81_FR_76582 81 FR 76370 - Submission for OMB Review; 30-Day Comment Request, National Institutes of Health Electronic Application System for Certificates of Confidentiality

81 FR 76370 - Submission for OMB Review; 30-Day Comment Request, National Institutes of Health Electronic Application System for Certificates of Confidentiality

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 212 (November 2, 2016)

Page Range76370-76371
FR Document2016-26445

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. This proposed information collection was previously published in the Federal Register on August 18, 2016 (81 FR 55207-55208) 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.

Federal Register, Volume 81 Issue 212 (Wednesday, November 2, 2016)
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76370-76371]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request, National 
Institutes of Health 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. This proposed information 
collection was previously published in the Federal Register on August 
18, 2016 (81 FR 55207-55208) 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.

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. Ann Hardy, NIH Extramural Human Research 
Protections Officer and NIH Coordinator, Certificates of 
Confidentiality, 3701 Rockledge Dr. Rm. 3002, Bethesda, MD 20892, or 
call non-toll-free number (301) 435-2690 or Email your request, 
including your address to: [email protected]. Formal requests for 
additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Office of Extramural Research (OER), NIH, 
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 NIH has submitted to the OMB a request for review and 
approval of the information collection listed below.
    Proposed Collection: Certificate of Confidentiality Electronic 
Application System, 0925-0689, expiration date 01/31/2017, OER, NIH.
    Need and Use of Information Collection: This application system 
provides one electronic form to be used by all research organizations 
that wish to request a Certificate of Confidentiality (CoC) from the 
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

[[Page 76371]]

agencies of Department of Health and Human Services (HHS), including 
the NIH, to authorize researchers conducting sensitive research to 
protect the privacy of human research subjects by enabling them to 
refuse to release names and identifying characteristics of subjects to 
anyone not connected with the research. At the NIH, the issuance of 
CoCs has been delegated to the individual NIH Institutes and Centers 
(ICs). To make the application process consistent across the entire 
agency, OER launched an electronic application system in 2015 that is 
used by research organizations that wish to request a CoC from any NIH 
IC. Having one system for all CoC applications to the NIH is more 
efficient for both applicants and NIH staff who process these requests. 
The NIH uses the information in the application to determine 
eligibility for a CoC and to issue the CoC to the requesting 
organization. It is anticipated that the NIH ICs will issue 
approximately 1300 new CoCs each year for eligible research projects.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total annualized burden hours 
estimate is 1,951.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average  time
               Type of respondents                   Number of     Frequency of    per  response   Total annual
                                                    respondents      response       (in hours)     burden  hours
----------------------------------------------------------------------------------------------------------------
CoC Applicants--Private.........................             455               1           90/60             683
CoC Applicants--State/local.....................             650               1           90/60             975
CoC Applicants--Small business..................             130               1           90/60             195
CoC Applicants--Federal.........................              65               1           90/60              98
----------------------------------------------------------------------------------------------------------------


    Dated: October 25, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-26445 Filed 11-1-16; 8:45 am]
 BILLING CODE 4140-01-P



                                                76370                            Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices

                                                                                                            ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                                                      Average
                                                                                                                                                                                                   Number of
                                                                                                                                                                        Number of                                   burden per              Total annual
                                                                                   Information collection forms                                                                                  responses per
                                                                                                                                                                       respondents                                   response               burden hours
                                                                                                                                                                                                   respondent        (in hours)

                                                     PHS Assignment Request Form ..............................................................                                      3,354                   1                 30/60               1,677
                                                     PHS Inclusion Enrollment Report .............................................................                                   3,354                   1                     1               3,354
                                                     Biosketch (Fellowship) ..............................................................................                           6,707                   1                     2              13,414
                                                     416–1 ........................................................................................................                     29                   1                    10                 290
                                                     PHS 416–5 ...............................................................................................                       6,707                   1                  5/60                 559
                                                     PHS 6031 .................................................................................................                      6,217                   1                  5/60                 518
                                                     VCOC Certification ...................................................................................                              6                   1                  5/60                   1
                                                     SBIR/STTR Funding Agreement Certification ..........................................                                            1,500                   1                 15/60                 375

                                                           Total Annual Burden Hours ...............................................................                  ........................        420,101    ........................        850,756



                                                  Dated: October 22, 2016.                                               93.865, Research for Mothers and Children;                                and associated response time, should be
                                                Lawrence A. Tabak,                                                       93.929, Center for Medical Rehabilitation                                 directed to the: Office of Management
                                                                                                                         Research; 93.209, Contraception and                                       and Budget, Office of Regulatory Affairs,
                                                Deputy Director, National Institutes of Health.
                                                                                                                         Infertility Loan Repayment Program, National
                                                [FR Doc. 2016–26448 Filed 11–1–16; 8:45 am]                              Institutes of Health, HHS)
                                                                                                                                                                                                   OIRA_submission@omb.eop.gov or by
                                                BILLING CODE 4140–01–P                                                                                                                             fax to 202–395–6974, Attention: Desk
                                                                                                                           Dated: October 27, 2016.                                                Officer for NIH.
                                                                                                                         Michelle Trout,
                                                                                                                                                                                                   FOR FURTHER INFORMATION CONTACT: To
                                                DEPARTMENT OF HEALTH AND                                                 Program Analyst, Office of Federal Advisory                               request more information on the
                                                HUMAN SERVICES                                                           Committee Policy.
                                                                                                                                                                                                   proposed project or to obtain a copy of
                                                                                                                         [FR Doc. 2016–26386 Filed 11–1–16; 8:45 am]
                                                                                                                                                                                                   the data collection plans and
                                                National Institutes of Health                                            BILLING CODE 4140–01–P                                                    instruments, contact: Dr. Ann Hardy,
                                                Eunice Kennedy Shriver National                                                                                                                    NIH Extramural Human Research
                                                Institute of Child Health & Human                                                                                                                  Protections Officer and NIH
                                                                                                                         DEPARTMENT OF HEALTH AND
                                                Development; Notice of Closed                                                                                                                      Coordinator, Certificates of
                                                                                                                         HUMAN SERVICES
                                                Meeting                                                                                                                                            Confidentiality, 3701 Rockledge Dr. Rm.
                                                                                                                         National Institutes of Health                                             3002, Bethesda, MD 20892, or call non-
                                                  Pursuant to section 10(d) of the                                                                                                                 toll-free number (301) 435–2690 or
                                                Federal Advisory Committee Act, as                                       Submission for OMB Review; 30-Day                                         Email your request, including your
                                                amended (5 U.S.C. App.), notice is                                       Comment Request, National Institutes                                      address to: hardyan@od.nih.gov. Formal
                                                hereby given of the following meeting.                                   of Health Electronic Application                                          requests for additional plans and
                                                  The meeting will be closed to the                                      System for Certificates of                                                instruments must be requested in
                                                public in accordance with the                                            Confidentiality                                                           writing.
                                                provisions set forth in sections
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                               AGENCY:         National Institutes of Health,                            SUPPLEMENTARY INFORMATION:     Office of
                                                as amended. The grant applications and                                   HHS.                                                                      Extramural Research (OER), NIH, may
                                                the discussions could disclose                                           ACTION:       Notice.                                                     not conduct or sponsor, and the
                                                confidential trade secrets or commercial                                                                                                           respondent is not required to respond
                                                                                                                         SUMMARY:   In compliance with the                                         to, an information collection that has
                                                property such as patentable material,                                    Paperwork Reduction Act of 1995, the
                                                and personal information concerning                                                                                                                been extended, revised, or implemented
                                                                                                                         National Institutes of Health (NIH) has                                   on or after October 1, 1995, unless it
                                                individuals associated with the grant                                    submitted to the Office of Management
                                                applications, the disclosure of which                                                                                                              displays a currently valid OMB control
                                                                                                                         and Budget (OMB) a request for review                                     number.
                                                would constitute a clearly unwarranted                                   and approval of the information
                                                invasion of personal privacy.                                                                                                                        In compliance with Section
                                                                                                                         collection listed below. This proposed                                    3507(a)(1)(D) of the Paperwork
                                                  Name of Committee: National Institute of                               information collection was previously                                     Reduction Act of 1995, the NIH has
                                                Child Health and Human Development                                       published in the Federal Register on                                      submitted to the OMB a request for
                                                Special Emphasis Panel.                                                  August 18, 2016 (81 FR 55207–55208)
                                                  Date: December 8, 2016.                                                                                                                          review and approval of the information
                                                                                                                         and allowed 60-days for public                                            collection listed below.
                                                  Time: 9:00 a.m. to 3:00 p.m.
                                                  Agenda: To review and evaluate grant
                                                                                                                         comment. No public comments were                                            Proposed Collection: Certificate of
                                                applications.                                                            received. The purpose of this notice is                                   Confidentiality Electronic Application
                                                  Place: National Institutes of Health, 6705                             to allow an additional 30 days for public                                 System, 0925–0689, expiration date 01/
                                                Rockledge Drive, Bethesda, MD 20817,                                     comment.                                                                  31/2017, OER, NIH.
                                                (Virtual Meeting).                                                       DATES: Comments regarding this                                              Need and Use of Information
                                                  Contact Person: Priscah Mujuru, DRPH,                                  information collection are best assured                                   Collection: This application system
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                                                COHNS, Scientific Review Officer, Scientific                             of having their full effect if received
                                                Review Branch, Eunice Kennedy Shriver
                                                                                                                                                                                                   provides one electronic form to be used
                                                                                                                         within 30-days of the date of this                                        by all research organizations that wish
                                                National Institute of Child Health and
                                                                                                                         publication.                                                              to request a Certificate of Confidentiality
                                                Human Development, NIH, 6100 Executive
                                                Boulevard, Suite 5B01, Bethesda, MD 20892–                               ADDRESSES: Written comments and/or                                        (CoC) from the NIH. As described in the
                                                7510, 301–435–6908, mujurup@mail.nih.gov.                                suggestions regarding the item(s)                                         authorizing legislation (Section 301(d)
                                                (Catalogue of Federal Domestic Assistance                                contained in this notice, especially                                      of the Public Health Service Act, 42
                                                Program Nos. 93.864, Population Research;                                regarding the estimated public burden                                     U.S.C. 241(d)), CoCs are issued by the


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                                                                              Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices                                                             76371

                                                agencies of Department of Health and                                (ICs). To make the application process                      CoC and to issue the CoC to the
                                                Human Services (HHS), including the                                 consistent across the entire agency, OER                    requesting organization. It is anticipated
                                                NIH, to authorize researchers                                       launched an electronic application                          that the NIH ICs will issue
                                                conducting sensitive research to protect                            system in 2015 that is used by research                     approximately 1300 new CoCs each year
                                                the privacy of human research subjects                              organizations that wish to request a CoC                    for eligible research projects.
                                                by enabling them to refuse to release                               from any NIH IC. Having one system for
                                                                                                                                                                                  OMB approval is requested for 3
                                                names and identifying characteristics of                            all CoC applications to the NIH is more
                                                subjects to anyone not connected with                               efficient for both applicants and NIH                       years. There are no costs to respondents
                                                the research. At the NIH, the issuance of                           staff who process these requests. The                       other than their time. The total
                                                CoCs has been delegated to the                                      NIH uses the information in the                             annualized burden hours estimate is
                                                individual NIH Institutes and Centers                               application to determine eligibility for a                  1,951.

                                                                                                                  ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                   Average       Total annual
                                                                                                                                                              Number of       Frequency of         time per
                                                                                     Type of respondents                                                                                                           burden
                                                                                                                                                             respondents        response          response          hours
                                                                                                                                                                                                  (in hours)

                                                CoC   Applicants—Private .................................................................................             455                 1             90/60            683
                                                CoC   Applicants—State/local ............................................................................              650                 1             90/60            975
                                                CoC   Applicants—Small business ....................................................................                   130                 1             90/60            195
                                                CoC   Applicants—Federal ................................................................................               65                 1             90/60             98



                                                  Dated: October 25, 2016.                                          Rockledge Drive, Suite 350, Bethesda,                       the proposed additional reporting
                                                Lawrence A. Tabak,                                                  Maryland 20892, or call a non-toll-free                     requirements for clinical trials.
                                                Deputy Director, National Institutes of Health.                     number 301–435–0941 or Email your                              Need and Use of Information
                                                [FR Doc. 2016–26445 Filed 11–1–16; 8:45 am]                         request, including your address to                          Collection: The RPPR is now required to
                                                BILLING CODE 4140–01–P                                              trialsinfo@od.nih.gov. Formal requests                      be used by all NIH, Food and Drug
                                                                                                                    for additional plans and instruments                        Administration, Centers for Disease
                                                                                                                    must be requested in writing.                               Control and Prevention, and Agency for
                                                DEPARTMENT OF HEALTH AND                                            SUPPLEMENTARY INFORMATION: Section                          Healthcare Research and Quality
                                                HUMAN SERVICES                                                      3506(c)(2)(A) of the Paperwork                              (AHRQ) grantees. Interim progress
                                                                                                                    Reduction Act of 1995 requires: written                     reports are required to continue support
                                                National Institutes of Health                                       comments and/or suggestions from the                        of a PHS grant for each budget year
                                                Proposed Collection; 60-Day Comment                                 public and affected agencies are invited                    within a competitive segment. The
                                                Request; Post-Award Reporting                                       to address one or more of the following                     phased transition to the RPPR required
                                                Requirements Including Research                                     points: (1) Whether the proposed                            the maintenance of dual reporting
                                                Performance Progress Report                                         collection of information is necessary                      processes for a period of time.
                                                Collection (Office of the Director)                                 for the proper performance of the                           Continued use of the PHS Non-
                                                                                                                    function of the agency, including                           competing Continuation Progress Report
                                                AGENCY:     National Institutes of Health,                          whether the information will have                           (PHS 2590), exists for a small group of
                                                HHS.                                                                practical utility; (2) The accuracy of the                  grantees. This collection also includes
                                                ACTION:    Notice.                                                  agency’s estimate of the burden of the                      other PHS post-award reporting
                                                                                                                    proposed collection of information,                         requirements: PHS 416–7 National
                                                SUMMARY:   In compliance with the                                   including the validity of the                               Research Service Award (NRSA)
                                                requirement of the Paperwork                                        methodology and assumptions used; (3)                       Termination Notice, PHS 2271
                                                Reduction Act of 1995 to provide                                    Ways to enhance the quality, utility, and                   Statement of Appointment, 6031–1
                                                opportunity for public comment on                                   clarity of the information to be                            NRSA Annual Payback Activities
                                                proposed data collection projects, the                              collected; and (4) Ways to minimizes                        Certification, HHS 568 Final Invention
                                                National Institutes of Health (NIH) will                            the burden of the collection of                             Statement and Certification, Final
                                                publish periodic summaries of proposed                              information on those who are to                             Progress Report instructions, iEdison,
                                                projects to be submitted to the Office of                           respond, including the use of                               and PHS 3734 Statement Relinquishing
                                                Management and Budget (OMB) for                                     appropriate automated, electronic,                          Interests and Rights in a PHS Research
                                                review and approval.                                                mechanical, or other technological                          Grant. The PHS 416–7, 2271, and 6031–
                                                DATES: Comments regarding this                                      collection techniques or other forms of                     1 are used by NRSA recipients to
                                                information collection are best assured                             information technology.                                     activate, terminate, and provide for
                                                of having their full effect if received                                Proposed Collection Title: Public                        payback of a NRSA. Closeout of an
                                                within 60 days of the date of this                                  Health Service (PHS) Post-award                             award requires a Final Invention
                                                publication.                                                        Reporting Requirements, Revision, OMB                       Statement (HHS 568) and Final Progress
                                                FOR FURTHER INFORMATION CONTACT: To                                 0925–0002, Expiration Date 10/31/2018.                      Report. iEdison allows grantees and
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                                                obtain a copy of the data collection                                Form numbers: PHS 2590, PHS 416–7,                          federal agencies to meet statutory
                                                plans and instruments, submit                                       PHS 2271, PHS 3734, PHS 6031–1, and                         requirements for reporting inventions
                                                comments in writing, or request more                                HHS 568. This collection represents a                       and patents. The PHS 3734 serves as the
                                                information on the proposed project,                                consolidation of post-award reporting                       official record of grantee relinquishment
                                                contact: Ms. Mikia P. Currie, Program                               requirements under the PRA, including                       of a PHS award when an award is
                                                Analyst, Office of Policy for Extramural                            the Research Performance Progress                           transferred from one grantee institution
                                                Research Administration, 6705                                       Report (RPPR). This collection includes                     to another. Pre-award reporting


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Document Created: 2016-11-02 01:40:44
Document Modified: 2016-11-02 01:40:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
ContactTo request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Ann Hardy, NIH Extramural Human Research Protections Officer and NIH Coordinator, Certificates of Confidentiality, 3701 Rockledge Dr. Rm. 3002, Bethesda, MD 20892, or call non-toll-free number (301) 435-2690 or Email your request,
FR Citation81 FR 76370 

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