1004 Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Proposed Rules 

Corrective Action Section (6MM–XU), 

Multimedia Division, EPA Region 6, 

1445 Ross Avenue, Dallas, Texas 75202– 

2733. 

4. Hand Delivery or Courier: Deliver 

your comments to Audray Lincoln, 

Region 6, Project Officer, LUST 

Prevention/Corrective Action Section 

(6MM–XU), Multimedia Division, EPA 

Region 6, 1445 Ross Avenue, Dallas, 

Texas 75202–2733. 

Instructions: Direct your comments to 

Docket ID No. EPA–R06–UST–2017– 

0504. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

available online at http://www.

regulations.gov, including any personal 

information provided, unless the 

comment includes information claimed 

to be Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. Do 

not submit information that you 

consider to be CBI or otherwise 

protected through http://www.

regulations.gov, or email. The Federal 

http://www.regulations.gov website is 

an ‘‘anonymous access’’ system, which 

means the EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to the EPA without 

going through http://www.

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the public docket and made available on 

the internet. If you submit an electronic 

comment, the EPA recommends that 

you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If the EPA cannot read your 

comment due to technical difficulties, 

and cannot contact you for clarification, 

the EPA may not be able to consider 

your comment. Electronic files should 

avoid the use of special characters, any 

form of encryption, and be free of any 

defects or viruses. 

You can view and copy the 

documents that form the basis for this 

codification and associated publicly 

available materials from 8:30 a.m. to 

4:00 p.m. Monday through Friday at the 

following location: EPA Region 6, 1445 

Ross Avenue, Dallas, Texas 75202–2733, 

phone number (214) 665–2239. 

Interested persons wanting to examine 

these documents should make an 

appointment with the office at least two 

weeks in advance. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Audray Lincoln, Region 6, Project 

Officer, LUST Prevention/Corrective 

Action Section (6MM–XU), Multimedia 

Division, EPA Region 6, 1445 Ross 

Avenue, Dallas, Texas 75202–2733, 

phone number (214) 665–2239, email 

address lincoln.audray@epa.gov. 

SUPPLEMENTARY INFORMATION: For 

additional information, see the direct 

final rule published in the ‘‘Rules and 

Regulations’’ section of this Federal 

Register. 

Authority: This rule is issued under the 

authority of Sections 2002(a), 9004, and 

7004(b) of the Solid Waste Disposal Act, as 

amended, 42 U.S.C. 6912, 6991c, 6991d, and 

6991e. 

Dated: November 3, 2017. 

Samuel Coleman, 

Acting Regional Administrator, Region 6. 

[FR Doc. 2018–00038 Filed 1–8–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 493 

[CMS–3326–NC] 

RIN 0938–ZB40 

Request for Information: Revisions to 

Personnel Regulations, Proficiency 

Testing Referral, Histocompatibility 

Regulations and Fee Regulations 

Under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information. 

SUMMARY: This request for information 

seeks public comment regarding several 

items related to Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) personnel requirements and 

histocompatibility requirements, which, 

with minor exception, have not been 

updated since 1992. We are also seeking 

public comment regarding the flexibility 

to impose alternative sanctions for 

laboratories issued a Certificate of 

Waiver (CoW) determined to have 

participated in proficiency testing (PT) 

referral. In addition, we are seeking 

public comment related to appropriate 

sanctions in situations where we 

determine that a laboratory has referred 

its PT samples to another laboratory and 

has reported the other laboratory’s result 

as their own. 

This request for information also 

seeks public comment regarding the 

updating of fees for determination of 

program compliance and additional fees 

for laboratories established under the 

CLIA regulations. We are also seeking 

public comment regarding the collection 

of other fees we are authorized to collect 

such as fees for revised certificates, post 

survey follow-up visits, complaint 

investigations, and activities related to 

imposition of sanctions. 

We intend to consider public 

comments (including information such 

as evidence, research, and trends) 

received in response to this request for 

information when we draft proposals, in 

consultation, as appropriate, with the 

Centers for Disease Control and 

Prevention (CDC), to update the existing 

CLIA regulations through future 

rulemaking. We are also soliciting 

public comment on other areas of CLIA 

which should be reviewed and 

potentially updated. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on March 12, 2018. 

ADDRESSES: In commenting, refer to file 

code CMS–3326–NC. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3326–NC, P.O. Box 8016, 

Baltimore, MD 21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3326–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW, Washington, 

DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 


jstallworth on DSKBBY8HB2PROD with PROPOSALS
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1Survey & Certification Letter 16–18–CLIA SC 

16–18–CLIA, S&C website: http://www.cms.gov/ 

Medicare/Provider-Enrollment-and-Certification/

SurveyCertificationGenInfo/Policy-and-Memos-toStates-and-Regions.html 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–7195 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

FOR FURTHER INFORMATION CONTACT: 

For general questions, please contact 

Caecilia Blondiaux, 410–786–2190. 

For personnel requirements, please 

contact Sarah Bennett, 410–786–3354. 

For proficiency testing referral, please 

contact Sarah Bennett, 410–786–3354. 

For histocompatibility, please contact 

Penelope Meyers, 410–786–3366. 

For CLIA fees, please contact Cindy 

Flacks, 410–786–6520. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. 

I. Background 

A. Personnel Requirements 

Generally, the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) regulations related to personnel 

requirements have not been updated 

since 1992, with the exception of minor 

changes to doctoral high complexity 

laboratory director qualifications in 

2003 (see 68 FR 3713). We are soliciting 

public comments (including 

information such as evidence, research, 

and trends) and intend to draft 

proposals, to update the existing CLIA 

personnel regulations through future 

rulemaking. The topics listed in this 

request for information are areas that the 

Centers for Disease Control and 

Prevention (CDC), CMS, stakeholders 

and State Agency surveyors identified 

as concepts that should be relevant to 

our efforts to update the CLIA personnel 

requirements to better reflect current 

knowledge, changes in the academic 

context and advancements in laboratory 

testing. Therefore, prior to starting the 

rulemaking process, we are seeking 

public comments (including 

information such as evidence, research, 

and trends), including stakeholder and 

surveyor feedback, specific to the topics 

discussed in this request for 

information. We intend to consider any 

such comments when we draft 

proposals to update the existing CLIA 

personnel regulations to better protect 

public health and safety and reflect 

current knowledge, changes in the 

academic context, and advancements in 

laboratory testing. 

1. Nursing Degrees 

As noted in Survey & Certification 

Letter 16–18–CLIA1, we currently 

consider a bachelor’s degree in nursing 

to be equivalent to a bachelor’s degree 

in biological science for purposes of the 

educational requirements for moderate 

and high complexity testing personnel 

under CLIA. We are considering drafting 

proposals to amend 42 CFR 493.1411 

(moderate complexity technical 

consultant), 493.1423 (moderate 

complexity testing personnel), and 

493.1489 (high complexity testing 

personnel) to expressly reflect that 

policy. We are also considering whether 

a nursing degree should be considered 

as a separate qualifying degree, as 

opposed to the equivalent of a biological 

science degree, for purposes of meeting 

the educational requirements for 

moderate and high complexity testing 

personnel and technical consultants. As 

such, we are also considering proposing 

to amend §§ 493.1411, 493.1423, and 

493.1489 to add a nursing degree as a 

separate qualifying degree to the current 

list of qualifying degrees for the 

moderate and high complexity testing 

personnel and technical consultants. 

We are seeking public comments 

(including information such as 

evidence, research, and trends) related 

to whether, for purposes of meeting the 

educational requirements for moderate 

complexity technical consultants and 

testing personnel and high complexity 

testing personnel, §§ 493.1411, 

493.1423, and 493.1489 should be 

amended: (1) To expressly reflect that a 

nursing degree is equivalent to a 

biological science degree; or (2) to add 

nursing degrees as a separate qualifying 

degree (as opposed to the equivalent of 

a biological science degree) to the 

current list of qualifying degrees. 

2. Physical Science Degrees 

Due to variation in usage and the 

absence of universally accepted 

definitions, a ‘‘physical science degree’’ 

is difficult to define for regulatory 

purposes. We note, however, that 

physical science is a broad discipline 

often described as the study of nonliving systems, such as astronomy, 

physics, and earth sciences. Generally, 

these types of degrees are not related to 

clinical laboratory testing. We note that 

in some instances, individuals with 

these types of degrees have been able to 

qualify as high complexity testing 

personnel under § 493.1489. 

We are seeking public comments 

(including information such as 

evidence, research, and trends) on what 

is considered a physical science degree 

and whether any physical science 

degree(s) should be considered as 

educational background(s) appropriate 

for qualifying to meet the CLIA 

educational requirements at 

§§ 493.1405, 493.1411, 493.1423, 

493.1443, 493.1449, 493.1461, and 

493.1489. 

3. Personnel Competencies 

We recognize that the personnel 

qualifications for general supervisors 

may be less stringent than those of 

technical consultants. However, the 

current CLIA regulations allow general 

supervisors with associate’s degrees 

(§ 493.1461) to perform competency 

assessment on high complexity testing 

personnel (see §§ 493.1461(c)(2), 

493.1489(b)(2)(i)), but because the 

personnel requirements for moderate 

complexity testing do not include the 

general supervisor category, the same 

general supervisors cannot perform 

competency assessment on moderate 

complexity testing personnel unless 

they can meet the regulatory 

qualifications of a technical consultant 

(§ 493.1411). Technical consultants, at a 

minimum, are required to have a 

bachelor’s degree in chemical, physical, 

or biological science or medical 

technology. We recognize that high 

complexity testing is inherently more 

involved than moderate complexity 

testing. We have received feedback from 

laboratories and other stakeholders that 

the difference in degree requirements to 

qualify to assess competency presents 

staffing challenges in laboratories. We 

are seeking public comments (including 

information such as evidence, research, 

and trends) regarding whether general 


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2See §§ 493.1405, 493.1406, 493.1411, 493.1423, 

493.1443, 493.1449, 493.1461, 493.1489, 493.1491. 

3See §§ 493.1405, 493.1406, 493.1411, 493.1423, 

493.1443, 493.1449, 493.1461, 493.1489, 493.1491. 

4See §§ 493.1405, 493.1411, 493.1423, 

493.1449(c) through (j) and (n) through (q), 

493.1461, 493.1489. 

5See §§ 493.1405, 493.1411, 493.1423, 

493.1449(c) through (j) and (n) through (q), 

493.1461, 493.1489. 

supervisors, with associate’s degrees, 

should be allowed to perform 

competency assessment for moderate 

complexity testing personnel in 

laboratories that perform both moderate 

and high complexity testing. 

4. Personnel Experience, Training and 

Skills 

Currently, when we refer to laboratory 

training, experience and/or skills,2 we 

mean that the individual qualifying has 

the training in and the experience with 

non-waived clinical laboratory testing or 

in the specialties and subspecialties in 

which the individual is performing 

testing. Generally, the type of training 

and experience required under the 

current CLIA personnel regulation at 

part 493, subpart M, is clinical in 

nature. This means examination and test 

performance on human specimens for 

purposes of obtaining or providing 

information for the diagnosis, treatment, 

and monitoring of patients. 

We are seeking public comments 

(including information such as 

evidence, research, and trends) on what 

should be considered appropriate 

laboratory training, experience and 

skills when determining the 

qualifications necessary for all 3

personnel to meet CLIA requirements, 

and what comprises appropriate 

documentation to verify the training, 

experience and skills for all personnel 

positions in part 493, subpart M. 

5. Non-Traditional Degrees 

Several current CLIA personnel 

requirements allow a position to be 

filled by an individual with a degree in 

a ‘‘chemical, physical, biological or 

clinical laboratory science, or medical 

technology.’’ 4 We recognize there are 

non-traditional degrees (for example, 

Regents Bachelor of Arts) that may 

include job experience in lieu of 

coursework and that typically do not 

include a major concentration of study 

(for example, biology or chemistry), but 

are instead classified as general 

education degrees. 

We are seeking public comments 

(including information such as 

evidence, research, and trends) related 

to such non-traditional degrees, 

specifically whether these types of 

degrees should be considered to meet 

the requirements for a chemical, 

physical, biological or clinical 

laboratory science, and/or medical 

technology degrees.5

B. Proficiency Testing Referral 

The Taking Essential Steps for Testing 

Act (‘‘TEST Act’’) (Pub. L. 112–202, 

enacted on December 4, 2012) amended 

section 353 of the Public Health Service 

Act (PHSA) to provide the Secretary 

with discretion as to which sanctions 

may be applied to cases of intentional 

PT referral. Such discretion may in 

some circumstances replace the 

automatic revocation of the laboratory’s 

CLIA certificate and subsequent 

imposition of the 2-year ban on the 

laboratory’s owner or operator, which 

would prevent them from owning or 

operating a CLIA-certified laboratory for 

2 years. 

1. Discretion for Category 1 PT Referral 

The final rule entitled, ‘‘Medicare 

Program; Prospective Payment System 

for Federally Qualified Health Centers; 

Changes to Contracting Policies for 

Rural Health Clinics; and Changes to 

Clinical Laboratory Improvement 

Amendments of 1988 Enforcement 

Actions for Proficiency Testing 

Referral’’, published in the May 2, 2014 

Federal Register (79 FR 25463 through 

25467 and 25480 through 25481), 

amended the regulations to implement 

the TEST Act and provide the 

prescriptive framework for the 

application of sanctions in PT referral 

cases (see also 79 FR 27106). These 

regulations allow for a more appropriate 

enforcement action based upon the 

nature and extent of an intentional PT 

referral violation and the penalties that 

are imposed. These regulations include 

three categories of sanctions for a PT 

referral to be applied under certain 

specified conditions, based on the 

severity and extent of the violation. 

These categories reserve revocation and 

the resulting laboratory director/owner/ 

operator prohibition for the most 

egregious violations while permitting 

less serious sanctions in cases where 

circumstances warrant. 

‘‘Category 1’’, found at 

§ 493.1840(b)(1), is for the most 

egregious violations, encompassing 

cases of repeat PT referral, regardless of 

circumstances revolving around the 

violation, and cases where a laboratory 

reports another laboratory’s PT results 

as its own to the PT program. This 

category includes the revocation of the 

laboratory’s CLIA certificate for at least 

1 year, bans the owner and operator 

from owning or operating a CLIAcertified laboratory for at least 1 year, 

and may include the imposition of a 

civil money penalty (CMP). The 

application of the owner exemption 

from the ban is determined on a caseby-case basis (see § 493.1840(b)(1)(ii)). 

We are seeking public comment 

related to applying discretion in 

situations where we determine that a 

laboratory has referred its PT samples to 

another laboratory and has reported the 

other laboratory’s PT results as its own, 

and under what circumstances the 

discretion should be applied. 

2. Alternative Sanctions for PT Referral 

by CoW Laboratories 

Section 353(d)(2)(C) of the PHSA 

states that laboratories issued a CoW are 

only exempt from subsections (f) and (g) 

of the statute. All other subsections 

apply, including the prohibition against 

PT referral in subsection (i), which 

refers to ‘‘any laboratory’’ that the 

Secretary determines has intentionally 

referred its PT samples. Therefore, CoW 

laboratories that participate in PT are 

not exempt from the ban against PT 

referral. Per § 493.1775(b), CoW 

laboratories may be inspected to 

determine if the laboratory is operated 

and testing is performed in a manner 

that does not constitute an imminent 

and serious risk to public health, 

evaluate a complaint, determine 

whether the laboratory is performing 

tests beyond the scope of its certificate, 

or to collect information regarding the 

appropriateness of tests specified as 

waived tests. In addition, § 493.1775(c) 

requires the laboratory to comply with 

the basic inspection requirements of 

§ 493.1773. However, the CLIA 

regulations at § 493.1804(c)(1) state that 

we do not impose alternative sanctions 

on CoW laboratories because those 

laboratories are not inspected for 

compliance with condition-level 

requirements. Therefore, our only 

recourse in cases of PT referral found at 

CoW laboratories are principal sanctions 

(that is, revocation, suspension, or 

limitation). 

We are seeking public comments 

(including information such as 

evidence, research, and trends) to 

determine if alternative sanctions 

instead of principal sanctions should be 

an option in these cases in order to 

create parity for all certificate types for 

laboratories determined to have 

participated in PT referral. 

C. Histocompatibility 

Generally, the CLIA regulations 

related to histocompatibility have not 

been updated since 1992, with the 

exception of certain changes in 2003 

(see 68 FR 3640). We are soliciting 


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6The Acceptability and Application of Virtual 

Crossmatching in lieu of Serologic Crossmatching 

for Transplantation (2014) https://ftp.cdc.gov/pub/

CLIAC_meeting_presentations/pdf/Addenda/ 

cliac1114/8_BRAY_Virtual_Crossmatch_

Workgroup_Report_Nov-2014.pdf. 

public comment and intend to draft 

proposals, to update the existing CLIA 

histocompatibility regulations through 

future rulemaking. The topics listed in 

this request for information are areas 

that CDC, CMS, the Clinical Laboratory 

Improvement Amendments Advisory 

Committee (CLIAC), and stakeholders 

identified as concepts that should be 

relevant to our efforts to update the 

CLIA histocompatibility requirements to 

better reflect current knowledge, 

changes in transplant medicine, and 

advancements in laboratory testing. We 

intend to consider any such information 

when we draft proposals to update the 

existing CLIA histocompatibility 

requirements to better protect the public 

health and safety and reflect current 

knowledge, changes in transplant 

medicine, and advancements in 

laboratory testing. 

1. Crossmatching 

As a result of changes in 

histocompatibility testing technology 

and practices, as well as advances in 

organ transplantation since 1992, we 

believe that some of the requirements 

found at § 493.1278 have become 

outdated and may preclude the use of 

current transplantation practices. For 

example, in some cases, performing a 

‘‘virtual crossmatch’’ has replaced the 

use of a ‘‘physical crossmatch’’ to 

determine compatibility between the 

donor and recipient. 

The CLIA regulations require a 

crossmatch to be performed as part of 

the laboratory testing process (see 42 

CFR 493.1278(e)). Although not 

specified in the regulation, the 

crossmatching procedures in use in 

1992 were physical crossmatches (also 

referred to as serologic crossmatches), 

that is, a mixing of specimens from 

donor and recipient to check for 

compatibility. We understand that these 

regulations are viewed by the 

transplantation community as a barrier 

to modernized decision-making 

approaches on organ acceptability based 

on risk assessment. 

Virtual crossmatching generally refers 

to an assessment of immunologic 

compatibility based on the patient’s 

alloantibody profile compared to the 

donor’s histocompatibility antigens. In 

virtual crossmatching, laboratory test 

results already performed on donors and 

recipients are compared in order to 

predict compatibility and determine 

whether an organ is acceptable for a 

patient. 

The CLIAC Virtual Crossmatch 

Workgroup was convened to gather 

information on the acceptability and 

application of virtual crossmatching in 

lieu of serologic crossmatching for 

transplantation. 

The workgroup reported on advances 

in the field of transplantation since the 

CLIA regulations were published in 

1992. These advances have made the 

physical crossmatching less significant 

or even obsolete in some cases. 

Specifically: 

• Histocompatibility testing has 

evolved from cell based assays to 

molecular typing and solid phase 

platforms for antibody detection, 

leading to improved accuracy, 

sensitivity, specificity. 

• Significant changes have occurred 

in the clinical practice of 

transplantation (for example, 

immunosuppression, desensitization 

practices), and improvements in antirejection therapies have led to improved 

outcomes and mitigation of risk due to 

antibodies against human leukocyte 

antigens (HLA). 

These advances have made virtual 

crossmatching a viable alternative to 

physical crossmatching. The Virtual 

Crossmatch Workgroup presented a 

report called the Acceptability and 

Application of Virtual Crossmatching in 

lieu of Serologic Crossmatching for 

Transplantation,6 to the full CLIAC at its 

November 2014 meeting. CLIAC 

deliberated on the report and 

recommended that we explore: 

• Regulatory changes or guidance(s) 

that would allow virtual crossmatching 

to replace physical crossmatching as a 

pre-requisite for organ transplant. 

• Appropriate criteria and decisionmaking algorithms, based on the Virtual 

Crossmatch Workgroup input provided 

to CLIAC, under which virtual 

crossmatching would be an appropriate 

substitute for physical crossmatching. 

The determination of appropriate 

criteria and decision-making algorithms 

should involve a process that includes 

an open comment period. 

We are seeking public comments 

(including information such as 

evidence, research, and trends) related 

to these two CLIAC recommendations; 

that is, whether virtual crossmatching 

should be an acceptable alternative to 

physical crossmatching, and under what 

criteria and decision-making algorithms 

virtual crossmatching would be an 

appropriate substitute for physical 

crossmatching. 

2. Updating the Histocompatibility 

Requirements 

Since the CLIA specialty requirements 

for histocompatibility testing were 

initially finalized in 1992, there have 

been many advancements in laboratory 

testing. We believe that some of the 

requirements found at § 493.1278 other 

than those related to crossmatching may 

also be outdated or are redundant with 

other requirements found in subpart K 

of the regulations. We are seeking public 

comments (including information such 

as evidence, research, and trends) 

related to any histocompatibility 

regulations that have become outdated, 

and suggestions for updating the 

histocompatibility regulations to align 

with current laboratory practice. 

D. CLIA Fees 

With the exception of the certificate 

fees notice which was published in the 

August 29, 1997 Federal Register (62 FR 

45915 through 45821), the CLIA 

regulations related to fees have not been 

updated since 1992, and we intend to 

update the CLIA regulations with regard 

to fees. These fee updates would 

include the determination of program 

compliance fees for laboratories holding 

a Certificate of Compliance (CoC), 

additional fees for laboratories holding 

a Certificate of Accreditation (CoA), fees 

for revised certificates, follow-up visits, 

complaint investigations, and activities 

related to the imposition of sanctions. 

Section 353(m) of the PHSA requires 

the Secretary to impose two separate 

types of fees: ‘‘certificate fees’’ and 

‘‘additional fees.’’ Certificate fees are 

imposed for the issuance and renewal of 

certificates (except that only a nominal 

fee may be required for the issuance and 

renewal of CoWs) and must be sufficient 

to cover the general costs of 

administering the CLIA program, 

including and evaluating and 

monitoring approved PT programs and 

accrediting bodies and implementing 

and monitoring compliance with 

program requirements. Additional fees 

are imposed for inspections of nonaccredited laboratories and for the cost 

of performing PT on laboratories that do 

not participate in approved PT 

programs. The additional fees must be 

sufficient to cover, among other things, 

the cost of carrying out such inspections 

and PT. Certificate and additional fees 

must vary by group or classification of 

laboratory, based on such 

considerations as the Secretary 

determines are relevant, which may 

include the dollar volume and scope of 

the testing being performed by the 

laboratories. The regulations provide for 

a methodology for determining 


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compliance fee amounts (§ 493.649) and 

periodic updating of the certificate fee 

amounts (§ 493.638(b)). 

1. Fees for Revised Certificate 

The regulations also allow for 

collection of fees for revised certificates 

(§ 493.639). We are exploring an 

appropriate methodology for 

determining a fair and reasonable fee to 

support these requests. At present, 

laboratories may request a revised 

certificate due to a change in name, 

location, director, services offered (for 

example, specialty or subspecialty), or 

certificate type (for example, CoC to 

Certificate of Provider-performed 

Microscopy (PPM) Procedures). There is 

a cost associated with such a request, 

including staff time to verify and make 

the edits in the data system, the 

contractor’s time to print the revised 

certificate, and the supplies required to 

print the revised certificate. The fee for 

revised certificate would likely be a 

standard nominal fee for such requests. 

2. Compliance Determination, 

Additional Fees, and Methodology for 

Determining Fee Amounts 

Laboratories holding a CoC are subject 

to fees for determination of program 

compliance according to the regulations 

at § 493.643(b). Laboratories that hold a 

CoA are subject to additional fees as 

outlined in § 493.645(b). As noted in 

this request for information, the statute 

requires certificate and additional fees 

to vary by group or classification of 

laboratory, based on such 

considerations as the Secretary 

determines are relevant, which may 

include the dollar volume and scope of 

the testing being performed by the 

laboratories. Section 493.643(c) lists the 

classifications, or schedules, of 

laboratories based on the laboratory’s 

scope and volume of testing. These 

schedules are used to determine the fee 

amount a laboratory is assessed and will 

not be revised. The compliance 

determination fees have not been 

increased since the final rule was 

published in 1992. The cost of 

conducting compliance determination 

activities (for example, surveys, PT 

reviews, and evaluating personnel) has 

increased over the life of the CLIA 

program. 

The regulations allow for us to collect 

fees for follow-up visits post survey, 

complaint investigations, and activities 

associated with imposing sanctions. 

Such fees for laboratories holding a CoC 

are outlined in §§ 493.643(b) and 

493.643(d), while laboratories holding a 

CoA, CoW and a PPM Certificate are 

subject to §§ 493.645(b)(2) and 

493.645(c), as applicable. We are 

exploring methodology for assessing a 

fair fee for these compliance 

determination activities. 

The methodology for determining fee 

amounts is found in § 493.649. The 

amount of the fee in each schedule for 

compliance determination inspections 

is based on the average hourly rate for 

each entity, which includes costs to 

perform required activities and 

necessary administration costs. The 

hourly rate is multiplied by the average 

number of hours required to perform 

these activities. We are seeking public 

comments (including information such 

as evidence, research, and trends) on an 

alternate method to calculate the 

average hourly rate for each entity as 

outlined in § 493.649(b). We are also 

seeking information on whether the 

method should be standardized and 

updated annually or as needed. 

We are therefore soliciting public 

comments (including information such 

as evidence, research, and trends) on the 

best method for instituting this 

regulatory authority to collect CLIA fees. 

II. Solicitation of Comments 

This is a request for information only. 

Respondents are encouraged to provide 

complete but concise responses to the 

questions listed in the sections outlined 

below. Please note that a response to 

every question is not required. This RFI 

is issued solely for information and 

planning purposes; it does not 

constitute a Request for Proposal, 

applications, proposal abstracts, or 

quotations. This RFI does not commit 

the Government to contract for any 

supplies or services or make a grant 

award. Further, we are not seeking 

proposals through this RFI and will not 

accept unsolicited proposals. 

Responders are advised that the U.S. 

Government will not pay for any 

information or administrative costs 

incurred in response to this RFI; all 

costs associated with responding to this 

RFI will be solely at the interested 

party’s expense. Not responding to this 

RFI does not preclude participation in 

any future procurement, if conducted. It 

is the responsibility of the potential 

responders to monitor this RFI 

announcement for additional 

information pertaining to this request. 

Please note that we will not respond to 

questions about the policy issues raised 

in this RFI. We may or may not choose 

to contact individual responders. Such 

communications would only serve to 

further clarify written responses. 

Contractor support personnel may be 

used to review RFI responses. 

Responses to this notice are not offers 

and cannot be accepted by the 

Government to form a binding contract 

or issue a grant. Information obtained as 

a result of this RFI may be used by the 

Government for program planning on a 

non-attribution basis. Respondents 

should not include any information that 

might be considered proprietary or 

confidential. This RFI should not be 

construed as a commitment or 

authorization to incur cost for which 

reimbursement would be required or 

sought. All submissions become 

Government property and will not be 

returned. We may publically post the 

comments received, or a summary 

thereof. 

We are soliciting public input on the 

following areas: 

A. Clarifications of Degree(s) 

• We are seeking public comment 

related to whether a bachelor’s degree in 

nursing should be considered 

equivalent to a bachelor’s degree in 

biological science or should be 

considered a qualifying degree to meet 

the CLIA requirements for moderate and 

high complexity testing personnel as 

well as for technical consultants. 

• We are seeking public comment on 

what is considered a physical science 

degree and if a physical science degrees 

have the educational backgrounds such 

that all or some should to be considered 

a qualifying degree to meet the intent of 

the CLIA requirements at §§ 493.1405, 

493.1411, 493.1423, 493.1443, 493.1449, 

493.1461, and 493.1489. 

• We are seeking public comment 

related to non-traditional degrees (for 

example, Regents Bachelor of Arts) 

specifically whether any of these types 

of degrees should be considered to meet 

the requirements for a chemical, 

physical, biological or clinical 

laboratory science, and/or medical 

laboratory technology degrees. 

B. Other Requirements for CLIA 

Personnel Categories 

• We are seeking public comment 

regarding whether general supervisors 

should be allowed to perform 

competency assessment for testing 

personnel performing moderate 

complexity testing in laboratories that 

perform both moderate and high 

complexity testing. 

• We are seeking public comment on 

what is appropriate laboratory training, 

experience and skills when qualifying 

all personnel to meet CLIA 

requirements, and what comprises 

appropriate documentation to verify the 

training, experience and skills for all 

personnel positions in part 493, subpart 

M. 


jstallworth on DSKBBY8HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Proposed Rules 1009 

C. Proficiency Testing Referral 

• We are seeking public comment 

regarding the feasibility of applying 

alternative sanctions in cases of PT 

referral that involve waived testing. 

• We are seeking public comment 

related to applying discretion in 

situations where we determine that a 

laboratory has referred its proficiency 

testing samples to another laboratory 

and has reported those results from 

another laboratory as their own, and 

under what circumstances should that 

discretion be applied. 

D. Histocompatibility 

• Virtual crossmatching: We are 

seeking public comment on the 

acceptability and application of virtual 

crossmatching in lieu of physical 

crossmatching for transplantation. 

• Criteria and decision making 

algorithms: We are seeking public 

comment on appropriate criteria and 

decision algorithms under which virtual 

crossmatching would be an appropriate 

substitute for physical crossmatching. 

We are also seeking public comment on 

the existence of commonly accepted 

current guidelines for virtual 

crossmatching in histocompatibility. 

• Updating histocompatibility 

regulations: We are seeking public 

comment on histocompatibility 

regulations that are no longer necessary 

because they are obsolete or redundant 

with requirements found in other 

sections of the CLIA regulations. We are 

also seeking public comment on any 

histocompatibility regulations that 

should be modified to reflect current 

practices. 

E. CLIA Fees 

• We are seeking public comments 

(including information such as 

evidence, research, and trends) on an 

alternate method to calculate the 

average hourly rate for each entity as 

outlined in § 493.649(b). We are also 

seeking comment on whether the 

method should be standardized and 

updated annually or as needed. 

• We are seeking public comment on 

a methodology that would set a fair and 

reasonable fee for revised certificate 

requests. We also seek comment as to 

whether fees should be nominal and, if 

nominal, whether such fee would cover 

the costs associated with the task. 

• We are seeking public comment to 

update the fees for determination of 

program compliance as well as 

additional fees to accredited laboratories 

as outlined in §§ 493.643(b) and 

493.645(b) respectively. We are also 

seeking comment on whether fees 

collected should be subject to the same 

ten schedules at § 493.643(c), and 

whether they should change based on 

any updates to the methodology for 

determining the average hourly rate. 

• We are seeking public comment on 

exploring an appropriate methodology 

for assessing a fair fee for other 

compliance determination activities to 

include performing follow-up visits, 

complaint investigations, and activities 

associated with imposition of sanctions. 

We are also soliciting general 

feedback from stakeholders on what 

other areas of CLIA they would 

potentially have recommendations for 

changing. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

However, section II of this document 

does contain a general solicitation of 

comments in the form of a request for 

information. In accordance with the 

implementing regulations of the 

Paperwork Reduction Act of 1995 

(PRA), specifically 5 CFR 1320.3(h)(4), 

this general solicitation is exempt from 

the PRA. Facts or opinions submitted in 

response to general solicitations of 

comments from the public, published in 

the Federal Register or other 

publications, regardless of the form or 

format thereof, provided that no person 

is required to supply specific 

information pertaining to the 

commenter, other than that necessary 

for self-identification, as a condition of 

the agency’s full consideration, are not 

generally considered information 

collections and therefore not subject to 

the PRA. Consequently, there is no need 

for review by the Office of Management 

and Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Dated: August 18, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: December 20, 2017. 

Eric D. Hargan, 

Acting Secretary, Department of Health and 

Human Services. 

[FR Doc. 2017–27887 Filed 1–5–18; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 660 

[Docket No. 170901860–7999–01] 

RIN 0648–BH18 

Fisheries Off West Coast States; 

Coastal Pelagic Species Fisheries; 

Multi-Year Annual Catch Limits for the 

Finfish Stocks in the Monitored Stock 

Category 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule. 

SUMMARY: NMFS issues this proposed 

rule to amend the regulations governing 

the fisheries for Coastal Pelagic Species 

(CPS) off the West coast to include 

annual catch limits (ACLs, which are 

the maximum allowable fishing levels 

for each year, for certain monitored 

finfish stocks (jack mackerel, central 

population of northern anchovy, 

northern subpopulation of northern 

anchovy) under the CPS Fishery 

Management Plan (FMP). A final rule 

published October 26, 2016, established 

these ACLs for the 2017 fishing year 

only; the purpose of this proposed rule 

is to codify these ACLs so they remain 

effective until revised through some 

future rulemaking. If the ACL for any 

one of these stocks is reached or 

projected to be reached, then fishing for 

that stock will be closed until it reopens 

at the start of the next fishing season. 

This rule is intended to conserve and 

manage these stocks off the U.S. West 

Coast. 

DATES: Comments must be received by 

February 8, 2018. 

ADDRESSES: You may submit comments 

on this document, identified by NOAA– 

NMFS–2017–0155, by any of the 

following methods: 

• Electronic Submissions: Submit all 

electronic public comments via the 

Federal e-Rulemaking Portal. Go to 


jstallworth on DSKBBY8HB2PROD with PROPOSALS