Notice of Class Deviation From Competition Requirements, 59161-59162 [2015-24965]
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Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices
list. FDA intends to discuss the
following nominated bulk drug
substances: Quinacrine hydrochloride,
methylsulfonylmethane, curcumin,
germanium sesquioxide, rubidium
chloride, and deoxy-D-glucose. The
nominators of these substances will be
invited to make a short presentation
supporting the nomination.
On October 28, 2015, during the
morning and afternoon sessions, the
committee will discuss four bulk drug
substances nominated for inclusion on
the section 503A bulk drug substances
list. FDA intends to discuss the
following nominated bulk drug
substances: Alanyl-L-glutamine,
glutaraldehyde, glycyrrhizin, and
domperidone. Other nominated
substances will be discussed at future
committee meetings.
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 Web site 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 Web site 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.
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 October 13, 2015.
Oral presentations from the public will
be scheduled between approximately
9:45 a.m. to 10 a.m., 1:30 p.m. to 1:45
p.m., and 4:15 p.m. to 4:30 p.m. on
October 27, 2015, and between
approximately 11 a.m. to 11:15 a.m. and
2:45 p.m. to 3:30 p.m. on October 28,
2015. 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 October 9, 2015. 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
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notify interested persons regarding their
request to speak by October 13, 2015.
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 Cindy Hong at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site 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: September 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–24834 Filed 9–30–15; 8:45 am]
59161
children with complex disabilities. The
purpose of this notice is to award a 12month supplement to LEND pediatric
audiology programs to: (1) Strengthen
the focus on testing for hearing loss in
young infants and children with autism
spectrum disorder (ASD) and other
related neurodevelopmental disabilities
(DD); and (2) to increase the number of
pediatric audiology trainees with
clinical and leadership skills to detect
hearing loss in these infants/children,
and to develop systems to increase
enrollment of identified infants/
children into early intervention
programs.
SUPPLEMENTARY INFORMATION:
Intended Recipients of the Awards:
University of Utah, UNC-Chapel Hill,
University of Pittsburgh, University of
Colorado, Vanderbilt University,
University of Miami, University of
South Dakota, University of
Washington, Children’s Hospital
Boston, University of Wisconsin.
Amount of Each Non-Competitive
Award: $70,000.
Period of Supplemental Funding:
7/1/2015–6/30/2016.
CFDA Number: 93.110.
BILLING CODE 4164–01–P
Authority: Autism Act of 2006, Public
Health Service (PHS) Act § 399BB(e)(1)(A),
codified at 42 U.S.C. 280i–1.
DEPARTMENT OF HEALTH & HUMAN
SERVICES
Justification: The ten LEND programs
discussed in this request are currently
in year 5 of a 5-year project period.
Approval of this request for a $70,000
program expansion supplement to each
of the ten grantees will allow the
programs to continue their work to
strengthen the focus on testing for
hearing loss in young infants and
children with ASD and other related
DD, to increase the number of pediatric
audiology trainees with clinical and
leadership skills to detect hearing loss
in these infants/children, and to enroll
identified infants/children into early
intervention programs.
The identified LEND grantees are
uniquely qualified to perform the
expanded activity because for the past 6
years they have provided enhanced
didactic and clinical training in
pediatric audiology and have increased
the number of trained pediatric
audiologists to provide critical services
in the community. If these grantees are
awarded a program expansion, LEND
will continue to increase the number of
pediatric audiology trainees with
clinical and leadership skills to detect
hearing loss in infants/children with
ASD and other related DD, and to enroll
identified infants/children into early
intervention programs. Each of the ten
LEND Programs that receive this
funding has made a commitment to
Health Resources and Services
Administration
Notice of Class Deviation From
Competition Requirements
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Class Deviation from
Competition Requirements: Program
Expansion Supplement Request for
Pediatric Audiology Supplements to ten
Leadership Education in
Neurodevelopmental and Other Related
Disabilities (LEND) Maternal and Child
Health (MCH) Training Programs.
AGENCY:
HRSA announces the award
of a program expansion supplement in
the amount of $70,000 each to ten
Leadership Education in
Neurodevelopment and Other Related
Disabilities (LEND) grantees with
existing graduate-level pediatric
audiology programs. The purpose of the
LEND Program is to enhance the clinical
expertise and leadership skills of
professionals dedicated to caring for
children with neurodevelopmental and
other related disabilities, including
autism, and to increase the number of
trained providers available to treat
SUMMARY:
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59162
Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices
three to four pediatric audiology
trainees in their programs. Without a
continuation of funds, the trainees will
be left with an incomplete training
experience. Disapproval of this request
may also prevent families of children
with ASD and other DD from receiving
appropriate services through trained
providers and create more burden on
families to access early intervention
services in a timely manner.
FOR FURTHER INFORMATION CONTACT:
Denise Sofka, RD, MPH, Division of
Maternal and Child Health Workforce
Development, Maternal and Child
Health Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 18W55, Rockville,
Grantee/organization name
Grant No.
University of Colorado ..........................................
University of Miami ...............................................
Children’s Hospital Boston ...................................
UNC-Chapel Hill ...................................................
University of Pittsburgh .........................................
University of South Dakota ...................................
Vanderbilt University .............................................
University of Utah .................................................
University of Washington ......................................
University of Wisconsin ........................................
T73MC11044
T73MC00013
T73MC00020
T73MC00030
T73MC00036
T73MC00037
T73MC00050
T73MC00054
T73MC00041
T73MC00044
Dated: September 24, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015–24965 Filed 9–30–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
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SUMMARY:
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21:04 Sep 30, 2015
Jkt 238001
Maryland 20857; DSofka@hrsa.gov.
Robyn J. Schulhof, MA, Division of
Maternal and Child Health Workforce
Development, Maternal and Child
Health Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 18W50, Rockville,
Maryland 20857; RSchulhof@hrsa.gov.
Current project
start date
Current project
end date
7/1/2011
7/1/2011
7/1/2011
7/1/2011
7/1/2011
7/1/2011
7/1/2011
7/1/2011
7/1/2011
7/1/2011
State
6/30/2016
6/30/2016
6/30/2016
6/30/2016
6/30/2016
6/30/2016
6/30/2016
6/30/2016
6/30/2016
6/30/2016
CO
FL
MA
NC
PA
SD
TN
UT
WA
WI
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593, or visit our Web
site at: https://www.hrsa.gov/
vaccinecompensation/.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
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Fiscal year
2014
authorized
funding level
$544,765
712,385
670,480
833,174
586,452
529,942
577,381
747,435
814,466
658,569
Fiscal year
2015
estimated
funding level
$614,765
782,385
740,480
903,174
656,452
599,942
648,289
817,435
884,466
734,054
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
August 1, 2015, through August 31,
2015. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Pages 59161-59162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24965]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Health Resources and Services Administration
Notice of Class Deviation From Competition Requirements
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of Class Deviation from Competition Requirements:
Program Expansion Supplement Request for Pediatric Audiology
Supplements to ten Leadership Education in Neurodevelopmental and Other
Related Disabilities (LEND) Maternal and Child Health (MCH) Training
Programs.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of a program expansion supplement in
the amount of $70,000 each to ten Leadership Education in
Neurodevelopment and Other Related Disabilities (LEND) grantees with
existing graduate-level pediatric audiology programs. The purpose of
the LEND Program is to enhance the clinical expertise and leadership
skills of professionals dedicated to caring for children with
neurodevelopmental and other related disabilities, including autism,
and to increase the number of trained providers available to treat
children with complex disabilities. The purpose of this notice is to
award a 12-month supplement to LEND pediatric audiology programs to:
(1) Strengthen the focus on testing for hearing loss in young infants
and children with autism spectrum disorder (ASD) and other related
neurodevelopmental disabilities (DD); and (2) to increase the number of
pediatric audiology trainees with clinical and leadership skills to
detect hearing loss in these infants/children, and to develop systems
to increase enrollment of identified infants/children into early
intervention programs.
SUPPLEMENTARY INFORMATION:
Intended Recipients of the Awards: University of Utah, UNC-Chapel
Hill, University of Pittsburgh, University of Colorado, Vanderbilt
University, University of Miami, University of South Dakota, University
of Washington, Children's Hospital Boston, University of Wisconsin.
Amount of Each Non-Competitive Award: $70,000.
Period of Supplemental Funding: 7/1/2015-6/30/2016.
CFDA Number: 93.110.
Authority: Autism Act of 2006, Public Health Service (PHS) Act
Sec. 399BB(e)(1)(A), codified at 42 U.S.C. 280i-1.
Justification: The ten LEND programs discussed in this request are
currently in year 5 of a 5-year project period. Approval of this
request for a $70,000 program expansion supplement to each of the ten
grantees will allow the programs to continue their work to strengthen
the focus on testing for hearing loss in young infants and children
with ASD and other related DD, to increase the number of pediatric
audiology trainees with clinical and leadership skills to detect
hearing loss in these infants/children, and to enroll identified
infants/children into early intervention programs.
The identified LEND grantees are uniquely qualified to perform the
expanded activity because for the past 6 years they have provided
enhanced didactic and clinical training in pediatric audiology and have
increased the number of trained pediatric audiologists to provide
critical services in the community. If these grantees are awarded a
program expansion, LEND will continue to increase the number of
pediatric audiology trainees with clinical and leadership skills to
detect hearing loss in infants/children with ASD and other related DD,
and to enroll identified infants/children into early intervention
programs. Each of the ten LEND Programs that receive this funding has
made a commitment to
[[Page 59162]]
three to four pediatric audiology trainees in their programs. Without a
continuation of funds, the trainees will be left with an incomplete
training experience. Disapproval of this request may also prevent
families of children with ASD and other DD from receiving appropriate
services through trained providers and create more burden on families
to access early intervention services in a timely manner.
FOR FURTHER INFORMATION CONTACT: Denise Sofka, RD, MPH, Division of
Maternal and Child Health Workforce Development, Maternal and Child
Health Bureau, Health Resources and Services Administration, 5600
Fishers Lane, Room 18W55, Rockville, Maryland 20857; DSofka@hrsa.gov.
Robyn J. Schulhof, MA, Division of Maternal and Child Health Workforce
Development, Maternal and Child Health Bureau, Health Resources and
Services Administration, 5600 Fishers Lane, Room 18W50, Rockville,
Maryland 20857; RSchulhof@hrsa.gov.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year Fiscal year
Current Current 2014 2015
Grantee/organization name Grant No. State project start project end authorized estimated
date date funding level funding level
--------------------------------------------------------------------------------------------------------------------------------------------------------
University of Colorado....................... T73MC11044 CO 7/1/2011 6/30/2016 $544,765 $614,765
University of Miami.......................... T73MC00013 FL 7/1/2011 6/30/2016 712,385 782,385
Children's Hospital Boston................... T73MC00020 MA 7/1/2011 6/30/2016 670,480 740,480
UNC-Chapel Hill.............................. T73MC00030 NC 7/1/2011 6/30/2016 833,174 903,174
University of Pittsburgh..................... T73MC00036 PA 7/1/2011 6/30/2016 586,452 656,452
University of South Dakota................... T73MC00037 SD 7/1/2011 6/30/2016 529,942 599,942
Vanderbilt University........................ T73MC00050 TN 7/1/2011 6/30/2016 577,381 648,289
University of Utah........................... T73MC00054 UT 7/1/2011 6/30/2016 747,435 817,435
University of Washington..................... T73MC00041 WA 7/1/2011 6/30/2016 814,466 884,466
University of Wisconsin...................... T73MC00044 WI 7/1/2011 6/30/2016 658,569 734,054
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: September 24, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-24965 Filed 9-30-15; 8:45 am]
BILLING CODE 4165-15-P
