30-day Notice

COC 30-day Notice.pdf

Electronic Application for NIH Certificates of Confidentialty (CoC E-application System)

30-day Notice

OMB: 0925-0689

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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:

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ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents

Number of
respondents

CoC Applicants—Private .................................................................................

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18:30 Dec 19, 2019

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Number of
responses per
respondent

372

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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)

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Number of
respondents

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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.

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