81 FR 12494 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 46 (March 9, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 46 (March 9, 2016)
| Page Range | 12494-12496 | |
| FR Document | 2016-05235 |
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)] [Notices] [Pages 12494-12496] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05235] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-16CM] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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 submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project The Cooperative Re-engagement Controlled Trial (CoRECT)--New-- National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). [[Page 12495]] Background and Brief Description The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of HIV/AIDS Prevention (DHAP) requests a new three year OMB approval for information collection for a new research study entitled ``The Cooperative Re-engagement Controlled Trial (CoRECT)''. The purpose of the study is to evaluate a combined health department and clinic intervention to improve engagement in HIV care. Increasing the number of people living with HIV who access HIV care and achieve viral load suppression addresses one of the priorities of the National HIV/ AIDS Strategy. The data collection is authorized under the Section 301 of the Public Health Service Act (42 U.S.C. 241). The CoRECT Study data collection is comprised of six core components: 1. Electronic clinic data abstraction (Electronic Medical Record (EMR) abstraction will be conducted by project clinic staff at each project clinic to develop the clinic-based ``Out of Care'' list;) 2. electronic surveillance data abstraction (Electronic surveillance data abstraction will be conducted by project health department staff at each health department to develop the health department based ``Out of Care'' list); 3. a ``Barriers to Care'' survey (These surveys will provide information regarding barriers to accessing healthcare (e.g., transportation, financial assistance, housing, substance abuse services, etc.)); 4. a ``Standard of Care'' survey (Investigators will administer this survey to clinic managers, at baseline and every six months during the study period to assess how the delivery of health services has evolved over time); 5. a Participant Eligibility Disposition form (a listing of potential out-of-care patients will be reviewed to determine those who appear to be out-of-care, as determined by study eligibility, versus those who meet criteria for exclusion); and 6. a Case Conference form (project health department staff will determine if potentially eligible patients met criteria for inclusion in the study and if so randomization will occur). Prospective data collection will provide information about participant's baseline characteristics including sex, race/ethnicity, HIV exposure risk category, CD4 and viral load test results, date of first clinic visit, and insurance status. HIV antiretroviral therapy (ART) can durably suppress the plasma HIV viral load, which improves individual survival and dramatically reduces further HIV transmission. Increasing the number of people living with HIV who access HIV care and achieve viral load suppression is a priority of the National HIV/AIDS Strategy. Within the continuum of HIV care in the United States, improvements in linkage to and retention in effective care provide the greatest opportunity to improve rates of HIV viral suppression. It is estimated that of the 1.2 million persons living with HIV in 2011, only 40% were engaged in HIV medical care and only 30% achieved viral suppression. HIV clinical trials with enhanced case management have demonstrated that interventions provided by the health department can improve linkage to HIV care and interventions provided by the clinic can improve retention in HIV care. Although linkage to care has improved in many health department jurisdictions, being linked to care is not enough. There is a need to ensure that: (i) People diagnosed with HIV and linked to care are engaging medical care (i.e., attending their enrollment appointment and returning for follow-up medical appointments); and (ii) people who have disengaged from HIV care (i.e., have missed medical appointments and have not been seen in clinic for more than 6 months) are able to efficiently re-engage in care. There have been no randomized controlled studies using a Data-to-Care approach to identify and re-engage out of care persons. Controlled studies such as the CoRECT study are critical to determine the effectiveness of HIV prevention interventions. The CoRECT study is a randomized controlled trial that seeks to establish a data-sharing partnership between health departments and HIV care clinical providers to identify HIV-infected persons who are out of care and evaluate an intervention that aims to have randomized participants: (a) Link to an HIV clinic; (b) remain in HIV medical care; (c) achieve HIV viral load suppression within 12 months; and (d) achieve durable HIV viral load suppression over 18 months. The study is funded by CDC through cooperative agreements with the Connecticut State Department of Public Health (in collaboration with Yale University School of Medicine), the Massachusetts State Department of Public Health, and the Philadelphia Department of Public Health. The total burden hours are 1,731. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondent Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- CoRECT Study Coordinator.............. Electronic transmittal 3 4 1 of surveillance variables. Clinic Data Manager................... Electronic transmittal 46 4 1 of clinical variables. CoRECT Study Participants............. Barriers to Care Survey. 1,200 1 30/60 Clinical Nurse Coordinator............ Standard of Care Survey. 46 2 45/60 Clinic Data Manager................... Case Conference Session. 46 12 1 CoRECT study Coordinator (health Case Conference Session. 3 12 1 department). CoRECT Study Coordinator (health Participant Eligibility 3 12 1 department). Disposition form. Clinic data manager................... Cost analysis form-- 46 1 1 baseline. CoRECT Study Coordinator.............. Start-up cost analysis 3 1 1 form--Health department. Clinic Data Manager................... Start-up Cost Analysis 46 1 1 form--Clinic. CoRECT Study Coordinator.............. Annual Costs Analysis 3 2 1.5 form-Health department. Clinic Data Manager................... Annual Costs Analysis 46 2 1.5 form--Clinic. ---------------------------------------------------------------------------------------------------------------- [[Page 12496]] 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. 2016-05235 Filed 3-8-16; 8:45 am] BILLING CODE 4163-18-P
![12494 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
collection requirement concerning the approval of the make-or-buy programs; DEPARTMENT OF HEALTH AND
Make-or-Buy Program. and HUMAN SERVICES
DATES: Submit comments on or before (iii) Prescribes the contract clause at
May 9, 2016. Centers for Disease Control and
FAR 52.215–9, Changes or Additions to
Prevention
ADDRESSES: Submit comments Make-or-Buy Programs, which specifies
identified by Information Collection the circumstances under which the [30Day–16–16CM]
9000–0078, Make-or-Buy Program, by contractor is required to submit for the
any of the following methods: contracting officer’s advance approval a Agency Forms Undergoing Paperwork
• Regulations.gov: http:// notification and justification of any Reduction Act Review
www.regulations.gov. Submit comments proposed change in the approved make-
via the Federal eRulemaking portal by or-buy program. The Centers for Disease Control and
searching the OMB control number. Prevention (CDC) has submitted the
The information is used to assure the following information collection request
Select the link ‘‘Submit a Comment’’
lowest overall cost to the Government to the Office of Management and Budget
that corresponds with ‘‘Information
for required supplies and services. (OMB) for review and approval in
Collection 9000–0078, Make-or-Buy
Program’’. Follow the instructions B. Annual Reporting Burden accordance with the Paperwork
provided at the ‘‘Submit a Comment’’ Reduction Act of 1995. The notice for
screen. Please include your name, Respondents: 150. the proposed information collection is
company name (if any), and Responses Per Respondent: 3. published to obtain comments from the
‘‘Information Collection 9000–0078, public and affected agencies.
Total Responses: 450. Written comments and suggestions
Make-or-Buy Program’’ on your attached
document. Hours per Response: 8. from the public and affected agencies
• Mail: General Services Total Burden Hours: 3,600. concerning the proposed collection of
Administration, Regulatory Secretariat information are encouraged. Your
Division (MVCB), 1800 F Street NW., C. Public Comments comments should address any of the
Washington, DC 20405. ATTN: Ms. following: (a) Evaluate whether the
Public comments are particularly proposed collection of information is
Flowers/IC 9000–0078, Make-or-Buy invited on: Whether this collection of
Program. necessary for the proper performance of
information is necessary for the proper the functions of the agency, including
Instructions: Please submit comments performance of functions of the Federal
only and cite Information Collection whether the information will have
Acquisition Regulation (FAR), and practical utility; (b) Evaluate the
9000–0078, Make-or-Buy Program, in all
whether it will have practical utility; accuracy of the agencies estimate of the
correspondence related to this
collection. Comments received generally whether our estimate of the public burden of the proposed collection of
will be posted without change to http:// burden of this collection of information information, including the validity of
www.regulations.gov, including any is accurate, and based on valid the methodology and assumptions used;
personal and/or business confidential assumptions and methodology; ways to (c) Enhance the quality, utility, and
information provided. To confirm enhance the quality, utility, and clarity clarity of the information to be
receipt of your comment(s), please of the information to be collected; and collected; (d) Minimize the burden of
check www.regulations.gov, ways in which we can minimize the the collection of information on those
approximately two to three days after burden of the collection of information who are to respond, including through
submission to verify posting (except on those who are to respond, through the use of appropriate automated,
allow 30 days for posting of comments the use of appropriate technological electronic, mechanical, or other
submitted by mail). collection techniques or other forms of technological collection techniques or
information technology. other forms of information technology,
FOR FURTHER INFORMATION CONTACT: Mr.
e.g., permitting electronic submission of
Edward Loeb, Procurement Analyst, Obtaining Copies of Proposals: responses; and (e) Assess information
Office of Acquisition Policy, GSA, 202– Requesters may obtain a copy of the collection costs.
501–0650 or via email at edward.loeb@ information collection documents from To request additional information on
gsa.gov. the General Services Administration, the proposed project or to obtain a copy
SUPPLEMENTARY INFORMATION: Regulatory Secretariat Division (MVCB), of the information collection plan and
1800 F Street NW., Washington, DC instruments, call (404) 639–7570 or
A. Purpose
20405, telephone 202–501–4755. Please send an email to omb@cdc.gov. Written
Price, performance, and/or cite OMB Control No. 9000–0078, Make- comments and/or suggestions regarding
implementation of socio-economic or-Buy Program, in all correspondence. the items contained in this notice
policies may be affected by make-or-buy should be directed to the Attention:
Dated: March 3, 2016.
decisions under certain Government CDC Desk Officer, Office of Management
prime contracts. Accordingly, FAR Lorin S. Curit,
and Budget, Washington, DC 20503 or
15.407–2, Make-or-Buy Programs: Director, Federal Acquisition Policy Division, by fax to (202) 395–5806. Written
(i) Sets forth circumstances under Office of Governmentwide Acquisition Policy, comments should be received within 30
which a Government contractor must Office of Acquisition Policy, Office of days of this notice.
submit for approval by the contracting Governmentwide Policy.
Proposed Project
Lhorne on DSK5TPTVN1PROD with NOTICES
officer a make-or-buy program, i.e., a [FR Doc. 2016–05204 Filed 3–8–16; 8:45 am]
written plan identifying major items to BILLING CODE 6820–EP–P The Cooperative Re-engagement
be produced or work efforts to be Controlled Trial (CoRECT)—New—
performed in the prime contractor’s National Center for HIV/AIDS, Viral
facilities and those to be subcontracted; Hepatitis, STD, and TB Prevention
(ii) Provides guidance to contracting (NCHHSTP), Centers for Disease Control
officers concerning the review and and Prevention (CDC).
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![12496 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
Leroy A. Richardson, Prevention and the Agency for Toxic DEPARTMENT OF HEALTH AND
Chief, Information Collection Review Office, Substances and Disease Registry. HUMAN SERVICES
Office of Scientific Integrity, Office of the
Catherine Ramadei,
Associate Director for Science, Office of the Centers for Disease Control and
Director, Centers for Disease Control and Acting Director, Management Analysis and
Services Office, Centers for Disease Control Prevention
Prevention.
and Prevention.
[FR Doc. 2016–05235 Filed 3–8–16; 8:45 am] Board of Scientific Counselors, Office
[FR Doc. 2016–05266 Filed 3–8–16; 8:45 am]
BILLING CODE 4163–18–P of Infectious Diseases (BSC, OID)
BILLING CODE 4163–18–P
In accordance with section 10(a)(2) of
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND the Federal Advisory Committee Act
HUMAN SERVICES HUMAN SERVICES (Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
Centers for Disease Control and Centers for Disease Control and announces the following meeting of the
Prevention Prevention aforementioned committee:
Disease, Disability, and Injury Disease, Disability, and Injury Time and Date: 2:00–4:00 p.m., EDT,
Prevention and Control Special Prevention and Control Special March 28, 2016.
Emphasis Panel (SEP): Initial Review Emphasis Panel (SEP): Initial Review Place: Teleconference.
In accordance with Section 10(a)(2) of Status: The meeting is open to the
In accordance with Section 10(a)(2) of public; the toll free dial in number is 1–
the Federal Advisory Committee Act
the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease 877–951–7311 with a pass code of
(Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) 7972741.
Control and Prevention (CDC) announces a meeting for the initial Purpose: The BSC, OID, provides
announces a meeting for the initial review of applications in response to advice and guidance to the Secretary,
review of applications in response to Funding Opportunity Announcement Department of Health and Human
Funding Opportunity Announcement (FOA), DP 16–002, Michigan Lupus Services; the Director, CDC; the
(FOA) DD 16–001, Centers for Autism Epidemiology and Surveillance (MILES) Director, OID; and the Directors of the
and Developmental Disabilities Program Longitudinal Cohort Study.
Time and Date: 11:00 a.m.–6:00 p.m., National Center for Immunization and
Research and Epidemiology (CADDRE):
EDT, April 5, 2016 (Closed). Respiratory Diseases, the National
Study to Explore Early Development
Place: Teleconference. Center for Emerging and Zoonotic
(SEED) 3.
Status: The meeting will be closed to Infectious Diseases, and the National
Time and Date: 10:00 a.m.–6:00 p.m., the public in accordance with Center for HIV/AIDS, Viral Hepatitis,
EDT, April 7, 2016 (Closed). provisions set forth in Section STD, and TB Prevention, CDC, in the
Place: Teleconference. 552b(c)(4) and (6), Title 5 U.S.C., and following areas: Strategies, goals, and
Status: The meeting will be closed to the Determination of the Director, priorities for programs; research within
the public in accordance with Management Analysis and Services the national centers; and overall
provisions set forth in Section Office, CDC, pursuant to Public Law 92– strategic direction and focus of OID and
463. the national centers.
552b(c)(4) and (6), Title 5 U.S.C., and Matters for Discussion: The meeting
the determination of the Director, will include the initial review, Matters for Discussion: Topics to be
Management Analysis and Services discussion, and evaluation of discussed during the teleconference
Office, CDC, pursuant to Public Law 92– applications received in response to include administrative/budget issues,
463. ‘‘FOA DP16–002, Michigan Lupus current emerging infectious disease
Matters for Discussion: The meeting Epidemiology and Surveillance (MILES) outbreak responses, and reports from
will include the initial review, Program Longitudinal Cohort Study’’. recent program meetings.
discussion, and evaluation of Contact Person for More Information: The agenda and any supplemental
applications received in response to Jaya Raman Ph.D., Scientific Review material will be available at
‘‘FOA DD16–001, Centers for Autism Officer, CDC, 4770 Buford Highway, www.cdc.gov/oid/BSC/
and Developmental Disabilities Mailstop F80, Atlanta, Georgia 30341, meetingschedule.html after March 20.
Research and Epidemiology (CADDRE): Telephone: (770) 488–6511, kva5@
cdc.gov. Agenda items are subject to change as
Study to Explore Early Development priorities dictate.
The Director, Management Analysis
(SEED) 3’’. and Services Office, has been delegated Contact Person for More Information:
Contact Person for More Information: the authority to sign Federal Register Robin Moseley, M.A.T., Designated
Jaya Raman Ph.D., Scientific Review notices pertaining to announcements of Federal Officer, OID, CDC, 1600 Clifton
Officer, CDC, 4770 Buford Highway, meetings and other committee Road NE., Mailstop D10, Atlanta,
Mailstop F80, Atlanta, Georgia 30341, management activities, for both the Georgia 30333, Telephone: (404) 639–
Telephone: (770) 488–6511, kva5@ Centers for Disease Control and 4461.
cdc.gov. Prevention and the Agency for Toxic
Substances and Disease Registry. The Director, Management Analysis
Lhorne on DSK5TPTVN1PROD with NOTICES
The Director, Management Analysis and Services Office has been delegated
and Services Office, has been delegated Catherine Ramadei, the authority to sign Federal Register
the authority to sign Federal Register Acting Director, Management Analysis and notices pertaining to announcements of
notices pertaining to announcements of Services Office, Centers for Disease Control meetings and other committee
meetings and other committee and Prevention.
management activities, for both the
management activities, for both the [FR Doc. 2016–05267 Filed 3–8–16; 8:45 am]
Centers for Disease Control and
Centers for Disease Control and BILLING CODE 4163–18–P
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Document Created: 2016-03-09 00:13:46
Document Modified: 2016-03-09 00:13:46
| 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 | |
| FR Citation | 81 FR 12494 |
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