Submission for OMB Review; Comment Request, 78370-78371 [E8-30172]
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Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Notices
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referenced requirements of subpart E of
Part 493. As a result, CMS concluded
that the submitted documents supported
exempting permit holding laboratories
under the CLEP from the CLIA program
requirements. Furthermore, a review of
CMS’ validation inspections conducted
by the CMS Regional Office in New
York, New York supported that
conclusion.
The Federal validation inspections of
CLEP permit holding laboratories, as
specified in § 493.563, were conducted
on a representative sample basis as well
as in response to any substantial
allegations of noncompliance
(complaint inspections). The outcome of
those validation inspections has been
and will continue to be CMS’ principal
tool for verifying that the laboratories
located within the State that hold valid
permits are in compliance with CLIA
requirements.
The CMS Regional Office in New
York has conducted validation
inspections of a representative sample
(approximately 5 percent) of the
laboratories inspected by the New York
State Office of Laboratory Quality
Assurance (LQA). For some of these
validation inspections, CMS surveyors
simply accompanied New York State’s
inspectors, each inspecting against his
or her agency’s respective regulations.
Analysis of the validation data revealed
no significant differences between the
State and Federal findings. The
validation surveys verified that the
CLEP inspection process covers all CLIA
conditions applicable to each laboratory
being inspected, and also verified that
the CLEP licensure (permit)
requirements meet or exceed CLIA
condition-level requirements. The CMS
validation surveys found the State
inspectors highly skilled and qualified.
The CLEP inspected laboratories in
timely fashion, that is, all laboratories
were inspected within the required 24month cycle. All parameters monitored
by CMS’ New York Regional Office to
date indicate that the State of New York
is meeting all requirements for approval
of CLIA exemption.
This Federal monitoring will continue
as an on-going process.
V. Conclusion
Based on review of the documents
submitted by the New York State
laboratory licensure program, CLEP,
pursuant to the requirements of subpart
E of part 493, as well as the outcome of
the validation inspections conducted by
the CMS Regional Office in New York,
we find that the State of New York
laboratory licensure program meets the
requirements of 42 CFR 493.551(a), and
that as a result, we may exempt from
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CLIA program requirements all State
licensed (permitted) or approved
laboratories.
Approval of the CLIA exemption for
laboratories located within and
permitted by the State of New York is
subject to removal if we determine that
the outcome of a comparability review
or a validation review inspection is not
acceptable, as described under § 493.573
and § 493.575, or if the State of New
York fails to pay the required fee every
2 years as required under § 493.646.
VI. Laboratory Data
In accordance with our regulations at
§ 493.557(b)(8), the State of New York
will continue to agree to provide us
with changes to a laboratory’s
specialties or subspecialties based on
the State’s survey. The State of New
York also will provide us with changes
in a laboratory’s certification status.
VII. Required Administrative Actions
CLIA is a user-fee funded program.
The registration fee paid by laboratories
is intended to cover the cost of the
development and administration of the
program. However, when a State’s
application for exemption is approved,
we do not charge a fee to laboratories in
the State. The State’s share of the costs
associated with CLIA must be collected
from the State, as specified in § 493.645.
Accordingly, the State of New York
must pay for the following:
• Costs of Federal inspection of
laboratories in the State to verify that
New York State’s CLEP requirements are
enforced in an appropriate manner. The
average Federal hourly rate is
multiplied by the total hours required to
perform Federal validation surveys
within the State.
• Costs incurred for Federal
investigations and surveys triggered by
complaints that are substantiated. We
will bill the State of New York on a
semiannual basis.
• The State of New York’s
proportionate share of the costs
associated with establishing,
maintaining, and improving the CLIA
computer system, a portion of those
services from which the State of New
York received direct benefit or
contributed to the CLIA program in the
State. Thus, the State of New York is
being charged for a portion of CMS’
direct and indirect costs as well as a
portion of the costs incurred by the CDC
and the Food and Drug Administration
(FDA) in carrying out their
responsibilities under CLIA.
In order to estimate the State of New
York’s proportionate share of the
general overhead costs to develop and
implement CLIA, we determined the
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ratio of laboratories in the State to the
total number of laboratories nationally.
Approximately 1.5 percent of the
registered laboratories are in the State of
New York. We determined that a
corresponding percentage of the
applicable CDC, FDA, and CMS costs
should be borne by the State of New
York.
The State of New York has agreed to
pay us the State’s pro rata share of the
overhead costs and anticipated costs of
actual validation and complaint
investigation surveys. A final
reconciliation for all laboratories and all
expenses will be made. We will
reimburse the State for any overpayment
or bill it for any balance.
VIII. Approval
In light of the foregoing, CMS grants
approval of the State of New York’s
laboratory licensure program (CLEP)
under Subpart E. All laboratories
located within the State of New York
and hold valid CLEP permits are CLIAexempt for all specialties and
subspecialties.
Authority: Section 353(p) of the Public
Health Service Act (42 U.S.C. 263a).
Dated: November 7, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–30452 Filed 12–19–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Proposed Projects
Title: Hispanic Healthy Marriage
Initiative Grantee Implementation
Evaluation.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), in
partnership with the Office of the
Assistant Secretary for Planning,
Research and Evaluation (ASPE), U.S.
Department of Health and Human
Services, is proposing an information
collection activity as part of the
Hispanic Healthy Marriage Initiative
(HHMI) Grantee Implementation
Evaluation study. The proposed
information collection consists of two
components: (1) Semistructured
interviews with key respondents
involved with selected marriage
education programs serving Hispanic
couples and individuals; and (2) focus
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Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Notices
couples and families that have
implications for the design and delivery
of healthy marriage education services
to Hispanics, recognizing their diversity
with respect to country of origin,
language, and level of acculturation,
among other factors.
groups with Hispanic individuals and
couples participating in selected
marriage education programs or
declining to participate in such
programs. Through this information
collection and other study activities,
ACF and ASPE seek to identify the
unique cultural needs of Hispanic
Respondents: Marriage education
program directors and managers; staff
responsible for outreach, recruitment
and intake activities in marriage
education programs; marriage education
instructors; and key persons in partner
organizations.
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Program Staff Discussion Guide .....................................................................
Partners/Community Leaders Discussion Guide .............................................
Participant Focus Group Discussion Guide .....................................................
81
54
180
1
1
1
2
2
1
162
108
180
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
450
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: December 11, 2008.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. E8–30172 Filed 12–19–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–D–0298] (formerly
Docket No. 2004D–0499)
Compliance Policy Guide;
Radiofrequency Identification
Feasibility Studies and Pilot Programs
for Drugs; Notice to Extend Expiration
Date
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of expiration
date.
SUMMARY: The Food and Drug
Administration (FDA) is extending the
expiration date of compliance policy
guide (CPG) Sec. 400.210 entitled
‘‘Radiofrequency Identification (RFID)
Feasibility Studies and Pilot Programs
for Drugs’’ to December 31, 2010.
FOR FURTHER INFORMATION CONTACT: Ilisa
Bernstein, Office of the Commissioner,
Office of Policy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, rm. 4341, Silver Spring,
MD 20993–0002, 301–796–4830.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 17, 2004
(69 FR 67360), FDA announced the
availability of CPG Sec. 400.210 entitled
‘‘Radiofrequency Identification (RFID)
Feasibility Studies and Pilot Programs
for Drugs.’’ FDA has identified RFID as
a promising technology to be used in the
various efforts to combat counterfeit
drugs. The CPG describes how the
agency intends to exercise its
enforcement discretion regarding certain
regulatory requirements that might
otherwise be applicable to studies
involving RFID technology for drugs.
The goal of the CPG is to facilitate
performance of RFID studies and to
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allow industry to gain experience with
the use of RFID technology and its effect
on the long-term safety and integrity of
the U.S. drug supply.
On September 27, 2007, the Food and
Drug Administration Amendments Act
of 2007 (FDAAA) was signed into law.
Section 913 of FDAAA addresses
pharmaceutical safety and creates
section 505D of the Federal Food, Drug,
and Cosmetic Act (the act). Section
505D(b) of the act requires the
development of standards for the
identification, validation,
authentication, and tracking and tracing
of prescription drugs. Section
505D(b)(3) of the act states that these
new standards shall address promising
technologies, which may include RFID
technology.
In implementing section 505D of the
act, FDA is currently addressing issues,
such as promising technologies, that are
relevant also for the CPG. In addition,
FDA is considering further the
experience of stakeholders and the
agency under the CPG. As we consider
all of these issues, the CPG will remain
in effect until December 31, 2010.
Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–30297 Filed 12–19–08; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Pages 78370-78371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30172]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Proposed Projects
Title: Hispanic Healthy Marriage Initiative Grantee Implementation
Evaluation.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF), in
partnership with the Office of the Assistant Secretary for Planning,
Research and Evaluation (ASPE), U.S. Department of Health and Human
Services, is proposing an information collection activity as part of
the Hispanic Healthy Marriage Initiative (HHMI) Grantee Implementation
Evaluation study. The proposed information collection consists of two
components: (1) Semistructured interviews with key respondents involved
with selected marriage education programs serving Hispanic couples and
individuals; and (2) focus
[[Page 78371]]
groups with Hispanic individuals and couples participating in selected
marriage education programs or declining to participate in such
programs. Through this information collection and other study
activities, ACF and ASPE seek to identify the unique cultural needs of
Hispanic couples and families that have implications for the design and
delivery of healthy marriage education services to Hispanics,
recognizing their diversity with respect to country of origin,
language, and level of acculturation, among other factors.
Respondents: Marriage education program directors and managers;
staff responsible for outreach, recruitment and intake activities in
marriage education programs; marriage education instructors; and key
persons in partner organizations.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Program Staff Discussion Guide.................. 81 1 2 162
Partners/Community Leaders Discussion Guide..... 54 1 2 108
Participant Focus Group Discussion Guide........ 180 1 1 180
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 450
----------------------------------------------------------------------------------------------------------------
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All
requests should be identified by the title of the information
collection. E-mail address: OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
6974, Attn: Desk Officer for the Administration for Children and
Families.
Dated: December 11, 2008.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. E8-30172 Filed 12-19-08; 8:45 am]
BILLING CODE 4184-01-M
