Advancing the Development of Diagnostic Tests and Biomarkers for Tuberculosis; Public Workshop; Request for Comments, 15443-15444 [2010-6864]
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Federal Register / Vol. 75, No. 59 / Monday, March 29, 2010 / Notices
or has an interest in such litigation, and
HHS determines that the use of such
records by the Department of Justice, the
court or other tribunal is relevant and
necessary to the litigation and would
help in the effective representation of
the governmental party, provided,
however, that in each case, HHS
determines that such disclosure is
compatible with the purpose for which
the records were collected.
5. The Department may disclose
information to appropriate Federal
agencies and Department contractors
that have a need to know the
information for the purpose of assisting
the Department’s efforts to respond to a
suspected or confirmed breach of the
security or confidentiality of
information maintained in this system
of records, and the information
disclosed is relevant and necessary for
that assistance.
DISCLOSURE TO CONSUMER REPORTING
AGENCIES:
None.
cprice-sewell on DSK89S0YB1PROD with NOTICES
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
1. Storage: Electronic files, file
folders, magnetic tape, and disk storage.
The needs of each project determine the
types of storage actually used.
2. Retrievability: By name or by an
assigned number.
3. Safeguards: Locked building,
locked rooms, locked file cabinets,
personnel screening, locked computer
rooms and computer tape vault, guard
service, password protection of
automated records and limited access to
only authorized personnel may be used.
Particular safeguards are selected as
appropriate to the type of records
included in each project. Authorized
personnel are limited to HRSA staff and
contractor personnel directly involved
in data collection, compilation, and
analysis. (Safeguards are in accordance
with Part 6, ADP Systems Security, of
the Department’s Information Resources
Management Manual, with Chapter 45–
13, Safeguarding Records Contained in
Systems of Records, of the Department’s
General Administration Manual, and
with supplementary Chapter PHS. 45–
13.)
4. Retention and Disposal: The
contractor removes personal identifiers
and destroys the records when they are
no longer needed, as appropriate to the
specific project. (Records may be retired
to a Federal Records Center and
subsequently disposed of in accordance
with the Records Control Schedule of
the Health Resources and Services
Administration). You may obtain a copy
VerDate Nov<24>2008
09:18 Apr 05, 2010
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of the disposal standard for a particular
project by writing to the System
Manager.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Office of Workforce Policy
and Performance Management, Bureau
of Health Professions, HRSA, 5600
Fishers Lane, Room 9A–18, Rockville,
MD 20857.
NOTIFICATION PROCEDURE:
Requests concerning whether the
system contains records about an
individual should be made to the
Systems Manager.
Request in person: A subject
individual who appears in person at a
specific location seeking access or
disclosure of records relating to him/her
shall provide his/her name, current
address, and at least one piece of
tangible identification such as driver’s
license, passport, voter registration card,
or union card. Identification papers
with current photographs are preferred
but not required. Additional
identification may be requested when
there is a request for access to records
which contain an apparent discrepancy
between information contained in the
records and that provided by the
individual requesting access to the
records. Where the subject individual
has no identification papers, the
responsible agency official shall require
that the subject individual certify in
writing that he/she is the individual
who he/she claims to be and that he/she
understands that the knowing and
willful request or acquisition of a record
concerning an individual under false
pretenses is a criminal offense subject to
a $5,000 fine.
Requests by mail: A written request
must contain the name and address of
the requester and his/her signature,
which is either notarized to verify his/
her identify or includes a written
certification that the requester is a
person he/she claims to be and that he/
she understands that the knowing and
willful request or acquisition of records
pertaining to an individual under false
pretenses is a criminal offense subject to
a $5,000 fine.
Requests by telephone: Because
positive identification of the caller
cannot be established, no requests by
telephone will be honored.
RECORDS ACCESS PROCEDURES:
To obtain access to your record,
contact the System Manager and
provide suitable identification for proof
of identity, a reasonable description of
the record and, if possible, information
about the specific project. You may also
request a list of accountable disclosures
that have been made of your record.
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15443
CONTESTING RECORDS PROCEDURES:
To correct your record, contact the
System Manager and provide:
a. Suitable identification for proof of
identity,
b. A reasonable description of the
record,
c. The specific information you want
corrected, and
d. A precise description of the
correction, with supporting justification.
The right to contest records is limited to
information which is incomplete,
irrelevant, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
Subject individuals, State and local
health departments, other health
providers, health professions schools,
and health professions associations may
provide information depending on the
individual project involved.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE PRIVACY ACT:
None.
[FR Doc. 2010–6878 Filed 3–26–10; 8:45 am]
BILLING CODE 4160–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0156]
Advancing the Development of
Diagnostic Tests and Biomarkers for
Tuberculosis; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) in partnership with the Centers
for Disease Control and Prevention
(CDC) and the National Institute of
Allergy and Infectious Diseases (NIAID)
is announcing a public workshop
entitled ‘‘Advancing the Development of
Diagnostic Tests and Biomarkers for
Tuberculosis (TB).’’ The purpose of the
workshop is to provide an environment
for FDA, CDC, and NIAID to engage
other interested parties in identifying
intellectual and procedural gaps in the
current development of TB diagnostic
tests, and in exploring models and
strategies that would expedite the
development of new diagnostic tests
and biomarkers for TB.
Date and Time: The public workshop
will be held on June 7 and 8, 2010, from
8 a.m. to 5 p.m.
Location: The public workshop will
be held at the National Labor College,
E:\FR\FM\29MRN1.SGM
29MRN1
15444
Federal Register / Vol. 75, No. 59 / Monday, March 29, 2010 / Notices
cprice-sewell on DSK89S0YB1PROD with NOTICES
10000 New Hampshire Ave., Silver
Spring, MD 20903.
Contact Person: Elizabeth Callaghan,
Office of Critical Path Programs (HF–
18), Office of the Commissioner, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
3458, Elizabeth.Callaghan@fda.hhs.gov;
or Nancy Masiello, Office of Critical
Path Programs (HF–18), Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1660,
Nancy.Masiello@fda.hhs.gov.
Registration: Persons interested in
attending the workshop must register by
close of business, June 3, 2010. If you
wish to attend this public workshop,
you must register by e-mail at
tbdiagmtg@fda.hhs.gov. Those without
e-mail access may register by contacting
one of the persons listed in the Contact
Person section of this document. When
registering, you must provide your
name, title, company, or organization (if
applicable), address, phone number,
and e-mail address (if applicable). There
is no fee to register for the public
workshop and registration will be on a
first-come, first-served basis. Early
registration is recommended because
seating is limited. Registration on the
day of the public workshop will be
permitted on a space-available basis
beginning at 7:30 a.m.
If you need special accommodations
due to a disability, please contact one of
the persons listed in the Contact Person
section of this document at least 14 days
prior to the workshop.
Comments: FDA, CDC, and NIAID are
holding this public workshop to obtain
information about developing new
diagnostic tests and biomarkers for TB.
The deadline for submitting comments
regarding this public workshop is
August 8, 2010.
Regardless of attendance at the public
workshop, interested persons may
submit written or electronic comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. Submit a single
copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified 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.
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
09:18 Apr 05, 2010
Jkt 220001
I. Background
Between the mid-1980s and early
1990s, reports of TB in the United States
increased, after years of decline. This
increase was associated with a
weakened network of TB services; the
human immunodeficiency virus (HIV)
epidemic; increased immigration of
persons from endemic areas for TB;
transmission of TB in surroundings with
higher risk of exposure (e.g., hospitals,
prisons); and the emergence of drugresistant TB. However, reported TB
cases substantially decreased in the
mid- to late 1990s with renewed efforts
on TB control and prevention, and a
major focus on resources.
In 2000, The National Academy of
Sciences’ Institute of Medicine (IOM)
issued a report1 concluding that TB can
be eliminated as a public health threat
in the United States with appropriate
funding for additional prevention and
control programs, and development of
new tools.
In 2003, the Federal TB Task Force
(FTBTF) issued a plan2 to implement
the IOM recommendations. A
reconvened FTBTF issued a plan in
20093 specifically for combating
multidrug-resistant TB (MDR TB) and
extensively drug-resistant TB (XDR TB).
Both plans addressed domestic and
global strategies, including partnerships
with global agencies, as well as detailed
action steps and specific agency roles.
II. Purpose of the Public Workshop
The workshop is intended to provide
an environment for FDA, CDC, and
NAID to engage other interested parties
in identifying intellectual and
procedural gaps in the current
development of TB diagnostic tests, and
in exploring models and strategies that
would expedite the development of new
diagnostic tests and biomarkers for TB.
Invited experts will address current
research and its barriers; both regulatory
and scientific perspectives on the
development of new diagnostic tests
and biomarkers for TB; resources for
developing new TB diagnostic tests; and
components of and requirements for a
TB specimen repository. At designated
1 Institute of Medicine, Ending Neglect: The
Elimination of Tuberculosis in the United States,
Committee on the Elimination of Tuberculosis in
the United States, Division of Health Promotion and
Disease Prevention, Institute of Medicine, 2000.
2 The Federal Tuberculosis Task Force, Federal
Tuberculosis Task Force Plan in Response to the
Institute of Medicine Report, Ending Neglect: The
Elimination of Tuberculosis in the United States,
Atlanta, GA: U.S. Department of Health and Human
Services, CDC, 2003.
3 ‘‘Plan to Combat Extensively Drug-Resistant
Tuberculosis: Recommendations of the Federal
Tuberculosis Task Force,’’ Morbidity and Mortality
Weekly Report, Recommendations and Reports, 58
(RR–3):1–43, February 13, 2009.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
times throughout the workshop, there
will be short discussions followed by
question and answer sessions.
Background information on the public
workshop, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at https://www.fda.gov/
ScienceResearch/SpecialTopics/
CriticalPathInitiative/
UpcomingEventsonCPI/
ucm203262.htm.
III. 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.
Dated: March 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6864 Filed 3–26–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2009–0001]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request, OMB No.
1660–NEW; FEMA Preparedness
Grants: Port Security Grant Program
(PSGP)
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 30-day notice and
request for comments; new information
collection; OMB No. 1660–NEW; FEMA
Form 089–5.
AGENCY:
SUMMARY: The Federal Emergency
Management Agency (FEMA) has
submitted the information collection
abstracted below to the Office of
Management and Budget for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 75, Number 59 (Monday, March 29, 2010)]
[Notices]
[Pages 15443-15444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6864]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0156]
Advancing the Development of Diagnostic Tests and Biomarkers for
Tuberculosis; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) in partnership with the
Centers for Disease Control and Prevention (CDC) and the National
Institute of Allergy and Infectious Diseases (NIAID) is announcing a
public workshop entitled ``Advancing the Development of Diagnostic
Tests and Biomarkers for Tuberculosis (TB).'' The purpose of the
workshop is to provide an environment for FDA, CDC, and NIAID to engage
other interested parties in identifying intellectual and procedural
gaps in the current development of TB diagnostic tests, and in
exploring models and strategies that would expedite the development of
new diagnostic tests and biomarkers for TB.
Date and Time: The public workshop will be held on June 7 and 8,
2010, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the National Labor
College,
[[Page 15444]]
10000 New Hampshire Ave., Silver Spring, MD 20903.
Contact Person: Elizabeth Callaghan, Office of Critical Path
Programs (HF-18), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3458,
Elizabeth.Callaghan@fda.hhs.gov; or Nancy Masiello, Office of Critical
Path Programs (HF-18), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1660,
Nancy.Masiello@fda.hhs.gov.
Registration: Persons interested in attending the workshop must
register by close of business, June 3, 2010. If you wish to attend this
public workshop, you must register by e-mail at tbdiagmtg@fda.hhs.gov.
Those without e-mail access may register by contacting one of the
persons listed in the Contact Person section of this document. When
registering, you must provide your name, title, company, or
organization (if applicable), address, phone number, and e-mail address
(if applicable). There is no fee to register for the public workshop
and registration will be on a first-come, first-served basis. Early
registration is recommended because seating is limited. Registration on
the day of the public workshop will be permitted on a space-available
basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact one of the persons listed in the Contact Person section of this
document at least 14 days prior to the workshop.
Comments: FDA, CDC, and NIAID are holding this public workshop to
obtain information about developing new diagnostic tests and biomarkers
for TB. The deadline for submitting comments regarding this public
workshop is August 8, 2010.
Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. Submit a single copy of electronic comments or two
paper copies of any mailed comments, except that individuals may submit
one paper copy. Comments are to be identified 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.
SUPPLEMENTARY INFORMATION:
I. Background
Between the mid-1980s and early 1990s, reports of TB in the United
States increased, after years of decline. This increase was associated
with a weakened network of TB services; the human immunodeficiency
virus (HIV) epidemic; increased immigration of persons from endemic
areas for TB; transmission of TB in surroundings with higher risk of
exposure (e.g., hospitals, prisons); and the emergence of drug-
resistant TB. However, reported TB cases substantially decreased in the
mid- to late 1990s with renewed efforts on TB control and prevention,
and a major focus on resources.
In 2000, The National Academy of Sciences' Institute of Medicine
(IOM) issued a report\1\ concluding that TB can be eliminated as a
public health threat in the United States with appropriate funding for
additional prevention and control programs, and development of new
tools.
---------------------------------------------------------------------------
\1\ Institute of Medicine, Ending Neglect: The Elimination of
Tuberculosis in the United States, Committee on the Elimination of
Tuberculosis in the United States, Division of Health Promotion and
Disease Prevention, Institute of Medicine, 2000.
---------------------------------------------------------------------------
In 2003, the Federal TB Task Force (FTBTF) issued a plan\2\ to
implement the IOM recommendations. A reconvened FTBTF issued a plan in
2009\3\ specifically for combating multidrug-resistant TB (MDR TB) and
extensively drug-resistant TB (XDR TB). Both plans addressed domestic
and global strategies, including partnerships with global agencies, as
well as detailed action steps and specific agency roles.
---------------------------------------------------------------------------
\2\ The Federal Tuberculosis Task Force, Federal Tuberculosis
Task Force Plan in Response to the Institute of Medicine Report,
Ending Neglect: The Elimination of Tuberculosis in the United
States, Atlanta, GA: U.S. Department of Health and Human Services,
CDC, 2003.
\3\ ``Plan to Combat Extensively Drug-Resistant Tuberculosis:
Recommendations of the Federal Tuberculosis Task Force,'' Morbidity
and Mortality Weekly Report, Recommendations and Reports, 58 (RR-
3):1-43, February 13, 2009.
---------------------------------------------------------------------------
II. Purpose of the Public Workshop
The workshop is intended to provide an environment for FDA, CDC,
and NAID to engage other interested parties in identifying intellectual
and procedural gaps in the current development of TB diagnostic tests,
and in exploring models and strategies that would expedite the
development of new diagnostic tests and biomarkers for TB. Invited
experts will address current research and its barriers; both regulatory
and scientific perspectives on the development of new diagnostic tests
and biomarkers for TB; resources for developing new TB diagnostic
tests; and components of and requirements for a TB specimen repository.
At designated times throughout the workshop, there will be short
discussions followed by question and answer sessions. Background
information on the public workshop, registration information, the
agenda, information about lodging, and other relevant information will
be posted, as it becomes available, on the Internet at https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/UpcomingEventsonCPI/ucm203262.htm.
III. 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.
Dated: March 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6864 Filed 3-26-10; 8:45 am]
BILLING CODE 4160-01-S
