Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children, 22285-22286 [2016-08691]
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Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
finalized, will represent the current
thinking of FDA on the product-specific
design of BE studies to support ANDAs.
They do not establish any rights for any
person and are not binding on FDA or
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approach if it satisfies the requirements
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IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: April 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08682 Filed 4–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Heritable Disorders in
Newborns and Children
Health Resources and Services
Administration, HHS.
ACTION: 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.
asabaliauskas 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.
Written nominations for
membership on the Committee must be
received on or before May 16, 2016.
ADDRESSES: Nomination packages must
be submitted electronically as email
DATES:
VerDate Sep<11>2014
17:27 Apr 14, 2016
Jkt 238001
attachments to Alaina Harris, Genetic
Services Branch, Maternal and Child
Health Bureau, Health Resources and
Services Administration,
aharris@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Genetic Services Branch,
Maternal and Child Health Bureau,
HRSA, at aharris@hrsa.gov or (301)
443–0721. 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.
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
22285
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, 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 representatives
from such federal agencies, public
health constituencies, and medical
professional societies as determined to
be necessary by the Secretary to fulfill
the duties of the Advisory Committee
established under subsection (b) of
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). Interested applicants may selfnominate 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
2017.
The following information must be
included in the package of materials
E:\FR\FM\15APN1.SGM
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22286
Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
submitted for each individual being
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. 2016–08691 Filed 4–14–16; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4165–15–P
VerDate Sep<11>2014
17:27 Apr 14, 2016
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health (NIH)
Office of Science Policy (OSP)
Recombinant or Synthetic Nucleic Acid
Research: Action Under the NIH
Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines)
The NIH OSP is amending
portions of the NIH Guidelines in order
to provide investigators with biosafety
guidance regarding the standards for
containment of non-human primates
(NHPs) in biosafety level (BL) 4
laboratories and to make such guidance
consistent with the expectations
articulated in the Centers for Disease
Control and Prevention (CDC)/NIH
Biosafety in Microbiological and
Biomedical Laboratories 5th edition
(BMBL). Specifically, the NIH
Guidelines will allow for housing of
NHPs in open caging in a dedicated
animal holding room provided there are
two physical barriers between that
animal holding room and noncontainment space within the
laboratory, the animal holding room has
negative air pressure with respect to any
adjacent non-containment corridors,
and there are specific decontamination
protocols in place before the door to the
animal holding room is opened to allow
for the periodic transfer of new animals
into the room. These amendments do
not change the current containment
requirements in the NIH Guidelines but
rather offer an alternative for achieving
primary containment without
compromising safety.
In addition, the recertification
requirement for biosafety cabinets in
BL4 laboratories is updated in
recognition of the technological
standards for modern biosafety cabinets.
The NIH OSP also is updating the
validation requirements for equipment
responsible for centralized heat
decontamination of liquid effluents in
laboratories working with large animals.
These amendments to the NIH
Guidelines will be implemented
immediately upon publication in the
Federal Register. These changes were
developed after extensive consultation
with biosafety experts, directors of and
principal investigators in BL4 facilities
working with NHPs, and CDC’s Division
of Select Agent and Toxins (DSAT)
leadership at a public workshop and
discussion at a public Recombinant
DNA Advisory Committee (RAC)
meeting. Publication in the Federal
SUMMARY:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
Register will inform the scientific and
biosafety communities.
FOR FURTHER INFORMATION CONTACT: If
you have questions, or require
additional information about these
changes, please contact the NIH OSP by
email at SciencePolicy@od.nih.gov, or
telephone at 301–496–9838.
SUPPLEMENTARY INFORMATION: The first
three editions of the BMBL and the NIH
Guidelines were consistent in their
approach to requiring primary
containment for animal work in BL4
containment laboratories. However, in
the early 1990s, the BMBL was amended
and the fourth edition stated that
animals housed in BL4 suit laboratories
(i.e., laboratories in which Class III
cabinets are not used but instead
personnel wear positive pressure
protective suits) should be housed in a
primary containment system (such as
open cages covered with filtered
bonnets and opened in laminar flow
hoods or other equivalent containment
systems). This language remains in the
current BMBL (5th edition). With the
change in the BMBL, primary
containment caging was arguably
preferred but no longer required under
BL4 containment. In contrast, the NIH
Guidelines have always required
primary containment caging for all
animals in BL4 laboratories.
Non-human primates are social
animals and require environmental
enrichment. Researchers in several U.S.
BL4 laboratories engaged in NHP
research approached the NIH OSP with
concerns that primary containment
caging in BL4 laboratories hindered the
creation of an environment that allowed
animals to benefit from adequate social
interaction. Also based on risk
assessments and experiences comparing
several primary containment caging
systems, the researchers concluded that
primary containment caging may
actually create new hazards for
laboratory workers. These findings
included interference with observation
of the animals from outside the room
leading to more frequent entries into the
BL4 animal room to monitor the
animals, and exacerbation of cramped
working conditions created by the
additional barriers required by some
containment systems, which increases
the difficulty of working in inflated
pressure suits as well as the potential
for damage to the pressure suit. In
addition, investigators stated that
current BL4 laboratory designs
incorporate sophisticated engineering
systems, which provide biosafety
protection in a dedicated animal room
equivalent to the primary containment
caging required under the NIH
E:\FR\FM\15APN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22285-22286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08691]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Solicitation of Nominations for Membership To Serve on the
Advisory Committee on Heritable Disorders in Newborns and Children
AGENCY: Health Resources and Services Administration, HHS.
ACTION: 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 May 16, 2016.
ADDRESSES: Nomination packages must be submitted electronically as
email attachments to Alaina Harris, Genetic Services Branch, Maternal
and Child Health Bureau, Health Resources and Services Administration,
aharris@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Alaina Harris, Genetic Services
Branch, Maternal and Child Health Bureau, HRSA, at aharris@hrsa.gov or
(301) 443-0721. 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, 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 representatives from such federal agencies, public health
constituencies, and medical professional societies as determined to be
necessary by the Secretary to fulfill the duties of the Advisory
Committee established under subsection (b) of 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).
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 2017.
The following information must be included in the package of
materials
[[Page 22286]]
submitted for each individual being 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. 2016-08691 Filed 4-14-16; 8:45 am]
BILLING CODE 4165-15-P
