81 FR 8203 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 32 (February 18, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 32 (February 18, 2016)
| Page Range | 8203-8204 | |
| FR Document | 2016-03304 |
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)] [Notices] [Pages 8203-8204] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03304] [[Page 8203]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-16-1019] 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 Integrating Community Pharmacists and Clinical Sites for Patient- Centered HIV Care (OMB 0920-1019, expires 8/31/2018)--Revision-- National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Medication Therapy Management (MTM) is a group of pharmacist provided services that is independent of, but can occur in conjunction with, provision of medication. Medication Therapy Management encompasses a broad range of professional activities and cognitive services within the licensed pharmacists' scope of practice and can include monitoring prescription filling patterns and timing of refills, checking for medication interactions, patient education, and monitoring of patient response to drug therapy. HIV specific MTM programs have demonstrated success in improving HIV medication therapy adherence and persistence. While MTM programs have be shown to be effective in increasing medication adherence for HIV-infected persons, no MTM programs have been expanded to incorporate primary medical providers in an effort to establish patient-centered HIV care. To address this problem, CDC has entered into a public- private partnership with Walgreen Company (a.k.a. Walgreens pharmacies, a national retail pharmacy chain) to develop and implement a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. The model program will be implemented in ten sites and will provide patient-centered HIV care for approximately 1,000 persons. The patient-centered HIV care model will include the core elements of MTM as well as additional services such as individualized medication adherence counseling, active monitoring of prescription refills and active collaboration between pharmacists and medical clinic providers to identify and resolve medication related treatment problems such as treatment effectiveness, adverse events and poor adherence. The expected outcomes of the model program are increased retention in HIV care, adherence to HIV medication therapy and viral load suppression. On May 16, 2014 OMB approved the collection of standardized information from ten project sites over the three-year project period and one retrospective data collection during the first year of the three-year project period. The retrospective data collection will provide information about clients' baseline characteristics prior to participation in the model program which is needed to compare outcomes before and after program implementation. On August 17, 2015, OMB approved the conduct of key informant interviews with program clinic and pharmacy staff in order to evaluate the program processes, administration of a staff communication questionnaire, and OMB approved the collection of time and cost data to be used to estimate the cost of the model program. CDC newly requests approval to administer a staff communication questionnaire for medical providers in order to determine how and if the model program improves patient outcomes through improved communication and collaboration between patients' clinical providers and pharmacists. The staff communication questionnaire for medical providers will be administered twice to program clinic staff. The staff communication questionnaire for medical providers is different from the previously improved staff communication questionnaire; the staff communication questionnaire for medical providers will be administered to program clinic staff whereas the staff communication questionnaire will be administered to program pharmacy staff. Pharmacy, laboratory, and medical data will be collected through abstraction of all participant clients' pharmacy and medical records. Pharmacy, laboratory and medical data are needed to monitor retention in care, adherence to therapy, viral load suppression and other health outcomes. Program specific data, such as the number of MTM elements completed per project site and time spent on program activities, will be collected by program. Qualitative data will be gathered from program staff through in-person or telephone interviews and through a questionnaire to program pharmacy staff and a separate questionnaire to program clinic staff. The data collection will allow CDC to conduct continuous program performance monitoring which includes identification of barriers to program implementation, solutions to those barriers, and documentation of client health outcomes. Performance monitoring will allow the model program to be adjusted, as needed, in order to develop a final implementation model that is self-sustaining and which can be used to establish similar collaborations in a variety of clinical settings. Collection of cost data will allow for the cost of the program to be estimated. There is no cost to participants other than their time. The total estimated annualized burden hours are 6,043. [[Page 8204]] Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Clinic Data Manager................... Project clinic 10 3 30/60 characteristics form. Pharmacist............................ Project pharmacy 10 3 30/60 characteristics form. Clinic Data Manager................... *Patient Demographic 10 100 5/60 Information form. Clinic Data Manager................... *Initial patient 10 100 1 information form. Clinic Data Manager................... Quarterly patient 10 400 30/60 information form. Pharmacist............................ Pharmacy record 10 400 30/60 abstraction form. Key informants........................ Interviewer data 60 2 30/60 collection worksheet. Project staff (pharmacists)........... Staff communication 30 2 30/60 questionnaire. Project staff (medical providers)..... Staff communication 40 2 30/60 questionnaire for medical providers. Clinic staff.......................... Clinic cost form........ 20 2 10 Pharmacy staff........................ Pharmacy cost form...... 20 2 10 ---------------------------------------------------------------------------------------------------------------- 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. 2016-03304 Filed 2-17-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8203
DEPARTMENT OF HEALTH AND TB Prevention (NCHHSTP), Centers for implementation. On August 17, 2015,
HUMAN SERVICES Disease Control and Prevention (CDC). OMB approved the conduct of key
informant interviews with program
Centers for Disease Control and Background and Brief Description
clinic and pharmacy staff in order to
Prevention Medication Therapy Management evaluate the program processes,
(MTM) is a group of pharmacist administration of a staff communication
[30 Day–16–1019] provided services that is independent questionnaire, and OMB approved the
of, but can occur in conjunction with, collection of time and cost data to be
Agency Forms Undergoing Paperwork provision of medication. Medication used to estimate the cost of the model
Reduction Act Review Therapy Management encompasses a program.
The Centers for Disease Control and broad range of professional activities CDC newly requests approval to
Prevention (CDC) has submitted the and cognitive services within the administer a staff communication
licensed pharmacists’ scope of practice questionnaire for medical providers in
following information collection request
and can include monitoring prescription order to determine how and if the model
to the Office of Management and Budget
filling patterns and timing of refills, program improves patient outcomes
(OMB) for review and approval in
checking for medication interactions, through improved communication and
accordance with the Paperwork
patient education, and monitoring of collaboration between patients’ clinical
Reduction Act of 1995. The notice for
patient response to drug therapy. providers and pharmacists. The staff
the proposed information collection is HIV specific MTM programs have
published to obtain comments from the communication questionnaire for
demonstrated success in improving HIV medical providers will be administered
public and affected agencies. medication therapy adherence and
Written comments and suggestions twice to program clinic staff. The staff
persistence. While MTM programs have
from the public and affected agencies communication questionnaire for
be shown to be effective in increasing
concerning the proposed collection of medical providers is different from the
medication adherence for HIV-infected
information are encouraged. Your previously improved staff
persons, no MTM programs have been
comments should address any of the communication questionnaire; the staff
expanded to incorporate primary
following: (a) Evaluate whether the communication questionnaire for
medical providers in an effort to
proposed collection of information is medical providers will be administered
establish patient-centered HIV care. To
necessary for the proper performance of to program clinic staff whereas the staff
address this problem, CDC has entered
the functions of the agency, including communication questionnaire will be
into a public-private partnership with
whether the information will have Walgreen Company (a.k.a. Walgreens administered to program pharmacy staff.
practical utility; (b) Evaluate the pharmacies, a national retail pharmacy Pharmacy, laboratory, and medical
accuracy of the agencies estimate of the chain) to develop and implement a data will be collected through
burden of the proposed collection of model of HIV care that integrates abstraction of all participant clients’
information, including the validity of community pharmacists with primary pharmacy and medical records.
the methodology and assumptions used; medical providers for patient-centered Pharmacy, laboratory and medical data
(c) Enhance the quality, utility, and HIV care. The model program will be are needed to monitor retention in care,
clarity of the information to be implemented in ten sites and will adherence to therapy, viral load
collected; (d) Minimize the burden of provide patient-centered HIV care for suppression and other health outcomes.
the collection of information on those approximately 1,000 persons. Program specific data, such as the
who are to respond, including through The patient-centered HIV care model number of MTM elements completed
the use of appropriate automated, will include the core elements of MTM per project site and time spent on
electronic, mechanical, or other as well as additional services such as program activities, will be collected by
technological collection techniques or individualized medication adherence program. Qualitative data will be
other forms of information technology, counseling, active monitoring of gathered from program staff through in-
e.g., permitting electronic submission of prescription refills and active person or telephone interviews and
responses; and (e) Assess information collaboration between pharmacists and through a questionnaire to program
collection costs. medical clinic providers to identify and pharmacy staff and a separate
To request additional information on resolve medication related treatment questionnaire to program clinic staff.
the proposed project or to obtain a copy problems such as treatment The data collection will allow CDC to
of the information collection plan and effectiveness, adverse events and poor conduct continuous program
instruments, call (404) 639–7570 or adherence. The expected outcomes of performance monitoring which includes
send an email to omb@cdc.gov. Written the model program are increased identification of barriers to program
comments and/or suggestions regarding retention in HIV care, adherence to HIV implementation, solutions to those
the items contained in this notice medication therapy and viral load barriers, and documentation of client
should be directed to the Attention: suppression. health outcomes. Performance
CDC Desk Officer, Office of Management On May 16, 2014 OMB approved the monitoring will allow the model
and Budget, Washington, DC 20503 or collection of standardized information program to be adjusted, as needed, in
by fax to (202) 395–5806. Written from ten project sites over the three-year order to develop a final implementation
comments should be received within 30 project period and one retrospective model that is self-sustaining and which
days of this notice. data collection during the first year of can be used to establish similar
the three-year project period. The collaborations in a variety of clinical
mstockstill on DSK4VPTVN1PROD with NOTICES
Proposed Project retrospective data collection will settings. Collection of cost data will
Integrating Community Pharmacists provide information about clients’ allow for the cost of the program to be
and Clinical Sites for Patient-Centered baseline characteristics prior to estimated.
HIV Care (OMB 0920–1019, expires 8/ participation in the model program There is no cost to participants other
31/2018)—Revision—National Center which is needed to compare outcomes than their time. The total estimated
for HIV/AIDS, Viral Hepatitis, STD, and before and after program annualized burden hours are 6,043.
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![8204 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Clinic Data Manager ....................................... Project clinic characteristics form .................. 10 3 30/60
Pharmacist ...................................................... Project pharmacy characteristics form ........... 10 3 30/60
Clinic Data Manager ....................................... *Patient Demographic Information form ......... 10 100 5/60
Clinic Data Manager ....................................... *Initial patient information form ...................... 10 100 1
Clinic Data Manager ....................................... Quarterly patient information form ................. 10 400 30/60
Pharmacist ...................................................... Pharmacy record abstraction form ................. 10 400 30/60
Key informants ................................................ Interviewer data collection worksheet ............ 60 2 30/60
Project staff (pharmacists) .............................. Staff communication questionnaire ................ 30 2 30/60
Project staff (medical providers) ..................... Staff communication questionnaire for med- 40 2 30/60
ical providers.
Clinic staff ....................................................... Clinic cost form .............................................. 20 2 10
Pharmacy staff ................................................ Pharmacy cost form ....................................... 20 2 10
Leroy A. Richardson, Medicare Enrollment and Appeals For the reason explained above, the
Chief, Information Collection Review Office, Group, Center for Medicare. following routine use is added to
Office of Scientific Integrity, Office of the Enrollment Data Base (EDB), System No.
Associate Director for Science, Office of the DATES: Effective Dates: The new routine
09–70–0502:
Director, Centers for Disease Control and use described in this notice will become
Prevention. effective without further notice 30 days 11. To the IRS for the purposes of reporting
after publication of this notice in the Medicare Part A enrollment information and
[FR Doc. 2016–03304 Filed 2–17–16; 8:45 am] to provide statements to the individual
BILLING CODE 4163–18–P
Federal Register, unless comments are enrollees with respect to whom information
received that warrant revisions to this is reported to the IRS.
Notice. Written comments should be
DEPARTMENT OF HEALTH AND submitted within 30 days. Celeste Dade-Vinson,
HUMAN SERVICES Health Insurance Specialist, Centers for
ADDRESSES: The public should address Medicare & Medicaid Services.
comments to: CMS Privacy Officer,
Centers for Medicare & Medicaid [FR Doc. 2016–03241 Filed 2–17–16; 8:45 am]
Division of Security, Privacy Policy and
Services BILLING CODE 4120–03–P
Governance, Information Security and
Privacy Act of 1974; Report of a New Privacy Group, Office of Enterprise
Routine Use for a CMS System of Information, CMS, 7500 Security DEPARTMENT OF HEALTH AND
Records Boulevard, Baltimore, MD 21244–1870, HUMAN SERVICES
Mailstop: N 1–24–08, Office: (410) 786–
AGENCY: Centers for Medicare & 5357 or via email: walter.stone@ Administration for Community Living
Medicaid Services (CMS), Department cms.hhs.gov. Comments received will be
of Health and Human Services (HHS). available for review at this location, by Information Collection; New Funding
appointment, during regular business Formula for the State Councils on
ACTION: Altered System Notice, Adding hours, Monday through Friday from Developmental Disabilities (SCDDs)
a New Routine Use for a CMS System 9:00 a.m.–3:00 p.m., Eastern Time zone. and Protection and Advocacy Systems
of Records. (P&As) Located in Each State and
FOR FURTHER INFORMATION CONTACT: Territory
SUMMARY: In accordance with the Roland Herrera, Health Insurance
requirements of the Privacy Act of 1974 Specialist, Division of Medicare AGENCY: Administration on Intellectual
(5 U.S.C. 552a), CMS is adding a new Enrollment Coordination, Medicare and Developmental Disabilities (AIDD),
routine use to the existing system of Enrollment and Appeals Group, CMS Administration on Disabilities (AoD),
records titled Enrollment Data Base Center for Medicare, 7500 Security Administration for Community Living
(EDB), System No. 09–70–0502, last Boulevard, Mail Stop C2–12–16, (ACL), Department of Health and
modified 73 Federal Register 10249 Baltimore, MD 21244, Office phone: Human Services (HHS), HHS.
(February 26, 2008), to assist with 410.786.0668, Facsimile: 443.380.5418, ACTION: Notice of guidance.
transmitting data to the Internal Email: roland.herrara@cms.hhs.gov.
SUMMARY: The Administration on
Revenue Service (IRS) for 10958 SUPPLEMENTARY INFORMATION: CMS is Intellectual and Developmental
processing. required to produce reports and Disabilities (AIDD) within the
The new routine use will authorize statements of enrollment in Medicare Administration on Disabilities (AoD),
CMS to disclose information maintained Part A to confirm enrollment in located within the Administration for
in the system ‘‘to the IRS for the minimum essential coverage under Community Living (ACL) at the United
mstockstill on DSK4VPTVN1PROD with NOTICES
purposes of reporting Medicare Part A Section 6055 of the Affordable Care Act. States Department of Health and Human
enrollment information and to provide The enrollment information must be Services (HHS), is soliciting comments
statements to the individual enrollees provided to the IRS for tax from the public on the New Funding
with respect to whom information is administration purposes to enable the Formula for the State Councils on
reported to the IRS. Disclosures made IRS to properly assess tax returns filed Developmental Disabilities (SCDDs) and
pursuant to the routine use will be to ensure that Medicare Part A Enrollees Protection and Advocacy Systems
coordinated through CMS’ Division of are not assessed a tax penalty for not (P&As) located in each State and
Medicare Enrollment Coordination, beenrolled in health care coverage. Territory.
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Document Created: 2016-02-18 07:46:41
Document Modified: 2016-02-18 07:46:41
| 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 8203 |
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