National Cancer Institute's Best Practices for Biospecimen Resources, 51830-51831 [2010-20872]
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Federal Register / Vol. 75, No. 162 / Monday, August 23, 2010 / Notices
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present regulatory challenges similar to
those posed by products using other
emerging technologies and that these
challenges may be magnified because
nanotechnology can be used in, or used
to make, any FDA-regulated product. In
addition, the properties of a material
with features in the nanoscale range
might change, impacting the safety and
effectiveness of the FDA-regulated
products.
The objective of this public workshop
is to obtain information on
manufacturing, characterization, and
evaluation of biocompatibility of
medical devices containing or utilizing
nanomaterials and nanostructures.
II. Public Participation
There are two types of opportunities
for participation planned for the public
workshop: Time limited oral
presentations and round-table
discussions.
If you wish to make an oral
presentation during the public
workshop, you must indicate this at the
time of registration. The number of
presentations may be limited based on
the number of requests received during
the public comment period. When
registering, you will be required to
identify the title of the topic you wish
to address in your presentation and
answer all the related questions on the
registration form at https://www.fda.gov/
MedicalDevices/NewsEvents/Workshops
Conferences/default.htm. FDA will do
its best to accommodate requests to
present and will focus discussion to the
topics described in this document (see
section III of this document).
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations, and to request time for
joint presentations. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is to begin.
To close each of the two sessions,
FDA will hold a round-table discussion
between FDA staff and selected
participants representing a range of
constituencies. If you wish to be a
participant in round-table discussions,
you must indicate this interest at the
time of registration, and also submit a
brief statement that describes your
experience or expertise with
nanotechnology. FDA will attempt to
have a range of constituencies
represented in this discussion group.
Others in attendance at the workshop
will have an opportunity to listen
during each round-table discussion and
provide public comments, time
permitting. FDA will determine the
participants based on the requests
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received. The participants in each
round-table discussion will remark on
the presentations given during the
session, engage in a dialogue with each
other and FDA staff, and provide closing
thoughts on the session. Round-table
participants will not be asked to
develop consensus opinions during the
discussion, but rather to provide their
individual perspectives.
III. Issues for Discussion
The workshop will focus on two
topics: (1) Manufacturing and
characterization of medical devices
containing or utilizing nanomaterials or
nanostructures; (2) biocompatibility
evaluation of medical devices
containing or utilizing nanomaterials or
nanostructures. The discussion on
manufacturing and characterization will
include the evaluation of physicochemical properties of nanomaterials or
nanostructures, characterization
methods required, device manufacturing
processes and evaluation of the final
processed device after sterilization, and
stability and aging studies. The
discussion on biocompatibility
evaluation will include testing for
potential release of nanomaterials and
additional testing considerations other
than standard testing methods to
determine the biocompatibility and
toxicity of devices containing or
utilizing nanomaterials or structures.
For further information, please refer to
the meeting registration Web page at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm.
IV. Transcripts
Please be advised that as soon as a
transcript is available, it can be obtained
in either hardcopy or on CD–ROM, after
submission of a Freedom of Information
Act request. Written requests are to be
sent to Division of Freedom of
Information (HFI–35), Office of
Management Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop. A transcript of the
public workshop will be available on
the Internet at https://www.fda.gov/
MedicalDevices/NewsEvents/Workshops
Conferences/default.htm (select the
appropriate meeting from the list).
Dated: August 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–20837 Filed 8–20–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute’s Best
Practices for Biospecimen Resources
National Institutes of Health
(NIH), National Cancer Institute (NCI).
ACTION: Notice with request for
comment.
AGENCY:
As part of the commitment to
maintaining current and scientifically
accurate best practices, the National
Cancer Institute (NCI) is seeking public
comment on a revised version of the
NCI Best Practices for Biospecimen
Resources. This revised version of the
NCI Best Practices is intended to both
respond to comments received from the
biospecimen resource community and
provide more current and detailed
recommendations related to
biospecimen and data quality. Major
revisions include the addition of new
sections on Biospecimen Resource
Management and Operations and
Conflict of Interest, expansion of
recommendations related to
Custodianship and Informed Consent
based on NCI workshops, addition of
current references throughout the
document and harmonization with
current federal guidance documents and
recommendations from international
biospecimen organizations.
DATES: Effective Date: The updated NCI
Best Practices for Biospecimen
Resources are open for public comment
for a period of 30 days. Comments must
be received by September 22, 2010 in
order to ensure consideration. After the
public comment period has closed, the
comments received by NCI will be
considered in a timely manner by the
NCI Office of Biorepositories and
Biospecimen Research. Subsequently,
appropriate changes will be made on the
Best Practices Web site https://
biospecimens.cancer.gov/bestpractices/.
ADDRESSES: Comments submitted via email should use nciobbr@mail.nih.gov
and enter ‘‘NCI Best Practices’’ in the
subject line. While NCI prefers that
comments be sent by email, NCI will
accept written comments. Written
comments may be sent to: NCI/OBRR,
NIH, 11400 Rockville Pike, Rockwall I
Building, Bethesda, MD 20892, Attn: Dr.
Nicole Lockhart.
FOR FURTHER INFORMATION CONTACT:
Implementation assistance and inquiries
should be directed to senior staff of the
relevant NCI Extramural and Intramural
Program offices.
SUPPLEMENTARY INFORMATION: The NCI
Best Practices for Biospecimen Research
SUMMARY:
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Federal Register / Vol. 75, No. 162 / Monday, August 23, 2010 / Notices
may be found online at https://
biospecimens.cancer.gov/bestpractices/.
Dated: August 12, 2010.
Douglas R. Lowy,
Deputy Director, National Cancer Institute,
National Institutes of Health.
[FR Doc. 2010–20872 Filed 8–20–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Request for Measures of Health Plan
Efforts To Address Health Plan
Members’ Health Literacy Needs
Agency for Healthcare Research
and Quality (AHRQ), DHHS.
ACTION: Notice of request for measures.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is
soliciting the submission of instruments
or items that measure how well health
plans and health providers address
health plan enrollees’ health literacy
needs and how well they communicate
with health plan enrollees. This
initiative is in response to the need
identified by AHRQ to develop a new
supplemental item set (the ‘‘new
instrument’’) for addressing health
literacy for the CAHPS® Health Plan
Survey. The intent of the planned
survey is to gain patients’ perspective
on how well health and health plan
information is communicated to them
by healthcare professionals and health
plans. The results of the planned survey
may become an important source of
information for health plans, clinicians,
group practices, and other interested
parties assessing quality of health
information or planning changes in how
health plan information is delivered to
health plan enrollees.
Based on prior work, there are several
functional areas that the new instrument
could address. Depending on the
communication mode, the new
instrument could assess, for example,
clarity and simplicity of provided health
information related to: (a) Preventive
services (e.g., risks and benefits of the
service, explanation of screening
results); (b) health problems/concerns
(e.g., information on how to stay healthy
or prevent illness); (c) treatment
choices, instructions, or goals (e.g., pros
and cons of each option); (d)
medications (e.g., reason for taking
medications, instructions on how to
take medications, possible side effects);
and, (e) care management/disease
management. A survey using the new
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SUMMARY:
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instrument may also assess the quality
of services supporting health
information delivery such as language
access (e.g., availability and timeliness
of customer service and interpreter
services in other languages, availability
of forms and patient education materials
in other languages), the quality and
accessibility of member services and
nurse advice lines, the quality and
accessibility of health plan information
on coverage, benefits, and billing
information (including availability in
other languages), health plan system
navigation and health plan environment
(language access and assistance in
completing medical paperwork or
forms, signage).
DATES: Please submit instruments and
supporting information on or before
October 22, 2010. AHRQ will not
respond individually to submitters, but
will consider all submitted instruments
and publicly report the results of the
review of the submissions in aggregate.
ADDRESSES: Submissions should include
a brief cover letter, a copy of the
instrument or items for consideration
and supporting information as specified
under the Submission Criteria below.
Submissions may be in the form of a
letter or e-mail, preferably with an
electronic file as an E-mail attachment.
Responses to this request should be
submitted to:
Cindy Brach, Center for Delivery,
Organization, and Markets, Agency for
Healthcare Research and Quality, 540
Gaither Road, Room 5129, Rockville,
MD 20850, Phone: (301) 427–1444, Fax:
(301) 427–1430, E-mail:
Cindy.Brach@AHRQ.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Cindy Brach, at the address above.
Submission Criteria
Instruments and items submitted
should focus on patients’ perspective on
quality of health and health plan
information provided by health plans,
clinicians, and/or group practices.
Measures submitted must meet these
criteria to be considered: (a) Assess
patients’ or their caregivers’ experiences
receiving health and health plan
information and (b) demonstrate
substantial reliability and validity.
Submitters must agree to grant to the
Government a nonexclusive,
irrevocable, royalty-free right to use,
distribute to the public, reproduce and
create derivative works from the
proffered instruments, items or their
arrangement. AHRQ must have the right
to freely use and authorize others to use
the new instrument, which will be
distributed under the CAHPS®
trademark. The new instrument will
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combine the best features of all the
submissions as well as any ideas that
may develop from reviewing them.
AHRQ, in collaboration with CAHPS
grantees, will evaluate all submitted
instruments or items. As they construct
the CAHPS instrument, they may select
one or more proffered instruments and
their items either in whole or in part or
modify the items prior to testing them.
AHRQ will own and assume
responsibility for new instrument as
well as any future modifications to it.
The new instrument will bear the
CAHPS® trademark and it will be made
freely available for use by all interested
parties.
Each submission should include the
following information: The name of the
instrument, domains included,
language(s) the instrument is available
in, evidence of cultural/cross group
comparability, if any, instrument
reliability (internal consistency, testretest, etc.), validity (content, construct,
criterion-related), response rates,
methods and results of cognitive
interviews/testing and field-testing and
description of sampling strategies
(including payer type) and data
collection protocols, including such
elements as mode of administration, use
of advance letters, timing and
frequencies of contacts. In addition, a
list of where the instrument has been
fielded should also be included in the
submission. Submission of copies of
existing report formats developed to
disclose findings to consumers and
providers is desirable, but not required.
Additionally, information about existing
database(s) for the instrument(s)
submitted is helpful, but not required
for submission. Evidence of the criteria
should be demonstrated through
publication and submission of peerreviewed journal article(s) or through
the best evidence available at the time
of submission. Please include citations
of peer-reviewed journal articles.
To facilitate handling of submissions,
please include full information about
the instrument developer or contact: (a)
Name; (b) title; (c) organization; (d)
mailing address; (e) telephone number;
(f) fax number; and (g) e-mail address.
SUPPLEMENTARY INFORMATION:
Background
The CAHPS program was initiated in
1995 to develop a survey and report on
the consumers’ perspective on the
quality of their health plans. Since that
time, the CAHPS program in
partnership with CMS and others has
expanded its scope and developed
surveys and reports regarding
individual clinicians, group practices,
in-center hemodialysis services, nursing
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]]>Agencies
[Federal Register Volume 75, Number 162 (Monday, August 23, 2010)]
[Notices]
[Pages 51830-51831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20872]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute's Best Practices for Biospecimen
Resources
AGENCY: National Institutes of Health (NIH), National Cancer Institute
(NCI).
ACTION: Notice with request for comment.
-----------------------------------------------------------------------
SUMMARY: As part of the commitment to maintaining current and
scientifically accurate best practices, the National Cancer Institute
(NCI) is seeking public comment on a revised version of the NCI Best
Practices for Biospecimen Resources. This revised version of the NCI
Best Practices is intended to both respond to comments received from
the biospecimen resource community and provide more current and
detailed recommendations related to biospecimen and data quality. Major
revisions include the addition of new sections on Biospecimen Resource
Management and Operations and Conflict of Interest, expansion of
recommendations related to Custodianship and Informed Consent based on
NCI workshops, addition of current references throughout the document
and harmonization with current federal guidance documents and
recommendations from international biospecimen organizations.
DATES: Effective Date: The updated NCI Best Practices for Biospecimen
Resources are open for public comment for a period of 30 days. Comments
must be received by September 22, 2010 in order to ensure
consideration. After the public comment period has closed, the comments
received by NCI will be considered in a timely manner by the NCI Office
of Biorepositories and Biospecimen Research. Subsequently, appropriate
changes will be made on the Best Practices Web site https://biospecimens.cancer.gov/bestpractices/.
ADDRESSES: Comments submitted via e-mail should use
nciobbr@mail.nih.gov and enter ``NCI Best Practices'' in the subject
line. While NCI prefers that comments be sent by email, NCI will accept
written comments. Written comments may be sent to: NCI/OBRR, NIH, 11400
Rockville Pike, Rockwall I Building, Bethesda, MD 20892, Attn: Dr.
Nicole Lockhart.
FOR FURTHER INFORMATION CONTACT: Implementation assistance and
inquiries should be directed to senior staff of the relevant NCI
Extramural and Intramural Program offices.
SUPPLEMENTARY INFORMATION: The NCI Best Practices for Biospecimen
Research
[[Page 51831]]
may be found online at https://biospecimens.cancer.gov/bestpractices/.
Dated: August 12, 2010.
Douglas R. Lowy,
Deputy Director, National Cancer Institute, National Institutes of
Health.
[FR Doc. 2010-20872 Filed 8-20-10; 8:45 am]
BILLING CODE 4140-01-P
