National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 30541 [2016-11554]
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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particular, the draft guidance provides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the goals of the draft guidance are to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This draft guidance is being issued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The draft guidance, when finalized, will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This draft guidance refers to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 The draft
guidance pertains to sponsors, clinical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the draft guidance are contained in our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]
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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]
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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
Frm 00027
Fmt 4703
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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
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[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Page 30541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11554]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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, 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]
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