Request for Information (RFI) on the National Institutes of Health Plan To Develop the Genetic Testing Registry, 33317-33319 [2010-14021]
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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Antibacterial Resistance and
Diagnostic Device and Drug
Development Research for Bacterial
Diseases; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop jointly sponsored by
the National Institute of Allergy and
Infectious Diseases and the Infectious
Diseases Society of America (IDSA)
regarding scientific and potential
research issues in antibacterial drug
resistance, rapid diagnostic device
development for bacterial diseases, and
antibacterial drug development. The
workshop will address antibacterial
drug resistance, mechanisms of
resistance, epidemiology of resistance,
and issues in the development of rapid
diagnostic devices and antibacterial
drugs for the diagnosis and treatment of
bacterial diseases. The input from this
public workshop will help in
developing topics for further discussion.
Dates and Times: The public
workshop will be held on July 26, 2010,
from 8 a.m. to 5:30 p.m. and on July 27,
2010, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Crowne Plaza Hotel, 8777
Georgia Ave., Silver Spring, MD 20910.
Seating is limited and available only on
a first-come, first-served basis.
Contact Persons: Chris Moser or Lori
Benner, Center for Drug Evaluation and
Research, Food and Drug
Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave.,
Bldg. 22, rm. 6209, Silver Spring, MD
20993–0002, 301–796–1300.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited. Seating will be
available on a first-come, first-served
basis. To register electronically, e-mail
registration information (including
name, title, firm name, address,
telephone, and fax number) to
arworkshop@fda.hhs.gov. Persons
without access to the Internet can call
Chris Moser or Lori Benner at 301–796–
1300 to register. Persons needing a sign
language interpreter or other special
accommodations should notify
Christine Moser or Lori Benner (see
Contact Persons) at least 7 days in
advance.
VerDate Mar<15>2010
15:04 Jun 10, 2010
Jkt 220001
FDA is
announcing a public workshop, jointly
sponsored by the National Institute of
Allergy and Infectious Diseases and the
Infectious Diseases Society of America,
regarding scientific issues in
antibacterial drug resistance and
product development for bacterial
diseases. Topics for discussion include
the following: (1) An overview and
discussion of the scale of the current
bacterial resistance problem, (2) current
understanding of the science and
mechanisms of bacterial resistance, (3)
the use of rapid diagnostics in the
diagnosis and management of bacterial
infections, and (4) the science of
antibacterial drug development. The
input from this workshop will help in
the further consideration of potential
areas of research in antibacterial
resistance and help in developing topics
in antibacterial drug development and
rapid diagnostic development for
further discussion.
The agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Webcasting: The workshop will be
simultaneously webcast. The public
may view the live webcast free by
registering through IDSA’s Web site at
https://www.idsociety.org until 24 hours
prior to the workshop. IDSA will do its
best to accommodate members of the
public who register after this time.
Videotaped workshop presentations will
also be available free on IDSA’s Web site
following the workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information 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.
Transcripts will also be available on the
Internet at https://www.fda.gov/FDAgov/
Drugs/NewsEvents/ucm211146.htm
approximately 45 days after the
workshop.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–14048 Filed 6–10–10; 8:45 am]
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33317
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information (RFI) on the
National Institutes of Health Plan To
Develop the Genetic Testing Registry
ACTION:
Notice.
SUMMARY: The National Institutes of
Health, an agency within the
Department of Health and Human
Services (HHS), is seeking input and
feedback on its plan to develop the
Genetic Testing Registry (GTR); a
centralized public resource that will
provide information about the
availability, scientific basis, and
usefulness of genetic tests. Submission
of test information to the GTR will be
voluntary, and the NIH expects to
receive wide interest and participation
from researchers, test developers, and
manufacturers.
SUPPLEMENTARY INFORMATION:
I. Background
The last decade has seen tremendous
advances in our knowledge of the
genomic and genetic factors involved in
health and disease. This increased
knowledge has been accompanied by a
rapid rise in the availability of genetic
tests. Although more than 2,000 genetic
tests are available, there is no single
public resource that provides
information about the validity and
usefulness of these tests. The NIH
believes that transparent access to such
information is vital to facilitate research
and to enable informed decision making
by patients, caregivers, health care
providers, clinical laboratory
professionals, payers, and policymakers.
Therefore, the NIH is initiating the
development of the GTR, an online
resource that will provide a centralized
location for researchers, test developers,
and manufacturers to submit
information voluntarily about genetic
tests, such as their intended use,
validity, and utility. The Registry will
serve as a resource for health care
providers and patients interested in
learning about the tests and easily
locating laboratories offering particular
genetic tests. By using standard
identifiers for genetic tests, GTR can
facilitate Health Information
Technology (HIT) exchange. The GTR
will be a repository of information about
genetic tests, not a repository of test
results.
On March 18, 2010, the NIH
announced that it would be creating the
GTR (see https://www.nih.gov/news/
health/mar2010/od-18.htm). This RFI
E:\FR\FM\11JNN1.SGM
11JNN1
33318
Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
notice is part of the public consultation
process referenced in that
announcement and described on the
NIH GTR Web site: https://
www.ncbi.nlm.nih.gov/gtr/.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
II. Data Elements
The NIH anticipates that the GTR will
contain information on a wide range of
genetic tests for inherited and somatic
genetic variations, including tests
ordered through health care providers
and those available directly to
consumers. The NIH is interested in
comments on the types of tests to
include within the GTR, as well as on
appropriate data elements to collect
about each test. The NIH’s working
definition of a genetic test, for purposes
of the Registry, is a test that involves an
analysis of human chromosomes,
deoxyribonucleic acid, ribonucleic acid,
genes and/or gene products (e.g.,
enzymes, other types of proteins, and
selected metabolites), which is
predominantly used to detect heritable
or somatic mutations, genotypes, or
chromosomal variations in structure or
number related to disease, health, and/
or personalized medicine.
The NIH expects that the GTR will be
most useful to health care providers,
patients and consumers, clinical
laboratory professionals, policymakers,
and researchers if it includes
information on the validity and utility
of genetic tests. This expectation is
consistent with recommendations of the
HHS Secretary’s Advisory Committee on
Genetics, Health, and Society
(SACGHS).i Validity includes both
analytical validity (a test’s ability to
measure the analyte or genotype of
interest accurately and reliably) and
clinical validity (the relationship
between a test result and health
outcome or phenotype). Utility is the
net balance of risks and benefits
associated with using a test i and
includes both clinical utility and
personal utility.
To assist researchers, consumers, and
providers in fully understanding a test,
it will be important to include
information about its molecular basis,
including, for example, information
about what the test detects and what
methods the test employs. Supporting
evidence for a test’s clinical validity
and/or utility may include published
data, systematic reviews, and practice
guidelines.
The NIH is particularly interested in
receiving comments on the type of data
elements that should be included in the
GTR and the level of information that
would adequately address these data
elements.
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15:04 Jun 10, 2010
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III. Request for Comments
The NIH is seeking input and advice
on the following items:
1. Are there any types of genetic tests
that should not be included in the GTR?
2. What are the potential uses of the
GTR for (1) researchers, (2) patients/
consumers, (3) health care providers, (4)
clinical laboratory professionals, (5)
payers, (6) genetic testing entities/data
submitters, (7) policymakers, and (8)
electronic health records?
3. What data elements are critical to
include for use by (1) researchers, (2)
patients/consumers, (3) health care
providers, (4) clinical laboratory
professionals, (5) payers, (6) genetic
testing entities/data submitters, (7)
policymakers, and (8) electronic health
records?
4. What are the potential benefits and
risks associated with facilitating public
access to information about the:
a. Availability and accessibility of
genetic tests?
b. Scientific basis and validity of
genetic tests?
c. Utility of genetic tests?
5. What is the best way to distinguish
between data fields left blank because of
an absence of data/evidence and those
left blank for other reasons? How
important is this distinction for
enhancing transparency, including for
the purpose of identifying research
opportunities?
6. To describe adequately and
accurately a genetic test, which of the
following data elements should be
included in the GTR? Are there other
data elements that should be added?
What information is necessary to
represent adequately each data element?
a. Contact information (e.g., location,
name of the laboratory director, and
contact information for the laboratory
performing the test)
b. Laboratory certifications (e.g.,
Federal or State certification of the
laboratory that performs the test)
c. Name of the test (e.g., common test
name, commercial name, marketing
materials about the test and/or genetic
testing entity, standard identifier (e.g.,
CPT codes, LOINC ii))
d. Regulatory clearances (e.g., for tests
reviewed by the Food and Drug
Administration, the 510(k) or premarket
approval (PMA) number)
e. Intended use of the test (e.g.,
diagnosis, screening, drug response)
f. Recommended patient population
g. Limitations of the test (e.g., is the
test validated only for certain
subpopulations or limited to particular
uses such as screening but not
diagnostic testing?)
h. Test methodology
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i. Analyte(s)—What is being measured
in the test (e.g., genetic sequence)
j. Specimen requirements (e.g., blood,
saliva, tissue samples, amniotic fluid)
k. Availability (e.g., is the submitter
the sole provider of the test or are there
multiple providers?)
l. Accessibility (e.g., accessible
through a health provider, public health
mandate, and/or direct-to-consumer)
m. Performance characteristicsi
i. Analytical sensitivity
ii. Analytical specificity
iii. Accuracy
iv. Precision
v. Reportable range of test results
vi. Reference range
vii. Method used for proficiency
testing (e.g., formal PT program,
alternative assessment) and score
n. Clinical validity i
i. Clinical sensitivity
ii. Clinical specificity
iii. Positive and negative predictive
value
iv. Prevalence
v. Penetrance
vi. Modifiers
o. Utility (e.g., clinical and/or
personal utility) or outcomes
i. Benefits
ii. Harms
iii. Added value, compared with
current management without genetic
testing
p. Cost (e.g., price of the test, health
insurance coverage)
7. What types of information might be
difficult for test providers to submit and
why?
8. What are the advantages and
disadvantages of collecting and
providing information on the molecular
basis of genetic tests, such as detailed
information about what the test detects
and the specific methods employed?
9. In addition to the data elements,
would it be helpful to reference other
resources, and if so, which ones (e.g.,
published studies, recommendations
from expert panels such as the
Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children, U.S. Preventive Services Task
Force, or Evaluation of Genomic
Applications in Practice and Prevention
Working Group)?
10. As the GTR is being designed,
what are the important processes to
consider to make the submission of data
as easy as possible for the data provider
(e.g., the capability of linking to
information that has been submitted to
other agencies, such as the Food and
Drug Administration and the Centers for
Medicare and Medicaid Services, or a
master file of data common to particular
tests)?
11. Which potential benefits and risks
would be most likely to affect the
E:\FR\FM\11JNN1.SGM
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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
decisions of researchers, test developers,
and manufacturers on whether to
submit data to the GTR, and what
factors will best encourage submission
of complete and accurate data?
12. What are the most effective
methods to ensure continued
stakeholder input into the maintenance
of the GTR?
13. For what purpose(s) would you
use the Registry to support your
professional efforts?
14. Are there any other issues that
NIH should consider in the
development of the GTR?
DATES: To assure consideration,
comments must be received by July 12,
2010.
Individuals, groups, and
organizations interested in commenting
on the NIH plan to develop the GTR, as
outlined in this RFI, may submit
comments by e-mail to GTR@od.nih.gov
or by mail to the following address: NIH
GTR RFI Comments, National Institutes
of Health, Office of Science Policy, 6705
Rockledge Drive, Room 750, Bethesda,
MD 20892. Comments will be made
publicly available, including any
personally identifiable or confidential
business information that they contain.
Trade secrets should not be submitted.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT: Dr.
Cathy Fomous, NIH Office of
Biotechnology Activities, 6705
Rockledge Drive, Room 750, Bethesda,
MD 20892; telephone 301–496–9838;
fax 301–496–9839; e-mail
CFomous@od.nih.gov.
Dated: June 4, 2010.
Francis S. Collins,
Director, National Institutes of Health.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Footnotes
i From the HHS Secretary’s Advisory
Committee on Genetics, Health and Society
2008 Report, U.S. System of Oversight of
Genetic Testing: A Response to the Charge of
the Secretary of Health and Human Services,
available at https://oba.od.nih.gov/oba/
SACGHS/reports/
SACGHS_oversight_report.pdf.
ii Logical Observation Identifiers Names
Codes (LOINC), a standard for unambiguous
identification of tests and other
measurements in health information
exchange. Available at https://loinc.org.
LOINC is a required standard in the
certification criteria for electronic health
records issued by the National Coordinator
for Health Information Technology, HHS
(https://edocket.access.gpo.gov/2010/E9–
31216.htm), to facilitate health information
exchange.
[FR Doc. 2010–14021 Filed 6–10–10; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Overview of This Information
Collection
United States Immigration and
Customs Enforcement
(1) Type of Information Collection:
New information collection.
(2) Title of the Form/Collection: ICE
Mutual Agreement between Government
and Employers (IMAGE) Information
Request and Membership Application.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form 73–028,
U.S. Immigration and Customs
Enforcement.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Businesses or other
for-profit and not-for-profit institutions.
The Immigration and Customs
Enforcement Mutual Agreement
between Government and Employers
(IMAGE) program is the outreach and
education component of the Office of
Investigations (OI) Worksite
Enforcement (WSE) program. IMAGE is
designed to build cooperative
relationships with the private sector to
enhance compliance with immigration
laws and reduce the number of
unauthorized aliens within the
American workforce. Under this
program ICE will partner with
businesses representing a cross-section
of industries. A business will initially
complete and prepare an IMAGE
membership application so that ICE can
properly evaluate the company for
inclusion in the IMAGE program. The
information provided by the company
plays a vital role in determining it
suitability for the program.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 100 responses at 90 minutes
(1.5 hours) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 150 annual burden hours.
Requests for a copy of the proposed
information collection instrument, with
instructions; or inquiries for additional
information should be requested via email to: forms.ice@dhs.gov with
‘‘IMAGE Program Application’’ in the
subject line.
Agency Information Collection
Activities: New Information Collection;
Comment Request
ACTION: 60-Day Notice of New
Information Collection; ICE Mutual
Agreement Between Government and
Employers (IMAGE).
The Department of Homeland
Security, U.S. Immigration and Customs
Enforcement (ICE), is submitted the
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection is
published to obtain comments from the
public and affected agencies. Comments
are encouraged and will be accepted for
sixty days until August 10, 2010.
Written comments and suggestions
regarding items contained in this notice,
and especially with regard to the
estimated public burden and associated
response time should be directed to the
Department of Homeland Security
(DHS), Joseph M. Gerhart, Chief,
Records Management Branch, U.S.
Immigration and Customs Enforcement,
500 12th Street, SW., Room 3138,
Washington, DC 20536; (202) 732–6337.
Comments are encouraged and will be
accepted for sixty days until August 10,
2010. Written comments and
suggestions from the public and affected
agencies concerning the proposed
collection of information should address
one or more of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
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Dated: June 3, 2010.
Joseph M. Gerhart,
Chief, Records Management Branch, U.S.
Immigration and Customs Enforcement,
Department of Homeland Security.
[FR Doc. 2010–14042 Filed 6–10–10; 8:45 am]
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Agencies
[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33317-33319]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14021]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information (RFI) on the National Institutes of
Health Plan To Develop the Genetic Testing Registry
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health, an agency within the
Department of Health and Human Services (HHS), is seeking input and
feedback on its plan to develop the Genetic Testing Registry (GTR); a
centralized public resource that will provide information about the
availability, scientific basis, and usefulness of genetic tests.
Submission of test information to the GTR will be voluntary, and the
NIH expects to receive wide interest and participation from
researchers, test developers, and manufacturers.
SUPPLEMENTARY INFORMATION:
I. Background
The last decade has seen tremendous advances in our knowledge of
the genomic and genetic factors involved in health and disease. This
increased knowledge has been accompanied by a rapid rise in the
availability of genetic tests. Although more than 2,000 genetic tests
are available, there is no single public resource that provides
information about the validity and usefulness of these tests. The NIH
believes that transparent access to such information is vital to
facilitate research and to enable informed decision making by patients,
caregivers, health care providers, clinical laboratory professionals,
payers, and policymakers. Therefore, the NIH is initiating the
development of the GTR, an online resource that will provide a
centralized location for researchers, test developers, and
manufacturers to submit information voluntarily about genetic tests,
such as their intended use, validity, and utility. The Registry will
serve as a resource for health care providers and patients interested
in learning about the tests and easily locating laboratories offering
particular genetic tests. By using standard identifiers for genetic
tests, GTR can facilitate Health Information Technology (HIT) exchange.
The GTR will be a repository of information about genetic tests, not a
repository of test results.
On March 18, 2010, the NIH announced that it would be creating the
GTR (see https://www.nih.gov/news/health/mar2010/od-18.htm). This RFI
[[Page 33318]]
notice is part of the public consultation process referenced in that
announcement and described on the NIH GTR Web site: https://www.ncbi.nlm.nih.gov/gtr/.
II. Data Elements
The NIH anticipates that the GTR will contain information on a wide
range of genetic tests for inherited and somatic genetic variations,
including tests ordered through health care providers and those
available directly to consumers. The NIH is interested in comments on
the types of tests to include within the GTR, as well as on appropriate
data elements to collect about each test. The NIH's working definition
of a genetic test, for purposes of the Registry, is a test that
involves an analysis of human chromosomes, deoxyribonucleic acid,
ribonucleic acid, genes and/or gene products (e.g., enzymes, other
types of proteins, and selected metabolites), which is predominantly
used to detect heritable or somatic mutations, genotypes, or
chromosomal variations in structure or number related to disease,
health, and/or personalized medicine.
The NIH expects that the GTR will be most useful to health care
providers, patients and consumers, clinical laboratory professionals,
policymakers, and researchers if it includes information on the
validity and utility of genetic tests. This expectation is consistent
with recommendations of the HHS Secretary's Advisory Committee on
Genetics, Health, and Society (SACGHS).i Validity includes both
analytical validity (a test's ability to measure the analyte or
genotype of interest accurately and reliably) and clinical validity
(the relationship between a test result and health outcome or
phenotype). Utility is the net balance of risks and benefits associated
with using a test i and includes both clinical utility and personal
utility.
To assist researchers, consumers, and providers in fully
understanding a test, it will be important to include information about
its molecular basis, including, for example, information about what the
test detects and what methods the test employs. Supporting evidence for
a test's clinical validity and/or utility may include published data,
systematic reviews, and practice guidelines.
The NIH is particularly interested in receiving comments on the
type of data elements that should be included in the GTR and the level
of information that would adequately address these data elements.
III. Request for Comments
The NIH is seeking input and advice on the following items:
1. Are there any types of genetic tests that should not be included
in the GTR?
2. What are the potential uses of the GTR for (1) researchers, (2)
patients/consumers, (3) health care providers, (4) clinical laboratory
professionals, (5) payers, (6) genetic testing entities/data
submitters, (7) policymakers, and (8) electronic health records?
3. What data elements are critical to include for use by (1)
researchers, (2) patients/consumers, (3) health care providers, (4)
clinical laboratory professionals, (5) payers, (6) genetic testing
entities/data submitters, (7) policymakers, and (8) electronic health
records?
4. What are the potential benefits and risks associated with
facilitating public access to information about the:
a. Availability and accessibility of genetic tests?
b. Scientific basis and validity of genetic tests?
c. Utility of genetic tests?
5. What is the best way to distinguish between data fields left
blank because of an absence of data/evidence and those left blank for
other reasons? How important is this distinction for enhancing
transparency, including for the purpose of identifying research
opportunities?
6. To describe adequately and accurately a genetic test, which of
the following data elements should be included in the GTR? Are there
other data elements that should be added? What information is necessary
to represent adequately each data element?
a. Contact information (e.g., location, name of the laboratory
director, and contact information for the laboratory performing the
test)
b. Laboratory certifications (e.g., Federal or State certification
of the laboratory that performs the test)
c. Name of the test (e.g., common test name, commercial name,
marketing materials about the test and/or genetic testing entity,
standard identifier (e.g., CPT codes, LOINC \ii\))
d. Regulatory clearances (e.g., for tests reviewed by the Food and
Drug Administration, the 510(k) or premarket approval (PMA) number)
e. Intended use of the test (e.g., diagnosis, screening, drug
response)
f. Recommended patient population
g. Limitations of the test (e.g., is the test validated only for
certain subpopulations or limited to particular uses such as screening
but not diagnostic testing?)
h. Test methodology
i. Analyte(s)--What is being measured in the test (e.g., genetic
sequence)
j. Specimen requirements (e.g., blood, saliva, tissue samples,
amniotic fluid)
k. Availability (e.g., is the submitter the sole provider of the
test or are there multiple providers?)
l. Accessibility (e.g., accessible through a health provider,
public health mandate, and/or direct-to-consumer)
m. Performance characteristics\i\
i. Analytical sensitivity
ii. Analytical specificity
iii. Accuracy
iv. Precision
v. Reportable range of test results
vi. Reference range
vii. Method used for proficiency testing (e.g., formal PT program,
alternative assessment) and score
n. Clinical validity \i\
i. Clinical sensitivity
ii. Clinical specificity
iii. Positive and negative predictive value
iv. Prevalence
v. Penetrance
vi. Modifiers
o. Utility (e.g., clinical and/or personal utility) or outcomes
i. Benefits
ii. Harms
iii. Added value, compared with current management without genetic
testing
p. Cost (e.g., price of the test, health insurance coverage)
7. What types of information might be difficult for test providers
to submit and why?
8. What are the advantages and disadvantages of collecting and
providing information on the molecular basis of genetic tests, such as
detailed information about what the test detects and the specific
methods employed?
9. In addition to the data elements, would it be helpful to
reference other resources, and if so, which ones (e.g., published
studies, recommendations from expert panels such as the Secretary's
Advisory Committee on Heritable Disorders in Newborns and Children,
U.S. Preventive Services Task Force, or Evaluation of Genomic
Applications in Practice and Prevention Working Group)?
10. As the GTR is being designed, what are the important processes
to consider to make the submission of data as easy as possible for the
data provider (e.g., the capability of linking to information that has
been submitted to other agencies, such as the Food and Drug
Administration and the Centers for Medicare and Medicaid Services, or a
master file of data common to particular tests)?
11. Which potential benefits and risks would be most likely to
affect the
[[Page 33319]]
decisions of researchers, test developers, and manufacturers on whether
to submit data to the GTR, and what factors will best encourage
submission of complete and accurate data?
12. What are the most effective methods to ensure continued
stakeholder input into the maintenance of the GTR?
13. For what purpose(s) would you use the Registry to support your
professional efforts?
14. Are there any other issues that NIH should consider in the
development of the GTR?
DATES: To assure consideration, comments must be received by July 12,
2010.
ADDRESSES: Individuals, groups, and organizations interested in
commenting on the NIH plan to develop the GTR, as outlined in this RFI,
may submit comments by e-mail to GTR@od.nih.gov or by mail to the
following address: NIH GTR RFI Comments, National Institutes of Health,
Office of Science Policy, 6705 Rockledge Drive, Room 750, Bethesda, MD
20892. Comments will be made publicly available, including any
personally identifiable or confidential business information that they
contain. Trade secrets should not be submitted.
FOR FURTHER INFORMATION CONTACT: Dr. Cathy Fomous, NIH Office of
Biotechnology Activities, 6705 Rockledge Drive, Room 750, Bethesda, MD
20892; telephone 301-496-9838; fax 301-496-9839; e-mail
CFomous@od.nih.gov.
Dated: June 4, 2010.
Francis S. Collins,
Director, National Institutes of Health.
Footnotes
i From the HHS Secretary's Advisory Committee on
Genetics, Health and Society 2008 Report, U.S. System of Oversight
of Genetic Testing: A Response to the Charge of the Secretary of
Health and Human Services, available at https://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf.
ii Logical Observation Identifiers Names Codes
(LOINC), a standard for unambiguous identification of tests and
other measurements in health information exchange. Available at
https://loinc.org. LOINC is a required standard in the certification
criteria for electronic health records issued by the National
Coordinator for Health Information Technology, HHS (https://edocket.access.gpo.gov/2010/E9-31216.htm), to facilitate health
information exchange.
[FR Doc. 2010-14021 Filed 6-10-10; 8:45 am]
BILLING CODE 4140-01-P