Proposed Information Collection Activity; Comment Request, 12800-12801 [2018-05923]
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Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices
D. Subpart K—Quality System for
Nonwaived Testing
The A2LA requirements are equal to
the CLIA requirements at §§ 493.1200
through 493.1299.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that the A2LA’s
requirements are equal to the CLIA
requirements at §§ 493.1403 through
493.1495 for laboratories that perform
moderate and high complexity testing.
F. Subpart Q—Inspections
We have determined that the A2LA
requirements for the submitted
subspecialties and specialties are equal
to or more stringent than the CLIA
requirements at §§ 493.1771 through
493.1780. The A2LA requires annual
review of all accredited laboratories.
The laboratory is required to submit any
updates on information about its
organization, facilities, key personnel
and results of any proficiency testing.
Laboratories may be required to undergo
an onsite surveillance visit if they do
not submit their annual review
documentation to the A2LA by the
established 30 day deadline, if
significant changes to the facility or
organization have occurred, or if
proficiency testing results have been
consistently poor. The CLIA regulations
do not have this requirement.
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G. Subpart R—Enforcement Procedures
The A2LA meets the requirements of
subpart R to the extent that it applies to
accreditation organizations. The A2LA
policy sets forth the actions the
organization takes when laboratories it
accredits do not comply with its
requirements and standards for
accreditation. When appropriate, the
A2LA will deny, suspend, or revoke
accreditation in a laboratory accredited
by the A2LA and report that action to
us within 30 days. The A2LA also
provides an appeals process for
laboratories that have had accreditation
denied, suspended, or revoked.
We have determined that the A2LA’s
laboratory enforcement and appeal
policies are equal to the requirements of
part 493, subpart R as they apply to
accreditation organizations.
IV. Federal Validation Inspections and
Continuing Oversight
The Federal validation inspections of
laboratories accredited by the A2LA
may be conducted on a representative
sample basis or in response to
substantial allegations of
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noncompliance (that is, complaint
inspections). The outcome of those
validation inspections, performed by
CMS or our agents, or the State survey
agencies, will be our principal means
for verifying that the laboratories
accredited by the A2LA remain in
compliance with CLIA requirements.
This Federal monitoring is an ongoing
process.
V. Removal of Approval as an
Accrediting Organization
Our regulations provide that we may
rescind the approval of an accreditation
organization, such as that of the A2LA,
for cause, before the end of the effective
date of approval. If we determine that
the A2LA has failed to adopt, maintain
and enforce requirements that are equal
to, or more stringent than, the CLIA
requirements, or that systemic problems
exist in its monitoring, inspection or
enforcement processes, we may impose
a probationary period, not to exceed 1
year, in which the A2LA would be
allowed to address any identified issues.
Should the A2LA be unable to address
the identified issues within that
timeframe, we may, in accordance with
the applicable regulations, revoke
A2LA’s deeming authority under CLIA.
Should circumstances result in our
withdrawal of the A2LA’s approval, we
will publish a notice in the Federal
Register explaining the basis for
removing its approval.
VI. Collection of Information
Requirements
This notice does not impose any
information collection and record
keeping requirements subject to the
Paperwork Reduction Act (PRA).
Consequently, it does not need to be
reviewed by the Office of Management
and Budget (OMB) under the authority
of the PRA. The requirements associated
with the accreditation process for
clinical laboratories under the CLIA
program, codified in 42 CFR part 493
subpart E, are currently approved by
OMB under OMB approval number
0938–0686.
VII. Executive Order 12866 Statement
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
Dated: March 8, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–05892 Filed 3–22–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Initial Medical Exam Form and
Initial Dental Exam Form.
OMB No.: 0970–0466.
Description:
The Administration for Children and
Families’ Office of Refugee Resettlement
(ORR) places unaccompanied minors in
their custody in licensed care provider
facilities until reunification with a
qualified sponsor. Care provider
facilities are required to provide
children with services such as
classroom education, mental health
services, and health care. Pursuant to
Exhibit 1, part A.2 of the Flores
Settlement Agreement (Jenny Lisette
Flores, et al., v. Janet Reno, Attorney
General of the United States, et al., Case
No. CV 85–4544–RJK (C.D. Cal. 1996),
care provider facilities, on behalf of
ORR, shall arrange for appropriate
routine medical and dental care and
emergency health care services,
including a complete medical
examination and screening for
infectious diseases within 48 hours of
admission, excluding weekends and
holidays, unless the minor was recently
examined at another facility;
appropriate immunizations in
accordance with the U.S. Public Health
Service (PHS), Center for Disease
Control; administration of prescribed
medication and special diets;
appropriate mental health interventions
when necessary for each minor in their
care.
The forms are to be used as
worksheets for clinicians, medical staff,
and health departments to compile
information that would otherwise have
been collected during the initial medical
or dental exam. Once completed, the
forms will be given to shelter staff for
data entry into ORR’s secure, electronic
data repository known as ‘The UAC
Portal’. Data will be used to record UC
health on admission and for case
management of any identified illnesses/
conditions.
Respondents: Office of Refugee
Resettlement Grantee staff.
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Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Initial Medical Exam Form (including Appendix A: Supplemental TB Screening Form) ......................................................................................................
Initial Dental Exam Form .................................................................................
Estimated Total Annual Burden
Hours: 9,225.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW, Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–05923 Filed 3–22–18; 8:45 am]
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150
150
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Division of Cancer
Epidemiology and Genetics (DCEG)
(National Cancer Institute)
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995, 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.
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.
ADDRESSES: 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: Jackie Lavigne,
Ph.D., MPH, Chief, Office of Education,
Division of Cancer Epidemiology and
Genetics, 9609 Medical Center Drive,
MSC, Bethesda, Maryland 20892 or call
non-toll-free number 240.276.7237 or
Email your request, including your
address to: lavignej@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on December 20, 2017, page
60407 (82 FR 60407) and allowed 60
days for public comment. No public
comments were received. The National
Cancer Institute (NCI), National
Institutes of Health, may not conduct or
SUMMARY:
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Number of
responses per
respondent
297
30
Average
burden hours
per response
0.20
0.07
Total burden
hours
8,910
315
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, 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
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: Fellowship
Program and Summer Student
Applications OMB No. 0925–0716
Expiration Date 05/31/2018 Extension,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute, Division of Cancer
Epidemiology and Genetics (DCEG)
Office of Education administers a
variety of programs and initiatives to
recruit pre-college through post-doctoral
educational level individuals into the
Intramural Research Program to
facilitate their development into future
biomedical scientists. DCEG trains postdoctoral, doctoral candidates, graduate
and baccalaureate students, through full
time fellowships, summer fellowships,
and internships in preparation for
research careers in cancer epidemiology
and genetics. The proposed information
collection involves brief online
applications completed by applicants to
the full time and the summer fellowship
programs. Full-time fellowships
include: Full-time Equivalents (FTE)
and non-FTE fellowships for US
citizens, permanent residents and
international fellows. These
applications are essential to the
administration of these training
programs as they enable OE to
determine the eligibility and quality of
potential awardees; to assess their
potential as future scientists; to
determine where mutual research
interests exist; and to make decisions
regarding which applicants will be
proposed and approved for traineeship
awards. In each case, completing the
application is voluntary, but in order to
receive due consideration, the
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[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Notices]
[Pages 12800-12801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05923]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Initial Medical Exam Form and Initial Dental Exam Form.
OMB No.: 0970-0466.
Description:
The Administration for Children and Families' Office of Refugee
Resettlement (ORR) places unaccompanied minors in their custody in
licensed care provider facilities until reunification with a qualified
sponsor. Care provider facilities are required to provide children with
services such as classroom education, mental health services, and
health care. Pursuant to Exhibit 1, part A.2 of the Flores Settlement
Agreement (Jenny Lisette Flores, et al., v. Janet Reno, Attorney
General of the United States, et al., Case No. CV 85-4544-RJK (C.D.
Cal. 1996), care provider facilities, on behalf of ORR, shall arrange
for appropriate routine medical and dental care and emergency health
care services, including a complete medical examination and screening
for infectious diseases within 48 hours of admission, excluding
weekends and holidays, unless the minor was recently examined at
another facility; appropriate immunizations in accordance with the U.S.
Public Health Service (PHS), Center for Disease Control; administration
of prescribed medication and special diets; appropriate mental health
interventions when necessary for each minor in their care.
The forms are to be used as worksheets for clinicians, medical
staff, and health departments to compile information that would
otherwise have been collected during the initial medical or dental
exam. Once completed, the forms will be given to shelter staff for data
entry into ORR's secure, electronic data repository known as `The UAC
Portal'. Data will be used to record UC health on admission and for
case management of any identified illnesses/conditions.
Respondents: Office of Refugee Resettlement Grantee staff.
[[Page 12801]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Initial Medical Exam Form (including Appendix A: 150 297 0.20 8,910
Supplemental TB Screening Form)................
Initial Dental Exam Form........................ 150 30 0.07 315
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 9,225.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: [email protected]. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is 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) 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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018-05923 Filed 3-22-18; 8:45 am]
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