80 FR 10489 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 38 (February 26, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 38 (February 26, 2015)
| Page Range | 10489-10491 | |
| FR Document | 2015-03985 |
[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)] [Notices] [Pages 10489-10491] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03985] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-15CK] 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 (LPGs): A New Paradigm for Metrics- College of American Pathologists--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 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 [[Page 10490]] 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 CAP submission will be described in this notice. The CAP project will address two LPGs that are important to clinical testing: immunohistochemistry test validation (IHC) and an algorithm for diagnosing acute leukemia (ALA). The ALA LPG is being co- developed with the American Society of Hematology (ASH). The intended users of the CAP's IHC LPGs will include pathologists, clinical laboratory directors, and laboratory managers overseeing the IHC staining department. For the CAP's ALA LPG the intended users are pathologists and hematologists overseeing testing for acute leukemia. Thus, all these professionals will be surveyed by CAP. Prior to entering into this cooperative agreement project with the CDC, the CAP had already completed a baseline IHC LPG information collection from laboratories that used IHC testing. Subsequent to this information collection, the CAP created and disseminated an IHC LPG in a peer reviewed journal. Because of this prior baseline assessment, the CAP will only need to collect post-dissemination data. For their ALA LPG CAP/ASH Algorithm for Initial Work-Up of Acute Leukemia, the CAP will conduct both a baseline and a post-dissemination evaluation using a survey and/or focus group. Because there are uncertainties concerning the specific focus group probes for the IHC LPG and the ALA LPG, this notice only provides a description of our collection of post- dissemination information for the IHC LPG and the baseline ALA LPG. The CAP hopes to achieve an 80% response rate, or 2668 out of 3335 potential respondents for the IHC LPG. This represents laboratories known to be currently performing IHC testing based upon their participation in CAP's IHC proficiency testing (PT) program and 450 additional laboratories identified by CDC using previous Centers for Medicare and Medicaid Services Part B reimbursement claims for IHC testing. The response rate for the baseline IHC survey was approximately 70% and more focused promotion is planned. We have identified a total of 3335 (2885 CAP-PT customers + 450 non-CAP-PT customers) laboratories that will be targeted by the IHC post- dissemination survey. Both populations represent laboratories that are CAP-accredited and non-CAP-accredited. Laboratories that are enrolled in CAP IHC PT programs will receive surveys with their PT mailings. Non-CAP-PT-customer laboratories will be surveyed via the US postal system, with a fax-back mechanism. Only one response per laboratory will be accepted. The CAP will need to collect both baseline and post-guideline dissemination information for the ALA LPG. CAP will allow only one response per computer internet protocol address. The CAP has a database of pathologists who have indicated specialization in hematopathology; these hematopathologists will be invited to participate. The CAP hopes to achieve an 80% response rate with their individual information collections, or 880 (80% x 1100 pathologists listed in the CAP database). The baseline survey for the ALA guideline includes questions about individual practices for diagnosing various types of acute leukemia and individual and laboratory reporting practices. The link to the baseline survey for the ALA guideline will be disseminated via email to hematopathologists in CAP's database. The online survey will be hosted by Survey Monkey. The CAP and CDC will strive to ensure a high response rate for their IHC and ALA surveys. CAP plans to advertise both surveys. Similarly, the CAP plans to maximize response rates for CAP-PT customer laboratories by sending reminders through the PT program. The CAP will also try to maximize response rates for the ALA survey by advertising it through various channels and sending an email reminder. For burden calculation, we assume one response per laboratory for the IHC survey to include (1) pathologists, (2) laboratory directors, and (3) other laboratory managers of IHC laboratories, which may consist of graduate level scientists (Ph.D.s and Masters level), approximately in a 25%:25%:50% distribution, respectively. We assume respondents for the ALA surveys may include multiple responses within a laboratory of pathologists and hematologists that sign out cases, approximately in a 95%:5% distribution, respectively. The IHC baseline survey, which was conducted prior to this CAP-CDC cooperative agreement, took 15 minutes to complete. The IHC post- dissemination survey is expected to take 20 minutes to complete. The ALA baseline survey is expected to take an average of 25 minutes to complete. The maximum times observed during pilot testing were 30 and 45 minutes, respectively. Results from the pilot tests were used to revise both surveys. The total Estimated Annualized Burden Hours for this ICR is 1,570. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Avgerage Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hrs.) ---------------------------------------------------------------------------------------------------------------- Pathologists.......................... IHC..................... 834 1 20/60 ALA..................... 1,045 1 25/60 Laboratory Directors.................. IHC..................... 834 1 20/60 Laboratory Managers................... IHC..................... 1,667 1 20/60 Hematologists......................... ALA..................... 55 1 25/60 ---------------------------------------------------------------------------------------------------------------- [[Page 10491]] 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. 2015-03985 Filed 2-25-15; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 10489
Background and Brief Description commercial organizations in tracking provisional estimates obtained on the
changes in trends of vital events. Monthly Vital Statistics Report Form in
The compilation of national vital Respondents for the Monthly Vital that they represent complete counts of
statistics dates back to the beginning of Statistics Reports Form are registration marriages, divorces, and annulments
the 20th century and has been officials in each State and Territory, the occurring during the months of the prior
conducted since 1960 by the Division of District of Columbia, and New York
Vital Statistics of the National Center for year. These final counts are usually
City. In addition, local (county) officials available from State or county officials
Health Statistics, CDC. The collection of in New Mexico who record marriages
the data is authorized by 42 U.S.C. 242k. about eight months after the end of the
occurring and divorces and annulments data year. The data are widely used by
This submission requests approval to granted in each county of New Mexico
collect the monthly and annually government, academic, private research,
will use this form. This form is also and commercial organizations in
summary statistics for three years. designed to collect counts of monthly tracking changes in trends of family
The Monthly Vital Statistics Report occurrences of births, deaths, infant formation and dissolution. Respondents
forms provide counts of monthly deaths, marriages, and divorces
occurrences of births, deaths, infant for the Annual Vital Statistics
immediately following the month of Occurrence Report Form are registration
deaths, marriages, and divorces. Similar occurrence.
data have been published since 1937 The Annual Vital Statistics officials in each State and Territory, the
and are the sole source of these data at Occurrence Report Form collects final District of Columbia, and New York
the National level. The data are used by annual counts of marriages and divorces City.
the Department of Health and Human by month for the United States and for There are no costs to respondents
Services and by other government, each State. The statistical counts other than their time. The total estimate
academic, and private research and requested on this form differ from annualized burden hours are 211.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)
State, Territory, and New Mexico County Of- Monthly Vital Statistics Report ....................... 91 12 10/60
ficials.
State, Territory, and other officials ................. Annual Vital Statistics Occurrence Report ..... 58 1 30/60
Leroy A. Richardson, following: (a) Evaluate whether the comments should be received within 30
Chief, Information Collection Review Office, proposed collection of information is days of this notice.
Office of Scientific Integrity, Office of the necessary for the proper performance of
Associate Director for Science, Office of the Proposed Project
the functions of the agency, including
Director, Centers for Disease Control and Improving the Impact of Laboratory
Prevention.
whether the information will have
practical utility; (b) Evaluate the Practice Guidelines (LPGs): A New
[FR Doc. 2015–03989 Filed 2–25–15; 8:45 am] Paradigm for Metrics- College of
accuracy of the agencies estimate of the
BILLING CODE 4163–18–P American Pathologists—NEW—Center
burden of the proposed collection of
for Surveillance, Epidemiology and
information, including the validity of Laboratory Services (CSELS), Centers for
DEPARTMENT OF HEALTH AND the methodology and assumptions used; Disease Control and Prevention (CDC).
HUMAN SERVICES (c) Enhance the quality, utility, and
clarity of the information to be Background and Brief Description
Centers for Disease Control and collected; (d) Minimize the burden of The Centers for Disease Control and
Prevention the collection of information on those Prevention is funding three 5-year
who are to respond, including through projects collectively entitled ‘‘Improving
[30Day–15–15CK]
the use of appropriate automated, the Impact of Laboratory Practice
Agency Forms Undergoing Paperwork electronic, mechanical, or other Guidelines: A New Paradigm for
Reduction Act Review technological collection techniques or Metrics’’. An ‘‘LPG’’ is defined as
other forms of information technology, written recommendations for voluntary,
The Centers for Disease Control and e.g., permitting electronic submission of standardized approaches for medical
Prevention (CDC) has submitted the responses; and (e) Assess information laboratory testing that takes into account
following information collection request collection costs. processes for test selection, sample
to the Office of Management and Budget procurement and processing, analytical
(OMB) for review and approval in To request additional information on methods, and results reporting for
accordance with the Paperwork the proposed project or to obtain a copy effective diagnosis and management of
Reduction Act of 1995. The notice for of the information collection plan and disease and health conditions. LPGs
the proposed information collection is instruments, call (404) 639–7570 or may be disseminated to, and used by,
rmajette on DSK2VPTVN1PROD with NOTICES
published to obtain comments from the send an email to omb@cdc.gov. Written laboratorians and clinicians to assist
public and affected agencies. comments and/or suggestions regarding with test selection and test result
Written comments and suggestions the items contained in this notice interpretation. The overall purpose of
from the public and affected agencies should be directed to the Attention: these cooperative agreements is to
concerning the proposed collection of CDC Desk Officer, Office of Management increase the effectiveness of LPGs by
information are encouraged. Your and Budget, Washington, DC 20503 or defining measures and collecting
comments should address any of the by fax to (202) 395–5806. Written information to inform better LPG
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![Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 10491
Leroy A. Richardson, DEPARTMENT OF HEALTH AND collected through surveys funded by
Chief, Information Collection Review Office, HUMAN SERVICES NIOSH and conducted by the US
Office of Scientific Integrity, Office of the Department of Agriculture’s National
Associate Director for Science, Office of the Centers for Disease Control and Agricultural Statistics Service (USDA–
Director, Centers for Disease Control and Prevention NASS) and the US Department of Labor
Prevention. (DOL). These surveillance data are used
[FR Doc. 2015–03985 Filed 2–25–15; 8:45 am]
[CDC–2015–0005, Docket Number NIOSH–
281] by NIOSH and others to estimate
BILLING CODE 4163–18–P injuries and injury rates and identify
Future Directions for the Surveillance safety hazards that increase injury risk.
of Agricultural Injuries; Public Meeting; Surveillance data have also been used
DEPARTMENT OF HEALTH AND Request for Comments to show that the US agricultural
HUMAN SERVICES production industry has changed. Over
AGENCY: National Institute for the past quarter century, both the size of
Centers for Disease Control and Occupational Safety and Health the workforce and the number of
Prevention (NIOSH) of the Centers for Disease injuries have declined. To maintain
Control and Prevention (CDC), statistically stable injury estimates with
Disease, Disability, and Injury Department of Health and Human the current approach of national-level
Prevention and Control Special Services (HHS). surveys, sample sizes would need to be
Emphasis Panel (SEP): Initial Review ACTION: Notice of public meeting and increased. As a result, this approach has
request for comment. become more resource-intensive and is
The meeting announced below no longer tenable for NIOSH.
concerns Comprehensive High-Impact SUMMARY: The National Institute for Beginning in 2015, NIOSH will not
HIV Prevention Projects for Community- Occupational Safety and Health of the reestablish interagency agreements with
Based Organizations, Funding Centers for Disease Control and USDA–NASS and DOL to collect survey
Opportunity Announcement (FOA) Prevention announces a public meeting data for the agricultural injury
PS15–1502, Initial Review. and an opportunity to comment on surveillance system. This change in
future directions for the surveillance of surveillance approach presents an
SUMMARY: This document corrects a injuries within the agricultural
notice that was published in the Federal opportunity for NIOSH to receive
production industry. To view the notice stakeholder input and rigorously
Register on February 9, 2015, Volume and related materials visit http:// examine future options for agricultural
80, Number 26, pages 6971 and 6972. www.regulations.gov and enter CDC– injury surveillance.
The times and dates should read as 2015–0005 in the search field and click To identify and assess different
follows: ‘‘Search.’’ options, NIOSH plans the following
DATES: Times and Dates: Public comment period: Comments activities: Hold the public meeting
must be received May 27, 2015. announced in this notice to initiate a
9 a.m.–4 p.m., Panels 1–5; March 3, national conversation regarding future
2015 (Closed). Table of Contents
agricultural injury surveillance; seek
9 a.m.–4 p.m., Panels 6–12; March 6, • DATE additional public comments through
2015 (Closed). • FOR FURTHER INFORMATION this docket on the most urgent priorities
CONTACT for injury surveillance in production
Status: The meeting will be closed to • SUPPLEMENTARY INFORMATION
the public in accordance with I. Background
agriculture; examine what NIOSH and
provisions set forth in Section 552b(c) II. Public Meeting agricultural injury stakeholders can do
(4) and (6), Title 5 U.S.C., and the III. Written Comments to meet the overall need for agricultural
Determination of the Director, injury surveillance; support a
DATES: A public meeting will be held on comprehensive, independent
Management Analysis and Services March 30, 2015, 1:00 p.m.–5:00 p.m.
Office, CDC, pursuant to Public Law 92– assessment of recommendations
Eastern Time, or after the last public resulting from a 2007 National Academy
463. commenter has spoken, whichever of Sciences (NAS) review and a 2012
FOR FURTHER INFORMATION CONTACT: occurs first. The public meeting will be follow-up independent panel review;
Elizabeth Wolfe, Public Health Advisor, held as a web-based conference only continue to engage with interested
CDC, 1600 Clifton Road NE., Mailstop available by remote access. parties as NIOSH plans its own future
E07, Atlanta, Georgia 30333, Telephone: FOR FURTHER INFORMATION CONTACT: directions for agricultural injury
(404) 639–8135. Kitty Hendricks, Division of Safety surveillance; and seek input on the need
The Director, Management Analysis Research, 1095 Willowdale Road, MS for a follow-up public meeting in Fall
and Services Office, has been delegated 1808, Morgantown, West Virginia 2015 to discuss NIOSH’s future plans
the authority to sign Federal Register 26505–2888, (304) 285–5916 (not a toll after having considered input received
notices pertaining to announcements of free number) or khendricks@cdc.gov. through the public meeting and public
meetings and other committee SUPPLEMENTARY INFORMATION: comment period.
management activities, for both the I. Background: NIOSH began a NIOSH is especially interested in
Centers for Disease Control and coordinated program in 1990 to address comments related to finding new ways
Prevention and the Agency for Toxic safety and health issues for workers and of doing surveillance using smarter,
Substances and Disease Registry. families in the US agricultural more cost-effective approaches; shifting
rmajette on DSK2VPTVN1PROD with NOTICES
production industry. In support of this surveillance from national to regional or
Catherine Ramadei, program, NIOSH established an local approaches, in recognition of the
Acting Director, Management Analysis and ongoing, national-level surveillance diversity of agricultural types in
Services Office, Centers for Disease Control system to monitor injuries to hired farm different parts of the country; and
and Prevention. workers, farmers, and farm family examining roles that partners can take to
[FR Doc. 2015–03952 Filed 2–25–15; 8:45 am] members. Data for the injury address the need for smarter agricultural
BILLING CODE 4163–18–P surveillance system are primarily injury surveillance.
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Document Created: 2015-12-18 13:04:59
Document Modified: 2015-12-18 13:04:59
| 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 10489 |
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