81 FR 22285 - Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 73 (April 15, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 73 (April 15, 2016)
| Page Range | 22285-22286 | |
| FR Document | 2016-08691 |
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)] [Notices] [Pages 22285-22286] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. FOR FURTHER INFORMATION CONTACT: Alaina Harris, Genetic Services Branch, Maternal and Child Health Bureau, HRSA, at [email protected] 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 http://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
![Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22285
finalized, will represent the current attachments to Alaina Harris, Genetic 300gg–13, non-grandfathered health
thinking of FDA on the product-specific Services Branch, Maternal and Child plans and group and individual health
design of BE studies to support ANDAs. Health Bureau, Health Resources and insurance issuers are required to cover
They do not establish any rights for any Services Administration, screenings included in the HRSA-
person and are not binding on FDA or aharris@hrsa.gov. supported comprehensive guidelines
the public. You can use an alternative FOR FURTHER INFORMATION CONTACT: without charging a co-payment, co-
approach if it satisfies the requirements Alaina Harris, Genetic Services Branch, insurance, or deductible for plan years
of the applicable statutes and Maternal and Child Health Bureau, (i.e., in the individual market, policy
regulations. HRSA, at aharris@hrsa.gov or (301) years) beginning on or after the date that
443–0721. A copy of the Committee is 1 year from the Secretary’s adoption
IV. Electronic Access
Charter and list of the current of the condition for screening.
Persons with access to the Internet Nominations: HRSA is requesting
membership can be obtained by
may obtain the draft guidance at either nominations to fill three (3) positions
accessing the Advisory Committee Web
http://www.fda.gov/Drugs/Guidance for voting members to serve on the
site at http://www.hrsa.gov/
ComplianceRegulatoryInformation/ Committee. Nominations of potential
advisorycommittees/mchbadvisory/
Guidances/default.htm or http:// candidates for consideration are being
heritabledisorders.
www.regulations.gov. sought for individuals who are medical,
SUPPLEMENTARY INFORMATION: The technical, or scientific professionals
Dated: April 7, 2016.
Committee is chartered under section with special expertise in the field of
Leslie Kux,
1111 of the Public Health Service (PHS) heritable disorders or in providing
Associate Commissioner for Policy. Act, 42 U.S.C. 300b–10, as amended by screening, counseling, testing, or
[FR Doc. 2016–08682 Filed 4–14–16; 8:45 am] the Newborn Screening Saves Lives specialty services for newborns and
BILLING CODE 4164–01–P Reauthorization Act of 2015 (Act). The children at risk for heritable disorders;
Committee was established in 2003 to who have expertise in ethics (i.e.,
advise the Secretary of the U.S. bioethics) and infectious diseases and
DEPARTMENT OF HEALTH AND Department of Health and Human
HUMAN SERVICES who have worked and published
Services regarding newborn screening material in the area of newborn
tests, technologies, policies, guidelines, screening; members of the public having
Health Resources and Services
and programs for effectively reducing special expertise about or concern with
Administration
morbidity and mortality in newborns heritable disorders; or representatives
Solicitation of Nominations for and children having or at risk for from such federal agencies, public
Membership To Serve on the Advisory heritable disorders. In addition, the health constituencies, and medical
Committee on Heritable Disorders in Committee provides advice and professional societies as determined to
Newborns and Children recommendations to the Secretary be necessary by the Secretary to fulfill
concerning the grants and projects the duties of the Advisory Committee
AGENCY: Health Resources and Services authorized under section 1109 of the established under subsection (b) of
Administration, HHS. PHS Act and technical information to section 1111 of the Public Health
ACTION: Request for nominations. develop policies and priorities for Service (PHS) Act, 42 U.S.C. 300b–10,
grants, including those that will as amended by the Newborn Screening
SUMMARY: The Health Resources and enhance the ability of the state and local
Services Administration (HRSA) is Saves Lives Reauthorization Act of 2015
health agencies to provide for newborn (Act). Interested applicants may self-
seeking nominations of qualified and child screening, counseling and
candidates to be considered for nominate or be nominated by another
health care services for newborns, and individual and/or organization.
appointment as members of the children having or at risk for heritable Individuals selected for appointment
Advisory Committee on Heritable disorders. to the Committee will be invited to
Disorders in Newborns and Children The Committee is governed by the serve for up to 4 years. Members who
(Committee). The Committee provides provisions of Public Law 92–463, as are not federal officers or permanent
advice, recommendations, and technical amended (5 U.S.C. App. 2), and 41 CFR federal employees are appointed as
information about aspects of heritable part 102–3, which set forth standards for special government employees and
disorders and newborn and childhood the formation and use of advisory receive a stipend and reimbursement for
screening to the Secretary of Health and committees. The Committee reviews per diem and any travel expenses
Human Services. HRSA is seeking and reports regularly on newborn and incurred for attending Committee
nominations of qualified candidates to childhood screening practices for meetings and/or conducting other
fill three positions on the Committee. heritable disorders, recommends business on behalf of the Committee, as
Authority: Section 1111 of the Public improvements in the national newborn authorized by section 5 U.S.C. 5703 for
Health Service (PHS) Act, Title XI, and childhood heritable screening persons employed intermittently in
§ 1111(g)(1) (42 U.S.C. 300b–10(g)(1)), as programs, and recommends conditions government service. Members who are
amended by the Newborn Screening Saves for inclusion in the Recommended
Lives Reauthorization Act of 2014. The officers or employees of the United
Committee is governed by the Federal Uniform Screening Panel (RUSP). The States Government shall not receive
Advisory Committee Act (FACA), as Committee’s recommendations additional compensation for service on
regarding additional conditions/ the Committee, but receive per diem
asabaliauskas on DSK3SPTVN1PROD with NOTICES
amended (5 U.S.C. App.), and 41 CFR part
102–3 and 41 CFR part 102–3, which set inherited disorders for screening that and travel expenses incurred for
forth standards for the formation and use of have been adopted by the Secretary are attending Committee meetings and/or
advisory committees. included in the RUSP and constitute conducting other business on behalf of
DATES: Written nominations for part of the comprehensive guidelines the Committee. Nominees will be
membership on the Committee must be supported by the Health Resources and invited to serve during calendar year
received on or before May 16, 2016. Services Administration. Pursuant to 2017.
ADDRESSES: Nomination packages must section 2713 of the Public Health The following information must be
be submitted electronically as email Service Act, codified at 42 U.S.C. included in the package of materials
VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1](https://thefederalregister.org/doc/81_FR_22358/page/1.svg)
![22286 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
submitted for each individual being DEPARTMENT OF HEALTH AND Register will inform the scientific and
nominated for consideration: (1) A HUMAN SERVICES biosafety communities.
statement that clearly states the name FOR FURTHER INFORMATION CONTACT: If
and affiliation of the nominee, the basis National Institutes of Health you have questions, or require
for the nomination (i.e., specific additional information about these
National Institutes of Health (NIH) changes, please contact the NIH OSP by
attributes such as expertise in bioethics,
Office of Science Policy (OSP) email at SciencePolicy@od.nih.gov, or
evidence review, public health,
Recombinant or Synthetic Nucleic Acid telephone at 301–496–9838.
laboratory, maternal and child health, or Research: Action Under the NIH
clinical expertise in heritable disorders, SUPPLEMENTARY INFORMATION: The first
Guidelines for Research Involving
which qualify the nominee for service in Recombinant or Synthetic Nucleic Acid three editions of the BMBL and the NIH
this capacity), and that the nominee is Molecules (NIH Guidelines) Guidelines were consistent in their
willing to serve as a member of the approach to requiring primary
Committee; (2) the nominee’s name, containment for animal work in BL4
SUMMARY: The NIH OSP is amending
address, and daytime telephone number containment laboratories. However, in
portions of the NIH Guidelines in order
and the home/or work address, the early 1990s, the BMBL was amended
to provide investigators with biosafety
telephone number, and email address; and the fourth edition stated that
guidance regarding the standards for
and (3) a current copy of the nominee’s animals housed in BL4 suit laboratories
containment of non-human primates
curriculum vitae. Nomination packages (i.e., laboratories in which Class III
(NHPs) in biosafety level (BL) 4
cabinets are not used but instead
may be summited directly by the laboratories and to make such guidance
personnel wear positive pressure
individual being nominated or by the consistent with the expectations
protective suits) should be housed in a
person/organization recommending the articulated in the Centers for Disease
primary containment system (such as
candidate. Control and Prevention (CDC)/NIH
open cages covered with filtered
The Department of Health and Human Biosafety in Microbiological and
bonnets and opened in laminar flow
Biomedical Laboratories 5th edition
Services will make every effort to ensure hoods or other equivalent containment
(BMBL). Specifically, the NIH
that the membership of the Committee systems). This language remains in the
Guidelines will allow for housing of
is fairly balanced in terms of points of current BMBL (5th edition). With the
NHPs in open caging in a dedicated
view represented. Every effort is made change in the BMBL, primary
animal holding room provided there are
to ensure that individuals from a broad containment caging was arguably
two physical barriers between that
representation of geographic areas, preferred but no longer required under
animal holding room and non-
gender, ethnic and minority groups, as BL4 containment. In contrast, the NIH
containment space within the
well as individuals with disabilities are Guidelines have always required
laboratory, the animal holding room has
given consideration for membership. primary containment caging for all
negative air pressure with respect to any
Appointments shall be made without animals in BL4 laboratories.
adjacent non-containment corridors,
discrimination on the basis of age, Non-human primates are social
and there are specific decontamination
animals and require environmental
ethnicity, gender, sexual orientation, protocols in place before the door to the
enrichment. Researchers in several U.S.
and cultural, religious, or animal holding room is opened to allow
BL4 laboratories engaged in NHP
socioeconomic status. for the periodic transfer of new animals
research approached the NIH OSP with
Individuals who are selected to be into the room. These amendments do
concerns that primary containment
considered for appointment will be not change the current containment
caging in BL4 laboratories hindered the
required to provide detailed information requirements in the NIH Guidelines but
creation of an environment that allowed
regarding their financial holdings, rather offer an alternative for achieving
animals to benefit from adequate social
primary containment without
consultancies, and research grants or interaction. Also based on risk
compromising safety.
contracts. Disclosure of this information assessments and experiences comparing
is necessary in order to determine if the In addition, the recertification several primary containment caging
selected candidate is involved in any requirement for biosafety cabinets in systems, the researchers concluded that
activity that may pose a potential BL4 laboratories is updated in primary containment caging may
recognition of the technological actually create new hazards for
conflict with the official duties to be
standards for modern biosafety cabinets. laboratory workers. These findings
performed as a member of the
The NIH OSP also is updating the included interference with observation
Committee.
validation requirements for equipment of the animals from outside the room
Jackie Painter, responsible for centralized heat leading to more frequent entries into the
Director, Division of the Executive Secretariat. decontamination of liquid effluents in BL4 animal room to monitor the
[FR Doc. 2016–08691 Filed 4–14–16; 8:45 am]
laboratories working with large animals. animals, and exacerbation of cramped
BILLING CODE 4165–15–P
These amendments to the NIH working conditions created by the
Guidelines will be implemented additional barriers required by some
immediately upon publication in the containment systems, which increases
Federal Register. These changes were the difficulty of working in inflated
developed after extensive consultation pressure suits as well as the potential
asabaliauskas on DSK3SPTVN1PROD with NOTICES
with biosafety experts, directors of and for damage to the pressure suit. In
principal investigators in BL4 facilities addition, investigators stated that
working with NHPs, and CDC’s Division current BL4 laboratory designs
of Select Agent and Toxins (DSAT) incorporate sophisticated engineering
leadership at a public workshop and systems, which provide biosafety
discussion at a public Recombinant protection in a dedicated animal room
DNA Advisory Committee (RAC) equivalent to the primary containment
meeting. Publication in the Federal caging required under the NIH
VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1](https://thefederalregister.org/doc/81_FR_22358/page/2.svg)
Document Created: 2016-04-15 00:55:48
Document Modified: 2016-04-15 00:55:48
| 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 | Request for nominations. | |
| Dates | Written nominations for membership on the Committee must be received on or before May 16, 2016. | |
| Contact | Alaina Harris, Genetic Services Branch, Maternal and Child Health Bureau, HRSA, at [email protected] 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 http://www.hrsa.gov/advisorycommittees/mchbadvisory/ heritabledisorders. | |
| FR Citation | 81 FR 22285 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR