Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files, 35921-35922 [06-5574]
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Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices
35921
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2006, THROUGH MARCH 31, 2006—Continued
PMA No./Docket No.
Applicant
Trade Name
P050007/2006M–0016
Abbott Vascular Devices (AVD)
STARCLOSE VASCULAR CLOSURE SYSTEM
H040005/2006M–0163
Karl Storz Endoscopy-America,
Inc.
KARL STORZ RIGID TTTS
FETOSCOPY INSTRUMENT
SET WITH 0 AND 12 DEGREE
SCOPE, KARL STORZ RIGID
TTTS FETOSCOPY INSTRUMENT SET WITH 30 DEGREE
SCOPE, AND KARL STORZ
SEMI-RIGID TTTS FETOSCOPY
INSTRUMENT SET
II. Electronic Access
Proposed Collection
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Title: 0917–0009, ‘‘Indian Health
Service Medical Staff’’
Typed of Information Collection
Request: Extension, without revision, of
currently approved information
collection, 0917–0009, ‘‘Indian Health
Service Medical Staff Credentials and
Privileges Files.’’
Form Numbers(s): None.
Need and Use of Information
Collection: This collection of
information is used to evaluate
individual health care providers
applying for medical staff privileges at
IHS health care facilities. The HHS
operates health care facilities that
provide health care services to
American Indians and Alaska Natives.
To provide these services, the IHS
employs (directly and under contract)
several categories of health care
providers including: Physicians (M.D.
and D.O.), dentists, psychologists,
optometrists, podiatrists, audiologists,
physician assistants, certified registered
nurse anesthetists, nurse practitioners,
and certified nurse midwives. The IHS
policy specifically requires physicians
and dentists to be members of the health
care facility medical staff where they
practice. Health care providers become
medical staff members, depending on
the local health care facility’s
capabilities and medical staff bylaws.
There are three types of IHS medical
staff applicants: (1) Health care
providers applying for direct
employment with IHS; (2) contractors
who will not seek to become IHS
employees; and (3) employed IHS health
care providers who seek to transfer
between IHS health care facilities.
National health care standards
developed by the Center for Medicare
and Medicaid Services (formerly the
Health Care Financing Administration),
the Joint Commission on the
Accreditation of Healthcare
Organizations (JCAHO), and other
Dated: June 13, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–9898 Filed 6–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Proposed Information Collection:
Indian Health Service Medical Staff
Credentials and Privileges Files
Indian Health Service, HHS.
The Indian Health Service
(IHS), as part of its continuing effort to
reduce paperwork and respondent
burden, conducts a pre-clearance
consultation program to provide the
general public and Federal agencies
with an opportunity to comment on
proposed and/or continuing collections
of information in accordance with the
Paperwork Reduction Act of 1995
continuing collections of information in
accordance with the Paperwork
Reduction Act of 1995 (PRA95) (44
U.S.C. 3506(c)(2)(A)). This program
helps to ensure that requested data can
be provided in the desired format,
reporting burden (time and financial
resources) is minimized, collection
instruments are clearly understood, and
the impact of collection requirements on
respondents can be properly assessed.
Currently, the IHS is providing a 60-day
advance opportunity for public
comment on a proposed new collection
of information to be submitted to the
Office of Management and Budget for
review.
AGENCY:
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SUMMARY:
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19:08 Jun 21, 2006
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Approval Date
December 21, 2005
March 31, 2006
accrediting organizations required
health care facilities to review, evaluate
and verify the credentials, training and
experience of medical staff applicants
prior to granting medical staff
privileges. To meet these standards, IHS
health care facilities require all medical
staff applicants to provide information
concerning their education, training,
licensure, and work experience and any
adverse disciplinary actions taken
against them. This information is then
verified with references supplied by the
applicant and may include: Former
employers, educational institutions,
licensure and certification boards, the
American Medical Association, the
Federation of State Medical Boards, the
National Practitioner Data Bank, and the
applicants themselves.
In addition to the initial granting of
medical staff membership and clinical
privileges, JCAHO standards require
that a review of the medical staff be
conducted not less than every two years.
This review evaluates the current
competence of the medical staff and
verifies whether they are maintaining
the licensure or certification
requirements of their specialty.
The medical staff credentials and
privileges records are maintained at the
health care facility where the health
care provider is a medical staff member.
The establishment of these records at
IHS health care facilities is not optional;
such records must be established and
maintained at all health care facilities in
the United States that are accredited by
JCAHO. Prior to the establishment of
this JCAHO requirement, the degree to
which medical staff applications were
verified for completeness and accuracy
varied greatly across America.
Affected Public: Individuals and
households.
Type of Respondents: Individuals.
Burden Hours: The table below
provides the estimated burden hours for
this information collection:
E:\FR\FM\22JNN1.SGM
22JNN1
35922
Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices
Responses
per
respondent
Est. number of
respondents
Data collection
Burden per
response *
Application to Medical Staff ......................................................................
Reference Letter .......................................................................................
Reappointment Request ...........................................................................
Ob-Gyn Privileges ....................................................................................
Internal Medicine ......................................................................................
Surgery Privileges ....................................................................................
Psychiatry Privileges ................................................................................
Anesthesia Privileges ...............................................................................
Dental Privileges .......................................................................................
Optometry Privileges ................................................................................
Psychology Privileges ...............................................................................
Audiology Privileges .................................................................................
Podiatry Privileges ....................................................................................
Radiology Privileges .................................................................................
Pathology Privileges .................................................................................
600
1800
200
25
387
23
18
16
128
21
23
6
6
9
3
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Total ...................................................................................................
3,265
........................
1.00
0.33
1.00
1.00
1.00
1.00
1.00
1.00
0.33
0.33
0.17
0.08
0.08
0.33
0.33
Total annual
burden hrs.
(60 mins) ....
(20 mins) ....
(60 mins) ....
(60 mins) ....
(60 mins) ....
(60 mins) ....
(60 mins) ....
(60 mins) ....
(20 mins) ....
(20 mins) ....
(10 mins) ....
(5 mins) ......
(5 mins) ......
(20 mins) ....
(20 mins) ....
600.0
594.0
200.0
25.0
387.0
23.0
18.0
16.0
42.2
6.9
3.9
0.48
0.48
2.9
.99
.............................
1,920.85
* For ease of understanding, burden hours are provided in actual minutes.
wwhite on PROD1PC61 with NOTICES
There are no capital costs, operating
costs and/or maintenance costs to
respondents.
Request for Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points: (a) Whether the information
collection activity is necessary to carry
out an agency function; (b) whether the
agency processes the information
collected in a useful and timely fashion;
(c) the accuracy of public burden
estimate (the estimated amount of time
needed for individual respondents to
provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimate are logical; (e) ways to enhance
the quality, utility, and clarity of the
information being collected; and (f)
ways to minimize the public burden
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Send Comments and Requests for
Further Information: For the proposed
collection or requests to obtain a copy
of the data collection instrument(s) and
instructions to: Mrs. Christina Rouleau,
IHS Reports Clearance Officer, 801
VerDate Aug<31>2005
19:08 Jun 21, 2006
Jkt 208001
Thompson Avenue, TMP Suite 450,
Rockville, MD 20852, call non-toll free
(301) 443–5938, send via facsimile to
(301) 443–2316, or send your e-mail
requests, comments, and return address
to: crouleau@hqe.ihs.gov.
Comment Due Date: Your comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: June 15, 2006.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. 06–5574 Filed 6–21–06; 8:45 am]
BILLING CODE 4165–16–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
ADDRESSES:
Government-Owned Inventions;
Availability for Licensing
Beta-Amyloid PET Imaging Agents
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
Description of Technology: Available
for licensing and commercial
development are two novel classes of
compounds useful as radioligands for in
vivo imaging of beta-amyloid (Aβ)
peptides and plaques in humans.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
E:\FR\FM\22JNN1.SGM
22JNN1
Agencies
[Federal Register Volume 71, Number 120 (Thursday, June 22, 2006)]
[Notices]
[Pages 35921-35922]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5574]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day Proposed Information
Collection: Indian Health Service Medical Staff Credentials and
Privileges Files
AGENCY: Indian Health Service, HHS.
SUMMARY: The Indian Health Service (IHS), as part of its continuing
effort to reduce paperwork and respondent burden, conducts a pre-
clearance consultation program to provide the general public and
Federal agencies with an opportunity to comment on proposed and/or
continuing collections of information in accordance with the Paperwork
Reduction Act of 1995 continuing collections of information in
accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C.
3506(c)(2)(A)). This program helps to ensure that requested data can be
provided in the desired format, reporting burden (time and financial
resources) is minimized, collection instruments are clearly understood,
and the impact of collection requirements on respondents can be
properly assessed. Currently, the IHS is providing a 60-day advance
opportunity for public comment on a proposed new collection of
information to be submitted to the Office of Management and Budget for
review.
Proposed Collection
Title: 0917-0009, ``Indian Health Service Medical Staff''
Typed of Information Collection Request: Extension, without
revision, of currently approved information collection, 0917-0009,
``Indian Health Service Medical Staff Credentials and Privileges
Files.''
Form Numbers(s): None.
Need and Use of Information Collection: This collection of
information is used to evaluate individual health care providers
applying for medical staff privileges at IHS health care facilities.
The HHS operates health care facilities that provide health care
services to American Indians and Alaska Natives. To provide these
services, the IHS employs (directly and under contract) several
categories of health care providers including: Physicians (M.D. and
D.O.), dentists, psychologists, optometrists, podiatrists,
audiologists, physician assistants, certified registered nurse
anesthetists, nurse practitioners, and certified nurse midwives. The
IHS policy specifically requires physicians and dentists to be members
of the health care facility medical staff where they practice. Health
care providers become medical staff members, depending on the local
health care facility's capabilities and medical staff bylaws. There are
three types of IHS medical staff applicants: (1) Health care providers
applying for direct employment with IHS; (2) contractors who will not
seek to become IHS employees; and (3) employed IHS health care
providers who seek to transfer between IHS health care facilities.
National health care standards developed by the Center for Medicare
and Medicaid Services (formerly the Health Care Financing
Administration), the Joint Commission on the Accreditation of
Healthcare Organizations (JCAHO), and other accrediting organizations
required health care facilities to review, evaluate and verify the
credentials, training and experience of medical staff applicants prior
to granting medical staff privileges. To meet these standards, IHS
health care facilities require all medical staff applicants to provide
information concerning their education, training, licensure, and work
experience and any adverse disciplinary actions taken against them.
This information is then verified with references supplied by the
applicant and may include: Former employers, educational institutions,
licensure and certification boards, the American Medical Association,
the Federation of State Medical Boards, the National Practitioner Data
Bank, and the applicants themselves.
In addition to the initial granting of medical staff membership and
clinical privileges, JCAHO standards require that a review of the
medical staff be conducted not less than every two years. This review
evaluates the current competence of the medical staff and verifies
whether they are maintaining the licensure or certification
requirements of their specialty.
The medical staff credentials and privileges records are maintained
at the health care facility where the health care provider is a medical
staff member. The establishment of these records at IHS health care
facilities is not optional; such records must be established and
maintained at all health care facilities in the United States that are
accredited by JCAHO. Prior to the establishment of this JCAHO
requirement, the degree to which medical staff applications were
verified for completeness and accuracy varied greatly across America.
Affected Public: Individuals and households.
Type of Respondents: Individuals.
Burden Hours: The table below provides the estimated burden hours
for this information collection:
[[Page 35922]]
----------------------------------------------------------------------------------------------------------------
Est. number of Responses per Total annual
Data collection respondents respondent Burden per response * burden hrs.
----------------------------------------------------------------------------------------------------------------
Application to Medical Staff....... 600 1 1.00 (60 mins)............. 600.0
Reference Letter................... 1800 1 0.33 (20 mins)............. 594.0
Reappointment Request.............. 200 1 1.00 (60 mins)............. 200.0
Ob-Gyn Privileges.................. 25 1 1.00 (60 mins)............. 25.0
Internal Medicine.................. 387 1 1.00 (60 mins)............. 387.0
Surgery Privileges................. 23 1 1.00 (60 mins)............. 23.0
Psychiatry Privileges.............. 18 1 1.00 (60 mins)............. 18.0
Anesthesia Privileges.............. 16 1 1.00 (60 mins)............. 16.0
Dental Privileges.................. 128 1 0.33 (20 mins)............. 42.2
Optometry Privileges............... 21 1 0.33 (20 mins)............. 6.9
Psychology Privileges.............. 23 1 0.17 (10 mins)............. 3.9
Audiology Privileges............... 6 1 0.08 (5 mins).............. 0.48
Podiatry Privileges................ 6 1 0.08 (5 mins).............. 0.48
Radiology Privileges............... 9 1 0.33 (20 mins)............. 2.9
Pathology Privileges............... 3 1 0.33 (20 mins)............. .99
----------------------------------------------------------------------------
Total.......................... 3,265 .............. ........................... 1,920.85
----------------------------------------------------------------------------------------------------------------
* For ease of understanding, burden hours are provided in actual minutes.
There are no capital costs, operating costs and/or maintenance
costs to respondents.
Request for Comments: Your written comments and/or suggestions are
invited on one or more of the following points: (a) Whether the
information collection activity is necessary to carry out an agency
function; (b) whether the agency processes the information collected in
a useful and timely fashion; (c) the accuracy of public burden estimate
(the estimated amount of time needed for individual respondents to
provide the requested information); (d) whether the methodology and
assumptions used to determine the estimate are logical; (e) ways to
enhance the quality, utility, and clarity of the information being
collected; and (f) ways to minimize the public burden through the use
of automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology.
Send Comments and Requests for Further Information: For the
proposed collection or requests to obtain a copy of the data collection
instrument(s) and instructions to: Mrs. Christina Rouleau, IHS Reports
Clearance Officer, 801 Thompson Avenue, TMP Suite 450, Rockville, MD
20852, call non-toll free (301) 443-5938, send via facsimile to (301)
443-2316, or send your e-mail requests, comments, and return address
to: crouleau@hqe.ihs.gov.
Comment Due Date: Your comments regarding this information
collection are best assured of having their full effect if received
within 60 days of the date of this publication.
Dated: June 15, 2006.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. 06-5574 Filed 6-21-06; 8:45 am]
BILLING CODE 4165-16-M