Federal Register Vol. 81, No.16,

With this interim final rule, the Food and Nutrition Service (FNS) amends the SNAP regulations at 7 CFR part 272 to require State agencies to access employment data through the National Directory of New Hires (NDNH) at the time of certification, including recertification, to determine the eligibility status and correct benefit amount for SNAP applicants and participants. This requirement codifies section 4013 of the Agricultural Act of 2014 (Pub. L. 113-79). The legislation was effective on February 7, 2014, and FNS implemented the mandated requirements, including that associated with the NDNH requirement, by directive to all SNAP State agencies on March 21, 2014. This interim rule also amends regulations at 7 CFR 272.2 to change the requirement for State agency submission of the “Program and Budget Summary Statement Part B—Program Activity Statement” (FNS-366B, OMB #0584-0594, expiration date 6/30/2017) from an annual submission based on the State fiscal year to a quarterly submission based on the Federal fiscal year.

Current regulations at § 273.2(f)(1)(i) require State agencies to verify gross non-exempt income for all households prior to certification or, in instances where the State's attempts to verify the income with the employer have been unsuccessful, use the best available information to determine benefits. Additionally, regulations at § 273.12(a) and § 273.21 establish the SNAP household's responsibility to report applicable changes in income while participating in the Program. Thus, the accuracy of Program benefits issued to a household relies on the accuracy of reported and verified information.

The NDNH is a repository of employment, unemployment insurance, and quarterly wage data maintained by the U.S. Department of Health and Human Services (HHS) Office of Child Support Enforcement (OCSE). The data residing in the NDNH includes W-4 (new hire) records from the State Directory of New Hires, quarterly wage and unemployment insurance data from the State workforce agencies, and new hire and quarterly wage data from Federal agencies. The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) mandated the establishment of the NDNH in 1996. A major component of the Federal Parent Locator Service (FPLS), the NDNH was originally established for State Child Support Enforcement (CSE) Agencies to locate non-custodial parents in order to establish and enforce child support orders. As of February 2015, there were 64,571 employers and 33,610 subsidiaries listed in the NDNH. The number of employers and their subsidiaries listed in the NDNH generally increase each year. In 2014, over 4,320 new employers were added to the database.

The NDNH may only be accessed by authorized agencies with legislative authority. On July 27, 2006, Public Law 109-250 amended section 453(j) of Social Security Act (42 U.S.C. 653(j)) by the adding a new paragraph (10), which authorized State agencies administering SNAP under the Food and Nutrition Act of 2008 [7 U.S.C. 2011 et seq.] to access NDNH data for carrying out Program responsibilities. Prior to the amendment, State SNAP agencies could only access employment data made available through their own State Directory of New Hires for the determination of SNAP eligibility. Public Law 109-250 gave State SNAP agencies the option to access NDNH, thus providing an opportunity to receive employment data from other States, multi-State employers, and Federal agencies. Despite this change in legislation, few State agencies exercised the option to use it. Most State agencies instead opted to access employment data via their respective State Directory of New Hires, State Workforce Agency, and other data sources. By now requiring State agencies to access NDNH data for SNAP, FNS believes States will benefit from a reduction in improper payments due to unreported income.

This rule codifies in § 272.16 the requirement that each State agency must establish a system to compare identifiable information about each adult household member against data from the NDNH. Section 4013 of the Agricultural Act of 2014 mandates that States use NDNH to verify applicant and participant employment data and enter into a computer matching agreement with HHS pursuant to the authority in 42 U.S.C. 653(j)(10). State agencies must enter into a computer matching agreement with HHS in order to access the NDNH. States must continue to adhere to requirements § 272.12 addressing the use of information obtained from computer matching programs. The State agency may only use the required data matching to verify that the employment status of adult household members is accurately reported on the SNAP application. Because the NDNH does not include employment data on individuals under the age of 18, this verification requirement is limited to adult household members. The law further mandates the State agency to conduct matches against NDNH new hire data at the time of certification. FNS believes that conducting the match at both initial application and recertification will meet the intent of section 4013, and is therefore codifying the requirement for both certification and recertification.

The NDNH maintains three data sets. While this rule addresses the requirement for State agency matching against the NDNH new hire data set, States have the option to match against the quarterly wage and unemployment insurance data sets at their own discretion. Because the timeliness of quarterly wage and quarterly unemployment insurance data may not provide a true benefit to the State agency in determining eligibility and benefit levels, this rule only requires that States match against NDNH new hire data at minimum.

Data matching has provided many positive results for the efficient and effective administration of the program. However, it has come to the attention of FNS that there has been some confusion regarding reporting systems and integrity provisions for SNAP, specifically with regard to simplified reporting. Therefore, FNS wishes to clarify that in addition to the requirements of these integrity provisions, State agencies are also expected to comply with the requirements of the reporting system applicable to SNAP households provided at 7 CFR 273.12. State options for action on reported changes during the certification period must be followed, even for required data matches.

Data received through NDNH is not considered verified upon receipt. Consistent with requirements set forth in the Privacy Act (5 U.S.C. 552a(p)) and in SNAP regulation at 7 CFR 272.12(c), the State agency may not take any adverse action to terminate, deny, suspend, or reduce benefits to an applicant or SNAP recipient based on information provided by the NDNH unless the match information has been independently verified and a Notice of Adverse Action or Notice of Denial has been sent to the household. The Privacy Act defines independent verification as the investigation and confirmation of specific information relating to an individual used as a basis for an adverse action against the individual. Should there be a delay in the State agency's ability to verify the NDNH new hire match results within the required application processing timeline, the State agency is expected to continue processing the application without the requested documentation verifying the information. If, after either certification or recertification is completed, the State agency receives verification of information obtained through the NDNH match indicating that the household is ineligible or was approved for the incorrect benefit amount, the State should deny, reduce or terminate benefits, as applicable, and establish a claim to collect any benefits that were overpaid, in accordance with regulations at § 273.18.

With this rule, FNS is also modifying a reporting requirement of Stte agencies by increasing the frequency of submitting a Program Activity Statement from an annual submission based on the State fiscal year to a quarterly submission based on the Federal fiscal year. Section 16(a) of the Food and Nutrition Act of 2008 authorizes 50 percent Federal reimbursement for State agency costs to administer SNAP. SNAP regulations at 7 CFR 272.2(a) require that State agencies plan and budget Program operations and establish objectives for the next year. The basic components of the State Plan of Operation are the Federal/State Agreement, the Budget Projection Statement and the Program Activity Statement (7 CFR 272.2(a)(2)). Under current regulations at 7 CFR 272.2(c), the State agency is required to submit to FNS for approval a Budget Projection Statement (FNS-366A) which projects total Federal administrative costs for the upcoming fiscal year and a Program Activity Statement (FNS-366B) which provides Program activity data for the preceding fiscal year. Current regulations at 7 CFR 272.2(e)(2)(ii) require State agencies to submit the Program Activity Statement to FNS no later than 45 days after the end of the State agency's fiscal year, which is typically August 15 for most States. The Program Activity Statement was created to substantiate the costs the State agency expects to incur during the next fiscal year. It currently provides data on the number of SNAP applications the State agency processed, the number of fair hearings the State agency conducted, and the fraud control activities in which the State agency was engaged in the preceding year. FNS uses the data to monitor State agency activity levels and performance.

While originally intended only to support the States' annual SNAP budget request by providing a summary of State SNAP activities in the previous State fiscal year, the data reported on the Program Activity Statement has also become a vital tool for monitoring State operations related to application processing, fair hearings, and fraud prevention activities. The data reported on the Program Activity Statement enables FNS to identify areas that may need improvement and to provide more effective technical assistance to State agencies. The Agency believes an increase in reporting frequency will allow for greater and more timely access to Program data. It will help States, FNS, and other stakeholders identify trends, inconsistencies and inefficiencies earlier in each fiscal year. A 2014 U.S. Government Accountability Office (GAO) performance audit of FNS (GAO-14-641, Enhanced Detection Tools and Reporting Could Improve Efforts to Combat Recipient Fraud) concluded that State-reported data on anti-fraud activities are not reliable for ensuring Program integrity and assessing States' performance. Additionally, the study warned that data inconsistencies could limit FNS' ability to identify more effective and efficient practices for State anti-fraud efforts. With more current data, States and other interested parties will be able to identify gaps and areas in need of greater attention, and allow States to respond more quickly to those gaps. This increased responsiveness, along with a concurrent FNS effort to update and improve the reliability of the data collected in the Program Activity Statement, will help to address directly the concerns raised by GAO. With this regulation, FNS is also aligning the new quarterly requirement to the Federal fiscal year. As most SNAP data is reported monthly, quarterly or annually based on the Federal fiscal year, this change will improve FNS' ability to conduct data analysis by using data collected over consistent periods of time.

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 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This interim final rule has been determined to be not significant and was not reviewed by the Office of Management and Budget (OMB) in conformance with Executive Order 12866.

This interim final rule has been designated as not significant by the Office of Management and Budget; therefore, no Regulatory Impact Analysis is required.

The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Agencies to analyze the impact of rulemaking on small entities and consider alternatives that would minimize any significant impacts on a substantial number of small entities. Pursuant to that review, it has been certified that this interim final rule would not have a significant impact on a substantial number of small entities. While there may be some impact on the State and local agencies that administer the Program in implementing this provision, the impact is not expected to be significant. Applicants and recipients may also be impacted to the extent that matching client information with records in the National Directory of New Hires may identify a client as ineligible for the Program, thus preventing them from Program participation.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local and Tribal governments and the private sector. Under section 202 of the UMRA, the Department generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with Federal mandates that may result in expenditures by State, local or Tribal governments, in the aggregate, or the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory alternatives and adopt the most cost effective or least burdensome alternative that achieves the objectives of the rule.

This interim final rule does not contain Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local and Tribal governments or the private sector of $100 million or more in any one year. Thus, the rule is not subject to the requirements of sections 202 and 205 of the UMRA.

The Supplemental Nutrition Assistance Program is listed in the Catalog of Federal Domestic Assistance under No. 10.551. For the reasons set forth in the Final Rule codified in 7 CFR part 3015, subpart V and related Notice (48 FR 29115, June 24, 1983), this Program is excluded from the scope of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under section (6)(b)(2)(B) of Executive Order 13132. The Department has considered the impact of this interim final rule on State and local governments and has determined that this rule does not have federalism implications. Therefore, under section 6(b) of the Executive Order, a federalism summary is not required.

This interim final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full and timely implementation. This rule is not intended to have retroactive effect unless so specified in the Effective Dates section of the final rule. Prior to any judicial challenge to the provisions of the final rule, all applicable administrative procedures must be exhausted.

FNS has reviewed this interim final rule in accordance with USDA Regulation 4300-4, “Civil Rights Impact Analysis,” to identify any major civil rights impacts the rule might have on Program participants on the basis of age, race, color, national origin, sex or disability. After a careful review of the rule's intent and provisions, FNS has determined that this rule is not expected to affect the participation of protected individuals in SNAP.

This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

FNS has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. On February 18, 2015, the agency held a webinar for tribal participation and comments. If a Tribe requests consultation, FNS will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.

The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; 5 CFR part 1320) requires the Office of Management and Budget (OMB) approve all collections of information by a Federal agency before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number.

In accordance with the Paperwork Reduction Act of 1995, this interim final rule contains information collections that are subject to review and approval by the Office of Management and Budget; therefore, FNS is submitting an information collection under 0584-NEW, which contains the burden information in the rule for OMB's review and approval. These changes are contingent upon OMB approval under the Paperwork Reduction Act of 1995. When the information collection requirements have been approved, the Department will publish a separate action in the Federal Register announcing OMB's approval. Once approved the new provisions in this rule and the burden requirement associated with the National Directory of New Hires will be merged into the existing information collection for Supplemental Nutrition Assistance Program (SNAP) Forms: Applications, Periodic Reporting, Notices, OMB Control Number #0584-0064, expiration date 4/30/2016, which is currently under revision. New provisions and burden requirements in this rule associated with the Program Activity Statement (FNS-366B) will be merged into the existing information collection for the Food and Nutrition Service Food Programs Reporting System (FPRS), OMB Control Number #0584-0594, expiration date 6/30/2017, which is currently under revision.

Comments on this interim final rule must be received by March 28, 2016.

Send comments to Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for FNS, Washington, DC 20403. Please also send a copy of your comments to Jane Duffield, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Alexandria, VA 22302. For further information, or for copies of the information collection, please contact Jane Duffield at the above address.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Title: Supplemental Nutrition Assistance Program: Requirement for National Directory of New Hires Employment Verification and Annual Program Activity Reporting.

OMB Number: 0584—NEW.

Expiration Date: N/A.

Type of Request: New Collection.

Abstract: This rule codifies section 4013 of the Agricultural Act of 2014, requiring State agencies to access employment data through the National Directory of New Hires (NDNH) at the time of certification, including recertification, to determine eligibility status and correct benefit amount for SNAP applicants. This rule also amends regulations at 7 CFR 272.2 to increase the frequency of the requirement for State agency submission of the Program Activity Statement from an annual requirement based on the State fiscal year to a quarterly requirement, unless otherwise directed by FNS, based on the Federal fiscal year.

State agencies are required to submit (quarterly) to FNS a Program Activity Statement (FNS-366B) providing a summary of Program activity for the State agency's operations during the previous reporting period. The activity report provides data on the number of applications processed, number of fair hearings and fraud control activity. FNS uses the data to monitor State agency activity levels and performance.

Applicant and Recipient Screening: The State agency must compare identifiable information about each adult household member against information from the NDNH. States must make the comparison of matched data at the time of application and recertification and must independently verify any positive match results.

Verification of Match: The State agency must independently verify the information prior to taking any adverse action against an individual. Should the State agency receive employment information via the NDNH that was previously unreported by the household, the State agency may issue a Request for Contact to the household to verify the information or contact the employer directly, depending upon applicable reporting requirements as defined at 7 CFR 273.12.

Notice: The Notice of Adverse Action or Notice of Denial is issued by State agencies to participating households whose benefits will be reduced or terminated as the result of a change in household circumstances. Should the State agency independently verify unreported or underreported income discovered through NDNH, and that income results in a reduction of benefits or change in eligibility, the State agency must take action by issuing the household a Notice of Adverse Action or Notice of Denial and adjusting benefits accordingly.

Burden Estimates: Out of the 251,482.35 hours requested for this new information collection request and after OMB's approval, FNS will merge the total reporting burden estimates into 0584-0064 are 249,252.64 burden hours & 12,276,992 total annual responses; and, the total reporting burden into 0584-0594 is 2,229.71 burden hours and 159 total annual responses. After approval into these existing collection packages and there are no recordkeeping requirements with these new or changing provisions.

See the burden breakdown by affected public below. After OMB approval of this information collection request, the program plans to publish another notice in the Federal Register announcing OMB's approval.

Respondents: State and local agencies, households.

Estimated Number of Respondents: 891,125.

Estimated Number of Responses per Respondent: 13.78.

Estimated Total Annual Burden on Respondents: 252,432.64 hours. See the table below for estimated total annual burden for each type of respondent.

The Department is committed to complying with the E-Government Act of 2002 to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Accordingly, 7 CFR part 272 is amended as follows:

Airworthiness Directive 2015-25-08, Amendment 39-18346 (80 FR 80234, December 24, 2015), currently requires repetitive inspections for any crack in the aft webs of the radial lap splices of the aft pressure bulkhead, and, if necessary, corrective actions, for all The Boeing Company Model 777 airplanes.

As published, paragraph (i)(4) of the regulatory text contains a reference to a nonexistent paragraph. Paragraph (i)(4) of the AD incorrectly references paragraph “(l)(4)(ii)”; however, the correct reference is paragraph “(i)(4)(ii).”

We reviewed Boeing Alert Service Bulletin 777-53A0078, dated December 5, 2014. This service information describes procedures for inspections of the lap splices in the web of the aft pressure bulkhead for cracking, and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This document corrects an error and correctly adds the AD as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13). Although no other part of the preamble or regulatory information has been corrected, we are publishing the entire rule in the Federal Register.

The effective date of this AD remains January 28, 2016.

Since this action only corrects a paragraph reference, it has no adverse economic impact and imposes no additional burden on any person. Therefore, we have determined that notice and public procedures are unnecessary.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain EA GP7270 turbofan engines. The NPRM published in the Federal Register on October 1, 2015 (80 FR 59081). The NPRM was prompted by the manufacturer informing us that the inspection criteria and repair procedures in the maintenance manual for aft bolt holes of the HPC cone shaft, also referred to as the “HPC forward stubshaft,” for the affected engines is incorrect. The NPRM proposed to require inspection of the HPC cone shaft and repair of affected parts, if needed. We are issuing this AD to prevent failure of the HPC cone shaft, which could lead to uncontained engine failure and damage to the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 59081, October 1, 2015) and the FAA's response to each comment.

EA requested that we expand the applicability to include the GP7272 and GP7277 engine models.

We disagree. There are no GP7272 or GP7277 engines in service nor have any been delivered. New engines would be delivered with corrected service information and would not be impacted by this AD. We did not change this AD.

EA requested that the unsafe condition statement be changed from “We are issuing this AD to prevent failure of the HPC cone shaft, which could lead to uncontained engine failure and damage to the airplane.” to “We are issuing this AD to prevent a hazardous engine condition.” The reason for this request is that no HPC cone shaft failures have occurred in the field.

We disagree. The unsafe condition statement describes the condition we are trying to prevent and is the justification for this AD. It does not describe what has occurred in the past. We did not change this AD.

EA requested that we revise the part nomenclature in the Applicability, Compliance, and Installation Prohibition paragraphs and in the unsafe condition statement to include both “cone shaft” and “forward stubshaft.” The part is referenced as a “cone shaft” in this AD and engine and component manuals; however, it is referred to as a “forward stubshaft” in the service bulletins (SBs).

We disagree. The part nomenclature listed in the airworthiness limitations section and engine maintenance manual is “cone shaft.” The Discussion section of this AD explains that the terms “cone shaft” and “forward stubshaft” are synonymous. We consider including both terms throughout this AD unnecessary. We did not change this AD.

EA requested that the Compliance paragraph be revised to include the word “pits” when describing the inspection criteria.

We agree. We revised paragraph (e)(1) and (f)(1) of this AD from “. . . nicks, dents, and scratches . . .” to “. . . nicks, dents, pits, and scratches. . . .”

EA requested that we replace “Do not reinstall the HPC cone shaft if the aft bolt hole has a nick, dent, or scratch that is greater than 0.002 inch in depth” in paragraph (e)(1) of this AD with “Comply with the Accomplishment Instructions in EA SB No. EAGP7-72-330 if the aft bolt hole has a nick, dent, pit, or scratch that is greater than the serviceable limit.”

We disagree. The current engine manual has an approved repair procedure for damage that is more severe than the installation requirements of this AD. It is not necessary to restate what is already allowed by the engine manual. We did not change this AD.

EA requested that the phrase “or later” be used when referring to SBs.

We disagree. We are only authorized to mandate use of SBs that we have reviewed and which are published. Since future revisions of SBs are not yet published, we are not authorized to mandate their use. We did not change this AD.

EA requested that we change the Installation Prohibition paragraph to read: “After the effective date of this AD, do not install an HPC cone shaft onto an engine: (1) that has accumulated more than 9,000 cycles since new that has not complied with this AD on an applicable part, and (2) has a nick, dent, or scratch in an HPC cone shaft aft bolt hole that is greater than the serviceable limit.”

We disagree. The intent of the Installation Prohibition paragraph is to mandate the new serviceable limit of 0.002 inch for damage to the inner diameter of the bolt holes for the entire GP7270 fleet. Any parts with damage beyond this limit may be repaired using the approved procedures listed in the engine manual, provided that you include shot peening as required by paragraph (f)(2) of this AD. We did not change this AD.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

EA has issued SB No. EAGP7-72-329, dated July 21, 2015 and SB No. EAGP7-72-330, dated July 21, 2015. The service information describes procedures for shotpeening the HPC forward stubshaft and inspecting the HPC forward stubshaft bolt-hole inner diameter respectively. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this final rule.

We estimate that this AD affects zero engines installed on airplanes of U.S. registry. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $0.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A318-111 and -112 airplanes; Model A319-111, -112, and -115 airplanes; Model A320-214 airplanes; and Model A321-111, -112, -211, -212, and -213 airplanes. The NPRM published in the Federal Register on July 2, 2015 (80 FR 38036).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0276, dated December 19, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A318-111 and -112 airplanes; Model A319-111, -112, and -115 airplanes; Model A320-214 airplanes; and Model A321-111, 112, -211, -212, and -213 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-1991-0003.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 38036, July 2, 2015) or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (80 FR 38036, July 2, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 38036, July 2, 2015).

Airbus has issued Service Bulletin A320-71-1062, dated July 28, 2014. Goodrich Aerostructures has issued Service Bulletin RA32071-151, dated June 11, 2014. The service information describes procedures for inspection and replacement of the hinge nuts of the fan cowl door. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 437 airplanes of U.S. registry.

We also estimate that it takes about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $74,290, or $170 per product.

We have received no definitive data that would enable us to provide a cost estimate for the on-condition actions specified in this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-1991; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain CFM CFM56-5B series turbofan engines. The NPRM published in the Federal Register on October 2, 2015 (80 FR 59672). The NPRM was prompted by a corrected lifing analysis by the engine manufacturer that shows the need to identify an initial and repetitive inspection threshold for certain P/N TRFs. The NPRM proposed to require initial and repetitive inspections of certain P/N TRFs on the LPT frame assembly. We are issuing this AD to correct the unsafe condition on these products.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 59672, October 2, 2015) or on the determination of the cost to the public.

We have revised the Compliance, paragraph (e) of this AD, to clarify the repetitive inspection requirements for when the initial inspection is done prior to the initial inspection threshold.

We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for the changes described above. We have determined that the changes described above are minor changes, as they:

• Are consistent with the intent that was proposed in the NPRM (80 FR 59672, October 2, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 59672, October 2, 2015).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We reviewed CFM Service Bulletin (SB) No. CFM56-5B S/B 72-0850, dated December 19, 2012, which describes procedures for inspecting the TRF. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this final rule.

We also reviewed CFM SB No. CFM56-5B S/B 72-0308. Operators subject to this AD are required to follow different initial and repetitive inspection intervals depending on whether CFM SB No. CFM56-5B S/B 72-0308 has been applied.

We estimate that this AD affects about 94 engines installed on airplanes of U.S. registry. We also estimate that it will take about 3 hours per engine to do the inspection. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $23,970.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR § 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

This amendment provides the affected CFRs, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore— (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

1. Pursuant to section 215 of the Federal Power Act (FPA),1 the Commission approves seven critical infrastructure protection (CIP) Reliability Standards: CIP-003-6 (Security Management Controls), CIP-004-6 (Personnel and Training), CIP-006-6 (Physical Security of BES Cyber Systems), CIP-007-6 (Systems Security Management), CIP-009-6 (Recovery Plans for BES Cyber Systems), CIP-010-2 (Configuration Change Management and Vulnerability Assessments), and CIP-011-2 (Information Protection) (proposed CIP Reliability Standards). The North American Electric Reliability Corporation (NERC), the Commission-certified Electric Reliability Organization (ERO), submitted the seven proposed CIP Reliability Standards in response to Order No. 791.2 The Commission also approves NERC's implementation plan and violation risk factor and violation severity level assignments. In addition, the Commission approves NERC's new or revised definitions for inclusion in the NERC Glossary of Terms Used in Reliability Standards (NERC Glossary), subject to modification. Further, the Commission approves the retirement of Reliability Standards CIP-003-5, CIP-004-5.1, CIP-006-5, CIP-007-5, CIP-009-5, CIP-010-1, and CIP-011-1.

2. The proposed CIP Reliability Standards are designed to mitigate the cybersecurity risks to bulk electric system facilities, systems, and equipment, which, if destroyed, degraded, or otherwise rendered unavailable as a result of a cybersecurity incident, would affect the reliable operation of the Bulk-Power System.3 As discussed below, the Commission finds that the proposed CIP Reliability Standards are just, reasonable, not unduly discriminatory or preferential, and in the public interest, and address the directives in Order No. 791 by: (1) Eliminating the “identify, assess, and correct” language in 17 of the CIP version 5 Standard requirements; (2) providing enhanced security controls for Low Impact assets; (3) providing controls to address the risks posed by transient electronic devices (e.g., thumb drives and laptop computers) used at High and Medium Impact BES Cyber Systems; and (4) addressing in an equally effective and efficient manner the need for a NERC Glossary definition for the term “communication networks.” Accordingly, the Commission approves the proposed CIP Reliability Standards because they improve the base-line cybersecurity posture of applicable entities compared to the current Commission-approved CIP Reliability Standards.

3. In addition, pursuant to FPA section 215(d)(5), the Commission directs NERC to develop certain modifications to improve the CIP Reliability Standards. First, NERC is directed to develop modifications to address the protection of transient electronic devices used at Low Impact BES Cyber Systems. As discussed below, the modifications developed by NERC should be designed to effectively address, in an appropriately tailored manner, the risks posed by transient electronic devices to Low Impact BES Cyber Systems. Second, the Commission directs NERC to develop modifications to CIP-006-6 to require protections for communication network components and data communicated between all bulk electric system Control Centers according to the risk posed to the bulk electric system. With regard to the questions raised in the Notice of Proposed Rulemaking (NOPR) concerning the potential need for additional remote access controls, NERC must conduct a comprehensive study that identifies the strength of the CIP version 5 remote access controls, the risks posed by remote access-related threats and vulnerabilities, and appropriate mitigating controls.4 Third, the Commission directs NERC to develop modifications to its definition for Low Impact External Routable Connectivity, as discussed in detail below.

4. The Commission, in the NOPR, also proposed to direct that NERC develop requirements relating to supply chain management for industrial control system hardware, software, and services.5 After review of comments on this topic, the Commission scheduled a staff-led technical conference for January 28, 2016, in order to facilitate a structured dialogue on supply chain risk management issues identified by the NOPR. Accordingly, this Final Rule does not address supply chain risk management issues. Rather, the Commission will determine the appropriate action on this issue after the scheduled technical conference.

5. Section 215 of the FPA requires a Commission-certified ERO to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval. Reliability Standards may be enforced by the ERO, subject to Commission oversight, or by the Commission independently.6 Pursuant to section 215 of the FPA, the Commission established a process to select and certify an ERO,7 and subsequently certified NERC.8

6. On November 22, 2013, in Order No. 791, the Commission approved the CIP version 5 Standards (Reliability Standards CIP-002-5 through CIP-009-5, and CIP-010-1 and CIP-011-1).9 The Commission determined that the CIP version 5 Standards improve the CIP Reliability Standards because, inter alia, they include a revised BES Cyber Asset categorization methodology that incorporates mandatory protections for all High, Medium, and Low Impact BES Cyber Assets, and because several new security controls should improve the security posture of responsible entities.10 In addition, pursuant to section 215(d)(5) of the FPA, the Commission directed NERC to: (1) Remove the “identify, assess, and correct” language in 17 of the CIP Standard requirements; (2) develop enhanced security controls for Low Impact assets; (3) develop controls to protect transient electronic devices; (4) create a NERC Glossary definition for the term “communication networks;” and (5) develop new or modified Reliability Standards to protect the nonprogrammable components of communications networks.

7. The Commission also directed NERC to conduct a survey of Cyber Assets that are included or excluded under the new BES Cyber Asset definition and submit an informational filing within one year.11 On February 3, 2015, NERC submitted an informational filing assessing the results of a survey conducted to identify the scope of assets subject to the definition of the term BES Cyber Asset as it is applied in the CIP version 5 Standards.

8. Finally, Order No. 791 directed Commission staff to convene a technical conference to examine the technical issues concerning communication security, remote access, and the National Institute of Standards and Technology (NIST) Risk Management Framework.12 On April 29, 2014, a staff-led technical conference was held pursuant to the Commission's directive. The topics discussed at the technical conference included: (1) The adequacy of the approved CIP version 5 Standards' protections for bulk electric system data being transmitted over data networks; (2) whether additional security controls are needed to protect bulk electric system communications networks, including remote systems access; and (3) the functional differences between the respective methods utilized for the identification, categorization, and specification of appropriate levels of protection for cyber assets using the CIP version 5 Standards as compared with those employed within the NIST Cybersecurity Framework.

The Union Pacific Railroad requested a temporary deviation for the Chicago and Northwestern Railroad Drawbridge, across the Upper Mississippi River, mile 839.2, at St. Paul, Minnesota to be closed to navigation from 12:01 a.m., January 18, 2016 until 11:59 p.m., January 23, 2016 and from 12:01 a.m., February 1, 2016 until 11:59 p.m., February 6, 2016 for a total of twelve days for scheduled maintenance and for replacement of the liftspan counter weight wire ropes on the bridge. This deviation is scheduled during the winter months causing the least impact on navigation under the bridge.

The Chicago and Northwestern Railroad Drawbridge currently operates in accordance with 33 CFR 117.671(b), which states the general requirement that the drawbridge shall open on signal except from December 15 through the last day of February drawbridge shall open on signal if at least 12 hours notice is given.

There are no alternate routes for vessels transiting this section of the Upper Mississippi River. The bridge cannot open in case of emergency.

The Chicago and Northwestern Railroad Drawbridge provides a vertical clearance of 25.1 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft and will not be significantly impacted. This temporary deviation has been coordinated with waterway users. No objections were received.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Preamble to this FR is organized as follows:

On October 6, 2008, HHS/CDC published an interim final rule (IFR) (73 FR 58047) to amend its regulations that govern medical examinations that aliens must undergo before they are admitted to the United States. HHS/CDC amended the definition of “communicable disease of public health significance” by adding (1) quarantinable diseases designated by Presidential Executive Order, and (2) those diseases that meet the criteria of a public health emergency of international concern which require notification to the World Health Organization (WHO) under the revised International Health Regulations (IHR) of 2005 (http://www.who.int/ihr/en/). These amendments to the definition of communicable disease of public health significance permitted a more flexible, risk-based approach to the medical examination, based on medical and epidemiologic factors. The IFR also updated the screening requirements for tuberculosis to be consistent with current medical knowledge and practice. The public was invited to comment on these amendments; the comment period ended December 5, 2008. On October 20, 2008, HHS/CDC published correcting amendments (73 FR 62210) that corrected an omission in the IFR. This document clarified that an alien of any age in the United States who applies for adjustment of status to permanent resident shall not be required to have a chest x-ray examination unless their tuberculin skin test, or an equivalent test that shows an immune response to Mycobacterium tuberculosis, is positive. HHS/CDC received three comments to the IFR, two comments from the public and one comment from a professional organization. A summary of those comments and a response to those comments are found at Section IV, below.

On June 23, 2015, HHS/CDC published a notice of proposed rulemaking (NPRM) (80 FR 35899) that proposed to amend its regulations to (1) revise the definition of communicable disease of public health significance by removing chancroid, granuloma inguinale, and lymphogranuloma venereum as inadmissible health-related conditions for aliens seeking admission to the United States; (2) update the notification of the health-related grounds of inadmissibility to include proof of vaccinations to align with existing requirements established by the Immigration and Nationality Act (INA) (8 U.S.C.A. 1101 et seq.); (3) revise the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction; (4) clarify and revise the evaluation requirements for tuberculosis; (5) clarify and revise the process for the HHS/CDC-appointed medical review board that convenes to reexamine the determination of a Class A medical condition based on an appeal; and (6) update the titles and designations of federal agencies within the text of the regulation. Specifically, HHS/CDC sought comment on:

1. Whether infectious Hansen's disease (previously referred to in regulation as infectious leprosy), infectious syphilis and/or gonorrhea should be removed from the definition of communicable disease of public health significance;

2. Whether the definition of communicable disease of public health significance and the scope of the medical examination should be revised as proposed in this regulation;

3. Whether the statutory requirement that aliens demonstrate proof of vaccinations should be incorporated into the regulations as a notifiable medical condition. To further clarify this question, HHS/CDC did not request comment on the statutory language itself as HHS/CDC does not have the authority to alter statutory language. Rather, we were interested in comment on the advisability of incorporating statutory language into regulations;

4. Whether the requirement that immigrants demonstrate proof of vaccination against vaccine-preventable diseases recommended by the Advisory Committee on Immunization Practices (ACIP) should be limited to only those vaccines for which a public health need exists at the time of immigration or adjustment of status. CDC has previously published criteria for determining whether a public health need exists at the time of immigration or adjustment of status. See 74 FR 58634 (Nov. 13, 2009). HHS/CDC was not seeking comment on the criteria, but rather on the incorporation of this standard into the regulations;

5. Whether the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction should be revised as proposed in this regulation;

6. Whether the requirements for evaluating the presence of tuberculosis in alien applicants should be clarified and revised as proposed in this regulation; and

7. Whether the process for convening a medical review board and reexamination of an alien by a medical review board should be revised as proposed in this regulation.

HHS/CDC is amending the regulation under the authority of 42 U.S.C. 252 and 8 U.S.C. 1182 and 1222.

Beginning in 1952, the language of the Immigration and Nationality Act (INA) mandated that, among other grounds for inadmissibility, aliens “who are afflicted with any dangerous contagious disease” are ineligible to receive a visa and therefore are excluded from admission into the United States. In 1990, Congress amended the INA by revising the classes of excludable aliens to provide that an alien who is determined (in accordance with regulation prescribed by the Secretary of Health and Human Services) to have a communicable disease of public health significance shall be excludable from the United States. Immigration Act of 1990, Public Law 101-649, section 601, 104 Stat. 4978 January 23, 1990; INA section 212(a)(1)(A)(i), 8 U.S.C. 1182(a)(1)(A)(i) (effective June 1, 1991). At the time of the 1990 INA amendments, the following specific communicable illnesses rendered an alien inadmissible: Active tuberculosis, infectious syphilis, gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum, granuloma inguinale, and human immunodeficiency virus (HIV) infection. HHS/CDC subsequently published a proposed rule that would have removed from the list all diseases except for active tuberculosis. 56 FR 2484 (January 23, 1991). Based on the review and consideration of public comments received on this proposal, HHS published an interim final rule retaining all communicable diseases on the list and committed its initial proposal for further study. See 56 FR 25000 (May 31, 1991). On October 6, 2008, HHS/CDC published an Interim Final Rule (IFR) announcing a revised definition of communicable disease of public health significance and revised scope of the medical examination in 42 CFR part 34. This IFR addressed concerns regarding emerging and reemerging diseases in alien populations who are bound for the United States. See 73 FR 58047 and 73 FR 62210.

With the 2008 revision to 42 CFR part 34, the definition of communicable disease of public health significance was modified to include two disease categories: (1) Quarantinable diseases designated by Presidential Executive Order; and (2) a communicable disease that may pose a public health emergency of international concern in accordance with the International Health Regulations (IHR) of 2005, provided the disease meets specified criteria in addition to the list of specific illnesses. Specific illnesses remaining as a communicable disease of public health significance were active tuberculosis, infectious syphilis, gonorrhea, infectious Hansen's disease (previously referred to in regulation as infectious leprosy), chancroid, lymphogranuloma venereum, granuloma inguinale, and HIV infection.

In response to a 2008 amendment to the INA, on July 2, 2009, HHS/CDC published a Notice of Proposed Rulemaking (NPRM) (74 FR 31798), which proposed two regulatory changes: (1) The removal of HIV infection from the definition of communicable disease of public health significance; and (2) removal of references to serologic testing for HIV from the scope of examinations. On November 2, 2009, HHS/CDC published a final rule, effective on January 4, 2010 (74 FR 56547), that removed HIV infection and testing for HIV infection from part 34 regulations.

HHS/CDC identified the need for this rulemaking through an annual retrospective review of its regulations. Executive Order 13563 “Improving Regulation and Regulatory Review” requires Federal agencies to periodically review existing regulations to eliminate those regulations that are obsolete, unnecessary, burdensome, or counterproductive or revise regulations to increase their effectiveness, efficiency, and flexibility.

Through this final rule, HHS/CDC will revise 42 CFR part 34 to reflect modern terminology and plain language commonly used in medicine and science by public health partners in the medical examination of aliens. Likewise, we are revising part 34 to include text that accurately reflects the statutory and administrative changes that have occurred within the Federal Government regarding agencies and/or departments responsible for this process. These revisions will ensure regulations that govern the medical examination of aliens are based upon accepted contemporary scientific principles as well as current medical practices.

The following is a section-by-section summary of the changes to part 34:

HHS/CDC is replacing the acronym “INS” within 34.1(c) with “DHS” to best reflect the administrative changes that have occurred within the Federal Government regarding agencies and/or departments responsible for the medical examination of aliens.

In this final rule, HHS/CDC is revising the definitions of: CDC, Communicable disease of public health significance, Civil Surgeon, Class A medical notification, Class B medical notification, Director, Drug abuse, Drug addiction, Medical notification, Medical hold document, Medical officer, Mental disorder and Physical disorder.

Additionally, HHS/CDC is adding definitions for DHS and HHS and removing the definition of INS.

The definition of CDC is updated to reflect the current official title of the Agency: Centers for Disease Control and Prevention, Department of Health and Human Services. In doing so, we removed “Public Health Services” from the definition.

This provision now defines communicable disease of public health significance as both a specific list of diseases and categories of diseases for which all aliens are inadmissible to the United States. This final rule removes three uncommon bacterial infections associated with genital ulcer disease: Chancroid, granuloma inguinale, and lymphogranuloma venereum, from the specific list of communicable disease of public health significance as provided for in 42 CFR 34.2(b).

HHS/CDC has removed the specific language of “District Director” and “INS” from the definition of civil surgeon to align with the specific language of the definition of civil surgeon as provided for in Department of Homeland Security (DHS) regulations in 8 CFR part 232. HHS/CDC is also removing “with not less than 4 years' professional experience” from the definition of civil surgeon. Through complimentary regulations promulgated by DHS at 8 CFR part 232, the requirement of 4 years' professional experience for civil surgeons will remain in effect. This change removes a redundancy found in HHS/CDC regulation and does not affect a substantive change in policy. HHS/CDC will continue to consult with the Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS) as needed, regarding recommendations for civil surgeon requirements. Therefore, the definition of civil surgeon means a physician designated by DHS to conduct medical examinations of aliens in the United States who are applying for adjustment of status to permanent residence or who are required by DHS to have a medical examination.

HHS/CDC is amending the definition of Class A medical notification by incorporating statutory language requiring documentary proof of vaccination. This requirement is provided by section 341 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA) which amended Section 212 of the INA. Part 34 is updated to explicitly include the requirement for proof of vaccination as previously specified in the IIRIRA. See Public Law 104-208, Div. C, 110 Stat. 3009-546. Lack of proof of vaccination will result in the issuance of a Class A medical notification. This additional language will not change current practices, but simply reflects updated statutory language.

The definition also includes the vaccination exemption specifically provided in Section 212 of the INA for an adopted child who is 10 years of age or younger. This exemption is applicable if, prior to the admission of the child, an adoptive or prospective adoptive parent, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that the child will be vaccinated within 30 days of the child's admission, or at the earliest time that is medically appropriate. Execution of this affidavit will prevent a Class A medical notification from being generated for lack of proof of vaccination. This additional language does not change current practices, but reflects updated statutory language.

The final rule updates the definition of Director to reflect the current official title of the CDC Director, as well as his/her delegation authorities.

We are adding DHS to the definitions in order to best reflect the administrative changes that have occurred within the Federal Government regarding agencies and/or departments responsible for the medical examination of aliens.

HHS/CDC is revising the definitions of drug abuse and drug addiction to align with the definitions of “substance use disorders” and “substance-induced disorders,” provided by the Diagnostic and Statistical Manual for Mental Disorders (DSM) published by the American Psychiatric Association (25). The DSM is the medical standard for the diagnosis of mental disorders and substance-related disorders and provides current diagnostic criteria based on the latest available evidence.

This final rule updates the definition of Medical hold document by replacing “INS” with “DHS”, replacing “Public Health Service” with “HHS/CDC” and replacing “quarantine inspector” with “quarantine officer.”

The final rule amends the definition of medical notification by adding proof of vaccination requirements as already provided by section 341 of the IIRIRA which amended Section 212 of the INA. This amendment updates part 34 to include the requirement for proof of vaccination that is currently specified in statute in the IIRIRA and for those ACIP-recommended vaccinations for which HHS/CDC determines, by applying criteria published in the Federal Register, a public health need exists at the time of immigration or adjustment of status. This is not a substantive change to the regulation, as it will not affect current practice.

Based on this update, medical notification, according to the INA, means a medical examination document issued to a consular authority or DHS by a medical examiner that includes the following additional language: “(2) Documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: Mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and any other vaccinations against vaccine-preventable diseases recommended by the ACIP for which HHS/CDC determines, by applying criteria published in the Federal Register, there is a public health need at the time of immigration or adjustment of status.”

The final rule removes “of the Public Health Service Commissioned Corps” from the definition of medical officer to reflect that a medical officer for these purposes is not required to be a member of the U.S. Public Health Service Commissioned Corps.

The final rule clarifies mental disorder as a currently accepted psychiatric diagnosis, as defined by the most recent edition of the DSM published by the American Psychiatric Association (17) or in another authoritative source as approved by the Director. This revision adds “most recent” to qualify the version of the DSM referenced in this definition and clarifies the intent of HHS/CDC that such diagnoses align with current science and medical practice. This update also allows for the possibility of other authoritative sources to be used in the future based on the most current medical science and in the event that the DSM is no longer the accepted authoritative source for determining a psychiatric diagnosis.

The final rule defines physical disorder to mean a currently accepted medical diagnosis, as defined by the most recent edition of the Manual of the International Classification of Diseases, Injuries, and Causes of Death (ICD) published by the World Health Organization (26) or in another authoritative source as approved by the Director. HHS/CDC is adding “most recent version” to qualify the version of the ICD referenced in this definition and to be consistent with the current Section 212 of the INA. HHS/CDC also allows for the possibility of other authoritative sources to be used in the future based on the most current medical science and in the event that the ICD is no longer the accepted authoritative source for determining a physical diagnosis.

This section applies to those aliens who are required to undergo a medical examination for U.S. immigration purposes. The scope of the examination outlines those matters that relate to inadmissible health-related conditions and was revised in 2008 through an interim final rule. The 2008 interim final rule provided specific screening and testing requirements for those diseases that meet the current definition of communicable disease of public health significance in § 34.2(b) of 42 CFR part 34. This final rule further updates this section to incorporate statutory language requiring documentation for vaccine-preventable disease and HHS/CDC's understanding that ACIP vaccine recommendations should only be applied in an immigration context when a public health need exists.

In 2009, HHS/CDC published a final notice in the Federal Register, adopting proposed criteria that HHS/CDC intended to use to determine which vaccines recommended by the ACIP for the general U.S. population should be required for immigrants seeking admission into the United States or seeking adjustment of status to that of an alien lawfully admitted for permanent residence based on public health needs (74 FR 58634). These criteria became effective on December 14, 2009. Since then, HHS/CDC has relied on such criteria to determine which vaccines aliens must receive as part of the immigration medical screening process.

The 2015 NPRM proposed to formally incorporate a reference to this criteria into this final rule. HHS/CDC did not receive public comment in opposition of the incorporation. Therefore, under this final rule, HHS/CDC has modified the regulatory text to reflect reference to these criteria where appropriate. We note that if there is a future need for HHS/CDC to reconsider these established criteria, HHS/CDC will solicit comments through publication in the Federal Register. In subsection (a)(2)(i), we have also inserted the word “current” in front of “physical or mental disorder” as stated in section 212 of INA.

The final rule revised § 34.3(a)(2) to include proof of vaccination requirements as provided by section 341 of IIRIRA of 1996 which amended Section 212 of the INA.

The final rule amends § 34.3(e)(1) to clarify the scope of examination requirements that apply to anyone who is required by DHS to have a medical examination for the purpose of determining their admissibility. The final rule adds § 34.3(e)(1)(v) “Applicants required by DHS to have a medical examination in connection with the determination of their admissibility into the United States.”

The final rule includes the following changes to provide consistency in the required evaluation for tuberculosis: Replace all references to “chest x-ray” in § 34.3(e) with “chest radiograph”; clarify that § 34.3(e)(3)(ii) applies to aliens in the United States; and to remove the specific size of chest radiograph provided in § 34.3(e)(5). These changes reflect current medical terminology and technical practice.

The final rule amends § 34.3(e)(2)(iii) by removing “and HIV” to correct the typographical error in the current rule language and reflect that testing for HIV is no longer required. The requirement for serologic testing for syphilis will remain and the final rule includes language to allow the Director to test for other communicable diseases of public health significance (as defined) through technical instructions.

The final rule amends §§ 34.3(e)(3)(i) and 34.3(e)(3)(ii) to reflect the scope of currently available medical tests. The final rule replaces “positive tuberculin reaction” with “positive test of immune response to Mycobacterium tuberculosis antigens” in §§ 34.3(e)(3)(i) and 34.3(e)(3)(ii).

To allow HHS/CDC discretion to apply appropriate medical screening procedures, the final rule amends §§ 34.3(e)(3)(iii) and 34.3(e)(3)(iv) regarding application of tests of immune response by adding “as determined by the Director.”

To allow for additional testing in medically appropriate circumstances, the final rule revises § 34.3(e)(4) by removing “subject to the chest radiograph requirement, and for whom the radiograph shows an abnormality suggestive of tuberculosis disease,” replaces “shall” with “may,” and adds “based on medical evaluation.” Thus, in the final rule, this revision reads: “All applicants may be required to undergo additional testing for tuberculosis based on the results of the medical evaluation.”

To reflect current practice and INA statutory language, the final rule amends § 34.3(b)(2) by adding “or other relevant records” to ensure that all appropriate available medical documentation may be considered. Thus, in the final rule, this revision reads: “For the examining physician to reach a determination or conclusion about the presence or absence of a physical or mental abnormality, disease, or disability, the scope of the examination shall include any laboratory or additional studies that are deemed necessary, either as a result of the physical examination or pertinent information elicited from the alien's medical history or other relevant records.”

The final rule includes language under § 34.3(f), transmission of records, to ensure that electronic submissions may be acceptable as provided by the Director. Finally, the final rule amends § 34.3(g)(4) by replacing “excludable” with “inadmissible” in § 34.3(g)(4) to reflect modern terminology.

The final rule revises § 34.4(b)(1)(ii) to include proof of vaccination requirements as provided by section 341 of the IIRIRA of 1996 which amended Section 212 of the INA and references criteria established by HHS/CDC and published in the Federal Register to determine which vaccines recommended by the ACIP will be required for U.S. immigration.

In addition, the final rule adds specific language regarding the exemption of vaccination requirements for an adopted child as provided in Section 212 of the INA.

Under this section, the final rule replaces “INS” with “DHS” and replaces “Public Health Services” with “HHS” to reflect modern agency titles and appropriate authorities relating to this provision.

The final rule revises this section to clarify the reexamination and review board's process and improve the expediency of the process. The revisions include removing the requirement that one medical officer must be a board-certified psychiatrist in cases where the alien's mental health is a basis for inadmissibility. The requirement for a board-certified psychiatrist is replaced with a requirement that the review board consist of at least one medical officer who is experienced in the diagnosis and treatment of the physical or mental disorder, or substance-related disorder for which the medical notification was made. Additionally, the final rule adds failure to present documented proof of having been vaccinated against vaccine preventable diseases as a basis for reexamination by the review board and adds clarifying language that the reexamination may be conducted, at the board's discretion, based on the written record.

On October 6, 2008, HHS/CDC published an interim final rule (IFR) (73 FR 58047) to amend its regulations that govern medical examinations that aliens must undergo before they are admitted to the United States. HHS/CDC amended the definition of “communicable disease of public health significance” by adding (1) quarantinable diseases designated by Presidential Executive Order, and (2) those diseases that meet the criteria of a public health emergency of international concern which require notification to the World Health Organization (WHO) under the International Health Regulations of 2005. These amendments to the definition of “communicable disease of public health significance” permitted a more flexible, risk-based approach to the medical examination, based on medical and epidemiologic factors. The IFR also updated the screening requirements for tuberculosis to be consistent with current medical knowledge and practice. The public was invited to comment on these amendments; the comment period ended December 5, 2008. On October 20, 2008, HHS/CDC published correcting amendments (73 FR 62210) that corrected an omission in the IFR. The correcting amendments clarified that an alien of any age in the United States who applies for adjustment of status to permanent resident shall not be required to have a chest x-ray examination unless their tuberculin skin test, or an equivalent test that shows an immune response to Mycobacterium tuberculosis, is positive. HHS/CDC received three comments to the IFR, two comments from the public and one comment from a professional organization. A summary of those comments and a response to those comments are found below.

One commenter urged HHS/CDC to remove HIV infection from the definition of communicable disease of public health significance, stating that HIV has specific methods of transmission and that the likelihood that an HIV positive individuals would present an unusual risk of disease is extremely low.

Response: HHS/CDC thanks the commenter for this comment and notes that HHS/CDC removed HIV infection from the definition of communicable disease of public health significance by rulemaking in 2009. No changes were made to the final rule based on this comment.

A second commenter expressed concern that HHS/CDC was creating a double standard; an alien in the United States with a newly identified disease would not be found inadmissible, but an alien overseas with the same disease would be found inadmissible. With this double standard, aliens overseas would be encouraged to avoid overseas medical examinations and find ways to illegally enter the United States. The commenter suggested that the best way to avoid this situation would be to apply the same standards to medical examinations performed overseas and those performed in the United States. Finally, the commenter suggested that part 34 should be revised to clearly differentiate between overseas medical examinations and those in the United States.

Response: HHS/CDC notes that the final rule does make a distinction between the medical examinations performed for those aliens outside of the United States and those already in the United States applying for adjustment of status to that of a lawful permanent resident. The distinction applies only to additional screening requirements for certain communicable diseases of public health significance where these diseases exist and for which importation into the United States would pose a threat as determined by the risk-based approach criteria. We reemphasize that both groups are required to undergo medical screening and the requirements for both groups are outlined in the regulation. No changes were made to the final rule based on this comment.

A third commenter expressed concern that the interim final rule did not include a provision to ensure that the public and the panel physicians are adequately notified of new and emerging diseases which could render individuals inadmissible and subject to an additional medical assessment. The commenter urged HHS to work closely with the Department of State to promptly notify the public of any health emergency or changes or additions to medical examinations through consular Web sites. Finally, the commenter was disappointed that HHS did not remove HIV infection as an inadmissible condition in this rulemaking.

Response: HHS/CDC notes that the regulation does contain a provision that all applicable additional requirements for medical screening and testing will be posted at the following Internet address: http://www.cdc.gov/immigrantrefugeehealth/exams/ti/index.html. HHS/CDC also works closely with the Department of State to ensure that all changes or additions to the medical examination are communicated to affected consular posts, panel physicians, and to the public. Finally, HHS/CDC removed HIV infection from the definition of communicable disease of public health significance by rulemaking in 2009. No changes were made to the final rule based on this comment.

HHS/CDC received 6 comments from the public on this NPRM. A summary of the comments is provided here.

One commenter protested the proposal to remove the three STIs from the list of communicable diseases of public health significance. The commenter also disagreed with HHS/CDC's proposal to incorporate a more flexible, risk-based approach, based on medical and epidemiologic factors. The comment points to recent outbreaks of Ebola, Bird and Swine Flu and states that screening should be more vigilant, and that not having stricter screening risks an outbreak.

Response: HHS/CDC thanks the commenter for this comment and notes that in the 2008 IFR, HHS/CDC amended the definition of communicable disease of public health significance by adding (1) quarantinable diseases designated by Presidential Executive Order, and (2) those diseases that meet the criteria of a public health emergency of international concern which require notification to the World Health Organization (WHO) under the International Health Regulations of 2005 which allows for screening of diseases in these categories which includes viral hemorrhagic fevers (such as Ebola) and flu that can cause a pandemic (including Bird and Swine variants). The addition of these categories of diseases along with the risk based approach allows HHS/CDC the ability to rapidly respond to unanticipated emerging or re-emerging outbreaks of disease and provides the framework to be able to screen and test individuals during disease outbreaks. HHS/CDC is confident that these changes will improve the ability of the United States to prevent the introduction and spread of infectious diseases, and to protect public health of the United States. No changes were made to the final rule based on this comment.

One commenter expressed concern about any disease coming off the list as these immigrants may be a public ward, and stated that individuals with HIV should not be allowed to immigrate to the United States. The commenter also noted that there was no comment period when HIV was removed from the list. The commenter also asks why unvaccinated children under ten should be allowed to immigrate to the United States. Finally, the commenter states that Ebola should be added to the list and that CDC should start thinking about other diseases to add to the definition of communicable diseases of public health significance.

Response: HHS/CDC thanks the commenter for this comment and notes that HHS/CDC removed HIV infection from the definition of communicable disease of public health significance by rulemaking in 2009. As part of this process, HHS/CDC issued a notice of proposed rulemaking which received over 20,000 comments; the majority of which were in favor of removing HIV infection from the list.

Under the Immigration and Nationality Act (INA), children under 10 years of age who are adopted by U.S. citizens are exempt from vaccination requirements prior to entry into the United States. These children must receive vaccinations in the United States within thirty days upon arrival. The above exception and requirements are based on statutory language provided in the INA and cannot be changed by HHS/CDC regulations. This exception does not apply to any other children seeking an immigrant visa or adjustment of status to lawful permanent resident in the United States.

In the 2008 IFR, HHS/CDC amended the definition of “communicable disease of public health significance” by adding (1) quarantinable diseases designated by Presidential Executive Order, and (2) those diseases that meet the criteria of a public health emergency of international concern which require notification to the World Health Organization (WHO) under the International Health Regulations of 2005. This allows for screening of diseases in these categories to be conducted during outbreaks and responses. Ebola and other hemorrhagic viral fevers are included in the current list of quarantinable diseases, and therefore are considered in the list of communicable diseases of public health significance. No changes were made to the final rule based on this comment.

One commenter stated that removing the STIs from the list of communicable diseases of public health significance may lead to decreased use of effective measures to prevent infection. This commenter stated that it is currently “too risky to the public good to downgrade the urgency of these types of preventable diseases.” The commenter continued by stating that there have been countless occurrences of “plagues taking over nations and killing off much of the populations,” and the commenter states that “there are many diseases that have not even been introduced yet and it is important to continue the current procedure in order to ensure nothing new `plagues' the nation.”

The same commenter stated that all aliens should be required to receive the same vaccinations that Americans receive. Additionally, the commenter submits that all immigrants should be revaccinated, as proof of vaccination from an immigrant's home country may not be reliable. The commenter also provides two standards for vaccination. They are as follows:

(1) If immigrating to the United States for economic reasons, the alien's standard of health should be comparable to the average resident of the United States.

(2) if immigrating to the United States for medical treatment otherwise unobtainable in the alien's home country, the alien must be insured to prevent burden to the U.S. taxpayer.

Response: HHS/CDC notes that, according to the analysis provided in the notice of proposed rulemaking, the incidence and prevalence of these STIs is declining globally and so the potential for introduction and spread of these diseases to the U.S. population is considered to be low. By removing the three STIs which no longer pose a threat to public health, the medical examination will be able to focus on the other communicable diseases which are considered more serious risks to the United States. Removing these 3 STIs does not mean that persons will not be treated for these infections if the infections are found during the medical examination. Removing these 3 STIs means that persons who have these infections are no longer considered inadmissible to the United States. HHS/CDC has incorporated into its regulations the vaccination requirements that are included in statutory language provided in the Immigration and Nationality Act (INA). Please see the relevant text of the INA at http://www.uscis.gov/iframe/ilink/docView/SLB/HTML/SLB/act.html. No changes were made to the final rule based on these comments.

Two commenters raised similar concerns regarding a statement made by HHS/CDC in the preamble of the 2015 NPRM regarding the inconclusive correlation between male circumcision and HIV prevention. Both commenters expressed disdain over the ethical, legal and methodological issues surrounding male circumcision as it relates to communicable disease. One commenter stated that some men from traditionally non-circumcising cultures [e.g. Hispanic/Latino communities] may read the NPRM and feel compelled to have themselves, and male children, circumcised in the belief that it may help them gain admittance to the U.S. Finally, both commenters concluded that any reference to male circumcision should be removed from the regulation.

Response: HHS/CDC thanks these commenters for their input. We note first that today's final rule does not contain any reference to male circumcision. Second, we clarify that whether a male is circumcised does not—and will not under today's final rule—have an effect on his medical examination or eventual admission into the United States. In the preamble language of the June 2015 NPRM, HHS/CDC stated: “. . . HIV prevention strategies such as male circumcision may be playing a role, although definitive studies of this effect are still pending.” This statement was made in addition to several other hypotheses which supported the underlying fact that “[D]eclining rates of these [STIs] are likely due to a variety of factors.” Other factors considered and listed in the NPRM included: Improved living conditions, better sanitation (e.g., availability of soap and water), condom use, educational efforts, improved recognition by physicians and treatment based on clinical presentation of sexually transmitted infections, treatment of sexual partners, as well as increased antibiotic usage for treatment of other unrelated conditions. No changes were made to the final rule based on these comments.

One commenter opposed the removal of the requirement that a board certified psychiatrist must be part of the review board for an alien seeking an appeal of mental disorder with associated harmful behavior. The commenter also supports updating the definitions of drug abuse, drug addiction and mental disorder to be made using current DSM standards and criteria. The commenter also indicated concerns about the policy behind the immigration medical examination and its likely discriminatory impact on those aliens with mental illness. The commenter further noted that the terms “drug abuser” and “drug addict” are obsolete and stigmatizing terms that require replacement in order to meet current scientific understanding of substance use disorders.

Response: HHS/CDC thanks the commenter for the comments and support for updating the definitions of drug abuse, drug addiction and mental disorder to reflect current DSM standards and criteria. As acknowledged by the commenter, changes to the medical examination as it relates to mental illness, including revising the terms “drug abuser” and “drug addict,” would require statutory language changes to the INA.

Regarding the comment about the requirement for a board certified psychiatrist to be a member of the review board, HHS/CDC notes that nothing in the regulations prevent the review board from including a board certified psychiatrist in mental disorder cases. However, the change in the regulation allows for another qualified mental health specialist to be on the review board in the event a board certified psychiatrist is not readily available. This allows for the review board process to proceed without any unnecessary delay that may affect the alien's immigration process. No changes were made to the final rule based on this comment.

This rulemaking is the result of HHS/CDC's annual retrospective regulatory review. Most of the amendments are administrative and will result in minor changes to current guidelines for overseas medical examinations required of persons seeking permanent entry to the United States. Therefore, alternatives to these administrative updates were not considered.

However, as we stated in the proposed rule, when considering updates to the definition of communicable disease of public health significance, HHS/CDC looked at all of the specific diseases listed in the definition. As stated previously in the Preamble, in this rulemaking, HHS/CDC is revising the definition of communicable disease of public health significance by removing these three uncommon health conditions: Chancroid; granuloma inguinale; and lymphogranuloma venereum.

We have decided not to remove infectious Hansen's disease (leprosy), gonorrhea, and/or infectious syphilis from the definition at this time. Our decision is based on epidemiological principles and current medical practice to assess these three diseases (infectious Hansen's disease, gonorrhea, and infectious syphilis). We believe that the medical examination provides the opportunity to screen for and treat these diseases, and, when identified in immigrants, provides a public health benefit to the United States as well as a health benefit to the individual. Further, while infection with these three diseases initially renders an alien inadmissible to the United States, treatment is available upon identification, and once appropriately treated, aliens with these conditions are no longer inadmissible. Continued screening for these three diseases during the medical examination provides an opportunity to identify and treat disease in alien populations and thus provide a measure of public health protection to the general U.S. population. HHS/CDC will continue to assess each of these remaining diseases as a communicable disease of public health significance through further scientific review.

HHS/CDC has examined the impacts of the proposed rule under Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993) and Executive Order 13563, Improving Regulation and Regulatory Review (76 FR 3821, January 21, 2011) (1, 2). Both Executive Orders direct agencies to evaluate any rule prior to promulgation to determine the regulatory impact in terms of costs and benefits to United States populations and businesses. Further, together, the two Executive Orders set the following requirements: Quantify costs and benefits where the new regulation creates a change in current practice; define qualitative costs and benefits; choose approaches that maximize benefits; support regulations that protect public health and safety; and minimize the impact of regulation. HHS/CDC has analyzed the rule as required by these Executive Orders and has determined that it is consistent with the principles set forth in the Executive Orders and the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) and that the rule will create minimal impact (3, 4).

This rule is not being treated as a significant regulatory action as defined by Executive Order 12866. As such, it has not been reviewed by the Office of Management and Budget (OMB).

There are two main impacts of this rule. First, we have updated the current regulation to reflect modern terminology, plain language, and current practice. Because there is no change in the baseline from these updates, no costs can be associated with these administrative updates to align the regulation with current practice.

Second, we have removed three sexually transmitted bacterial infections, chancroid, granuloma inguinale and lymphogranuloma venereum, from the definition of communicable disease of public health significance (5). In doing this, aliens seeking permanent entry to the United States (immigrants, refugees and asylees) will no longer be examined for these diseases during the mandatory medical examinations that are part of the process of admission to the United States. The impact of dropping this portion of the examination is likely to be minimal. On the positive side, the physicians administering the exam will be able to focus on other areas of patient health. On the negative side, there is the potential for a negligible increase in the numbers of disease cases entering the United States. However, as we explain subsequently, this impact is likely to be small. Further, the costs associated with the current disease burden in the United States are also very limited. Therefore, the potential introduction of a very small number of cases will not change the current cost structure associated with the current disease burden.

As discussed in detail below, the three bacterial infections (chancroid, granuloma inguinale and lymphogranuloma venereum), are transmitted through sexual contact, have never been common in the United States and over the past two decades are observed to be increasingly rare throughout the world. Of the three conditions, only laboratory-diagnosed cases of chancroid are reportable in the United States, and since 2005 fewer than 30 chancroid cases annually were reported to CDC from the U.S. states and territories (6-23). While some U.S. cities (7) keep records of cases of granuloma inguinale and lymphogranuloma venereum, neither condition is included on the list of diseases reported to the CDC by clinicians and public health departments (6). Online searches and a few available publications indicate that both conditions most typically occur in tropical and impoverished settings (i.e., with limited access to water, hygiene); and both conditions have become increasingly uncommon over time. A review of the literature published during the past five years identified only a handful of case reports on granuloma inguinale, and the vast majority of these cases were cases outside the United States (12-17). Sporadic small outbreaks of lymphogranuloma venereum have occurred over the past 10 years in Europe and the United States (18-20). The numbers of lymphogranuloma venereum cases are small, have been almost exclusively among men who have sex with men, and numbers are not systematically collected for country populations (18-20).

When HHS/CDC originally attempted to estimate the disease impact to calculate the cost associated with removing these three diseases, we tried to examine the disease rates in the regions or countries of origin of aliens seeking entry to the United States. In the most recent report from DHS, the Annual Yearbook of Immigration Statistics, DHS reports on the regions and countries of origin of aliens (24). Unfortunately, we have been unable to find disease data that correlates with DHS population data for region of origination of aliens (24). Data on chancroid, granuloma inguinale and lymphogranuloma venereum are not systematically collected by any country outside of the United States either by specific countries or regions listed by DHS for aliens, or from the World Health Organization (WHO) (8, 22, 23). Ultimately, we were unable to correlate the originating regions of aliens entering the United States permanently (immigrants, refugees, and asylees) with the rates of the three diseases in the countries of origin.

Potential for onward transmission of these infections to the U.S. population is deemed to be extremely low. While we do not have country or region-specific rates for these diseases, our review of the literature supports the supposition that the potential introduction of additional cases into the United States by aliens is likely to have a negligible impact on the U.S. population. These primarily tropical infections can be prevented through improved personal hygiene (11) and protected sex (use of a condom) (12). New infections can be effectively treated and cured with a short, uncomplicated course of antibiotic therapy.

Economic analysis and cost results. HHS/CDC has determined that the costs associated with chancroid, granuloma inguinale and lymphogranuloma venereum are currently very low. Given the pattern of diminishing caseloads reported in the literature and available data (6-21), HHS/CDC projects that future costs will remain low. A more detailed analysis as required by E.O. 12866 and 13563 can be found in the docket for this NPRM. A summary follows below.

Summary. There is no international disease incidence data available for chancroid, granuloma inguinale or lymphogranuloma venereum. There is some data available for numbers of cases of chancroid observed in the United States over a number of years (6) and DHS also provides data regarding the numbers of legal foreign residents in the United States (24). In the full analysis we used the chancroid data to estimate a range of costs to treat chancroid in the United States (6) at the highest and lowest caseloads observed. An estimated component for granuloma inguinale and lymphogranuloma venereum was added by assumption because of lack of either domestic or international data. The costs were then prorated to reflect the foreign population residing in the United States using DHS data (24).

Cost estimates were derived for three alternatives titled Low, High, and Extreme. The Low and High alternatives were based on the lowest (most recent) and highest reported caseloads of chancroid (6). The Extreme alternative is six times the highest rate of chancroid ever reported in the United States. Finally, often chancroid, granuloma inguinale, and lymphogranuloma venereum are co-morbid with other STIs, e.g., HIV, syphilis, or gonorrhea (6, 8, 21). Therefore costs are estimated to both treat cases with or without co-morbidity.

The results of the analysis are reported in Table 1. Because of a decreasing trend in reported cases, it is conservative to estimate the annualized burden of these diseases based on past reporting (i.e. the number of cases observed in the future are likely to continue decreasing). Further, it was assumed that all cases are detected and treated within the first year after arrival. As a result of these assumptions, monetized costs were unaffected by the choice of discount rate.

The results are not economically significant, i.e. more than $100 million of costs and benefits in a single year.

Estimated benefits of this rule. The benefits to this rule are also qualitative. Aliens as well as the panel physicians and civil surgeons inherently benefit from having current, up-to-date regulations with modern terminology that reflects modern practice and plain language. The physicians administering the exam will be able to devote more time and training to other, more common and/or more serious health issues. The proposed changes do not impose any additional costs on aliens, panel physicians, or civil surgeons.

Comparison of costs and benefits. Given the potential impact of the rulemaking, we conclude that the benefits of the rule justify any costs. See Tables 2 and 3 below.

Under the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), agencies are required to analyze regulatory options to minimize significant economic impact of a rule on small businesses, small governmental units, and small not-for-profit organizations. We have analyzed the costs and benefits of the final rule, as required by Executive Order 12866, and a preliminary regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. Based on the cost benefit analysis, we expect the rule to have little or no economic impact on small entities.

The Paperwork Reduction Act applies to the data collection requirements found in 42 CFR part 34. The U.S. Department of State is responsible for providing forms to panel physicians, and the Department of Homeland Security is responsible for providing forms to civil surgeons to document the medical examination and screening information for aliens. The Office of Management and Budget (OMB) approved this data collection under OMB Control No. 1405-0113, which will expire on September 30, 2017. We note also that the medical examination form that civil surgeons use is the I-693 and the OMB control number provided on the I-693 is 1615-0033 (expiration date 3/31/2017).

HHS/CDC has determined that the amendments to 42 CFR part 34 will not have a significant impact on the human environment.

HHS/CDC has reviewed this rule under Executive Order 12988 on Civil Justice Reform and determines that this final rule meets the standard in the Executive Order.

Under Executive Order 13132, if the rule would limit or preempt State authorities, then a federalism analysis is required. The agency must consult with State and local officials to determine whether the rule would have a substantial direct effect on State or local Governments, as well as whether it would either preempt State law or impose a substantial direct cost of compliance on them.

HHS/CDC has determined that this rule will not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

Under 63 FR 31883 (June 10, 1998), Executive Departments and Agencies are required to use plain language in all proposed and final rules. HHS/CDC has attempted to use plain language in this rulemaking to make our intentions and rationale clear. We received no public comment regarding plain language.

For the reasons discussed in the preamble, the Centers for Disease Control and Prevention, Department of Health and Human Services revises 42 CFR part 34 to read as follows:

NMFS manages the king and Tanner crab fisheries in the U.S. exclusive economic zone of the Bering Sea and Aleutian Islands (BSAI) under the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (Crab FMP). The Council prepared, and NMFS approved, the Crab FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801 et seq. Regulations governing U.S. fisheries and implementing the Crab FMP appear at 50 CFR parts 600 and 680.

This rule modifies regulations that specify how IPQ use caps apply to IPQ issued for EBT and WBT crab fisheries for the 2015/2016 crab fishing year. The 2015/2016 crab fishing year ends on June 30, 2016. The following sections describe (1) the BSAI crab fisheries, (2) general background on IPQ use caps and custom processing arrangements, (3) IPQ use caps applicable to the EBT and WBT crab fisheries, and (4) this rule and justification for emergency action.

The Crab Rationalization Program (Program) was implemented on March 2, 2005 (70 FR 10174). The Program established a limited access privilege program for nine crab fisheries in the BSAI, including the EBT and WBT crab fisheries, and assigned quota share (QS) to persons based on their historic participation in one or more of those nine BSAI crab fisheries during a specific time period. Under the Program, NMFS issued four types of QS: catcher vessel owner (CVO) QS was assigned to holders of License Limitation Program (LLP) licenses who delivered their catch to shoreside crab processors or to stationary floating crab processors; catcher/processor vessel owner QS was assigned to LLP license holders who harvested and processed their catch at sea; captains and crew on board catcher/processor vessels were issued catcher/processor crew QS; and captains and crew on board catcher vessels were issued catcher vessel crew QS. Each year, a person who holds QS may receive an exclusive harvest privilege for a portion of the annual total allowable catch, called individual fishing quota (IFQ).

NMFS also issued processor quota share (PQS) under the Program. Each year PQS yields an exclusive privilege to process a portion of the IFQ in each of the nine BSAI crab fisheries. This annual exclusive processing privilege is called individual processor quota (IPQ). Only a portion of the QS issued yields IFQ that is required to be delivered to a processor with IPQ. Quota share derived from deliveries made by catcher vessel owners (i.e., CVO QS) is subject to designation as either Class A IFQ or Class B IFQ. Ninety percent of the IFQ derived from CVO QS is designated as Class A IFQ, and the remaining 10 percent is designated as Class B IFQ. Class A IFQ must be matched and delivered to a processor with IPQ. Class B IFQ is not required to be delivered to a specific processor with IPQ. Each year there is a one-to-one match of the total pounds of Class A IFQ with the total pounds of IPQ issued in each crab fishery.

NMFS issued QS and PQS for the EBT and WBT crab fisheries. Unlike the QS and PQS issued for most other crab fisheries, the QS and PQS issued for the EBT and WBT crab fisheries are not subject to regional delivery and processing requirements, commonly known as regionalization. Therefore, the Class A IFQ that results from EBT and WBT QS, and the IPQ that results from EBT and WBT PQS, can be delivered to, and processed at, any otherwise eligible processing facility.

In addition, the PQS and resulting IPQ issued for the EBT and WBT crab fisheries are not subject to right-of-first-refusal (ROFR) provisions included in the Program. The ROFR provisions provide certain communities with an option to purchase PQS or IPQ that would otherwise be used outside of the community holding the ROFR.

Because the EBT and WBT crab fisheries are not subject to regionalization or ROFR provisions, crab harvested under a Class A IFQ permit in these fisheries can be delivered to processors in a broad geographic area more easily than crab harvested under Class A IFQ permits in crab fisheries subject to regionalization and ROFR provisions. The rationale for exempting the EBT and WBT crab fisheries from regionalization and ROFR provisions is described in the Program EIS (see ADDRESSES), and in the final rule implementing the Program (March 2, 2005, 70 FR 10174).

When the Council recommended the Program, it expressed concern about the potential for excessive consolidation of QS and PQS, and the resulting annual IFQ and IPQ. Excessive consolidation could have adverse effects on crab markets, price setting negotiations between harvesters and processors, employment opportunities for harvesting and processing crew, tax revenue to communities in which crab are landed, and other factors considered and described in the Program EIS (see ADDRESSES). To address these concerns, the Program limits the amount of QS that a person can hold, the amount of IFQ that a person can use, and the amount of IFQ that can be used on board a vessel. Similarly, the Program limits the amount of PQS that a person can hold, the amount of IPQ that a person can use, and the amount of IPQ that can be processed at a given facility. These limits are commonly referred to as use caps.

In each of the nine BSAI crab fisheries under the Program, a person is limited to holding no more than 30 percent of the PQS initially issued in the fishery and using no more than the amount of IPQ resulting from 30 percent of the initially issued PQS in a given fishery, with a limited exemption for persons receiving more than 30 percent of the initially issued PQS. The rationale for the IPQ use caps is described in the Program EIS (see ADDRESSES) and the final rule implementing the Program (70 FR 10174, March 2, 2005). According to information in section 6.1.1 of the RIR (see ADDRESSES), no person in the EBT or WBT crab fisheries received in excess of 30 percent of the initially issued PQS. Therefore, no person may use an amount of EBT or WBT IPQ greater than an amount resulting from 30 percent of the initially issued EBT or WBT PQS.

The Program is designed to minimize the potential for a single person to evade the PQS and IPQ use caps through the use of corporate affiliations or other legal relationships. To accomplish this, § 680.7(a)(7) prohibits an IPQ holder from using more IPQ than the maximum amount of IPQ that may be held by that person and states that a person's IPQ use cap is calculated by summing the total amount of IPQ that is held by that person and IPQ held by other persons who are affiliated with that person. The term “affiliation” is defined in § 680.2. Additional terms used in the definition of “affiliation” are described in § 680.2, and NMFS refers the reader to that section for additional detail.

Under § 680.7(a)(7), any IPQ crab that is “custom processed” at a facility an IPQ holder owns will be applied against the IPQ use cap of the facility owner, unless specifically exempted by § 680.42(b)(7). A custom processing arrangement exists when an IPQ holder has a contract with the owners of a processing facility to have his or her crab processed at that facility, and the IPQ holder (1) does not have an ownership interest in that processing facility, and (2) is not otherwise affiliated with the owners of that processing facility. In custom processing arrangements, the IPQ holder contracts with a facility operator to have the IPQ crab processed according to that IPQ holder's specifications. Custom processing arrangements typically occur when an IPQ holder does not own a shoreside processing facility or cannot economically operate a stationary floating crab processor.

Shortly after implementation of the Program, the Council submitted and NMFS approved Amendment 27 to the Crab FMP (74 FR 25449, May 28, 2009). Amendment 27 was designed to improve operational efficiencies in crab fisheries with historically low total allowable catches or that occur in more remote regions by exempting certain IPQ crab processed under a custom processing arrangement from applying against the IPQ use cap of the owner of the facility at which IPQ crab are custom processed. For ease of reference, this preamble refers to this exemption as a “custom processing arrangement exemption.” NMFS refers the reader to the preamble to the final rule implementing Amendment 27 to the Crab FMP for additional information regarding the rationale for custom processing arrangement exemptions in specific BSAI crab fisheries. Section 680.42(b)(7) describes the BSAI crab fisheries and other requirements that qualify for a custom processing arrangement exemption.

Section 680.42(b)(7)(ii)(A) lists the six BSAI crab fisheries for which the custom processing arrangement exemption applies. These are: Bering Sea C. opilio with a North Region designation, Eastern Aleutian Islands golden king crab, Pribilof Island blue and red king crab, Saint Matthew blue king crab, Western Aleutian golden king crab processed west of 174° W. long., and Western Aleutian Islands red king crab. As described later in this preamble, the custom processing arrangement exemption implemented under Amendment 27 does not apply to custom processing arrangements in the EBT and WBT crab fisheries.

Under the custom processing arrangement exemption, NMFS does not apply any IPQ used at a facility through a custom processing arrangement against the IPQ use cap of the owners of that facility provided there is no affiliation between the person whose IPQ crab is processed at that facility and the IPQ holders who own that facility. Effectively, § 680.42(b)(7)(ii)(A) does not count IPQ crab that are custom processed at a facility owned by an IPQ holder against the IPQ use cap of the owner of the processing facility. In such a case, a person who holds IPQ and who owns a processing facility is credited only with the amount of IPQ crab used by that person, or any affiliates of that person, when calculating IPQ use caps. In sum, these regulations allow processing facility owners who also hold IPQ to be able to use their facility, or facilities, to establish custom processing arrangements with other IPQ holders to process more crab, thereby improving throughput and providing a more economically viable processing operation.

Section 680.42(b)(7)(ii)(B) provides a custom processing arrangement exemption in the six BSAI crab fisheries described above provided that the facility, at which the IPQ crab are custom processed, meets specific requirements. Under the custom processing arrangement exemption, IPQ crab that are custom processed do not count against the IPQ use cap of persons owning the facility if the facility is located within the boundaries of a home rule, first class, or second class city in the State of Alaska on the effective date of regulations implementing Amendment 27 (June 29, 2009) and is either (1) a shoreside crab processor or (2) a stationary floating crab processor that is located within a harbor and moored at a dock, docking facility, or other permanent mooring buoy, with specific provisions applicable to the City of Atka. The specific provisions applicable to facilities operating within the City of Atka are not directly relevant to the EBT and WBT crab fisheries and this rule, and are not addressed further. Additional information on the facilities to which the custom processing arrangement exemption applies is found in the preamble to the final rule implementing Amendment 27 (74 FR 25449, May 28, 2009) and is not repeated here.

Finally, § 680.7(a)(8) prohibits a shoreside crab processor or a stationary floating crab processor in which no IPQ holder has a 10 percent or greater ownership interest in the processing facility from receiving more than 30 percent of the IPQ issued for a particular crab fishery. However, IPQ crab processed under a custom processing arrangement does not apply against the limit on the maximum amount of IPQ crab that can be processed at a facility. These regulations effectively allow more than 30 percent of the IPQ for the six BSAI crab fisheries to be processed at a facility if there is no affiliation between the person whose IPQ crab is processed at that facility and the IPQ holders who own that facility.

Regulations implementing Amendment 27 also modified the calculation of IPQ use caps for IPQ crab subject to ROFR provisions (see § 680.42(b)(7)(ii)(C)). However, as noted earlier in this preamble, ROFR requirements do not apply to EBT and WBT crab. Therefore, modifications to IPQ use cap calculations for IPQ crab subject to ROFR provisions are not described further in this rule.

As noted earlier, EBT and WBT IPQ crab that are processed under a custom processing arrangement are not exempt from IPQ use caps and will apply against a person's IPQ use cap if that person owns the facility (i.e., has a 10 percent or greater direct or indirect ownership interest) at which those IPQ crab are processed. Given the percentage at which the IPQ use caps are set, a minimum of four persons who are not affiliated with each other must receive and process EBT or WBT IPQ crab to ensure that all Class A IFQ can be delivered and processed with no person exceeding the IPQ use caps. Similarly, at least four facilities that are not affiliated through common ownership (i.e., a 10 percent or greater direct or indirect ownership interest) must be used to receive and process EBT and WBT IPQ crab to ensure that all Class A IFQ can be delivered and processed with no facility exceeding the IPQ use caps.

When the Council recommended and NMFS implemented Amendment 27, the Council and NMFS did not deem it necessary to grant the EBT and WBT crab fisheries a custom processing arrangement exemption. The preamble to the proposed rule implementing Amendment 27 explains that the Council and NMFS did not recommend a custom processing arrangement exemption for EBT and WBT IPQ crab because “Bering Sea C. bairdi crab are not subject to regionalization and therefore the need to exempt custom processing arrangements from the IPQ use cap does not appear necessary because crab can be effectively delivered to any processor with matching IPQ in any location” (73 FR 54351, September 19, 2008).

Since the implementation of Amendment 27, there has been additional consolidation in the BSAI crab processing sector. As Section 6.2.1 of the RIR describes (see ADDRESSES), during the 2015/2016 crab fishing year there appear to be only three unique unaffiliated persons (processors) who have received EBT and WBT IPQ crab at their facilities. These three processors are the Maruha-Nichiro Corporation, which includes Alyeska Seafoods, Peter Pan Seafoods, and Westward Seafoods; Trident Seafoods; and Unisea Seafoods. Information in section 6.2.1 indicates that these three processors also own and operate all facilities that have processed EBT and WBT IPQ crab during the 2015/2016 crab fishing year.

The net effect of this processor consolidation is that there are less than the required minimum of four unique and unaffiliated processors active in the EBT and WBT crab fisheries. Therefore, only 90 percent of the Class A IFQ can be delivered to, and only 90 percent of the IPQ may be used at, facilities owned and operated by Maruha-Nichiro Corporation, Trident Seafoods, and Unisea Seafoods without causing the IPQ use caps to be exceeded. The remaining 10 percent of the 2015/2016 EBT Class A IFQ/IPQ, or 826,322 pounds, and the remaining 10 percent of the 2015/2016 WBT Class A IFQ/IPQ, or 615,489 pounds, must be either delivered to processing facilities that are not affiliated with Maruha-Nichiro Corporation, Trident Seafoods, or Unisea Seafoods or left unharvested (see Section 6.2.1 of the RIR for more detail). In total, 10 percent of the Class A IFQ/IPQ for both the EBT and WBT crab fisheries equals 1,441,811 pounds.

Sections 7.1 and 7.2 of the RIR indicate that developing or using an alternative processing facility not affiliated with the Maruha-Nichiro Corporation, Trident Seafoods, or Unisea Seafoods would not be a feasible processing option for the remainder of the 2015/2016 crab fishing year for several reasons. First, even though the 2015/2016 crab fishing year ends on June 30, 2016, under the Crab FMP, the Crab FMP authorizes the State of Alaska to establish specific regulations that define the length of a crab fishing season during a crab fishing year. By State of Alaska regulation, the EBT and WBT 2015/2016 crab fishing seasons end on March 31, 2016. This regulatory closure date of the EBT and WBT crab fisheries provides very limited time for IPQ holders to find an alternative processing facility.

Second, although there are alternative shoreside processing facilities not affiliated with the Maruha-Nichiro Corporation, Trident Seafoods, or Unisea Seafoods, most of those facilities are located far from the Bering Sea crab fishing grounds, such as in Kodiak, Alaska. Transporting EBT or WBT crab to those locations would result in longer trips with increased fuel and operating costs for harvesters, result in lost fishing days while the crab are being transported, and increase the potential for deadloss (death) of crab, which becomes increasingly likely the longer that the crab are held in storage tanks and transported. In addition, alternative shoreside processing facilities, regardless of their location to the BSAI crab fishing grounds, have not provisioned and planned their processing operations to accommodate a relatively small proportion of the EBT and WBT IPQ allocations (i.e., only 10 percent of the EBT and WBT IPQ). The costs of provisioning those alternative shoreside facilities for a relatively small amount of crab and without adequate planning would likely impose substantial additional costs relative to processing operations provisioned and planned prior to the start of the EBT and WBT crab fisheries. Deliveries to alternative shoreside processing facilities would impose a substantial burden and cost on Class A IFQ holders in terms of added delivery costs and time.

Third, sections 7.1 and 7.2 of the RIR indicate that using a stationary floating crab processor would not be a feasible processing option for the remainder of the 2015/2016 crab fishing year. Establishing a contract with a stationary floating crab processor, outfitting the vessel, and establishing a market for delivered Class A IFQ EBT and WBT crab in the short amount of time available before the end of the fisheries would present many of the same logistical challenges that are present for alternative shoreside processing facilities.

Finally, any IPQ holder hoping to secure an alternative shoreside processing facility or a stationary floating crab processor will have very little negotiating leverage with any unaffiliated processing facility given the amount of time remaining for the EBT and WBT crab season. That lack of negotiating leverage in establishing delivery terms and conditions could impose additional costs on IPQ holders and harvesters that may make such deliveries uneconomic. Sections 7.1 and 7.2 of the RIR conclude that there do not appear to be any viable delivery options available for 10 percent of the EBT and WBT Class A IFQ during the remainder of the 2015/2016 crab fishing year.

This rule temporarily suspends the existing § 680.42(b)(7)(ii) and adds a temporary § 680.42(b)(7)(iii) that includes EBT and WBT IPQ crab received during the 2015/2016 crab fishing year to the list of BSAI crab fisheries already receiving a custom processing arrangement exemption. This allows EBT and WBT IPQ crab received for custom processing by the three processors operating in these fisheries to qualify for a custom processing arrangement exemption and not apply against the IPQ use caps for these processors. With this rule, all EBT and WBT IPQ crab received during the 2015/2016 crab fishing year under custom processing arrangements at the facilities owned by the Maruha-Nichiro Corporation, Trident Seafoods, or Unisea Seafoods will not be counted against the IPQ use cap of the facility or the facility owners. The custom processing arrangement exemption implemented by this rule will allow the three processors to custom process crab for unaffiliated IPQ holders who have custom processing arrangements with the processors, thereby allowing harvesters with Class A IFQ to fully harvest and deliver their allocations of EBT and WBT crab to IPQ holders with a custom processing arrangement at facilities operating in the these fisheries.

Section 305(c) of the Magnuson-Stevens Act provides authority for rulemaking to address an emergency. Under that section, a regional fishery management council may recommend emergency rulemaking if it finds an emergency exists. NMFS' Policy Guidelines for the Use of Emergency Rules provide that the only legal prerequisite for such rulemaking is that an emergency must exist, and that NMFS must have an administrative record justifying emergency regulatory action and demonstrating compliance with the Magnuson-Stevens Act and the National Standards (see NMFS Instruction 01-101-07 (March 31, 2008) and 62 FR 44421, August 21, 1997). Emergency rulemaking is intended for circumstances that are “extremely urgent,” where “substantial harm to or disruption of the . . . fishery . . . would be caused in the time it would take to follow standard rulemaking procedures.”

Under NMFS' Policy Guidelines for the Use of Emergency Rules (62 FR 44421, August 21, 1997), the phrase “an emergency exists involving any fishery” is defined as a situation that meets the following three criteria:

(1) Results from recent, unforeseen events or recently discovered circumstances; and

(2) Presents serious conservation or management problems in the fishery; and

(3) Can be addressed through emergency regulations for which the immediate benefits outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as would be expected under the normal rulemaking process.

The following sections review each of these criteria and describe why the Council and NMFS determined that allowing EBT and WBT IPQ crab to qualify for a custom processing arrangement exemption for the remainder of the 2015/2016 crab fishing year meets these criteria.

The Council and NMFS recently discovered that the processors currently receiving EBT and WBT crab are constrained by the IPQ use caps from being able to fully process all Class A IFQ issued for the EBT and WBT crab fisheries in 2015/2016. The one processing facility that previously operated in the EBT and WBT crab fisheries, and that was not affiliated with the Maruha-Nichiro Corporation, Trident Seafoods, or Unisea Seafoods, recently terminated its 2015/2016 BSAI crab processing operations. Harvesters with the Intercooperative Crab Exchange (ICE) notified the Council and NMFS that given these operational factors, the application of IPQ use caps in the EBT and WBT fisheries could limit their ability to fully harvest their Class A IFQ allocations. ICE is a crab cooperative that represents most of the EBT and WBT QS holders and receives most of Class A IFQ in the EBT and WBT crab fisheries. ICE submitted a petition to the Council requesting that the Council recommend an emergency rule to provide a custom processing arrangement exemption for EBT and WBT IPQ crab on December 9, 2015. The Council recommended an emergency rule to provide that custom processing arrangement exemption on December 15, 2015.

Harvesters with EBT and WBT Class A IFQ and the Council noted that harvesters are not responsible for the operational decisions of processors, and harvesters were not aware until recently of the impact of this decision on IPQ use cap calculations and their ability to fully harvest and deliver their Class A IFQ. Harvesters with Class A IFQ have stated that they did not become aware of the lack of adequate processing capacity under the IPQ use caps until after the EBT and WBT crab fisheries were underway for the 2015/2016 crab fishing year. Consequently, harvesters with Class A IFQ did not foresee that the IPQ use cap would constrain them from delivering the full amount of their EBT and WBT Class A IFQ allocations.

Section 680.20(h) requires Class A IFQ holders to “share match” with processors holding available IPQ as a condition of making crab deliveries. Harvesters with Class A IFQ were able to share match their EBT and WBT Class A IFQ before the fishery start date of October 15, 2015, and reasonably concluded they would be able to deliver their Class A IFQ crab to specific IPQ holders operating at specific facilities. The application of the IPQ use caps in the EBT and WBT crab fisheries, the consolidation of processors receiving EBT and EBT Class A IFQ, and the lack of a custom processing arrangement exemption for EBT and WBT IPQ constrain the ability for Class A IFQ holders to fully harvest and deliver their crab given the processing options available in the EBT and WBT crab fisheries. The Council and NMFS determined that this is a recent and unforeseen event due to recently discovered circumstances outside of the control of Class A IFQ holders. The consolidation of processors below the minimum needed to process all of the EBT and WBT Class A IFQ without exceeding the IPQ use caps was not foreseen by the Council and NMFS and was recently discovered after the start of the 2015/2016 EBT and EBT crab fishing seasons.

The Council and NMFS determined that this criterion is met because without an emergency rule there will be a substantial adverse economic impact on harvesters, processors, and communities. Without an emergency rule, as much as 10 percent of the Class A IFQ for both the EBT and WBT crab fisheries, or 1,441,811 pounds of crab, will be unable to be harvested due to an insufficient number of adequate processing facilities that can receive Class A IFQ without IPQ holders exceeding their IPQ use caps. The lost revenue from this forgone harvest is estimated to be approximately $ 3.4 million in ex-vessel value and $ 4.95 million in first wholesale value based on estimated ex-vessel and wholesale values of EBT and WBT crab in 2015/2016 (see Sections 7.1 and 7.2 of the RIR for additional detail).

Without a custom processing arrangement exemption, harvesters with Class A EBT and WBT IFQ would be unable to harvest allocations provided to them due to limitations imposed on IPQ holders and processors that receive EBT and WBT crab would not be able to fully process the EBT and WBT crab resource. In addition to lost revenue to harvesters and processors, communities where EBT and WBT crab are delivered will not receive benefits from labor payments and tax revenue without this rule. This rule is the only mechanism to restore the forgone harvest and lost revenue because other BSAI crab fisheries that could substitute for this lost revenue are fully allocated and are not available to compensate EBT and WBT Class A IFQ holders. Section 7 of the RIR provides additional detail on the economic impacts of this rule.

The Council and NMFS also determined that implementation of this rule will not create conservation issues with regard to BSAI crab generally, or the EBT and WBT crab fisheries specifically. This rule will allow Class A IFQ holders in the EBT and WBT crab fisheries to fully harvest their IFQ allocations, but still limit the overall amount of harvest in these fisheries to the IFQ allocations authorized for the 2015/2016 crab fishing year.

NMFS and the Council have determined that the emergency situation created by the lack of adequate processing facilities that can be used to receive all EBT and WBT IPQ crab can be addressed by emergency regulations. As explained earlier in this preamble, creating a temporary custom processing arrangement exemption through this rule will allow harvesters to fully harvest their Class A IFQ allocations in the EBT and WBT crab fisheries without creating conservation and management issues for the resource or direct users of BSAI crab resources, and is consistent with the goals of the Program (see Section 5 of the RIR for additional detail).

To address the emergency, NMFS must implement an emergency rule that waives the comment period and delay in effective date otherwise required by law. The benefits of these waivers will serve the public interest by allowing for the complete harvest of EBT and WBT crab within the relatively short amount of time remaining in the 2015/2016 EBT and WBT crab seasons. Any delay in effectiveness will preclude the ability to completely harvest and process EBT and WBT crab during the 2015/2016 crab fishing year.

Without the waivers, Class A IFQ holders in the EBT and WBT crab fisheries will not have sufficient time to prosecute these fisheries as intended. As noted earlier, the EBT and WBT crab fisheries close by State of Alaska regulation on March 31, 2016. Harvesters are currently prosecuting the EBT and WBT crab fisheries and due to the unique nature of the EBT and WBT crab fisheries, harvesters will need as much time as possible to harvest the 1,441,811 pounds of Tanner crab. Additionally, for the rule to be effective in providing relief, Class A IFQ holders need to know as soon as possible that they have available processors to deliver the remainder of their EBT and WBT Class A IFQ.

Harvesters in the EBT and WBT crab fisheries submitted a petition for emergency action to the Council shortly before the start of the Council's December 2015 meeting that began on December 9, 2015. They asked that the Council revise the custom processing arrangement exemption to include the EBT and WBT crab fisheries. The fisheries that receive a custom processing arrangement exemption are specified in the Crab FMP and applying the exemption to additional fisheries would require an amendment to the Crab FMP. In order for the Council to recommend an amendment to the Crab FMP, the Council would need to notice the public that such an action was being considered prior to a Council meeting consistent with established public notice requirements. Because the Council was not aware of this issue until shortly before its December 2015 meeting, no such notice could have been provided for the December 2015 Council meeting. The next scheduled meeting of the Council is February 2016, and that is the earliest date at which the Council could notice the public that it is considering amending the Crab FMP.

Secretarial review of fishery management plan (FMP) amendments must follow the process set forth in section 304 of the Magnuson-Stevens Act, which requires more time to complete than is available to provide relief for the EBT and WBT crab fishery participants given the regulatory closure of the EBT and WBT crab fisheries on March 31, 2016. While the normal rulemaking process is the preferred avenue for making regulatory changes, as it provides interested parties the full ability to comment, the Council and NMFS have determined that in this case, the cost of the forgone harvest opportunity outweighs the benefit of using the more protracted, standard process because it would be ineffective for addressing the immediate issue. The Council initiated a typical FMP amendment process in December 2015 to address this situation in a more permanent manner.

The purpose of this rule is to temporarily allow EBT and WBT IPQ crab to be subject to a custom processing arrangement exemption for the 2015/2016 crab fishing year, while allowing continued analysis of the issue in a separate, and standard, FMP amendment process. This rule is needed to allow the complete harvesting and processing of the EBT and WBT crab fisheries during the 2015/2016 crab fishing year and will temporarily ameliorate unforeseen adverse economic consequences due to the insufficient number of adequate processing facilities.

The Assistant Administrator for Fisheries, NOAA, has determined that this rule is consistent with the National Standards, other provisions of the Magnuson-Stevens Act, and other applicable laws.

The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be impracticable and contrary to the public interest. This rule will allow for the full harvesting and processing of the EBT and WBT crab fisheries and should prevent economic losses from the limitations on the use of EBT and WBT IPQ created by the unforeseen lack of adequate processing capacity. This rule will avoid adverse economic impacts to harvesters, processors, and communities that would otherwise result if the EBT and WBT crab fisheries could not be fully harvested during the 2015/2016 crab fishing year. If this rule were delayed to allow for notice and comment, impacted entities would likely be prevented from harvesting 826,322 pounds of EBT crab and 615,489 pounds of WBT crab that would otherwise be available to impacted entities through the remainder of the 2015/2016 crab fishing year. The lost revenue from this forgone harvest is estimated to be approximately $3.4 million in ex-vessel value and $4.95 million in first wholesale value. In addition to lost revenue to harvesters and processors, communities where EBT and WBT crab are delivered will not receive benefits from labor payments and tax revenue without this rule. Fishermen, shoreside processors, and communities that participate in the EBT and WBT crab fisheries would have limited alternatives to mitigate this significant, negative economic impact. Providing relief through this rule as soon as possible is likely to ensure that these crab can be harvested before the regulatory closure of the EBT and WBT crab fisheries, provide the associated harvesting and processing revenues, and provide benefits to communities engaged in these crab fisheries. This rule promotes the goals and objectives of the Program, the Crab FMP, and the Magnuson-Stevens Act by removing a restriction that is preventing the otherwise authorized harvesting and processing of fishery resources.

As explained earlier, the lack of sufficient processing capacity in the EBT and WBT crab fisheries was not foreseen prior to or at the start of the EBT and EBT crab fisheries and was only recently discovered. Harvesters with Class A IFQ in the EBT and WBT crab fisheries are not responsible for the decisions of processors to cease operations of processing facilities, and were not aware of the impact of any operational decisions on their ability to harvest and deliver their Class A IFQ. Class A IFQ holders are not able to mitigate fishing operations in a manner that avoids the use of IPQ. Therefore, Class A IFQ holders cannot undertake actions that will allow them to fully harvest their EBT and WBT Class A IFQ without being constrained by regulations that require that IPQ use caps not be exceeded.

Finally, if required to go through notice-and-comment rulemaking, Class A IFQ holders would not have sufficient time to harvest their Class A IFQ prior to the closure of the EBT and WBT crab fisheries on March 31, 2016. In addition to the notice-and-comment requirements under the Administrative Procedure Act, the Magnuson-Stevens Act FMP amendment process sets forth certain requirements that must be followed, such as a 60-day comment period on an FMP amendment. Because the EBT and WBT crab fisheries close by regulation on March 31, 2016, there is not enough time to follow the FMP amendment process prescribed by the Magnuson-Stevens Act and provide sufficient time for the harvest of EBT and WBT Class A IFQ. NMFS has no way other than this rule to amend IPQ use cap regulations to provide fishing opportunities for the EBT and WBT crab fisheries during the 2015/2016 crab fishing year that would otherwise be forgone. Amending IPQ use cap regulations in the EBT and WBT crab fisheries through this rule for the remainder of the 2015/2016 crab fishing year provides immediate economic benefits that outweigh the value of the deliberative notice-and-comment rulemaking process.

Similarly, for the reasons above that support the need to implement this rule in a timely manner, the Assistant Administrator for Fisheries finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness provision of the Administrative Procedure Act and make this rule effective immediately upon publication in the Federal Register. As stated above, this rule will allow for harvesting and processing of the remainder of the Class A IFQ in the EBT and WBT crab fisheries for the 2015/2016 crab fishing year, and will prevent economic losses from the inability to fully harvest and process Class A IFQ in the EBT and WBT crab fisheries.

This action is being taken pursuant to the emergency provision of the Magnuson-Stevens Act and is exempt from Office of Management and Budget review. The RIR prepared for this rule is available from NMFS (see ADDRESSES).

This rule is exempt from the procedures of the Regulatory Flexibility Act because this rule is not subject to the requirement to provide prior notice and opportunity for public comment pursuant to 5 U.S.C. 553 or any other law. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

For the reasons set out in the preamble, 50 CFR part 680 is amended as follows: