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
1010 Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Proposed Rules 

1Market squid is statutorily exempt from the 

general requirement to be managed using an ACL 

because of their short life-cycle. 

www.regulations.gov/#!docketDetail;

D=NOAA-NMFS-2017-0155, click the 

‘‘Comment Now!’’ icon, complete the 

required fields, and enter or attach your 

comments. 

• Mail: Submit written comments to 

Barry A. Thom, Regional Administrator, 

West Coast Region, NMFS, 501 W. 

Ocean Blvd., Ste. 420, Long Beach, CA 

90802–4250; Attn: Joshua Lindsay. 

• Instructions: Comments must be 

submitted by one of the above methods 

to ensure that the comments are 

received, documented, and considered 

by NMFS. Comments sent by any other 

method, to any other address or 

individual, or received after the end of 

the comment period, may not be 

considered. All comments received are 

a part of the public record and will 

generally be posted for public viewing 

on www.regulations.gov without change. 

All personal identifying information 

(e.g., name, address, etc.) submitted 

voluntarily by the sender will be 

publicly accessible. Do not submit 

confidential business information, or 

otherwise sensitive or protected 

information. NMFS will accept 

anonymous comments (enter ‘‘N/A’’ in 

the required fields if you wish to remain 

anonymous). 

FOR FURTHER INFORMATION CONTACT: 

Joshua Lindsay, West Coast Region, 

NMFS, (562) 980–4034. 

SUPPLEMENTARY INFORMATION: The CPS 

fishery in the U.S. exclusive economic 

zone (EEZ) off the West Coast is 

managed under the CPS FMP, which 

was developed by the Pacific Fishery 

Management Council (Council) 

pursuant to the Magnuson-Stevens 

Fishery Conservation and Management 

Act (MSA), 16 U.S.C. 1801 et seq. The 

six species managed under the CPS FMP 

are Pacific sardine, Pacific mackerel, 

jack mackerel, northern anchovy 

(northern and central subpopulations), 

market squid and krill. The CPS FMP is 

implemented by regulations at 50 CFR 

part 660, subpart I. 

Management unit stocks in the CPS 

FMP are classified under three 

management categories: Active, 

monitored and prohibited harvest 

species. Stocks in the active category 

(Pacific sardine and Pacific mackerel) 

are managed by regular stock 

assessments and periodic or annual 

adjustments of target harvest levels 

based on those stock assessments. 

Fisheries for these stocks have 

biologically significant levels of catch, 

or biological or socioeconomic 

considerations requiring this type of 

relatively intense harvest management 

procedures. In contrast, stocks in the 

monitored category (jack mackerel, 

northern anchovy, and market squid 1), 

are managed by means of qualitative 

comparison to available abundance data 

without regular stock assessments or 

annual adjustments to target harvest 

levels, and then tracking landings 

against the relevant ACL to ensure 

overfishing does not occur. Fisheries for 

monitored stocks do not have 

biologically significant catch levels and, 

therefore, do not require intensive 

harvest management. As a result, 

monitored stocks have been adequately 

managed by tracking landings and 

examining available abundance indices. 

Species in both categories may be 

subject to management measures such 

as catch allocation, gear regulations, 

closed areas, closed seasons, or other 

forms of regulation. For example, trip 

limits and a limited entry permit 

program are already in place for all CPS 

finfish. The prohibited harvest species 

category is comprised only of krill, 

which is managed by a prohibition on 

targeting and retention. 

In September 2011, NMFS approved 

Amendment 13 to the CPS FMP, which 

modified the framework process used to 

set and adjust fishery specifications and 

for setting ACLs and accountability 

measures (AMs). Amendment 13 

conformed the CPS FMP with the 2007 

amendments to the MSA and the NMFS 

revised MSA National Standard 1 (NS1) 

guidelines at 50 CFR 600.310, which for 

the first time required ACLs be 

established for management unit species 

(with exceptions). Specifically, 

Amendment 13 maintained the existing 

reference points and the primary harvest 

control rules for the monitored stocks 

(jack mackerel, northern anchovy and 

market squid), including the large 

uncertainty buffer built into the 

acceptable biological catch (ABC) 

control rule for the finfish stocks, as 

well as the overfishing criteria for 

market squid, but modified these 

reference points and control rules to 

align with the revised NS1 guidelines 

and to comply with the new statutory 

requirement to establish a process for 

setting ACLs and AMs. This included a 

default management framework under 

which the overfishing limit (OFL) for 

each monitored stock was set equal to 

their existing maximum sustainable 

yield (MSY) value, if available, and ABC 

values were reduced from the OFL by 75 

percent as an uncertainty buffer (in 

accordance with the existing ABC 

control rule, under which ABC equals 

25 percent of OFL/MSY). ACLs are then 

set either equal to or lower than the 

ABC; annual catch targets (ACTs), if 

deemed necessary, can be set less than 

or equal to the ACL, primarily to 

account for potential management 

uncertainty. 

Compared to the management 

framework for stocks in the active 

category, which utilizes annual 

estimates of biomass to calculate the 

applicable annual harvest levels, the 

ACLs for the monitored finfish stocks 

are not based on annual estimates of 

biomass or any single estimate of 

biomass. As described above, ACLs for 

monitored finfish are set at the ABC 

levels, which are no higher than 25 

percent of the OFLs. OFLs are set equal 

to MSY—an estimate that is intended to 

reflect the largest average fishing 

mortality rate or yield that can be taken 

from a stock over the long term. 

Although the control rules and harvest 

policies for monitored CPS stocks are 

simpler than the active category control 

rules, the inclusion of a large nondiscretionary buffer between the OFL 

and ABC both protects the stock from 

overfishing and allows for a small 

sustainable harvest. In recognition of the 

low fishing effort and landings for these 

stocks, the Council chose this type of 

passive framework to manage monitored 

finfish because the passive framework 

has proven sufficient to prevent 

overfishing while allowing for 

sustainable annual harvests even when 

the year-to-year biomasses of these 

stocks fluctuate. 

Although the OFLs and ABCs for 

these monitored finfish stocks were 

previously established and are not being 

revised by this rulemaking, 

understanding these values is relevant 

to ACLs because generally the ACL for 

monitored stocks is expected to be set 

at ABC. Per the framework that was 

established through Amendment 13, the 

OFLs for the central subpopulation of 

northern anchovy and jack mackerel 

were set based on MSY values that were 

established through Amendment 8 to 

the FMP. In 2015, Amendment 14 to the 

CPS FMP established an FMSY of 0.3 as 

the MSY reference point for the 

northern subpopulation of northern 

anchovy in the CPS FMP. However, 

because the framework in the FMP for 

setting ABCs is based on applying a 

percentage to numerical MSY/OFLs, it 

was necessary to determine a numerical 

OFL value through the specifications 

process. Because the northern 

subpopulation of the northern anchovy 

is currently lightly fished and effort has 

been inconsistent over time, it was 

determined that using a catch time 

series as a way of setting the OFL was 

not appropriate, as it likely was an 

unreliable indicator of stock status. 


jstallworth on DSKBBY8HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Proposed Rules 1011 

2An annual catch target of 1,500 mt for the 

northern subpopulation of northern anchovy was 

also established by the October 26, 2016, final rule, 

but is used for internal monitoring rather than 

regulating the public and therefore need not be 

codified. 

Therefore, the best available scientific 

information on the population and 

biology of northern subpopulation 

northern anchovy was compiled to 

develop an OFL. The available 

information included two separate 

estimates of biomass, and the average of 

these two estimates was approximately 

130,000 mt. After reviewing this 

information, the SSC recommended that 

the OFL be set by multiplying the 

average of these two biomass estimates 

(130,000 mt), by an FMSY 0.3. This 

calculation results in an OFL of 39,000 

mt, and with the established uncertainty 

buffer of 75 percent, an ABC of 9,750 

mt. 

Through this action, NMFS is 

proposing to codify in 50 CFR part 660 

subpart I ACLs for the three populations 

of CPS finfish, which were implemented 

for calendar year 2017 in the final rule 

published on October 26, 2016, at 81 FR 

74309.2 The ACLs are: Jack mackerel, 

31,000 mt; northern subpopulation of 

northern anchovy, 9,750 mt; and, 

central subpopulation of northern 

anchovy, 25,000 mt. These ACLs were 

recommended to NMFS by the Council, 

and were based on recommendations 

from its advisory bodies according to 

the framework in the FMP established 

through Amendment 13. 

NMFS notes that although the 

proposed ACLs are equal to their 

respective ABCs, NMFS has determined 

that they are still at a level such that 

overfishing will not occur. The 

management framework, including the 

buffer between the OFL and ABC built 

into the harvest policy for CPS stocks in 

the monitored category, was 

recommended by the Council’s SSC, 

adopted by the Council and approved 

by NMFS as supported by the best 

available science and as determined in 

a manner that appropriately accounts 

for the various types of scientific 

uncertainty surrounding the OFL. This 

framework for accounting for 

uncertainty was subsequently used to 

establish the existing OFLs and ABCs 

for these stocks, and NMFS does not 

propose to revise the existing OFLs and 

ABCs by this proposed rule. 

Additionally, setting lower ACLs or 

establishing additional ACTs to account 

for management uncertainty is 

unnecessary at this time, as managers 

have the ability to manage and track the 

landings of these fisheries to ensure the 

ACLs are not exceeded. Catches of the 

three finfish stocks in the monitored 

category—northern anchovy (northern 

and central subpopulations) and jack 

mackerel—have remained well below 

their respective ACL (previously ABC) 

levels since implementation of the CPS 

FMP in 2000, with average catches in 

the ten-year period from 2006–2015 of 

approximately 8,000 mt, 295 mt, and 

580 mt for the central and northern 

subpopulations of northern anchovy 

and jack mackerel, respectively. 

This proposed action will allow the 

proposed ACLs to remain in place for 

each subsequent calendar year until 

changed. The Council and NMFS would 

consider future changes if landings 

increase and consistently reach the 

ABC/ACL level, if new scientific 

information becomes available to 

warrant changes, or if changes are made 

in the future to the existing ABCs or 

OFLs. The ACLs proposed in this action 

provide a means to monitor these stocks 

on an annual basis and prevent 

overfishing, as each year the total 

harvest of each stock will be assessed 

against their respective ACLs. These 

ACLs would remain in place until 

changed according to the FMP 

framework. Except for the northern 

subpopulation of northern anchovy, the 

OFL and ABC specifications for the rest 

of these stocks have already been set in 

the FMP, and NMFS is not establishing 

or revising them by this action. The OFL 

and ABC specifications for the northern 

subpopulation of northern anchovy 

were established in the final rule 

published October 26, 2016, which 

established these ACLs for the 2017 

fishing year only. 

If an ACL is reached, or is expected 

to be reached for one of these fisheries, 

the directed fishery would be closed 

until the beginning of the next fishing 

season. The NMFS West Coast Regional 

Administrator would publish a notice in 

the Federal Register announcing the 

date of any such closure. Additionally, 

nearing or exceeding one of these ACLs 

would trigger a review of whether the 

fishery should be moved into the 

actively managed category of the FMP. 

Classification 

Pursuant to section 304(b)(1)(A) of the 

Magnuson-Stevens Fishery 

Conservation and Management Act, the 

NMFS Assistant Administrator has 

determined that this proposed rule is 

consistent with the CPS FMP, other 

provisions of the Magnuson-Stevens 

Fishery Conservation and Management 

Act, and other applicable law. 

This proposed rule has been 

determined to be not significant for 

purposes of Executive Order 12866. 

The Chief Counsel for Regulation of 

the Department of Commerce certified 

to the Chief Counsel for Advocacy of the 

Small Business Administration (SBA) 

that this proposed rule, if adopted, 

would not have a significant economic 

impact on a substantial number of small 

entities, for the reasons described 

below. 

The primary action being 

implemented through this rule as it 

relates to potential economic impacts on 

small entities is the codification of 

multi-year ACLs for the two sub-stocks 

of northern anchovy and for jack 

mackerel in the U.S. EEZ off the West 

coast. The CPS FMP and its 

implementing regulations require NMFS 

to set ACLs for these fisheries based on 

the harvest control rules in the FMP. 

For Regulatory Flexibility Act (RFA) 

purposes only, NMFS has established a 

small business size standard for 

businesses, including their affiliates, 

whose primary industry is commercial 

fishing (see 50 CFR 200.2). A business 

primarily engaged in commercial fishing 

(NAICS code 11411) is classified as a 

small business if it is independently 

owned and operated, is not dominant in 

its field of operation (including its 

affiliates), and has combined annual 

receipts not in excess of $11 million for 

all its affiliated operations worldwide. 

The average annual per vessel 

revenue in 2016 for the West Coast CPS 

finfish small purse seine fleet, as well as 

the few vessels that target anchovy off 

of Oregon and Washington, was below 

$11 million; therefore, all of these 

vessels are considered small businesses 

under the SBA size standards. Because 

each affected vessel is a small business, 

this proposed rule has an equal effect on 

all of these small entities, and therefore 

will impact a substantial number of 

these small entities in the same manner. 

The corresponding annual revenues 

from these species averaged to about 

$62,000 and $1,900,000, for jack 

mackerel and northern anchovy, 

respectively. 

The entities that would be affected by 

the proposed action are the vessels that 

harvest jack mackerel and northern 

anchovy as part of the West Coast CPS 

purse seine fleet. Jack mackerel and 

northern anchovy are components of the 

CPS purse seine fishery off the U.S. 

West Coast, which generally fishes a 

complex of species, including Pacific 

sardine, Pacific mackerel and market 

squid. Currently there are 58 vessels 

permitted in the Federal CPS limited 

entry fishery off California. Annually 

over the past 5 years, as few as 2 and 

as many as 57 (an average 22) of these 

CPS vessels landed anchovy and jack 

mackerel. Approximately 26 baitfish 

licenses are issued annually in the state 

of Washington to harvest northern 


jstallworth on DSKBBY8HB2PROD with PROPOSALS
1012 Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Proposed Rules 

anchovy. Since 2009, the state of Oregon 

has not required a permit to harvest 

anchovy in Oregon waters. Jack 

mackerel is currently not fished in 

Oregon and Washington. 

To evaluate whether this proposed 

rule could potentially reduce the 

profitability of the affected vessels, 

NMFS compared current and average 

recent historical landings to the ACLs 

that would be codified in this proposed 

rule, if approved. The multi-year ACL 

(maximum fishing level for each year) 

for the central subpopulation of 

northern anchovy is 25,000 mt and for 

the northern subpopulation ACL is 

9,750 mt. In 2016, 6,644 mt of the 

central population of northern anchovy 

and 7,263 mt of the northern 

subpopulation of northern anchovy 

were landed. The annual average 

harvest from 2007 to 2016 for the central 

and northern subpopulations of 

northern anchovy is 7,400 mt and 910 

mt, respectively. The jack mackerel ACL 

is 31,000 mt. In 2016, approximately 

374 mt of jack mackerel were landed 

and average annual landings of jack 

mackerel over the last 10 years (2007– 

2016) was 662 mt. Prior landings of 

these stocks have been well below the 

proposed ACLs. Therefore, although 

codifying ACLs for these stocks is 

considered a new management measure 

for these fisheries, based on current and 

historical landings of these stocks, this 

proposed action is not expected to result 

in changes in fishery operations. As a 

result, it is unlikely that the ACLs that 

would be codified in this rule, if 

approved, would limit the profitability 

of the fleets catching these stocks. 

Therefore, this action would not have 

any economic impact, let alone impose 

a significant economic impact on any of 

the small entities participating in these 

fisheries. 

Based on the analysis above, the 

proposed action, if adopted, would not 

have a significant economic impact on 

a substantial number of small entities. 

As a result, an Initial Regulatory 

Flexibility Analysis is not required, and 

none has been prepared. 

This action does not contain a 

collection of information requirement 

for purposes of the Paperwork 

Reduction Act. 

List of Subjects in 50 CFR Part 660 

Fisheries, Fishing, Reporting and 

recordkeeping requirements. 

Dated: January 2, 2018. 

Samuel D. Rauch, III, 

Deputy Assistant Administrator for 

Regulatory Programs, National Marine 

Fisheries Service. 

For the reasons set out in the 

preamble, 50 CFR part 660 is proposed 

to be amended as follows: 

PART 660—FISHERIES OFF WEST 

COAST STATES 

■ 1. The authority citation for part 660 

continues to read as follows: 

Authority: 16 U.S.C. 1801 et seq., 16 

U.S.C. 773 et seq., and 16 U.S.C. 7001 et seq. 

■ 2. In § 660.509, paragraph (a) is 

revised to read as follows: 

§ 660.509 Accountability measures 

(season closures). 

(a) General rule. When the directed 

fishery allocation, incidental allocation, 

or an annual catch limit is reached for 

any CPS species it shall be closed until 

the beginning of the next fishing period 

or season. Regional Administrator shall 

announce in the Federal Register the 

date of such closure, as well as any 

incidental harvest level(s) 

recommended by the Council and 

approved by NMFS. 

* * * * * 

■ 3. In § 660.511, a new paragraph (i) is 

added to read as follows: 

§ 660.511 Catch restrictions. 

* * * * * 

(i) The following ACLs apply to 

fishing for monitored stocks of CPS 

finfish: 

(1) Jack mackerel: 31,000 mt. 

(2) Northern Anchovy (N. 

Subpopulation): 9,750 mt. 

(3) Northern Anchovy (Central 

Subpopulation): 25,000 mt. 

[FR Doc. 2018–00084 Filed 1–8–18; 8:45 a.m.] 

BILLING CODE 3510–22–P 


jstallworth on DSKBBY8HB2PROD with PROPOSALS