60 Day FRN

Attachment B CAP LPG NEW_Published 60-Day FRN.pdf

Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics - College of American Pathologists

60 Day FRN

OMB: 0920-1067

Document [pdf]
Download: pdf | pdf
65219

Federal Register / Vol. 79, No. 212 / Monday, November 3, 2014 / Notices
may have resulted in undocumented
radiation exposures, characterizing
radiological protection and monitoring
practices, and identify co-workers and
other witnesses as may be necessary to
confirm undocumented information. In
this process, NIOSH uses a computer
assisted telephone interview (CATI)
system, which allows interviews to be
conducted more efficiently and quickly
as opposed to a paper-based interview
instrument. Both interviews are
voluntary and failure to participate in
either or both interviews will not have
a negative effect on the claim, although
voluntary participation may assist the
claimant by adding important
information that may not be otherwise
available. NIOSH is requesting a three
year approval for these data collection
activities.

information to provide to NIOSH about
the claim at this time. The form notifies
the claimant that signing the form
allows NIOSH to forward a dose
reconstruction report to DOL and to the
claimant, and closes the record on data
used for the dose reconstruction.
Signing this form does not indicate that
the claimant agrees with the outcome of
the dose reconstruction. The dose
reconstruction results will be supplied
to the claimant and to the DOL, the
agency that will utilize them as one part
of its determination of whether the
claimant is eligible for compensation
under the Act. It is estimated that 8,400
claimants will complete the conclusion
form which takes approximately 5
minutes per response.
The total estimated burden hours are
4,900. There is no cost to respondents
other than their time.

NIOSH uses the data collected in this
process to complete an individual dose
reconstruction that accounts, as fully as
possible, for the radiation dose incurred
by the employee in the line of duty for
DOE nuclear weapons production
programs. After dose reconstruction,
NIOSH also performs a brief, voluntary
final interview with the claimant to
explain the results and to allow the
claimant to confirm or question the
records NIOSH has compiled. This will
also be the final opportunity for the
claimant to supplement the dose
reconstruction record. Approximately
4,200 claimants will be interviewed
with an average burden of one hour per
response.
At the conclusion of the dose
reconstruction process, the claimant
submits a conclusion form to confirm
that the claimant has no further

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
hours

Form name

Claimant ............................................
Claimant ............................................

Initial interview ..................................
Conclusion form OCAS–1 ................

4,200
8,400

1
1

1
5/60

4,200
700

Total ...........................................

...........................................................

........................

........................

........................

4,900

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. 2014–26032 Filed 10–31–14; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day 15–15CK]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

mstockstill on DSK4VPTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

Type of respondent

The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send

VerDate Sep<11>2014

17:37 Oct 31, 2014

Jkt 235001

comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection
techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology

PO 00000

Frm 00045

Fmt 4703

Sfmt 4703

and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 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

E:\FR\FM\03NON1.SGM

03NON1

65220

Federal Register / Vol. 79, No. 212 / Monday, November 3, 2014 / Notices

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, the Clinical and
Laboratory Standards Institute, 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 Hematologists
(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

hematopathologists will be invited to
participate. The CAP hopes to achieve
an 80% response rate with their
individual data collections, or 880 (80%
× 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,
who will be provided a link to the
Qualtrics site that hosts the survey.
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 non-CAP-accredited laboratories by
sending reminders through the US
postal system. The CAP will also try to
maximize response rates for the ALA
survey by advertising it through various
channels.
For burden calculation, we assume
one response per laboratory. We assume
respondents for the IHC survey will
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 will
include 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 and the ALA
baseline survey are also expected to take
15 minutes. Each survey will be pilot
tested with nine or fewer respondents
before deployment to assure that they
require 15 minutes or less to complete.
CDC is requesting a one-year OMB
approval to collect the information.
There are no costs to respondents other
than their time.

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 data 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 postdissemination data. For their ALA LPG
CAP/ASH Algorithm for Initial Work-Up
of Acute Leukemia, the CAP will
conduct both a baseline and a postdissemination survey. 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 2,668 out of 3,335
potential respondents. 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 CMS Part B reimbursement
claims for IHC testing. The response rate
for the baseline IHC survey was
approximately 70% but through more
focused promotion the CAP hopes to
increase participation. We have
identified a total of 3,335 (2,885 CAPaccredited + 450 non-CAP-accredited)
laboratories that will be targeted by the
IHC post-dissemination survey.
CAP-accredited laboratories that are
enrolled in IHC PT will receive surveys
with their PT mailings. Non-CAPaccredited laboratories will be surveyed
via the US postal system, with a faxback mechanism.
The CAP will need to collect both
baseline and post-guideline
dissemination data 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

mstockstill on DSK4VPTVN1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Form
name

Type of respondent

Pathologist ..........................................................................................
Laboratory Directors ...........................................................................
Laboratory Managers ..........................................................................
Hematologist .......................................................................................

VerDate Sep<11>2014

17:37 Oct 31, 2014

Jkt 235001

PO 00000

Frm 00046

Number of
respondents

IHC
ALA
IHC
IHC
ALA

Fmt 4703

Sfmt 4703

Number of
responses per
respondent

834
1,045
834
1,667
55

E:\FR\FM\03NON1.SGM

1
2
1
1
2

03NON1

Average
burden per
response
(in hours)
15/60
15/60
15/60
15/60
15/60

Total burden
hours
209
523
209
417
28

Federal Register / Vol. 79, No. 212 / Monday, November 3, 2014 / Notices

65221

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form
name

Type of respondent

Total .............................................................................................

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.

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

........................

........................

........................

Dated: October 28, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–26025 Filed 10–31–14; 8:45 am]
BILLING CODE 4140–01–P

[FR Doc. 2014–26030 Filed 10–31–14; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health

National Institutes of Health

National Cancer Institute; Notice of
Meeting

National Institute on Drug Abuse;
Notice of Closed Meeting

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the Joint meeting of
the National Cancer Advisory Board
(NCAB) and NCI Board of Scientific
Advisors (BSA).
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
A portion of the Joint NCAB/BSA
meeting will be closed to the public in
accordance with the provisions set forth
in section 552b(c)(6), Title 5 U.S.C., as
amended for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel qualification
and performance, and the competence
of individual investigators, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.

mstockstill on DSK4VPTVN1PROD with NOTICES

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIDA.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute on Drug Abuse,
including consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIDA.
Date: November 20, 2014.
Closed: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: Intramural Research Program,
National Institute on Drug Abuse, NIH, Johns
Hopkins Bayview Campus, Baltimore, MD
21223.
Contact Person: Joshua Kysiak, Program
Specialist, Biomedical Research Center,
Intramural Research Program, National
Institute on Drug Abuse, NIH, DHHS, 251
Bayview Boulevard, Baltimore, MD 21224,
443–740–2465, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)

VerDate Sep<11>2014

17:37 Oct 31, 2014

Jkt 235001

Name of Committee: National Cancer
Advisory Board; ad Hoc Subcommittee on
Global Cancer Research.
Open: December 1, 2014, 6:00 p.m. to 7:30
p.m.
Agenda: Discussion on Global Cancer
Research.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, Bethesda, Maryland
20814.
Contact Person: Dr. Edward Trimble,
Executive Secretary, NCAB ad Hoc
Subcommittee on Global Cancer Research,
National Cancer Institute, National Institutes
of Health, 9609 Medical Center Drive, Room

PO 00000

Frm 00047

Fmt 4703

Sfmt 4703

Total burden
hours
1,386

3W–562, Bethesda, MD 20892, (240) 276–
5796, [email protected].
Name of Committee: National Cancer
Advisory Board and NCI Board of Scientific
Advisors.
Open: December 2, 2014, 8:30 a.m. to 5:15
p.m.
Agenda: Joint meeting of the National
Cancer Advisory Board; and NCI Board of
Scientific Advisors; NCI Board of Scientific
Advisors Concepts Review, NCI Director’s
report, and presentations.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, C Wing, 6th
Floor, Conference Room 10, Bethesda, MD
20892.
Closed: December 2, 2014, 5:15 p.m. to
6:00 p.m.
Agenda: Review of intramural program site
visit outcomes and the discussion of
confidential personnel issues.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, C Wing, 6th
Floor, Conference Room 10, Bethesda, MD
20892.
Contact Person: Dr. Paulette S. Gray,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 9606
Medical Center Drive, Room 7W–444,
Bethesda, MD 20892, (240) 276–6340.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit. Information is also available on the
Institute’s/Center’s home page: NCAB:
http://deainfo.nci.nih.gov/advisory/ncab/
ncab.htm, BSA: http://deainfo.nci.nih.gov/
advisory/bsa/bsa.htm, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)

E:\FR\FM\03NON1.SGM

03NON1


File Typeapplication/pdf
File Modified2014-11-01
File Created2014-11-01

© 2024 OMB.report | Privacy Policy