83 FR 55729 - Submission for OMB Review; 30-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 216 (November 7, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 216 (November 7, 2018)
| Page Range | 55729-55730 | |
| FR Document | 2018-24313 |
[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)] [Notices] [Pages 55729-55730] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24313] ----------------------------------------------------------------------- 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/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH. 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: 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: [email protected]. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on April 27, 2018, page 18576 (Vol 83) 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) 0925-0774 exp. date 6/30/19--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 deidentified study data and biospecimen inventories--a list of biospecimens available at the NICHD [[Page 55730]] 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 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 study data archived in NICHD DASH without creating an account. Users who wish to submit or request research data and/or 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 ---------------------------------------------------------------------------------------------------------------- Number of Average time Form Number of responses per per response Total annual respondents respondent (in hours) burden hour ---------------------------------------------------------------------------------------------------------------- User Registration............................... 200 1 5/60 17 Data Submission and Biospecimen Inventory 36 1 2 72 Submissions.................................... 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: November 1, 2018. Jennifer M. Guimond, Project Clearance Liaison, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. [FR Doc. 2018-24313 Filed 11-6-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices 55729
guidance is to assist sponsors in the DEPARTMENT OF HEALTH AND fax to 202–395–6974, Attention: Desk
clinical development of fixed HUMAN SERVICES Officer for NIH.
combination drug products for the FOR FURTHER INFORMATION CONTACT: To
treatment of hypertension. The guidance National Institutes of Health request more information on the
focuses on development of two-drug proposed project or to obtain a copy of
National Institute on Aging; Amended
combinations of previously approved the data collection plans and
Notice of Meeting
drug products. This guidance instruments, contact: Rohan Hazra,
incorporates the comments received for Notice is hereby given of a change in M.D., Eunice Kennedy Shriver National
and finalizes the draft guidance for the meeting of the National Institute on Institute of Child Health and Human
industry entitled ‘‘Hypertension: Aging Special Emphasis Panel, Development (NICHD), National
Developing Fixed-Dose Combination November 19, 2018, 8:30 a.m. to Institutes of Health, 6710B Rockledge
Drugs for Treatment’’ issued on January November 19, 2018, 4:00 p.m., National Drive, Room 2113, Bethesda, MD 20817,
26, 2018 (83 FR 3735). All the public Institute on Aging, Gateway Building, or call non-toll-free number (301)–435–
comments received on the draft 7201 Wisconsin Avenue, Suite 2W200, 6868 or Email your request, including
guidance have been considered, and the Bethesda, MD 20892 which was your address to: rohan.hazra@nih.gov.
guidance was revised as appropriate published in the Federal Register on SUPPLEMENTARY INFORMATION: This
primarily for editorial changes. October 30, 2018, 83 FR 54605. proposed information collection was
The meeting notice is amended to previously published in the Federal
This guidance is being issued change the meeting location from the Register on April 27, 2018, page 18576
consistent with FDA’s good guidance National Institute on Aging, Gateway (Vol 83) and allowed 60 days for public
practices regulation (21 CFR 10.115). Building, 7201 Wisconsin Avenue, Suite comment. No public comments were
The guidance represents the current 2W200, Bethesda, MD 20892 to received. The purpose of this notice is
thinking of FDA on ‘‘Hypertension: Bethesda Marriott, 5151 Pooks Hill to allow an additional 30 days for public
Developing Fixed-Combination Drug Road, Bethesda, MD 20814. The meeting comment.
Products for Treatment.’’ It does not is closed to the public. The Eunice Kennedy Shriver National
establish any rights for any person and Dated: November 1, 2018. Institute of Child Health and Human
is not binding on FDA or the public. Melanie J. Pantoja, Development (NICHD), National
You can use an alternative approach if Program Analyst, Office of Federal Advisory
Institutes of Health, may not conduct or
it satisfies the requirements of the Committee Policy. sponsor, and the respondent is not
applicable statutes and regulations. This [FR Doc. 2018–24293 Filed 11–6–18; 8:45 am]
required to respond to, an information
guidance is not subject to Executive collection that has been extended,
BILLING CODE 4140–01–P
Order 12866. revised, or implemented on or after
October 1, 1995, unless it displays a
II. Paperwork Reduction Act of 1995 currently valid OMB control number.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES In compliance with Section
This guidance refers to previously
3507(a)(1)(D) of the Paperwork
approved collections of information that Reduction Act of 1995, the National
are subject to review by the Office of National Institutes of Health
Institutes of Health (NIH) has submitted
Management and Budget (OMB) under Submission for OMB Review; 30-day to the Office of Management and Budget
the Paperwork Reduction Act of 1995 Comment Request: Data and Specimen (OMB) a request for review and
(44 U.S.C. 3501–3520). The collections Hub (DASH) (Eunice Kennedy Shriver approval of the information collection
of information in 21 CFR part 312 has National Institute of Child Health and listed below.
been approved under OMB control Human Development) Proposed Collection: Data and
number 0910–0014. The collection of Specimen Hub (DASH) 0925–0774 exp.
information in the guidance for industry AGENCY: National Institutes of Health, date 6/30/19—REVISION; Eunice
entitled ‘‘Hypertension Indication: Drug HHS. Kennedy Shriver National Institute of
Labeling for Cardiovascular Outcome ACTION: Notice. Child Health and Human Development
Claims’’ (available at https:// SUMMARY: In compliance with the (NICHD), National Institutes of Health
www.fda.gov/ucm/groups/fdagov- Paperwork Reduction Act of 1995, the (NIH).
public/@fdagov-drugs-gen/documents/ National Institutes of Health (NIH) has Need and Use of Information
document/ucm075072.pdf) has been submitted to the Office of Management Collection:
approved under OMB control number This is a request to revise the
and Budget (OMB) a request for review
0910–0670. previously approved submission to add
and approval of the information
the collection of additional information
III. Electronic Access collection listed below.
from Users who will request
DATES: Comments regarding this biospecimens, submit the Institutional
Persons with access to the internet information collection are best assured Certification for data/biospecimen
may obtain the guidance at either of having their full effect if received inventory, and submit DASH data/
https://www.fda.gov/Drugs/Guidance within 30-days of the date of this biospecimen Annual Progress Report for
ComplianceRegulatoryInformation/ publication. the NICHD Data and Specimen Hub
Guidances/default.htm or https:// ADDRESSES: Written comments and/or (DASH). DASH has been established by
amozie on DSK3GDR082PROD with NOTICES1
www.regulations.gov. suggestions regarding the item(s) NICHD as a data sharing mechanism for
Dated: November 1, 2018. contained in this notice, especially biomedical research investigators. It
Leslie Kux, regarding the estimated public burden serves as a centralized resource for
and associated response time, should be investigators to store and access
Associate Commissioner for Policy.
directed to the: Office of Management deidentified study data and
[FR Doc. 2018–24315 Filed 11–6–18; 8:45 am]
and Budget, Office of Regulatory Affairs, biospecimen inventories—a list of
BILLING CODE 4164–01–P OIRA_submission@omb.eop.gov or by biospecimens available at the NICHD
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![55730 Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
Biorepository—from studies funded by data archived in NICHD DASH without • Monitor data submissions, data
NICHD. The potential for public benefit creating an account. Users who wish to requests and biospecimen requests
to be achieved through sharing study submit or request research data and/or • Notify interested recipients of updates
data and/or biospecimen inventories for biospecimen inventories must register to data and biospecimen inventories
secondary analysis is significant. NICHD for an account. stored in NICHD DASH
DASH supports NICHD’s mission to Information will be collected from
ensure that every person is born healthy • Help NICHD understand the use of
those wishing to create an account,
and wanted, that women suffer no NICHD DASH study data and
sufficient to identify them as unique
harmful effects from reproductive Users. Those submitting or requesting biospecimen inventories by the
processes, and that all children have the data and/or biospecimen inventories research community
chance to achieve their full potential for will be required to provide additional All the data collected from use of
healthy and productive lives, free from supporting information to ensure proper
disease or disability, and to ensure the NICHD DASH except for information
use and security of NICHD DASH study provided in the annual progress reports
health, productivity, independence, and data and biospecimen inventories. The
well-being of all people through optimal are for the purposes of internal
information collected is limited to the administrative management of NICHD
rehabilitation. Study data and essential data required to ensure the
biospecimen sharing and reuse will DASH. Information gathered through
management of Users in NICHD DASH the annual progress reports may be used
promote testing of new hypotheses from is efficient and the sharing of data and
data already collected, facilitate in publications describing performance
biospecimens among investigators is
transdisciplinary collaboration, of the DASH system.
effective. The primary uses of the
accelerate scientific findings and enable OMB approval is requested for 3
information collected from Users by
NICHD to maximize the return on its years. There are no costs to respondents
NICHD will be to:
investments in research. other than their time. The total
Anyone can access NICHD DASH to • Communicate with the Users with estimated annualized burden hours are
browse and view descriptive regards to their data submission, data
204.
information about the studies and study requests and biospecimen requests
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average time
Number of responses Total annual
Form per response
respondents per burden hour
(in hours)
respondent
User Registration ............................................................................................. 200 1 5/60 17
Data Submission and Biospecimen Inventory Submissions ........................... 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: November 1, 2018. as amended. The contract proposals and (Catalogue of Federal Domestic Assistance
Jennifer M. Guimond, the discussions could disclose Program Nos. 93.233, National Center for
Project Clearance Liaison, Eunice Kennedy confidential trade secrets or commercial Sleep Disorders Research; 93.837, Heart and
Shriver National Institute of Child Health and property such as patentable material, Vascular Diseases Research; 93.838, Lung
Human Development, National Institutes of and personal information concerning Diseases Research; 93.839, Blood Diseases
Health. individuals associated with the contract and Resources Research, National Institutes
[FR Doc. 2018–24313 Filed 11–6–18; 8:45 am] proposals, the disclosure of which of Health, HHS)
BILLING CODE 4140–01–P would constitute a clearly unwarranted Dated: November 1, 2018.
invasion of personal privacy. Ronald J. Livingston, Jr.,
DEPARTMENT OF HEALTH AND Name of Committee: National Heart, Lung, Program Analyst, Office of Federal Advisory
HUMAN SERVICES and Blood Institute Special Emphasis Panel; Committee Policy.
Primate Center for Gene Therapy. [FR Doc. 2018–24294 Filed 11–6–18; 8:45 am]
National Institutes of Health Date: November 30, 2018. BILLING CODE 4140–01–P
Time: 2:00 p.m. to 4:00 p.m.
National Heart, Lung, and Blood Agenda: To review and evaluate contract
Institute; Notice of Closed Meeting proposals.
Place: National Institutes of Health, 6701
Pursuant to section 10(d) of the Rockledge Drive, Room 7180, Bethesda, MD
amozie on DSK3GDR082PROD with NOTICES1
Federal Advisory Committee Act, as 20892 (Telephone Conference Call).
amended, notice is hereby given of the Contact Person: Tony L Creazzo, Ph.D.,
following meeting. Scientific Review Officer, Office of Scientific
The meeting will be closed to the Review/DERA National Heart, Lung, and
public in accordance with the Blood Institute, National Institutes of Health,
provisions set forth in sections 6701 Rockledge Drive, Room 7180, Bethesda,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MD 20892–7924, 301–827–7913.
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Document Created: 2018-11-07 00:04:41
Document Modified: 2018-11-07 00:04:41
| 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 30-days of the date of this publication. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, 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 | |
| FR Citation | 83 FR 55729 |
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