Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry, 31410-31411 [2018-14435]
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Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices
National Standards for Culturally and
Linguistically Appropriate Services in
Health and Health Care at https://
minorityhealth.hhs.gov/omh/
browse.aspx?lvl=2&lvlid=53.
Pursuant to 45 CFR 80.3(d), an
individual shall not be deemed
subjected to discrimination by reason of
his or her exclusion from benefits
limited by Federal law to individuals
eligible for benefits and services from
the IHS.
Recipients will be required to sign the
HHS–690 Assurance of Compliance
form which can be obtained from the
following website: https://www.hhs.gov/
sites/default/files/forms/hhs-690.pdf,
and send it directly to the: U.S.
Department of Health and Human
Services, Office for Civil Rights, 200
Independence Avenue SW, Room 509F,
Washington, DC 20201.
amozie on DSK3GDR082PROD with NOTICES1
E. Federal Awardee Performance and
Integrity Information System (FAPIIS)
The IHS is required to review and
consider any information about the
applicant that is in the Federal Awardee
Performance and Integrity Information
System (FAPIIS) before making any
award in excess of the simplified
acquisition threshold (currently
$150,000) over the period of
performance. An applicant may review
and comment on any information about
itself that a Federal awarding agency
previously entered. The IHS will
consider any comments by the
applicant, in addition to other
information in FAPIIS in making a
judgment about the applicant’s integrity,
business ethics, and record of
performance under Federal awards
when completing the review of risk
posed by the applicant as described in
45 CFR 75.205.
As required by 45 CFR part 75
Appendix XII of the Uniform Guidance,
non-Federal entities (NFEs) are required
to disclose in FAPIIS any information
about criminal, civil, and administrative
proceedings, and/or affirm that there is
no new information to provide. This
applies to NFEs that receive Federal
awards (currently active grants,
cooperative agreements, and
procurement contracts) greater than
$10,000,000 for any period of time
during the period of performance of an
award/project.
Mandatory Disclosure Requirements
As required by 2 CFR part 200 of the
Uniform Guidance, and the HHS
implementing regulations at 45 CFR part
75, effective January 1, 2016, the IHS
must require a non-Federal entity or an
applicant for a Federal award to
disclose, in a timely manner, in writing,
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16:43 Jul 03, 2018
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to the IHS or pass-through entity, all
violations of Federal criminal law
involving fraud, bribery, or gratutity
violations potentially affecting the
Federal award.
Submission is required for all
applicants and recipients, in writing, to
the IHS and to the HHS Office of
Inspector General. 45 CFR 75.113.
Disclosures must be sent in writing to:
U.S. Department of Health and Human
Services, Indian Health Service,
Division of Grants Management, ATTN:
Robert Tarwater, Director, 5600 Fishers
Lane, Mailstop: 09E70, Rockville, MD
20857. (Include ‘‘Mandatory Grant
Disclosures’’ in subject line).
Telephone: (301) 443–5204.
Fax: (301) 594–0899.
Email: Robert.Tarwater@ihs.gov.
AND
U.S. Department of Health and
Human Services, Office of Inspector
General, ATTN: Mandatory Grant
Disclosures, Intake Coordinator, 330
Independence Avenue SW, Cohen
Building, Room 5527, Washington, DC
20201.
Website: https://oig.hhs.gov/fraud/
reportfraud/index.asp. (Include
‘‘Manatory Grant Disclosures’’ in subject
line).
Fax: (202) 205–0604 (Include
‘‘Mandatory Grant Disclosures’’ in
subject line) or
Email:
MandatoryGranteeDisclosures@
oig.hhs.gov.
Failure to make required disclosures
can result in any of the remedies
described in 45 CFR 75.371 Remedies
for noncompliance, including
suspension or debarment (See 2 CFR
part 180 and Part 376, and 31 U.S.C.
3321).
VII. Agency Contacts
1. Questions on the programmatic
issues may be directed to: Ms. Roselyn
Tso, Director, Office of Direct Service
and Contracting Tribes, Indian Health
Service, 5600 Fishers Lane, Mail Stop:
08E17, Rockville, MD 20857,
Telephone: (301) 443–1104, Email:
roselyn.tso@ihs.gov.
2. Questions on grants management
and fiscal matters may be directed to:
Ms. Vanietta Armstrong, Grants
Management Specialist, Indian Health
Service, OMS/DGM, 5600 Fishers Lane,
Mail Stop: 09E70, Rockville, MD 20857,
Telephone: (301) 443–4792, Fax: (301)
594–0899, Email: vanietta.armstrong@
ihs.gov.
3. Questions on technical systems
matters may be directed to: Mr. Paul
Gettys, Grant Systems Coordinator, 5600
Fishers Lane, Mail Stop: 09E70,
PO 00000
Frm 00052
Fmt 4703
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Rockville, MD 20857, Telephone: (301)
443–2114; or the DGM main line (301)
443–5204, Fax: (301) 594–0899, Email:
paul.gettys@ihs.gov.
VIII. Other Information
The Public Health Service strongly
encourages all recipients of cooperative
agreement and contracts provide a
smoke-free workplace and promote the
non-use of all tobacco products. In
addition, Pubic Law 103–227, the ProChildren Act of 1994, prohibits smoking
in certain facilities (or in some cases,
any portion of the facility) in which
regular or routine education, library,
day care, health care, or early childhood
development services are provided to
children. This is consistent with the
HHS mission to protect and advance the
physical and mental health of the
American people.
Dated: June 26, 2018.
Michael D. Weahkee,
RADM, Assistant Surgeon General, USPHS,
Acting Director, Indian Health Service.
[FR Doc. 2018–14426 Filed 7–3–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The Genetic
Testing Registry
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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.
SUMMARY:
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: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
ADDRESSES:
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Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices
the data collection plans and
instruments, contact: Dr. Dina Paltoo,
Director, Scientific Data Sharing Policy
Division, Office of Science Policy, NIH,
6705 Rockledge Dr., Suite 750,
Bethesda, MD 20892, or call non-tollfree number (301) 496–9838, or Email
your request, including your address to:
SciencePolicy@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on April 2, 2018, page 14018
(83 FR 14018) 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.
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: The Genetic
Testing Registry, 0925–0651, Expiration
Date 07/31/2018—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 10,000 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
4,198.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per
respondent
Average
time per
response
(in hours)
Total annual
burden hour
Type of respondent
Form name
Laboratory Personnel Using Bulk Submission ...............
Optional Fields.
Minimal Fields .....
313
25
18/60
2,348
.............................
Minimal Fields .....
313
64
25
25
6/60
30/60
783
800
.............................
64
25
10/60
267
.............................
377
18,850
........................
4,198
Laboratory Personnel Not Using Bulk Submission ........
Optional Fields.
Total .........................................................................
Dated: June 28, 2018.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2018–14435 Filed 7–3–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
amozie on DSK3GDR082PROD with NOTICES1
Center for Mental Health Services;
Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration (SAMHSA),
Center for Mental Health Services
(CMHS) National Advisory Council
(NAC) will meet on August 1, 2018,
from 9:00 a.m. to 5:00 p.m. E.D.T. The
NAC will convene in both open and
closed sessions on August 1, 2018.
The closed portion of the meeting will
include discussion of grant applications
that were reviewed by SAMHSA’s
Initial Review Groups, and involves an
examination of confidential financial
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and business information as well as
personal information concerning the
applications. Therefore, the meeting
will be closed to the public from 9:00
a.m. to 9:30 a.m., as determined by the
Assistant Secretary for Mental Health
and Substance Use, SAMHSA in
accordance with Title 5 U.S.C.
§ 552b(c)(4) and (6) and Title 5 U.S.C.
App. 2, § 10(d).
The remainder of this meeting will be
open to the public from 9:30 a.m. to 5:00
p.m., E.D.T., to include discussion of
the Center’s policy issues, updates on
the Interdepartmental Serious Mental
Illness Coordinating Committee,
presentations on Suicide Prevention,
School Mental Health/Child Trauma
and a conversation with the Assistant
Secretary for Mental Health and
Substance Use.
Attendance by the public will be
limited to available space. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the council. Written
submissions should be forwarded to the
contact person (below) on or before July
17, 2018. Oral presentations from the
public will be scheduled at the
conclusion of the meeting on
Wednesday, August 1, 2018. Five
PO 00000
Frm 00053
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minutes will be allotted for each
presentation. Meeting information and a
roster of Council members may be
obtained either by accessing the
SAMHSA Council website at https://
www.samhsa.gov/about-us/advisorycouncils/cmhs-national-advisorycouncil or by contacting Ms. Pamela
Foote (see contact information below).
The meeting can be accessed via
telephone. To obtain the conference
call-in number and access code, submit
written or brief oral comments, or
request special accommodations for
persons with disabilities, please register
at the SAMHSA’s Advisory Council
website at https://nac.samhsa.gov/
Registration/meetingsRegistration.aspx,
or contact Pamela Foote (see contact
information below).
Committee Name: Substance Abuse
and Mental Health Services
Administration Center for Mental
Health Services National Advisory
Council.
Dates/Time/Type: Wednesday,
August 1, 2018, 9:00 a.m. to 9:30 a.m.
EDT: CLOSED; Wednesday, August 1,
2018, 9:30 a.m. to 5:00 p.m. EDT: OPEN.
Place: SAMHSA, 5600 Fishers Lane,
5th Floor, Conference Room 5W11,
Rockville, Maryland 20857.
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]]>Agencies
[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31410-31411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14435]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; The Genetic
Testing Registry
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
[[Page 31411]]
the data collection plans and instruments, contact: Dr. Dina Paltoo,
Director, Scientific Data Sharing Policy Division, 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: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on April 2, 2018, page
14018 (83 FR 14018) 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.
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: The Genetic Testing Registry, 0925-0651,
Expiration Date 07/31/2018--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 10,000 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 4,198.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Form name Number of responses per per response Total annual
respondents respondent (in hours) burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Laboratory Personnel Using Bulk Submission..... Minimal Fields......................... 313 25 18/60 2,348
Optional Fields................................
....................................... 313 25 6/60 783
Laboratory Personnel Not Using Bulk Submission. Minimal Fields......................... 64 25 30/60 800
Optional Fields................................
....................................... 64 25 10/60 267
---------------------------------------------------------------
Total...................................... ....................................... 377 18,850 .............. 4,198
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: June 28, 2018.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2018-14435 Filed 7-3-18; 8:45 am]
BILLING CODE 4140-01-P
