Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45511 

1See: https://www.whitehouse.gov/the-pressoffice/2017/01/20/memorandum-heads-executivedepartments-and-agencies. 

interest furthered by the request. The 

CSB ordinarily will presume that when 

a news media requester has satisfied the 

factors in paragraphs (k)(2)(i) and (ii) of 

this section, the request is not primarily 

in the commercial interest of the 

requester. Disclosure to data brokers or 

others who merely compile and market 

government information for direct 

economic return will not be presumed 

to primarily serve the public interest. 

(3) Where only some of the records to 

be released satisfy the requirements for 

a waiver of fees, a waiver must be 

granted for those records. 

(4) Requests for a waiver or reduction 

of fees should be made when the request 

is first submitted to the CSB and should 

address the criteria referenced above. A 

requester may submit a fee waiver 

request at a later time so long as the 

underlying record request is pending or 

on administrative appeal. When a 

requester who has committed to pay 

fees subsequently asks for a waiver of 

those fees and that waiver is denied, the 

requester must pay any costs incurred 

up to the date the fee waiver request 

was received. 

Dated: September 25, 2017 

Kara Wenzel, 

Acting General Counsel, Chemical Safety and 

Hazard Investigation Board. 

[FR Doc. 2017–20853 Filed 9–28–17; 8:45 am] 

BILLING CODE 6350–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 10 

RIN 0906–AB11 

340B Drug Pricing Program Ceiling 

Price and Manufacturer Civil Monetary 

Penalties Regulation 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Final rule; further delay of 

effective date. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) 

administers section 340B of the Public 

Health Service Act (PHSA), known as 

the ‘‘340B Drug Pricing Program’’ or the 

‘‘340B Program.’’ HRSA published a 

final rule on January 5, 2017, that set 

forth the calculation of the ceiling price 

and application of civil monetary 

penalties. The final rule applied to all 

drug manufacturers that are required to 

make their drugs available to covered 

entities under the 340B Program. On 

August 21, 2017, HHS solicited 

comments on further delaying the 

effective date of the January 5, 2017, 

final rule to July 1, 2018 (82 FR 39553). 

HHS proposed this action to allow a 

more deliberate process of considering 

alternative and supplemental regulatory 

provisions and to allow for sufficient 

time for additional rulemaking. After 

consideration of the comments received 

on the proposed rule, HHS is delaying 

the effective date of the January 5, 2017, 

final rule, to July 1, 2018. 

DATES: As of September 29, 2017, the 

effective date of the final rule published 

in the Federal Register (82 FR 1210, 

January 5, 2017) is further delayed to 

July 1, 2018. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Krista Pedley, Director, Office of 

Pharmacy Affairs, Healthcare Systems 

Bureau, HRSA, 5600 Fishers Lane, Mail 

Stop 08W05A, Rockville, MD 20857, or 

by telephone at 301–594–4353. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On September 30, 2010, HHS 

published an advanced notice of 

proposed rulemaking (ANPRM) in the 

Federal Register, ‘‘340B Drug Pricing 

Program Manufacturer Civil Monetary 

Penalties’’ (75 FR 57230, September 20, 

2010). HHS subsequently published a 

notice of proposed rulemaking (NPRM) 

on June 17, 2015, to implement CMPs 

for manufacturers that knowingly and 

intentionally charge a covered entity 

more than the ceiling price for a covered 

outpatient drug; to provide clarity 

regarding the requirement that 

manufacturers calculate the 340B 

ceiling price on a quarterly basis; and to 

establish the requirement that a 

manufacturer charge $.01 (penny 

pricing) for drugs when the ceiling price 

calculation equals zero (80 FR 34583, 

June 17, 2015). The public comment 

period closed on August 17, 2015, and 

HRSA received 35 comments. After 

review of the initial comments, HHS 

reopened the comment period (81 FR 

22960, April 19, 2016) to invite 

additional comments on the following 

areas of the NPRM: 340B ceiling price 

calculations that result in a ceiling price 

that equals zero (penny pricing); the 

methodology that manufacturers use 

when estimating the ceiling price for a 

new covered outpatient drug; and the 

definition of the ‘‘knowing and 

intentional’’ standard to be applied 

when assessing a CMP for 

manufacturers that overcharge a covered 

entity. The comment period closed May 

19, 2016, and HHS received 72 

comments. 

On January 5, 2017, HHS published a 

final rule in the Federal Register (82 FR 

1210, January 5, 2017); comments from 

both the original comment period 

established in the NPRM and the 

reopened comment period announced 

in the April 19, 2016 notice were 

considered in the development of the 

final rule. The provisions of that final 

rule were to be effective March 6, 2017; 

however, HHS issued a subsequent final 

rule (82 FR 12508, March 6, 2017) 

delaying the effective date to March 21, 

2017, in accordance with a January 20, 

2017, memorandum from the Assistant 

to the President and Chief of Staff, titled 

‘‘Regulatory Freeze Pending Review.’’ 1

In the January 5, 2017, final rule, HHS 

acknowledged that the effective date fell 

during the middle of a quarter and 

stakeholders needed time to adjust 

systems and update their policies and 

procedures. As such, HHS stated that it 

intended to enforce the requirements of 

the final rule at the start of the next 

quarter, which began April 1, 2017. 

After further consideration and to 

provide affected parties sufficient time 

to make needed changes to facilitate 

compliance, and because questions were 

raised, HHS issued an interim final rule 

(82 FR 14332, March 20, 2017), to delay 

the effective date of the final rule to May 

22, 2017, and solicited additional 

comments on whether that date should 

be further extended to October 1, 2017. 

HHS received 51 comments on the 

interim final rule, some supporting and 

some opposing the delay of the effective 

date to May 22, 2017, or alternatively to 

October 1, 2017. After careful 

consideration of the comments received, 

HHS delayed the effective date of the 

January 5, 2017, final rule to October 1, 

2017 (82 FR 22893, May 19, 2017). 

HHS subsequently published a 

proposed rule (82 FR 39553, August 21, 

2017) to further delay the effective date 

of the final rule to July 1, 2018. The 

further delay allows necessary time to 

fully consider the substantial questions 

of fact, law, and policy raised by the 

rule, consistent with the aforementioned 

‘‘Regulatory Freeze Pending Review,’’ 

memorandum. Requiring manufacturers 

to make targeted and potentially costly 

changes to pricing systems and business 

procedures in order to comply with a 

rule that is under further consideration 

and for which substantive questions 

have been raised would be disruptive. 

The further delay allows HHS to 

consider objections regarding the timing 

of the effective date and challenges 

associated with complying with the 

rule, as well as other objections to the 

rule. 

In addition, Executive Order 13765 

(82 FR 8351) titled, ‘‘Minimizing the 


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45512 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

2See: https://www.whitehouse.gov/the-pressoffice/2017/01/2/executive-order-minimizingeconomic-burden-patient-protection-and. 

Economic Burden of the Patient 

Protection and Affordable Care Act 

Pending Repeal,’’ specifically instructs 

HHS and all other heads of executive 

offices to utilize all authority and 

discretion available to delay the 

implementation of certain provisions or 

requirements of the Patient Protection 

and Affordable Care Act.2 HHS based 

the January 5, 2017, final rule on 

changes made to the 340B Program by 

the Patient Protection and Affordable 

Care Act. HHS proposed to delay the 

effective date of the January 5, 2017, 

final rule to July 1, 2018, to allow for a 

sufficient amount of time to consider 

the regulatory burdens that may be 

posed by this final rule. HHS continues 

to examine important substantive issues 

in matters covered by the rule and 

intends to engage in additional 

rulemaking on these issues. 

HHS received a number of comments 

on the proposed rule both supporting 

and opposing the delay of the effective 

date to July 1, 2018. After careful 

consideration of the comments received, 

HHS has decided to delay the effective 

date of the January 5, 2017, final rule to 

July 1, 2018. As HHS changed the 

effective date of the final rule to July 1, 

2018, enforcement will be delayed to 

July 1, 2018. HHS continues to believe 

that the delay of the effective date 

provides regulated entities sufficient 

time to implement the requirements of 

the rule, as well as allowing a more 

deliberate process of considering 

alternative and supplemental regulatory 

provisions, and to allow for sufficient 

time for additional rulemaking. 

Section 553(d) of the Administrative 

Procedure Act (APA) (5 U.S.C. 551 et 

seq.) requires that Federal agencies 

provide at least 30 days after 

publication of a final rule in the Federal 

Register before making it effective, 

unless good cause can be found not to 

do so. HHS finds good cause for making 

this final rule effective less than 30 days 

after publication in the Federal Register 

given that failure to do so would result 

in the final rule published on January 5, 

2017, going into effect on October 1, 

2017, for several weeks before a final 

rule delaying the effective date until 

July 1, 2018, would go into effect. To 

preclude this uncertainty in the 

marketplace and to ease the burdens of 

stakeholders, HHS believes that a clear 

effective date is an important goal and 

one that becomes particularly important 

when it is paired with potential civil 

monetary penalties. The additional time 

provided to the public before the rule 

takes effect will assist stakeholders in 

preparing to comply with these new 

program requirements. 

II. Analysis and Responses to Public 

Comments 

In the proposed rule, HHS solicited 

comments regarding whether we should 

delay the January 5, 2017, final rule to 

July 1, 2018. We received 97 comments 

containing a number of issues from 

covered entities, manufacturers, and 

groups representing these stakeholders. 

In this final rule, we will only respond 

to comments related to whether HHS 

should delay the January 5, 2017, final 

rule to July 1, 2018. We did not consider 

and do not address comments that 

raised issues beyond the narrow scope 

of the proposed rule, including 

comments related to withdrawal of the 

rule or comments related to broader 

policy matters. However, HHS intends 

to engage in further rulemaking on 

issues covered in the January 5, 2017, 

final rule. We have summarized the 

relevant comments received and 

provided our responses below. 

Comment: Some commenters 

supported HHS’s proposed delay of the 

effective date of the final rule until not 

only July 1, 2018, but until HHS fulfills 

its commitment to engage in additional 

rulemaking that cures the substantive 

legal and practical concerns with the 

final rule. These commenters 

recommend that HRSA tie the further 

delay of the effective date of the final 

rule to the completion of such 

rulemaking, as opposed to a certain 

date. 

Response: HHS has decided to delay 

the effective date to July 1, 2018, to 

provide affected parties sufficient time 

to make needed changes to facilitate 

compliance and because HHS continues 

to examine important substantive issues 

arising from the January 5, 2017, final 

rule. After reviewing the comments 

received from stakeholders regarding 

objections on the timing of the effective 

date and challenges associated with 

complying with the final rule, HHS has 

determined that delaying the effective 

date to July 1, 2018, is necessary to 

consider some of the issues raised. HHS 

believes that delaying the effective date 

to July 1, 2018, provides sufficient time 

to address these issues and does not 

believe a further delay is necessary at 

this time. 

Comment: Some commenters stated 

that the January 5, 2017, final rule 

contains several policies that are 

inconsistent with the 340B statute and 

imposes needless burdens on 

manufacturers. These commenters urge 

HHS to delay the effective date to July 

1, 2018, and use the additional time to 

reconsider the policies included in the 

final rule. 

Responses: HHS intends to engage in 

further rulemaking and believes that 

this delay will provide HHS with time 

to consider the substantial questions of 

fact, law, and policy raised by the rule. 

Comment: Several commenters 

explained that a delay in the effective 

date of the final rule is also necessary 

to align with the Administration 

priorities of analyzing final, but not yet 

effective, regulations, and removing or 

minimizing unwarranted economic and 

regulatory burdens related to the 

Affordable Care Act, the law that added 

the provisions of the 340B statute that 

are the subject of the final rule. 

Response: HHS agrees with the 

commenters. Executive Order 13765 

instructs agencies to use discretion to 

delay the implementation of certain 

provisions of requirements of the 

Patient Protection and Affordable Care 

Act. As previously mentioned, HHS 

based the January 5, 2017, final rule on 

changes made to the 340B Program by 

the Patient Protection and Affordable 

Care Act. As such, HHS is complying 

with Executive Order 13765 to delay 

implementation on provisions of that 

law that ‘‘. . . impose a fiscal burden on 

any State or a cost, fee, tax, penalty, or 

regulatory burden on individuals, 

families, healthcare providers, health 

insurers, patients, recipients of 

healthcare services, purchasers of health 

insurance, or makers of medical devices, 

products, or medications.’’ The policies 

finalized in the January 5, 2017, final 

rule will require targeted and 

potentially costly changes to pricing 

systems and business procedures for 

manufacturers affected by the rule. 

Thus, HHS is delaying the effective date 

to July 1, 2018. 

Comment: Some commenters 

recommend that HHS delay the effective 

date of the final rule until HHS 

concurrently addresses 340B covered 

entity compliance obligations and 

penalties under the 340B statute, which 

is necessary to strengthen the integrity 

of the 340B Program. 

Response: HHS plans to issue separate 

policy documents for the different areas 

of the 340B program integrity provisions 

in the 340B statute and disagrees with 

the commenters advising HHS to 

address these issues concurrently. 

Comment: Many commenters opposed 

delaying the effective date to July 1, 

2018. Commenters recommended that 

HHS use its statutory rulemaking 

authority to balance the scales of 

enforcement and oversight in the 340B 

Program, and expressed concern that 

drug manufacturers have engaged in 

discriminatory pricing strategies due to 


asabaliauskas on DSKBBXCHB2PROD with RULES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 45513 

a lack of oversight and enforcement 

with respect to manufacturer behavior. 

They explained that various factors, 

including extensive data regarding 

overcharging covered entities, HHS’s 

inability to address overcharges, and 

HHS’s admission that many 

manufacturers are still out of 

compliance highlight the need for the 

final rule to go into effect immediately. 

They further explained that the January 

5, 2017, final rule is critical to ensuring 

that drug manufacturers uphold the 

intent of the 340B Program. The 

commenters also disagreed that ‘‘a more 

deliberative process is needed’’ as there 

have been multiple delays and 

stakeholders were given various 

opportunities to comment. 

Response: HHS does not agree that 

that we should enforce the final rule 

immediately. We are delaying the 

effective date of the January 5, 2017, 

final rule to July 1, 2018, because the 

delay will provide stakeholders with 

additional time to come into compliance 

and provide time to consider the 

substantial questions of fact, law, and 

policy raised by the rule. The final rule 

does not represent the only method for 

HHS to address manufacturer 

overcharges. In addition to the final 

rule, HHS performs audits of 

manufacturers, investigates all 

allegations of overcharging, and 

participates in settlements that have 

returned millions of dollars to covered 

entities. HHS believes that it would be 

disruptive to require stakeholders to 

make potentially costly changes to 

pricing systems and business 

procedures in order to comply with a 

rule that is under further consideration 

and for which substantive questions 

have been raised. 

While stakeholders had the 

opportunity to provide comments on the 

final rule, the 340B Program is a 

complex program that is affected by 

changes in other areas of health care. 

HHS has determined that this 

complexity and changing environment 

warrants further review of the final rule. 

Comment: Many commenters 

supported further delaying the effective 

date to July 1, 2018, at a minimum, and 

agreed with HHS that more time was 

needed for stakeholders to come into 

compliance and to consider substantial 

questions of fact, law and policy raised 

by the January 5, 2017, final rule. 

Response: HHS agrees with the 

commenters and will delay the effective 

date of the January 5, 2017, final rule to 

July 1, 2018. 

III. Regulatory Impact Analysis 

HHS examined the effects of this final 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 8, 

2011), the Regulatory Flexibility Act 

(Pub. L. 96–354, September 19, 1980), 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4), Executive Order 

13132 on Federalism (August 4, 1999), 

the Congressional Review Act, and 

Executive Order 13771 on Reducing 

Regulation and Controlling Regulatory 

Costs (January 30, 2017). 

Executive Orders 12866, 13563 and 

13771 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 is 

supplemental to and reaffirms the 

principles, structures, and definitions 

governing regulatory review as 

established in Executive Order 12866, 

emphasizing the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. Section 3(f) 

of Executive Order 12866 defines a 

‘‘significant regulatory action’’ as an 

action that is likely to result in a rule: 

(1) Having an annual effect on the 

economy of $100 million or more in any 

1 year, or adversely and materially 

affecting a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or Tribal governments or 

communities (also referred to as 

‘‘economically significant’’); (2) creating 

a serious inconsistency or otherwise 

interfering with an action taken or 

planned by another agency; (3) 

materially altering the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or (4) 

raising novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. 

A regulatory impact analysis (RIA) 

must be prepared for major rules with 

economically significant effects ($100 

million or more in any 1 year), and a 

‘‘significant’’ regulatory action is subject 

to review by the Office of Management 

and Budget (OMB) and is therefore, not 

a major rule under the Congressional 

Review Act. 

HHS does not believe that a delay of 

the effective date of the January 5, 2017, 

final rule will have an economic impact 

of $100 million or more, and is, 

therefore, not designated as an 

‘‘economically significant’’ rule under 

section 3(f)(1) of the Executive Order 

12866. Therefore, the economic impact 

of having no rule in place related to the 

policies addressed in the final rule is 

believed to be minimal, as the policies 

would not yet be required or 

enforceable. 

Executive Order 13771, titled 

‘‘Reducing Regulation and Controlling 

Regulatory Costs,’’ was issued on 

January 30, 2017. This final rule is not 

expected to be an EO 13771 regulatory 

action because this final rule is not 

significant under EO 12866. 

The Regulatory Flexibility Act (RFA) 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) (RFA) and the Small 

Business Regulatory Enforcement and 

Fairness Act of 1996, which amended 

the RFA, require HHS to analyze 

options for regulatory relief of small 

businesses. If a rule has a significant 

economic effect on a substantial number 

of small entities, the Secretary must 

specifically consider the economic 

effect of the rule on small entities and 

analyze regulatory options that could 

lessen the impact of the rule. HHS will 

use an RFA threshold of at least a 3 

percent impact on at least 5 percent of 

small entities. 

For purposes of the RFA, HHS 

considers all health care providers to be 

small entities either by meeting the 

Small Business Administration (SBA) 

size standard for a small business, or by 

being a nonprofit organization that is 

not dominant in its market. The current 

SBA size standard for health care 

providers ranges from annual receipts of 

$7 million to $35.5 million. As of 

January 1, 2017, over 12,000 covered 

entities participate in the 340B Program, 

which represent safety-net health care 

providers across the country. HHS has 

determined, and the Secretary certifies 

that this final rule will not have a 

significant impact on the operations of 

a substantial number of small 

manufacturers; therefore, we are not 

preparing an analysis of impact for this 

RFA. HHS estimates that the economic 

impact on small entities and small 

manufacturers will be minimal. 

Unfunded Mandates Reform Act 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and Tribal governments, in the 


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45514 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Rules and Regulations 

aggregate, or by the private sector, of 

$100 million or more (adjusted annually 

for inflation) in any one year.’’ In 2017, 

that threshold is approximately $148 

million. HHS does not expect this rule 

to exceed the threshold. 

Executive Order 13132—Federalism 

HHS has reviewed this final rule in 

accordance with Executive Order 13132 

regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ This final 

rule would not ‘‘have substantial direct 

effects on the States, or on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ 

Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)) requires that OMB 

approve all collections of information 

by a federal agency from the public 

before they can be implemented. This 

final rule is projected to have no impact 

on current reporting and recordkeeping 

burden for manufacturers under the 

340B Program. This final rule would 

result in no new reporting burdens. 

Comments are welcome on the accuracy 

of this statement. 

Dated: September 22, 2017. 

George Sigounas, 

Administrator, Health Resources and Services 

Administration. 

Thomas E. Price, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2017–20911 Filed 9–28–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

Federal Motor Vehicle Safety 

Standards 

CFR Correction 

In Title 49 of the Code of Federal 

Regulations, Parts 400 to 571, revised as 

of October 1, 2016, on page 319, in 

§ 571.106, standard S5.3.11 is reinstated 

to read as follows: 

§ 571.106 Standard No. 106; Brake hoses. 

* * * * * 

S5. Requirements—hydraulic brake 

hose, brake hose assemblies, and brake 

hose end fittings. 

* * * * * 

S5.3.11 Dynamic ozone test. A 

hydraulic brake hose shall not show 

cracks visible without magnification 

after having been subjected to a 48-hour 

dynamic ozone test (S6.9). 

* * * * * 

[FR Doc. 2017–21085 Filed 9–28–17; 8:45 am] 

BILLING CODE 1301–00–D 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 300 

[Docket No. 170815764–7877–01] 

RIN 0648–BH12 

International Fisheries; Pacific Tuna 

Fisheries; Revised 2017 Fishing 

Restrictions for Tropical Tuna in the 

Eastern Pacific Ocean 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS is issuing regulations 

under the Tuna Conventions Act to 

implement amendments to Resolution 

C–17–01 (Conservation of Tuna in the 

Eastern Pacific Ocean During 2017) per 

Resolution C–17–02 (Conservation 

Measures for Tropical Tunas in the 

Eastern Pacific Ocean During 2018– 

2020 and Amendment to Resolution C– 

17–01) which was adopted by the InterAmerican Tropical Tuna Commission 

(IATTC or Commission) in July 2017. 

Applicable to the purse seine fleet 

fishing for tropical tunas (bigeye, 

yellowfin, and skipjack tuna) in the 

eastern Pacific Ocean (EPO) and only for 

the remainder of the 2017 calendar year, 

the amendments to Resolution C–17–01 

remove the total allowable catches 

(TACs) for bigeye tuna (BET) and 

yellowfin tuna (YFT), and replace them 

with an extension in the purse seine 

closure period from 62 days to 72 days. 

Additionally, to ensure that the time/ 

area closure, known as the corralito, 

does not overlap with the extended 

closure periods, the amendments also 

shift the dates for the corralito closure. 

This rule is necessary for the 

conservation of tropical tuna stocks in 

the EPO and for the United States to 

satisfy its obligations as a member of the 

IATTC. 

DATES: This final rule is effective 

September 29, 2017. 

ADDRESSES: Copies of supporting 

documents that were prepared for this 

final rule, including the regulatory 

impact review (RIR) are available via the 

Federal e-Rulemaking Portal: http://

www.regulations.gov, docket NOAA– 

NMFS–2017–0024 or contact with the 

Regional Administrator, Barry A. Thom, 

NMFS West Coast Region, 1201 NE 

Lloyd Blvd., Suite 1100, Portland, OR 

97232–1274, or 

RegionalAdministrator.WCRHMS@

noaa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Taylor Debevec, NMFS at 562–980– 

4066. 

SUPPLEMENTARY INFORMATION: 

Background on the IATTC 

The United States is a member of the 

IATTC, which was established under 

the 1949 Convention for the 

Establishment of an Inter-American 

Tropical Tuna Commission. In 2003, the 

IATTC took the first step to dramatically 

revise the 1949 Convention by adopting 

the Convention for the Strengthening of 

the IATTC Established by the 1949 

Convention between the United States 

of America and the Republic of Costa 

Rica (Antigua Convention), which did 

not enter into force until 2010 when the 

requite number of members agreed to 

the revisions. After the Antigua 

Convention had entered into force in 

2010, the United States acceded to the 

Antigua Convention on February 24, 

2016. The full text of the Antigua 

Convention is available at: https://

www.iattc.org/PDFFiles2/Antigua_

Convention_Jun_2003.pdf. 

The IATTC consists of 21 member 

nations and four cooperating nonmember nations and facilitates scientific 

research into, as well as the 

conservation and management of, tuna 

and tuna-like species in the IATTC 

Convention Area. The IATTC 

Convention Area is defined as waters of 

the EPO within the area bounded by the 

west coast of the Americas and by 50° 

N. latitude, 150° W. longitude, and 50° 

S. latitude. The IATTC maintains a 

scientific research and fishery 

monitoring program and regularly 

assesses the status of tuna, sharks, and 

billfish stocks in the EPO to determine 

appropriate catch limits and other 

measures deemed necessary to promote 

sustainable fisheries and prevent the 

overexploitation of these stocks. 

International Obligations of the United 

States Under the Antigua Convention 

As a Party to the Antigua Convention 

and a member of the IATTC, the United 

States is legally bound to implement 

decisions of the IATTC. The Tuna 

Conventions Act (16 U.S.C. 951 et seq.) 

directs the Secretary of Commerce, in 

consultation with the Secretary of State 


asabaliauskas on DSKBBXCHB2PROD with RULES