington, DC Prevention, 1600 Clifton Road NE., MS–
Analyst, Office of Acquisition Policy, at 20405, telephone 202–501–4755. D74, Atlanta, Georgia 30329.
202–501–1448 or via email at Please cite OMB Control No. 9000– Instructions: All submissions received
curtis.glover@gsa.gov. 0055, Freight Classification Description, must include the agency name and
SUPPLEMENTARY INFORMATION: in all correspondence. Docket Number. All relevant comments
A. Purpose Edward Loeb,
received will be posted without change
to Regulations.gov, including any
The Government is required to Acting Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
personal information provided. For
provide, in solicitations, a complete access to the docket to read background
Policy, Office of Governmentwide Policy.
description of the supplies to be documents or comments received, go to
[FR Doc. 2015–30141 Filed 11–25–15; 8:45 am]
acquired and the packing requirements Regulations.gov.
to determine transportation (freight rate) BILLING CODE 6820–EP–P
Please note: All public comment should be
charges for the evaluation of offers. submitted through the Federal eRulemaking
Generally, the freight rate for supplies is portal (Regulations.gov) or by U.S. mail to the
based on the ratings applicable to the DEPARTMENT OF HEALTH AND address listed above.
freight classification description HUMAN SERVICES
published in the National Motor Freight FOR FURTHER INFORMATION CONTACT: To
Classification (for carriers) and the Centers for Disease Control and request more information on the
Uniform Freight Classification (for rail) Prevention proposed project or to obtain a copy of
filed with Federal and State regulatory [60Day–16–16ET; Docket No. CDC–2015– the information collection plan and
bodies. 0107] instruments, contact the Information
When the Government purchases Collection Review Office, Centers for
Proposed Data Collection Submitted Disease Control and Prevention, 1600
mstockstill on DSK4VPTVN1PROD with NOTICES
supplies that are new to the supply
system, nonstandard, or modifications for Public Comment and Clifton Road NE., MS–D74, Atlanta,
of previously shipped supplies, and Recommendations Georgia 30329; phone: 404–639–7570;
different freight classifications may Email: omb@cdc.gov.
AGENCY: Centers for Disease Control and
apply, per FAR clause 52.247–53, Prevention (CDC), Department of Health SUPPLEMENTARY INFORMATION: Under the
offerors are requested to indicate the full and Human Services (HHS). Paperwork Reduction Act of 1995 (PRA)
Uniform Freight Classification or (44 U.S.C. 3501–3520), Federal agencies
ACTION: Notice with comment period.
National Motor Freight Classification must obtain approval from the Office of
VerDate Sep<11>2014 19:01 Nov 25, 2015 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1](https://thefederalregister.org/doc/80_FR_74334/page/1.svg)
![74108 Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices
services for those diagnosed with antiretroviral (ARV) treatment; 2. CDC HIV program grantees will
established HIV infection; 7. STD Retention interventions; 3. Re- collect, enter or upload, and report
screening and treatment; 8. Partner engagement interventions; 4. Adherence agency-identifying information, budget
services for patients with STDs; 9. interventions; 5. STD screening and data, information on the HIV prevention
Behavioral risk reduction interventions; treatment; 6. Partner services; 7. and care services, and client
10. Screening for behavioral health and Behavioral risk reduction interventions; demographic characteristics with an
social services’ needs; 11. Linkage to 8. Screening patients for behavioral estimate of 2,466 burden hours. It is
behavioral health and social services; health and social services’ needs; 9. estimated that the 37 respondents will
12. Navigators to assist accessing HIV Linkage to behavioral health and social see approximately 200 patients per year.
prevention and behavioral health and
services; 10. Navigators to assist linking The respondents will take about 20
social services; 13. Navigators to assist
to care and accessing behavioral health minutes to enter the data for each of the
enrollment in a health plan. The
and social services; 11. Navigators to 200 patients using the monitoring and
following are the eleven HIV care
services: 1. HIV primary care, including assist enrollment in a health plan. evaluation form.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Type of Number of burden per Total burden
Form name responses per
respondents respondents response hours
respondent (in hours)
Health jurisdictions ............................ Health Department Collaborative ..... 37 200 20/60 2,466
Leroy A. Richardson, program implementation and collection of information they conduct
Chief, Information Collection Review Office, achievement of outcomes. or sponsor. In addition, the PRA also
Office of Scientific Integrity, Office of the DATES: Written comments must be requires Federal agencies to provide a
Associate Director for Science, Office of the received on or before January 26, 2016. 60-day notice in the Federal Register
Director, Centers for Disease Control and concerning each proposed collection of
Prevention. ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015– information, including each new
[FR Doc. 2015–30130 Filed 11–25–15; 8:45 am] proposed collection, each proposed
0108 by any of the following methods:
BILLING CODE 4163–18–P
Federal eRulemaking Portal: extension of existing collection of
Regulation.gov. Follow the instructions information, and each reinstatement of
for submitting comments. previously approved information
DEPARTMENT OF HEALTH AND collection before submitting the
HUMAN SERVICES Mail: Leroy A. Richardson,
Information Collection Review Office, collection to OMB for approval. To
Centers for Disease Control and Centers for Disease Control and comply with this requirement, we are
Prevention Prevention, 1600 Clifton Road NE., publishing this notice of a proposed
MS—D74, Atlanta, Georgia 30329. data collection as described below.
[60Day–16–16FE; Docket No. CDC–2015– Comments are invited on: (a) Whether
Instructions: All submissions received
0108] the proposed collection of information
must include the agency name and
Docket Number. All relevant comments is necessary for the proper performance
Proposed Data Collection Submitted
received will be posted without change of the functions of the agency, including
for Public Comment and
to Regulations.gov, including any whether the information shall have
Recommendations
personal information provided. For practical utility; (b) the accuracy of the
AGENCY: Centers for Disease Control and access to the docket to read background agency’s estimate of the burden of the
Prevention (CDC), Department of Health documents or comments received, go to proposed collection of information; (c)
and Human Services (HHS). Regulations.gov. ways to enhance the quality, utility, and
ACTION: Notice with comment period. clarity of the information to be
Please note: All public comment should be
submitted through the Federal eRulemaking
collected; (d) ways to minimize the
SUMMARY: The Centers for Disease portal (Regulations.gov) or by U.S. mail to the burden of the collection of information
Control and Prevention (CDC), as part of address listed above. on respondents, including through the
its continuing efforts to reduce public use of automated collection techniques
burden and maximize the utility of FOR FURTHER INFORMATION CONTACT: To or other forms of information
government information, invites the request more information on the technology; and (e) estimates of capital
general public and other Federal proposed project or to obtain a copy of or start-up costs and costs of operation,
agencies to take this opportunity to the information collection plan and maintenance, and purchase of services
comment on proposed and/or instruments, contact the Information to provide information. Burden means
continuing information collections, as Collection Review Office, Centers for the total time, effort, or financial
required by the Paperwork Reduction Disease Control and Prevention, 1600 resources expended by persons to
Clifton Road NE., MS—D74, Atlanta,
mstockstill on DSK4VPTVN1PROD with NOTICES
Act of 1995. This notice invites generate, maintain, retain, disclose or
comment on a proposed information Georgia 30329; phone: 404–639–7570; provide information to or for a Federal
collection entitled ‘‘Monitoring and Email: omb@cdc.gov. agency. This includes the time needed
Reporting System for Rape Prevention SUPPLEMENTARY INFORMATION: Under the to review instructions; to develop,
and Education (RPE) Awardees.’’ CDC Paperwork Reduction Act of 1995 (PRA) acquire, install and utilize technology
will use the information collected to (44 U.S.C. 3501–3520), Federal agencies and systems for the purpose of
monitor cooperative agreement must obtain approval from the Office of collecting, validating and verifying
awardees and to identify challenges to Management and Budget (OMB) for each information, processing and
VerDate Sep<11>2014 19:01 Nov 25, 2015 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1](https://thefederalregister.org/doc/80_FR_74334/page/3.svg)
Document Created: 2015-12-14 14:05:07
Document Modified: 2015-12-14 14:05:07
| 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 26, 2016. | |
| 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 | 80 FR 74106 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR