National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 52115-52116 [2019-21223]
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Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Meghana Chalasani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 240–
402–6525, Fax: 301–847–8443,
Meghana.Chalasani@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry, FDA staff,
and other stakeholders entitled ‘‘PatientFocused Drug Development: Methods
To Identify What Is Important to
Patients.’’ This guidance (Guidance 2) is
the second in a series of four
methodological patient-focused drug
development guidance documents that
FDA committed to develop to describe
how stakeholders (patients, researchers,
medical product developers, and others)
can collect and submit information from
patients and caregivers to be used for
medical product development and
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regulatory decision-making. This series
of guidance documents is intended to
facilitate the advancement and use of
systematic approaches to collect and use
robust and meaningful patient and
caregiver input that can more
consistently inform medical product
development and regulatory decisionmaking. The purpose of Guidance 2 is
to present a range of methods and
established best research practices to
identify what is important to patients
with respect to burden of disease,
burden of treatment, and the benefits
and risks in the management of the
patient’s disease. The methods and best
practices presented can help elicit
relevant information from patients and
other stakeholders, such as how their
disease affects their daily lives; what
they find most troublesome; and the
challenges, problems, and burdens of
the treatment for the disease.
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 ‘‘Patient-Focused Drug Development:
Methods To Identify What Is Important
to Patients.’’ 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. This guidance is not
subject to Executive Order 12866.
II. Additional Information
Section 3002 of Title III, Subtitle A of
the 21st Century Cures Act (Pub. L. 114–
255), directs FDA to develop patientfocused drug development guidance to
address a number of areas, including
under section 3002(c)(2)
(methodological approaches that may be
used to develop and identify what is
important to patients with respect to
burden of disease, burden of treatment,
and the benefits and risks in the
management of the patient’s disease).
In addition, FDA committed to meet
certain performance goals under the
sixth authorization of the Prescription
Drug User Fee Act. These goal
commitments were developed in
consultation with patient and consumer
advocates, healthcare professionals, and
other public stakeholders, as part of
negotiations with regulated industry.
Section J.1 of the commitment letter,
‘‘Enhancing the Incorporation of the
Patient’s Voice in Drug Development
and Decision-Making’’ (available at
https://www.fda.gov/media/99140/
download), outlines work, including the
development of a series of guidance
documents and associated public
workshops to facilitate the advancement
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and use of systematic approaches to
collect and use robust and meaningful
patient and caregiver input that can
more consistently inform drug
development, and, as appropriate,
regulatory decision-making.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–21226 Filed 9–30–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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; RNCP-Wide Dosimetry
Guidance & Monitoring of Sources and
Irradiation Protocols (Clinical Trial Not
Allowed).
Date: October 22, 2019.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892.
Contact Person: Louis A. Rosenthal, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Rm 3G42B, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9834,
Bethesda, MD 20892–9834, (240) 669–5070,
rosenthalla@niaid.nih.gov.
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Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices
(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: September 25, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–21223 Filed 9–30–19; 8:45 am]
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Review Branch, Division of Extramural
Activities/Scientific Review Program, 3G53A,
National Institutes of Health, NIAID, 5601
Fishers Lane, MSC 9823, Rockville, MD
20892–9823, 301–761–7322, julio.aliberti@
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: September 25, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–21224 Filed 9–30–19; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSK3GLQ082PROD with NOTICES
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.,
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; Global Infectious Disease
Research Administration Development
Award for Low-and Middle-Income Country
Institutions (G11).
Date: October 16, 2019.
Time: 9:00 a.m. to 12:00 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: Ann Marie M. Brighenti,
Ph.D., Scientific Review Officer, Program
Management & Operations Branch, Division
of Extramural Activities/Scientific Review
Program, RM 3E71, National Institutes of
Health, NIAID, 5601 Fishers Lane, Rockville,
MD 20852, 301–761–3100, cruza@
niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Centers for Medical
Countermeasures Against Radiation
Consortium.
Date: October 23–25, 2019.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Palomar, 2121 P Street NW,
Washington, DC 20037.
Contact Person: Julio C. Aliberti, Ph.D.,
Scientific Review Officer, Immunology
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Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
SUMMARY: Pursuant to the Federal
Advisory Committee Act, notice is
hereby given that the Secretary’s
Advisory Committee on Human
Research Protections (SACHRP) will
hold a meeting that will be open to the
public. Information about SACHRP and
the full meeting agenda will be posted
on the SACHRP website at: https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Wednesday, October 16, 2019, from 8:30
a.m. until 4:30 p.m., and Thursday,
October 17, 2019, from 8:30 a.m. until
3:00 p.m.
ADDRESSES: 6700B Rockledge Drive,
Bethesda, MD 20817.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
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The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
The SACHRP meeting will open to the
public at 8:30 a.m., on Wednesday,
October 16, 2019, followed by opening
remarks from Dr. Jerry Menikoff,
Director of OHRP and Dr. Stephen
Rosenfeld, SACHRP Chair.
The SAS subcommittee will discuss
their revised recommendation questions
posed to SACHRP regarding Deceased
Organ Intervention Research (DDIR),
with an emphasis on recipient informed
consent. This will be followed by a
discussion of Ethical Issues and
Regulatory Considerations Regarding
Re-consent, and Charging Subjects to
Participate in Clinical Trials. The
meeting is scheduled to end at
approximately 4:30 p.m.
The meeting will begin at 8:30 a.m.,
Thursday, October 17, 2019. The SOH
subcommittee will discuss draft
recommendations regarding End User
Licensing Agreements & Terms of
Service; Considerations for IRB Review,
and finally, Site Monitoring under the
New sIRB Mandate. Additional time is
reserved for emerging topics and
continuing the previous day’s
discussions. The meeting will adjourn at
approximately 3:00 p.m.
Time will be allotted for public
comment on both days. On-site
registration is required for participation
in the live public comment session.
Note that public comment must be
relevant to topics currently being
addressed by the SACHRP. Individuals
submitting written statements as public
comment should email or fax their
comments to SACHRP at SACHRP@
hhs.gov at least five business days prior
to the meeting.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify one of
the designated SACHRP points of
contact at the address/phone number
listed above at least one week prior to
the meeting.
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[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52115-52116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21223]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting 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; RNCP-Wide Dosimetry Guidance &
Monitoring of Sources and Irradiation Protocols (Clinical Trial Not
Allowed).
Date: October 22, 2019.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, 5601 Fishers Lane,
Rockville, MD 20892.
Contact Person: Louis A. Rosenthal, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, Rm 3G42B, National Institutes of Health/NIAID, 5601
Fishers Lane, MSC 9834, Bethesda, MD 20892-9834, (240) 669-5070,
[email protected].
[[Page 52116]]
(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: September 25, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-21223 Filed 9-30-19; 8:45 am]
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