Agency Information Collection Activities: Proposed Collection; Comment Request, 27779-27781 [2019-12606]
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Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
Dated at Washington, DC, on June 11, 2019.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2019–12553 Filed 6–13–19; 8:45 am]
BILLING CODE 6714–01–P
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
A. Solicitation of Public Comment
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[OMB Control No. 9000–0114; Docket No.
2019–0003; Sequence No. 9]
Information Collection; Right of First
Refusal of Employment
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for comments.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995 and
the Office of Management and Budget
(OMB) regulations, the FAR Council
invites the public to comment upon a
renewal concerning right of first refusal
employment.
DATES: Submit comments on or before
August 13, 2019.
ADDRESSES: The FAR Council invites
interested persons to submit comments
on this collection by either of the
following methods:
• Federal eRulemaking Portal: This
website provides the ability to type
short comments directly into the
comment field or attach a file for
lengthier comments. Go to https://
www.regulations.gov and follow the
instructions on the site.
• Mail: General Services
Administration, Regulatory Secretariat
Divison (MVCB), 1800 F Street NW,
Washington, DC 20405. ATTN: Ms.
Mandell/IC 9000–0114, Right of First
Refusal of Employment.
Instructions: Please submit comments
only and cite Information Collection
9000–0114, Right of First Refusal of
Employment, in all correspondence
related to this collection. Comments
received generally will be posted
without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
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SUMMARY:
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check www.regulations.gov,
approximately two-to-three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Mr.
Michael O. Jackson, Procurement
Analyst, Office of Governmentwide
Acquisition Policy, GSA, at 202–208–
4949 or via email at michaelo.jackson@
gsa.gov.
SUPPLEMENTARY INFORMATION:
Written comments and suggestions
from the public should address one or
more of the following four points:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) 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.
B. Purpose
As prescribed in FAR 7.305(c), the
clause at FAR 52.207–3, Right of First
Refusal of Employment, deals with
adversely affected or separated
Government employees resulting from
the conversion of work from in-house
performance to performance by contract.
The clause requires the contractor to
give these employees an opportunity to
work for the contractor who is awarded
the contract.
The information gathered will be used
by the Government to gain knowledge of
which employees, adversely affected or
separated as a result of the contract
award, have gained employment with
the contractor within 90 days after
contract performance begins.
C. Annual Reporting Burden
Number of Respondents: 10.
Responses per Respondent: 1.
Total Responses: 10.
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27779
Hours per Response: 3.
Total Burden Hours: 30.
Frequency of Collection: On occasion.
Affected Public: Businesses or other
for-profit and not-for profit
organizations.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC
20405, telephone 202–501–4755.
Please cite OMB Control No. 9000–
0114, Right of First Refusal of
Employment, in all correspondence.
Dated: June 7, 2019.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2019–12570 Filed 6–13–19; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project
‘‘Systematic Review Data Repository.’’
In accordance with the Paperwork
Reduction Act, AHRQ invites the public
to comment on this proposed
information collection.
DATES: Comments on this notice must be
received on or before 60 days after date
of publication.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
SUMMARY:
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Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
emails at doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Systematic Review Data Repository
(SRDR)
In 1997, AHRQ launched an initiative
to promote evidence-based practice in
everyday care through establishment of
the Evidence-based Practice Center
(EPC) Program. Since then, the EPCs
have been reviewing all relevant
scientific literature on a wide spectrum
of clinical and health services topics to
produce various types of evidence
reports. A majority of these evidence
reports are systematic reviews (SRs),
which are used as evidence bases for
clinical practice guidelines, research
agendas, healthcare coverage, and other
health related policies. Performing SRs
is costly in time, labor, and money.
Moreover, there is an increasing
expectation of quicker turnaround in
producing SRs to accommodate the fast
moving pace of innovations and new
scientific discoveries in healthcare.
Some SRs overlap or are replicated;
independent teams of SR producers
often extract data from the same studies,
resulting in replication of work. Current
methodology makes it difficult to
harness and reuse previous work when
updating SRs.
In an effort to reduce the economic
burden of conducting SRs, the EPC
Program undertook development of a
collaborative, Web-based repository of
systematic review data called the
Systematic Review Data Repository
(SRDR). This resource serves as both an
archive and data extraction tool, shared
among organizations and individuals
producing SRs worldwide, enabling the
creation of a central database of SR data.
This database is collaboratively vetted,
freely accessible, and integrates
seamlessly with reviewers’ existing
workflows, with the ultimate goal of
facilitating the efficient generation and
update of evidence reviews, and thus
speeding and improving policy-making
with regards to health care. Currently,
there are two versions of the database:
(1) The original version called ‘‘SRDR’’;
and (2) an upgraded version with
increased functionality. Further upgrade
of the database is planned for the next
year (to be called ‘‘SRDR 2.0’’). The
SRDR project encompasses the various
iterations of the database.
The SRDR project aims to achieve the
following goals:
(1) Create online easy-to-use Webbased tools for conducting systematic
reviews to facilitate extraction of data
from primary studies;
(2) Develop an open-access searchable
archive of key questions addressed in
systematic reviews;
(3) Maintain a public repository of
primary study data including provision
of technical support for repository users;
and
(4) Develop a process for making
summary data from systematic reviews
digitally shareable to end-users.
This study is being conducted by
AHRQ through its contractor, Brown
University, pursuant to AHRQ’s
statutory authority to conduct and
support research on health care and on
systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of healthcare
services, including database
development. 42 U.S.C 299a(a)(1) and
(8).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
(1) Collect registration data and
information on SRs from SR producers
who will populate the SRDR system.
SRDR uses a three-tiered
categorization of users and collection of
registration data that depends on the
type of user: (1) ‘‘Contributors’’ are SR
producers who use SRDR as a tool to
support production of the SR and share
scientific data from their SRs.
Registration data will be collected from
these users; (2) ‘‘Commentators’’
provide comments (i.e. opinions) on
publicly available scientific data in
SRDR. Registration data will be
collected from these users; (3) ‘‘General
public’’ users only view scientific data
publicly available in SRDR. No data will
be collected from these type of users.
All Contributors and Commentators
will undergo a simple self-registration
process by providing a username,
password, email address, and
institution. Collection of registration
data from Contributors and
Commentators is required due to the use
of SRDR both as a database and as a tool
for assisting in the production of a SR,
including providing comments in the
various sections of a particular project
on SRDR. In addition, provision of an
email address and institution
information allows the administrators of
SRDR to confirm that requests are being
made by actual people and not
potentially malicious software code
such as bots and other cybersecurity
threats.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in the
SRDR. In 2017, 176 users registered as
Commentators and 206 users registered
as Contributors. Registration will take
approximately 2 minutes per user. We
thus calculate the total burden hours
required for registration for all users
annually is 12.73 hours.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
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Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Registration of users as Commentators or Contributors .........................
382
1
2/60
12.73
Total ..................................................................................................
382
..........................
..........................
12.73
Exhibit 2 shows the estimated cost
burden associated with the respondents’
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time to participate in the SRDR. The
total cost burden to respondents is
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estimated at an average of $501.82
annually.
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27781
Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average hourly
wage rate *
Total cost
burden
Registration of users as Commentators or Contributors .........................
382
12.73
a $39.42
$501.82
Total ..................................................................................................
382
12.73
..........................
501.82
* National Compensation Survey: Occupational wages in the United States May 2018, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
Available at: https://www.bls.gov/oes/current/oes290000.htm.
a Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29–0000.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in AHRQ’s subsequent request
for OMB approval of the proposed
information collection. All comments
will become a matter of public record.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–12606 Filed 6–13–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1876]
Testing for Biotin Interference in In
Vitro Diagnostic Devices; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Testing for Biotin
Interference in In Vitro Diagnostic
Devices; Draft Guidance for Industry.’’
The draft guidance document provides
FDA’s recommendations on the testing
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for interference by biotin on the
performance of in vitro diagnostic
devices (IVDs). The draft guidance is
intended to help device developers and
clinicians understand how FDA
recommends biotin interference testing
should be performed and how the
results of the testing should be
communicated to end users, including
clinical laboratories and clinicians. FDA
also recommends that manufacturers of
currently marketed devices consider
these draft recommendations.
Submit either electronic or
written comments on the draft guidance
by August 13, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–1876 for ‘‘Testing for Biotin
Interference in In Vitro Diagnostic
Devices; Draft Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
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]]>Agencies
[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Notices]
[Pages 27779-27781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12606]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project ``Systematic Review Data Repository.'' In accordance with the
Paperwork Reduction Act, AHRQ invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be received on or before 60 days
after date of publication.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
[email protected].
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
[[Page 27780]]
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by emails at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Systematic Review Data Repository (SRDR)
In 1997, AHRQ launched an initiative to promote evidence-based
practice in everyday care through establishment of the Evidence-based
Practice Center (EPC) Program. Since then, the EPCs have been reviewing
all relevant scientific literature on a wide spectrum of clinical and
health services topics to produce various types of evidence reports. A
majority of these evidence reports are systematic reviews (SRs), which
are used as evidence bases for clinical practice guidelines, research
agendas, healthcare coverage, and other health related policies.
Performing SRs is costly in time, labor, and money. Moreover, there is
an increasing expectation of quicker turnaround in producing SRs to
accommodate the fast moving pace of innovations and new scientific
discoveries in healthcare. Some SRs overlap or are replicated;
independent teams of SR producers often extract data from the same
studies, resulting in replication of work. Current methodology makes it
difficult to harness and reuse previous work when updating SRs.
In an effort to reduce the economic burden of conducting SRs, the
EPC Program undertook development of a collaborative, Web-based
repository of systematic review data called the Systematic Review Data
Repository (SRDR). This resource serves as both an archive and data
extraction tool, shared among organizations and individuals producing
SRs worldwide, enabling the creation of a central database of SR data.
This database is collaboratively vetted, freely accessible, and
integrates seamlessly with reviewers' existing workflows, with the
ultimate goal of facilitating the efficient generation and update of
evidence reviews, and thus speeding and improving policy-making with
regards to health care. Currently, there are two versions of the
database: (1) The original version called ``SRDR''; and (2) an upgraded
version with increased functionality. Further upgrade of the database
is planned for the next year (to be called ``SRDR 2.0''). The SRDR
project encompasses the various iterations of the database.
The SRDR project aims to achieve the following goals:
(1) Create online easy-to-use Web-based tools for conducting
systematic reviews to facilitate extraction of data from primary
studies;
(2) Develop an open-access searchable archive of key questions
addressed in systematic reviews;
(3) Maintain a public repository of primary study data including
provision of technical support for repository users; and
(4) Develop a process for making summary data from systematic
reviews digitally shareable to end-users.
This study is being conducted by AHRQ through its contractor, Brown
University, pursuant to AHRQ's statutory authority to conduct and
support research on health care and on systems for the delivery of such
care, including activities with respect to the quality, effectiveness,
efficiency, appropriateness and value of healthcare services, including
database development. 42 U.S.C 299a(a)(1) and (8).
Method of Collection
To achieve the goals of this project the following data collections
will be implemented:
(1) Collect registration data and information on SRs from SR
producers who will populate the SRDR system.
SRDR uses a three-tiered categorization of users and collection of
registration data that depends on the type of user: (1)
``Contributors'' are SR producers who use SRDR as a tool to support
production of the SR and share scientific data from their SRs.
Registration data will be collected from these users; (2)
``Commentators'' provide comments (i.e. opinions) on publicly available
scientific data in SRDR. Registration data will be collected from these
users; (3) ``General public'' users only view scientific data publicly
available in SRDR. No data will be collected from these type of users.
All Contributors and Commentators will undergo a simple self-
registration process by providing a username, password, email address,
and institution. Collection of registration data from Contributors and
Commentators is required due to the use of SRDR both as a database and
as a tool for assisting in the production of a SR, including providing
comments in the various sections of a particular project on SRDR. In
addition, provision of an email address and institution information
allows the administrators of SRDR to confirm that requests are being
made by actual people and not potentially malicious software code such
as bots and other cybersecurity threats.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in the SRDR. In 2017, 176 users
registered as Commentators and 206 users registered as Contributors.
Registration will take approximately 2 minutes per user. We thus
calculate the total burden hours required for registration for all
users annually is 12.73 hours.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Registration of users as Commentators or 382 1 2/60 12.73
Contributors...............................
-------------------------------------------------------------------
Total................................... 382 ............... ............... 12.73
----------------------------------------------------------------------------------------------------------------
Exhibit 2 shows the estimated cost burden associated with the
respondents' time to participate in the SRDR. The total cost burden to
respondents is estimated at an average of $501.82 annually.
[[Page 27781]]
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Registration of users as Commentators or 382 12.73 \a\ $39.42 $501.82
Contributors...............................
-------------------------------------------------------------------
Total................................... 382 12.73 ............... 501.82
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2018, ``U.S. Department of Labor,
Bureau of Labor Statistics.'' Available at: https://www.bls.gov/oes/current/oes290000.htm.
\a\ Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29-0000.
Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of AHRQ's health care research and
health care information dissemination functions, including whether the
information will have practical utility; (b) the accuracy of AHRQ's
estimate of burden (including hours and costs) of the proposed
collection(s) of information; (c) ways to enhance the quality, utility
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information upon the
respondents, including the use of automated collection techniques or
other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in AHRQ's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-12606 Filed 6-13-19; 8:45 am]
BILLING CODE 4160-90-P
