Advisory Committee on Heritable Disorders in Newborns and Children Request for Nominations, 36825-36826 [2015-15744]
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Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
FDA based the burden estimates in
Table 1 of this document on past
experience with direct contact with the
medical device manufacturers and
anticipated changes in the medical
device manufacturing patterns for the
specific devices being monitored. FDA
estimates that approximately 125
manufacturers would be contacted by
telephone and/or electronic mail 3 times
per year either to obtain primary data or
to verify/validate data. Because the
requested data represent data elements
that are monitored or tracked by
manufacturers as part of routine
inventory management activities, it is
anticipated that for most manufacturers,
the estimated time required of
manufacturers to complete the data
request will not exceed 30 minutes per
request cycle.
Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15641 Filed 6–25–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders in Newborns and Children
Request for Nominations
Health Resources and Services
Administration, HHS.
ACTION: Notice of request for
nominations.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
seeking nominations of qualified
candidates to be considered for
appointment as members of the
Advisory Committee on Heritable
Disorders in Newborns and Children
(Committee). The Committee provides
advice, recommendations, and technical
information about aspects of heritable
disorders and newborn and childhood
screening to the Secretary of Health and
Human Services. HRSA is seeking
nominations of qualified candidates to
fill three positions on the Committee.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Authority: Section 1111 of the Public
Health Service (PHS) Act, Title XI,
§ 1111(g)(1) (42 U.S.C. 300b–10(g)(1)), as
amended by the Newborn Screening Saves
Lives Reauthorization Act of 2014. The
Committee is governed by the Federal
Advisory Committee Act (FACA), as
amended (5 U.S.C. App.), and 41 CFR part
102–3 and 41 CFR part 102–3, which set
forth standards for the formation and use of
advisory committees.
VerDate Sep<11>2014
18:15 Jun 25, 2015
Jkt 235001
Written nominations for
membership on the Committee must be
received on or before July 27, 2015.
ADDRESSES: Nomination packages must
be submitted electronically as email
attachments to Ms. Lisa M. Vasquez,
Genetic Services Branch, Maternal and
Child Health Bureau, Health Resources
and Services Administration, lvasquez@
hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Ms.
Lisa Vasquez, Genetic Services Branch,
Maternal and Child Health Bureau,
HRSA, at lvasquez@hrsa.gov or (301)
443–4948. A copy of the Committee
Charter and list of the current
membership can be obtained by
accessing the Advisory Committee Web
site at https://www.hrsa.gov/
advisorycommittees/mchbadvisory/
heritabledisorders.
SUPPLEMENTARY INFORMATION: The
Committee is chartered under section
1111 of the Public Health Service (PHS)
Act, 42 U.S.C. 300b–10, as amended by
the Newborn Screening Saves Lives
Reauthorization Act of 2015 (Act). The
Committee was established in 2003 to
advise the Secretary of the U.S.
Department of Health and Human
Services regarding newborn screening
tests, technologies, policies, guidelines,
and programs for effectively reducing
morbidity and mortality in newborns
and children having or at risk for
heritable disorders. In addition, the
Committee provides advice and
recommendations to the Secretary
concerning the grants and projects
authorized under section 1109 of the
PHS Act and technical information to
develop policies and priorities for
grants, including those that will
enhance the ability of the state and local
health agencies to provide for newborn
and child screening, counseling and
health care services for newborns, and
children having or at risk for heritable
disorders.
The Committee is governed by the
provisions of Public Law 92–463, as
amended (5 U.S.C. App. 2), and 41 CFR
part 102–3, which set forth standards for
the formation and use of advisory
committees. The Committee reviews
and reports regularly on newborn and
childhood screening practices for
heritable disorders, recommends
improvements in the national newborn
and childhood heritable screening
programs, and recommends conditions
for inclusion in the Recommended
Uniform Screening Panel (RUSP). The
Committee’s recommendations
regarding additional conditions/
inherited disorders for screening that
have been adopted by the Secretary are
included in the RUSP and constitute
DATES:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
36825
part of the comprehensive guidelines
supported by the Health Resources and
Services Administration. Pursuant to
section 2713 of the Public Health
Service Act, codified at 42 U.S.C.
300gg–13, non-grandfathered health
plans and group and individual health
insurance issuers are required to cover
screenings included in the HRSAsupported comprehensive guidelines
without charging a co-payment, coinsurance, or deductible for plan years
(i.e., in the individual market, policy
years) beginning on or after the date that
is 1 year from the Secretary’s adoption
of the condition for screening.
Nominations: HRSA is requesting
nominations to fill three (3) positions
for voting members to serve on the
Committee. Nominations of potential
candidates for consideration are being
sought for individuals who are medical,
technical, public health, or scientific
professionals with special expertise in
the field of heritable disorders or in
providing screening, counseling, testing,
or specialty services for newborns and
children at risk for heritable disorders;
who have expertise in ethics (i.e.,
bioethics) and infectious diseases and
who have worked and published
material in the area of newborn
screening; members of the public having
special expertise about or concern with
heritable disorders; or members from
such federal agencies, public health
constituencies, and medical
professional societies as determined to
be necessary by the Secretary. Interested
applicants may self-nominate or be
nominated by another individual and/or
organization.
Individuals selected for appointment
to the Committee will be invited to
serve for up to 4 years. Members who
are not federal officers or permanent
federal employees are appointed as
special government employees and
receive a stipend and reimbursement for
per diem and any travel expenses
incurred for attending Committee
meetings and/or conducting other
business on behalf of the Committee, as
authorized by section 5 U.S.C. 5703 for
persons employed intermittently in
government service. Members who are
officers or employees of the United
States Government shall not receive
additional compensation for service on
the Committee, but receive per diem
and travel expenses incurred for
attending Committee meetings and/or
conducting other business on behalf of
the Committee. Nominees will be
invited to serve during calendar year
2016.
The following information must be
included in the package of materials
submitted for each individual being
E:\FR\FM\26JNN1.SGM
26JNN1
36826
Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
nominated for consideration: (1) A
statement that clearly states the name
and affiliation of the nominee, the basis
for the nomination (i.e., specific
attributes such as expertise in bioethics,
evidence review, public health,
laboratory, maternal and child health, or
clinical expertise in heritable disorders,
which qualify the nominee for service in
this capacity), and that the nominee is
willing to serve as a member of the
Committee; (2) the nominee’s name,
address, and daytime telephone number
and the home/or work address,
telephone number, and email address;
and (3) a current copy of the nominee’s
curriculum vitae. Nomination packages
may be summited directly by the
individual being nominated or by the
person/organization recommending the
candidate.
The Department of Health and Human
Services will make every effort to ensure
that the membership of the Committee
is fairly balanced in terms of points of
view represented. Every effort is made
to ensure that individuals from a broad
representation of geographic areas,
gender, ethnic and minority groups, as
well as individuals with disabilities are
given consideration for membership.
Appointments shall be made without
discrimination on the basis of age,
ethnicity, gender, sexual orientation,
and cultural, religious, or
socioeconomic status.
Individuals who are selected to be
considered for appointment will be
required to provide detailed information
regarding their financial holdings,
consultancies, and research grants or
contracts. Disclosure of this information
is necessary in order to determine if the
selected candidate is involved in any
activity that may pose a potential
conflict with the official duties to be
performed as a member of the
Committee.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–15744 Filed 6–25–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Infant
Mortality (ACIM).
VerDate Sep<11>2014
18:15 Jun 25, 2015
Jkt 235001
Dates and Times: July 13, 2015, 8:30
a.m.–5:30 p.m. (EST), July 14, 2015, 8:30
a.m.–3:30 p.m. (EST).
Place: Virtual via Webinar URL:
https://hrsa.connectsolutions.com/
sacim_seminar_200/. Call-In Number:
1.888.942.8170. Passcode: 3494113.
Status: The meeting is open to the
public with attendance limited to
availability of call-in lines. For more
details and registration, please visit the
ACIM Web site: https://www.hrsa.gov/
advisorycommittees/mchbadvisory/
InfantMortality/).
Purpose: The Committee provides
advice and recommendations to the
Secretary of Health and Human Services
on the following: Department of Health
and Human Services’ programs that
focus on reducing infant mortality and
improving the health status of infants
and pregnant women; and factors
affecting the continuum of care with
respect to maternal and child health
care. The Committee focuses on
outcomes following childbirth;
strategies to coordinate myriad federal,
state, local, and private programs and
efforts that are designed to deal with the
health and social problems impacting
infant mortality; and the
implementation of the Healthy Start
program and Healthy People 2020 infant
mortality objectives.
Agenda: Topics that will be discussed
include the following: HRSA Update;
MCHB Update; Healthy Start Program
Update; the PREEMIE Act; and, ACIM’s
recommendations for the HHS National
Strategy to Address Infant Mortality,
specifically, Strategy 5: Invest in
adequate data, monitoring, and
surveillance systems to measure access,
quality, and outcomes.
Proposed agenda items are subject to
change as priorities dictate. The most
current agenda will be posted on the
ACIM Web site.
Time will be provided for public
comments limited to 5 minutes each.
Comments are to be submitted in
writing no later than 5:00 p.m. EST on
Friday July 3, 2015.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the Committee should contact Michael
C. Lu, M.D., M.P.H., Executive
Secretary, ACIM, Health Resources and
Services Administration, Room 18 W,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857, telephone:
(301) 443–2170.
Individuals who are submitting public
comments or who have questions
regarding the meeting and location
should contact David S. de la Cruz,
Ph.D., M.P.H., ACIM Designated Federal
Official, HRSA, Maternal and Child
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Health Bureau, telephone: (301) 443–
0543, or email: David.delaCruz@
hrsa.hhs.gov.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–15741 Filed 6–25–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of an AntiTSLPR Chimeric Antigen Receptor
(CAR) for the Treatment of Human
Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive license to practice the
inventions embodied in U.S. Provisional
Patent Application 61/912,948 entitled
‘‘Thymic Stromal Lymphopoietin
Receptor-Specific Chimeric Antigen
Receptors and Methods Using Same’’
[HHS Ref. E–008–2014/0–US–01], U.S.
Provisional Patent Application 61/
991,697 entitled ‘‘Thymic Stromal
Lymphopoietin Receptor-Specific
Chimeric Antigen Receptors and
Methods Using Same’’ [HHS Ref. E–
008–2014/1–US–01], PCT Patent
Application PCT/US2014/063096
entitled ‘‘Thymic Stromal
Lymphopoietin Receptor-Specific
Chimeric Antigen Receptors and
Methods Using Same’’ [HHS Ref. E–
008–2014/2–PCT–01], and all related
continuing and foreign patents/patent
applications for the technology family,
to Lentigen Technology, Inc. The patent
rights in these inventions have been
assigned to and/or exclusively licensed
to the Government of the United States
of America.
The prospective exclusive licensed
territory may be worldwide, and the
field of use may be limited to:
‘‘The development of a TSLPR–CARbased immunotherapy using chimeric
antigen receptors (CARs) having:
(1) The complementary determining
region (CDR) sequences of either
(a) the anti-TSLPR antibody known as
2D10 or
(b) the anti-TSLPR antibody known as
3G11; and
(2) a T cell signaling domain
SUMMARY:
E:\FR\FM\26JNN1.SGM
26JNN1
]]>Agencies
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36825-36826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15744]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Heritable Disorders in Newborns and
Children Request for Nominations
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of request for nominations.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA) is
seeking nominations of qualified candidates to be considered for
appointment as members of the Advisory Committee on Heritable Disorders
in Newborns and Children (Committee). The Committee provides advice,
recommendations, and technical information about aspects of heritable
disorders and newborn and childhood screening to the Secretary of
Health and Human Services. HRSA is seeking nominations of qualified
candidates to fill three positions on the Committee.
Authority: Section 1111 of the Public Health Service (PHS) Act,
Title XI, Sec. 1111(g)(1) (42 U.S.C. 300b-10(g)(1)), as amended by
the Newborn Screening Saves Lives Reauthorization Act of 2014. The
Committee is governed by the Federal Advisory Committee Act (FACA),
as amended (5 U.S.C. App.), and 41 CFR part 102-3 and 41 CFR part
102-3, which set forth standards for the formation and use of
advisory committees.
DATES: Written nominations for membership on the Committee must be
received on or before July 27, 2015.
ADDRESSES: Nomination packages must be submitted electronically as
email attachments to Ms. Lisa M. Vasquez, Genetic Services Branch,
Maternal and Child Health Bureau, Health Resources and Services
Administration, lvasquez@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Ms. Lisa Vasquez, Genetic Services
Branch, Maternal and Child Health Bureau, HRSA, at lvasquez@hrsa.gov or
(301) 443-4948. A copy of the Committee Charter and list of the current
membership can be obtained by accessing the Advisory Committee Web site
at https://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
SUPPLEMENTARY INFORMATION: The Committee is chartered under section
1111 of the Public Health Service (PHS) Act, 42 U.S.C. 300b-10, as
amended by the Newborn Screening Saves Lives Reauthorization Act of
2015 (Act). The Committee was established in 2003 to advise the
Secretary of the U.S. Department of Health and Human Services regarding
newborn screening tests, technologies, policies, guidelines, and
programs for effectively reducing morbidity and mortality in newborns
and children having or at risk for heritable disorders. In addition,
the Committee provides advice and recommendations to the Secretary
concerning the grants and projects authorized under section 1109 of the
PHS Act and technical information to develop policies and priorities
for grants, including those that will enhance the ability of the state
and local health agencies to provide for newborn and child screening,
counseling and health care services for newborns, and children having
or at risk for heritable disorders.
The Committee is governed by the provisions of Public Law 92-463,
as amended (5 U.S.C. App. 2), and 41 CFR part 102-3, which set forth
standards for the formation and use of advisory committees. The
Committee reviews and reports regularly on newborn and childhood
screening practices for heritable disorders, recommends improvements in
the national newborn and childhood heritable screening programs, and
recommends conditions for inclusion in the Recommended Uniform
Screening Panel (RUSP). The Committee's recommendations regarding
additional conditions/inherited disorders for screening that have been
adopted by the Secretary are included in the RUSP and constitute part
of the comprehensive guidelines supported by the Health Resources and
Services Administration. Pursuant to section 2713 of the Public Health
Service Act, codified at 42 U.S.C. 300gg-13, non-grandfathered health
plans and group and individual health insurance issuers are required to
cover screenings included in the HRSA-supported comprehensive
guidelines without charging a co-payment, co-insurance, or deductible
for plan years (i.e., in the individual market, policy years) beginning
on or after the date that is 1 year from the Secretary's adoption of
the condition for screening.
Nominations: HRSA is requesting nominations to fill three (3)
positions for voting members to serve on the Committee. Nominations of
potential candidates for consideration are being sought for individuals
who are medical, technical, public health, or scientific professionals
with special expertise in the field of heritable disorders or in
providing screening, counseling, testing, or specialty services for
newborns and children at risk for heritable disorders; who have
expertise in ethics (i.e., bioethics) and infectious diseases and who
have worked and published material in the area of newborn screening;
members of the public having special expertise about or concern with
heritable disorders; or members from such federal agencies, public
health constituencies, and medical professional societies as determined
to be necessary by the Secretary. Interested applicants may self-
nominate or be nominated by another individual and/or organization.
Individuals selected for appointment to the Committee will be
invited to serve for up to 4 years. Members who are not federal
officers or permanent federal employees are appointed as special
government employees and receive a stipend and reimbursement for per
diem and any travel expenses incurred for attending Committee meetings
and/or conducting other business on behalf of the Committee, as
authorized by section 5 U.S.C. 5703 for persons employed intermittently
in government service. Members who are officers or employees of the
United States Government shall not receive additional compensation for
service on the Committee, but receive per diem and travel expenses
incurred for attending Committee meetings and/or conducting other
business on behalf of the Committee. Nominees will be invited to serve
during calendar year 2016.
The following information must be included in the package of
materials submitted for each individual being
[[Page 36826]]
nominated for consideration: (1) A statement that clearly states the
name and affiliation of the nominee, the basis for the nomination
(i.e., specific attributes such as expertise in bioethics, evidence
review, public health, laboratory, maternal and child health, or
clinical expertise in heritable disorders, which qualify the nominee
for service in this capacity), and that the nominee is willing to serve
as a member of the Committee; (2) the nominee's name, address, and
daytime telephone number and the home/or work address, telephone
number, and email address; and (3) a current copy of the nominee's
curriculum vitae. Nomination packages may be summited directly by the
individual being nominated or by the person/organization recommending
the candidate.
The Department of Health and Human Services will make every effort
to ensure that the membership of the Committee is fairly balanced in
terms of points of view represented. Every effort is made to ensure
that individuals from a broad representation of geographic areas,
gender, ethnic and minority groups, as well as individuals with
disabilities are given consideration for membership. Appointments shall
be made without discrimination on the basis of age, ethnicity, gender,
sexual orientation, and cultural, religious, or socioeconomic status.
Individuals who are selected to be considered for appointment will
be required to provide detailed information regarding their financial
holdings, consultancies, and research grants or contracts. Disclosure
of this information is necessary in order to determine if the selected
candidate is involved in any activity that may pose a potential
conflict with the official duties to be performed as a member of the
Committee.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-15744 Filed 6-25-15; 8:45 am]
BILLING CODE 4165-15-P
