30-day FRN

37324

Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices

Bureau, HRSA, 5600 Fishers Lane,
8W60, Rockville, Maryland 20857; 301–
443–6839; or [email protected].
SUPPLEMENTARY INFORMATION: ACBSCT
provides advice and recommendations
to the Secretary of HHS (Secretary) and
the HRSA Administrator on the
activities of the C.W. Bill Young Cell
Transplantation Program and the
National Cord Blood Inventory Program.
The principal purpose of these programs
is to make blood stem cells from adult
donors and cord blood units available
for patients who need a transplant to
treat life-threatening conditions such as
leukemia, and who lack a suitably
matched relative who can be the donor.
During the September 10, 2019,
meeting, ACBSCT will discuss issues
related to utilization of cord blood for
transplant and utilization of blood stem
cells in cellular therapies. Agenda items
are subject to change as priorities
dictate. Refer to the ACBSCT website for
any updated information concerning the
meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to ACBSCT
must be sent to Robert Walsh, DFO,
using the contact information above at
least three business days before the
meeting.
Individuals who plan to participate in
the webinar and need special assistance
or other reasonable accommodations
should notify Robert Walsh at the
address and phone number listed above
at least 10 business days before the
meeting.

as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
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
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Resource-Related
Research Projects (R24).
Date: August 20, 2019.
Time: 10:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: David C. Chang, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 5601
Fishers Lane, MSC 9823, Rockville, MD
20852 [email protected].
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement (U01
Clinical Trial Required).
Date: August 22, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Roberta Binder, Ph.D.
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G21A, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, (240) 669–5050,
[email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)

[FR Doc. 2019–16306 Filed 7–30–19; 8:45 am]

Dated: July 25, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.

BILLING CODE 4165–15–P

[FR Doc. 2019–16245 Filed 7–30–19; 8:45 am]

Maria G. Button,
Director, Division of the Executive Secretariat.

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health

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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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.,

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National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Proposed
Collection; 60-Day Comment Request;
NIH Information Collection Forms To
Support Genomic Data Sharing for
Research Purposes (Office of Director)
AGENCY:

National Institutes of Health,

HHS.
ACTION:

PO 00000

Notice.

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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,
[email protected] or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Lyric A. Jorgenson, Acting
Director, Division of Scientific Data
Sharing Policy, Office of Science Policy,
NIH, 6705 Rockledge Dr., Suite 750,
Bethesda, MD 20892, or call non-tollfree
number (301) 496–9838 or email your
request including your address to:
[email protected].
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on May 1, 2019, page 18555 (84
FR 18555) 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 Office of the Director (OD),
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: NIH Information
Collection Forms to Support Genomic
Data Sharing for Research Purposes—
0925–0670—Expiration Date 07/31/
2019—Revision—Office of the Director
(OD), National Institutes of Health
(NIH).
ADDRESSES:

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37325

Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
Need and Use of Information
Collection: Sharing research data
supports the National Institutes of
Health (NIH) mission and is essential to
facilitate the translation of research
results into knowledge, products, and
procedures that improve human health.
NIH has longstanding policies to make
a broad range of research data, including
genomic data, publicly available in a
timely manner from the research
activities that it funds. Genomic
research data sharing is an integral
element of the NIH mission as it
facilitates advances in our
understanding of factors that influence
health and disease, while also providing
opportunities to accelerate research
through the power of combining large
and information-rich datasets. To
promote robust sharing of human and
non-human data from a wide range of
large-scale genomic research and
provide appropriate protections for
research involving human data, the NIH
issued the NIH Genomic Data Sharing
Policy (NIH GDS Policy). Human
genomic data submissions and
controlled access are managed through
a central data repository, the database of
Genotypes and Phenotypes (dbGaP)

access datasets that conforms to any
data use limitations, agree to the
Genomic Data User Code of Conduct,
and agree to the terms of access through
a Data Use Certification agreement.
Requests to renew data access and
reports to close out data use are similar
to the initial data access request,
requiring sign-off by both the requestor
and the institution, but also ask for
information about how the data have
been used, and about publications,
presentations, or intellectual property
based on the research conducted with
the accessed data as well as any data
security issues or other data
management incidents. NIH has
developed online forms, available
through dbGaP, in an effort to reduce
the burden for researchers and their
institutional officials to complete the
study registration, data submission, data
access, and renewal and closeout
processes.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
5,850.

which is administered by the National
Center for Biotechnology Information
(NCBI), part of the National Library of
Medicine at NIH. Under the NIH GDS
Policy, all investigators who receive
NIH funding to conduct large-scale
genomic research are expected to
register studies with human genomic
data in dbGaP, no matter which NIHdesignated data repository will maintain
the data. As part of the registration
process, investigators must provide
basic study information such as the type
of data that will be submitted to dbGaP,
a description of the study, and an
institutional assurance (i.e. Institutional
Certification) of the data submission
which delineates any limitations on the
secondary use of the data (e.g., data
cannot be shared with for-profit
companies, data can be used only for
research of particular diseases).
Investigators interested in using
controlled-access data for secondary
research must apply through dbGaP and
be granted permission from the relevant
NIH Data Access Committee(s). As part
of the application process, investigators
and their institutions must provide
information such as a description of the
proposed research use of controlled

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Type of respondent

Number of respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total annual
burden hour

Study Registration and Data Submission
dbGaP Registration and Submission.

Investigator Submitting Data

300 ........................................

1

1

300

Institutional Official to Certify
Submission.

300 ........................................

1

30/60

150

1,500 .....................................

2

45/60

2,250

1,500 .....................................

2

30/60

1,500

2

15/60

750

2

18/60

900

12,600

........................

5,850

Requesting Access to Data
Data Access Request ............
Data Access Request ............

Requester Submitting Request.
Institutional Signing Official
to Certify Request.

Project Renewal or Project Close-out
Project Renewal or Project
Close-out form.
Project Renewal or Project
Close-out form.

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Total ...............................

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Requester Submitting Request.
Institutional Signing Official
to Certify Request.

1,500 (same individuals as
above).
1,500 (same individuals as
above).

...............................................

...............................................

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37326

Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices

Dated: July 24, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–16289 Filed 7–30–19; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Loan Repayment
Programs (Office of the Director)
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 to review
and approve 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

ADDRESSES:

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: Loan Repayment
Programs (LRP), 0925–0361, expiration
date 08/31/19, EXTENSION, Office of
the Director (OD), National Institutes of
Health.
Need and Use of Information
Collection: The NIH makes available
financial assistance, in the form of
educational loan repayment, to M.D.,
Ph.D., Pharm.D., Psy.D., D.O., D.D.S.,
D.M.D., D.P.M., DC, N.D., O.D., D.V.M,
or equivalent doctoral degree holders
who perform biomedical or behavioral
research in NIH intramural laboratories
or as extramural grantees or scientists
funded by domestic non-profit
organizations for a minimum of two
years (three years for the General
Research subcategory) in research areas
supporting the mission and priorities of
the NIH. The information proposed for
collection will be used by the DLR to
determine an applicant’s eligibility for
the program.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
27,481.

directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
[email protected] or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
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: Steve Boehlert,
Director of Operations, Division of Loan
Repayment, National Institutes of
Health, 6700B Rockledge Dr., Room
2300 (MSC 6904), Bethesda, Maryland
20892–6904 or email your request,
including your address to BoehlerS@
od.nih.gov or call (301) 451–4465.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on May 21, 2019, page numbers
23060–23061 (84 FR 23060) 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 Office of the Director (OD), National
Institutes of Health (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.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondent

Average time
per response
(in hours)

Total annual
burden hours

Initial Extramural Applicants ............................................................................
Renewal Extramural Applicants .......................................................................
Initial Intramural Applicants .............................................................................
Renewal Intramural Applicants ........................................................................
Recommenders ................................................................................................
Institutional Contacts .......................................................................................
NIH LRP Coordinators .....................................................................................

1,650
1,000
40
40
10,760
2,650
80

1
1
1
1
1
1
1

8
8
8
8
30/60
5/60
30/60

13,200
8,000
320
320
5,380
221
40

Total ..........................................................................................................

16,220

16,220

........................

27,481

Dated: July 24, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–16288 Filed 7–30–19; 8:45 am]
BILLING CODE 4140–01–P
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Number of
responses per
respondent

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences Amended; Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
General Medical Sciences Council,
September 19, 2019, 9:00 a.m. to
September 20, 2019, 12:00 p.m.,
National Institutes of Health, Natcher

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Building, 45 Center Drive, Conference
Rooms E1 & E2, Bethesda, MD 20892,
which was published in the Federal
Register on February 14, 2019, 84 FR
4089.
The meeting notice is amended to
change the date and time of the meeting
from September 19–20, 2019, 9:00 a.m.–
12:00 p.m. to September 19, 2019, 8:30
a.m.–5:00 p.m. The meeting is partially
closed to the public.

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