Secure Supply Chain Pilot Program; Correction, 59706 [2013-23563]
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59706
Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices
comparability review or a validation
review inspection is not acceptable, as
described under § 493.573 and
§ 493.575, or if the State of Washington
fails to pay the required fee every 2
years as required under § 493.646.
Laboratory Data
In accordance with our regulations at
§ 493.557(b)(8), the approval of this
exemption for laboratories located in
and licensed by the State of Washington
is conditioned on the State of
Washington’s continued compliance
with the assertions made in its
application, especially the provision of
information to us about changes to a
laboratory’s specialties or subspecialties
based on the state’s survey, and changes
to a laboratory’s certification status,
such as a change from a CLIA certificate
of compliance to a CLIA certificate of
waiver.
pmangrum on DSK3VPTVN1PROD with NOTICES
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.
The State of Washington must pay for
the following:
• Costs of federal inspections of
laboratories in the state to verify that
Washington State’s laboratory licensure
program requirements are equivalent to
or more stringent than those in the CLIA
program, and that they 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 surveys,
including investigations of complaints
that are substantiated. We will bill the
State of Washington on a semiannual
basis.
• The State of Washington’s
proportionate share of the costs
associated with establishing,
maintaining, and improving the CLIA
computer system, based on the portion
of those services from which the State
of Washington received direct benefit or
which contributed to the CLIA program
in the state. Thus, the State of
Washington is being charged for a
portion of our direct and indirect costs
of administering the CLIA program.
Such costs will be incurred by CMS, the
Centers for Disease Control and
Prevention (CDC), the Food and Drug
Administration (FDA) and contractors
VerDate Mar<15>2010
14:21 Sep 26, 2013
Jkt 229001
working on behalf of these respective
agencies.
To estimate the State of Washington’s
proportionate share of the general
overhead costs to develop and
implement CLIA, we determined the
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
Washington. We determined that a
corresponding percentage of the
applicable CMS, CDC, FDA, and their
respective contractor costs should be
borne by the State of Washington.
The State of Washington has agreed to
pay the state’s pro rata share of the
anticipated overhead costs and costs of
actual validation (including 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.
II. Approval
In light of the foregoing, we grant
approval of the State of Washington’s
laboratory licensure program under
subpart E. All laboratories located in
and licensed by the State of Washington
under the Medical Test Site law,
Chapter 70.42 of the Revised Code of
Washington, are CLIA-exempt for all
specialties and subspecialties until
September 27, 2019.
FOR FURTHER INFORMATION CONTACT:
Katharine Neckers, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Building 51, Rm. 4259,
301–796–3339, email:
Katharine.Neckers@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR
Doc. 2013–20215, appearing on page
51192 in the Federal Register of August
20, 2013, the following correction is
made:
On page 51194, in the second column,
under ‘‘IV. Process for Applying to
Participate in the Pilot,’’ in the third full
paragraph, the sentence that reads ‘‘For
communications other than the
submission of the SSCPP application
(Form FDA 3676), please contact the
CDER SSCPP mailbox at
SSCPPMailbox@fda.hhs.gov’’ is
corrected to read ‘‘For communications
other than the submission of the SSCPP
application (Form FDA 3676), please
contact the CDER SSCPP mailbox at
CDERSSCPP@fda.hhs.gov.’’
Dated: September 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23563 Filed 9–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: Section 353(p) of the Public
Health Service Act (42 U.S.C. 263a).
National Institutes of Health
Dated: August 8, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Proposed Collection; 30-Day Comment
Request; Evaluation of a Kidney
Disease Education and Awareness
Program in the Hispanic Community
[FR Doc. 2013–23659 Filed 9–26–13; 8:45 am]
SUMMARY:
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0656]
Secure Supply Chain Pilot Program;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
document that appeared in the Federal
Register of August 20, 2013 (78 FR
51192). The document announced the
start of the Secure Supply Chain Pilot
Program (SSCPP). The document was
published with an incorrect email
address for the SSCPP mailbox. This
document corrects that error.
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Under the provisions of
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. This proposed information
collection was previously published in
the Federal Register on July 19, 2013,
Volume 78, pages 43214–43215, and
allowed 60-days for public comment.
One public comment was received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Kidney Disease Education
Program, the National Institute of
Diabetes and Digestive and Kidney
Diseases, the National Institutes of
Health (NIH), 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
October 1, 1995, unless it displays a
currently valid OMB control number.
E:\FR\FM\27SEN1.SGM
27SEN1
Agencies
[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Page 59706]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23563]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0656]
Secure Supply Chain Pilot Program; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a
document that appeared in the Federal Register of August 20, 2013 (78
FR 51192). The document announced the start of the Secure Supply Chain
Pilot Program (SSCPP). The document was published with an incorrect
email address for the SSCPP mailbox. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Katharine Neckers, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Building 51, Rm. 4259, 301-796-3339, email:
Katharine.Neckers@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc. 2013-20215, appearing on page
51192 in the Federal Register of August 20, 2013, the following
correction is made:
On page 51194, in the second column, under ``IV. Process for
Applying to Participate in the Pilot,'' in the third full paragraph,
the sentence that reads ``For communications other than the submission
of the SSCPP application (Form FDA 3676), please contact the CDER SSCPP
mailbox at SSCPPMailbox@fda.hhs.gov'' is corrected to read ``For
communications other than the submission of the SSCPP application (Form
FDA 3676), please contact the CDER SSCPP mailbox at
CDERSSCPP@fda.hhs.gov.''
Dated: September 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23563 Filed 9-26-13; 8:45 am]
BILLING CODE 4160-01-P