Submission for OMB Review; 30-Day Comment Request; NIH Electronic Application System for Certificates of Confidentiality, 70199-70200 [2019-27521]

Download as PDF 70199 Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Notices Estimated number of respondents Data collection instrument(s) Total ................................................................................................. 2,600 Responses per respondent Average burden hour per response * ........................ ................................ Total annual burden (current) 800 * For ease of understanding, burden hours are provided in actual minutes. Annual number of respondents were factored based on total IHS providers credentialed and privileged on the indicated cycles in the paragraphs above. There are no capital costs, operating costs and/or maintenance costs to respondents. Requests for Comments: Your written comments and/or suggestions are invited on one or more of the following points: (a) Whether the information collection activity is necessary to carry out an agency function; (b) whether the agency processes the information collected in a useful and timely fashion; (c) the accuracy of public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information); (d) whether the methodology and assumptions used to determine the estimate is logical; (e) ways to enhance the quality, utility, and clarity of the information being collected; and (f) ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Chris Buchanan, Deputy Director, RADM, Assistant Surgeon General, USPHS, Indian Health Service. [FR Doc. 2019–27442 Filed 12–19–19; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; NIH Electronic Application System for Certificates of Confidentiality AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has SUMMARY: 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: Electronic Application for NIH Certificates of Confidentiality (CoC E-application System), 0925–0689, REVISION, exp., date 12/31/2019, Office of Extramural Research (OER), National Institutes of Health (NIH). Need and Use of Information Collection: This request system provides one electronic form to be used by all research organizations that request a Certificate of Confidentiality (CoC) from NIH. As described in the authorizing legislation (Section 301(d) of the Public Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by the agencies of Department of Health and Human Services (DHHS), including NIH, to authorize researchers to protect the privacy of human research subjects by prohibiting them from releasing names and identifying characteristics of research participants to anyone not connected with the research, except in limited circumstances specified in the statute. At NIH, the issuance of CoCs has been delegated to the NIH OER in the NIH Office of the Director. NIH received 529 requests for CoCs from April 2017 through March 2018 and expects to receive approximately the same number of requests in subsequent years. The NIH has been using an online CoC system to review requests and issue CoCs since 2015. The current CoC request form includes 15 sections of information collected from research organizations. The information provided will be used to determine eligibility for a CoC and to issue the CoC to the requesting organization. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 794. 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. 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 the data collection plans and instruments, contact: Dr. Pamela Reed Kearney, Division of Human Subjects Research, OER, NIH, 6705 Rockledge Dr., Building Rockledge 1, Room 812–C, Bethesda, MD 20817, or email your request, including your address, to: NIH-CoC-Coordinator@mail.nih.gov; telephone number: 301–402–2512. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on August 14, 2019, page 40426–40427 (84 FR 40426) 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 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 December 31, 2019, 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 ADDRESSES: jbell on DSKJLSW7X2PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Number of respondents CoC Applicants—Private ................................................................................. VerDate Sep<11>2014 18:30 Dec 19, 2019 Jkt 250001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Number of responses per respondent 372 E:\FR\FM\20DEN1.SGM 1 20DEN1 Average burden per response (in hours) 90/60 Total annual burden hours 558 70200 Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Type of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hours CoC Applicants—State/local ............................................................................ CoC Applicants—Small business .................................................................... CoC Applicants—Federal ................................................................................ 26 53 78 1 1 1 90/60 90/60 90/60 3 80 117 Total .......................................................................................................... ........................ 529 ........................ 794 Dated: December 15, 2019. Lawrence Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2019–27521 Filed 12–19–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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. ADDRESSES: VerDate Sep<11>2014 18:30 Dec 19, 2019 To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Winnie Martinez, Project Officer, 6707 Democracy Blvd., 9th Floor, Bethesda, MD 20892 or call non-toll-free number (301) 435–2988 or Email your request, including your address to: Winnie.Martinez@nih.gov. FOR FURTHER INFORMATION CONTACT: This proposed information collection was previously published in the Federal Register on October 16, 2019, page 55318–55319 (84 FR 55318) 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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 Title: Office of Minority Health Research Coordination Training and Mentor Programs Applications in use with OMB Control Number 0925–0748, exp., date 12/31/ 2019 REVISION, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH). SUPPLEMENTARY INFORMATION: Submission for OMB Review; 30-Day Comment Request; Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases) jbell on DSKJLSW7X2PROD with NOTICES Number of respondents Jkt 250001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Need and Use of Information Collection: In 2000, the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health established the Office of Minority Health Research Coordination to address the burden of diseases and disorders that disproportionately impact the health of minority populations. One of the major goals of the office is to build and sustain a pipeline of researchers from underrepresented populations in the biomedical, behavioral, clinical, and social sciences, with a focus on NIDDK mission areas. The office accomplishes this goal by administering a variety of programs and initiatives to recruit high school through post-doctoral educational level individuals into OMHRC research training and mentor programs: The Short-Term Research Experience for Underrepresented Persons (STEP–UP), the Diversity Summer Research Training Program (DSRTP) for Undergraduate Students, Network of Minority Health Research Investigators (NMRI), the NIH/National Medical Association (NMA) Academic Career Fellow Travel Awards, and the NIH/National Hispanic Medical Association (NHMA) Academic Career Fellow Travel Awards. Identification of participants to matriculate into the program and initiatives comes from applications and related forms hosted through the NIDDK website. The proposed information collection activity is necessary in order to determine the eligibility and quality of potential awardees for traineeship in these programs. OMB approval is requested for three (3) years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,291. E:\FR\FM\20DEN1.SGM 20DEN1

Agencies

[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Notices]
[Pages 70199-70200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27521]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; NIH Electronic 
Application System for Certificates of Confidentiality

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 the data collection plans and 
instruments, contact: Dr. Pamela Reed Kearney, Division of Human 
Subjects Research, OER, NIH, 6705 Rockledge Dr., Building Rockledge 1, 
Room 812-C, Bethesda, MD 20817, or email your request, including your 
address, to: [email protected]; telephone number: 301-
402-2512.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on August 14, 2019, page 
40426-40427 (84 FR 40426) 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 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 December 
31, 2019, 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: Electronic Application for NIH Certificates of 
Confidentiality (CoC E-application System), 0925-0689, REVISION, exp., 
date 12/31/2019, Office of Extramural Research (OER), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: This request system 
provides one electronic form to be used by all research organizations 
that request a Certificate of Confidentiality (CoC) from NIH. As 
described in the authorizing legislation (Section 301(d) of the Public 
Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by the agencies 
of Department of Health and Human Services (DHHS), including NIH, to 
authorize researchers to protect the privacy of human research subjects 
by prohibiting them from releasing names and identifying 
characteristics of research participants to anyone not connected with 
the research, except in limited circumstances specified in the statute. 
At NIH, the issuance of CoCs has been delegated to the NIH OER in the 
NIH Office of the Director. NIH received 529 requests for CoCs from 
April 2017 through March 2018 and expects to receive approximately the 
same number of requests in subsequent years. The NIH has been using an 
online CoC system to review requests and issue CoCs since 2015. The 
current CoC request form includes 15 sections of information collected 
from research organizations. The information provided will be used to 
determine eligibility for a CoC and to issue the CoC to the requesting 
organization.
    OMB approval is requested for three years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 794.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
               Type of respondents                   Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
CoC Applicants--Private.........................             372               1           90/60             558

[[Page 70200]]

 
CoC Applicants--State/local.....................              26               1           90/60               3
CoC Applicants--Small business..................              53               1           90/60              80
CoC Applicants--Federal.........................              78               1           90/60             117
                                                 ---------------------------------------------------------------
    Total.......................................  ..............             529  ..............             794
----------------------------------------------------------------------------------------------------------------


    Dated: December 15, 2019.
Lawrence Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-27521 Filed 12-19-19; 8:45 am]
 BILLING CODE 4140-01-P


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