Notice of Class Deviation From Competition Requirements, 59161-59162 [2015-24965]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES6 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 http://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 VerDate Sep<11>2014 21:04 Sep 30, 2015 Jkt 238001 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 http://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: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\01OCN1.SGM 01OCN1 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 mstockstill on DSK4VPTVN1PROD with NOTICES6 SUMMARY: VerDate Sep<11>2014 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: http://www.hrsa.gov/ vaccinecompensation/index.html. 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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]


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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.

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                                                                                                                            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
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    Dated: September 24, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-24965 Filed 9-30-15; 8:45 am]
BILLING CODE 4165-15-P