Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic Priorities Document; Request for Comments, 60767-60768 [2010-24603]
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Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices
SYSTEM MANAGER(S) AND ADDRESS:
Director, Division of Practitioner Data
Banks, Bureau of Health Professions,
Health Resources and Services
Administration, Room 8–103, Parklawn
Building, 5600 Fishers Lane, Rockville,
Maryland 20857.
NOTIFICATION PROCEDURE:
Information is available upon request,
to the persons or entities, or to the
authorized agents in such form or
manner as the Secretary prescribes. The
subject of a report is notified via U.S.
mail when a record concerning the
individual is submitted to the Data Bank
via Subject Notification Document
(SND).
REQUESTS BY MAIL:
Practitioners may submit a ‘‘Request
for Information Disclosure’’ to the
address under system location for any
report on themselves. The request must
contain the following: Name, address,
date of birth, gender, Social Security
Number (optional), professional schools
and years of graduation, and the
professional license(s). For license,
include: The license number, the field
of licensure, the name of the State or
Territory in which the license is held,
and DEA registration number(s). The
practitioner must submit a signed and
notarized self-query request.
PENALTIES FOR VIOLATION:
Submitting a request under false
pretenses is a criminal offense and
subject to a civil monetary penalty of up
to $11,000 for each violation.
REQUESTS IN PERSON:
Due to security considerations, the
Data Bank cannot accept requests in
person.
REQUEST BY TELEPHONE:
Practitioners may provide all of the
identifying information stated above to
the Data Bank Customer Service Center
operator. Before the data request is
fulfilled, the operator will return a
paper copy of this information for
verification, signature and notarization.
emcdonald on DSK2BSOYB1PROD with NOTICES
RECORD ACCESS PROCEDURES:
Request for access of records in the
Data Bank may be completed online at:
https://www.npdb-hipdb.hrsa.gov. The
requests are submitted over the web
using the Integrated Query and
Reporting Service (IQRS), Query and
Reporting Extensible Markup Language
Service (QRXS), Interface Control
Document (ICD) Transfer Program (ITP)
or the Proactive Disclosure Service
(PDS). Self-query, as described
previously, may be initiated via the
electronic system and is completed
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using the conventional mail system.
Requesters, including self-queries, will
receive an accounting of disclosure that
has been made of their records, if any.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
CONTESTING RECORD PROCEDURES:
BILLING CODE 4160–15–P
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of any report filed in it to the subject
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herself and file a dispute. To dispute the
accuracy of the information, the
individual must contact the Data Bank
and the reporting entity to: (1) Request
for the reporting entity to file correction
to the report; and (2) request the
information be entered into a ‘‘disputed’’
status and submit a statement regarding
the basis for the inaccuracy of the
information in the report. If the
reporting entity declines to change the
disputed report or takes no actions, the
subject may request that the Secretary of
HHS review the disputed report. In
order to seek a Secretarial Review, the
subject must: (1) Provide written
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information of the report; (2) submit
supporting documentation or
justification substantiating that the
reporting entity’s information is
inaccurate; and (3) submit proof that the
subject individual has attempted to
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reporter’s basis for action. Additional
detail on the process of dispute
resolution and Secretarial Review
process can be found at 45 CFR § 60.14
of the Data Bank regulations.
RECORD SOURCE CATEGORIES:
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are submitted by the following entities:
(1) Insurance companies and others who
have made payment as a result of a
malpractice action or claim, (2) State
Boards of Medical and Dental
Examiners; (3) State Licensing Boards;
(4) hospitals and other health care
entities; (5) DEA; and (6) Federal
entities which employ health
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practitioner licensing and certification
authorities (including medical and
dental boards), State entity licensing
and certification authorities, peer
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[FR Doc. 2010–24568 Filed 9–30–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0506]
Office of the Commissioner; Request
for Comments on the Food and Drug
Administration Fiscal Year 2011–2015
Strategic Priorities Document; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is seeking public
comment on its draft Strategic Priorities
FY 2011–2015. FDA has identified these
strategic priorities and goals that will
guide its efforts to achieve its public
health mission. FDA is seeking public
comment to help further refine these
priorities and goals.
DATES: Submit either electronic or
written comments by November 1, 2010.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Darian Tarver, Office of Planning, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 4219,
Silver Spring, MD 20993–0002, 301–
796–4850.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
FDA is posting its draft Strategic
Priorities FY 2011–2015 to ensure that
key stakeholders are given an
opportunity to comment on this
document.
The purpose of this document is to
outline FDA’s strategic intentions and
plans for the next 5 years (fiscal year
(FY) 2011 through 2015). This
document identifies four key crosscutting strategic priorities and four
strategic program goals that will guide
efforts to achieve FDA’s public health
mission and to fulfill its role in
supporting the larger mission and
strategic goals of the Department of
E:\FR\FM\01OCN1.SGM
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60768
Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices
Health and Human Services. The four
cross-cutting strategic priorities are: (1)
Advance Regulatory Science and
Innovation, (2) Strengthen the Safety
and Integrity of the Global Supply
Chain, (3) Strengthen Compliance and
Enforcement Activities to Support
Public Health, and (4) Expand Efforts to
Meet the Needs of Special Populations.
The four strategic program goals are: (1)
Advance Food Safety and Nutrition, (2)
Promote Public Health by Advancing
the Safety and Effectiveness of Medical
Products, (3) Establish an Effective
Tobacco Regulation, Prevention, and
Control Program, and (4) Manage for
Organizational Excellence and
Accountability.
The strategic planning process is an
opportunity for FDA to further refine
and strengthen the strategic
management structure currently in
place. For comparison purposes, the
current FDA Strategic Action Plan 2007
can be viewed at https://www.fda.gov/
downloads/AboutFDA/Reports
ManualsForms/Reports/Strategic
ActionPlan/UCM061415.pdf.
FDA has made significant progress in
its strategic planning efforts. As we
build on this progress we look forward
to receiving your comments by (see
DATES). The text of the draft strategic
priorities document is available in a
‘‘pdf’’ (portable document format)
downloadable format through FDA’s
Web site: https://www.fda.gov/
AboutFDA/.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) 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.
emcdonald on DSK2BSOYB1PROD with NOTICES
Dated: September 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24603 Filed 9–30–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0257]
Single-Ingredient Oral Colchicine
Products; Enforcement Action Dates
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or agency) is
announcing its intention to take
enforcement action against unapproved
single-ingredient oral colchicine
products and persons1 who manufacture
or cause the manufacture of such
products or their shipment in interstate
commerce. Unapproved singleingredient oral colchicine products have
been associated with serious adverse
events, including fatalities. Singleingredient oral colchicine products are
new drugs that require approved
applications because they are not
generally recognized as safe and
effective. Currently one firm has
obtained approved applications to
market single-ingredient oral colchicine
for the treatment of acute gout flares,
prophylaxis of gout flares, and
prophylaxis of attacks of Familial
Mediterranean Fever (FMF). All other
manufacturers who wish to market
single-ingredient oral colchicine
products for these or other indications
must obtain FDA approval of a new
drug application (NDA) or an
abbreviated new drug application
(ANDA).
DATES: This notice is effective October
1, 2010. For information about
enforcement dates, see SUPPLEMENTARY
INFORMATION, section III.C.
ADDRESSES: All communications in
response to this notice should be
identified with Docket No. FDA–2010–
N–0257 and directed to the appropriate
office listed as follows:
Regarding applications under section
505(b) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
355(b)): Division of Anesthesia,
Analgesia and Rheumatology Products,
Office of New Drugs, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Silver Spring,
MD 20993–0002.
All other communications: See the
SUMMARY:
FOR FURTHER INFORMATION CONTACT
section of this document.
1A ‘‘person’’ includes individuals, partnerships,
corporations, or associations (section 201 of the
Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 321(e)).
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FOR FURTHER INFORMATION CONTACT:
Karen Rothschild, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5237,
Silver Spring, MD 20993–0002, 301–
796–3689, e-mail:
Karen.Rothschild@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Colchicine is an alkaloid of the
Colchicum autumnale plant, also
known as autumn crocus or meadow
saffron. Colchicum was initially
described in the 1st century A.D. by
Dioscorides in the Materia Medica.
Medical use of colchicum for gout pain
dates back to the 6th century. It was
used for several centuries, but the use of
colchicum in the treatment of gout
substantially declined by the 15th
century because of its toxicity.
Colchicum was reintroduced as a
treatment for acute gout beginning in
1763. Colchicine was first isolated from
colchicum in 1820 and made available
in oral dosage form during the 19th
century. Colchicine in oral dosage form
is currently marketed in the United
States as approved and unapproved
products, both as a single ingredient and
in combination with probenecid.
Colchicine for injection has been
available in the United States since the
1950s and has been administered
intravenously for the treatment of acute
gout flares. In the Federal Register of
February 8, 2008 (73 FR 7565), FDA
announced its intention to take
enforcement action against unapproved
drug products containing colchicine for
injection. Single-ingredient oral
colchicine products, the subject of this
notice, have also been marketed in the
United States without approved
applications to treat acute gout flares,
and are more commonly marketed in
conjunction with uric acid lowering
agents for the daily prophylaxis of flares
of gout. Daily oral colchicine has also
been the standard of care since the
1970s for the prophylaxis of attacks of
FMF.
One firm, Mutual Pharmaceutical Co.,
Inc. (Mutual), of Philadelphia, PA, has
received approval for three NDAs for
single-ingredient oral colchicine. These
approvals are: NDA 22–352 for the
treatment of FMF,2 approved on July 29,
2 Because the incidence of FMF in the United
States is rare, Mutual sought and was granted
orphan drug status for its product covered by NDA
22–352 under section 526 of the act (21 U.S.C.
360bb). The term ‘‘orphan drug’’ refers to a product
that treats a rare disease affecting fewer than
200,000 Americans. Enacted in 1983, the intent of
the Orphan Drug Act is to stimulate the research,
development, and approval of products that treat
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 75, Number 190 (Friday, October 1, 2010)]
[Notices]
[Pages 60767-60768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24603]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0506]
Office of the Commissioner; Request for Comments on the Food and
Drug Administration Fiscal Year 2011-2015 Strategic Priorities
Document; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is seeking public
comment on its draft Strategic Priorities FY 2011-2015. FDA has
identified these strategic priorities and goals that will guide its
efforts to achieve its public health mission. FDA is seeking public
comment to help further refine these priorities and goals.
DATES: Submit either electronic or written comments by November 1,
2010.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Darian Tarver, Office of Planning,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm.
4219, Silver Spring, MD 20993-0002, 301-796-4850.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is posting its draft Strategic Priorities FY 2011-2015 to
ensure that key stakeholders are given an opportunity to comment on
this document.
The purpose of this document is to outline FDA's strategic
intentions and plans for the next 5 years (fiscal year (FY) 2011
through 2015). This document identifies four key cross-cutting
strategic priorities and four strategic program goals that will guide
efforts to achieve FDA's public health mission and to fulfill its role
in supporting the larger mission and strategic goals of the Department
of
[[Page 60768]]
Health and Human Services. The four cross-cutting strategic priorities
are: (1) Advance Regulatory Science and Innovation, (2) Strengthen the
Safety and Integrity of the Global Supply Chain, (3) Strengthen
Compliance and Enforcement Activities to Support Public Health, and (4)
Expand Efforts to Meet the Needs of Special Populations. The four
strategic program goals are: (1) Advance Food Safety and Nutrition, (2)
Promote Public Health by Advancing the Safety and Effectiveness of
Medical Products, (3) Establish an Effective Tobacco Regulation,
Prevention, and Control Program, and (4) Manage for Organizational
Excellence and Accountability.
The strategic planning process is an opportunity for FDA to further
refine and strengthen the strategic management structure currently in
place. For comparison purposes, the current FDA Strategic Action Plan
2007 can be viewed at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/StrategicActionPlan/UCM061415.pdf.
FDA has made significant progress in its strategic planning
efforts. As we build on this progress we look forward to receiving your
comments by (see DATES). The text of the draft strategic priorities
document is available in a ``pdf'' (portable document format)
downloadable format through FDA's Web site: https://www.fda.gov/AboutFDA/.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) 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: September 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24603 Filed 9-30-10; 8:45 am]
BILLING CODE 4160-01-S
