Agency Forms Undergoing Paperwork Reduction Act Review, 40291-40292 [2020-14330]
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Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
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SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data about topics related to personnel
performing informatics activities, as
well as data storage and retention
practices related to the use of next
generation sequencing (NGS)
technology. In addition, CDC invites
comments specifically on the following
questions:
(1) What are the roles and
responsibilities for all personnel
performing bioinformatics or pathology/
laboratory informatics activities? What
training is considered essential for each
of the roles? What competencies are
considered essential for each of the
roles? What minimum educational
requirements (degrees or courses) are
required for each of the roles?
(2) What are the challenges for
recruitment and retention of
bioinformatics or pathology/laboratory
informatics personnel?
(3) What are examples of how NGS
data files are used in addition to
generating a clinical test result?
(4) What NGS data files should be
retained for quality assurance, repeat
analyses, or subsequent analyses? How
long should these NGS data files be
retained?
(5) What are the challenges and
approaches for laboratories to maintain
and utilize previous versions of
sequence analysis software?
Please note that comments received,
including attachments and other
supporting materials, are part of the
public record and are subject to public
disclosure.
Comments will be posted on https://
www.regulations.gov. Therefore, do not
include any information in your
comment or supporting materials that
you consider confidential or
inappropriate for public disclosure. If
you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be on
public display. Do not submit public
comments by email. CDC will review all
submissions and may choose to redact,
or withhold, submissions containing
private or proprietary information such
as Social Security numbers, medical
information, inappropriate language, or
duplicate/near duplicate examples of a
mass-mail campaign.
Background and Brief Description
Clinical laboratory testing technology
has advanced significantly since the
CLIA regulations were first
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implemented approximately 30 years
ago. Next generation sequencing (NGS)
technologies provide the highthroughput capability to rapidly and
cost-effectively sequence large regions
and mixed populations of DNA and
RNA, when compared to traditional
sequencing methods. This technology
results in a significant increase in data
that requires specialized analysis to
derive a clinically meaningful result.
NGS has led to improvements in
diagnoses and patient care in many
areas of medicine that include medical
genetics, pediatrics, oncology, and
microbiology. In some instances, NGS
has led to life-saving diagnoses and
treatment pathways, not achievable
using other testing modalities. One
element that differentiates NGS from
most laboratory methodologies is its
significant reliance on informatics to
achieve a meaningful and reportable
result. As a consequence, clinical
laboratories require personnel
knowledgeable in bioinformatics or
pathology/laboratory informatics to
design and manage the bioinformatics
analysis.
While CLIA regulations apply to
clinical NGS testing, there is a lack of
clarity regarding how the general CLIA
quality system and personnel
requirements should be specifically
implemented for the NGS
bioinformatics components. In April
2019, CLIAC made eight
recommendations regarding CLIA’s
application to NGS-based technologies.
This request for information is soliciting
comments from the public for more
information on topic areas mentioned in
two of the recommendations,
specifically, the qualifications of
personnel performing bioinformatics
activities; storage and retention of NGS
data files; and maintenance of sequence
analysis software. The April 2019
CLIAC summary is available in the
docket under the Supporting Materials
tab and at https://www.cdc.gov/cliac/
past-meetings.html.
The qualifications and responsibilities
of personnel performing the informatics
component of the testing process are not
addressed in the CLIA regulations. For
the purpose of this request for
information, the informatics component
of NGS includes the analysis of NGS
machine-generated data and subsequent
computational processes. Therefore,
CDC is asking the public to describe
different responsibilities of personnel
providing bioinformatics or pathology/
laboratory informatics expertise such as
validating and assuring that the
informatics pipeline meets documented
performance specifications.
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40291
CDC is also interested in learning the
skills, training, and education of
personnel who will fill bioinformatics
or pathology/laboratory informatics
positions, and how clinical and public
health laboratories can recruit and
retain personnel with these identified
skills.
Lastly, the NGS testing process
generates large amounts of data and
requires multiple file types. CLIA
regulations specify at 42 CFR
493.1105(a)(3) that all
analytic systems records must be kept
for at least two years, but the regulations
do not specify the types of data to be
captured or the retention time for a
given data type. The regulations do not
address the capability to access and
reanalyze the data after the test is
performed. This capability may require
retention of the version of software used
in the original analysis. CDC requests
comment from the public on this topic.
HHS/CDC has posted all related
materials to the docket on
www.regulations.gov.
Dated: June 30, 2020.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2020–14417 Filed 7–2–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–20GX]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Validated
Follow-up Interview of Clinicians on
Outpatient Antibiotic Stewardship
Interventions to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on February
10, 2020 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
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40292
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
(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.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Validated Follow-up Interview of
Clinicians on Outpatient Antibiotic
Stewardship Interventions—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Code of Federal Regulations
under subsections C and D of section
247d–5 authorizes education of medical
and health services personnel in
antimicrobial resistance and appropriate
use of antibiotics and the funding of
eligible entities to increase capacity to
detect, monitor, and combat
antimicrobial resistance. Through the
Centers for Disease Control and
Prevention’s (CDC) SHEPheRD funding
mechanism, the University of Utah has
been awarded a contract to perform
such work as stated above within a
research framework in the urgent care
setting, with interventions based on the
Core Elements of Outpatient Antibiotic
Stewardship. Intermountain Healthcare
is the subcontractor for this work, and
operates the clinics participating in the
intervention arm of this research study.
The proposed request for data
collection will allow Intermountain
Healthcare to explore knowledge,
attitudes, and practices among
clinicians to identify barriers and
facilitators after the implementation of
the antibiotic stewardship program in
the urgent care setting of participating
clinics. CDC requests approval for 207
estimated annualized burden hours.
There is no cost to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Urgent Care Clinician ..................................
Urgent Care Clinician ..................................
Interview Guide ...........................................
Survey .........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–14330 Filed 7–2–20; 8:45 am]
BILLING CODE 4163–18–P
Food and Drug Administration
[Docket No. FDA–2019–N–3018]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Healthcare
Provider Perception of Boxed Warning
Information Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
SUMMARY:
04:41 Jul 03, 2020
Submit written comments
(including recommendations) on the
collection of information by August 5,
2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comment’’ or
by using the search function. The title
of this information collection is
‘‘Healthcare Provider Perception of
Boxed Warning Information Survey.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Notice.
VerDate Sep<11>2014
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Number of
respondents
Type of respondents
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Number of
responses per
respondent
40
250
Average burden
per response
(in hours)
1
1
1
40/60
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Healthcare Provider Perception of
Boxed Warning Information Survey
OMB Control Number 0910—NEW
I. Background
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(C)) authorizes
FDA to conduct research relating to
drugs and other FDA regulated products
in carrying out the provisions of the
FD&C Act.
The proposed collection of
information will investigate healthcare
providers’ (HCPs’) awareness,
perceptions, and beliefs about the
benefits and risks of an FDA-approved
product that carries a boxed warning.
The prescribing information for an FDAapproved drug or biologic (sometimes
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Agencies
[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Pages 40291-40292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14330]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-20-20GX]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Validated Follow-up Interview of Clinicians
on Outpatient Antibiotic Stewardship Interventions to the Office of
Management and Budget (OMB) for review and approval. CDC previously
published a ``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on February 10, 2020 to obtain comments from
the public and affected agencies. CDC did not receive comments related
to the previous notice. This notice serves to allow an additional 30
days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
[[Page 40292]]
(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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Validated Follow-up Interview of Clinicians on Outpatient
Antibiotic Stewardship Interventions--New--National Center for Emerging
and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Code of Federal Regulations under subsections C and D of
section 247d-5 authorizes education of medical and health services
personnel in antimicrobial resistance and appropriate use of
antibiotics and the funding of eligible entities to increase capacity
to detect, monitor, and combat antimicrobial resistance. Through the
Centers for Disease Control and Prevention's (CDC) SHEPheRD funding
mechanism, the University of Utah has been awarded a contract to
perform such work as stated above within a research framework in the
urgent care setting, with interventions based on the Core Elements of
Outpatient Antibiotic Stewardship. Intermountain Healthcare is the
subcontractor for this work, and operates the clinics participating in
the intervention arm of this research study.
The proposed request for data collection will allow Intermountain
Healthcare to explore knowledge, attitudes, and practices among
clinicians to identify barriers and facilitators after the
implementation of the antibiotic stewardship program in the urgent care
setting of participating clinics. CDC requests approval for 207
estimated annualized burden hours. There is no cost to respondents
other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Urgent Care Clinician............... Interview Guide........ 40 1 1
Urgent Care Clinician............... Survey................. 250 1 40/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-14330 Filed 7-2-20; 8:45 am]
BILLING CODE 4163-18-P