Submission for OMB Review; 30-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development), 18548-18549 [2021-07313]
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18548
Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
NICEATM and ICCVAM members
before the meeting. Written public
statements received after the deadline
may be reviewed by NICEATM and
ICCVAM at a future date.
Materials submitted to accompany
oral public statements or standalone
written statements should include the
submitters name, affiliation (if any),
mailing address, telephone, email, and
sponsoring organization (if any) with
the document. National Toxicology
Program guidelines for public
statements are at https://
ntp.niehs.nih.gov/ntp/about_ntp/
guidelines_public_comments_508.pdf.
Responses to this notice are
voluntary. No proprietary, classified,
confidential, or sensitive information
should be included in statements
submitted in response to this notice or
presented during the meeting. This
request for input is for planning
purposes only and is not a solicitation
for applications or an obligation on the
part of the U.S. Government to provide
support for any ideas identified in
response to the request. Please note that
the U.S. Government will not pay for
the preparation of any information
submitted or for its use of that
information.
Background Information on ICCVAM
and NICEATM: ICCVAM is an
interagency committee composed of
representatives from 17 federal
regulatory and research agencies that
require, use, generate, or disseminate
toxicological and safety testing
information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
and integrated testing strategies with
regulatory applicability and promotes
the scientific validation and regulatory
acceptance of testing methods that more
accurately assess the safety and hazards
of chemicals and products and replace,
reduce, or refine (enhance animal wellbeing and lessen or avoid pain and
distress) animal use.
The ICCVAM Authorization Act of
2000 (42 U.S.C. 285l–3) establishes
ICCVAM as a permanent interagency
committee of NIEHS and provides the
authority for ICCVAM involvement in
activities relevant to the development of
alternative test methods. Additional
information about ICCVAM can be
found at https://ntp.niehs.nih.gov/go/
iccvam.
NICEATM administers ICCVAM,
provides scientific and operational
support for ICCVAM-related activities,
and conducts and publishes analyses
and evaluations of data from new,
revised, and alternative testing
approaches. NICEATM and ICCVAM
work collaboratively to evaluate new
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and improved testing approaches
applicable to the needs of U.S. federal
agencies. NICEATM and ICCVAM
welcome the public nomination of new,
revised, and alternative test methods
and strategies for validation studies and
technical evaluations. Additional
information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/
niceatm.
Dated: March 26, 2021.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2021–07315 Filed 4–8–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Data and Specimen
Hub (DASH) (Eunice Kennedy Shriver
National Institute of Child Health and
Human Development)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
Written 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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Regina Bures,
Ph.D., Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health, 6710B Rockledge
Drive, Room 2160, Bethesda, MD 20817,
or call non-toll-free number (301)–496–
9485 or Email your request, including
ADDRESSES:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
your address to: NICHD.DASH@
mail.nih.gov.
This
proposed information collection was
previously published in the Federal
Register on January 14, 2021, page
3160–3162 (86 FR 3160–3162) and
allowed 60 days for public comment. No
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Data and
Specimen Hub (DASH)-0925–0744
expiration date 01/31/2022, REVISION,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This is a request to revise the
previously approved submission (OMB
number: 0925–0744) to add the
collection of additional information
from Users who will submit information
to NICHD Data and Specimen Hub
(DASH) about studies, and data
collections stored in publicly accessible
external archives—a process hereinafter
referred to as ‘cataloging’ in DASH.
DASH has been established by NICHD
as a data sharing mechanism for
biomedical research investigators. It
serves as a centralized resource for
investigators to share and access deidentified study data from studies
funded by NICHD. DASH also serves as
a portal for requesting biospecimens
from selected DASH studies.
NICHD also supports other public
archives, data collections, and
resources, such as Data Sharing for
Demographic Research (DSDR), NICHD/
DIPHR Biospecimen Repository Access
and Data Sharing (BRADS), the Down
Syndrome Registry (DS-Connect),
Zebrafish Information Network (ZFIN),
etc. In addition to these NICHD-funded
public archives, many collaborative
studies funded through NICHD are
dispersed across other National
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09APN1.SGM
09APN1
18549
Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
Institutes of Health (NIH) designated
archives, including the National Heart,
Lung, and Blood Institute (NHLBI)
Biologic Specimen and Data Repository
Information Coordinating Center
(BioLINCC), and other NIH-wide
repositories, such as the Database of
Genotypes and Phenotypes (dbGaP).
In an effort to link these data
resources and increase the visibility of
NICHD-funded studies and data
collections, DASH will enable Users to
catalog studies and data collections
stored in other external archives to
facilitate their discovery through DASH.
Users submitting studies or data
collections for cataloging in DASH will
provide descriptive information about
the study required to populate the Study
Overview Page in DASH. This
cataloging process closely mirrors the
existing study data submission process
in DASH; however, no study
documentation or data will be uploaded
to DASH. Requesters will be directed to
the external archive via a URL link to
obtain access to the data stored in the
external archives and resources.
The potential for public benefit to be
achieved through sharing study data
and/or biospecimen inventories through
DASH for secondary analysis is
significant. Additionally, the ability to
centralize information regarding where
to find, and how to access, studies, and
data collections funded by NICHD
stored across various public archives
(i.e., cataloged studies and data
collections) further helps to promote
information discovery and reuse of data.
collected is limited to the essential data
required to ensure the management of
Users in NICHD DASH is efficient and
the sharing of data and biospecimens
among investigators is effective. The
primary uses of the information
collected from Uses by NICHD will be
to:
• Communicate with the Users
regarding data submission, study catalog
submission, data collection catalog
submission, data requests and
biospecimen requests;
• Monitor data submissions, study
catalog submission, data collection
catalog submission, data requests and
biospecimen requests;
• Notify interested Users of updates
to data and biospecimen inventories
stored in NICHD DASH; and
• Help NICHD understand the use of
NICHD DASH study data and
biospecimen inventories by the research
community.
All the data collected from use of
NICHD DASH except for information
provided in the annual progress reports
are for the purposes of internal
administrative management of NICHD
DASH. Information gathered through
the annual progress reports may be used
in publications describing performance
of the DASH system.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
211.
NICHD DASH supports NICHD’s
mission to ensure that every person is
born healthy and wanted; that women
suffer no harmful effects from
reproductive processes; that all children
have the chance to achieve their full
potential for healthy and productive
lives, free from disease or disability; and
to ensure the health, productivity,
independence, and well-being of all
people through optimal rehabilitation.
Study data and biospecimen sharing
and reuse will promote testing of new
hypotheses from data and biospecimens
already collected, facilitate transdisciplinary collaboration, accelerate
scientific findings and enable NICHD to
maximize the return on its investments
in research.
Anyone can access NICHD DASH to
browse and view descriptive
information about the studies and data
collections without creating an account.
Users who wish to submit studies or
request data stored in DASH, and/or
request biospecimens (stored in NICHD
contracted Biorepository) must register
for an account; Users who wish to
submit a study catalog and/or data
collection catalog must also register for
an account.
Information will be collected from
those wishing to create an account,
sufficient to identify them as unique
Users. Those submitting or requesting
data and/or biospecimens will be
required to provide additional
supporting information to ensure proper
use and security of NICHD DASH study
data and biospecimens. The information
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Frequency of
response per
respondent
Average time
per response
(in hours)
Total annual
burden hour
User Registration .............................................................................................
Data and Biospecimen Inventory Submissions ...............................................
Study Catalog Submission ..............................................................................
Data Collection Catalog Submission ...............................................................
Data Request ...................................................................................................
Biospecimen Request ......................................................................................
Data Use Annual Progress Report ..................................................................
Biospecimen Use Annual Progress Report .....................................................
Institutional Certification Template ..................................................................
200
36
10
6
60
36
60
36
36
1
1
1
1
1
1
1
1
1
5/60
2
30/60
15/60
1
1
10/60
10/60
5/60
17
72
5
2
60
36
10
6
3
Total ..........................................................................................................
200
200
........................
211
Dated: April 1, 2021.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver National Institute of Child Health and
Human Development, National Institutes of
Health.
[FR Doc. 2021–07313 Filed 4–8–21; 8:45 am]
BILLING CODE 4140–01–P
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PO 00000
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Fmt 4703
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]]>Agencies
[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18548-18549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Data and
Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child
Health and Human Development)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30-days of the date of
this publication.
ADDRESSES: Written 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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Regina Bures, Ph.D., Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD),
National Institutes of Health, 6710B Rockledge Drive, Room 2160,
Bethesda, MD 20817, or call non-toll-free number (301)-496-9485 or
Email your request, including your address to: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on January 14, 2021, page
3160-3162 (86 FR 3160-3162) and allowed 60 days for public comment. No
public comments were received. The purpose of this notice is to allow
an additional 30 days for public comment.
The Eunice Kennedy Shriver National Institute of Child Health and
Human Development (NICHD), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
Proposed Collection: Data and Specimen Hub (DASH)-0925-0744
expiration date 01/31/2022, REVISION, Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information Collection: This is a request to revise
the previously approved submission (OMB number: 0925-0744) to add the
collection of additional information from Users who will submit
information to NICHD Data and Specimen Hub (DASH) about studies, and
data collections stored in publicly accessible external archives--a
process hereinafter referred to as `cataloging' in DASH.
DASH has been established by NICHD as a data sharing mechanism for
biomedical research investigators. It serves as a centralized resource
for investigators to share and access de-identified study data from
studies funded by NICHD. DASH also serves as a portal for requesting
biospecimens from selected DASH studies.
NICHD also supports other public archives, data collections, and
resources, such as Data Sharing for Demographic Research (DSDR), NICHD/
DIPHR Biospecimen Repository Access and Data Sharing (BRADS), the Down
Syndrome Registry (DS-Connect), Zebrafish Information Network (ZFIN),
etc. In addition to these NICHD-funded public archives, many
collaborative studies funded through NICHD are dispersed across other
National
[[Page 18549]]
Institutes of Health (NIH) designated archives, including the National
Heart, Lung, and Blood Institute (NHLBI) Biologic Specimen and Data
Repository Information Coordinating Center (BioLINCC), and other NIH-
wide repositories, such as the Database of Genotypes and Phenotypes
(dbGaP).
In an effort to link these data resources and increase the
visibility of NICHD-funded studies and data collections, DASH will
enable Users to catalog studies and data collections stored in other
external archives to facilitate their discovery through DASH. Users
submitting studies or data collections for cataloging in DASH will
provide descriptive information about the study required to populate
the Study Overview Page in DASH. This cataloging process closely
mirrors the existing study data submission process in DASH; however, no
study documentation or data will be uploaded to DASH. Requesters will
be directed to the external archive via a URL link to obtain access to
the data stored in the external archives and resources.
The potential for public benefit to be achieved through sharing
study data and/or biospecimen inventories through DASH for secondary
analysis is significant. Additionally, the ability to centralize
information regarding where to find, and how to access, studies, and
data collections funded by NICHD stored across various public archives
(i.e., cataloged studies and data collections) further helps to promote
information discovery and reuse of data. NICHD DASH supports NICHD's
mission to ensure that every person is born healthy and wanted; that
women suffer no harmful effects from reproductive processes; that all
children have the chance to achieve their full potential for healthy
and productive lives, free from disease or disability; and to ensure
the health, productivity, independence, and well-being of all people
through optimal rehabilitation. Study data and biospecimen sharing and
reuse will promote testing of new hypotheses from data and biospecimens
already collected, facilitate trans-disciplinary collaboration,
accelerate scientific findings and enable NICHD to maximize the return
on its investments in research.
Anyone can access NICHD DASH to browse and view descriptive
information about the studies and data collections without creating an
account. Users who wish to submit studies or request data stored in
DASH, and/or request biospecimens (stored in NICHD contracted
Biorepository) must register for an account; Users who wish to submit a
study catalog and/or data collection catalog must also register for an
account.
Information will be collected from those wishing to create an
account, sufficient to identify them as unique Users. Those submitting
or requesting data and/or biospecimens will be required to provide
additional supporting information to ensure proper use and security of
NICHD DASH study data and biospecimens. The information collected is
limited to the essential data required to ensure the management of
Users in NICHD DASH is efficient and the sharing of data and
biospecimens among investigators is effective. The primary uses of the
information collected from Uses by NICHD will be to:
Communicate with the Users regarding data submission,
study catalog submission, data collection catalog submission, data
requests and biospecimen requests;
Monitor data submissions, study catalog submission, data
collection catalog submission, data requests and biospecimen requests;
Notify interested Users of updates to data and biospecimen
inventories stored in NICHD DASH; and
Help NICHD understand the use of NICHD DASH study data and
biospecimen inventories by the research community.
All the data collected from use of NICHD DASH except for
information provided in the annual progress reports are for the
purposes of internal administrative management of NICHD DASH.
Information gathered through the annual progress reports may be used in
publications describing performance of the DASH system.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 211.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Frequency of Average time
Form name Number of response per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
User Registration............................... 200 1 5/60 17
Data and Biospecimen Inventory Submissions...... 36 1 2 72
Study Catalog Submission........................ 10 1 30/60 5
Data Collection Catalog Submission.............. 6 1 15/60 2
Data Request.................................... 60 1 1 60
Biospecimen Request............................. 36 1 1 36
Data Use Annual Progress Report................. 60 1 10/60 10
Biospecimen Use Annual Progress Report.......... 36 1 10/60 6
Institutional Certification Template............ 36 1 5/60 3
---------------------------------------------------------------
Total....................................... 200 200 .............. 211
----------------------------------------------------------------------------------------------------------------
Dated: April 1, 2021.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2021-07313 Filed 4-8-21; 8:45 am]
BILLING CODE 4140-01-P
