Advisory Committee on Organ Transplantation; Notice of Meeting, 44936-44937 [2011-18935]
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44936
Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
In addition, in September 2009, FDA
convened an internal 510(k) Working
Group to conduct a comprehensive
assessment of the 510(k) process. The
510(k) Working Group evaluated the
510(k) program with the goal of
strengthening the program and
improving the consistency in the
Agency’s decisionmaking process. In
August 2010, the Center for Devices and
Radiological Health (CDRH) published
two documents in consideration of the
comments made at the public meeting
and the Agency’s preliminary
assessment of the program. These
documents are titled ‘‘CDRH
Preliminary Internal Evaluations—
Volume I: 510(k) Working Group
Preliminary Report and
Recommendations’’ and ‘‘CDRH
Preliminary Internal Evaluations—
Volume II: Task Force on the Utilization
of Science in Regulatory Decision
Making Preliminary Report and
Recommendations’’ (https://
www.fda.gov/AboutFDA/CentersOffices/
CDRH/CDRHReports/ucm239448.htm).
In January 2011, CDRH published the
‘‘Plan of Action for Implementation of
510(k) and Science Recommendations’’
(https://www.fda.gov/downloads/
AboutFDA/CentersOffices/CDRH/
CDRHReports/UCM239450.pdf). One of
the action items identified in the Plan
of Action included publication of an
update to the 1997 Device Modifications
Guidance.
The recommendations in this draft
guidance document are consistent with
longstanding FDA policy for when a
modification to a device does and does
not require the submission of a 510(k).
The guidance has been updated,
however, to address issues associated
with software and other rapidly
changing technologies, and to provide
greater clarity about changes that do not
trigger the need for a new premarket
submission. This guidance uses
examples of modifications to devices
involving such technologies to illustrate
changes that require a new 510(k), and
changes that may simply be
documented in accordance with a
manufacturer’s existing Quality System
without prompting the need for a new
510(k) submission. FDA believes
increased certainty about the regulatory
consequences of device modifications is
critical to facilitating advancements in
device technology. FDA is specifically
interested in seeking comments on the
changes described, types of changes that
are not covered by this document but
should be, and illustrative examples of
types of changes.
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II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on when a new 510(k) should be
submitted for a change or modification
to a legally marketed device. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
ADDRESSES),
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive the draft guidance entitled
‘‘510(k) Device Modifications: Deciding
When To Submit a 510(k) for a Change
to an Existing Device,’’ you may either
send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1793 to identify the guidance
you are requesting.
[FR Doc. 2011–18923 Filed 7–26–11; 8:45 am]
IV. 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 56.115 have
been approved under OMB control
number 0910–0130; the collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 803 have
been approved under OMB control
number 0910–0437; the collections of
information in 21 CFR part 807, subpart
E have been approved under OMB
control number 0910–0120; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; and
the collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
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either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: July 21, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Organ
Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Organ
Transplantation (ACOT).
Date and Times: August 23, 2011, 1 p.m.
to 5 p.m.; August 24, 2011, 8:30 a.m. to 5
p.m.
Place: Georgetown University Hotel and
Conference Center, 3800 Reservoir Road,
NW., Washington, DC 20057.
Status: The meeting will be open to the
public.
Purpose: Under the authority of 42 U.S.C.
217a, Section 222 of the Public Health
Service Act, as amended, and 42 CFR 121.12
(2000), ACOT was established to assist the
Secretary in enhancing organ donation,
ensuring that the system of organ
transplantation is grounded in the best
available medical science, and assuring the
public that the system is as effective and
equitable as possible, and, thereby,
increasing public confidence in the integrity
and effectiveness of the transplantation
system. ACOT is composed of up to 25
members, including the Chair. Members are
serving as Special Government Employees
and have diverse backgrounds in fields such
as organ donation, health care public policy,
transplantation medicine and surgery, critical
care medicine and other medical specialties
involved in the identification and referral of
donors, non-physician transplant
professions, nursing, epidemiology,
immunology, law and bioethics, behavioral
sciences, economics and statistics, as well as
representatives of transplant candidates,
transplant recipients, organ donors, and
family members.
Agenda: The Committee meeting will
convene at 1 p.m. The Committee will hear
reports from two ACOT Work Groups:
Declining Rates of Donation/Geographical
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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
and Other Variations in Organ Distribution
and the Alignment of the Centers for
Medicare and Medicaid Services’ Regulatory
Requirements with the Organ Procurement
and Transplantation Network and the Health
Resources and Services Administration.
ACOT presentations will include an update
on the Kidney Allocation Policy; financial
challenges of kidney paired donation;
circulatory determination of death criteria;
organ donation and transplantation alliance;
vascularized composite allografts; and
disease transmission and informed consent.
Agenda items are subject to change as
priorities indicate.
After the presentations and Committee
discussions, members of the public will have
an opportunity to provide comments.
Because of the Committee’s full agenda and
the timeframe in which to cover the agenda
topics, public comment will be limited. All
public comments will be included in the
record of the ACOT meeting. Meeting
summary notes will be made available on the
Department’s donation Web site at https://
www.organdonor.gov/legislation.asp. The
draft meeting agenda will be available on the
Department’s donation Web site at https://
www.organdonor.gov/legislation.asp and at
https://www.team-psa.com/dot/spring2011/
ACOT.
Registration can be completed by e-mailing
or faxing a confirmation of participation to
Brittany Carey, with the HRM/Professional
and Scientific Associates (PSA), the logistical
support contractor for the meeting. Ms.
Carey’s e-mail address is b_carey@teampsa.com and her fax number is (703) 234–
1701. Individuals without access to the
Internet who wish to register may call
Brittany Carey with HRM/PSA at (703) 889–
9033.
For Further Information Contact: Patricia
Stroup, Executive Secretary, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers Lane,
Room 12C–06, Rockville, Maryland 20857;
telephone (301) 443–1127.
Dated: July 21, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–18935 Filed 7–26–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sroberts on DSK5SPTVN1PROD with NOTICES
Request for Comments Under the
Paperwork Reduction Act, Section
3506
The National Institute of
Health (NIH), as part of its continuing
effort to reduce paperwork and
respondent burden, invites the general
public and other Federal agencies to
take this opportunity to comment on
proposed and/or continuing information
collections, as required by the
SUMMARY:
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Paperwork Reduction Act of 1995,
Section 3506.
Proposed Collection: Title: The
Genetic Testing Registry; Type of
Information Collection Request: New
collection; Need and Use of Information
Collection: Laboratory tests for more
than 2,000 genetic conditions are
available; however, there is no
centralized public resource that
provides information about the
availability and scientific basis of these
tests. Recognizing the importance of
making this information easily
accessible to health care providers,
patients, consumers, and others, NIH is
developing a voluntary registry of
genetic tests. The Genetic Testing
Registry (GTR) will provide a
centralized, online location for test
developers, manufacturers, and
researchers to submit detailed
information about genetic tests. The
overarching goal of the GTR is to
advance the public health and research
in the genetic basis of health and
disease.
As such, the Registry will have
several key functions, including (1)
encouraging providers of genetic tests to
enhance transparency by publicly
sharing information about the
availability and utility of their tests; (2)
providing an information resource for
the public, including health care
providers, patients, and researchers, to
locate laboratories that offer particular
tests; and (3) facilitating genetic and
genomic data-sharing for research and
new scientific discoveries.
Frequency of Response: The
information will be submitted
voluntarily on a non-repeating,
continual basis, which means
submitters will register a test once and
can add new tests on a continual basis.
Submitters will be requested to update
their test information at least once every
12 months.
Description of Respondents:
Submitters to the GTR are expected to
include clinical laboratories, test
manufacturers, researchers, and entities
that report and interpret tests performed
elsewhere. The GTR is not limited to
U.S. respondents; it will also include
submissions from outside the United
States. Information will be collected and
managed using an online submission
system.
Estimate of Burden: Data from the
GeneTests Laboratory Directory, which
is currently the most comprehensive
listing available for laboratories that
provide genetic tests, was used to
estimate both the number of
participating laboratories as well as the
number of genetic tests which might be
submitted to the GTR. Analysis of the
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44937
database showed that there are 593
laboratories and approximately 7,800
genetic tests listed in GeneTests.
Approximately half of the laboratories
in GeneTests (291, or 49 percent) list 12
or fewer tests, while approximately 40
percent (239) list between 13 and 100
tests, and the remaining 10 percent (63)
list 100 or more tests. To account for
genetic test providers that are not listed
in GeneTests, the number of laboratories
was multiplied by 1.2, bringing the
estimated number of potential
participants in GTR to 770. A multiplier
of 1.2 was used to account for tests that
are not in GeneTests but that might be
submitted to the GTR, including test
categories not covered by GeneTests
(e.g., pharmacogenomic tests), as well as
tests that meet the criteria for GeneTests
but that have not been submitted to the
database. Applying the 1.2 multiplier
yields an estimated 9,360 tests for
which information could be submitted
to GTR.
Although participation in the GTR is
voluntary, in order to participate, the
submitter must provide information for
a certain subset of data fields, identified
as the ‘‘minimal fields.’’ GTR includes
31 minimal fields and 85 optional
fields. Separate estimates of hour
burden are provided for minimal,
optional, and all fields (Table 1). The
calculations include the time and effort
necessary for the test provider to gather
information for the data elements and to
enter the information into the GTR
online submission form.
Based on simulated trials of entering
test information into GTR, it will take
submitters an average of 0.5 hours per
test to provide information for the
minimal fields. With an average of 12.2
tests per respondent, the estimated
annual hour burden for a respondent to
complete the minimal fields is 6.1
hours. An estimated additional 2.5
hours per test was projected for the
optional fields for an annual burden of
30.5 hours per respondent. The annual
hour burden for a respondent to
complete all fields is 36.6 hours.
The calculations for annual burden
reflect the average time for submitters
who are familiar with their tests and
know where to find information about
the tests. For those submitters who are
not familiar with information about
their tests, it may take longer than the
estimated 2.5 hours to provide the
optional fields information. However,
submitters should become more
efficient in data entry as they gain
experience with GTR, and significant
time savings can be achieved by
laboratories with large numbers of tests
who use the bulk upload feature. In
addition, those test providers whose
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]]>Agencies
[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44936-44937]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18935]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Organ Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Advisory Committee on Organ Transplantation (ACOT).
Date and Times: August 23, 2011, 1 p.m. to 5 p.m.; August 24,
2011, 8:30 a.m. to 5 p.m.
Place: Georgetown University Hotel and Conference Center, 3800
Reservoir Road, NW., Washington, DC 20057.
Status: The meeting will be open to the public.
Purpose: Under the authority of 42 U.S.C. 217a, Section 222 of
the Public Health Service Act, as amended, and 42 CFR 121.12 (2000),
ACOT was established to assist the Secretary in enhancing organ
donation, ensuring that the system of organ transplantation is
grounded in the best available medical science, and assuring the
public that the system is as effective and equitable as possible,
and, thereby, increasing public confidence in the integrity and
effectiveness of the transplantation system. ACOT is composed of up
to 25 members, including the Chair. Members are serving as Special
Government Employees and have diverse backgrounds in fields such as
organ donation, health care public policy, transplantation medicine
and surgery, critical care medicine and other medical specialties
involved in the identification and referral of donors, non-physician
transplant professions, nursing, epidemiology, immunology, law and
bioethics, behavioral sciences, economics and statistics, as well as
representatives of transplant candidates, transplant recipients,
organ donors, and family members.
Agenda: The Committee meeting will convene at 1 p.m. The
Committee will hear reports from two ACOT Work Groups: Declining
Rates of Donation/Geographical
[[Page 44937]]
and Other Variations in Organ Distribution and the Alignment of the
Centers for Medicare and Medicaid Services' Regulatory Requirements
with the Organ Procurement and Transplantation Network and the
Health Resources and Services Administration. ACOT presentations
will include an update on the Kidney Allocation Policy; financial
challenges of kidney paired donation; circulatory determination of
death criteria; organ donation and transplantation alliance;
vascularized composite allografts; and disease transmission and
informed consent. Agenda items are subject to change as priorities
indicate.
After the presentations and Committee discussions, members of
the public will have an opportunity to provide comments. Because of
the Committee's full agenda and the timeframe in which to cover the
agenda topics, public comment will be limited. All public comments
will be included in the record of the ACOT meeting. Meeting summary
notes will be made available on the Department's donation Web site
at https://www.organdonor.gov/legislation.asp. The draft meeting
agenda will be available on the Department's donation Web site at
https://www.organdonor.gov/legislation.asp and at https://www.team-psa.com/dot/spring2011/ACOT.
Registration can be completed by e-mailing or faxing a
confirmation of participation to Brittany Carey, with the HRM/
Professional and Scientific Associates (PSA), the logistical support
contractor for the meeting. Ms. Carey's e-mail address is psa.com">b_carey@team-psa.com and her fax number is (703) 234-1701. Individuals
without access to the Internet who wish to register may call
Brittany Carey with HRM/PSA at (703) 889-9033.
For Further Information Contact: Patricia Stroup, Executive
Secretary, Healthcare Systems Bureau, Health Resources and Services
Administration, 5600 Fishers Lane, Room 12C-06, Rockville, Maryland
20857; telephone (301) 443-1127.
Dated: July 21, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-18935 Filed 7-26-11; 8:45 am]
BILLING CODE 4165-15-P
