Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files, 44885-44887 [2016-16207]
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44885
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
on the process for updating ANDA
labeling after approval of the NDA for
the RLD has been withdrawn. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. 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This draft guidance refers to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 § 314.94(a)(8) and 21
CFR 314.97 have been approved under
OMB Control No. 0910–0001.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16157 Filed 7–8–16; 8:45 am]
BILLING CODE 4164–01–P
Office of the Secretary
[Document Identifier: HHS–OS–0990–0221–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
renewal of the approved information
collection assigned OMB control
number 0990–0221, scheduled to expire
on September 30, 2016. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before August 10, 2016.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUMMARY:
When
submitting comments or requesting
information, please include the OMB
control number 0990–0221 and
document identifier HHS–OS–0990–
0221–30D for reference.
Information Collection Request Title:
Family Planning Annual Report: Forms
and Instructions.
Abstract: The Office of Population
Affairs within the Office of the Assistant
Secretary for Health seeks to renew the
currently approved Family Planning
Annual Report (FPAR) data collection
and reporting tool (OMB No. 0990–
0221). This annual reporting
requirement is for family planning
services delivery projects authorized
and funded by the title X Family
Planning Program [‘‘Population
Research and Voluntary Family
Planning Programs’’ (Pub. L. 91–572)],
which was enacted in 1970 as title X of
the Public Health Service Act (section
1001; 42 U.S.C. 300). The FPAR data
collection and reporting tool remains
unchanged in this request to renew
OMB approval to collect essential,
annual data from title X grantees.
Likely Respondents: Respondents for
this annual reporting requirement are
centers that receive funding directly
from OPA for family planning services
authorized and funded under the title X
Family Planning Program [‘‘Population
Research and Voluntary Family
Planning Programs’’ (Pub. L. 91–572)],
which was enacted in 1970 as title X of
the Public Health Service Act (section
1001 of title X of the Public Health
Service Act, 42 United States Code
[U.S.C.] 300).
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent
Average
annualized
burden per
response
(hours)
Annualized
total burden
(hours)
Type of respondent
Form
name
Number of
respondents
Grantees ..............................................
FPAR .......
93 grantees .........................................
1
36
3,348
Totals ............................................
..................
93 .........................................................
........................
........................
3,348
Terry S. Clark,
Asst. Information Collection Clearance
Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–16300 Filed 7–8–16; 8:45 am]
Indian Health Service
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BILLING CODE 4150–34–P
Request for Public Comment: 30-Day
Proposed Information Collection:
Indian Health Service Medical Staff
Credentials and Privileges Files
AGENCY:
ACTION:
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Indian Health Service, HHS.
Notice.
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Fmt 4703
Sfmt 4703
In compliance with the
Paperwork Reduction Act of 1995 which
requires 30 days for public comment on
proposed information collection
projects, the Indian Health Service (IHS)
is submitting to the Office of
Management and Budget (OMB) a
request for an extension of a previously
approved collection of information
titled, ‘‘Indian Health Service Medical
Staff Credentials and Privileges Files,’’
OMB Control Number 0917–0009,
which expires August 31, 2016. This
SUMMARY:
E:\FR\FM\11JYN1.SGM
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44886
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
proposed information collection project
was previously published in the Federal
Register (81 FR 23318) on April 20,
2016, and allowed 60 days for public
comment. The IHS received no public
comments regarding this collection. The
purpose of this notice is to allow 30
days for public comment to be
submitted directly to OMB.
Proposed Collection: Title: 0917–
0009, ‘‘Indian Health Service Medical
Staff Credentials and Privileges Files.’’
Type 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: 0917–0009. 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 IHS 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. 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 Centers for Medicare
and Medicaid Services, the Joint
Commission, and other accrediting
organizations require health care
facilities to review, evaluate and verify
the credentials, training and experience
of medical staff applicants prior to
granting medical staff privileges. In
order 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, the Joint Commission
standards require that a review of the
Estimated
number of
respondents
Data collection instrument(s)
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 a Joint
Commission requirement. Prior to the
establishment of this Joint Commission
requirement, the degree to which
medical staff applications were
maintained at all health care facilities in
the United States that are verified for
completeness and accuracy varied
greatly across the Nation.
The application process has been
streamlined and is using information
technology to make the application
electronically available on the Internet.
The application may be found at the
IHS.gov Web site address: https://
www.ihs.gov/IHM/
index.cfm?module=dsp_ihm_pc_p3c1_
ex#ManualExhibit3-1-A.
Affected Public: Individuals and
households.
Type of Respondents: Individuals.
The table below provides: Types of
data collection instruments, Estimated
number of respondents, Number of
annual number of responses, Average
burden per response, and Total annual
burden hours.
Responses
per
respondent
Average burden hour
per response *
Application to Medical Staff ..............................................................
Reference Letter ...............................................................................
Reappointment Request ...................................................................
Ob-Gyn Privileges .............................................................................
Internal Medicine ..............................................................................
Surgery Privileges .............................................................................
Psychiatry Privileges .........................................................................
Anesthesia Privileges .......................................................................
Dental Privileges ...............................................................................
Psychology Privileges .......................................................................
Audiology Privileges .........................................................................
Podiatry Privileges ............................................................................
Radiology Privileges .........................................................................
Pathology Privileges .........................................................................
570
1,710
190
20
325
20
13
15
150
30
7
7
8
3
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Total ...........................................................................................
3,068
........................
1.00
0.33
1.00
1.00
1.00
1.00
1.00
1.00
0.33
0.17
0.08
0.08
0.33
0.33
Total annual
burden hours
(60 mins) ..............
(20 mins) ..............
(60 mins) ..............
(60 mins) ..............
(60 mins) ..............
(60 mins) ..............
(60 mins) ..............
(60 mins) ..............
(20 mins) ..............
(10 mins) ..............
(5 mins) ................
(5 mins) ................
(20 mins) ..............
(20 mins) ..............
570
570
190
20
325
20
13
15
50
5
1
1
3
1
.......................................
1,784
sradovich on DSK3GDR082PROD with NOTICES
* 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
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16:55 Jul 08, 2016
Jkt 238001
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
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Fmt 4703
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provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimate is logical; (e) ways to enhance
the quality, utility, and clarity of the
information being collected; and (f)
ways to minimize the public burden
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Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
ADDRESSES: To request additional
information, please contact Lisa Neel by
one of the following methods:
• Mail: Lisa Neel, Program Manager,
HIV Program, Office of Clinical and
Preventive Services, Indian Health
Service, 5600 Fishers Lane, Mail Stop:
08N06–A, Rockville, MD 20857.
• Phone: 301–443–4305.
• Email: Lisa.Neel@ihs.gov.
• Fax: 301–443–4305.
Direct Your Comments to OMB: Send
your comments and suggestions
regarding the proposed information
collection contained in this notice,
especially regarding the estimated
public burden and associated response
time to: Office of Management and
Budget, Office of Regulatory Affairs,
New Executive Office Building, Room
10235, Washington, DC 20503,
Attention: Desk Officer for IHS.
Comment Due Date: Your comments
regarding this information collection is
best assured of having full effect if
received within 30 days of the date of
this publication.
Dated: June 29, 2016.
Elizabeth A. Fowler,
Deputy Director for Management Operations,
Indian Health Service.
[FR Doc. 2016–16207 Filed 7–8–16; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Notice of Meeting
Center for Substance Abuse
Prevention, Substance Abuse and
Mental Health Services Administration,
HHS.
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Prevention
(CSAP) Drug Testing Advisory Board
(DTAB) will meet on July 26 and July
27, 2016. The DTAB will convene in
both open and closed sessions over
these two days.
On July 26, 2016 from 9:00 a.m. to
5:00 p.m. EDT, the meeting will be open
to the public to provide an update on
the status of the Mandatory Guidelines
for Federal Workplace Drug Testing
sradovich on DSK3GDR082PROD with NOTICES
AGENCY:
VerDate Sep<11>2014
16:55 Jul 08, 2016
Jkt 238001
Programs for urine and oral fluid. A
description of technical issues
associated with hair testing will also be
provided.
The public is invited to attend the
open session in person or to listen via
web conference. Due to the limited
seating space and call-in capacity,
registration is requested. Public
comments are welcome. To register,
make arrangements to attend, obtain the
teleconference call-in numbers and
access codes, submit written or brief
oral comments, or request special
accommodations for persons with
disabilities, please register at the
SAMHSA Advisory Committees’ Web
site at https://nac.samhsa.gov/
Registration/meetingsRegistration.aspx
or contact the CSAP DTAB Designated
Federal Official, Brian Makela (see
contact information below).
On July 27, 2016 between 9:00 a.m.
and 2:00 p.m. E.D.T., the Board will
meet in closed session to discuss
proposed revisions to the Mandatory
Guidelines for Federal Workplace Drug
Testing Programs. This portion of the
meeting is closed to the public as
determined by the Administrator,
SAMHSA, in accordance with 5 U.S.C.
552b(c)(9)(B) and 5 U.S.C. App. 2,
Section 10(d).
Substantive program information, a
summary of the meeting, and a roster of
DTAB members may be obtained as
soon as possible after the meeting by
accessing the SAMHSA Advisory
Committees Web site, https://
www.nace.samhsa.gov/
MeetingList.aspx, or by contacting Brian
Makela. The transcript for the open
meeting will also be available on the
SAMHSA Committee Web site within
three weeks after the meeting.
Committee Name: Substance Abuse
and Mental Health Services
Administration’s Center for Substance
Abuse Prevention, Drug Testing
Advisory Board.
Dates/Time/Type: July 26, 2016 from
9:00 a.m. to 5:00 p.m. E.D.T.: OPEN;
July 27, 2016 from 9:00 a.m. to 2:00 p.m.
E.D.T.: CLOSED.
Place: 7500 Old Georgetown Rd.,
Bethesda, Maryland 20814.
Contact: Brian Makela, Designated
Federal Official, CSAP Drug Testing
Advisory Board, 5600 Fishers Lane,
Room 16N02B, Rockville, Maryland
20857, Telephone: 240–276–2600,
Email: brian.makela@samhsa.hhs.gov.
Summer King,
Statistician.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Confidentiality of
Alcohol and Drug Abuse Patient
Records—(OMB No. 0930–0092)—
Revision
Statute (42 U.S.C. 290dd–2) and
regulations (42 CFR part 2) require
federally conducted, regulated, or
directly or indirectly assisted alcohol
and drug abuse programs to keep
alcohol and drug abuse patient records
confidential. Information requirements
are (1) written disclosure to patients
about Federal laws and regulations that
protect the confidentiality of each
patient, and (2) documenting ‘‘medical
personnel’’ status of recipients of a
disclosure to meet a medical emergency.
Annual burden estimates for these
requirements are summarized in the
table below:
[FR Doc. 2016–16358 Filed 7–8–16; 8:45 am]
BILLING CODE 4162–20–P
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]]>Agencies
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44885-44887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16207]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Request for Public Comment: 30-Day Proposed Information
Collection: Indian Health Service Medical Staff Credentials and
Privileges Files
AGENCY: Indian Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995 which
requires 30 days for public comment on proposed information collection
projects, the Indian Health Service (IHS) is submitting to the Office
of Management and Budget (OMB) a request for an extension of a
previously approved collection of information titled, ``Indian Health
Service Medical Staff Credentials and Privileges Files,'' OMB Control
Number 0917-0009, which expires August 31, 2016. This
[[Page 44886]]
proposed information collection project was previously published in the
Federal Register (81 FR 23318) on April 20, 2016, and allowed 60 days
for public comment. The IHS received no public comments regarding this
collection. The purpose of this notice is to allow 30 days for public
comment to be submitted directly to OMB.
Proposed Collection: Title: 0917-0009, ``Indian Health Service
Medical Staff Credentials and Privileges Files.'' Type 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: 0917-0009. 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 IHS 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. 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 Centers for
Medicare and Medicaid Services, the Joint Commission, and other
accrediting organizations require health care facilities to review,
evaluate and verify the credentials, training and experience of medical
staff applicants prior to granting medical staff privileges. In order
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, the Joint Commission 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 a Joint Commission requirement. Prior to the
establishment of this Joint Commission requirement, the degree to which
medical staff applications were maintained at all health care
facilities in the United States that are verified for completeness and
accuracy varied greatly across the Nation.
The application process has been streamlined and is using
information technology to make the application electronically available
on the Internet. The application may be found at the IHS.gov Web site
address: https://www.ihs.gov/IHM/index.cfm?module=dsp_ihm_pc_p3c1_ex#ManualExhibit3-1-A.
Affected Public: Individuals and households.
Type of Respondents: Individuals.
The table below provides: Types of data collection instruments,
Estimated number of respondents, Number of annual number of responses,
Average burden per response, and Total annual burden hours.
----------------------------------------------------------------------------------------------------------------
Estimated
Data collection instrument(s) number of Responses per Average burden hour per Total annual
respondents respondent response * burden hours
----------------------------------------------------------------------------------------------------------------
Application to Medical Staff.......... 570 1 1.00 (60 mins).......... 570
Reference Letter...................... 1,710 1 0.33 (20 mins).......... 570
Reappointment Request................. 190 1 1.00 (60 mins).......... 190
Ob-Gyn Privileges..................... 20 1 1.00 (60 mins).......... 20
Internal Medicine..................... 325 1 1.00 (60 mins).......... 325
Surgery Privileges.................... 20 1 1.00 (60 mins).......... 20
Psychiatry Privileges................. 13 1 1.00 (60 mins).......... 13
Anesthesia Privileges................. 15 1 1.00 (60 mins).......... 15
Dental Privileges..................... 150 1 0.33 (20 mins).......... 50
Psychology Privileges................. 30 1 0.17 (10 mins).......... 5
Audiology Privileges.................. 7 1 0.08 (5 mins)........... 1
Podiatry Privileges................... 7 1 0.08 (5 mins)........... 1
Radiology Privileges.................. 8 1 0.33 (20 mins).......... 3
Pathology Privileges.................. 3 1 0.33 (20 mins).......... 1
-------------------------------------------------------------------------
Total............................. 3,068 .............. ........................ 1,784
----------------------------------------------------------------------------------------------------------------
* 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 is logical; (e) ways to
enhance the quality, utility, and clarity of the information being
collected; and (f) ways to minimize the public burden
[[Page 44887]]
through the use of automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
ADDRESSES: To request additional information, please contact Lisa Neel
by one of the following methods:
Mail: Lisa Neel, Program Manager, HIV Program, Office of
Clinical and Preventive Services, Indian Health Service, 5600 Fishers
Lane, Mail Stop: 08N06-A, Rockville, MD 20857.
Phone: 301-443-4305.
Email: Lisa.Neel@ihs.gov.
Fax: 301-443-4305.
Direct Your Comments to OMB: Send your comments and suggestions
regarding the proposed information collection contained in this notice,
especially regarding the estimated public burden and associated
response time to: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for IHS.
Comment Due Date: Your comments regarding this information
collection is best assured of having full effect if received within 30
days of the date of this publication.
Dated: June 29, 2016.
Elizabeth A. Fowler,
Deputy Director for Management Operations, Indian Health Service.
[FR Doc. 2016-16207 Filed 7-8-16; 8:45 am]
BILLING CODE 4165-16-P
