[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Pages 21645-21647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9625]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Secretary's Advisory Committee on Heritable Disorders in Newborns
and Children
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Request for public comment on a Secretary's Advisory Committee
on Heritable Disorders in Newborns and Children's commissioned report:
Considerations and Recommendations
[[Page 21646]]
for National Guidance Regarding the Retention and Use of Residual Dried
Blood Spot Specimens after Newborn Screening.
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SUMMARY: The Secretary's Advisory Committee on Heritable Disorders in
Newborns and Children (SACHDNC) was established under Section 1111 of
the Public Health Service (PHS) Act, 42 U.S.C. 300b-10, as amended in
the Newborn Screening Saves Lives Act of 2008 (Act). The SACHDNC is
governed by the provisions of the Federal Advisory Committee Act
(FACA), as amended (5 U.S.C. App.), which sets forth standards for the
formation and use of advisory committees. The SACHDNC provides advice
to the Secretary about aspects of newborn and childhood screening and
technical information for the development of policies and priorities
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 changing dynamics of emerging technology and the complexity of
genetics require an assessment of the state of the art in newborn
screening and a perspective on the future directions such programs
should take. Newborn screening is a highly successful public health
program that identifies rare genetic, congenital and functional
disorders, ensures early management and endeavors to ensure follow-up
for those affected. Each State has a law that either requires or allows
newborn screening and States are responsible for oversight and
implementation of their respective newborn screening program. State
newborn screening policies are usually developed with input from multi-
disciplinary advisory committees that include consumers, health care
and public health professionals and other interested stakeholders.
While State administration of newborn screening programs fosters local
control and accountability, it also gives rise to wide variation in
practices across the country, including disparate policies on the
retention and use of dried blood spot specimens after newborn screening
has been finished. Given the tremendous potential to advance science
and clinical care for newborns, children and their families through the
use of residual newborn screening blood specimens, the SACHDNC calls
upon policymakers, the public health community, health care providers
and families to work together to protect this valuable resource for the
public good.
This notice is designed to review the issues facing State newborn
screening programs related to the retention and use of residual newborn
screening specimens. It will lay the foundation for developing national
guidance to States in this area, and encourage an approach to future
policymaking that enables residual specimens use to advance science and
clinical care for newborns, children and their families. The core
principles of protecting patient privacy, confidentiality and ensuring
public trust are at the core of these recommendations.
Because newborn screening is the only public health screening
program that reaches the entire population of newborns in the U.S., it
is unique, and the processes surrounding it must be thoughtfully
approached. Residual blood specimens provide an excellent opportunity
for storage in a biobank for approved research uses after screening and
validating are complete. However, at the present time, research is a
secondary purpose that may not be adequately addressed in some existing
State laws or policies. Newborn screening programs should approach the
use of residual specimens carefully, anticipating both the potential
benefits and risks.
The SACHDNC believes that national guidance on the retention and
use of residual newborn screening specimens for research would help
States to navigate these complex issues. To assist in this process, the
SACHDNC makes the following recommendations to the Secretary of the
Department of Health and Human Services (HHS) and requests action by
the Secretary where applicable:
(1) All State newborn screening programs should have a policy in
place that has been reviewed by the State attorney general or other
appropriate legal authority addressing the disposition of dried blood
specimens remaining after newborn screening. Policymakers should
consider the value of the specimens as a promising resource for
research, the importance of protecting the privacy and confidentiality
of families and the necessity of ensuring the public's trust.
The policy should specify appropriate use and storage
after the completion of newborn screen testing and verification
according to laboratory Quality Assurance (QA) procedures. Parties
responsible for drafting the policy should consider whether consent or
dissent from families is necessary for uses other than newborn
screening and, if so, under what circumstances. Multidisciplinary
input, including from consumers, should be solicited and thoughtfully
considered in developing such a policy. The specimen disposition policy
should include the length of time for which specimens will be stored
and storage conditions. Compliance with storage processes included in
NCCLS/CLSI Standard LA4-A5 or its current edition is recommended
(Clinical and Laboratory Standards Institute (CLSI). Blood collection
on filter paper for newborn screening programs; approved standard--
fifth edition. CLSI document LA4-A5. Wayne, PA: Clinical and Laboratory
Standards Institute; 2007.) Any data linkages should be carefully
addressed, and privacy and confidentiality should be ensured.
(2) All State newborn screening programs should have a policy in
place that has been reviewed by the State attorney general or other
appropriate legal authority that specifies who may access and use dried
blood specimens once they arrive at the State-designated newborn
screening laboratory, including further access after newborn screening
tests are completed.
Multidisciplinary input, including from consumers, should
be solicited and thoughtfully considered in developing such a policy.
The specimen access policy should address any uses prior to and after
the newborn screening laboratory testing and validation process.
Policies that permit the approved use of dried blood spot specimens for
purposes other than newborn screening should address handling and
disposition of the specimen and measures to protect the privacy and
confidentiality of any associated patient information.
(3) All State newborn screening programs should develop a well-
defined strategy to educate health care professionals who provide
patients with pre- and post-natal care about newborn screening and the
potential use of residual dried blood specimens for research.
The strategy should include steps to inform and train
health care professionals about the newborn screening system, the
State's policy on the potential use of residual newborn screening
specimens, and their educational responsibilities with respect to
expectant parents and parents of newborns. Educational programs should
take steps to educate professionals treating new parents who did not
have ready access to prenatal care, and, therefore, did not receive
information about the newborn screening system at that time.
(4) All State newborn screening programs should work proactively to
ensure that all families of newborns are
[[Page 21647]]
educated about newborn screening as a part of prenatal and postnatal
care.
As part of the educational process, all State newborn
screening programs should maintain and distribute educationally and
culturally appropriate information that includes basic information
about the use or potential use of the residual newborn screening
specimens. Processes should be in place to evaluate the extent, timing
and understanding of parental education with an eye towards educational
program improvement. While prenatal care should serve as the primary
target of educational programs, they also should be designed to reach
parents that do not have access to those services and require postnatal
education about newborn screening. Educational materials should address
potential uses of residual newborn screening specimens, long-term
storage policies, procedures for withdrawal of consent, opting-out of
future research use, requesting the destruction of samples, limitations
with regard to consent once samples have been distributed for research,
and information on stewardship of specimens.
(5) If residual blood specimens are to be available for any purpose
other than the legally required newborn screening process for which
they were obtained, an indication of the parents' awareness and
willingness to participate should exist in compliance with federal
research requirements, if applicable (45 CFR 46).
Depending on the purposes for which specimens will be
used, a parental consent (opt-in) or a dissent (opt-out) process may
meet this requirement, if necessary, or a waiver of consent may be
appropriate. The State attorney general or other appropriate legal
authority should review this process. The use of residual newborn
screening specimens for program evaluation (e.g., repeat testing as a
quality check) or process improvement (e.g., non-commercial, internal
program new test development or refinement) are valid components of the
public health newborn screening program, and, therefore, should not
require additional consent. However, once the use of a residual newborn
screening specimens moves beyond the State mandated uses of program
evaluation and quality assurance, treatment efficacy and test
refinement, each State should consider whether separate or blanket
consent/dissent processes for approved studies is required from
parents, legal guardians or individuals screened upon the age of
majority for the use of residual newborn screening specimens.
(6) Provide administrative support and funding to SACHDNC to:
Facilitate a national dialogue among federal and State
stakeholders about policies for the retention and use of residual
newborn screening specimens, including model consent and dissent
processes;
Develop national guidance for consent or dissent for the
secondary use of specimens and mechanisms to ensure privacy and
confidentiality, including methods for opting in or out of
repositories; and
Collect and analyze national data on the utility of any
additional consent or dissent processes implemented relative to
potential research uses of residual newborn screening specimens;
(7) Provide administrative support and funding to the Health
Resources and Services Administration Maternal and Child Health Bureau
to award grants to States to:
Develop model educational programs for the general public
on the importance of newborn screening and the potential uses of
residual newborn screening specimens to generate population-based
knowledge about health and disease; and
Create educational materials directed to health care
professionals and consumers with facts about potential uses of residual
newborn screening specimens and other related issues, including those
outlined in recommendation (Jinks DC, Minter M, Tarver DA, Vanderford
M, Hejtmancik JF, McCabe ER. Molecular genetic diagnosis of sickle cell
disease using dried blood specimens on blotters used for newborn
screening. Hum Genet. 1989 Mar; 81(4):363-).
SACHDNC is now seeking public comments on the report and its
recommendations.
DATES: The public is encouraged to submit written comments on the
report and its recommendations by June 25, 2010.
ADDRESSES: The following mailing address should be used: Maternal and
Child Health Bureau, Health Resources and Services Administration, 5600
Fishers Lane, Parklawn Building, 18A-19, Rockville, MD 20857. HRSA/
MCHB's facsimile number is 301-480-1312. Comments can also be sent via
e-mail to [email protected]. All public comments received will be
available for public inspection at MCHB/HRSA's office between the hours
of 8:30 a.m. and 5 p.m.
FOR FURTHER INFORMATION CONTACT: Questions about this request for
public comment can be directed to Michele Lloyd-Puryear, MD, PhD, by e-
mail ([email protected]). The report will be posted on SACHDNC's
Web site at http://www.hrsa.gov/heritabledisorderscommittee/.
Dated: April 20, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010-9625 Filed 4-23-10; 8:45 am]
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