80 FR 35360 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 118 (June 19, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 118 (June 19, 2015)
| Page Range | 35360-35362 | |
| FR Document | 2015-15128 |
[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)] [Notices] [Pages 35360-35362] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15128] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-15GE] 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 Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics--Clinical and Laboratory Standards Institute--NEW --Center for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC) is funding three 5-year projects collectively entitled ``Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics''. An ``LPG'' is defined as written recommendations for voluntary, standardized approaches for medical laboratory testing that takes into account processes for test selection, sample procurement and processing, analytical methods, and results reporting for effective diagnosis and management of disease and health conditions. LPGs may be disseminated to, and used by, laboratorians and clinicians to assist with test selection and test result interpretation. The overall purpose of these cooperative agreements is to increase the effectiveness of LPGs by defining measures and collecting information to inform better LPG creation, revision, dissemination, promotion, uptake, and impact on clinical testing and public health. The project will explore how these processes and their impediments and facilitators differ among various intended users of LPGs. Through this demonstration project, CDC seeks to understand how to customize LPG creation and promotion to better serve these intended users of LPGs. An important goal is to help organizations that sponsor the development of LPGs create a sustainable approach for continuous quality improvement to evaluate and improve an LPG's impact through better collection of information. The CDC selected three organizations that currently create and disseminate LPGs to support activities under a cooperative agreement funding mechanism to improve the impact of their LPGs. The American Society for Microbiology (ASM), the Clinical and Laboratory Standards Institute (CLSI), and the College of American Pathologists (CAP), will each use their LPGs as models to better understand how to improve uptake and impact of these and future LPGs. Only the CLSI submission will be described in this notice. Specifically, the CLSI project will address two LPGs that are important to clinical testing and have a high public health impact: POCT12, Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities and POCT13, Glucose Monitoring in Settings without Laboratory Support. These LPGs provide guidance and recommendations for personnel monitoring patient glucose levels at sites that have access to a hospital laboratory and at locations, such as physician offices or nursing [[Page 35361]] homes, that do not have an on-site moderate or high complexity laboratory. It is expected that as a result of sustained improvements in the process of creating and updating these clinical LPGs, public health, which depends upon accurate and appropriate laboratory testing guided by the use of LPGs, will also generally benefit. The intended users of the CLSI's POCT12 and POCT13 LPGs will include point-of-care coordinators, clinical laboratory directors, medical technologists, nurses, and medical doctors. The CLSI plans to collect information using the same survey instrument, ``Fingerstick Glucose Survey'' (FGS), on three separate occasions. During the first information collection (FGS1), all targeted respondents will be asked to complete the survey. Respondents who indicate that they are not familiar with either POCT12 or POCT13 will be asked to provide an email address and offered a free copy of the applicable LPG. This subset of respondents will be asked to complete the same survey (FGS2) 4-6 months after receiving the free LPG. After analysis of the information collected during the first 2 surveys, CLSI will make improvements to POCT12 and POCT13, such as provision of educational materials or helpful products such as quality control logs, and may also alter their marketing campaigns to address issues related to awareness and use of CLSI documents. The third survey (FGS3) will then be sent to all targeted respondents approximately 2.5 years after the first survey to obtain information that can be used to evaluate the impact of these improvements. Respondents that received a free copy of POCT12 or POCT13 following the first survey will also be contacted by email and asked to take the third survey. A link to the survey will be distributed to all targeted respondents either by email or postcard. The CLSI will solicit participation from physician office laboratories, Department of Defense laboratories, and hospitals that offer point-of-care glucose testing. Participants will be recruited by COLA, the Joint Commission and a Point-of-Care Coordinator network, who have agreed to distribute links to the survey through their membership mailing lists. In addition, participants will also be solicited through mailing lists purchased by CLSI from Clinscan and the American Hospital Association. Clinical sites offering point-of-care glucose testing in the Department of Defense medical system will also be asked to participate through the Department of Defense Clinical Laboratory Improvement Program (CLIP). In order to obtain the needed number of respondents for a statistically valid study, additional laboratories, selected at random from a database of Clinical Laboratory Improvement Amendment (CLIA) certificate holders, will also be solicited. The survey will contain instructions to direct it to the individual in each laboratory responsible for the development or revision of procedures for fingerstick glucose testing. Directing the survey to the individual with this specific responsibility will help to ensure that only one response will be obtained from each participating laboratory. Respondents include point-of-care coordinators, clinical laboratory directors, managers, and supervisors, medical technologists, nurses, and medical doctors. The CLSI hopes to achieve an 80% response rate with their laboratory information collections, or 24,000 out of about 30,000 potential respondents. The second survey will occur approximately 4-6 months after the initial survey and will only target responders from the first survey that received a complimentary copy of one of the LPG documents. CLSI anticipates that approximately 12,000 participants will be asked to take the second survey. Approximately two and a half years after the initial survey, the same survey will be sent to the same laboratories as the first survey (i.e. we will solicit approximately 30,000 potential respondents and expect about 24,000 individuals to take the survey). The third survey will measure the impact of the modifications to the documents and marketing strategy made based on the data collected from the first 2 surveys. The response rate for all surveys will be maximized by repeated reminders using the same channel that will be used to distribute the survey. All targeted laboratories will receive an email or postcard approximately one month before distribution of the survey. This letter will describe the survey and our purpose for collecting information. Another email or postcard with a link to the survey will then be sent to the same targeted laboratories. We also plan to resend the link to the survey to all targeted laboratories approximately one month later to remind them of the survey. The CLSI believes completion of the survey will take approximately 15 minutes. The survey will be pilot tested with 9 or fewer respondents before deployment to assure that they require 15 minutes or less to complete. The total estimated annualized burden is 6,173 hours. This is calculated by dividing the total burden hours by the number of years (three) over which data is collected. The maximum burden is 7,407 hours that occurs in years 1 and 3. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondent Form name respondents responses per response (in respondent hours) -------------------------------------------------------------------------------------------------- Point-of-Care Coordinators........ FGS1 500 1 15/60 FGS2 250 1 15/60 FGS3 500 1 15/60 Laboratory Directors.............. FGS1 4,276 1 15/60 FGS2 2,138 1 15/60 FGS3 4,276 1 15/60 Laboratory Managers............... FGS1 4,276 1 15/60 FGS2 2,138 1 15/60 FGS3 4,276 1 15/60 Laboratory Supervisors............ FGS1 4,276 1 15/60 FGS2 2,138 1 15/60 FGS3 4,276 1 15/60 Medical Technologists............. FGS1 7,800 1 15/60 FGS2 3,900 1 15/60 FGS3 7,800 1 15/60 [[Page 35362]] Nurses............................ FGS1 5,000 1 15/60 FGS2 2,500 1 15/60 FGS3 5,000 1 15/60 Medical Doctors................... FGS1 3,500 1 15/60 FGS2 1,750 1 15/60 FGS3 3,500 1 15/60 ---------------------------------------------------------------------------------------------------------------- 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. 2015-15128 Filed 6-18-15; 8:45 am] BILLING CODE 4163-18-P
![35360 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
Office of Acquisition Policy, GSA, 202– DEPARTMENT OF HEALTH AND Background and Brief Description
501–0650 or email edward.loeb@ HUMAN SERVICES The Centers for Disease Control and
gsa.gov. Prevention (CDC) is funding three 5-year
Centers for Disease Control and
SUPPLEMENTARY INFORMATION: projects collectively entitled ‘‘Improving
Prevention
the Impact of Laboratory Practice
A. Purpose [30Day–15–15GE] Guidelines: A New Paradigm for
The clause at FAR 52.215–14, Metrics’’. An ‘‘LPG’’ is defined as
Integrity of Unit Prices, requires offerors Agency Forms Undergoing Paperwork written recommendations for voluntary,
and contractors under Federal contracts Reduction Act Review standardized approaches for medical
that are to be awarded without adequate laboratory testing that takes into account
price competition to identify in their The Centers for Disease Control and
processes for test selection, sample
proposals those supplies which they Prevention (CDC) has submitted the
following information collection request procurement and processing, analytical
will not manufacture or to which they methods, and results reporting for
to the Office of Management and Budget
will not contribute significant value. effective diagnosis and management of
(OMB) for review and approval in
The policies included in the FAR are disease and health conditions. LPGs
accordance with the Paperwork
required by 41 U.S.C. 3503 (a)(1)(A)(for may be disseminated to, and used by,
Reduction Act of 1995. The notice for
the civilian agencies) and 10.U.S.C laboratorians and clinicians to assist
the proposed information collection is
2306a(b)(1)(A)(i)(for DOD and NASA). with test selection and test result
published to obtain comments from the
The rule contains no reporting interpretation. The overall purpose of
public and affected agencies.
requirements on contracts below the Written comments and suggestions these cooperative agreements is to
simplified acquisition threshold, from the public and affected agencies increase the effectiveness of LPGs by
construction and architect-engineering concerning the proposed collection of defining measures and collecting
services, utility services, service information are encouraged. Your information to inform better LPG
contracts where supplies are not comments should address any of the creation, revision, dissemination,
required, commercial items, and following: (a) Evaluate whether the promotion, uptake, and impact on
contracts for petroleum products. proposed collection of information is clinical testing and public health. The
B. Annual Reporting Burden necessary for the proper performance of project will explore how these processes
the functions of the agency, including and their impediments and facilitators
Respondents: 950. differ among various intended users of
whether the information will have
Responses per Respondent: 10. LPGs. Through this demonstration
practical utility; (b) Evaluate the
Annual Responses: 9,500. project, CDC seeks to understand how to
accuracy of the agencies estimate of the
Hours per Response: 1. customize LPG creation and promotion
burden of the proposed collection of
Total Burden Hours: 9,500. to better serve these intended users of
information, including the validity of
C. Public Comments the methodology and assumptions used; LPGs. An important goal is to help
(c) Enhance the quality, utility, and organizations that sponsor the
Public comments are particularly
clarity of the information to be development of LPGs create a
invited on: Whether this collection of
collected; (d) Minimize the burden of sustainable approach for continuous
information is necessary; whether it will
the collection of information on those quality improvement to evaluate and
have practical utility; whether our
who are to respond, including through improve an LPG’s impact through better
estimate of the public burden of this
the use of appropriate automated, collection of information.
collection of information is accurate, The CDC selected three organizations
and based on valid assumptions and electronic, mechanical, or other
technological collection techniques or that currently create and disseminate
methodology; ways to enhance the LPGs to support activities under a
quality, utility, and clarity of the other forms of information technology,
e.g., permitting electronic submission of cooperative agreement funding
information to be collected; and ways in mechanism to improve the impact of
which we can minimize the burden of responses; and (e) Assess information
collection costs. their LPGs. The American Society for
the collection of information on those Microbiology (ASM), the Clinical and
who are to respond, through the use of To request additional information on
the proposed project or to obtain a copy Laboratory Standards Institute (CLSI),
appropriate technological collection and the College of American
techniques or other forms of information of the information collection plan and
instruments, call (404) 639–7570 or Pathologists (CAP), will each use their
technology. LPGs as models to better understand
Obtaining Copies of Proposals: send an email to omb@cdc.gov. Written
comments and/or suggestions regarding how to improve uptake and impact of
Requesters may obtain a copy of the
the items contained in this notice these and future LPGs. Only the CLSI
information collection documents from
should be directed to the Attention: submission will be described in this
the General Services Administration,
CDC Desk Officer, Office of Management notice.
Regulatory Secretariat Division (MVCB), Specifically, the CLSI project will
1800 F Street, NW., Washington, DC, and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written address two LPGs that are important to
20405, telephone 202501–4755. Please clinical testing and have a high public
cite OMB Control No. 9000–0080, comments should be received within 30
days of this notice. health impact: POCT12, Point-of-Care
Integrity of Unit Prices. Blood Glucose Testing in Acute and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Dated: June 15, 2015. Proposed Project Chronic Care Facilities and POCT13,
Edward Loeb, Improving the Impact of Laboratory Glucose Monitoring in Settings without
Acting Director, Federal Acquisition Policy Practice Guidelines: A New Paradigm Laboratory Support. These LPGs
Division, Office of Governmentwide for Metrics—Clinical and Laboratory provide guidance and recommendations
Acquisition Policy, Office of Acquisition Standards Institute—NEW —Center for for personnel monitoring patient
Policy, Office of Governmentwide Policy. Surveillance, Epidemiology and glucose levels at sites that have access
[FR Doc. 2015–15131 Filed 6–18–15; 8:45 am] Laboratory Services (CSELS), Centers for to a hospital laboratory and at locations,
BILLING CODE 6820–EP–P Disease Control and Prevention (CDC). such as physician offices or nursing
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![35362 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number burden per
Type of respondent Form name responses per
of respondents response
respondent (in hours)
Nurses .............................................................................................................. FGS1 5,000 1 15/60
FGS2 2,500 1 15/60
FGS3 5,000 1 15/60
Medical Doctors ............................................................................................... FGS1 3,500 1 15/60
FGS2 1,750 1 15/60
FGS3 3,500 1 15/60
Leroy A. Richardson, DATES: Comments on the collection(s) of comply with this requirement, CMS is
Chief, Information Collection Review Office, information must be received by the publishing this notice that summarizes
Office of Scientific Integrity, Office of the OMB desk officer by July 20, 2015. the following proposed collection(s) of
Associate Director for Science, Office of the ADDRESSES: When commenting on the information for public comment:
Director, Centers for Disease Control and proposed information collections, 1. Type of Information Collection
Prevention.
please reference the document identifier Request: Revision of a currently
[FR Doc. 2015–15128 Filed 6–18–15; 8:45 am] or OMB control number. To be assured approved collection; Title of
BILLING CODE 4163–18–P consideration, comments and Information Collection: Medicare
recommendations must be received by Prescription Drug Benefit Program; Use:
the OMB desk officer via one of the Part D plans and, to the extent
DEPARTMENT OF HEALTH AND following transmissions: OMB, Office of applicable, MA organizations use the
HUMAN SERVICES Information and Regulatory Affairs, information to comply with the
Attention: CMS Desk Officer, Fax eligibility and associated Part D
Centers for Medicare & Medicaid Number: (202) 395–5806, or Email: participating requirements. We use this
Services OIRA_submission@omb.eop.gov. information to approve contract
To obtain copies of a supporting applications, monitor compliance with
[Document Identifier: CMS–10141 and CMS– statement and any related forms for the contract requirements, make proper
10540] proposed collection(s) summarized in payment to plans, and to ensure that
this notice, you may make your request correct information is disclosed to
Agency Information Collection using one of following: potential and current enrollees. Form
Activities: Submission for OMB 1. Access CMS’ Web site address at Number: CMS–10141 (OMB control
Review; Comment Request http://www.cms.hhs.gov/ number 0938–0964); Frequency: Once;
PaperworkReductionActof1995. Affected Public: Private sector (Business
ACTION: Notice. 2. Email your request, including your or other for-profit and Not-for-profit
address, phone number, OMB number, institutions); Number of Respondents:
SUMMARY: The Centers for Medicare & and CMS document identifier, to 4,101,066; Total Annual Responses:
Medicaid Services (CMS) is announcing Paperwork@cms.hhs.gov. 46,099,944; Total Annual Hours:
an opportunity for the public to 3. Call the Reports Clearance Office at 7,572,223. (For policy questions
comment on CMS’ intention to collect (410) 786–1326. regarding this collection contact
information from the public. Under the FOR FURTHER INFORMATION CONTACT: Deborah Larwood at 410–786–9500).
Paperwork Reduction Act of 1995 Reports Clearance Office at (410) 786– 2. Type of Information Collection
(PRA), federal agencies are required to 1326. Request: New collection (Reqeust for a
publish notice in the Federal Register SUPPLEMENTARY INFORMATION: Under the new OMB control number); Title of
concerning each proposed collection of Paperwork Reduction Act of 1995 (PRA) Information Collection: Quality
information, including each proposed (44 U.S.C. 3501–3520), federal agencies Improvement Strategy Implementation
extension or reinstatement of an existing must obtain approval from the Office of Plan and Progress Report; Use: Section
collection of information, and to allow Management and Budget (OMB) for each 1311(c)(1)(E) of the Affordable Care Act
a second opportunity for public collection of information they conduct requires qualified health plans (QHPs)
comment on the notice. Interested or sponsor. The term ‘‘collection of offered through an Exchange must
persons are invited to send comments information’’ is defined in 44 U.S.C. implement a quality improvement
regarding the burden estimate or any 3502(3) and 5 CFR 1320.3(c) and strategy (QIS) as described in section
other aspect of this collection of includes agency requests or 1311(g)(1). Section 1311(g)(3) of the
information, including any of the requirements that members of the public Affordable Care Act specifies the
following subjects: (1) The necessity and submit reports, keep records, or provide guidelines under Section 1311(g)(2)
utility of the proposed information information to a third party. Section shall require the periodic reporting to
collection for the proper performance of 3506(c)(2)(A) of the PRA (44 U.S.C. the applicable Exchange the activities
asabaliauskas on DSK5VPTVN1PROD with NOTICES
the agency’s functions; (2) the accuracy 3506(c)(2)(A)) requires federal agencies that a qualified health plan has
of the estimated burden; (3) ways to to publish a 30-day notice in the conducted to implement a strategy as
enhance the quality, utility, and clarity Federal Register concerning each described in section 1311(g)(1). We
of the information to be collected; and proposed collection of information, intend to have QHP issuers complete
(4) the use of automated collection including each proposed extension or the QIS Plan and Reporting Template
techniques or other forms of information reinstatement of an existing collection annually for initial certification and
technology to minimize the information of information, before submitting the subsequent annual updates of progress
collection burden. collection to OMB for approval. To in implementation of their strategy. The
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Document Created: 2018-02-22 11:10:28
Document Modified: 2018-02-22 11:10:28
| 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 35360 |
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