published 30-day FRN

18548

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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 http://
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
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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:

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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]
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