### 59704 Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices

C. Summary Table of Adjustments in
the AIC Threshold Amounts

In the following table we list the CYs 2010 through 2014 threshold amounts.

CY 2010 CY 2011 CY 2012 CY 2013 CY 2014

ALJ Hearing ......................................................................... $130 $130 $130 $140 $140

Judicial Review .................................................................... 1,260 1,300 1,350 1,400 1,430

III. Collection of Information Requirements

This document does not impose
information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).

(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: September 23, 2013. Marilyn Tavenner, Administrator, Centers for Medicare &
Medicaid Services.

[FR Doc. 2013–23655 Filed 9–26–13; 8:45 am]

**BILLING CODE 4120–01–P**

**DEPARTMENT OF HEALTH AND**
**HUMAN SERVICES**

**Centers for Medicare & Medicaid**
**Services**

**[CMS–3111–N]**

**Medicare, Medicaid, and CLIA Programs; Clinical Laboratory**  **Improvement Amendments of 1988 Exemption of Laboratories Licensed**  **by the State of Washington**

**AGENCY :**  Centers for Medicare & Medicaid Services (CMS), HHS.

**ACTION :**  Notice.

**SUMMARY :**  This notice announces that laboratories located in and licensed by the State of Washington that possess a
valid license under the Medical Test Site law, Chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years.

**DATES :**  The exemption granted by this notice is effective from September 27, 2013 to September 27, 2019.

**FOR FURTHER INFORMATION CONTACT :**  Sandra Farragut, (410) 786–3531.

**SUPPLEMENTARY INFORMATION :**  I. Background and Legislative Authority

Section 353 of the Public Health Service Act (PHSA), as amended by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100–578), which was enacted on October 31, 1988, generally provides that no laboratory may perform tests on human specimens for the diagnosis, prevention or treatment of any disease or impairment of, or assessment of the health of, human beings unless it has a certificate to perform that category of tests issued by the Secretary of the Department of Health and Human Services (HHS). Under section 1861(s) of the Social Security Act (the Act), the Medicare program will only pay for laboratory services if the laboratory has a CLIA certificate. Section 1902(a)(9)(C) of the Act requires that state Medicaid plans pay only for laboratory services furnished by CLIA-certified laboratories. Thus, although subject to specified exemptions and exceptions, laboratories generally must have a current and valid
CLIA certificate to test human specimens for medical purposes noted above to be eligible for payment for
those tests from the Medicare or Medicaid programs. Regulations implementing section 353 of the PHSA are contained in 42 CFR part 493.

Section 353(p) of the PHSA provides for the exemption of laboratories from CLIA requirements in states that enact legal requirements that are equal to or more stringent than CLIA’s statutory and regulatory requirements. Section 353(p) of the PHSA is implemented in subpart E of our regulations at 42 CFR part 493. Sections 493.551 and 493.553 provide that we may exempt from CLIA requirements, for a period not to exceed 6 years, all state-licensed or -approved
laboratories in a state if the state licensure program meets the specified conditions. Section 493.559 provides that we will publish a notice in the Federal Register when we grant exemption to an approved state licensure program. It also provides that the notice will include the following:

• The basis for granting the exemption. • A description of how the laboratory requirements are equal to or more stringent than those of CLIA.

• The term of approval, not to exceed 6 years.

State of Washington’s Application for CLIA Exemption of Its Laboratories

The State of Washington has applied for exemption of its laboratories from CLIA program requirements. The State of Washington submitted all of the applicable information and attestations required by § 493.551, § 493.553, and § 493.557 for state licensure programs seeking exemption of their licensed laboratories from CLIA program requirements.

Examples of documents and
information submitted include: a comparison of its laboratory licensure requirements with comparable CLIA condition-level requirements (that is, a crosswalk); and a description of the following: Its inspection process; its proficiency testing monitoring process; its data management and analysis system; its investigative and response procedures for complaints received against laboratories; and its policy regarding announced and unannounced inspections.

CMS Analysis of Washington’s Application and Supporting

Documentation

To determine whether we should grant a CLIA exemption to laboratories licensed by a state, we review the application and additional
documentation that the state submits to us and conducts a detailed and in-depth comparison of the state licensure program and CLIA’s statutory and regulatory requirements to determine whether the state program meets the requirements at subpart E of part 493.

In summary, the state generally must
demonstrate that:

• It has state laws in effect that provide for a state licensure program that has requirements that are equal toor more stringent than CLIA conditionlevel requirements for laboratories.

• It has implemented a state licensure program with requirements that are equal to or more stringent than the CLIA condition-level requirements such that a


### 59705 Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices

laboratory licensed by the state program
would meet the CLIA condition-level requirements if it were inspected against those requirements.

• The requirements under that state licensure program meet or exceed the requirements of § 493.553, § 493.555, and § 493.557(b) and is suitable for approval by us under § 493.551. For example, among other things, the program would need to:

++ Demonstrate that it has enforcement authority and
administrative structures and resources adequate to enforce its laboratory requirements.

++ Permit us or our agents to inspect
laboratories within the state.

++ Require laboratories within the state to submit to inspections by us or our agents as a condition of licensure.

++ Agree to pay any costs associated
with our activities to validate their state licensure program as well as the state’s pro rata share of the general overhead to develop and implement CLIA as specified in § 493.645(a), § 493.646(b), and § 493.557(b).

++ Take appropriate enforcement action against laboratories found by us or our agents out of compliance with requirements comparable to CLIA condition-level requirements, as specified in § 493.557(b).

As specified in our regulations at § 493.555 and § 493.557(b), our review of a state licensure program includes (but is not necessarily limited to) an evaluation of the following:

• Whether the state’s requirements for laboratories are equal to or more stringent than the CLIA condition-level requirements.

• The state’s inspection process requirements to determine the following:

++ The comparability of the full inspection and complaint inspection procedures to those of CMS.

++ The state’s enforcement procedures for laboratories found to be out of compliance with its requirements.

• The ability of the state to provide us with electronic data and reports with
the adverse or corrective actions resulting from proficiency testing (PT)
results that constitute unsuccessful participation in CMS-approved PT programs and with other data we determine to be necessary for validation
review and assessment of the state’s inspection process requirements.

• The state’s agreement with us to ensure that the agreement obligates the state to do the following:

++ Notify us within 30 days of the action taken against any CLIA-exempt laboratory that has had its licensure or approval withdrawn or revoked or been in any way sanctioned.

++ Notify us within 10 days of any deficiency identified in a CLIA-exempt laboratory in cases when the deficiency poses an immediate jeopardy to the laboratory’s patients or a hazard to the general public.

++ Notify each laboratory licensed by the state under its approved state licensure program within 10 days of a withdrawal of our approval of the state’s licensure program, and the resulting loss of the laboratory’s exemption from
CLIA based on its licensure under that

program.

++ Provide us with written notification of any changes in the state’s licensure (or approval) and inspection requirements.

++ Disclose to us or our agent any laboratory’s PT results in accordance with the state’s confidentiality requirements.

++ Take appropriate enforcement action against laboratories that we or our agents find to be out of compliance with CLIA condition-level requirements in a validation survey, and report these
enforcement actions to us.

++ Notify us of all newly licensed laboratories, and any changes in the specialties and subspecialties for which any laboratory performs testing, within 30 days.

++ Provide us, as requested, inspection schedules for validation

purposes.

In keeping with the process described above, we evaluated the application and supporting materials that were submitted by Washington State to verify that the laboratories licensed through its program will meet or exceed the requirements of the following subparts of part 493: Subpart H, Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing; Subpart J, Facility Administration for Nonwaived Testing; Subpart K, Quality Systems for Nonwaived Testing, Subpart M, Personnel for Nonwaived Testing; Subpart Q, Inspection; and Subpart R, Enforcement Procedures.

We found that Washington State’s laboratory licensure program requirements mapped to all the CLIA condition-level requirements. Its licensure program’s inspection process and proficiency testing monitoring processes were adequate. Other
materials that were submitted demonstrated compliance with the other above-referenced requirements of subpart E of part 493. As a result, we
concluded that the submitted documents supported exempting laboratories licensed under that program from the CLIA program requirements. Furthermore, a review of our validation inspections conducted by our regional office in Seattle, Washington, supported
this conclusion.

The federal validation inspections of CLIA-exempt 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 our principal tool for verifying that the laboratories located in, and licensed by the state are in compliance with CLIA requirements.

Our regional office in Seattle, Washington, has conducted validation inspections of a representative sample (approximately 5 percent) of the laboratories inspected by the Washington State Office of Laboratory Quality Assurance (LQA). The validation inspections were primarily of the concurrent type; that is, our surveyors accompanied Washington 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 State of Washington inspection process covers all CLIA conditions applicable to each laboratory being inspected and also verified that the state laboratory licensure requirements meet or exceed CLIA condition-level requirements. Our validation surveys found the state inspectors highly skilled and qualified. The LQA inspected laboratories in a timely fashion; that is, all laboratories were inspected within the required 24- month cycle. All parameters monitored by our Seattle office to date indicate that the State of Washington is meeting all requirements for approval of CLIA exemption. This federal monitoring will continue as an on-going process.

Conclusion

Based on review of the documents submitted by the Washington state licensure program pursuant to the requirements of subpart E of part 493, as
well as the outcome of the validation inspections conducted by our regional office in Seattle, we find that the State of Washington’s licensure program meets the requirements of 42 CFR 493.551(a), and that, as a result, we may exempt from CLIA program requirements all state-licensed or -approved laboratories.

Approval of the CLIA exemption for laboratories located in and licensed by the State of Washington laboratory licensure program is subject to removal
if we determine that the outcome of a


### 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.

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 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.

Authority: Section 353(p) of the Public Health Service Act (42 U.S.C. 263a).

Dated: August 8, 2013. Marilyn Tavenner, Administrator, Centers for Medicare &
Medicaid Services.

[FR Doc. 2013–23659 Filed 9–26–13; 8:45 am]

**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.

**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**

**DEPARTMENT OF HEALTH AND**
**HUMAN SERVICES**

**National Institutes of Health**

**Proposed Collection; 30-Day Comment Request; Evaluation of a Kidney** 
**Disease Education and Awareness Program in the Hispanic Community** 

**SUMMARY :**  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.