Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 10489 

Background and Brief Description 

The compilation of national vital 

statistics dates back to the beginning of 

the 20th century and has been 

conducted since 1960 by the Division of 

Vital Statistics of the National Center for 

Health Statistics, CDC. The collection of 

the data is authorized by 42 U.S.C. 242k. 

This submission requests approval to 

collect the monthly and annually 

summary statistics for three years. 

The Monthly Vital Statistics Report 

forms provide counts of monthly 

occurrences of births, deaths, infant 

deaths, marriages, and divorces. Similar 

data have been published since 1937 

and are the sole source of these data at 

the National level. The data are used by 

the Department of Health and Human 

Services and by other government, 

academic, and private research and 

commercial organizations in tracking 

changes in trends of vital events. 

Respondents for the Monthly Vital 

Statistics Reports Form are registration 

officials in each State and Territory, the 

District of Columbia, and New York 

City. In addition, local (county) officials 

in New Mexico who record marriages 

occurring and divorces and annulments 

granted in each county of New Mexico 

will use this form. This form is also 

designed to collect counts of monthly 

occurrences of births, deaths, infant 

deaths, marriages, and divorces 

immediately following the month of 

occurrence. 

The Annual Vital Statistics 

Occurrence Report Form collects final 

annual counts of marriages and divorces 

by month for the United States and for 

each State. The statistical counts 

requested on this form differ from 

provisional estimates obtained on the 

Monthly Vital Statistics Report Form in 

that they represent complete counts of 

marriages, divorces, and annulments 

occurring during the months of the prior 

year. These final counts are usually 

available from State or county officials 

about eight months after the end of the 

data year. The data are widely used by 

government, academic, private research, 

and commercial organizations in 

tracking changes in trends of family 

formation and dissolution. Respondents 

for the Annual Vital Statistics 

Occurrence Report Form are registration 

officials in each State and Territory, the 

District of Columbia, and New York 

City. 

There are no costs to respondents 

other than their time. The total estimate 

annualized burden hours are 211. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hrs.) 

State, Territory, and New Mexico County Officials.Monthly Vital Statistics Report ....................... 91 12 10/60 

State, Territory, and other officials ................. Annual Vital Statistics Occurrence Report ..... 58 1 30/60 

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. 2015–03989 Filed 2–25–15; 8:45 am] 

BILLING CODE 4163–18–P 

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 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 

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 


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10490 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 

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 postdissemination 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–PTcustomer laboratories will be surveyed 

via the US postal system, with a faxback 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 postdissemination 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

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avgerage 

burden per 

response 

(in 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 


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Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

The meeting announced below 

concerns Comprehensive High-Impact 

HIV Prevention Projects for CommunityBased Organizations, Funding 

Opportunity Announcement (FOA) 

PS15–1502, Initial Review. 

SUMMARY: This document corrects a 

notice that was published in the Federal 

Register on February 9, 2015, Volume 

80, Number 26, pages 6971 and 6972. 

The times and dates should read as 

follows: 

DATES: Times and Dates: 

9 a.m.–4 p.m., Panels 1–5; March 3, 

2015 (Closed). 

9 a.m.–4 p.m., Panels 6–12; March 6, 

2015 (Closed). 

Status: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 552b(c) 

(4) and (6), Title 5 U.S.C., and the 

Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Wolfe, Public Health Advisor, 

CDC, 1600 Clifton Road NE., Mailstop 

E07, Atlanta, Georgia 30333, Telephone: 

(404) 639–8135. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Catherine Ramadei, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2015–03952 Filed 2–25–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[CDC–2015–0005, Docket Number NIOSH– 

281] 

Future Directions for the Surveillance 

of Agricultural Injuries; Public Meeting; 

Request for Comments 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of public meeting and 

request for comment. 

SUMMARY: The National Institute for 

Occupational Safety and Health of the 

Centers for Disease Control and 

Prevention announces a public meeting 

and an opportunity to comment on 

future directions for the surveillance of 

injuries within the agricultural 

production industry. To view the notice 

and related materials visit http://

www.regulations.gov and enter CDC– 

2015–0005 in the search field and click 

‘‘Search.’’ 

Public comment period: Comments 

must be received May 27, 2015. 

Table of Contents 

• DATE 

• FOR FURTHER INFORMATION 

CONTACT 

• SUPPLEMENTARY INFORMATION 

I. Background 

II. Public Meeting 

III. Written Comments 

DATES: A public meeting will be held on 

March 30, 2015, 1:00 p.m.–5:00 p.m. 

Eastern Time, or after the last public 

commenter has spoken, whichever 

occurs first. The public meeting will be 

held as a web-based conference only 

available by remote access. 

FOR FURTHER INFORMATION CONTACT: 

Kitty Hendricks, Division of Safety 

Research, 1095 Willowdale Road, MS 

1808, Morgantown, West Virginia 

26505–2888, (304) 285–5916 (not a toll 

free number) or khendricks@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background: NIOSH began a 

coordinated program in 1990 to address 

safety and health issues for workers and 

families in the US agricultural 

production industry. In support of this 

program, NIOSH established an 

ongoing, national-level surveillance 

system to monitor injuries to hired farm 

workers, farmers, and farm family 

members. Data for the injury 

surveillance system are primarily 

collected through surveys funded by 

NIOSH and conducted by the US 

Department of Agriculture’s National 

Agricultural Statistics Service (USDA– 

NASS) and the US Department of Labor 

(DOL). These surveillance data are used 

by NIOSH and others to estimate 

injuries and injury rates and identify 

safety hazards that increase injury risk. 

Surveillance data have also been used 

to show that the US agricultural 

production industry has changed. Over 

the past quarter century, both the size of 

the workforce and the number of 

injuries have declined. To maintain 

statistically stable injury estimates with 

the current approach of national-level 

surveys, sample sizes would need to be 

increased. As a result, this approach has 

become more resource-intensive and is 

no longer tenable for NIOSH. 

Beginning in 2015, NIOSH will not 

reestablish interagency agreements with 

USDA–NASS and DOL to collect survey 

data for the agricultural injury 

surveillance system. This change in 

surveillance approach presents an 

opportunity for NIOSH to receive 

stakeholder input and rigorously 

examine future options for agricultural 

injury surveillance. 

To identify and assess different 

options, NIOSH plans the following 

activities: Hold the public meeting 

announced in this notice to initiate a 

national conversation regarding future 

agricultural injury surveillance; seek 

additional public comments through 

this docket on the most urgent priorities 

for injury surveillance in production 

agriculture; examine what NIOSH and 

agricultural injury stakeholders can do 

to meet the overall need for agricultural 

injury surveillance; support a 

comprehensive, independent 

assessment of recommendations 

resulting from a 2007 National Academy 

of Sciences (NAS) review and a 2012 

follow-up independent panel review; 

continue to engage with interested 

parties as NIOSH plans its own future 

directions for agricultural injury 

surveillance; and seek input on the need 

for a follow-up public meeting in Fall 

2015 to discuss NIOSH’s future plans 

after having considered input received 

through the public meeting and public 

comment period. 

NIOSH is especially interested in 

comments related to finding new ways 

of doing surveillance using smarter, 

more cost-effective approaches; shifting 

surveillance from national to regional or 

local approaches, in recognition of the 

diversity of agricultural types in 

different parts of the country; and 

examining roles that partners can take to 

address the need for smarter agricultural 

injury surveillance. 


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