80 FR 18640 - Submission for OMB Review; 30-day Comment Request; National Institute of Health Neurobiobank Tissue Access Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 66 (April 7, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 66 (April 7, 2015)
| Page Range | 18640-18641 | |
| FR Document | 2015-07871 |
[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)] [Notices] [Pages 18640-18641] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07871] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request; National Institute of Health Neurobiobank Tissue Access Request SUMMARY: Under the provisions of 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. This proposed information collection was previously published in the Federal Register on February 13, 2014, page 8723 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 National Institute of Mental Health (NIMH), 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. Direct Comments to OMB: 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: nimhprapubliccomments@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: National Institute of Health Neurobiobank Tissue Access Request--Existing without OMB Clearance--National Institute of Mental Health (NIMH), National Institute of Health (NIH). Need and Use of Information Collection: NIMH is seeking OMB approval for two Neurobiobank data collections: (1) Pre-Mortem Donor Recruitment Form, and (2) Tissue Access Request Form. The pre-mortem donor form will collect information from potential donors to ensure and enable appropriate research use of the tissues and biospecimens. Knowledge about the health history surrounding a particular tissue or biospecimen is essential to ethical scientific research conducted upon it. The tissue access request form will collect information from researchers who wish to gain access to the tissue stored throughout the Neurobiobank network, The NIH Neurobiobank Tissue Access Request form is necessary to verify that the researcher ``Recipient'' Principal Investigators and their organization or corporations applying to use the tissue is qualified to conduct human tissue research and have approved assurance from the DHHS Office of Human Research Protections to access tissue or biospecimens from the National Neurobiobank for research purposes. The primary use of this information is to document, track, monitor, and evaluate the appropriate use of the Neurobiobank tissue and biospecimen resources, as well as to notify interested recipients of updates, corrections, or other changes to the 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 38. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Frequency of burden per Total annual Form respondents response response (in burden hours hours) ---------------------------------------------------------------------------------------------------------------- Neurobiobank Tissue Access Request.............. 50 1 30/60 25 Pre-Mortem Donor Recruitment Form............... 50 1 15/60 13 --------------------------------------------------------------- Total....................................... 100 .............. .............. 38 ---------------------------------------------------------------------------------------------------------------- [[Page 18641]] Dated: March 30, 2015. Keisha L. Shropshire, NIMH Project Clearance Officer, NIMH, NIH. [FR Doc. 2015-07871 Filed 4-6-15; 8:45 am] BILLING CODE CODE 4140-01-P
![18640 Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices
and for recoveries under the Federal DEPARTMENT OF HEALTH AND Boulevard, MSC 9667, Rockville Pike,
Medical Care Recovery Act (42 U.S.C. HUMAN SERVICES Bethesda, MD 20892, or call 301–443–
§§ 2651–2653). The Medicare Part A 4335 or Email your request, including
inpatient rates are excluded from the National Institutes of Health your address to:
table below as they are paid based on nimhprapubliccomments@mail.nih.gov.
the prospective payment system. Since Submission for OMB Review; 30-day Formal requests for additional plans and
the inpatient rates set forth below do not Comment Request; National Institute instruments must be requested in
include all physician services and of Health Neurobiobank Tissue Access writing.
practitioner services, additional Request
Proposed Collection: National
payment shall be available to the extent SUMMARY: Under the provisions of Institute of Health Neurobiobank Tissue
that those services are provided. Section 3507(a)(1)(D) of the Paperwork Access Request—Existing without OMB
Reduction Act of 1995, the National Clearance—National Institute of Mental
Calendar Institutes of Health (NIH) has submitted
Year Health (NIMH), National Institute of
2015 to the Office of Management and Budget Health (NIH).
(OMB) a request for review and
Need and Use of Information
Inpatient Hospital Per Diem Rate approval of the information collection
Collection: NIMH is seeking OMB
(Excludes Physician/Practitioner listed below. This proposed information
Services) collection was previously published in approval for two Neurobiobank data
Lower 48 States ........................... $2,443 the Federal Register on February 13, collections: (1) Pre-Mortem Donor
Alaska ........................................... 2,926 2014, page 8723 and allowed 60-days Recruitment Form, and (2) Tissue
Outpatient Per Visit Rate (Exclud- for public comment. No public Access Request Form. The pre-mortem
ing Medicare) comments were received. The purpose donor form will collect information
Lower 48 States ........................... 350
of this notice is to allow an additional from potential donors to ensure and
Alaska ........................................... 601 enable appropriate research use of the
Outpatient Per Visit Rate (Medi- 30 days for public comment. The
National Institute of Mental Health tissues and biospecimens. Knowledge
care) about the health history surrounding a
Lower 48 States ........................... 307 (NIMH), National Institutes of Health,
may not conduct or sponsor, and the particular tissue or biospecimen is
Alaska ........................................... 564
Medicare Part B Inpatient Ancil- respondent is not required to respond essential to ethical scientific research
lary Per Diem Rate to, an information collection that has conducted upon it. The tissue access
Lower 48 States ........................... 516 been extended, revised, or implemented request form will collect information
Alaska ........................................... 956 on or after October 1, 1995, unless it from researchers who wish to gain
displays a currently valid OMB control access to the tissue stored throughout
Outpatient Surgery Rate (Medicare) number. the Neurobiobank network, The NIH
Direct Comments to OMB: Written Neurobiobank Tissue Access Request
Established Medicare rates for comments and/or suggestions regarding form is necessary to verify that the
freestanding Ambulatory Surgery the item(s) contained in this notice, researcher ‘‘Recipient’’ Principal
Centers. especially regarding the estimated Investigators and their organization or
Effective Date for Calendar Year 2015 public burden and associated response corporations applying to use the tissue
Rates time, should be directed to the: Office is qualified to conduct human tissue
of Management and Budget, Office of research and have approved assurance
Consistent with previous annual rate Regulatory Affairs, OIRA_submission@ from the DHHS Office of Human
revisions, the Calendar Year 2015 rates omb.eop.gov or by fax to 202–395–6974, Research Protections to access tissue or
will be effective for services provided Attention: NIH Desk Officer. biospecimens from the National
on/or after January 1, 2015 to the extent Comment Due Date: Comments Neurobiobank for research purposes.
consistent with payment authorities regarding this information collection are The primary use of this information is
including the applicable Medicaid State best assured of having their full effect if to document, track, monitor, and
plan. received within 30-days of the date of evaluate the appropriate use of the
this publication. Neurobiobank tissue and biospecimen
Dated: December 12, 2014.
FOR FURTHER INFORMATION CONTACT: To resources, as well as to notify interested
Yvette Roubideaux,
obtain a copy of the data collection recipients of updates, corrections, or
Acting Director, Indian Health Service. other changes to the system.
plans and instruments or request more
Editorial Note: The Federal Register information on the proposed project OMB approval is requested for 3
received this document for publication on contact: NIMH Project Clearance years. There are no costs to respondents
March 31, 2015. Liaison, Science Policy and Evaluation other than their time. The total
[FR Doc. 2015–07779 Filed 4–6–15; 8:45 am] Branch, OSPPC, NIMH, NIH, estimated annualized burden hours are
BILLING CODE 4160–16–P Neuroscience Center, 6001 Executive 38.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Frequency of burden per Total annual
Form
mstockstill on DSK4VPTVN1PROD with NOTICES
respondents response response burden hours
(in hours)
Neurobiobank Tissue Access Request ............................................................ 50 1 30/60 25
Pre-Mortem Donor Recruitment Form ............................................................. 50 1 15/60 13
Total .......................................................................................................... 100 ........................ ........................ 38
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![Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 18641
Dated: March 30, 2015. applicable, the business or professional mechanical, or other technological
Keisha L. Shropshire, affiliation of the interested person. collection techniques or other forms of
In the interest of security, NIH has information technology.
NIMH Project Clearance Officer, NIMH, NIH.
instituted stringent procedures for entrance
[FR Doc. 2015–07871 Filed 4–6–15; 8:45 am] To Submit Comments and For Further
onto the NIH campus. All visitor vehicles,
BILLING CODE CODE 4140–01–P including taxicabs, hotel, and airport shuttles Information: To obtain a copy of the
will be inspected before being allowed on data collection plans and instruments,
campus. Visitors will be asked to show one submit comments in writing, or request
DEPARTMENT OF HEALTH AND form of identification (for example, a more information on the proposed
HUMAN SERVICES government-issued photo ID, driver’s license, project, contact: Paris Watson, Senior
or passport) and to state the purpose of their Advisor, NIH Office of Disease
National Institutes of Health visit. Prevention, 6100 Executive Blvd., Room
Information is also available on the
2B03, Bethesda, MD 20892 or call (301)
National Institute on Deafness and Institute’s/Center’s home page: http://
www.nidcd.nih.gov/about/Pages/Advisory- 496–1508 or email your request,
Other Communication Disorders; including your address to prevention@
Groups-and-Review-Committees.aspx, where
Notice of Meeting an agenda and any additional information for mail.nih.gov. Formal requests for
Pursuant to section 10(d) of the the meeting will be posted when available. additional plans and instruments must
Federal Advisory Committee Act, as (Catalogue of Federal Domestic Assistance be requested in writing.
amended (5 U.S.C. App.), notice is Program Nos. 93.173, Biological Research DATES: Comments Due Date: Comments
Related to Deafness and Communicative regarding this information collection are
hereby given of a meeting of the Disorders, National Institutes of Health, HHS)
National Deafness and Other best assured of having their full effect if
Communication Disorders Advisory Dated: April 1, 2015. received within 60 days of the date of
Council. Melanie J. Gray, this publication.
The meeting will be open to the Program Analyst, Office of Federal Advisory Proposed Collection: Identifying
public as indicated below, with Committee Policy. Experts in Prevention Science Methods
attendance limited to space available. [FR Doc. 2015–07864 Filed 4–6–15; 8:45 am] to Include on NIH Review Panels,
Individuals who plan to attend and BILLING CODE CODE 4140–01–P 0925—New, Office of Disease
need special assistance, such as sign Prevention (ODP), National Institutes of
language interpretation or other Health (NIH).
reasonable accommodations, should DEPARTMENT OF HEALTH AND Need and Use of Information
notify the Contact Person listed below HUMAN SERVICES Collection: The Office of Disease
in advance of the meeting. Prevention (ODP) is the lead Office at
The meeting will be closed to the National Institutes of Health the National Institutes of Health (NIH)
public in accordance with the responsible for assessing, facilitating,
Proposed Collection; 60-day Comment and stimulating research in disease
provisions set forth in sections Request: Identifying Experts in
552b(c)(4) and 552b(c)(6), title 5 U.S.C., prevention and health promotion, and
Prevention Science Methods To disseminating the results of this
as amended. The grant applications and Include on NIH Review Panels (OD)
the discussions could disclose research to improve public health.
confidential trade secrets or commercial SUMMARY: In compliance with the Prevention is preferable to treatment,
property such as patentable material, requirement of Section 3506(c)(2)(A) of and research on disease prevention is an
and personal information concerning the Paperwork Reduction Act of 1995, important part of the NIH’s mission. The
individuals associated with the grant regarding the opportunity for public knowledge gained from this research
applications, the disclosure of which comment on proposed data collection leads to stronger clinical practice, health
would constitute a clearly unwarranted projects, the National Institutes of policy, and community health
invasion of personal privacy. Health (NIH), Office of Disease programs. ODP collaborates with the
Prevention (ODP) will publish periodic NIH, other Department of Health and
Name of Committee: National Deafness and
Other Communication Disorders Advisory summaries of proposed projects to be Human Services (DHHS) agencies, and
Council. submitted to the Office of Management other public and private partners to
Date: May 29, 2015. and Budget (OMB) for review and achieve the Office’s mission and goals.
Closed: 8:30 a.m. to 9:30 a.m. approval. One of our priorities is to promote the
Agenda: To review and evaluate grant Written comments and/or suggestions use of the best available methods in
applications. from the public and affected agencies prevention research and support the
Place: National Institutes of Health, are invited to address one or more of the development of better methods. One of
Building 31, Conference Room 6, 31 Center following points: (1) Whether the our strategies is to help the Center for
Drive, Bethesda, MD 20892. proposed collection of information is Scientific Review (CSR) identify experts
Open: 9:30 a.m. to 2:00 p.m.
Agenda: Staff reports on divisional,
necessary for the proper performance of in prevention science methods to
programmatic, and special activities. the function of the agency, including include on their review panels. This
Place: National Institutes of Health, whether the information will have will strengthen the panels and improve
Building 31, Conference Room 6, 31 Center practical utility; (2) The accuracy of the the quality of the prevention research
Drive, Bethesda, MD 20892. agency’s estimate of the burden of the supported by the NIH. To identify
Contact Person: CRAIG A. JORDAN, Ph.D., proposed collection of information, experts in prevention science methods,
Director, Division of Extramural Activities,
mstockstill on DSK4VPTVN1PROD with NOTICES
including the validity of the we worked with our contractor, IQ
NIDCD, NIH, Room 8345, MSC 9670, 6001 methodology and assumptions used; (3) Solutions, Inc., to develop online
Executive Blvd., Bethesda, MD 20892–9670, The quality, utility, and clarity of the software which will allow us to collect
301–496–8693, jordanc@nidcd.nih.gov.
Any interested person may file written
information to be collected; and (4) scientists’ names, contact information,
comments with the committee by forwarding Minimize the burden of the collection of and resumes, as well as to have those
the statement to the Contact Person listed on information on those who are to scientists identify their level of
this notice. The statement should include the respond, including the use of expertise in a variety of prevention
name, address, telephone number and when appropriate automated, electronic, science methods and content areas. The
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Document Created: 2018-02-21 10:05:27
Document Modified: 2018-02-21 10:05:27
| 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 | |
| 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 obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, | |
| FR Citation | 80 FR 18640 |
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