National Practitioner Data Bank; Name Change of Proactive Disclosure Service (PDS) to Continuous Query, 59144-59145 [2011-24403]
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Dated: September 20, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–24532 Filed 9–22–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
[Docket No. FDA–2010–N–0318]
Novartis Pharmaceuticals Corp. et al.;
Withdrawal of Approval of 27 New
Drug Applications and 58 Abbreviated
New Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of July 21, 2010 (75 FR 42455).
The document withdrew approval of 27
new drug applications (NDAs) and 58
abbreviated new drug applications
(ANDAs) from multiple applicants. The
published document excluded a
footnote in the table. This document
corrects that error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 3208,
Silver Spring, MD 20993–0002, 301–
796–9148.
In FR Doc.
2010–17785, appearing on page 42455,
in the Federal Register of Wednesday,
July 21, 2010, the following correction
is made:
1. On page 42456, in Table 1, under
the ‘‘Drug’’ column, correct the entry for
‘‘Proventil (albuterol USP) Inhalation
Aerosol’’ to read ‘‘Proventil (albuterol
USP) Inhalation Aerosol 1’’.
2. On page 42456, at the end of the
table, add footnote number 1 to read:
SUPPLEMENTARY INFORMATION:
This product included an oral pressurized
metered-dose inhaler that contained
chlorofluorocarbons (CFCs) as a propellant.
CFCs may no longer be used as a propellant
for any albuterol metered-dose inhalers. (See
70 FR 17168, April 4, 2005.)
Dated: September 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–24400 Filed 9–22–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Practitioner Data Bank; Name
Change of Proactive Disclosure
Service (PDS) to Continuous Query
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice.
SUMMARY: On March 7, 2007, the Health
Resources and Services Administration
(HRSA), Department of Health and
Human Services (HHS), published in
the Federal Register a notice
announcing the implementation of a
prototype for querying the National
Practitioner Data Bank (NPDB), then
known as Proactive Disclosure Service
(PDS). This notice announces that the
prototype status is removed and that
PDS is now known as Continuous
Query.
DATES: The effective date of this status
upgrade and name change is September
23, 2011.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Practitioner Data
Banks, Bureau of Health Professions,
Health Resources and Services
Administration, Parklawn Building,
5600 Fishers Lane, Room 8–103,
Rockville, MD 20857; telephone
number: (301) 443–2300.
SUPPLEMENTARY INFORMATION:
I. Background
On March 7, 2007, the National
Practitioner Data Bank (NPDB)
published in the Federal Register (72
FR 10227) a notice announcing a
Proactive Disclosure Service (PDS)
prototype. The PDS was offered as an
alternative to the traditional querying of
the NPDB and allowed for on-going
monitoring of a practitioner’s
credentials. PDS is a subscription
service that notifies subscribers, which
are registered entities that are eligible to
query the NPDB or the Healthcare
Integrity and Protection Data Bank
(HIPDB), of new information on any of
their enrolled practitioners within 24
hours of the NPDB or HIPDB receipt of
the information. The PDS prototype was
available for enrollment beginning on
April 30, 2007 to a select group of NPDB
registered entities. A few months later
PDS was opened to all NPDB registered
entities, as well as to those registered in
the HIPDB. In the last year (July 1, 2010
through June 30, 2011), 1,965 entities
had practitioner enrollments through
PDS versus 14,370 entities that
submitted traditional queries on
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Federal Register / Vol. 76, No. 185 / Friday, September 23, 2011 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
practitioners in the NPDB. Unlike a
traditional query, PDS enrolled
practitioners are continuously
monitored and subscribed entities need
not pay for multiple queries each time
they want to access new information on
a practitioner. The following table
charts the growth of PDS enrollments
beginning in June 2007 through June
2010 for the NPDB and the HIPDB:
Reduction Act of 1995, the National
Institute of Nursing (NINR), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This information
collection was previously published in
the Federal Register on June 16, 2011,
page 35221 and allowed 60 days for
public comment. No public comments
NUMBER OF PRACTITIONERS ENROLLED were received. The purpose of this
IN PDS
notice is to allow an additional 30 days
for public comment.
Month/year
NPDB
HIPDB
5 CFR 1320.5 (General requirements)
Reporting and Recordkeeping
June 2010 .............
481,794
125,649
June 2009 .............
311,275
101,720 Requirements: Final Rule requires that
June 2008 .............
113,631
12,592 the agency inform the potential persons
June 2007 .............
47,641
2,005 who are to respond to the collection of
information that such persons are not
The number of enrollments is steadily required to respond to the collection of
climbing and re-enrollment rates for this information unless it displays a
service are approximately 90 percent.
currently valid OMB control number.
This service is quickly becoming the
This information is required to be stated
benchmark for monitoring practitioner
in the 30-day Federal Register Notice.
credentials because it is designed and
Proposed Collection: Title: NINR Enddeveloped to meet new accreditation
of-Life and Palliative Care Science
standards that require on-going
Needs Assessment: Funding Source
monitoring of practitioners. In light of
(Survey of Authors). Type of
these developments, HRSA is making
Information Collection Request: NEW.
this service a permanent feature. The
Need and Use of Information Collection:
name change from PDS to Continuous
The NINR End-of-Life Science Palliative
Query better captures the true nature of
Care (EOL PC) Needs Assessment:
this service, which is the continuous
Funding Source Questionnaire will
monitoring of enrolled practitioners.
obtain information on funding sources
All aspects of the PDS querying
of EOL PC research published studies
service as described in the March 7,
for which a funding source is not cited
2007 notice are still in effect except for
or the information is unclear. Target
the upgrade from prototype to
participants are authors of publiclypermanent status and the name change
available EOL PC research studies
set forth in this notice.
published between 1997–2010 for
whom a funding source is unknown or
II. Revisions to Previous Notice
unclear. The questionnaire inquires
This notice is to inform the public
about the funding source of the
that the prototype status for PDS is
published study, type of funding
removed and that the name of the PDS
received, year of funding, and duration
querying service has been changed to
of funded study. This is a 7-item
Continuous Query.
questionnaire that takes approximately
Dated: September 16, 2011.
5 minutes to complete. Data collected is
Mary K. Wakefield,
part of a needs assessment to address
Administrator, Health Resources and Services the breadth and depth of EOL PC
Administration.
scientific issues for use in stimulating
[FR Doc. 2011–24403 Filed 9–22–11; 8:45 am]
research capacity in the field. Frequency
of Response: One time. Affected Public:
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Individual authors of publicly available
EOL PC research publications who do
DEPARTMENT OF HEALTH AND
not list a funding source or the source
HUMAN SERVICES
is unclear within their publication. Type
of Respondents: EOL PC researchers.
National Institutes of Health
The annual reporting burden is as
follows: Estimated Number of
Submission for OMB Review;
Respondents: 1840; Estimated Number
Comment Request; NINR End-of-Life
of Responses per Respondent: 1;
and Palliative Care Science Needs
Average Burden Hours Per Response:
Assessment: Funding Source (Survey
.08; and Estimated Total Annual Burden
of Authors)
Hours Requested: 147. There are no
Summary: Under the provisions of
Capital Costs, Operating or Maintenance
Section 3507(a)(1)(D) of the Paperwork
Costs to report.
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Request for comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Direct comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Amanda Greene, Office of Science
Policy and Public Liaison, NINR, NIH,
Democracy One, 6701 Democracy Blvd.,
Suite 710, Bethesda, MD 20892 or call
non-toll-free number (301) 496–9601 or
E-mail your request, including your
address to: amanda.greene@nih.gov.
Comments due date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: September 16, 2011.
Amanda Greene,
Science Evaluation Officer, NINR, National
Institutes of Health.
[FR Doc. 2011–24510 Filed 9–22–11; 8:45 am]
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Pages 59144-59145]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24403]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Practitioner Data Bank; Name Change of Proactive
Disclosure Service (PDS) to Continuous Query
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: On March 7, 2007, the Health Resources and Services
Administration (HRSA), Department of Health and Human Services (HHS),
published in the Federal Register a notice announcing the
implementation of a prototype for querying the National Practitioner
Data Bank (NPDB), then known as Proactive Disclosure Service (PDS).
This notice announces that the prototype status is removed and that PDS
is now known as Continuous Query.
DATES: The effective date of this status upgrade and name change is
September 23, 2011.
FOR FURTHER INFORMATION CONTACT: Director, Division of Practitioner
Data Banks, Bureau of Health Professions, Health Resources and Services
Administration, Parklawn Building, 5600 Fishers Lane, Room 8-103,
Rockville, MD 20857; telephone number: (301) 443-2300.
SUPPLEMENTARY INFORMATION:
I. Background
On March 7, 2007, the National Practitioner Data Bank (NPDB)
published in the Federal Register (72 FR 10227) a notice announcing a
Proactive Disclosure Service (PDS) prototype. The PDS was offered as an
alternative to the traditional querying of the NPDB and allowed for on-
going monitoring of a practitioner's credentials. PDS is a subscription
service that notifies subscribers, which are registered entities that
are eligible to query the NPDB or the Healthcare Integrity and
Protection Data Bank (HIPDB), of new information on any of their
enrolled practitioners within 24 hours of the NPDB or HIPDB receipt of
the information. The PDS prototype was available for enrollment
beginning on April 30, 2007 to a select group of NPDB registered
entities. A few months later PDS was opened to all NPDB registered
entities, as well as to those registered in the HIPDB. In the last year
(July 1, 2010 through June 30, 2011), 1,965 entities had practitioner
enrollments through PDS versus 14,370 entities that submitted
traditional queries on
[[Page 59145]]
practitioners in the NPDB. Unlike a traditional query, PDS enrolled
practitioners are continuously monitored and subscribed entities need
not pay for multiple queries each time they want to access new
information on a practitioner. The following table charts the growth of
PDS enrollments beginning in June 2007 through June 2010 for the NPDB
and the HIPDB:
Number of Practitioners Enrolled in PDS
------------------------------------------------------------------------
Month/year NPDB HIPDB
------------------------------------------------------------------------
June 2010....................................... 481,794 125,649
June 2009....................................... 311,275 101,720
June 2008....................................... 113,631 12,592
June 2007....................................... 47,641 2,005
------------------------------------------------------------------------
The number of enrollments is steadily climbing and re-enrollment
rates for this service are approximately 90 percent. This service is
quickly becoming the benchmark for monitoring practitioner credentials
because it is designed and developed to meet new accreditation
standards that require on-going monitoring of practitioners. In light
of these developments, HRSA is making this service a permanent feature.
The name change from PDS to Continuous Query better captures the true
nature of this service, which is the continuous monitoring of enrolled
practitioners.
All aspects of the PDS querying service as described in the March
7, 2007 notice are still in effect except for the upgrade from
prototype to permanent status and the name change set forth in this
notice.
II. Revisions to Previous Notice
This notice is to inform the public that the prototype status for
PDS is removed and that the name of the PDS querying service has been
changed to Continuous Query.
Dated: September 16, 2011.
Mary K. Wakefield,
Administrator, Health Resources and Services Administration.
[FR Doc. 2011-24403 Filed 9-22-11; 8:45 am]
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