Submission for OMB Review; Comment Request Information Program on the Genetic Testing Registry, 72424-72425 [2011-30286]

Download as PDF 72424 Federal Register / Vol. 76, No. 226 / Wednesday, November 23, 2011 / Notices collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: National Sample Survey of Nurse Practitioners (OMB No. 0915–xxxx)—[New] The number of nurse practitioners (NP) in the United States has been growing rapidly over the past decade, and continued growth is expected as the annual number of graduates from NP programs is at an all time high. Furthermore, over the past 20 years, financial and regulatory changes have impacted the growth in NPs. The expansion of health insurance under the ‘‘Patient Protection and Affordable Care Act’’ (Pub. L. 111–148) will have an impact on the demand for services. With increasing numbers, NPs are poised to play a critical role in the nation’s efforts to expand access to health care services. Despite the increasing number and roles of NPs, unfortunately, there are currently only limited, inconsistent data available to policy makers and the health care community. Accordingly, it is difficult for these leaders to quantify or fully understand the role of NPs in the current (or future projected course of the) health care system. In fact, it is difficult to estimate with confidence the number of NPs practicing in the U.S. today. The primary purpose of the Bureau of Health Profession’s National Sample Survey of Nurse Practitioners data collection is to: (1) Improve estimates of NPs providing services; (2) describe the settings where NPs are working; (3) identify the positions/roles in which Number of respondents Instrument NPs are working; (4) describe the activities and services NPs are providing in the healthcare workforce; (5) determine the specialties in which NPs are working; (6) explore NPs’ satisfaction with and perception of the extent to which they are working to their full scope of practice; and (7) assess variations in practice settings, positions, and practice patterns by demographic and educational characteristics. The statutory provision that authorizes this data collection is section 761(b) of the Public Health Service Act, ‘‘National Center for Health Care Workforce Analysis,’’ which is codified at 42 U.S.C. 294n(b). The information obtained from this survey will ultimately lead to more accurate and complete national estimates of the current NP supply as well as assist in the development of more accurate NP supply and demand projections. The annual estimate of burden is as follows: Responses per respondent Total responses Hours per response Total burden hours National Sample Survey of Nurse Practitioners ........ 14,300 1 14,300 .33 4,719 Total .................................................................... 14,300 .......................... 14,300 .......................... 4,719 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Dated: November 17, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2011–30214 Filed 11–22–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES sroberts on DSK5SPTVN1PROD with NOTICES National Institutes of Health Submission for OMB Review; Comment Request Information Program on the Genetic Testing Registry National Institutes of Health (NIH), PHS, DHHS. ACTION: Request for comments AGENCY: Under the provisions of Section 3507(a) (1)(D) of the Paperwork SUMMARY: VerDate Mar<15>2010 17:03 Nov 22, 2011 Jkt 226001 Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 27, 2011, (76 FR 44937) and allowed 60 days for public comment. Twelve public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The 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. Proposed Collection: Title: The Genetic Testing Registry; Type of Information Collection Request: New collection; Need and Use of Information Collection: Laboratory tests for more than 2,000 genetic conditions are available; however, there is no centralized public resource that provides information about the availability and scientific basis of these tests. Recognizing the importance of making this information easily accessible to PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 health care providers, patients, consumers, and others, NIH is developing a voluntary registry of genetic tests. The Genetic Testing Registry (GTR) will provide a centralized, online location for test developers, manufacturers, and researchers to submit detailed information about genetic tests. The overarching goal of the GTR is to advance the public health and research in the genetic basis of health and disease. As such, the Registry will have several key functions, including (1) Encouraging providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests; (2) providing an information resource for the public, including health care providers, patients, and researchers, to locate laboratories that offer particular tests; and (3) facilitating genetic and genomic data-sharing for research and new scientific discoveries. Frequency of Response: The information will be submitted voluntarily on a non-repeating, continual basis. Submitters will be requested to update their test information at least once every 12 months. E:\FR\FM\23NON1.SGM 23NON1 Federal Register / Vol. 76, No. 226 / Wednesday, November 23, 2011 / Notices Respondents: Submitters to the GTR are expected to include clinical laboratories, researchers, and entities that report and interpret tests performed elsewhere. The GTR is not limited to U.S. respondents; it will also include submissions from outside the United States. Information will be collected and managed using an online submission system. Estimate of Burden: Although participation in the GTR is voluntary, in order to participate, respondents must provide information for a certain subset of fields, identified as the ‘‘minimal fields.’’ GTR includes 31 minimal fields and 85 optional fields. Sixteen of the 31 minimal fields refer to contact data and other information about the laboratory, which the respondent completes only once. These data will autopopulate new 72425 test records, leaving 15 minimal fields that require completion. The GTR will also support bulk submission as an XML file or uploading subsets of information from spreadsheets, which will significantly reduce the burden for laboratories that want to provide information on multiple genetic tests. The annualized cost to respondents is estimated at $1,103. ESTIMATES OF HOUR BURDEN Estimated number of respondents Type of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested 770 12 Minimal Fields: 0.5 ......................... Optional Fields: 2.5 ........................ Minimal Fields: 4,620. Optional Fields: 23,100. Total ......................................... sroberts on DSK5SPTVN1PROD with NOTICES Laboratory ....................................... Personnel ........................................ 770 ........................ 3.0 .................................................. 27,720. Request For Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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. 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: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instrument, contact: Amy P. Patterson, M.D., Associate Director for Science Policy, NIH, by mail to the Office of Biotechnology Activities, 6705 Rockledge Dr., Suite 750, Bethesda, MD 20892; telephone (301) 496–9838; fax (301) 496–9839; or email gtr@od.nih.gov; or refer to the GTR Web site at https://oba.od.nih.gov/gtr/gtr.html. VerDate Mar<15>2010 17:03 Nov 22, 2011 Jkt 226001 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. Dated: November 16, 2011. Amy P. Patterson, Associate Director for Science Policy, NIH. [FR Doc. 2011–30286 Filed 11–22–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentablematerial, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Hemodialysis and Markers of Heart Failure. Date: December 5, 2011. Time: 2 p.m. to 3 p.m. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Barbara A WoynarowskA, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 754, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 402–7172, woynarowskab@niddk.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special; Emphasis Panel. HAPO Follow up Studies. Date:December 7, 2011. Time: 3 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Carol J. Goter-Robinson, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 748, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7791, goterrobinsonc@extra.niddk.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Ancillary Study to the Hispanic Community Health Study. Date: December 8, 2011. Time: 4:30 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Notices]
[Pages 72424-72425]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30286]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request Information Program on 
the Genetic Testing Registry

AGENCY: National Institutes of Health (NIH), PHS, DHHS.

ACTION: Request for comments

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

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 to review and approve the information collection listed below. 
This proposed information collection was previously published in the 
Federal Register on July 27, 2011, (76 FR 44937) and allowed 60 days 
for public comment. Twelve public comments were received. The purpose 
of this notice is to allow an additional 30 days for public comment. 
The 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.
    Proposed Collection: Title: The Genetic Testing Registry; Type of 
Information Collection Request: New collection; Need and Use of 
Information Collection: Laboratory tests for more than 2,000 genetic 
conditions are available; however, there is no centralized public 
resource that provides information about the availability and 
scientific basis of these tests.
    Recognizing the importance of making this information easily 
accessible to health care providers, patients, consumers, and others, 
NIH is developing a voluntary registry of genetic tests. The Genetic 
Testing Registry (GTR) will provide a centralized, online location for 
test developers, manufacturers, and researchers to submit detailed 
information about genetic tests. The overarching goal of the GTR is to 
advance the public health and research in the genetic basis of health 
and disease. As such, the Registry will have several key functions, 
including (1) Encouraging providers of genetic tests to enhance 
transparency by publicly sharing information about the availability and 
utility of their tests; (2) providing an information resource for the 
public, including health care providers, patients, and researchers, to 
locate laboratories that offer particular tests; and (3) facilitating 
genetic and genomic data-sharing for research and new scientific 
discoveries.
    Frequency of Response: The information will be submitted 
voluntarily on a non-repeating, continual basis. Submitters will be 
requested to update their test information at least once every 12 
months.

[[Page 72425]]

    Respondents: Submitters to the GTR are expected to include clinical 
laboratories, researchers, and entities that report and interpret tests 
performed elsewhere. The GTR is not limited to U.S. respondents; it 
will also include submissions from outside the United States. 
Information will be collected and managed using an online submission 
system.
    Estimate of Burden: Although participation in the GTR is voluntary, 
in order to participate, respondents must provide information for a 
certain subset of fields, identified as the ``minimal fields.'' GTR 
includes 31 minimal fields and 85 optional fields. Sixteen of the 31 
minimal fields refer to contact data and other information about the 
laboratory, which the respondent completes only once. These data will 
autopopulate new test records, leaving 15 minimal fields that require 
completion. The GTR will also support bulk submission as an XML file or 
uploading subsets of information from spreadsheets, which will 
significantly reduce the burden for laboratories that want to provide 
information on multiple genetic tests. The annualized cost to 
respondents is estimated at $1,103.

                                            Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
                                                       Estimated
                                       Estimated       number of     Average burden hours     Estimated total
       Type of  respondents            number of     responses per      per  response       annual burden hours
                                      respondents     respondent                                 requested
----------------------------------------------------------------------------------------------------------------
Laboratory........................             770              12  Minimal Fields: 0.5..  Minimal Fields:
Personnel.........................                                  Optional Fields: 2.5.   4,620.
                                                                                           Optional Fields:
                                                                                            23,100.
                                   -----------------------------------------------------------------------------
    Total.........................             770  ..............  3.0..................  27,720.
----------------------------------------------------------------------------------------------------------------

    Request For Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate 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) Evaluate 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) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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.
    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: Desk Officer for NIH. To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instrument, contact: Amy P. Patterson, M.D., Associate Director for 
Science Policy, NIH, by mail to the Office of Biotechnology Activities, 
6705 Rockledge Dr., Suite 750, Bethesda, MD 20892; telephone (301) 496-
9838; fax (301) 496-9839; or email gtr@od.nih.gov; or refer to the GTR 
Web site at https://oba.od.nih.gov/gtr/gtr.html.
    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.

    Dated: November 16, 2011.
Amy P. Patterson,
Associate Director for Science Policy, NIH.
[FR Doc. 2011-30286 Filed 11-22-11; 8:45 am]
BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.