83 FR 31410 - Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 129 (July 5, 2018)

Page Range		31410-31411
FR Document		2018-14435

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.

Federal Register, Volume 83 Issue 129 (Thursday, July 5, 2018)

[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31410-31411]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14435]


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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.

-----------------------------------------------------------------------

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

31410 Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices

National Standards for Culturally and to the IHS or pass-through entity, all Rockville, MD 20857, Telephone: (301)
Linguistically Appropriate Services in violations of Federal criminal law 443–2114; or the DGM main line (301)
Health and Health Care at https:// involving fraud, bribery, or gratutity 443–5204, Fax: (301) 594–0899, Email:
minorityhealth.hhs.gov/omh/ violations potentially affecting the paul.gettys@ihs.gov.
browse.aspx?lvl=2&lvlid=53. Federal award.
Pursuant to 45 CFR 80.3(d), an VIII. Other Information
Submission is required for all
individual shall not be deemed applicants and recipients, in writing, to The Public Health Service strongly
subjected to discrimination by reason of the IHS and to the HHS Office of encourages all recipients of cooperative
his or her exclusion from benefits Inspector General. 45 CFR 75.113. agreement and contracts provide a
limited by Federal law to individuals Disclosures must be sent in writing to: smoke-free workplace and promote the
eligible for benefits and services from U.S. Department of Health and Human non-use of all tobacco products. In
the IHS. Services, Indian Health Service, addition, Pubic Law 103–227, the Pro-
Recipients will be required to sign the Division of Grants Management, ATTN: Children Act of 1994, prohibits smoking
HHS–690 Assurance of Compliance Robert Tarwater, Director, 5600 Fishers in certain facilities (or in some cases,
form which can be obtained from the Lane, Mailstop: 09E70, Rockville, MD any portion of the facility) in which
following website: http://www.hhs.gov/ 20857. (Include ‘‘Mandatory Grant regular or routine education, library,
sites/default/files/forms/hhs-690.pdf, Disclosures’’ in subject line). day care, health care, or early childhood
and send it directly to the: U.S. Telephone: (301) 443–5204. development services are provided to
Department of Health and Human Fax: (301) 594–0899. children. This is consistent with the
Services, Office for Civil Rights, 200 Email: Robert.Tarwater@ihs.gov. HHS mission to protect and advance the
Independence Avenue SW, Room 509F, physical and mental health of the
AND
Washington, DC 20201. American people.
U.S. Department of Health and
E. Federal Awardee Performance and Human Services, Office of Inspector Dated: June 26, 2018.
Integrity Information System (FAPIIS) General, ATTN: Mandatory Grant Michael D. Weahkee,
The IHS is required to review and Disclosures, Intake Coordinator, 330 RADM, Assistant Surgeon General, USPHS,
consider any information about the Independence Avenue SW, Cohen Acting Director, Indian Health Service.
applicant that is in the Federal Awardee Building, Room 5527, Washington, DC [FR Doc. 2018–14426 Filed 7–3–18; 8:45 am]
Performance and Integrity Information 20201. BILLING CODE 4165–16–P
System (FAPIIS) before making any Website: http://oig.hhs.gov/fraud/
award in excess of the simplified reportfraud/index.asp. (Include
acquisition threshold (currently ‘‘Manatory Grant Disclosures’’ in subject DEPARTMENT OF HEALTH AND
$150,000) over the period of line). HUMAN SERVICES
performance. An applicant may review Fax: (202) 205–0604 (Include
and comment on any information about ‘‘Mandatory Grant Disclosures’’ in National Institutes of Health
itself that a Federal awarding agency subject line) or
Email: Submission for OMB Review; 30-Day
previously entered. The IHS will Comment Request; The Genetic
consider any comments by the MandatoryGranteeDisclosures@
oig.hhs.gov. Testing Registry
applicant, in addition to other
information in FAPIIS in making a Failure to make required disclosures AGENCY: National Institutes of Health,
judgment about the applicant’s integrity, can result in any of the remedies HHS.
business ethics, and record of described in 45 CFR 75.371 Remedies ACTION: Notice.
performance under Federal awards for noncompliance, including
when completing the review of risk suspension or debarment (See 2 CFR SUMMARY: In compliance with the
posed by the applicant as described in part 180 and Part 376, and 31 U.S.C. Paperwork Reduction Act of 1995, the
45 CFR 75.205. 3321). National Institutes of Health (NIH) has
As required by 45 CFR part 75 VII. Agency Contacts submitted to the Office of Management
Appendix XII of the Uniform Guidance, and Budget (OMB) a request for review
non-Federal entities (NFEs) are required 1. Questions on the programmatic and approval of the information
to disclose in FAPIIS any information issues may be directed to: Ms. Roselyn collection listed below.
about criminal, civil, and administrative Tso, Director, Office of Direct Service DATES: Comments regarding this
proceedings, and/or affirm that there is and Contracting Tribes, Indian Health information collection are best assured
no new information to provide. This Service, 5600 Fishers Lane, Mail Stop: of having their full effect if received
applies to NFEs that receive Federal 08E17, Rockville, MD 20857, within 30-days of the date of this
awards (currently active grants, Telephone: (301) 443–1104, Email: publication.
cooperative agreements, and roselyn.tso@ihs.gov.
procurement contracts) greater than 2. Questions on grants management ADDRESSES: Written comments and/or
$10,000,000 for any period of time and fiscal matters may be directed to: suggestions regarding the item(s)
during the period of performance of an Ms. Vanietta Armstrong, Grants contained in this notice, especially
award/project. Management Specialist, Indian Health regarding the estimated public burden
Service, OMS/DGM, 5600 Fishers Lane, and associated response time, should be
Mandatory Disclosure Requirements Mail Stop: 09E70, Rockville, MD 20857, directed to the: Office of Management
amozie on DSK3GDR082PROD with NOTICES1

As required by 2 CFR part 200 of the Telephone: (301) 443–4792, Fax: (301) and Budget, Office of Regulatory Affairs,
Uniform Guidance, and the HHS 594–0899, Email: vanietta.armstrong@ OIRA_submission@omb.eop.gov or by
implementing regulations at 45 CFR part ihs.gov. fax to 202–395–6974, Attention: Desk
75, effective January 1, 2016, the IHS 3. Questions on technical systems Officer for NIH.
must require a non-Federal entity or an matters may be directed to: Mr. Paul FOR FURTHER INFORMATION CONTACT: To
applicant for a Federal award to Gettys, Grant Systems Coordinator, 5600 request more information on the
disclose, in a timely manner, in writing, Fishers Lane, Mail Stop: 09E70, proposed project or to obtain a copy of

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Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices 31411

the data collection plans and and the respondent is not required to Need and Use of Information
instruments, contact: Dr. Dina Paltoo, respond to, an information collection Collection: Clinical laboratory tests are
Director, Scientific Data Sharing Policy that has been extended, revised, or available for more than 10,000 genetic
Division, Office of Science Policy, NIH, implemented on or after October 1, conditions. The Genetic Testing Registry
6705 Rockledge Dr., Suite 750, 1995, unless it displays a currently valid (GTR) provides a centralized, online
Bethesda, MD 20892, or call non-toll- OMB control number. location for test developers,
free number (301) 496–9838, or Email manufacturers, and researchers to
In compliance with Section
your request, including your address to: voluntarily submit detailed information
3507(a)(1)(D) of the Paperwork
SciencePolicy@mail.nih.gov. about the availability and scientific
Reduction Act of 1995, the National
SUPPLEMENTARY INFORMATION: This basis of their genetic tests. The GTR is
Institutes of Health (NIH) has submitted of value to clinicians by providing
proposed information collection was
to the Office of Management and Budget information about the accuracy,
previously published in the Federal
(OMB) a request for review and validity, and usefulness of genetic tests.
Register on April 2, 2018, page 14018
approval of the information collection The GTR also highlights evidence gaps
(83 FR 14018) and allowed 60 days for
public comment. No public comments listed below. where additional research is needed.
were received. The purpose of this Proposed Collection: The Genetic OMB approval is requested for 3
notice is to allow an additional 30 days Testing Registry, 0925–0651, Expiration years. There are no costs to respondents
for public comment. The Office of the Date 07/31/2018—EXTENSION, Office other than their time. The total
Director (OD), National Institutes of of the Director (OD), National Institutes estimated annualized burden hours are
Health, may not conduct or sponsor, of Health (NIH). 4,198.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses time per Total annual
Type of respondent Form name respondents per response burden hour
respondent (in hours)

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. and business information as well as minutes will be allotted for each
Lawrence A. Tabak, personal information concerning the presentation. Meeting information and a
Principal Deputy Director, National Institutes applications. Therefore, the meeting roster of Council members may be
of Health. will be closed to the public from 9:00 obtained either by accessing the
[FR Doc. 2018–14435 Filed 7–3–18; 8:45 am] a.m. to 9:30 a.m., as determined by the SAMHSA Council website at http://
BILLING CODE 4140–01–P Assistant Secretary for Mental Health www.samhsa.gov/about-us/advisory-
and Substance Use, SAMHSA in councils/cmhs-national-advisory-
accordance with Title 5 U.S.C. council or by contacting Ms. Pamela
DEPARTMENT OF HEALTH AND § 552b(c)(4) and (6) and Title 5 U.S.C. Foote (see contact information below).
HUMAN SERVICES App. 2, § 10(d). The meeting can be accessed via
The remainder of this meeting will be telephone. To obtain the conference
Substance Abuse and Mental Health open to the public from 9:30 a.m. to 5:00 call-in number and access code, submit
Services Administration p.m., E.D.T., to include discussion of written or brief oral comments, or
the Center’s policy issues, updates on request special accommodations for
Center for Mental Health Services; the Interdepartmental Serious Mental persons with disabilities, please register
Notice of Meeting Illness Coordinating Committee, at the SAMHSA’s Advisory Council
presentations on Suicide Prevention, website at http://nac.samhsa.gov/
Pursuant to Public Law 92–463, School Mental Health/Child Trauma Registration/meetingsRegistration.aspx,
notice is hereby given that the and a conversation with the Assistant or contact Pamela Foote (see contact
Substance Abuse and Mental Health Secretary for Mental Health and information below).
Services Administration (SAMHSA), Substance Use. Committee Name: Substance Abuse
Center for Mental Health Services Attendance by the public will be and Mental Health Services
(CMHS) National Advisory Council limited to available space. Interested Administration Center for Mental
(NAC) will meet on August 1, 2018, persons may present data, information, Health Services National Advisory
from 9:00 a.m. to 5:00 p.m. E.D.T. The or views, orally or in writing, on issues Council.
amozie on DSK3GDR082PROD with NOTICES1

NAC will convene in both open and pending before the council. Written Dates/Time/Type: Wednesday,
closed sessions on August 1, 2018. submissions should be forwarded to the August 1, 2018, 9:00 a.m. to 9:30 a.m.
The closed portion of the meeting will contact person (below) on or before July EDT: CLOSED; Wednesday, August 1,
include discussion of grant applications 17, 2018. Oral presentations from the 2018, 9:30 a.m. to 5:00 p.m. EDT: OPEN.
that were reviewed by SAMHSA’s public will be scheduled at the Place: SAMHSA, 5600 Fishers Lane,
Initial Review Groups, and involves an conclusion of the meeting on 5th Floor, Conference Room 5W11,
examination of confidential financial Wednesday, August 1, 2018. Five Rockville, Maryland 20857.

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Document Created: 2018-07-03 23:39:50
Document Modified: 2018-07-03 23:39:50

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: 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
FR Citation		83 FR 31410

83 FR 31410 - Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 129 (July 5, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health