Submission for OMB Review; 30-Day Comment Request; National Institutes of Health (NIH) Loan Repayment Programs; Office of the Director (OD), 30541-30543 [2016-11618]
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Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices
jstallworth on DSK7TPTVN1PROD with NOTICES
regulated clinical investigations. In
particular, the draft guidance provides
recommendations on the following: (1)
Deciding whether and how to use EHRs
as a source of data in clinical
investigations; (2) using EHRs that are
interoperable with electronic systems
supporting clinical investigations; (3)
ensuring the quality and the integrity of
EHR data that are collected and used as
electronic source data in clinical
investigations; and (4) ensuring that the
use of EHR data collected and used as
electronic source data in clinical
investigations meet FDA’s inspection,
recordkeeping, and record retention
requirements. In an effort to modernize
and streamline clinical investigations,
the goals of the draft guidance are to
facilitate use of EHR data in clinical
investigations and to promote the
interoperability of EHRs and electronic
systems supporting the clinical
investigation.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the use of EHR data in clinical
investigations. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
collections of information that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The draft
guidance pertains to sponsors, clinical
investigators, contract research
organizations, IRBs, and other interested
parties who use EHR systems as
electronic source data in FDA-regulated
clinical investigations and who send
certain information to FDA or others or
who keep certain records and make
them available to FDA inspectors. The
collections of information discussed in
the draft guidance are contained in our
investigational new drug regulations in
part 312 (21 CFR part 312), approved
under OMB control number 0910–0014,
including §§ 312.58(a) and 312.62(b);
investigational device exemption
regulations in § 812.140 (21 CFR
812.140) approved under OMB control
number 0910–0078; and electronic
records; electronic signatures
regulations in 21 CFR part 11, approved
under OMB control number 0910–0303.
The use of EHR systems as a source of
data, as described in the draft guidance,
would not result in any new costs,
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including capital costs or operating and
maintenance costs, because sponsors
and others already have and are
experienced with using computer-based
equipment and software necessary to be
consistent with the draft guidance.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
default.htm, or https://
www.regulations.gov.
Dated: May 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–11564 Filed 5–16–16; 8:45 am]
BILLING CODE 4164–01–P
30541
Bethesda, MD 20892–9823, (240) 669–5082,
Travis.Taylor@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases, Special
Emphasis Panel, Rapid Assessment of Zika
Virus (ZIKV) Complications (R21).
Date: June 14, 2016.
Time: 12:00 p.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health 3F100,
5601 Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Amir E. Zeituni, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities
NIAID/NIH/DHHS, 5601 Fishers Lane, MSC–
9834 Rockville, MD 20852, 301–496–2550,
amir.zeituni@nih.gov.
(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)
Dated: May 11, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–11554 Filed 5–16–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, 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 Peer Review Meeting.
Date: June 9, 2016.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, Room
3G61, 5601 Fishers Lane, Rockville, MD
20892 (Telephone Conference Call).
Contact Person: Travis J Taylor, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G62B 5601 Fishers Lane, MSC 9823,
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submission for OMB Review; 30-Day
Comment Request; National Institutes
of Health (NIH) Loan Repayment
Programs; Office of the Director (OD)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Division of
Loan Repayment (DLR), 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.
This proposed information collection
was previously published in the Federal
Register on February 19, 2016, and page
numbers 8514–8516, 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 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.
Direct Comments to OMB: 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
E:\FR\FM\17MYN1.SGM
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Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
For Further Information: To obtain a
copy of the data collection plans and
instruments or request more information
on the proposed project contact: Steve
Boehlert, Director of Operations,
Division of Loan Repayment, National
Institutes of Health, 6011 Executive
Blvd., Room 206 (MSC 7650), Bethesda,
Maryland 20892–7650. Mr. Boehlert
may be contacted via email at
BoehlerS@od.nih.gov or by calling 301–
451–4465. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: National
Institutes of Health (NIH) Loan
Repayment Programs (LRP). Type of
Information Collection Request:
Extension of a currently approved
collection (OMB No. 0925–0361,
expiration date 06/30/17). Form
Numbers: NIH 2674–1, NIH 2674–2,
NIH 2674–3, NIH 2674–4, NIH 2674–5,
NIH 2674–6, NIH 2674–7, NIH 2674–8,
NIH 2674–9, NIH 2674–10, NIH 2674–
11, NIH 2674–12, NIH 2674–13, NIH
2674–14, NIH 2674–15, NIH 2674–16,
authorized by Section 487F (42 U.S.C.
288–6); the Extramural Clinical
Research LRP for Individuals from
Disadvantaged Backgrounds (ECR–LRP)
is authorized by an amendment to
Section 487E (42 U.S.C. 288–5); the
Contraception and Infertility Research
LRP (CIR–LRP) is authorized by Section
487B (42 U.S.C. 288–2); and the Health
Disparities Research Loan Repayment
Program (HD–LRP) is authorized by
Section 485G (42 U.S.C. 287c–33).
The Loan Repayment Programs can
repay up to $35,000 per year toward a
participant’s extant eligible educational
loans, directly to financial institutions.
The information proposed for collection
will be used by the Division of Loan
Repayment to determine an applicant’s
eligibility for participation in the
program.
Frequency of Response: Initial
application and one or two-year renewal
application.
Affected Public: Individuals or
households; Nonprofits; and Businesses
or other for-profit.
Type of Respondents: Physicians,
other scientific or medical personnel,
and institutional representatives.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
33,242.
NIH 2674–17, NIH 2674–18, NIH 2674–
19, and NIH 2674–20.
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 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 Loan Repayment Program
(LRP)) in research areas supporting the
mission and priorities of the NIH.
The AIDS Research Loan Repayment
Program (AIDS–LRP) is authorized by
Section 487A of the Public Health
Service Act (42 U.S.C. 288–1); the
Clinical Research Loan Repayment
Program for Individuals from
Disadvantaged Backgrounds (CR–LRP)
is authorized by Section 487E (42 U.S.C.
288–5); the General Research Loan
Repayment Program (GR–LRP) is
authorized by Section 487C of the
Public Health Service Act (42 U.S.C.
288–3); the Clinical Research Loan
Repayment Program (LRP–CR) is
authorized by Section 487F (42 U.S.C.
288–5a); the Pediatric Research Loan
Repayment Program (PR–LRP) is
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Estimated
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
requested
40
40
120
8
1
1
1
1
10
1
30/60
15/60
400
40
60
2
Subtotal .............................................................................................
208
........................
........................
502
Extramural LRPs:
Initial Applicants ........................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
Financial Institutions .................................................................................
1,650
1,480
4,950
100
1
1
1
1
11
1
30/60
15/60
18,150
1,480
2,475
25
Subtotal .............................................................................................
8,180
........................
........................
22,130
Intramural LRPs:
Renewal Applicants ..................................................................................
Advisors/Supervisors ................................................................................
jstallworth on DSK7TPTVN1PROD with NOTICES
Intramural LRPs:
Initial Applicants ........................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
Financial Institutions .................................................................................
40
40
1
1
7
2
280
80
Subtotal .............................................................................................
80
........................
........................
360
Extramural LRPS:
Renewal Applicants ..................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
1,000
750
3,000
1
1
1
8
1
30/60
8,000
750
1,500
Subtotal ......................................................................................
4,750
........................
........................
10,250
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Federal Register / Vol. 81, No. 95 / Tuesday, May 17, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Total ...................................................................................................
Dated: May 11, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–11618 Filed 5–16–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development in the
U.S. in accordance with 35 U.S.C. 209
and 37 CFR part 404 to achieve
expeditious commercialization of
results of federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
Drive, Mail Stop 9702, Rockville, MD
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Method for
Purifying Antibodies.
Description of Technology: This
technology is a method for purifying a
biologic composition, comprising
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:32 May 16, 2016
Jkt 238001
Estimated
number of
responses per
respondent
Average
burden hours
per response
........................
........................
Number of
respondents
Type of respondent
13,218
diafiltering the biologic composition
into a composition comprising
phosphate buffered saline (PBS) to
obtain a purified composition. The
method is particularly useful for
removing one or more impurities from
the biologic composition, such as bis(2hydroxyethyl)aminotris(hydroxymethyl)methane (Bistris).The technology is directed to large
scale manufacturing of Chimeric 14.18
(Ch14.18) monoclonal antibodies.
Ch14.18 is an anti-GD2 monoclonal
antibody and has been described in
Gillies et al., Journal of Immunological
Methods 125:191–202 (1989).
Potential Commercial Applications:
• Large scale manufacturing of
chimeric monoclonal antibodies
Value Proposition:
• Cost effective means of removing
impurities to produce GMP grade
chimeric antibodies for regulatory
approval.
Development Stage: Clinical Phase II,
FDA/EMA approved Chemistry,
Manufacturing and Controls (CMC) large
scale manufacturing to produce GMP
grade chimeric antibodies.
Inventor(s): David A. Meh (United
Therapeutics Corporation), Timothy
Atolagbe (United Therapeutics
Corporation), G. Mark Farquharson
(United Therapeutics Corporation),
Samir Shaban (National Cancer
Institute), Mary Koleck (National Cancer
Institute), George Mitra (National Cancer
Institute).
Intellectual Property:
HHS Ref. No. E–291–2014/0–US–01,
corresponding to US Provisional Patent
App. No. 62/028,994, filed July 25,
2014, entitled ‘‘Method for Purifying
Antibodies using PBS’’
HHS Ref. No. E–291–2014/0–US–02,
corresponding to US Patent App. No.
14/809,211, filed July 25, 2015, entitled
‘‘Method for Purifying Antibodies using
PBS’’
HHS Ref. No. E–291–2014/0–PCT–03,
corresponding to International Patent
App. No. PCT/US2015/042241, filed
July 27, 2015, entitled ‘‘Method for
Purifying Antibodies’’
Publications:
1. FDA published document: https://
www.accessdata.fda.gov/drugsatfda_
docs/nda/2015/
125516Orig1s000TOC.cfm
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Annual
burden hours
requested
33,242
2. US Food and Drug Administration.
FDA approves first therapy for high-risk
neuroblastoma.https://www.fda.gov/
NewsEvents/Newsroom/
PressAnnouncements/ucm437460.htm
3. WO2016015048 METHOD FOR
PURIFYING ANTIBODIES https://
patentscope.wipo.int/search/en/
detail.jsf?docId=WO2016015048
Contact Information: Requests for
copies of the patent application or
inquiries about licensing, research
collaborations, and co-development
opportunities should be sent to John D.
Hewes, Ph.D., email: john.hewes@
nih.gov.
Dated: May 11, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–11556 Filed 5–16–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development in the
U.S. in accordance with 35 U.S.C. 209
and 37 CFR part 404 to achieve
expeditious commercialization of
results of federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
SUMMARY:
E:\FR\FM\17MYN1.SGM
17MYN1
]]>Agencies
[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Pages 30541-30543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11618]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; National
Institutes of Health (NIH) Loan Repayment Programs; Office of the
Director (OD)
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the Division of Loan Repayment (DLR),
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. This proposed information
collection was previously published in the Federal Register on February
19, 2016, and page numbers 8514-8516, 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 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.
Direct Comments to OMB: 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
[[Page 30542]]
of Management and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH
Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
For Further Information: To obtain a copy of the data collection
plans and instruments or request more information on the proposed
project contact: Steve Boehlert, Director of Operations, Division of
Loan Repayment, National Institutes of Health, 6011 Executive Blvd.,
Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Mr. Boehlert may be
contacted via email at BoehlerS@od.nih.gov or by calling 301-451-4465.
Formal requests for additional plans and instruments must be requested
in writing.
Proposed Collection: National Institutes of Health (NIH) Loan
Repayment Programs (LRP). Type of Information Collection Request:
Extension of a currently approved collection (OMB No. 0925-0361,
expiration date 06/30/17). Form Numbers: NIH 2674-1, NIH 2674-2, NIH
2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH
2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-
14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, NIH 2674-19,
and NIH 2674-20.
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 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 Loan
Repayment Program (LRP)) in research areas supporting the mission and
priorities of the NIH.
The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized
by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the
Clinical Research Loan Repayment Program for Individuals from
Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42
U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is
authorized by Section 487C of the Public Health Service Act (42 U.S.C.
288-3); the Clinical Research Loan Repayment Program (LRP-CR) is
authorized by Section 487F (42 U.S.C. 288-5a); the Pediatric Research
Loan Repayment Program (PR-LRP) is authorized by Section 487F (42
U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals
from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment
to Section 487E (42 U.S.C. 288-5); the Contraception and Infertility
Research LRP (CIR-LRP) is authorized by Section 487B (42 U.S.C. 288-2);
and the Health Disparities Research Loan Repayment Program (HD-LRP) is
authorized by Section 485G (42 U.S.C. 287c-33).
The Loan Repayment Programs can repay up to $35,000 per year toward
a participant's extant eligible educational loans, directly to
financial institutions. The information proposed for collection will be
used by the Division of Loan Repayment to determine an applicant's
eligibility for participation in the program.
Frequency of Response: Initial application and one or two-year
renewal application.
Affected Public: Individuals or households; Nonprofits; and
Businesses or other for-profit.
Type of Respondents: Physicians, other scientific or medical
personnel, and institutional representatives.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 33,242.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated
Number of number of Average burden Annual burden
Type of respondent respondents responses per hours per hours
respondent response requested
----------------------------------------------------------------------------------------------------------------
Intramural LRPs:
Initial Applicants.......................... 40 1 10 400
Advisors/Supervisors........................ 40 1 1 40
Recommenders................................ 120 1 30/60 60
Financial Institutions...................... 8 1 15/60 2
---------------------------------------------------------------
Subtotal................................ 208 .............. .............. 502
---------------------------------------------------------------
Extramural LRPs:
Initial Applicants.......................... 1,650 1 11 18,150
Advisors/Supervisors........................ 1,480 1 1 1,480
Recommenders................................ 4,950 1 30/60 2,475
Financial Institutions...................... 100 1 15/60 25
---------------------------------------------------------------
Subtotal................................ 8,180 .............. .............. 22,130
---------------------------------------------------------------
Intramural LRPs:
Renewal Applicants.......................... 40 1 7 280
Advisors/Supervisors........................ 40 1 2 80
---------------------------------------------------------------
Subtotal................................ 80 .............. .............. 360
---------------------------------------------------------------
Extramural LRPS:
Renewal Applicants.......................... 1,000 1 8 8,000
Advisors/Supervisors........................ 750 1 1 750
Recommenders................................ 3,000 1 30/60 1,500
---------------------------------------------------------------
Subtotal............................ 4,750 .............. .............. 10,250
---------------------------------------------------------------
[[Page 30543]]
Total................................... 13,218 .............. .............. 33,242
----------------------------------------------------------------------------------------------------------------
Dated: May 11, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-11618 Filed 5-16-16; 8:45 am]
BILLING CODE 4140-01-P
