83 FR 18575 - Proposed Collection; 60-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 82 (April 27, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 82 (April 27, 2018)
| Page Range | 18575-18576 | |
| FR Document | 2018-08901 |
[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)] [Notices] [Pages 18575-18576] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08901] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-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 requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Rohan Hazra, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, 6710B Rockledge Drive, Room 2113, Bethesda, MD 20817, or call non-toll-free number (301)-435-6868 or Email your request, including your address to: rohan.hazra@nih.gov. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Data and Specimen Hub (DASH)-0925-0744 expiration date 06/30/2019, 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 to add the collection of additional information from Users who will request biospecimens, submit the Institutional Certification for data/ biospecimen inventory, and submit DASH data/biospecimen Annual Progress Report for the NICHD Data and Specimen Hub (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 store and access de-identified study data and biospecimen inventories--a list of biospecimens available at the NICHD Biorepository--from studies funded by NICHD. The potential for public benefit to be achieved through sharing study data and/or biospecimen inventories for secondary analysis is significant. 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, and 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 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 study data archived in NICHD DASH without creating an account. Users who wish to submit or request research data and/or [[Page 18576]] biospecimen inventories must 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 biospecimen inventories will be required to provide additional supporting information to ensure proper use and security of NICHD DASH study data and biospecimen inventories. 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 Users by NICHD will be to:Communicate with the Users with regards to their data submission, data requests and biospecimen requests Monitor data submissions, data requests and biospecimen requests Notify interested recipients of updates to data and biospecimen inventories stored in NICHD DASH 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 204. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average time Type of form Number of Frequency of per response Total annual respondents response (in hours) burden hour ---------------------------------------------------------------------------------------------------------------- User Registration............................... 200 1 5/60 17 Data and Biospecimen Inventory Submission....... 36 1 2 72 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 .............. 204 ---------------------------------------------------------------------------------------------------------------- Dated: April 17, 2018. Jennifer M. Guimond, Project Clearance Liaison, Eunice Kennedy Shriver, National Institute of Child Health and Human Development, National Institutes of Health. [FR Doc. 2018-08901 Filed 4-26-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices 18575
meeting, see the DMICC website, Dated: April 18, 2018. agency’s estimate of the burden of the
www.diabetescommittee.gov, or contact Bruce T. Roberts, proposed collection of information,
Dr. B. Tibor Roberts, Executive Executive Secretary, DMICC, Office of including the validity of the
Secretary of the Diabetes Mellitus Scientific Program and Policy Analysis, methodology and assumptions used; (3)
Interagency Coordinating Committee, National Institute of Diabetes and Digestive Ways to enhance the quality, utility, and
National Institute of Diabetes and and Kidney Diseases, National Institutes of clarity of the information to be
Health. collected; and (4) Ways to minimizes
Digestive and Kidney Diseases, 31
Center Drive, Building 31A, Room [FR Doc. 2018–08900 Filed 4–26–18; 8:45 am] the burden of the collection of
9A19, MSC 2560, Bethesda, MD 20892– BILLING CODE 4140–01–P information on those who are to
2560, telephone: 301–496–6623; FAX: respond, including the use of
301–480–6741; email: dmicc@ appropriate automated, electronic,
DEPARTMENT OF HEALTH AND mechanical, or other technological
mail.nih.gov. HUMAN SERVICES collection techniques or other forms of
SUPPLEMENTARY INFORMATION: The information technology.
National Institutes of Health Proposed Collection Title: Data and
DMICC, chaired by the National
Institute of Diabetes and Digestive and Specimen Hub (DASH)–0925–0744
Proposed Collection; 60-Day Comment expiration date 06/30/2019, REVISION,
Kidney Diseases (NIDDK) comprising Request Data and Specimen Hub
members of the Department of Health Eunice Kennedy Shriver National
(DASH) (Eunice Kennedy Shriver Institute of Child Health and Human
and Human Services and other federal National Institute of Child Health and Development (NICHD), National
agencies that support diabetes-related Human Development) Institutes of Health (NIH).
activities, facilitates cooperation,
communication, and collaboration on AGENCY: National Institutes of Health, Need and Use of Information Collection
HHS.
diabetes among government entities. This is a request to revise the
DMICC meetings, held several times a ACTION: Notice.
previously approved submission to add
year, provide an opportunity for SUMMARY: In compliance with the the collection of additional information
Committee members to learn about and requirement of the Paperwork from Users who will request
discuss current and future diabetes Reduction Act of 1995 to provide biospecimens, submit the Institutional
programs in DMICC member opportunity for public comment on Certification for data/biospecimen
organizations and to identify proposed data collection projects, the inventory, and submit DASH data/
opportunities for collaboration. The National Institutes of Health will biospecimen Annual Progress Report for
May 29, 2018 DMICC meeting will focus publish periodic summaries of proposed the NICHD Data and Specimen Hub
on fostering research on older adults projects to be submitted to the Office of (DASH). DASH has been established by
with diabetes receiving long term care. Management and Budget (OMB) for NICHD as a data sharing mechanism for
review and approval. biomedical research investigators. It
Any member of the public interested
DATES: Comments regarding this serves as a centralized resource for
in presenting oral comments to the investigators to store and access de-
Committee should notify the contact information collection are best assured
of having their full effect if received identified study data and biospecimen
person listed on this notice at least 10 inventories—a list of biospecimens
days in advance of the meeting. within 60 days of the date of this
publication. available at the NICHD Biorepository—
Interested individuals and from studies funded by NICHD. The
representatives or organizations should FOR FURTHER INFORMATION CONTACT: To potential for public benefit to be
submit a letter of intent, a brief obtain a copy of the data collection achieved through sharing study data
description of the organization plans and instruments, submit and/or biospecimen inventories for
represented, and a written copy of their comments in writing, or request more secondary analysis is significant. NICHD
oral presentation in advance of the information on the proposed project, DASH supports NICHD’s mission to
meeting. Only one representative of an contact: Rohan Hazra, M.D., Eunice ensure that every person is born healthy
organization will be allowed to present; Kennedy Shriver National Institute of and wanted, that women suffer no
oral comments and presentations will be Child Health and Human Development harmful effects from reproductive
limited to a maximum of 5 minutes. (NICHD), National Institutes of Health, processes, and that all children have the
Printed and electronic copies are 6710B Rockledge Drive, Room 2113, chance to achieve their full potential for
requested for the record. In addition, Bethesda, MD 20817, or call non-toll- healthy and productive lives, free from
any interested person may file written free number (301)–435–6868 or Email disease or disability, and to ensure the
comments with the Committee by your request, including your address to: health, productivity, independence, and
forwarding their statement to the rohan.hazra@nih.gov. Formal requests well-being of all people through optimal
for additional plans and instruments rehabilitation. Study data and
contact person listed on this notice. The
must be requested in writing. biospecimen sharing and reuse will
statement should include the name,
SUPPLEMENTARY INFORMATION: Section promote testing of new hypotheses from
address, telephone number and when
applicable, the business or professional 3506(c)(2)(A) of the Paperwork data already collected, facilitate trans-
Reduction Act of 1995 requires: written disciplinary collaboration, accelerate
affiliation of the interested person.
comments and/or suggestions from the scientific findings and enable NICHD to
Because of time constraints for the
public and affected agencies are invited maximize the return on its investments
daltland on DSKBBV9HB2PROD with NOTICES
meeting, oral comments will be allowed
to address one or more of the following in research.
on a first-come, first-serve basis.
points: (1) Whether the proposed Anyone can access NICHD DASH to
Members of the public who would collection of information is necessary browse and view descriptive
like to receive email notification about for the proper performance of the information about the studies and study
future DMICC meetings should register function of the agency, including data archived in NICHD DASH without
for the listserv available on the DMICC whether the information will have creating an account. Users who wish to
website, www.diabetescommittee.gov. practical utility; (2) The accuracy of the submit or request research data and/or
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![18576 Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
biospecimen inventories must register biospecimens among investigators is All the data collected from use of
for an account. effective. The primary uses of the NICHD DASH except for information
Information will be collected from information collected from Users by provided in the annual progress reports
those wishing to create an account, NICHD will be to: are for the purposes of internal
• Communicate with the Users with administrative management of NICHD
sufficient to identify them as unique
regards to their data submission, data DASH. Information gathered through
Users. Those submitting or requesting
requests and biospecimen requests the annual progress reports may be used
data and/or biospecimen inventories • Monitor data submissions, data
will be required to provide additional in publications describing performance
requests and biospecimen requests
supporting information to ensure proper • Notify interested recipients of updates of the DASH system.
use and security of NICHD DASH study to data and biospecimen inventories OMB approval is requested for 3
data and biospecimen inventories. The stored in NICHD DASH years. There are no costs to respondents
information collected is limited to the • Help NICHD understand the use of other than their time. The total
essential data required to ensure the NICHD DASH study data and estimated annualized burden hours are
management of Users in NICHD DASH biospecimen inventories by the 204.
is efficient and the sharing of data and research community
ESTIMATED ANNUALIZED BURDEN HOURS
Average time
Number of Frequency of Total annual
Type of form per response
respondents response burden hour
(in hours)
User Registration ............................................................................................. 200 1 5/60 17
Data and Biospecimen Inventory Submission ................................................. 36 1 2 72
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 ........................ 204
Dated: April 17, 2018. ADDRESSES: Written comments and/or revised, or implemented on or after
Jennifer M. Guimond, suggestions regarding the item(s) October 1, 1995, unless it displays a
Project Clearance Liaison, Eunice Kennedy contained in this notice, especially currently valid OMB control number.
Shriver, National Institute of Child Health regarding the estimated public burden In compliance with Section
and Human Development, National Institutes and associated response time, should be 3507(a)(1)(D) of the Paperwork
of Health. directed to the: Office of Management Reduction Act of 1995, the National
[FR Doc. 2018–08901 Filed 4–26–18; 8:45 am] and Budget, Office of Regulatory Affairs, Institutes of Health (NIH) has submitted
BILLING CODE 4140–01–P OIRA_submission@omb.eop.gov or by to the Office of Management and Budget
fax to 202–395–6974, Attention: Desk (OMB) a request for review and
Officer for NIH. approval of the information collection
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: To listed below.
HUMAN SERVICES request more information on the Proposed Collection: CTEP Branch
proposed project or to obtain a copy of and Support Contracts Forms and
National Institutes of Health the data collection plans and Surveys, 0925–0753 Expiration Date 06/
Submission for OMB Review; 30-Day instruments, contact: Michael Montello, 30/2020, REVISION, National Cancer
Comment Request Pharm.D., Shanda Finnigan, MPH, RN, Institute (NCI), National Institutes of
CCRC or Jacquelyn Goldberg, JD, Cancer Health (NIH).
CTEP Branch and Support Contracts Therapy Evaluation Program, Division Need and Use of Information
Forms and Surveys (National Cancer of Cancer Treatment and Diagnosis, Collection: The National Cancer
Institute) 9609 Medical Center Drive, Rockville, Institute (NCI) Cancer Therapy
AGENCY: National Institutes of Health, MD 20850 or call non-toll-free number Evaluation Program (CTEP) and the
HHS. (240–276–6080) or email your request, Division of Cancer Prevention (DCP)
ACTION: Notice. including your address to: ctsucontact@ fund an extensive national program of
westat.com. cancer research, sponsoring clinical
SUMMARY: In compliance with the SUPPLEMENTARY INFORMATION: This trials in cancer prevention, symptom
Paperwork Reduction Act of 1995, the proposed information collection was management and treatment for qualified
National Institutes of Health (NIH) has previously published in the Federal clinical investigators. As part of this
submitted to the Office of Management Register on February 21, 2018, page effort, CTEP implements programs to
and Budget (OMB) a request for review 7483 (83 FR 7483) and allowed 60 days register clinical site investigators and
daltland on DSKBBV9HB2PROD with NOTICES
and approval of the information for public comment. No public clinical site staff, and to oversee the
collection listed below. comments were received. The National conduct of research at the clinical sites.
DATES: Comments regarding this Cancer Institute (NCI), National CTEP and DCP also oversee two support
information collection are best assured Institutes of Health, may not conduct or programs, the NCI Central Institutional
of having their full effect if received sponsor, and the respondent is not Review Board (CIRB) and the Cancer
within 30-days of the date of this required to respond to, an information Trial Support Unit (CTSU). The
publication. collection that has been extended, combined systems and processes for
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Document Created: 2018-04-27 01:45:47
Document Modified: 2018-04-27 01:45:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| Contact | To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Rohan Hazra, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, 6710B Rockledge Drive, Room 2113, Bethesda, MD 20817, or call non-toll-free | |
| FR Citation | 83 FR 18575 |
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