Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children, 62873-62874 [2018-26518]
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Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices
Establishments and Transfusion
Services to Enhance the Safety and
Availability of Platelets for Transfusion;
Draft Guidance for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
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made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
VerDate Sep<11>2014
20:35 Dec 04, 2018
Jkt 247001
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Jonathan McKnight, Center for Biologics
Evaluation and Research, Food and
Drug Administration, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Bacterial
Risk Control Strategies for Blood
Collection Establishments and
Transfusion Services to Enhance the
Safety and Availability of Platelets for
Transfusion; Draft Guidance for
Industry.’’ The draft guidance provides
blood collection establishments and
transfusion services with
recommendations to control the risk of
bacterial contamination of room
temperature stored platelets intended
for transfusion. The draft guidance
provides recommendations for all
platelet products, including platelets
manufactured by automated methods
(apheresis platelets), WBD platelets,
pooled platelets (pre-storage and poststorage) and platelets stored in additive
solutions. Additionally, this guidance
provides licensed blood establishments
with recommendations on how to report
implementation of manufacturing and
labeling changes under 21 CFR 601.12.
The draft guidance replaces the draft
guidance of the same title dated March
2016 (81 FR 13798; March 15, 2016).
Most recently, FDA convened a Blood
Products Advisory Committee (BPAC)
meeting in July 2018 to discuss bacterial
contamination of platelets and strategies
to control the risk. At this meeting,
BPAC considered the scientific evidence
and operational considerations of all
available strategies to control the risk of
bacterial contamination of platelets with
5-day and 7-day dating, including
bacterial testing strategies using culturebased devices, rapid bacterial detection
devices, and the implementation of
pathogen reduction technology. The
data presented and BPAC’s discussion
at the July 2018 meeting provided the
foundation for the recommendations in
this guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
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62873
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on bacterial risk control strategies for
blood collection establishments and
transfusion services to enhance the
safety and availability of platelets for
transfusion. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338; the collections of
information in 21 CFR part 606 have
been approved under OMB control
number 0910–0116; and the collections
of information in 21 CFR part 607 have
been approved under OMB control
number 0910–0052.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: November 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26477 Filed 12–4–18; 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 (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Advisory Committee on Heritable
SUMMARY:
E:\FR\FM\06DEN1.SGM
06DEN1
62874
Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices
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 HHS
(Secretary). HRSA is seeking
nominations of qualified candidates to
fill up to five positions on the
Committee.
Written nominations for
membership on the Committee must be
received on or before January 4, 2019.
ADDRESSES: Nomination packages must
be submitted electronically as email
attachments to Andrea Matthews,
Genetic Services Branch, Maternal and
Child Health Bureau, HRSA, at
AMatthews@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Andrea Matthews, MCHB, HRSA 5600
Fishers Lane, Room 18–N–34D ,
Rockville, MD 20857; 301–945–3062; or
AMatthews@hrsa.gov. A copy of the
Committee charter and list of the
current membership may be obtained by
accessing the Committee website at
https://www.hrsa.gov/advisorycommittees/heritable-disorders/about/
index.html.
DATES:
The
Committee was established in 2003 to
advise the Secretary 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 meets four
times each calendar year, or at the
discretion of the Designated Federal
Officer in consultation with the Chair.
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
khammond on DSK30JT082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
20:35 Dec 04, 2018
Jkt 247001
constitute part of the comprehensive
guidelines supported by HRSA pursuant
to section 2713 of the PHS Act, codified
at 42 U.S.C. 300gg–13. Under this
provision, 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 for voting members to
serve on the Committee to fill one
position in 2019 and up to four
positions in 2020. The Secretary
appoints Committee members with the
expertise needed to fulfill the duties of
the Advisory Committee. The
membership requirements are set forth
at 42 U.S.C. 300b–10(c)(2). Nominees
sought 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 with, or at
risk for having, heritable disorders;
individuals who have expertise in ethics
(e.g., 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; and/or
representatives from such federal
agencies, public health constituencies,
and medical professional societies.
Interested applicants may self-nominate
or be nominated by another individual
or organization. Nominees must reside
in the United States and cannot be
funded for international travel.
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 travel expenses incurred
for attending Committee meetings and/
or conducting other business on behalf
of the Committee, as authorized by 5
U.S.C. 5703 of the FACA for persons
employed intermittently in government
service. Members who are already
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.
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Fmt 4703
Sfmt 4703
The following information must be
included in the package of materials
submitted for each individual being
nominated for consideration: (1) A
statement that includes the name and
affiliation of the nominee and a clear
statement regarding the basis for the
nomination, including the area(s) of
expertise that may support eligibility of
a nominee for service on the Committee,
as described above; (2) confirmation the
nominee is willing to serve as a member
of the Committee; (3) the nominee’s
contact information (please include
home address, work address, daytime
telephone number, and an email
address); and (4) a current copy of the
nominee’s curriculum vitae.
Nomination packages may be submitted
directly by the individual being
nominated or by the person/
organization recommending the
candidate.
HHS will endeavor to ensure that the
membership of the Committee is fairly
balanced in terms of points of view
represented and that individuals from a
broad representation of geographic
areas, gender, ethnic and minority
groups, as well as individuals with
disabilities, are considered 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 required in order for HRSA 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 and to identify any
required remedial action needed to
address the potential conflict.
Authority: Section 1111 of the Public
Health Service (PHS) Act, as amended by the
Newborn Screening Saves Lives
Reauthorization Act of 2014 (42 U.S.C. 300b10). The Committee is governed by the
Federal Advisory Committee Act (FACA), as
amended (5 U.S.C. App.), and 41 CFR part
102–3, which set forth standards for the
formation and use of advisory committees.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–26518 Filed 12–5–18; 8:45 am]
BILLING CODE 4165–15–P
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]]>Agencies
[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62873-62874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26518]
-----------------------------------------------------------------------
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 (HRSA), Department
of Health and Human Services (HHS).
ACTION: Request for nominations.
-----------------------------------------------------------------------
SUMMARY: HRSA is seeking nominations of qualified candidates to be
considered for appointment as members of the Advisory Committee on
Heritable
[[Page 62874]]
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 HHS (Secretary). HRSA is seeking nominations of qualified
candidates to fill up to five positions on the Committee.
DATES: Written nominations for membership on the Committee must be
received on or before January 4, 2019.
ADDRESSES: Nomination packages must be submitted electronically as
email attachments to Andrea Matthews, Genetic Services Branch, Maternal
and Child Health Bureau, HRSA, at [email protected].
FOR FURTHER INFORMATION CONTACT: Andrea Matthews, MCHB, HRSA 5600
Fishers Lane, Room 18-N-34D , Rockville, MD 20857; 301-945-3062; or
[email protected]. A copy of the Committee charter and list of the
current membership may be obtained by accessing the Committee website
at https://www.hrsa.gov/advisory-committees/heritable-disorders/about/.
SUPPLEMENTARY INFORMATION: The Committee was established in 2003 to
advise the Secretary 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 meets four times each calendar year, or at the
discretion of the Designated Federal Officer in consultation with the
Chair.
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 HRSA
pursuant to section 2713 of the PHS Act, codified at 42 U.S.C. 300gg-
13. Under this provision, 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 for voting members to
serve on the Committee to fill one position in 2019 and up to four
positions in 2020. The Secretary appoints Committee members with the
expertise needed to fulfill the duties of the Advisory Committee. The
membership requirements are set forth at 42 U.S.C. 300b-10(c)(2).
Nominees sought 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 with, or at risk for having, heritable disorders;
individuals who have expertise in ethics (e.g., 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; and/or
representatives from such federal agencies, public health
constituencies, and medical professional societies. Interested
applicants may self-nominate or be nominated by another individual or
organization. Nominees must reside in the United States and cannot be
funded for international travel.
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 travel expenses incurred for attending Committee meetings and/
or conducting other business on behalf of the Committee, as authorized
by 5 U.S.C. 5703 of the FACA for persons employed intermittently in
government service. Members who are already 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.
The following information must be included in the package of
materials submitted for each individual being nominated for
consideration: (1) A statement that includes the name and affiliation
of the nominee and a clear statement regarding the basis for the
nomination, including the area(s) of expertise that may support
eligibility of a nominee for service on the Committee, as described
above; (2) confirmation the nominee is willing to serve as a member of
the Committee; (3) the nominee's contact information (please include
home address, work address, daytime telephone number, and an email
address); and (4) a current copy of the nominee's curriculum vitae.
Nomination packages may be submitted directly by the individual being
nominated or by the person/organization recommending the candidate.
HHS will endeavor to ensure that the membership of the Committee is
fairly balanced in terms of points of view represented and that
individuals from a broad representation of geographic areas, gender,
ethnic and minority groups, as well as individuals with disabilities,
are considered 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 required in order for HRSA 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 and to identify any required remedial action needed to
address the potential conflict.
Authority: Section 1111 of the Public Health Service (PHS) Act,
as amended by the Newborn Screening Saves Lives Reauthorization Act
of 2014 (42 U.S.C. 300b-10). The Committee is governed by the
Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App.),
and 41 CFR part 102-3, which set forth standards for the formation
and use of advisory committees.
Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-26518 Filed 12-5-18; 8:45 am]
BILLING CODE 4165-15-P
