Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry, 11210-11211 [2015-04255]
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
11210
Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices
Liability and Indemnification: By
participating in this Challenge, each
Solver agrees to assume any and all
risks and waive claims against the
federal government and its related
entities, except in the case of willful
misconduct, for any injury, death,
damage, or loss of property, revenue, or
profits, whether direct, indirect, or
consequential, arising from
participation in this Challenge, whether
the injury, death, damage, or loss arises
through negligence or otherwise. By
participating in this Challenge, each
Solver agrees to indemnify the federal
government against third party claims
for damages arising from or related to
Challenge activities.
Insurance: Based on the subject
matter of the Challenge, the type of
work that it will possibly require, as
well as an analysis of the likelihood of
any claims for death, bodily injury, or
property damage, or loss potentially
resulting from competition
participation. Solvers are not required to
obtain liability insurance or
demonstrate financial responsibility in
order to participate in this Challenge.
Privacy, Data Security, Ethics, and
Compliance: Solvers are required to
identify and address privacy and
security issues in their proposed
projects and describe specific solutions
for meeting them. In addition to
complying with appropriate policies,
procedures, and protections for data that
ensures all privacy requirements and
institutional policies are met, use of
data should not allow the identification
of the individual from whom the data
was collected. Solvers are responsible
for compliance with all applicable
federal, state, local, and institutional
laws, regulations, and policies. These
may include, but are not limited to,
Health Information Portability and
Accountability Act (HIPAA) protections,
Department of Health and Human
Services (HHS) Protection of Human
Subjects regulations, and Food and Drug
Administration (FDA) regulations. It is
the responsibility of the Solver to obtain
approvals (e.g., from an Institutional
Review Board), if required. The
following links are intended as a
starting point for addressing regulatory
requirements but should not be
interpreted as a complete list of
resources on these issues:
HIPAA
Main link: https://www.hhs.gov/ocr/
privacy/.
Summary of the HIPAA Privacy Rule:
https://www.hhs.gov/ocr/privacy/
VerDate Sep<11>2014
16:55 Feb 27, 2015
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hipaa/understanding/summary/
index.html.
Summary of the HIPAA Security Rule:
https://www.hhs.gov/ocr/privacy/
hipaa/understanding/
srsummary.html.
Human Subjects—HHS
Office for Human Research Protections:
https://www.hhs.gov/ohrp/.
Protection of Human Subjects
Regulations: https://www.hhs.gov/
ohrp/humansubjects/guidance/
45cfr46.html.
Policy & Guidance: https://www.hhs.gov/
ohrp/policy/.
Institutional Review Boards
&Assurances: https://www.hhs.gov/
ohrp/assurances/.
Human Subjects—FDA
Clinical Trials: https://www.fda.gov/
ScienceResearch/SpecialTopics/
RunningClinicalTrials/default.htm.
Office of Good Clinical Practice:
https://www.fda.gov/AboutFDA/
CentersOffices/
OfficeofMedicalProductsandTobacco/
OfficeofScienceandHealthCoordination/
ucm2018191.
Consumer Protection—Federal Trade
Commission
Bureau of Consumer Protection:
https://business.ftc.gov/privacy-andsecurity.
Dated: February 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015–04254 Filed 2–27–15; 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; The Genetic
Testing Registry
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 November 25,
2014, page 70194 and allowed 60 days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
SUMMARY:
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30 days for public comment. The Office
of the Director (OD), 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.
To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Ms. Sarah Carr, Acting Director,
Office of Clinical Research and
Bioethics Policy, Office of Science
Policy, NIH, 6705 Rockledge Dr., Suite
750, Bethesda, MD 20892, or call nontoll-free number (301) 496–9838, or
Email your request, including your
address to: OCRBP-OSP@od.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: The Genetic
Testing Registry, 0925–0651,
EXTENSION—Office of the Director
(OD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: Clinical laboratory tests are
available for more than 5,000 genetic
conditions. The Genetic Testing Registry
(GTR) provides a centralized, online
location for test developers,
manufacturers, and researchers to
voluntarily submit detailed information
about the availability and scientific
basis of their genetic tests. The GTR is
of value to clinicians by providing
information about the accuracy,
validity, and usefulness of genetic tests.
The GTR also highlights evidence gaps
where additional research is needed.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
5,536.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\02MRN1.SGM
02MRN1
11211
Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Laboratory Personnel Using Bulk Submission .....
Laboratory Personnel Not Using Bulk Submission.
Dated: February 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015–04255 Filed 2–27–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Board of Scientific Advisors,
March 11, 2015, 9:00 a.m. to March 11,
2015, 5:00 p.m., National Institutes of
Health, Building 31, 31 Center Drive,
Bethesda, MD 20892 which was
published in the Federal Register on
February 19, 2015, 80FR8889.
This Notice is being amended to
change the start time of the meeting
from 9:00 a.m. to 8:30 a.m. The meeting
is open to the public.
Dated: February 24, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–04170 Filed 2–27–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Environmental
Health Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
VerDate Sep<11>2014
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Number of
respondents
Form name
Minimal Fields
Optional Fields
Minimal Fields
Optional Fields
..............
.............
..............
.............
Number of
responses per
respondent
190
159
116
97
29
29
29
29
Average
burden per
response
(in hours)
Total annual
burden hours
18/60
14/60
30/60
24/60
1,653
1,076
1,682
1,125
notify the Contact Person listed below
in advance of the meeting.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Name of Committee: National Advisory
Environmental Health Sciences Council.
Date: March 16, 2015.
Open: March 16, 2015, 11:00 a.m. to 3:00
p.m.
Agenda: Discussion of program policies
and issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Contact Person: Gwen W Collman, Ph.D.,
Interim Director, Division of Extramural
Research & Training, National Institutes of
Health, Nat. Inst. of Environmental Health
Sciences, 615 Davis Dr., KEY615/3112,
Research Triangle Park, NC 27709, (919) 541–
4980, collman@niehs.nih.gov.
This is the open session rescheduled from
February 18–19, 2015 meeting, which was
postponed due to inclement weather.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.niehs.nih.gov/about/boards/naehsc/
index.cfm, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Substance Abuse and Mental Health
Services Administration
Dated: February 24, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–04168 Filed 2–27–15; 8:45 am]
BILLING CODE 4140–01–P
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Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine Drug
Testing for Federal Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITF) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908);
September 30, 1997 (62 FR 51118);
April 13, 2004 (69 FR 19644); November
25, 2008 (73 FR 71858); December 10,
2008 (73 FR 75122); and on April 30,
2010 (75 FR 22809).
A notice listing all currently HHScertified laboratories and IITFs is
published in the Federal Register
during the first week of each month. If
any laboratory or IITF certification is
suspended or revoked, the laboratory or
IITF will be omitted from subsequent
lists until such time as it is restored to
full certification under the Mandatory
Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
Internet at https://beta.samhsa.gov/
workplace.
FOR FURTHER INFORMATION CONTACT:
Giselle Hersh, Division of Workplace
Programs, SAMHSA/CSAP, Room 7–
1051, One Choke Cherry Road,
SUMMARY:
E:\FR\FM\02MRN1.SGM
02MRN1
]]>Agencies
[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)]
[Notices]
[Pages 11210-11211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04255]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; The Genetic
Testing Registry
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 November 25, 2014, page 70194 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 Office
of the Director (OD), 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: Ms. Sarah Carr, Acting Director, Office of
Clinical Research and Bioethics Policy, Office of Science Policy, NIH,
6705 Rockledge Dr., Suite 750, Bethesda, MD 20892, or call non-toll-
free number (301) 496-9838, or Email your request, including your
address to: OCRBP-OSP@od.nih.gov. Formal requests for additional plans
and instruments must be requested in writing.
Proposed Collection: The Genetic Testing Registry, 0925-0651,
EXTENSION--Office of the Director (OD), National Institutes of Health
(NIH).
Need and Use of Information Collection: Clinical laboratory tests
are available for more than 5,000 genetic conditions. The Genetic
Testing Registry (GTR) provides a centralized, online location for test
developers, manufacturers, and researchers to voluntarily submit
detailed information about the availability and scientific basis of
their genetic tests. The GTR is of value to clinicians by providing
information about the accuracy, validity, and usefulness of genetic
tests. The GTR also highlights evidence gaps where additional research
is needed.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 5,536.
[[Page 11211]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Laboratory Personnel Using Minimal Fields.. 190 29 18/60 1,653
Bulk Submission. Optional Fields. 159 29 14/60 1,076
Laboratory Personnel Not Using Minimal Fields.. 116 29 30/60 1,682
Bulk Submission. Optional Fields. 97 29 24/60 1,125
----------------------------------------------------------------------------------------------------------------
Dated: February 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-04255 Filed 2-27-15; 8:45 am]
BILLING CODE 4140-01-P
