83 FR 14018 - Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 63 (April 2, 2018)

Page Range		14018-14018
FR Document		2018-06572

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH), Office of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Federal Register, Volume 83 Issue 63 (Monday, April 2, 2018)

[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Page 14018]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-06572]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-Day Comment Request; The Genetic Testing
Registry

AGENCY: National Institutes of Health, Department of Health and Human
Services.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health (NIH), Office of
the Director (OD) will publish periodic summaries of proposed projects
to be submitted to the Office of Management and Budget (OMB) for review
and approval.

DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.

FOR FURTHER INFORMATION CONTACT: 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. Dina
Paltoo, Director, Division of Scientific Data Sharing 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: SciencePolicy@mail.nih.gov. Formal requests
for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: 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) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to 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.
Proposed Collection Title: 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
----------------------------------------------------------------------------------------------------------------
Average Total
Number of Number of time per annual
Type of respondent Form name respondents responses per response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Laboratory Personnel Using Bulk Minimal Fields....... 313 25 18/60 2,348
Submission.
Optional Fields...... 313 25 6/60 783
Laboratory Personnel Not Using Bulk Minimal Fields....... 64 25 30/60 800
Submission.
Optional Fields...... 64 25 10/60 267
-----------------------------------------------------
Total.......................... ..................... 377 18,850 ........... 4198
----------------------------------------------------------------------------------------------------------------

Dated: March 24, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-06572 Filed 3-30-18; 8:45 am]
BILLING CODE 4140-01-P

14018 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices

the HPV Implementation work group. SUMMARY: In compliance with the whether the information will have
All agenda items are tentative and requirement of the Paperwork practical utility; (2) The accuracy of the
subject to change. Information on the Reduction Act of 1995 to provide agency’s estimate of the burden of the
final meeting agenda will be posted opportunity for public comment on proposed collection of information,
prior to the meeting on the NVAC proposed data collection projects, the including the validity of the
website: http://www.hhs.gov/nvpo/ National Institutes of Health (NIH), methodology and assumptions used; (3)
nvac/index.html. Office of the Director (OD) will publish Ways to enhance the quality, utility, and
Members of the public will have the periodic summaries of proposed clarity of the information to be
opportunity to provide comments at the projects to be submitted to the Office of collected; and (4) Ways to minimize the
NVAC meeting during the public Management and Budget (OMB) for burden of the collection of information
comment periods designated on the review and approval. on those who are to respond, including
agenda. Public comments made during DATES: Comments regarding this the use of appropriate automated,
the meeting will be limited to three information collection are best assured electronic, mechanical, or other
minutes per person to ensure time is of having their full effect if received technological collection techniques or
allotted for all those wishing to speak. within 60 days of the date of this other forms of information technology.
Individuals are also welcome to submit publication.
their written comments. Written Proposed Collection Title: The
comments should not exceed three FOR FURTHER INFORMATION CONTACT: To Genetic Testing Registry, 0925–0651,
pages in length. Individuals submitting obtain a copy of the data collection Expiration Date 07/31/2018—
written comments should email their plans and instruments, submit EXTENSION, Office of the Director
comments to the National Vaccine comments in writing, or request more (OD), National Institutes of Health
Program Office (nvac@hhs.gov) at least information on the proposed project, (NIH).
five business days prior to the meeting. contact: Dr. Dina Paltoo, Director,
Division of Scientific Data Sharing Need and Use of Information
Dated: March 27, 2018. Collection: Clinical laboratory tests are
Policy, Office of Science Policy, NIH,
Roula Sweis, 6705 Rockledge Dr., Suite 750, available for more than 10,000 genetic
Deputy Director, National Vaccine Program Bethesda, MD 20892, or call nontoll— conditions. The Genetic Testing Registry
Office. free number (301) 496–9838, or Email (GTR) provides a centralized, online
[FR Doc. 2018–06663 Filed 3–30–18; 8:45 am] your request, including your address to: location for test developers,
BILLING CODE 4150–44–P SciencePolicy@mail.nih.gov. Formal manufacturers, and researchers to
requests for additional plans and voluntarily submit detailed information
instruments must be requested in about the availability and scientific
DEPARTMENT OF HEALTH AND writing. basis of their genetic tests. The GTR is
HUMAN SERVICES of value to clinicians by providing
SUPPLEMENTARY INFORMATION: Section
information about the accuracy,
National Institutes of Health 3506(c)(2)(A) of the Paperwork
validity, and usefulness of genetic tests.
Reduction Act of 1995 requires: Written
Proposed Collection; 60-Day Comment comments and/or suggestions from the The GTR also highlights evidence gaps
Request; The Genetic Testing Registry public and affected agencies are invited where additional research is needed.
to address one or more of the following OMB approval is requested for 3
AGENCY: National Institutes of Health,
Department of Health and Human points: (1) Whether the proposed years. There are no costs to respondents
Services. collection of information is necessary other than their time. The total
for the proper performance of the estimated annualized burden hours are
ACTION: Notice.
function of the agency, including 4,198.

ESTIMATED ANNUALIZED BURDEN HOURS
Average Total
Number of
Number of time per annual
Type of respondent Form name responses per
respondents response burden
respondent (in hours) 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 .................... 4198

Dated: March 24, 2018. DEPARTMENT OF HEALTH AND amended, notice is hereby given of the
Lawrence A. Tabak, HUMAN SERVICES following meeting.
Deputy Director, National Institutes of Health. The meeting will be closed to the
National Institutes of Health public in accordance with the
daltland on DSKBBV9HB2PROD with NOTICES

[FR Doc. 2018–06572 Filed 3–30–18; 8:45 am]
provisions set forth in sections
BILLING CODE 4140–01–P
National Eye Institute; Notice of Closed 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Meeting as amended. The grant applications and
the discussions could disclose
Pursuant to section 10(d) of the confidential trade secrets or commercial
Federal Advisory Committee Act, as property such as patentable material,
and personal information concerning

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Document Created: 2018-11-01 09:08:03
Document Modified: 2018-11-01 09:08:03

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 60 days of the date of this publication.
Contact		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. Dina Paltoo, Director, Division of Scientific Data Sharing 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,
FR Citation		83 FR 14018

83 FR 14018 - Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 63 (April 2, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health