80 FR 11210 - 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 80, Issue 40 (March 2, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 40 (March 2, 2015)
| Page Range | 11210-11211 | |
| FR Document | 2015-04255 |
[Federal Register Volume 80, Number 40 (Monday, March 2, 2015)] [Notices] [Pages 11210-11211] From the Federal Register Online [www.thefederalregister.org] [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
![11210 Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices
Liability and Indemnification: By hipaa/understanding/summary/ 30 days for public comment. The Office
participating in this Challenge, each index.html. of the Director (OD), National Institutes
Solver agrees to assume any and all Summary of the HIPAA Security Rule: of Health, may not conduct or sponsor,
risks and waive claims against the http://www.hhs.gov/ocr/privacy/ and the respondent is not required to
federal government and its related hipaa/understanding/ respond to, an information collection
entities, except in the case of willful srsummary.html. that has been extended, revised, or
misconduct, for any injury, death, implemented on or after October 1,
Human Subjects—HHS
damage, or loss of property, revenue, or 1995, unless it displays a currently valid
profits, whether direct, indirect, or Office for Human Research Protections: OMB control number.
consequential, arising from http://www.hhs.gov/ohrp/index.html. Direct Comments to OMB: Written
participation in this Challenge, whether Protection of Human Subjects comments and/or suggestions regarding
the injury, death, damage, or loss arises Regulations: http://www.hhs.gov/ the item(s) contained in this notice,
through negligence or otherwise. By ohrp/humansubjects/guidance/ especially regarding the estimated
participating in this Challenge, each 45cfr46.html. public burden and associated response
Solver agrees to indemnify the federal Policy & Guidance: http://www.hhs.gov/ time, should be directed to the: Office
government against third party claims ohrp/policy/index.html. of Management and Budget, Office of
for damages arising from or related to Institutional Review Boards Regulatory Affairs, OIRA_submission@
Challenge activities. &Assurances: http://www.hhs.gov/ omb.eop.gov or by fax to 202–395–6974,
Insurance: Based on the subject ohrp/assurances/index.html. Attention: NIH Desk Officer.
matter of the Challenge, the type of
Human Subjects—FDA Comment Due Date: Comments
work that it will possibly require, as
well as an analysis of the likelihood of Clinical Trials: http://www.fda.gov/ regarding this information collection are
any claims for death, bodily injury, or ScienceResearch/SpecialTopics/ best assured of having their full effect if
property damage, or loss potentially RunningClinicalTrials/default.htm. received within 30-days of the date of
resulting from competition Office of Good Clinical Practice: this publication.
participation. Solvers are not required to http://www.fda.gov/AboutFDA/ FOR FURTHER INFORMATION CONTACT: To
obtain liability insurance or CentersOffices/ obtain a copy of the data collection
demonstrate financial responsibility in OfficeofMedicalProductsandTobacco/ plans and instruments or request more
order to participate in this Challenge. OfficeofScienceandHealthCoordination/ information on the proposed project
Privacy, Data Security, Ethics, and ucm2018191. contact: Ms. Sarah Carr, Acting Director,
Compliance: Solvers are required to Office of Clinical Research and
Consumer Protection—Federal Trade
identify and address privacy and Bioethics Policy, Office of Science
Commission
security issues in their proposed Policy, NIH, 6705 Rockledge Dr., Suite
projects and describe specific solutions Bureau of Consumer Protection: 750, Bethesda, MD 20892, or call non-
for meeting them. In addition to http://business.ftc.gov/privacy-and- toll-free number (301) 496–9838, or
complying with appropriate policies, security. Email your request, including your
procedures, and protections for data that Dated: February 23, 2015. address to: OCRBP-OSP@od.nih.gov.
ensures all privacy requirements and Lawrence A. Tabak, Formal requests for additional plans and
institutional policies are met, use of instruments must be requested in
Deputy Director, National Institutes of Health.
data should not allow the identification writing.
[FR Doc. 2015–04254 Filed 2–27–15; 8:45 am]
of the individual from whom the data Proposed Collection: The Genetic
was collected. Solvers are responsible BILLING CODE 4140–01–P
Testing Registry, 0925–0651,
for compliance with all applicable EXTENSION—Office of the Director
federal, state, local, and institutional (OD), National Institutes of Health
DEPARTMENT OF HEALTH AND
laws, regulations, and policies. These (NIH).
HUMAN SERVICES
may include, but are not limited to,
Health Information Portability and Need and Use of Information
National Institutes of Health Collection: Clinical laboratory tests are
Accountability Act (HIPAA) protections,
Department of Health and Human available for more than 5,000 genetic
Submission for OMB Review; 30-Day conditions. The Genetic Testing Registry
Services (HHS) Protection of Human Comment Request; The Genetic
Subjects regulations, and Food and Drug (GTR) provides a centralized, online
Testing Registry location for test developers,
Administration (FDA) regulations. It is
the responsibility of the Solver to obtain SUMMARY: Under the provisions of manufacturers, and researchers to
approvals (e.g., from an Institutional Section 3507(a)(1)(D) of the Paperwork voluntarily submit detailed information
Review Board), if required. The Reduction Act of 1995, the National about the availability and scientific
following links are intended as a Institutes of Health (NIH) has submitted basis of their genetic tests. The GTR is
starting point for addressing regulatory to the Office of Management and Budget of value to clinicians by providing
requirements but should not be (OMB) a request for review and information about the accuracy,
interpreted as a complete list of approval of the information collection validity, and usefulness of genetic tests.
resources on these issues: listed below. This proposed information The GTR also highlights evidence gaps
collection was previously published in where additional research is needed.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HIPAA the Federal Register on November 25, OMB approval is requested for 3
Main link: http://www.hhs.gov/ocr/ 2014, page 70194 and allowed 60 days years. There are no costs to respondents
privacy/index.html. for public comment. No public other than their time. The total
Summary of the HIPAA Privacy Rule: comments were received. The purpose estimated annualized burden hours are
http://www.hhs.gov/ocr/privacy/ of this notice is to allow an additional 5,536.
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![Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Notices 11211
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
Type of respondent Form name responses per
respondents response burden hours
respondent (in hours)
Laboratory Personnel Using Bulk Submission ..... Minimal Fields .............. 190 29 18/60 1,653
Optional Fields ............. 159 29 14/60 1,076
Laboratory Personnel Not Using Bulk Submis- Minimal Fields .............. 116 29 30/60 1,682
sion. Optional Fields ............. 97 29 24/60 1,125
Dated: February 23, 2015. notify the Contact Person listed below DEPARTMENT OF HEALTH AND
Lawrence A. Tabak, in advance of the meeting. HUMAN SERVICES
Deputy Director, National Institutes of Health. Name of Committee: National Advisory
[FR Doc. 2015–04255 Filed 2–27–15; 8:45 am] Substance Abuse and Mental Health
Environmental Health Sciences Council.
Services Administration
BILLING CODE 4140–01–P Date: March 16, 2015.
Open: March 16, 2015, 11:00 a.m. to 3:00 Current List of HHS-Certified
p.m. Laboratories and Instrumented Initial
DEPARTMENT OF HEALTH AND Agenda: Discussion of program policies
HUMAN SERVICES Testing Facilities Which Meet Minimum
and issues. Standards To Engage in Urine Drug
Place: Nat. Inst. of Environmental Health
National Institutes of Health Testing for Federal Agencies
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research AGENCY: Substance Abuse and Mental
National Cancer Institute Amended
Triangle Park, NC 27709. Health Services Administration, HHS.
Notice of Meeting
Contact Person: Gwen W Collman, Ph.D., ACTION: Notice.
Notice is hereby given of a change in Interim Director, Division of Extramural
the meeting of the National Cancer Research & Training, National Institutes of SUMMARY: The Department of Health and
Institute Board of Scientific Advisors, Health, Nat. Inst. of Environmental Health Human Services (HHS) notifies federal
March 11, 2015, 9:00 a.m. to March 11, Sciences, 615 Davis Dr., KEY615/3112, agencies of the laboratories and
2015, 5:00 p.m., National Institutes of Research Triangle Park, NC 27709, (919) 541– Instrumented Initial Testing Facilities
Health, Building 31, 31 Center Drive, 4980, collman@niehs.nih.gov. (IITF) currently certified to meet the
Bethesda, MD 20892 which was This is the open session rescheduled from standards of the Mandatory Guidelines
published in the Federal Register on February 18–19, 2015 meeting, which was for Federal Workplace Drug Testing
February 19, 2015, 80FR8889. postponed due to inclement weather. Programs (Mandatory Guidelines). The
This Notice is being amended to Any interested person may file written Mandatory Guidelines were first
change the start time of the meeting comments with the committee by forwarding published in the Federal Register on
from 9:00 a.m. to 8:30 a.m. The meeting the statement to the Contact Person listed on April 11, 1988 (53 FR 11970), and
is open to the public. this notice. The statement should include the subsequently revised in the Federal
name, address, telephone number and when Register on June 9, 1994 (59 FR 29908);
Dated: February 24, 2015. September 30, 1997 (62 FR 51118);
applicable, the business or professional
Melanie J. Gray, affiliation of the interested person. April 13, 2004 (69 FR 19644); November
Program Analyst, Office of Federal Advisory Information is also available on the 25, 2008 (73 FR 71858); December 10,
Committee Policy. Institute’s/Center’s home page: http:// 2008 (73 FR 75122); and on April 30,
[FR Doc. 2015–04170 Filed 2–27–15; 8:45 am] www.niehs.nih.gov/about/boards/naehsc/ 2010 (75 FR 22809).
BILLING CODE 4140–01–P index.cfm, where an agenda and any A notice listing all currently HHS-
additional information for the meeting will certified laboratories and IITFs is
be posted when available. published in the Federal Register
DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance during the first week of each month. If
HUMAN SERVICES Program Nos. 93.115, Biometry and Risk any laboratory or IITF certification is
Estimation—Health Risks from suspended or revoked, the laboratory or
National Institutes of Health IITF will be omitted from subsequent
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety lists until such time as it is restored to
National Institute of Environmental
Training; 93.143, NIEHS Superfund full certification under the Mandatory
Health Sciences; Notice of Meeting
Hazardous Substances—Basic Research and Guidelines.
Pursuant to section 10(d) of the Education; 93.894, Resources and Manpower If any laboratory or IITF has
Federal Advisory Committee Act, as Development in the Environmental Health withdrawn from the HHS National
amended (5 U.S.C. App.), notice is Sciences; 93.113, Biological Response to Laboratory Certification Program (NLCP)
hereby given of a meeting of the Environmental Health Hazards; 93.114, during the past month, it will be listed
National Advisory Environmental Applied Toxicological Research and Testing, at the end and will be omitted from the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Health Sciences Council. National Institutes of Health, HHS) monthly listing thereafter.
The meeting will be open to the This notice is also available on the
Dated: February 24, 2015.
public as indicated below, with Internet at http://beta.samhsa.gov/
Carolyn Baum, workplace.
attendance limited to space available.
Program Analyst, Office of Federal Advisory
Individuals who plan to attend and FOR FURTHER INFORMATION CONTACT:
Committee Policy.
need special assistance, such as sign Giselle Hersh, Division of Workplace
[FR Doc. 2015–04168 Filed 2–27–15; 8:45 am]
language interpretation or other Programs, SAMHSA/CSAP, Room 7–
reasonable accommodations, should BILLING CODE 4140–01–P 1051, One Choke Cherry Road,
VerDate Sep<11>2014 16:55 Feb 27, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1](https://thefederalregister.org/doc/80_FR_11250/page/2.svg)
Document Created: 2015-12-18 12:07:05
Document Modified: 2015-12-18 12:07:05
| 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: 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 | |
| FR Citation | 80 FR 11210 |
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