Allergenic Products Advisory Committee; Notice of Meeting, 10451-10452 [2020-03604]
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Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices
Section 1: Introduction
• Provides information on regulatory
policy and guidance background,
purpose, document control, new
features of eCTD v4.0, and guidelines
for an eCTD v4.0 submission.
Section 2: Submission Contents
• Recommends and provides details
on specific topics organized by their
placement (by module) in the eCTD
submission.
Section 3: Combination Products
• Recommends and provides details
on device combination product
information organized by their
placement in the eCTD submission.
Section 4: Two-Way Communications
• Provides details on the two-way
communication process.
Section 5: Rules for Submission
Tracking Information
• Provides details on the submission
tracking relationships for an FDA eCTD
submission.
The FDA eCTD v4.0 Module 1
Implementation Package will provide
the detailed specifications to create
Module 1 of an eCTD v4.0-based
electronic submission for CDER or
CBER. The Implementation Package will
provide the technical specifications and
the necessary components to create a
valid FDA eCTD v4.0 submission. The
Implementation Package contains the
following components:
FDA Regional Controlled Vocabulary for
Transition Mapping Message DTD 3.3
• Provides a human readable version
of the controlled vocabulary transition
mapping for the transition from Module
1 DTD 3.3.
II. Electronic Access
Persons with access to the internet
may obtain the eCTD v4.0 Technical
Conformance Guide and the FDA eCTD
v4.0 Module 1 Implementation Package
at either https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
FormsSubmissionRequirements/
ElectronicSubmissions/ucm309911.htm
or https://www.regulations.gov.
Dated: February 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03574 Filed 2–21–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Allergenic Products Advisory
Committee; Notice of Meeting
FDA eCTD Module 1 Implementation
Guide
AGENCY:
• The technical specification for the
FDA eCTD v4.0 Module 1 using the
Health Level Seven Regulated Product
Submission Release 2, Normative
standard.
ACTION:
• Includes region-specific vocabulary
and the files intended for implementers
to use as a computable version of the
controlled vocabulary content.
FDA Regional Module XML Samples
• Includes samples of M1 eCTD v4.0
xml.
FDA Object Identifiers (OID) Listing
• Provides the OIDs to be used for the
FDA Module 1 controlled vocabulary.
FDA Regional Controlled Vocabulary
• Includes region-specific vocabulary
and these files are intended as the
human readable version of the
controlled vocabulary content.
VerDate Sep<11>2014
18:30 Feb 21, 2020
Jkt 250001
Food and Drug Administration,
HHS.
FDA Regional Genericode Controlled
Vocabulary Files
lotter on DSKBCFDHB2PROD with NOTICES
FDA Regional Controlled Vocabulary for
Transition Mapping Message DTD 2.01
• Provides a human readable version
of the controlled vocabulary transition
mapping for the transition from Module
1 DTD 2.01.
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Allergenic Products
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on May
15, 2020, from 8:30 a.m. to 3 p.m.
ADDRESSES: The meeting will be held at
FDA White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31, Conference
Center, the Great Room (Rm. 1503),
Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For security information,
please refer to https://www.fda.gov/
AboutFDA/WorkingatFDA/
BuildingsandFacilities/
SUMMARY:
PO 00000
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10451
WhiteOakCampusInformation/
ucm241740.htm. For those unable to
attend in person, the meeting will also
be webcast and will be available at the
following link: https://
collaboration.fda.gov/apac051520/.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Kathleen Hayes or Monique Hill, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6307C, Silver Spring, MD 20993–0002,
301–796–7864, Kathleen.Hayes@
fda.hhs.gov, or 301–796–4620,
monique.hill@fda.hhs.gov, respectively;
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s
website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On May 15, 2020, the Center
for Biologics Evaluation and Research’s
(CBER) Allergenic Products Advisory
Committee (APAC) will meet in open
session to discuss and make
recommendations on the safety and
efficacy of Peanut (Arachis hypogaea)
Allergen Extract manufactured by DBV
Technologies, S.A for treatment of
patients 4 through 11 years old with a
confirmed diagnosis of peanut allergy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
E:\FR\FM\24FEN1.SGM
24FEN1
10452
Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 / Notices
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before May 8, 2020. Oral
presentations from the public will be
scheduled between approximately 11:45
a.m. to 12:45 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 30,
2020. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 1, 2020.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Kathleen
Hayes at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
lotter on DSKBCFDHB2PROD with NOTICES
[FR Doc. 2020–03604 Filed 2–21–20; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
‘‘Low Income Levels’’ Used for Various
Health Professions and Nursing
Programs Authorized in Titles III, VII,
and VIII of the Public Health Service
Act
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is updating income
levels used to identify a ‘‘low income
family’’ for the purpose of determining
eligibility for programs that provide
health professions and nursing training
to individuals from disadvantaged
backgrounds. These various programs
are authorized in Titles III, VII, and VIII
of the Public Health Service Act.
SUPPLEMENTARY INFORMATION: HHS
periodically publishes in the Federal
Register low-income levels to be used
by institutions receiving grants and
cooperative agreements to determine
eligibility for programs providing
training for (1) disadvantaged
individuals, (2) individuals from
disadvantaged backgrounds, or (3)
individuals from low-income families.
Many health professions and nursing
grant and cooperative agreement
awardees use the low-income levels to
determine whether potential program
participants are from an economically
disadvantaged background and would
be eligible to participate in the program,
as well as to determine the amount of
funding the individual receives. Awards
are generally made to accredited schools
of medicine, osteopathic medicine,
public health, dentistry, veterinary
medicine, optometry, pharmacy, allied
health, podiatric medicine, nursing, and
chiropractic; public or private nonprofit
schools which offer graduate programs
in behavioral health and mental health
practice; and other public or private
nonprofit health or education entities to
assist the disadvantaged to enter and
graduate from health professions and
nursing schools. Some programs
provide for the repayment of health
professions or nursing education loans
for disadvantaged students.
A ‘‘low-income family/household’’ for
workforce training programs included in
Titles III, VII, and VIII of the Public
Health Service Act is defined as having
an annual income that does not exceed
200 percent of the Department’s poverty
guidelines. A family is a group of two
SUMMARY:
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or more individuals related by birth,
marriage, or adoption who live together.
Most HRSA programs use the income
of a student’s parent(s) to compute low
income status. However, a ‘‘household’’
may potentially be only one person.
Other HRSA programs, depending upon
the legislative intent of the program, the
programmatic purpose related to income
level, as well as the age and
circumstances of the participant, will
apply these low income standards to the
individual student to determine
eligibility, as long as he or she is not
listed as a dependent on the tax form of
his or her parent(s). Each program
announces the rationale and choice of
methodology for determining lowincome levels in program guidance.
Low-income levels are adjusted
annually based on HHS’s poverty
guidelines. HHS’s poverty guidelines
are based on poverty thresholds
published by the U.S. Census Bureau,
adjusted annually for changes in the
Consumer Price Index. The income
figures below have been updated to
reflect the Department’s 2020 poverty
guidelines as published in 85 FR 12
(January 17, 2020).
LOW INCOME LEVELS BASED ON THE
2020 POVERTY GUIDELINES FOR THE
48 CONTIGUOUS STATES AND THE
DISTRICT OF COLUMBIA
Persons in family/household *
1
2
3
4
5
6
7
8
............................................
............................................
............................................
............................................
............................................
............................................
............................................
............................................
Income level **
$25,520
34,480
43,440
52,400
61,360
70.320
79,280
88,240
For families with more than 8 persons, add
$8,960 for each additional person.
* Includes only dependents listed on federal
income tax forms.
** Adjusted gross income for calendar year
2019.
LOW INCOME LEVELS BASED ON THE
2020 POVERTY GUIDELINES FOR
ALASKA
Persons in family/household *
1
2
3
4
5
6
7
8
............................................
............................................
............................................
............................................
............................................
............................................
............................................
............................................
Income level **
$31,900
43,100
54,300
65,500
76,700
87,900
99,100
110,300
For families with more than 8 persons, add
$11,200 for each additional person.
* Includes only dependents listed on federal
income tax forms.
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10451-10452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03604]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Allergenic Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Allergenic Products Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on May 15, 2020, from 8:30 a.m. to 3
p.m.
ADDRESSES: The meeting will be held at FDA White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31, Conference Center, the Great Room (Rm. 1503),
Silver Spring, MD 20993-0002. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. For
those unable to attend in person, the meeting will also be webcast and
will be available at the following link: https://collaboration.fda.gov/apac051520/. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Kathleen Hayes or Monique Hill, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-
0002, 301-796-7864, [email protected], or 301-796-4620,
[email protected], respectively; or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On May 15, 2020, the Center for Biologics Evaluation and
Research's (CBER) Allergenic Products Advisory Committee (APAC) will
meet in open session to discuss and make recommendations on the safety
and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured
by DBV Technologies, S.A for treatment of patients 4 through 11 years
old with a confirmed diagnosis of peanut allergy.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
[[Page 10452]]
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
8, 2020. Oral presentations from the public will be scheduled between
approximately 11:45 a.m. to 12:45 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before April 30, 2020. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by May 1, 2020.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Kathleen Hayes at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03604 Filed 2-21-20; 8:45 am]
BILLING CODE 4164-01-P
