80 FR 30682 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 80, Issue 103 (May 29, 2015)

Page Range		30682-30683
FR Document		2015-12996

Federal Register, Volume 80 Issue 103 (Friday, May 29, 2015)

[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Pages 30682-30683]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-12996]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-1019]

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 omb@cdc.gov. 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 No. 0920-1019, Expires 05/31/2017)--[Revision]--
National Center for HIV, Hepatitis, STD, and TB Prevention, Centers for
Disease Control and Prevention (CDC).

Background and Brief Description

Revisions to this information collection include the addition of an
Interviewer data collection worksheet, Key Informant Interviewer
script, Staff communication questionnaire, Clinic cost form and
Pharmacy cost form. These additions are needed in order to determine
changes to clinic and pharmacy work systems, processes and outcomes in
relation to the model project and how and if the model program improves
patient outcomes through improved communication and collaboration
between patients' clinical providers and pharmacists. In order to
determine the general feasibility of the model program, the time
required conducting program activities and the associated cost of
program activities must be determined. Collection of data from the
previously approved Initial patient information forms, Quarterly
patient information forms, Pharmacy record abstraction forms, Project
clinic characteristics forms, and Project pharmacy characteristics
forms is ongoing. Clinic staff will use the initial information Sheet
to explain the project to patients.
CDC has entered into a partnership with Walgreen Company (a.k.a.
Walgreens pharmacies, a national retail pharmacy chain) and the
University of North Texas Health Science Center 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 at ten sites and will provide patient-
centered HIV care for approximately 1,000 persons.
The patient-centered HIV care model includes the core elements of
pharmacist provided Medication Therapy Management (MTM) as well as
additional pharmacist 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 HIV viral load
suppression.
Pharmacy, laboratory and medical data are collected through
abstraction of participant clients' pharmacy and medical records. These
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
project sites' characteristics, will be collected by project sites.
This information 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 30683]]

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 pharmacists and clinic staff.. Staff communication 70 2 15/60
questionnaire.
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. 2015-12996 Filed 5-28-15; 8:45 am]
BILLING CODE 4163-18-P

30682 Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices

government risk assessments. Selection the functions of the agency, including characteristics forms, and Project
of contractors about which information whether the information will have pharmacy characteristics forms is
may be collected during the assessment practical utility; (b) Evaluate the ongoing. Clinic staff will use the initial
process will be a risk-based decision accuracy of the agencies estimate of the information Sheet to explain the project
made at the discretion of a participating burden of the proposed collection of to patients.
agency. information, including the validity of CDC has entered into a partnership
Definition: Information system in this the methodology and assumptions used; with Walgreen Company (a.k.a.
notice means a discrete set of (c) Enhance the quality, utility, and Walgreens pharmacies, a national retail
information resources organized clarity of the information to be pharmacy chain) and the University of
expressly for the collection, processing, collected; (d) Minimize the burden of North Texas Health Science Center to
maintenance, use, sharing, the collection of information on those develop and implement a model of HIV
dissemination, or disposition of who are to respond, including through care that integrates community
information. Information systems also the use of appropriate automated, pharmacists with primary medical
include specialized systems such as electronic, mechanical, or other providers for patient-centered HIV care.
industrial or process controls systems, technological collection techniques or The model program will be
telephone switching or private branch other forms of information technology, implemented at ten sites and will
exchange (PBX) systems, and e.g., permitting electronic submission of provide patient-centered HIV care for
environmental control systems (see, responses; and (e) Assess information approximately 1,000 persons.
National Institute of Standards and collection costs. The patient-centered HIV care model
Technology Special Publication 800–53 To request additional information on includes the core elements of
Rev. 4). Links to relevant documents can the proposed project or to obtain a copy pharmacist provided Medication
be found at: Business Due Diligence RFI: of the information collection plan and Therapy Management (MTM) as well as
https://www.fbo.gov/ instruments, call (404) 639–7570 or additional pharmacist services such as
index?s=opportunity&mode send an email to omb@cdc.gov. Written individualized medication adherence
=form&id=230732591f542b7da comments and/or suggestions regarding counseling, active monitoring of
9b9fc3e6c167eec&tab=core&_cview=0; the items contained in this notice prescription refills and active
Executive Order 13636, Improving should be directed to the Attention: collaboration between pharmacists and
Critical Infrastructure Cybersecurity: CDC Desk Officer, Office of Management medical clinic providers to identify and
http://www.gsa.gov/portal/content/ and Budget, Washington, DC 20503 or resolve medication related treatment
176547. by fax to (202) 395–5806. Written problems such as treatment
Dated: May 21, 2015. comments should be received within 30 effectiveness, adverse events and poor
Giancarlo Brizzi, days of this notice. adherence. The expected outcomes of
Acting Associate Administrator, Office of Proposed Project the model program are increased
Government-wide Policy, General Services retention in HIV care, adherence to HIV
Administration. Integrating Community Pharmacists
medication therapy and HIV viral load
[FR Doc. 2015–13016 Filed 5–28–15; 8:45 am] and Clinical Sites for Patient-Centered
suppression.
BILLING CODE 6820–14–P
HIV Care (OMB No. 0920–1019, Expires
05/31/2017)—[Revision]—National Pharmacy, laboratory and medical
Center for HIV, Hepatitis, STD, and TB data are collected through abstraction of
Prevention, Centers for Disease Control participant clients’ pharmacy and
DEPARTMENT OF HEALTH AND medical records. These data are needed
and Prevention (CDC).
HUMAN SERVICES to monitor retention in care, adherence
Background and Brief Description to therapy, viral load suppression and
Centers for Disease Control and
Revisions to this information other health outcomes. Program specific
Prevention
collection include the addition of an data, such as the number of MTM
[30Day–15–1019] Interviewer data collection worksheet, elements completed per project site and
Key Informant Interviewer script, Staff project sites’ characteristics, will be
Agency Forms Undergoing Paperwork communication questionnaire, Clinic collected by project sites.
Reduction Act Review cost form and Pharmacy cost form. This information collection will allow
The Centers for Disease Control and These additions are needed in order to CDC to conduct continuous program
Prevention (CDC) has submitted the determine changes to clinic and performance monitoring which includes
following information collection request pharmacy work systems, processes and identification of barriers to program
to the Office of Management and Budget outcomes in relation to the model implementation, solutions to those
(OMB) for review and approval in project and how and if the model barriers, and documentation of client
accordance with the Paperwork program improves patient outcomes health outcomes. Performance
Reduction Act of 1995. The notice for through improved communication and monitoring will allow the model
the proposed information collection is collaboration between patients’ clinical program to be adjusted, as needed, in
published to obtain comments from the providers and pharmacists. In order to order to develop a final implementation
public and affected agencies. determine the general feasibility of the model that is self-sustaining and which
Written comments and suggestions model program, the time required can be used to establish similar
from the public and affected agencies conducting program activities and the collaborations in a variety of clinical
concerning the proposed collection of associated cost of program activities settings. Collection of cost data will
Lhorne on DSK2VPTVN1PROD with NOTICES

information are encouraged. Your must be determined. Collection of data allow for the cost of the program to be
comments should address any of the from the previously approved Initial estimated. There is no cost to
following: (a) Evaluate whether the patient information forms, Quarterly participants other than their time. The
proposed collection of information is patient information forms, Pharmacy total estimated annualized burden hours
necessary for the proper performance of record abstraction forms, Project clinic are 6,043.

VerDate Sep<11>2014 15:17 May 28, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\29MYN1.SGM 29MYN1

Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices 30683

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 pharmacists and clinic staff ................ Staff communication questionnaire ................ 70 2 15/60
Clinic staff ....................................................... Clinic cost form .............................................. 20 2 10
Pharmacy staff ................................................ Pharmacy cost form ....................................... 20 2 10

Leroy A. Richardson, DATES: Comments on the collection(s) of including each proposed extension or
Chief, Information Collection Review Office, information must be received by the reinstatement of an existing collection
Office of Scientific Integrity, Office of the OMB desk officer by June 29, 2015. of information, before submitting the
Associate Director for Science, Office of the collection to OMB for approval. To
ADDRESSES: When commenting on the
Director, Centers for Disease Control and
Prevention. proposed information collections, comply with this requirement, CMS is
please reference the document identifier publishing this notice that summarizes
[FR Doc. 2015–12996 Filed 5–28–15; 8:45 am]
or OMB control number. To be assured the following proposed collection(s) of
BILLING CODE 4163–18–P
consideration, comments and information for public comment:
recommendations must be received by 1. Type of Information Collection
DEPARTMENT OF HEALTH AND the OMB desk officer via one of the
Request: Extension of a currently
HUMAN SERVICES following transmissions: OMB, Office of
approved collection; Title of
Information and Regulatory Affairs,
Information Collection: National
Centers for Medicare & Medicaid Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email: Implementation of the Hospital CAHPS
Services
OIRA_submission@omb.eop.gov . Survey; Use: The HCAHPS (Hospital
[Document Identifier: CMS–10102] Consumer Assessment of Healthcare
To obtain copies of a supporting
statement and any related forms for the Providers and Systems) Survey, also
Agency Information Collection known as the CAHPS® Hospital Survey
Activities: Submission for OMB proposed collection(s) summarized in
this notice, you may make your request or Hospital CAHPS®, is a standardized
Review; Comment Request
using one of following: survey instrument and data collection
ACTION: Notice. 1. Access CMS’ Web site address at methodology that has been in use since
http://www.cms.hhs.gov/ 2006 to measure patients’ perspectives
SUMMARY: The Centers for Medicare & PaperworkReductionActof1995. of hospital care. While many hospitals
Medicaid Services (CMS) is announcing 2. Email your request, including your collect information on patient
an opportunity for the public to address, phone number, OMB number, satisfaction, HCAHPS created a national
comment on CMS’ intention to collect and CMS document identifier, to standard for collecting and public
information from the public. Under the Paperwork@cms.hhs.gov. reporting information that enables valid
Paperwork Reduction Act of 1995 3. Call the Reports Clearance Office at comparisons to be made across all
(PRA), federal agencies are required to (410) 786–1326.
publish notice in the Federal Register hospitals to support consumer choice.
FOR FURTHER INFORMATION CONTACT: Form Number: CMS–10102 (OMB
concerning each proposed collection of
Reports Clearance Office at (410) 786– control number 0938–0981); Frequency:
information, including each proposed
1326. Occasionally; Affected Public: Private
extension or reinstatement of an existing
collection of information, and to allow SUPPLEMENTARY INFORMATION: Under the sector (Business or other for-profits and
a second opportunity for public Paperwork Reduction Act of 1995 (PRA) Not-for-profit institutions); Number of
comment on the notice. Interested (44 U.S.C. 3501–3520), federal agencies Respondents: 4,200; Total Annual
persons are invited to send comments must obtain approval from the Office of Responses: 3,100,000; Total Annual
regarding the burden estimate or any Management and Budget (OMB) for each Hours: 413,230. (For policy questions
other aspect of this collection of collection of information they conduct regarding this collection contact
information, including any of the or sponsor. The term ‘‘collection of William Lehrman at 410–786–1037.)
following subjects: (1) The necessity and information’’ is defined in 44 U.S.C.
Dated: May 23, 2015.
utility of the proposed information 3502(3) and 5 CFR 1320.3(c) and
collection for the proper performance of includes agency requests or William N. Parham, III,
the agency’s functions; (2) the accuracy requirements that members of the public Director, Paperwork Reduction Staff, Office
Lhorne on DSK2VPTVN1PROD with NOTICES

of the estimated burden; (3) ways to submit reports, keep records, or provide of Strategic Operations and Regulatory
enhance the quality, utility, and clarity information to a third party. Section Affairs.
of the information to be collected; and 3506(c)(2)(A) of the PRA (44 U.S.C. [FR Doc. 2015–12993 Filed 5–28–15; 8:45 am]
(4) the use of automated collection 3506(c)(2)(A)) requires federal agencies BILLING CODE 4120–01–P
techniques or other forms of information to publish a 30-day notice in the
technology to minimize the information Federal Register concerning each
collection burden. proposed collection of information,

VerDate Sep<11>2014 15:17 May 28, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 9990 E:\FR\FM\29MYN1.SGM 29MYN1

Document Created: 2015-12-15 15:31:49
Document Modified: 2015-12-15 15:31:49

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		80 FR 30682

80 FR 30682 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 103 (May 29, 2015)

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