Request for Public Comment: 60 Day Information Collection: Indian Health Service Medical Staff Credentials, 70197-70199 [2019-27442]
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Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Notices
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911 or Ei Thu Lwin, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–0728.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Demonstrating Substantial Evidence of
Effectiveness for Human Drug and
Biological Products.’’ This guidance
complements and expands on the 1998
guidance. The 1998 guidance was
issued in response to the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115),
which stated that the substantial
evidence requirement for effectiveness,
which had generally been interpreted as
calling for two adequate and wellcontrolled trials, could also be met by a
single trial plus confirmatory evidence.
The 1998 guidance, therefore, provided
many examples of the types of evidence
that could be considered confirmatory
evidence, with a specific focus on
adequate and well-controlled trials of
the test agent in related populations or
indications, as well as a number of
illustrations of a single adequate and
well-controlled trial supported by
convincing evidence of the drug’s
mechanism of action in treating a
disease or condition.
FDAMA, thus, introduced a specific
new area of flexibility in the evidence
needed to support effectiveness, but
there are many other characteristics of
the evidence supporting effectiveness
that can vary (notably, trial designs, trial
endpoints, statistical methodology), and
evidence that varies in such ways
potentially can provide substantial
evidence of effectiveness but because of
these characteristics may provide
greater or lesser certainty. These
characteristics also deserve
consideration and were not discussed in
the 1998 guidance. FDA’s use of these
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various designs, endpoints, and
analyses which can differ in the strength
of evidence they provide, reflects the
Agency’s longstanding flexibility when
considering the types of data and
evidence that can meet the substantial
evidence requirement.
Although FDA’s evidentiary standard
for effectiveness has not changed since
1998, the evolution of drug
development and science has led to
changes in the types of drug
development programs submitted to the
Agency. Specifically, there are more
programs studying serious diseases
lacking effective treatment, more
programs in rare diseases, and more
programs for therapies targeted at
disease subsets. There is a need for more
Agency guidance on the flexibility in
the amount and type of evidence needed
to meet the substantial evidence
standard in these circumstances. The
approaches discussed in this guidance
can yield evidence that meets the
statutory standard for substantial
evidence and reflect the evolving
landscape of drug development.
This guidance discusses the quality of
evidence to establish effectiveness,
including trial designs and trial
endpoints. It also discusses the quantity
of evidence needed in a given
development program, i.e., two
adequate and well-controlled trials, one
adequate and well-controlled trial plus
confirmatory evidence, or reliance on a
previous finding of effectiveness of an
approved drug when scientifically
justified and legally permissible (i.e., no
new effectiveness or pharmacodynamic
data would be needed). The guidance
also expands upon the discussions
included in the 1998 guidance on the
types of mechanistic and pharmacologic
evidence and non-clinical evidence that
can constitute confirmatory evidence.
Although randomized superiority
trials with a placebo- or active-control
design generally provide the strongest
evidence of effectiveness, this guidance
discusses the circumstances under
which trials not using a placebo control,
superiority design, or randomization
may be acceptable. In addition, this
guidance also discusses situations in
which human efficacy trials are not
ethical or feasible, and the animal rule
may be applied. In all cases, FDA must
reach the conclusion that there is
substantial evidence of effectiveness to
approve a drug; however, the degree of
certainty supporting such a conclusion
may differ, depending on clinical
circumstances (e.g., severity and rarity
of the disease and unmet medical need).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
PO 00000
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70197
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Demonstrating Substantial Evidence
of Effectiveness for Human Drug and
Biological Products.’’ 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 21 CFR part 312 for
submission of an investigational new
drug application have been approved
under OMB control number 0910–0014.
The collections of information in 21
CFR 314.50 for submission of an NDA
have been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR part 601 for
submission of a BLA have been
approved under OMB control number
0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics, or https://
www.regulations.gov.
Dated: December 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27524 Filed 12–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60 Day
Information Collection: Indian Health
Service Medical Staff Credentials
Indian Health Service, HHS.
Notice and request for
comments. Request for revision to a
collection.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the
general public to comment on the
information collection titled, ‘‘Indian
SUMMARY:
E:\FR\FM\20DEN1.SGM
20DEN1
70198
Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
Health Service Medical Staff
Credentials,’’ OMB Control Number
0917–0009, which expires February 29,
2020.
DATES: Comment Due Date: February 18,
2020. Your comments regarding this
information collection are best assured
of having full effect if received within
60 days of the date of this publication.
ADDRESSES: Send your written
comments, requests for more
information on the collection, or
requests to obtain a copy of the data
collection instrument and instructions
to Juliana Sadovich by one of the
following methods:
• Mail: Juliana Sadovich, Ph.D., RN,
CPHQ, Director, Office of Quality,
Indian Health Service, 5600 Fishers
Lane, Mail Stop: 08N78, Rockville, MD
20857.
• Phone: 301–443–4330.
• Email: Juliana.Sadovich@ihs.gov.
SUPPLEMENTARY INFORMATION: This
notice announces our intent to revise
the collection already approved by
OMB, and to solicit comments on
specific aspects of the information
collection. The purpose of this notice is
to allow 60 days for public comment to
be submitted to IHS. A copy of the
supporting statement is available at
www.regulations.gov (see Docket ID
IHS–2019–01).
Information Collection Title: ‘‘Indian
Health Service Medical Staff Credentials
and Privileges Files, 0917–0009.’’ Type
of Information Collection Request:
Extension of an approved information
collection, and revised to, ‘‘Indian
Health Service Medical Staff
Credentials, 0917–0009.’’ 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, 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
Estimated
number of
respondents
Data collection instrument(s)
Initial Application to Medical Staff ...........................................................
Application Packet/Signature Documents ...............................................
Reappointment Application to Medical Staff ...........................................
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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 via the internet.
The IHS is transforming credentialing,
which include granting privileges, into
a centrally installed, automated,
standardized, electronic/digital,
measurable, portable, accessible, and
efficient business process to improve
the effectiveness of application and reapplication to Medical Staffs, movement
of practitioners within the IHS system,
and recruitment/retention of highquality practitioners. The credentialing
process no longer requires paper/pdf
forms for granting privileges. The
electronic credentialing system
incorporates privileges as part of the
overall process for credentialing,
eliminating the need for paper, and
allows tailoring the needs to site
specifications. Privileges will differ
across IHS Areas and clinics, in
compliance with accreditation
standards.
The adoption of a central source IT
system for medical practitioner staff
credentialing/privileging data will
enhance the quality, accuracy, and
efficiency of the IHS credentialing/
privileging process, which is expected
to improve the recruitment and
retention rates of medical practitioner
staff at IHS. Cost savings will be
obtained through the termination of
disparate business processes; reduction
of paperwork duplication; and
eliminating systems that do not provide
IHS enterprise access to credentialing/
privileging information. Additionally,
communicating information
electronically can reduce costs and
errors, promote collaboration, ensure
accreditation/privileging requirements
are met, and help bring practitioners on
board more quickly, which will improve
recruitment and retention.
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
600
1,300
700
Sfmt 4703
E:\FR\FM\20DEN1.SGM
Average
burden hour
per response *
1
1
1
0.583 (35 min) .......
0.167 (10 min) .......
0.333 (20 min) .......
20DEN1
Total annual
burden
(current)
350
217
233
70199
Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Notices
Estimated
number of
respondents
Data collection instrument(s)
Total .................................................................................................
2,600
Responses
per
respondent
Average
burden hour
per response *
........................
................................
Total annual
burden
(current)
800
* For ease of understanding, burden hours are provided in actual minutes.
Annual number of respondents were
factored based on total IHS providers
credentialed and privileged on the
indicated cycles in the paragraphs
above. There are no capital costs,
operating costs and/or maintenance
costs to respondents.
Requests 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
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Chris Buchanan,
Deputy Director, RADM, Assistant Surgeon
General, USPHS, Indian Health Service.
[FR Doc. 2019–27442 Filed 12–19–19; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; NIH Electronic
Application System for Certificates of
Confidentiality
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
SUMMARY:
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.
Proposed Collection: Electronic
Application for NIH Certificates of
Confidentiality (CoC E-application
System), 0925–0689, REVISION, exp.,
date 12/31/2019, Office of Extramural
Research (OER), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This request system provides
one electronic form to be used by all
research organizations that request a
Certificate of Confidentiality (CoC) from
NIH. As described in the authorizing
legislation (Section 301(d) of the Public
Health Service Act, 42 U.S.C. 241(d)),
CoCs are issued by the agencies of
Department of Health and Human
Services (DHHS), including NIH, to
authorize researchers to protect the
privacy of human research subjects by
prohibiting them from releasing names
and identifying characteristics of
research participants to anyone not
connected with the research, except in
limited circumstances specified in the
statute. At NIH, the issuance of CoCs
has been delegated to the NIH OER in
the NIH Office of the Director. NIH
received 529 requests for CoCs from
April 2017 through March 2018 and
expects to receive approximately the
same number of requests in subsequent
years. The NIH has been using an online
CoC system to review requests and issue
CoCs since 2015. The current CoC
request form includes 15 sections of
information collected from research
organizations. The information provided
will be used to determine eligibility for
a CoC and to issue the CoC to the
requesting organization.
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
794.
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Dr. Pamela Reed
Kearney, Division of Human Subjects
Research, OER, NIH, 6705 Rockledge
Dr., Building Rockledge 1, Room 812–C,
Bethesda, MD 20817, or email your
request, including your address, to:
NIH-CoC-Coordinator@mail.nih.gov;
telephone number: 301–402–2512.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on August 14, 2019, page
40426–40427 (84 FR 40426) and
allowed 60 days for public comment. No
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after December 31, 2019, unless it
displays a currently valid OMB control
number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
ADDRESSES:
jbell on DSKJLSW7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Number of
respondents
CoC Applicants—Private .................................................................................
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18:30 Dec 19, 2019
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PO 00000
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Sfmt 4703
Number of
responses per
respondent
372
E:\FR\FM\20DEN1.SGM
1
20DEN1
Average
burden per
response
(in hours)
90/60
Total annual
burden hours
558
]]>Agencies
[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Notices]
[Pages 70197-70199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27442]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60 Day Information Collection: Indian
Health Service Medical Staff Credentials
AGENCY: Indian Health Service, HHS.
ACTION: Notice and request for comments. Request for revision to a
collection.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the general public to comment on
the information collection titled, ``Indian
[[Page 70198]]
Health Service Medical Staff Credentials,'' OMB Control Number 0917-
0009, which expires February 29, 2020.
DATES: Comment Due Date: February 18, 2020. Your comments regarding
this information collection are best assured of having full effect if
received within 60 days of the date of this publication.
ADDRESSES: Send your written comments, requests for more information on
the collection, or requests to obtain a copy of the data collection
instrument and instructions to Juliana Sadovich by one of the following
methods:
Mail: Juliana Sadovich, Ph.D., RN, CPHQ, Director, Office
of Quality, Indian Health Service, 5600 Fishers Lane, Mail Stop: 08N78,
Rockville, MD 20857.
Phone: 301-443-4330.
Email: [email protected].
SUPPLEMENTARY INFORMATION: This notice announces our intent to revise
the collection already approved by OMB, and to solicit comments on
specific aspects of the information collection. The purpose of this
notice is to allow 60 days for public comment to be submitted to IHS. A
copy of the supporting statement is available at www.regulations.gov
(see Docket ID IHS-2019-01).
Information Collection Title: ``Indian Health Service Medical Staff
Credentials and Privileges Files, 0917-0009.'' Type of Information
Collection Request: Extension of an approved information collection,
and revised to, ``Indian Health Service Medical Staff Credentials,
0917-0009.'' 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, 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
via the internet. The IHS is transforming credentialing, which include
granting privileges, into a centrally installed, automated,
standardized, electronic/digital, measurable, portable, accessible, and
efficient business process to improve the effectiveness of application
and re-application to Medical Staffs, movement of practitioners within
the IHS system, and recruitment/retention of high-quality
practitioners. The credentialing process no longer requires paper/pdf
forms for granting privileges. The electronic credentialing system
incorporates privileges as part of the overall process for
credentialing, eliminating the need for paper, and allows tailoring the
needs to site specifications. Privileges will differ across IHS Areas
and clinics, in compliance with accreditation standards.
The adoption of a central source IT system for medical practitioner
staff credentialing/privileging data will enhance the quality,
accuracy, and efficiency of the IHS credentialing/privileging process,
which is expected to improve the recruitment and retention rates of
medical practitioner staff at IHS. Cost savings will be obtained
through the termination of disparate business processes; reduction of
paperwork duplication; and eliminating systems that do not provide IHS
enterprise access to credentialing/privileging information.
Additionally, communicating information electronically can reduce costs
and errors, promote collaboration, ensure accreditation/privileging
requirements are met, and help bring practitioners on board more
quickly, which will improve recruitment and retention.
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 Total annual
Data collection instrument(s) number of Responses per Average burden hour per burden
respondents respondent response * (current)
----------------------------------------------------------------------------------------------------------------
Initial Application to Medical 600 1 0.583 (35 min)............... 350
Staff.
Application Packet/Signature 1,300 1 0.167 (10 min)............... 217
Documents.
Reappointment Application to 700 1 0.333 (20 min)............... 233
Medical Staff.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
[[Page 70199]]
Total........................ 2,600 .............. ............................. 800
----------------------------------------------------------------------------------------------------------------
* For ease of understanding, burden hours are provided in actual minutes.
Annual number of respondents were factored based on total IHS
providers credentialed and privileged on the indicated cycles in the
paragraphs above. There are no capital costs, operating costs and/or
maintenance costs to respondents.
Requests 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 through the use
of automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology.
Chris Buchanan,
Deputy Director, RADM, Assistant Surgeon General, USPHS, Indian Health
Service.
[FR Doc. 2019-27442 Filed 12-19-19; 8:45 am]
BILLING CODE 4165-16-P
