80 FR 59161 - Notice of Class Deviation From Competition Requirements
DEPARTMENT OF HEALTH & HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 190 (October 1, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 190 (October 1, 2015)
| Page Range | 59161-59162 | |
| FR Document | 2015-24965 |
[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)] [Notices] [Pages 59161-59162] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices 59161
list. FDA intends to discuss the notify interested persons regarding their children with complex disabilities. The
following nominated bulk drug request to speak by October 13, 2015. purpose of this notice is to award a 12-
substances: Quinacrine hydrochloride, Persons attending FDA’s advisory month supplement to LEND pediatric
methylsulfonylmethane, curcumin, committee meetings are advised that the audiology programs to: (1) Strengthen
germanium sesquioxide, rubidium Agency is not responsible for providing the focus on testing for hearing loss in
chloride, and deoxy-D-glucose. The access to electrical outlets. young infants and children with autism
nominators of these substances will be FDA welcomes the attendance of the spectrum disorder (ASD) and other
invited to make a short presentation public at its advisory committee related neurodevelopmental disabilities
supporting the nomination. meetings and will make every effort to (DD); and (2) to increase the number of
On October 28, 2015, during the accommodate persons with disabilities. pediatric audiology trainees with
morning and afternoon sessions, the If you require accommodations due to a clinical and leadership skills to detect
committee will discuss four bulk drug disability, please contact Cindy Hong at hearing loss in these infants/children,
substances nominated for inclusion on least 7 days in advance of the meeting. and to develop systems to increase
the section 503A bulk drug substances FDA is committed to the orderly enrollment of identified infants/
list. FDA intends to discuss the conduct of its advisory committee children into early intervention
following nominated bulk drug meetings. Please visit our Web site at programs.
substances: Alanyl-L-glutamine, http://www.fda.gov/ SUPPLEMENTARY INFORMATION:
glutaraldehyde, glycyrrhizin, and AdvisoryCommittees/ Intended Recipients of the Awards:
domperidone. Other nominated AboutAdvisoryCommittees/ University of Utah, UNC-Chapel Hill,
substances will be discussed at future ucm111462.htm for procedures on University of Pittsburgh, University of
committee meetings. public conduct during advisory Colorado, Vanderbilt University,
FDA intends to make background committee meetings. University of Miami, University of
material available to the public no later Notice of this meeting is given under South Dakota, University of
than 2 business days before the meeting. the Federal Advisory Committee Act (5 Washington, Children’s Hospital
If FDA is unable to post the background U.S.C. app. 2). Boston, University of Wisconsin.
material on its Web site prior to the Dated: September 25, 2015. Amount of Each Non-Competitive
meeting, the background material will Jill Hartzler Warner, Award: $70,000.
be made publicly available at the Associate Commissioner for Special Medical Period of Supplemental Funding:
location of the advisory committee Programs. 7/1/2015–6/30/2016.
meeting, and the background material [FR Doc. 2015–24834 Filed 9–30–15; 8:45 am]
CFDA Number: 93.110.
will be posted on FDA’s Web site after BILLING CODE 4164–01–P Authority: Autism Act of 2006, Public
the meeting. Background material is Health Service (PHS) Act § 399BB(e)(1)(A),
available at http://www.fda.gov/ codified at 42 U.S.C. 280i–1.
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH & HUMAN Justification: The ten LEND programs
default.htm. Scroll down to the SERVICES discussed in this request are currently
appropriate advisory committee meeting in year 5 of a 5-year project period.
link. Health Resources and Services Approval of this request for a $70,000
Procedure: Interested persons may Administration program expansion supplement to each
present data, information, or views, of the ten grantees will allow the
orally or in writing, on issues pending Notice of Class Deviation From
programs to continue their work to
before the committee. Written Competition Requirements
strengthen the focus on testing for
submissions may be made to the contact AGENCY: Health Resources and Services hearing loss in young infants and
person on or before October 13, 2015. Administration (HRSA), Department of children with ASD and other related
Oral presentations from the public will Health and Human Services (HHS). DD, to increase the number of pediatric
be scheduled between approximately ACTION: Notice of Class Deviation from audiology trainees with clinical and
9:45 a.m. to 10 a.m., 1:30 p.m. to 1:45 Competition Requirements: Program leadership skills to detect hearing loss
p.m., and 4:15 p.m. to 4:30 p.m. on Expansion Supplement Request for in these infants/children, and to enroll
October 27, 2015, and between Pediatric Audiology Supplements to ten identified infants/children into early
approximately 11 a.m. to 11:15 a.m. and Leadership Education in intervention programs.
2:45 p.m. to 3:30 p.m. on October 28, Neurodevelopmental and Other Related The identified LEND grantees are
2015. Those individuals interested in Disabilities (LEND) Maternal and Child uniquely qualified to perform the
making formal oral presentations should Health (MCH) Training Programs. expanded activity because for the past 6
notify the contact person and submit a years they have provided enhanced
brief statement of the general nature of SUMMARY: HRSA announces the award didactic and clinical training in
the evidence or arguments they wish to of a program expansion supplement in pediatric audiology and have increased
present, the names and addresses of the amount of $70,000 each to ten the number of trained pediatric
proposed participants, and an Leadership Education in audiologists to provide critical services
indication of the approximate time Neurodevelopment and Other Related in the community. If these grantees are
requested to make their presentation on Disabilities (LEND) grantees with awarded a program expansion, LEND
or before October 9, 2015. Time allotted existing graduate-level pediatric will continue to increase the number of
mstockstill on DSK4VPTVN1PROD with NOTICES6
for each presentation may be limited. If audiology programs. The purpose of the pediatric audiology trainees with
the number of registrants requesting to LEND Program is to enhance the clinical clinical and leadership skills to detect
speak is greater than can be reasonably expertise and leadership skills of hearing loss in infants/children with
accommodated during the scheduled professionals dedicated to caring for ASD and other related DD, and to enroll
open public hearing session, FDA may children with neurodevelopmental and identified infants/children into early
conduct a lottery to determine the other related disabilities, including intervention programs. Each of the ten
speakers for the scheduled open public autism, and to increase the number of LEND Programs that receive this
hearing session. The contact person will trained providers available to treat funding has made a commitment to
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![59162 Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices
three to four pediatric audiology families to access early intervention Maryland 20857; DSofka@hrsa.gov.
trainees in their programs. Without a services in a timely manner. Robyn J. Schulhof, MA, Division of
continuation of funds, the trainees will FOR FURTHER INFORMATION CONTACT: Maternal and Child Health Workforce
be left with an incomplete training Denise Sofka, RD, MPH, Division of Development, Maternal and Child
experience. Disapproval of this request Maternal and Child Health Workforce Health Bureau, Health Resources and
may also prevent families of children Development, Maternal and Child Services Administration, 5600 Fishers
with ASD and other DD from receiving Health Bureau, Health Resources and Lane, Room 18W50, Rockville,
appropriate services through trained Services Administration, 5600 Fishers Maryland 20857; RSchulhof@hrsa.gov.
providers and create more burden on Lane, Room 18W55, Rockville,
Fiscal year Fiscal year
Current project Current project 2014 2015
Grantee/organization name Grant No. State start date end date authorized estimated
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. HRSA’s role in the Program, contact the manifested outside the time periods
James Macrae, Director, National Vaccine Injury specified in the Table, but only if the
Acting Administrator. Compensation Program, 5600 Fishers petitioner shows that the condition was
[FR Doc. 2015–24965 Filed 9–30–15; 8:45 am] Lane, Room 11C–26, Rockville, MD caused by one of the listed vaccines.
BILLING CODE 4165–15–P
20857; (301) 443–6593, or visit our Web Section 2112(b)(2) of the PHS Act, 42
site at: http://www.hrsa.gov/ U.S.C. 300aa–12(b)(2), requires that
vaccinecompensation/index.html. ‘‘[w]ithin 30 days after the Secretary
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: The receives service of any petition filed
HUMAN SERVICES Program provides a system of no-fault under section 2111 the Secretary shall
compensation for certain individuals publish notice of such petition in the
Health Resources and Services who have been injured by specified Federal Register.’’ Set forth below is a
Administration childhood vaccines. Subtitle 2 of Title list of petitions received by HRSA on
XXI of the PHS Act, 42 U.S.C. 300aa– August 1, 2015, through August 31,
National Vaccine Injury Compensation 10 et seq., provides that those seeking 2015. This list provides the name of
Program; List of Petitions Received compensation are to file a petition with petitioner, city and state of vaccination
the U.S. Court of Federal Claims and to (if unknown then city and state of
AGENCY: Health Resources and Services
serve a copy of the petition on the person or attorney filing claim), and
Administration, HHS.
Secretary of Health and Human case number. In cases where the Court
ACTION: Notice. Services, who is named as the has redacted the name of a petitioner
respondent in each proceeding. The and/or the case number, the list reflects
SUMMARY: The Health Resources and
Secretary has delegated this such redaction.
Services Administration (HRSA) is Section 2112(b)(2) also provides that
responsibility under the Program to
publishing this notice of petitions the special master ‘‘shall afford all
HRSA. The Court is directed by statute
received under the National Vaccine interested persons an opportunity to
to appoint special masters who take
Injury Compensation Program (the submit relevant, written information’’
evidence, conduct hearings as
Program), as required by Section relating to the following:
appropriate, and make initial decisions
2112(b)(2) of the Public Health Service as to eligibility for, and amount of, 1. The existence of evidence ‘‘that
(PHS) Act, as amended. While the compensation. there is not a preponderance of the
Secretary of Health and Human Services A petition may be filed with respect evidence that the illness, disability,
is named as the respondent in all to injuries, disabilities, illnesses, injury, condition, or death described in
proceedings brought by the filing of conditions, and deaths resulting from the petition is due to factors unrelated
petitions for compensation under the vaccines described in the Vaccine Injury to the administration of the vaccine
Program, the United States Court of Table (the Table) set forth at 42 CFR described in the petition,’’ and
Federal Claims is charged by statute 100.3. This Table lists for each covered 2. Any allegation in a petition that the
with responsibility for considering and childhood vaccine the conditions that petitioner either:
mstockstill on DSK4VPTVN1PROD with NOTICES6
acting upon the petitions. may lead to compensation and, for each a. ‘‘[S]ustained, or had significantly
FOR FURTHER INFORMATION CONTACT: For condition, the time period for aggravated, any illness, disability,
information about requirements for occurrence of the first symptom or injury, or condition not set forth in the
filing petitions, and the Program in manifestation of onset or of significant Vaccine Injury Table but which was
general, contact the Clerk, United States aggravation after vaccine caused by’’ one of the vaccines referred
Court of Federal Claims, 717 Madison administration. Compensation may also to in the Table, or
Place NW., Washington, DC 20005, be awarded for conditions not listed in b. ‘‘[S]ustained, or had significantly
(202) 357–6400. For information on the Table and for conditions that are aggravated, any illness, disability,
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Document Created: 2015-12-15 08:40:32
Document Modified: 2015-12-15 08:40:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| 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; [email protected] 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; [email protected] | |
| FR Citation | 80 FR 59161 |
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