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80 FR 22543 - Proposed Collection; 60-Day Comment Request: National Children's Study (NCS) Data Archive and Repository (NICHD)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 77 (April 22, 2015)

Page Range22543-22543
FR Document2015-09359

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. 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) 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 the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Jack Moye, 6100 Executive Boulevard, Rockville Pike, MD 20891 or call 301- 594-8624 or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing.

Federal Register, Volume 80 Issue 77 (Wednesday, April 22, 2015) 
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Page 22543]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request: National Children's 
Study (NCS) Data Archive and Repository (NICHD)

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the Eunice Kennedy Shriver 
National Institute of Child Health and Human Development (NICHD), the 
National Institutes of Health (NIH) will publish periodic summaries of 
proposed projects to be submitted to the Office of Management and 
Budget (OMB) for review and approval.
    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) 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 the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology.
    To Submit Comments and for Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Dr. Jack 
Moye, 6100 Executive Boulevard, Rockville Pike, MD 20891 or call 301-
594-8624 or Email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.

DATES: Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: National Children's Study (NCS) Data Archive 
and Repository, 0925-NEW, National Institute of Child Health and Human 
Development (NICHD), National Institutes of Health (NIH).
    Need and Use of Information Collection: The primary use of this 
data archive and repository is to facilitate, document, track, monitor, 
and evaluate the access of NCS Vanguard Study data previously 
collected. There are two planned levels of data access associated with 
NCS Vanguard Study data: (1) Through a de-identified dataset containing 
key variables. Access requirements for the de-identified dataset would 
be modest, requiring that the investigators, promise not to attempt to 
re-identify participants, agree to cite the NCS as the source of the 
data, and submit a copy of any paper submitted or published using the 
data; (2) through a secure, virtual data enclave wherein users could 
access and analyze data, provided that they describe their research 
plan, submit IRB approval documentation, complete a Data User Agreement 
(DUA) DUA, and agree to submit a copy of any paper submitted or 
published using the data. In the planned virtual data enclave, the 
investigator cannot download any participant-level data for use outside 
of the protected analytic environment. Upon approval of the research 
project the data files specified in the DUA would be placed in the 
investigator's project space within the data enclave by the enclave 
staff. Final analytic results would be screened by the enclave staff 
for identifiable information prior to release back to the investigator.
    There is no plan to publish the data collected under this request. 
These data are for internal monitoring purposes to assess the enclave 
resource requirements.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 154.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
                      Form                           Number of     Frequency of   per response (   Total annual
                                                    respondents      response        in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
De-identified data access.......................             300               1           10/60              50
Enclave data access.............................             100               1               1             100
Additional data access..........................              50               1            5/60               4
----------------------------------------------------------------------------------------------------------------


    Dated: April 10, 2015.
Sarah L. Glavin,
Project Clearance Officer, Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, Deputy Director, Office of Science 
Policy, Analysis, and Communications, Eunice Kennedy Shriver National 
Institute of Child Health and Human Development, National Institutes of 
Health.
[FR Doc. 2015-09359 Filed 4-21-15; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22543 Dated: April 16, 2015. methodology and assumptions used; (3) with NCS Vanguard Study data: (1) David Sharlip, the quality, utility, and clarity of the Through a de-identified dataset Project Clearance Liaison, NLM, NIH. information to be collected; and (4) containing key variables. Access [FR Doc. 2015–09362 Filed 4–21–15; 8:45 am] minimize the burden of the collection of requirements for the de-identified BILLING CODE 4140–01–P information on those who are to dataset would be modest, requiring that respond, including the use of the investigators, promise not to attempt appropriate automated, electronic, to re-identify participants, agree to cite DEPARTMENT OF HEALTH AND mechanical, or other technological the NCS as the source of the data, and HUMAN SERVICES collection techniques or other forms of submit a copy of any paper submitted or information technology. published using the data; (2) through a National Institutes of Health To Submit Comments and for Further secure, virtual data enclave wherein Information: To obtain a copy of the users could access and analyze data, Proposed Collection; 60-Day Comment data collection plans and instruments, provided that they describe their Request: National Children’s Study submit comments in writing, or request research plan, submit IRB approval (NCS) Data Archive and Repository more information on the proposed (NICHD) documentation, complete a Data User project, contact: Dr. Jack Moye, 6100 Agreement (DUA) DUA, and agree to SUMMARY: In compliance with the Executive Boulevard, Rockville Pike, submit a copy of any paper submitted or requirement of Section 3506(c)(2)(A) of MD 20891 or call 301–594–8624 or published using the data. In the planned the Paperwork Reduction Act of 1995, Email your request, including your virtual data enclave, the investigator for opportunity for public comment on address to: moyej@mail.nih.gov. Formal cannot download any participant-level proposed data collection projects, the requests for additional plans and data for use outside of the protected Eunice Kennedy Shriver National instruments must be requested in analytic environment. Upon approval of Institute of Child Health and Human writing. the research project the data files Development (NICHD), the National DATES: Comment Due Date: Comments specified in the DUA would be placed Institutes of Health (NIH) will publish regarding this information collection are in the investigator’s project space within periodic summaries of proposed best assured of having their full effect if the data enclave by the enclave staff. projects to be submitted to the Office of received within 60 days of the date of Final analytic results would be screened Management and Budget (OMB) for this publication. by the enclave staff for identifiable review and approval. Proposed Collection: National information prior to release back to the Written comments and/or suggestions Children’s Study (NCS) Data Archive investigator. from the public and affected agencies and Repository, 0925–NEW, National are invited to address one or more of the Institute of Child Health and Human There is no plan to publish the data following points: (1) Whether the Development (NICHD), National collected under this request. These data proposed collection of information is Institutes of Health (NIH). are for internal monitoring purposes to necessary for the proper performance of Need and Use of Information assess the enclave resource the function of the agency, including Collection: The primary use of this data requirements. whether the information will have archive and repository is to facilitate, OMB approval is requested for 3 practical utility; (2) the accuracy of the document, track, monitor, and evaluate years. There are no costs to respondents agency’s estimate of the burden of the the access of NCS Vanguard Study data other than their time. The total proposed collection of information, previously collected. There are two estimated annualized burden hours are including the validity of the planned levels of data access associated 154. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Frequency time per Total annual Form respondents of response response burden hour ( in hours) De-identified data access ................................................................................ 300 1 10/60 50 Enclave data access ........................................................................................ 100 1 1 100 Additional data access ..................................................................................... 50 1 5/60 4 Dated: April 10, 2015. DEPARTMENT OF HOMELAND SUMMARY: This notice advises the public Sarah L. Glavin, SECURITY of the quarterly Internal Revenue Project Clearance Officer, Eunice Kennedy Service interest rates used to calculate Shriver National Institute of Child Health and U.S. Customs and Border Protection interest on overdue accounts Human Development, Deputy Director, Office (underpayments) and refunds of Science Policy, Analysis, and Quarterly IRS Interest Rates Used in (overpayments) of customs duties. For Communications, Eunice Kennedy Shriver Calculating Interest on Overdue the calendar quarter beginning April 1, asabaliauskas on DSK5VPTVN1PROD with NOTICES National Institute of Child Health and Human Accounts and Refunds on Customs 2015, the interest rates for overpayments Development, National Institutes of Health. Duties will be 2 percent for corporations and 3 [FR Doc. 2015–09359 Filed 4–21–15; 8:45 am] percent for non-corporations, and the AGENCY: U.S. Customs and Border BILLING CODE 4140–01–P interest rate for underpayments will be Protection, Department of Homeland 3 percent for both corporations and non- Security. corporations. This notice is published ACTION: General notice. for the convenience of the importing VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\22APN1.SGM 22APN1


Document Created: 2015-12-16 08:27:57
Document Modified: 2015-12-16 08:27:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 22543 
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