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)
National Institutes of Health
Federal Register Volume 81, Issue 212 (November 2, 2016)
| Page Range | 76370-76371 | |
| FR Document | 2016-26445 |
[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] ----------------------------------------------------------------------- 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
sradovich on DSK3GMQ082PROD with NOTICES
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
sradovich on DSK3GMQ082PROD with NOTICES
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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. | |
| 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, | |
| FR Citation | 81 FR 76370 |
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